Phase 3 Trial of 177 Lu-Dotatate for Midgut Neuroendocrine Tumors.

Autor: Strosberg J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., El-Haddad G; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Wolin E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Hendifar A; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Yao J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Chasen B; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Mittra E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Kunz PL; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Kulke MH; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Jacene H; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Bushnell D; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., O'Dorisio TM; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Baum RP; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Kulkarni HR; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Caplin M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Lebtahi R; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Hobday T; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Delpassand E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Van Cutsem E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Benson A; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Srirajaskanthan R; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Pavel M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Mora J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Berlin J; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Grande E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Reed N; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Seregni E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Öberg K; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Lopera Sierra M; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Santoro P; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Thevenet T; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Erion JL; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Ruszniewski P; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Kwekkeboom D; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.)., Krenning E; From the Moffitt Cancer Center, Tampa, FL (J.S., G.E.-H.); Markey Cancer Center, University of Kentucky, Lexington (E.W.); Cedars Sinai Medical Center, Los Angeles (A.H.), and Stanford University School of Medicine, Stanford (E.M., P.L.K.) - both in California; University of Texas M.D. Anderson Cancer Center (J.Y., B.C.) and Excel Diagnostics Imaging Clinic (E.D.), Houston; Dana-Farber Cancer Institute, Boston (M.H.K., H.J.); University of Iowa, Iowa City (D.B., T.M.O.); Zentralklinik, Bad Berka (R.P.B., H.R.K.), and Charité-Universitätsmedizin, Berlin (M.P.) - both in Germany; Royal Free Hospital (M.C.) and King's College Hospital NHS Foundation Trust (R.S.), London, and Beatson Oncology Centre, Glasgow (N.R.) - all in the United Kingdom; Hôpital Beaujon, Clichy (R.L., P.R.), and Advanced Accelerator Applications, St. Genis-Pouilly (T.T.) - both in France; Mayo Clinic College of Medicine, Rochester, MN (T.H.); University Hospitals and KU Leuven, Leuven, Belgium (E.V.C.); Robert H. Lurie Comprehensive Cancer Center, Chicago (A.B.); Hospital Universitari de Bellvitge, Barcelona (J.M.), and Hospital Universitario Ramón y Cajal, Madrid (E.G.) - both in Spain; Vanderbilt University Medical Center, Nashville (J.B.); Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan (E.S.); University Hospital, Uppsala University, Uppsala, Sweden (K.O.); Advanced Accelerator Applications USA, New York (M.L.S., P.S., J.L.E.); and Erasmus Medical Center, Rotterdam, the Netherlands (D.K., E.K.).
Jazyk: angličtina
Zdroj: The New England journal of medicine [N Engl J Med] 2017 Jan 12; Vol. 376 (2), pp. 125-135.
DOI: 10.1056/NEJMoa1607427
Abstrakt: Background: Patients with advanced midgut neuroendocrine tumors who have had disease progression during first-line somatostatin analogue therapy have limited therapeutic options. This randomized, controlled trial evaluated the efficacy and safety of lutetium-177 ( 177 Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors.
Methods: We randomly assigned 229 patients who had well-differentiated, metastatic midgut neuroendocrine tumors to receive either 177 Lu-Dotatate (116 patients) at a dose of 7.4 GBq every 8 weeks (four intravenous infusions, plus best supportive care including octreotide long-acting repeatable [LAR] administered intramuscularly at a dose of 30 mg) ( 177 Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here.
Results: At the data-cutoff date for the primary analysis, the estimated rate of progression-free survival at month 20 was 65.2% (95% confidence interval [CI], 50.0 to 76.8) in the 177 Lu-Dotatate group and 10.8% (95% CI, 3.5 to 23.0) in the control group. The response rate was 18% in the 177 Lu-Dotatate group versus 3% in the control group (P<0.001). In the planned interim analysis of overall survival, 14 deaths occurred in the 177 Lu-Dotatate group and 26 in the control group (P=0.004). Grade 3 or 4 neutropenia, thrombocytopenia, and lymphopenia occurred in 1%, 2%, and 9%, respectively, of patients in the 177 Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame.
Conclusions: Treatment with 177 Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR among patients with advanced midgut neuroendocrine tumors. Preliminary evidence of an overall survival benefit was seen in an interim analysis; confirmation will be required in the planned final analysis. Clinically significant myelosuppression occurred in less than 10% of patients in the 177 Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).
Databáze: MEDLINE