Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial

Autor: Judith Trotman, Sally F Barrington, David Belada, Michel Meignan, Robert MacEwan, Carolyn Owen, Václav Ptáčník, András Rosta, Günter R Fingerle-Rowson, Jiawen Zhu, Tina Nielsen, Deniz Sahin, Wolfgang Hiddemann, Robert E Marcus, Andrew Davies, Mark Hertzberg, Andrew Grigg, Paul Cannell, Hang Quach, Stephen Opat, Constantine Tam, Paula Marlton, Ann Janssens, Fritz Offner, Koen Van eygen, Randeep Sangha, Pam Mckay, Jonathan Wilson, Richard Van Der Jagt, Daryl Roitman, Marek Trneny, Jiri Mayer, Katell Le Du, Philippe Solal-Celigny, Guillaume Cartron, Charles Foussard, Norbert Frickhofen, Peter Schmidt, Ullrich Graeven, Tobias Gaska, Rudolf Schlag, Martin Sökler, Gabriele Prange-Krex, Axel Florschütz, Hans-Walter Lindemann, Christoph Schimmelpfennig, Solveig Tonndorf, Mathias Hänel, Georg Hess, Enrico Schalk, Heiko Hütten, Gottfried Doelken, Michael Pfreundschuh, Ulrich Keller, Michael Herold, Roswitha Forstpointner, Ursula Vehling-Kaiser, Martin Hoffmann, Zita Borbenyi, Miklos Udvardy, Judit Demeter, Alessandro Rambaldi, Enrica Morra, Federico Massimo, Ignazio Majolino, Monica Balzarotti, Gianpietro Semenzato, Miguel Angel Canales Albendea, Francisco Javier Peñalver Parraga, Alfonso Soler Campos, Juan Manuel Sancho Cia, Jose Antonio Marquez Navarro, Carlos Grande Garcia, Herman Nilsson-Ehle, Helen Mccarthy, Chris Pocock, Shalal Sadullah, Ram Malladi, John Radford, Ed Kanfer, Anton Kruger, Dominic Culligan, Martin Dyer, Ruth Pettengell, John Seymour, John Gribben, Saad Al-Ismail, Faris Al-Refaie, Norbert Blesing, Christopher Macnamara, Ann O'callaghan, Andrew Haynes, George Follows, Roderick Johnson, David Cunningham, Kristian Bowles, Graham Collins, Eve Gallop-Evans, Stephen Robinson, Chezhian Subash, James Bailey, Viran Holden, Jeffrey Neidhart, Moacyr De Oliveira, Haluk Tezcan, Kevin Kim, Suman Kambhampati, Keith Lanier, John Mcclean, Kensei Tobinai, Kiyohiko Hatake, Michinori Ogura, Toshiki Uchida, Kiyoshi Ando, Tomohiro Kinoshita, Thomas Höhler, Heribert Stauder, Andreas Kirsch, Michael Koenigsmann, Stephan Kremers, Thomas Illmer, Mathias Witzens-Harig, Paul La Roseé, Jan Dürig, Michael Kneba, Manfred Hensel, Stefan Fuxius, Lothar Bergmann, Kai Hübel, Christian Buske, Reinhard Marks, Gerald Wulf, Christian Lerchenmueller, Rudolf Schmits, Mark Reinwald, Eva Lengfelder, Fiona Scott, Takaaki Chou, Masafumi Taniwaki, Isao Yoshida, Kenichi Ishizawa, Naokuni Uike, Nobuhiko Uoshima, Yuri Kamitsuji, Shinsuke Iida, Ken Ohmine, Kisato Nosaka, Kazuhiko Ide, Takayuki Ishikawa, Pierre Desjardins, Nicholas Finn, Jun Zhu, Wei Li, Li Yu, Hanyun Ren, Yuan Kai Shi, Gang Wu, Xiaonan Hong, Qingyuan Zhang, Jifeng Feng, Rong Zhan, Tongyu Lin, Sirpa Leppa, Regis Costello, Adrian Tempescul, Laurence Sanhes, Olivier Tournilhac, Heinz Kirchen, Holger Hebart, Rudolf Weide, Kathleen Jentsch-Ullrich, Irit Avivi, Arnon Nagler, Ronit Gurion, Ofer Shpilberg, Pietro Leoni, Luca Baldini, Olga Samoylova, Alexandr Myasnikov, Tran-Der Tan, Hung Chang, Kyoya Kumagai, Norifumi Tsukamoto, Kunihiro Tsukasaki, Patrick Beatty, Noriko Usui, Koji Izutsu, Tohru Murayama, Tatsuo Ichinohe, Kohmei Kubo, Fumihiro Ishida, J. Thaddeus Beck, Frank Griesinger, Dzhelil Osmanov, Shaker Dakhil, Aline Clavert, Dai Maruyama, Yasuhito Terui, Kazuhito Yamamoto, Ekkehard Eigendorff, Tsutomu Kobayashi, Satoshi Ichikawa, Ilseung Choi, Katsuya Wada, Yoshitaka Kikukawa, Masao Matsuoka, Takayuki Yoshino, Yosuke Minami
Přispěvatelé: Dürig, Jan (Beitragende*r), The University of Sydney, Service de médecine nucléaire [Créteil], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Prince of Wales Medical Research Institute, University of New South Wales [Sydney] (UNSW), University of Melbourne, Universiteit Gent = Ghent University [Belgium] (UGENT), Service d'hématologie et oncologie médicale, Hôpital Lapeyronie-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Semmelweis University of Medicine [Budapest], Queens Elizabeth Hospital [Birmingham], Queen Mary University of London (QMUL), IBM Thomas J. Watson Research Center, IBM, Department of Computing and Information Systems, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie-Université de Montpellier (UM)
Rok vydání: 2018
Předmět:
Male
Time Factors
[SDV]Life Sciences [q-bio]
Follicular lymphoma
Medizin
chemistry.chemical_compound
0302 clinical medicine
Antineoplastic Agents
Immunological
Obinutuzumab
Antineoplastic Combined Chemotherapy Protocols
Clinical endpoint
Prospective Studies
Lymphoma
Follicular
Randomized Controlled Trials as Topic
education.field_of_study
Manchester Cancer Research Centre
Hazard ratio
Middle Aged
Progression-Free Survival
3. Good health
Oncology
030220 oncology & carcinogenesis
Female
Immunotherapy
Rituximab
medicine.drug
Bendamustine
medicine.medical_specialty
Population
Antibodies
Monoclonal
Humanized
03 medical and health sciences
Predictive Value of Tests
Internal medicine
medicine
Humans
Progression-free survival
education
Aged
Neoplasm Staging
Retrospective Studies
business.industry
ResearchInstitutes_Networks_Beacons/mcrc
medicine.disease
chemistry
Clinical Trials
Phase III as Topic
Positron-Emission Tomography
business
Tomography
X-Ray Computed
Progressive disease
030215 immunology
Zdroj: Lancet Oncology
Lancet Oncology, Elsevier, 2018, 19 (11), pp.1530--1542. ⟨10.1016/S1470-2045(18)30618-1⟩
Trotman, J, Barrington, S F, Belada, D, Meignan, M, MacEwan, R, Owen, C, Ptáčník, V, Rosta, A, Fingerle-Rowson, G R, Zhu, J, Nielsen, T, Sahin, D, Hiddemann, W, Marcus, R E, Davies, A 2018, ' Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM) : secondary analysis of a randomised, phase 3 trial ', The Lancet Oncology, vol. 19, no. 11, pp. 1530-1542 . https://doi.org/10.1016/S1470-2045(18)30618-1
PET investigators from the GALLIUM study 2018, ' Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM) : secondary analysis of a randomised, phase 3 trial ', The Lancet Oncology, vol. 19, no. 11, pp. 1530-1542 . https://doi.org/10.1016/S1470-2045(18)30618-1
ISSN: 1474-5488
1470-2045
Popis: BACKGROUND: Initial results from the ongoing GALLIUM trial have shown that patients with follicular lymphoma have a longer progression-free survival after first-line immunochemotherapy with obinutuzumab than with rituximab. The aim of this secondary analysis was to evaluate the prognostic value of PET-CT responses after first-line immunochemotherapy in the GALLIUM study.METHODS: GALLIUM is an open-label, parallel-group randomised, phase 3 trial, which recruited previously untreated patients with CD20-positive follicular lymphoma (grades 1-3a; disease stage III/IV, or stage II with largest tumour diameter ≥7 cm) who were aged 18 years or older and met the criteria for needing treatment. Eligible patients were randomly assigned in a 1:1 ratio to receive intravenous administration of obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1, then day 1 of subsequent cycles) or rituximab (375 mg/m2 on day 1 of each cycle), in six 21-day cycles with cyclophosphamide, doxorubicin, vincristine, and prednisone (known as CHOP; oral administration) followed by two 21-day cycles of antibody alone, or eight 21-day cycles cyclophosphamide, vincristine, and prednisone (known as CVP; oral administration), or six 28-day cycles with bendamustine, followed by maintenance antibody every 2 months for up to 2 years. The primary endpoint of the trial, investigator-assessed progression-free survival, has been reported previously. This secondary analysis reports PET and CT-based responses at end-of-induction therapy and explains their relation with progression-free and overall survival outcomes in patients with available scans. As per protocol, during the trial, PET scans (mandatory in the first 170 patients enrolled at sites with available PET facilities, and optional thereafter), acquired at baseline and end of induction (PET population), were assessed prospectively by investigators and an independent review committee (IRC) applying International Harmonisation Project (IHP) 2007 response criteria, and retrospectively by the IRC only applying current Lugano 2014 response criteria. IRC members (but not study investigators) were masked to treatment and clinical outcome when assessing response. The landmark analyses excluded patients who died or progressed (contrast enhanced CT-based assessment of progressive disease, or started next anti-lymphoma treatment) before or at end of induction. GALLIUM is registered at ClinicalTrials.gov, number NCT01332968.FINDINGS: 1202 patients were enrolled in GALLIUM between July 6, 2011, and Feb 4, 2014, of whom 595 were included in the PET population; 533 (IHP 2007; prospective analysis), and 508 (Lugano 2014; retrospective analysis) were analysed for progression-free survival (landmark analysis). At end of induction, 390 of 595 patients (65·5% [95% CI 61·6-69·4]) achieved PET complete response according to IHP 2007 criteria, and 450 (75·6% [95% CI 72·0-79·0]) obtained PET complete metabolic response according to Lugano 2014 criteria. With a median of 43·3 months of observation (IQR 36·2-51·8), 2·5-year progression-free survival from end of induction was 87·8% (95% CI 83·9-90·8) in PET complete responders and 72·0% (63·1-79·0) in non-complete responders according to IRC-assessed IHP 2007 criteria (hazard ratio [HR] 0·4, 95% CI 0·3-0·6, pINTERPRETATION: Our results suggest that PET is a better imaging modality than contrast-enhanced CT for response assessment after first-line immunochemotherapy in patients with follicular lymphoma. PET assessment according to Lugano 2014 response criteria provides a platform for investigation of response-adapted therapeutic approaches. Additional supportive data are welcomed.FUNDING: F Hoffmann-La Roche.
Databáze: OpenAIRE
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