Canadian cancer trials group LY.17: A randomized phase II study evaluating novel salvage therapy pre-autologous stem cell transplant in relapsed/refractory diffuse large B-cell lymphoma-outcome of rituximab-dose-intensive cyclophosphamide, etoposide, cisplatin (R-DICEP) versus R-GDP.

Autor: Stewart DA; Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada., Kuruvilla J; University Health Network, Princess Margaret Cancer Center, Toronto, Ontario, Canada., Lee D; Queens University, Kingston, Ontario, Canada., Dudebout JJ; Queens University, Kingston, Ontario, Canada., Chua N; Cross Cancer Institute, University of Alberta, Edmonton, Alberta, Canada., Larouche JF; Hôpital Enfant-Jésus, Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada., Baetz T; Queens University, Kingston, Ontario, Canada., Shafey M; Tom Baker Cancer Centre, University of Calgary, Calgary, Alberta, Canada., Abdel-Samad N; The Moncton Hospital, Moncton, New Brunswick, Canada., Robinson S; Queen Elizabeth II Health Science Center, Halifax, Nova Scotia, Canada., Fleury I; Maisonneuve-Rosemont Hospital, Institute of Hematology, Oncology and Cell Therapy, Montreal University, Montreal, Quebec, Canada., Fraser G; Juravinski Cancer Centre, McMaster University, Ontario, Hamilton, Canada., Skrabek P; Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada., Kukreti V; University Health Network, Princess Margaret Cancer Center, Toronto, Ontario, Canada., Kelly J; Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada., Hay AE; Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada., Shepherd LE; Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada., Chen BE; Canadian Cancer Trials Group, Queen's University, Kingston, Ontario, Canada., Crump M; University Health Network, Princess Margaret Cancer Center, Toronto, Ontario, Canada.
Jazyk: angličtina
Zdroj: British journal of haematology [Br J Haematol] 2024 Sep; Vol. 205 (3), pp. 881-890. Date of Electronic Publication: 2024 May 27.
DOI: 10.1111/bjh.19555
Abstrakt: The Canadian Cancer Trials Group (CCTG) LY.17 is an ongoing multi-arm randomized phase II trial evaluating novel salvage therapies compared with R-GDP (rituximab, gemcitabine, dexamethasone and cisplatin) in autologous stem cell transplantation (ASCT)-eligible patients with relapsed/refractory diffuse large B-cell lymphoma (RR-DLBCL). This component of the LY.17 trial evaluated a dose-intensive chemotherapy approach using a single cycle of inpatient R-DICEP (rituximab, dose-intensive cyclophosphamide, etoposide and cisplatin) to achieve both lymphoma response and stem cell mobilization, shortening time to ASCT. This report is the result of the protocol-specified second interim analysis of the 67 patients who were randomized to either 1 cycle of R-DICEP or to 3 cycles of R-GDP. The overall response rate (ORR) was 65.6% for R-DICEP and 48.6% for R-GDP. The ASCT rate was 71.9% versus 54.3%, and 1-year progression-free survival rate was 42% versus 32%, respectively, for R-DICEP versus R-GDP. Although the improvement in ORR for R-DICEP versus R-GDP exceeded the pre-specified 10% threshold to proceed to full accrual of 64 patients/arm, higher rates of grade 3-5 toxicities, and the need for hospitalization led to the decision to stop this arm of the study. CCTG LY.17 will continue to evaluate different salvage regimens that incorporate novel agents.
(© 2024 The Author(s). British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
Databáze: MEDLINE
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