Phase II study of dose-adjusted gemcitabine, dexamethasone, cisplatin, and rituximab in elderly relapsed diffuse large B-cell lymphoma patients.

High-dose chemotherapy and autologous stem cell transplantation (ASCT) are too toxic for elderly patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Therefore, effective and tolerable regimens for elderly patients are urgently needed. The present phase II study assessed the efficacy and safety of dose-adjusted therapy with gemcitabine, dexamethasone, cisplatin, and rituximab (GDP-R) in this population. ASCT-ineligible elderly patients with relapsed or refractory DLBCL received dose-adjusted GDP-R in each 28-day cycle for up to six cycles. The primary endpoint was overall response rate (ORR), and secondary endpoints were complete response (CR) rate, progression-free survival (PFS), and safety. Thirty-three patients were enrolled and received dose-adjusted GDP-R. The median age was 75 years (range: 68-87 years). The ORR was 82.8% (90% confidence interval [CI], 67.1-93.0%), with a CR rate of 58.6% (90% CI, 41.7-74.1%). At a median follow-up of 20.9 months, the 2-year PFS rate was 46.8% (90% CI, 30.7-61.5%) and the 2-year overall survival rate was 63.2% (90% CI, 45.8-76.3%). The most frequently observed grade 4 adverse events were neutropenia (63.6%), thrombocytopenia (57.6%), and lymphocytopenia (39.4%). Dose-adjusted GDP-R is a promising salvage regimen for ASCT-ineligible elderly patients with relapsed DLBCL after rituximab-containing chemotherapy and warrants further investigation.

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© 2020 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd.

Déclaration de conflit d'intérêts

KO is a consultant to SRL. HI received research funding from Chugai. NS received research funding from Ono, A2 Healthcare, Astellas, Janssen, Merck Sharp & Dohme, Otsuka, Pfizer, PPD SNBL, Sumitomo Dainippon Pharma, Daiichi Sankyo, and Bristol‐Myers Squibb. IY and SY received research funding from Kyowa Kirin and Chugai. KS received research funding from Novartis, GlaxoSmithKline, Janssen, Abbvie, Takeda, Sanofi, Bristol‐Myers Squibb, Ono, Merck Sharp & Dohme, Alexion, Daiichi Sankyo, and Celgene. OK received research funding from Kyowa Kirin, Chugai, Celgene, and Daiichi Sankyo. HN received research funding from Bayer Yakuhin, Takeda, Kyowa‐Kirin, Esai, Bristol‐Myers Squibb, Ono, Zenyaku Kogyo, Solasia, AstraZeneca, SymBio, IQVIA service Japan, Mundipharma, Chugai, and Janssen. HI received honoraria from Novartis, Celgne, Astellas, and Janssen. IY received honoraria from Celgene, Mundipharma, Bristol‐Myers Squibb, Shire Japan, Jansen, Mochida, Merck Sharp & Dohme, Takeda, and Taiho and grants and personal fees from Kyowa Kirin and Chugai. SY received honoraria from Bristol‐Meyers Squibb, Takeda, Eisai, Otsuka, and Celgene. KS received honoraria from Takeda, Bristol‐Myers Squibb, Ono, and Celgene. HN received honoraria from Ono, Celgene, Takeda, Esai, Bristol‐Myers Squibb, Chugai, Mundipharma, Sanofi, Janssen, Zenyaku Kogyo, Novartis, Merck Sharp & Dohme, and Chordia Therapeutics. AK received personal fees from Bayer Yakuhin as a member of the data monitoring committee. All other authors declare no conflict of interest.