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Patients' decision‐making, experiences and preferences regarding Pixantrone treatment in relapsed aggressive B‐cell lymphoma: Research protocol for a longitudinal qualitative study

intravenously [IV], day 1), bendamustine (B, 70 mg/m2 IV, days 2 and 3), and cytarabine (500 mg/m2, IV on days 2 to 4) every 21 days, up to 6 cycles. T‐cell lymphomas did not receive R. All patients had received anthracycline containing induction therapy (CHOP or CHOP‐like), 5 (22%) had previous ASCT, and median number of previous treatment was 2 (range 1‐4). Median time from initial lymphoma diagnosis was 29 months (4‐120). Overall, 57% had relapsed disease, and 43% had refractory disease, with 17% of patients being refractory both to CHOP and DHAP/GDP. Response was assessed according to IWG 2007 criteria. Results: Patients received a median of 4 cycles of R‐BAC (2‐6). Overall, OR was 74%, and CR was 52%. Among different histologies, OR was 75% in DLBCL (CR 58%), 78% in t‐DLBCL (CR 56%), and 50% in T‐cell lymphoma (one partial remission, one stable disease). Refractory patients had an OR of 60% (CR 30%). The median overall survival and PFS were 15.4 (9‐19) and 10.2 (7‐14) months, respectively (Figure 1). Median duration of response was 14.7 months (4‐24). Treatment was well tolerated, with main toxicity being hematological, as expected. Treatment discontinuations before cycle 4 were due to toxicity/adverse events in 17%, progressive disease in 17%, and other reasons in 13%. Nine patients (39%) received cytarabine dose reduction (2 days instead of 3), due to advanced age or toxicity. Neither number of previous lines nor relapsed vs refractory disease were associated with significantly different PFS. Conclusions: R‐BAC had promising activity with an acceptable toxicity profile in this small explorative cohort of heavily pretreated R/R aggressive lymphomas. Our results suggest that R‐BAC should be further investigated in this setting.