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Efficacy and safety of bosutinib (BOS) for Philadelphia chromosome–positive (Ph+) leukemia in older versus younger patients (pts).
J Clin Oncol 30, 2012 (suppl; abstr 6511)
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: BOS is an oral dual Src/Abl kinase inhibitor with potent activity in Ph+ leukemia. Methods: Efficacy and safety of BOS 500 mg/d was evaluated in older (≥65 y; n = 119) and younger (<65 y; n = 451) pts in 3 cohorts: chronic phase chronic myeloid leukemia (CP CML) after imatinib (IM; CP2L cohort; n = 287); CP CML after IM + dasatinib (DAS) and/or nilotinib (NIL; CP3L cohort; n = 119); and accelerated/blast phase (AP/BP) CML or acute lymphoblastic leukemia after IM ± DAS and/or NIL (ADV cohort; n = 164). Results: Baseline events (≥65 y vs <65 y) included respiratory disorders (35% vs 13%), cardiac disorders (29% vs 9%), and diabetes (4% vs 4%). Median baseline medications were 3 (≥65 y) and 5 (<65 y). Median BOS duration was 11 mo and median follow-up was 31 mo for all pts. 80% of ³65 y and 67% of <65 y pts discontinued BOS, including 32% and 18% due to an adverse event (AE; most commonly thrombocytopenia [6% vs 3%]). Rates of response were similar or lower in older versus younger pts (Table). On-treatment transformation to AP/BP CML was similar between groups. Incidences of nonhematologic treatment-emergent AEs were generally similar between older and younger pts, notably (all grades/grade ≥3 for ≥65 y vs <65 y): diarrhea (85%/9% vs 81%/8%), infection (56%/15% vs 49%/10%), and edema (8%/0% vs 4%/<1%). Common grade ≥3 lab abnormalities (≥65 y vs <65 y) were thrombocytopenia (35% vs 35%), neutropenia (21% vs 25%), and anemia (19% vs 19%). Conclusions: BOS demonstrated similar efficacy and acceptable safety in both older and younger pts across Ph+ leukemia cohorts.
|≥65 y||<65 y||≥65 y||<65 y||≥65 y||<65 y|
|2-y probability of maintaining CHRb||67%||75%||65%||69%||75%||54%|
|2-y probability of maintaining MCyRb||73%||74%||83%||56%||20%||31%|
|Transformation to AP/BP||3%||5%||4%||4%||4%||3%|
|2-y probability of survivalb||87%||92%||80%||85%||43%||46%|
Abbreviations: MHR, major hematologic response; CHR, complete hematologic response; MCyR, major cytogenetic response; CCyR, complete cytogenetic response.
aEvaluable pts had received ≥1 dose of BOS and a valid baseline assessment.
Abstracts by Tim H. Brummendorf:
Evolution of bosutinib (BOS) toxicity in patients (pts) with Ph+ leukemia after resistance/intolerance to prior therapy.
Cilengitide with cetuximab, cisplatin, and 5-FU in recurrent and/or metastatic squamous cell cancer of the head and neck: The ADVANTAGE phase II trial.
Clinical and sociodemographic data of cancer patients seeking out-patient based psycho-oncological psychotherapy.
Presentations by Tim H. Brummendorf:
Efficacy and safety of bosutinib (BOS) for Philadelphia chromosome–positive (Ph+) leukemia in older versus younger patients (pts).Session: Leukemia, Myelodysplasia, and Transplantation (Poster Discussion Session)
Bosutinib (BOS) as third-line therapy for chronic phase (CP) chronic myeloid leukemia (CML) following failure with imatinib (IM) and dasatinib (DAS) or nilotinib (NIL).Session: Leukemia, Myelodysplasia, and Transplantation (General Poster Session)