期刊
ANNALS OF ONCOLOGY
卷 21, 期 11, 页码 2246-2254出版社
OXFORD UNIV PRESS
DOI: 10.1093/annonc/mdq211
关键词
classical Hodgkin's lymphoma; Fc gamma RIIIa polymorphism; gemcitabine; pneumonitis; SGN-30
类别
资金
- National Cancer Institute [CA31946, CA33601, K23 CA109004-01A1]
Background: Based on in vitro synergistic cytotoxicity when anti-CD30 antibodies are combined with gemcitabine, the Cancer and Leukemia Group B conducted a double-blind, randomized, phase II trial of SGN-30 with gemcitabine, vinorelbine, and pegylated liposomal doxorubicin (GVD) in patients with relapsed Hodgkin's lymphoma. Patients and methods: In part 1 of the trial, 16 patients received SGN-30 with GVD to assess the safety of the combination. In part 2, patients were randomly allocated to SGN-30 (n = 7) or placebo (n = 7) with GVD to determine overall response rate (ORR). Results: ORR in all 30 patients was 63% (65% with SGN-30 plus GVD, n = 23, and 57% with placebo plus GVD, n = 7). Median event-free survival was 9.0 months, with no difference between the two arms. Grades 3-5 pneumonitis occurred in five patients receiving SGN-30 and GVD, leading to premature closure of the trial. All five patients with pulmonary toxicity had a V/F polymorphism in the Fc gamma RIIIa gene (P = 0.008). Conclusions: Together with historical data demonstrating a 2% incidence of pulmonary events with GVD, these results indicate that SGN-30 cannot safely be administered concurrently. The risk of pneumonitis with SGN-30 and GVD is greatest in patients with an Fc gamma RIIIa V/F polymorphism.
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