Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 23, Issue 12, Pages 2831-2839Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2005.04.044
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Purpose To determine whether BMS-275291, a broad-spectrum matrix metalloproteinase inhibitor (MMPI), added to systemic chemotherapy improved survival in advanced non-small-cell lung cancer (NSCLC). In early phase studies, BMS-275291 was not associated with dose-limiting joint toxicity seen with other MMPIs. Patients and Methods Chemotherapy-naive patients with stage IIIB/IV NSCLC, performance status (PS) 0 to 2, and adequate organ function were eligible. All patients received paclitaxel 200 mg/m(2) plus carboplatin (area under the curve, 6 mg/mL-min) intravenously every 21 days for up to 8 cycles, and were randomly assigned to receive BMS-275291, 1,200 mg orally daily, or placebo until disease progression. The primary study end point was survival (OS); secondary end points included progression-free survival (PFS), response rates (RR), toxicity, and quality of life. Results From 2000 to 2002, 774 patients were randomly assigned. Pretreatment characteristics were well balanced between arms: median age, 61 years; male sex, 73 %; stage IV, 79 %; PS 0 to 1,88 %. Interim safety analysis revealed no survival advantage and increased toxicity in the experimental arm, and study treatment was stopped. Median CS, PFS and FIR in the final analysis in the BMS-275291 arm were 8.6 months, 4.9 months, and 25.8 % respectively, and in the control arm 9.2 months, 5.3 months, 33.7 %. Toxicity was significantly higher in the BMS-275291 arm, including flu-like symptoms, rash, hypersensitivity reactions (8.6 % v 2.4 %), and febrile neutropenia (9.7 % v 5.5 %). Conclusion BMS-275291 added to chemotherapy increases toxicity and does not improve survival in advanced NSCLC.
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