Abstract
7325 Background: Non-platinum regimen may improve efficacy with less toxicity than platinum-based combination. Synergistic effects between gemcitabine and irinotecan have been reported in preclinical studies. We designed a phase II trial to evaluate the efficacy and toxicity of CPT-11 plus Gemcitabine administered every 2 weeks in pts with either refractory or relapsed NSCLC. Methods: Patients with refractory or relapsed NSCLC who had experienced treatment failure with one or two prior chemotherapy regimen were considered eligible. Patients were required to have Eastern Cooperation Oncology Group (ECOG) performance status (PS) of 0 to 2 and adequate organ function; signed informed consent was also required. CPT-11 150 mg/m2 followed by GEM 1000mg/m2, both on days 1+15, recycled every 28 days. Results: Between November 2001 and February 2002, 30 patients were enrolled on this phase II trial. Twenty-seven of these patients were accessible for response, survival, and toxicity. The median age was 60.9 years (range: 37–74), and median ECOG PS was 1. Gender= 17 males/10 females, histologies; adenocarcinoma: 16, squamous: 7, others: 4. Eighteen patients had prior taxane+platinum-based treatment. Grade 3 hematologic toxicities included luecopenia (11.1%), anemia (14.8%), and thrombocytopenia (7.4%). Grade 3 nonhematologic toxicities were diarrhea (3.7%), liver injury (3.7%), dyspnea (3.7%), and nausea (3.7%). Grade 4 hematologic and non-hematologic toxicities were never encountered. Objective responses in this phase II were; PR: 5/27 (18.5%), SD: 9/27 (33.3%) and PD: 13/27 (48.1%). The median survival 7.5 months. 1-year survival was 34.9%. Conclusions: Bi-weekly GEM+CPT-11 was active and well tolerated, with an acceptable response rate and reasonable median survival time, in patients with refractory or relapsed non-small cell lung cancer. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration AstraZeneca
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