A phase II study of weekly irinotecan and carboplatin for previously untreated extensive disease small cell lung cancer

Abstract

19078 Background: The prognosis for the patients with extensive disease small cell lung cancer (ED-SCLC) is still poor. We conducted a phase II study to evaluate the efficacy and safety of weekly irinotecan (CPT) and carboplatin (CBDCA) regimen for patients with ED-SCLC. Methods: Patients with previously untreated ED-SCLC, ECOG-PS 0–2, adequate organ function and willingness to provide informed consent were eligible. Patients with massive pleural effusion and symptomatic brain metastasis were excluded. CBDCA (AUC 2) and CPT (50 mg/m2) were administered on days 1 & 8 of every 3-week cycle. Treatment was continued until progression, up to a maximum of 6 cycles or unacceptable toxicity. The primary endpoint was response rate. Toxicity and efficacy analyses were performed on the intent-to-treat (ITT) population. Toxicity was graded by CTC version 2.0. Planned sample size was 55 patients. Results: Between Dec. 2003 and Sep. 2006, 56 patients were enrolled and 55 patients were eligible. Patients baseline characteristics are: 47 men and 7 women; PS0=14, PS1=38, PS2=3; median age 64 years. A total of 215 cycles were administered with an average of 3.9 cycles per patient. Of 55 ITT patients, 5 achieved CR, 36 PR, 4 SD and 4 PD, resulting in an ORR of 74.5%. Six patients could not be evaluated for response due to early withdrawal. Median survival is 14.1 months (CI 95%: 11.5–17.0) and 1 year survival rate is 58.15%. Median time to progression is 5.1 months (CI 95%: 4.6–6.8). The chief grade >2 toxicities included leukocytopenia 2 (0.9%), neutropenia 32(14.7%), appetite loss 10 (4.6%), nausea 7(3.2%), infection 5 (2%), fatigue 5(2%), diarrhea 2 (0.9%), One grade 5 infection was reported. Conclusions: Weekly CBDCA and CPT is well tolerated and has promising anti-cancer activity in ED-SCLC. No significant financial relationships to disclose.