Platinum-etoposide chemotherapy in elderly patients with small-cell lung cancer: Results of a randomized multicenter phase II study assessing attenuated-dose or full-dose with lenograstim prophylaxis - A Forza Operativa Nazionale Italiana Carcinoma Polmonare and Gruppo Studio Tumori Polmonari Veneto (FONICAP-GSTPV) study

Purpose Small-cell lung cancer (SCLC) is increasingly diagnosed in elderly patients, who are at higher risk of treatment-related morbidity and mortality. We conducted a randomized two-stage phase II study to assess the therapeutic index of two different platinum/etoposide regimens, attenuated-dose (AD) and full-dose (FD) plus prophylactic lenograstim. Patients and Methods SCLC patients older than 70 years were randomized to receive four courses of cisplatin 25 mg/m(2) on days 1 and 2, and etoposide 60 mg/m(2) on days 1, 2, and 3 every 3 weeks (AD); or cisplatin 40 mg/m(2) on days 1 and 2, and etoposide 100 mg/m(2) on days 1 2 and 3 every,, 3 weeks, plus lenograstim 5 mg/kg days 5 through 12, every 3 weeks (FD). A combined primary end point named therapeutic success (TS), which took into account activity, toxicity, and compliance, was used. Results Ninety-five patients were enrolled. Seventy-five percent and 72% of the patients in the AD and FD arms, respectively, completed the treatment as per protocol. Response rate was 39% and 69% in the AD and FD arms, respectively, and 1-year survival probability was 18% and 39%, respectively. Treatment was well tolerated in both groups, with no grade 3 to 4 myelotoxicity in the AD arm, and 12% myelotoxicity in the FD arm. Overall, the observed TSs were 10 (36%) of 28 patients and 42 (63%) of 67 patients for AD and FD treatments respectively. Conclusion In elderly patients with SCLC a full-dose cisplatin/etoposide regimen combined with prophylactic lenograstim is active and feasible, while attenuated doses of the same regimen are associated with a poor therapeutic outcome. (C) 2005 by American Society of Clinical Oncology.