Cisplatin, etoposide, and paclitaxel with granulocyte colony-stimulating factor in untreated patients with extensive-stage small cell lung cancer: A phase II trial of the southwest oncology group

Purpose: This study was designed to determine the efficacy and toxicity of cisplatin, etoposide, and paclitaxel (PET) in patients with extensive-stage small cell lung cancer (ES-SCLC). Experimental Design: Chemo-naive adult patients with a performance status ( PS) of 0-2 and adequate organ function were eligible. Patients received cis platin 80 mg/m(2) Lv., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m(2) i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m(2) p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 mug/kg was injected s.c. on days 4-14. Results: Eighty-eight patients were assessable. The median age was 60 years ; 50% were male, 78% had PS of 0-1, 28% had PS of 2, 53% had multiple sites , and 13% had brain involvement. The overall response rate was 57% with 10 (12%) of 84 patients achieving a complete response. Median progression-free survival was 6 months [95% confidence interval (CI), 5-7 months] with a me dian survival of 11 months (95% CI, 8-13 months) and a I-year survival rate of 43% (95% CI, 33-54%). Six patients (7%) died from toxicity. Grade 5 tox icity occurred in 3 (14%) of 22 patients (with a PS of 2) versus 3 (5%) of 61 patients (with a PS of 0-1; P, not significant). Grade 4 neutropenia dev eloped in 40% of patients. Grade 3 nonhematological toxicities were primari ly nausea (20%), vomiting (16%), and fatigue (14%). Conclusion: The survival result achieved was superior to prior SWOG experie nces; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Inte rgroup trial comparing PET to cisplatin+etoposide in PS-0-1 patients with E S-SCLC.