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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^{1 ,,2}

University of Colorado, Denver, Colorado 80262 [K. K., P. A. B.]; Southwest Oncology Group Statistical Center, Seattle, Washington 98109 [L. L., J. J. C.]; University of Washington, Seattle, Washington 98195 [R. B. L.]; Columbus Community Clinical Oncology Program, Columbus, Ohio 43213 [J. Z.]; University of Kansas Medical Center, Kansas City, Missouri 66216 [S. A. T.]; University of Cincinnati Medical Center, Cincinnati, Ohio 45219 [D. R.]; and University of California, Davis, Sacramento, California 95817 [D. R. G.]

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 cisplatin 80 mg/m² i.v., etoposide 80 mg/m-2 i.v., and paclitaxel 175 mg/m² i.v. over a 3-h period on day 1 followed by etoposide 160 mg/m² p.o. on days 2 and 3 every 21 days for six cycles. G-CSF 5 µg/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 median survival of 11 months (95% CI, 8–13 months) and a 1-year survival rate of 43% (95% CI, 33–54%). Six patients (7%) died from toxicity. Grade 5 toxicity 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 developed in 40% of patients. Grade 3 nonhematological toxicities were primarily nausea (20%), vomiting (16%), and fatigue (14%).

Conclusion: The survival result achieved was superior to prior SWOG experiences; however, the toxic death rate was unacceptably high in PS-2 patients. These results provide the largest database for the ongoing randomized Intergroup trial comparing PET to cisplatin+etoposide in PS-0–1 patients with ES-SCLC.

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