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.

Abstract

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/m(2) i.v., 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 microg/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.

• Authors: K Kelly, L Lovato, P A Bunn Jr, R B Livingston, J Zangmeister, S A Taylor, D Roychowdhury, J J Crowley, D R Gandara, Southwest Oncology Group
• Journal: Clinical cancer research : an official journal of the American Association for Cancer Research (Clin Cancer Res) Vol. 7 Issue 8 Pg. 2325-9 (Aug 2001) ISSN: 1078-0432 [Print] United States
• PMID: 11489808 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Granulocyte Colony-Stimulating Factor
• Etoposide
• Paclitaxel
• Cisplatin

Topics

• Adult
• Aged
• Anemia (chemically induced)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Small Cell (drug therapy, pathology)
• Cisplatin (administration & dosage, adverse effects)
• Etoposide (administration & dosage, adverse effects)
• Fatigue (chemically induced)
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects)
• Humans
• Lung Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Nausea (chemically induced)
• Neutropenia (chemically induced)
• Paclitaxel (administration & dosage, adverse effects)
• Survival Analysis
• Thrombocytopenia (chemically induced)
• Treatment Outcome
• Vomiting (chemically induced)