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Randomized Phase III Intergroup Trial of Etoposide and Cisplatin With or Without Paclitaxel and Granulocyte Colony-Stimulating Factor in Patients With Extensive-Stage Small-Cell Lung Cancer: Cancer and Leukemia Group B Trial 9732

From the University of Tennessee-Memphis, Memphis; Vanderbilt University, Nashville, TN; Duke University, Durham; Wake Forest University School of Medicine, Winston-Salem, NC; University of Colorado Cancer Center, Denver, CO; Mayo Clinic, Rochester, MN; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; University of Chicago, Chicago, IL; The Ohio State University Medical Center, Columbus, OH; University of California at San Diego, San Diego, CA; and Medical University of South Carolina, Charleston, SC

Address reprint requests to Harvey B. Niell, MD, 4170 Walnut Grove Rd, Memphis, TN 31187; e-mail: hniell{at}utmem.edu

PURPOSE: To determine, in a randomized comparison, whether the addition of paclitaxel to etoposide and cisplatin improves the time to progression and overall survival in patients with extensive small-cell lung cancer (SCLC) compared with standard etoposide and cisplatin and to compare the regimens' toxicity.

PATIENTS AND METHODS: Eligible patients (N = 587) with untreated extensive SCLC were randomly assigned to receive either cisplatin 80 mg/m² on day 1 and etoposide 80 mg/m² on days 1 through 3 administered every 3 weeks for six cycles (EP) or cisplatin 80 mg/m² on day 1, paclitaxel 175 mg/m² over 4 hours on day 1, and etoposide 80 mg/m² on days 1 to 3 followed by recombinant human granulocyte colony-stimulating factor on days 4 to 18 administered every 3 weeks for six cycles (PET).

RESULTS: Reporting of demographics, response, and survival included 565 patients, of whom 282 were randomly assigned to receive EP and 283 were assigned to receive PET. Overall response rates were 68% for the EP arm and 75% for the PET arm. Median failure-free survival time was 5.9 months for the EP arm and 6 months for the PET arm (P = .179). Median overall survival time was 9.9 months for patients on EP and 10.6 months for patients on PET (P = .169). Toxic deaths occurred in 2.4% of the patients on EP and 6.5% of patients on PET.

CONCLUSION: PET did not improve the time to progression or survival in patients with extensive SCLC compared with EP alone and was associated with unacceptable toxicity.

Supported by Bristol-Myers Pharmaceutical Corp through a CRADA agreement with the National Cancer Institute (Bethesda, MD). Also supported by grant Nos. CA47555, CA47577, CA03927, CA49957, CA21115, CA SWOG, CA25224, CA12046, CA41287, CA77658, CA11789, and CA03927.

Presented at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, Florida, May 18-21, 2002 and at the 10th World Congress on Lung Cancer, Vancouver, British Columbia, Canada, August 10-14, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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