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Phase II Study of Consolidation Paclitaxel After Concurrent Chemoradiation in Poor-Risk Stage III Non–Small-Cell Lung Cancer: SWOG S9712

Angela M. Davies, Kari Chansky, Derick H.M. Lau, Bryan R. Leigh, Laurie E. Gaspar, Geoffrey R. Weiss, Antoinette J. Wozniak, John J. Crowley, David R. Gandara

From the University of California, Davis, Sacramento, CA; Southwest Oncology Group Statistical Center, Seattle, WA; University of Colorado Health Science Center, Denver, CO; University of Texas Health Science Center, San Antonio, San Antonio, TX; and Karmanos Cancer Institute, Wayne State University, Detroit, MI

Address reprint requests to Southwest Oncology Group (S9712), Operations Office, 14980 Omicron Dr, San Antonio, Texas 78245-3217; e-mail: angela.davies{at}ucdmc.ucdavis.edu

Purpose A previous Southwest Oncology Group (SWOG) study (S9429) demonstrated efficacy and tolerability of concurrent chemoradiotherapy in poor-risk stage III non–small-cell lung cancer (NSCLC). This study evaluated adding consolidation paclitaxel after chemoradiotherapy for a similar patient cohort.

Patients and Methods Patients with histologically/cytologically determined stage III NSCLC were eligible based on performance status (PS) 2 and either low albumin or weight loss more than 10%, poor pulmonary function, or comorbidities precluding cisplatin use. Treatment was carboplatin 200 mg/m² days 1, 3, 29, and 31, and etoposide 50 mg/m² days 1 through 4, and 29 to 32. Beginning day 1, thoracic radiation was delivered at 1.8 Gy in 25 fractions plus 16-Gy boost (total dose, 61 Gy). Patients without disease progression received paclitaxel 175 mg/m² every 21days for three cycles.

Results Characteristics of 87 eligible patients were age 51 to 82 years; 57% PS 0 to 1, 43% PS 2; and 51% stage IIIA, 49% stage IIIB. Toxicities of concurrent chemoradiotherapy included grade 3 esophagitis (7%) and grade 3/4 neutropenia (43%). Fifty-four assessable patients received paclitaxel consolidation. Four treatment-related deaths occurred during chemoradiotherapy and four occurred during consolidation. Overall response rate was 53%. Median progression free- and overall survival were 6.1 and 10.2 months, respectively. One- and 2-year survival rates were 43% and 25%.

Conclusion Compared with a previous SWOG trial in a similar patient population, the addition of consolidation paclitaxel after chemoradiotherapy resulted in increased toxicity without a survival advantage. More PS 2 patients (43% v 18%) enrolled onto S9712, which may explain increased toxicity and lack of benefit. The optimal chemoradiotherapy approach for poor-risk patients remains to be defined.

Supported in part by the following Public Health Service Cooperative Agreement grants awarded by the National Cancer Institute, Department of Health and Human Services: Grants No. CA38926, CA32102, CA46441, CA37981, CA22433, CA14028, CA35261, CA04919, CA46282, CA58658, CA52654, CA35128, CA35192, CA35431, CA45461, CA76448, CA45807, CA35176, CA12644, CA46136, CA27057, CA16385, CA67575, CA35996, CA58415, CA35119, CA20319, CA76447, CA68183, CA35178, CA67663, CA63844, CA58723, CA35281, CA45560, CA74647, and CA42777.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, 2002, Orlando, FL.

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

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