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Randomized Phase II Trial of Induction Chemotherapy Followed by Concurrent Chemotherapy and Dose-Escalated Thoracic Conformal Radiotherapy (74 Gy) in Stage III Non–Small-Cell Lung Cancer: CALGB 30105

Mark A. Socinski, A. William Blackstock, Jeffrey A. Bogart, Xiaofei Wang, Michael Munley, Julian Rosenman, Lin Gu, Gregory A. Masters, Peter Ungaro, Arthur Sleeper, Mark Green, Antonius A. Miller, Everett E. Vokes

From the Lineberger Comprehensive Cancer Center, University of North Carolina-Chapel Hill, Chapel Hill; Wake Forest University School of Medicine, Winston-Salem; Cancer and Leukemia Group B Statistical Center, Duke University Medical Center, Durham; Southeast Cancer Control Consortium Inc Community Clinical Oncology Program, Goldsboro, NC; State University of New York Upstate Medical University, Syracuse, NY; Helen F. Graham Cancer Center and Christiana Care CCOP, Wilmington, DE; and the University of Chicago, Chicago, IL

Corresponding author: Mark A. Socinski, MD, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, University of North Carolina, CB# 7305, Chapel Hill, NC 27599; e-mail: socinski{at}med.unc.edu

Purpose To evaluate 74 Gy thoracic radiation therapy (TRT) with induction and concurrent chemotherapy in stage IIIA/B non–small-cell lung cancer (NSCLC).

Patients and Methods Patients with stage IIIA/B NSCLC were randomly assigned to induction chemotherapy with either carboplatin (area under the curve [AUC], 6; days 1 and 22) with paclitaxel (225 mg/m²; days 1 and 22; arm A) or carboplatin (AUC, 5; days 1 and 22) with gemcitabine (1,000 mg/m²; days 1, 8, 22, and 29; arm B). On day 43, arm A received weekly carboplatin (AUC, 2) and paclitaxel (45 mg/m²) while arm B received biweekly gemcitabine (35 mg/m²) both delivered concurrently with 74 Gy of TRT utilizing three-dimensional treatment planning. The primary end point was survival at 18 months.

Results Forty-three and 26 patients were accrued to arms A and B, respectively. Arm B was closed prematurely due to a high rate of grade 4 to 5 pulmonary toxicity. The overall response rate was 66.6% (95% CI, 50.5% to 80.4%) and 69.2% (95% CI, 48.2% to 85.7%) on arm A and B, respectively. The median survival time (MST) and 1-year survival rate was 24.3 months (95% CI, 12.3 to 36.4) and 66.7% (95% CI, 50.3 to 78.7) and 12.5 months (95% CI, 9.4 to 27.6) and 50.0% (95% CI, 29.9 to 67.2) for arms A and B, respectively. The primary toxicities included esophagitis, pulmonary, and fatigue.

Conclusion Arm A reached the primary end point with an estimated MST longer than 18 months and will be compared with a standard dose of TRT in a planned randomized phase III trial in the United States cooperative groups.

Supported by Grants No. CA47559, CA03927, CA21060, CA33601, CA45418, CA45808, and CA41287; by grant no. CA31946 from the National Cancer Institute to the Cancer and Leukemia Group B (Richard L. Schilsky, MD) and by grant no. CA33601 to the Cancer and Leukemia Group B Statistical Center (Stephen George, PhD).

The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.

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

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