Originally published as JCO Early Release 10.1200/JCO.2005.55.405 on August 8 2005

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Combined Chemoradiotherapy Regimens of Paclitaxel and Carboplatin for Locally Advanced Non–Small-Cell Lung Cancer: A Randomized Phase II Locally Advanced Multi-Modality Protocol

From the University of Pittsburgh Cancer Institute, Pittsburgh, PA; The University of Texas Southwestern Medical Center, Dallas, TX; Rush Medical College, Rush University Medical Center, Chicago, IL; American College of Radiology, Reston, VA; Highlands Oncology Center, Fayetteville, AR; Dayton Community Clinical Oncology Program, Dayton, OH; Thomas Jefferson University, Philadelphia, PA

Address reprint requests to Chandra P. Belani, MD, Professor of Medicine, University of Pittsburgh School of Medicine, Co-Director, Lung and Thoracic Malignancies Program, University of Pittsburgh Cancer Institute, UPMC Cancer Pavilion, 5150 Centre Ave, 5th Floor, Pittsburgh, PA 15232; e-mail: belanicp{at}upmc.edu

PURPOSE: This phase II noncomparative randomized trial was conducted to determine the optimal sequencing and integration of paclitaxel/carboplatin with standard daily thoracic radiation therapy (TRT), in patients with locally advanced unresected stage III non–small-cell lung cancer (NSCLC). Survival data were compared with historical standard sequential chemoradiotherapy data from the Radiation Therapy Oncology Group.

PATIENTS AND METHODS: Patients with unresected stages IIIA and IIIB NSCLC, with Karnofsky performance status 70% and weight loss 10%, received two cycles of induction paclitaxel (200 mg/m²)/carboplatin (area under the plasma concentration time curve [AUC] = 6) followed by TRT 63.0 Gy (arm 1, sequential) or two cycles of induction paclitaxel (200 mg/m²)/carboplatin (AUC = 6) followed by weekly paclitaxel (45 mg/m²)/carboplatin (AUC = 2) with concurrent TRT 63.0 Gy (arm 2, induction/concurrent), or weekly paclitaxel (45 mg/m²)/carboplatin (AUC = 2)/TRT (63.0 Gy) followed by two cycles of paclitaxel (200 mg/m²)/carboplatin (AUC = 6; arm 3, concurrent/consolidation).

RESULTS: With a median follow-up time of 39.6 months, median overall survival was 13.0, 12.7, and 16.3 months for arms 1, 2, and 3, respectively. During induction chemotherapy, grade 3/4 granulocytopenia occurred in 32% and 38% of patients on study arms 1 and 2, respectively. The most common locoregional grade 3/4 toxicity during and after TRT was esophagitis, which was more pronounced with the administration of concurrent chemoradiotherapy on study arms 2 and 3 (19% and 28%, respectively).

CONCLUSION: Concurrent weekly paclitaxel, carboplatin, and TRT followed by consolidation seems to be associated with the best outcome, although this schedule was associated with greater toxicity.

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

Supported by a grant from Bristol-Myers Squibb Company.

Presented in part at the 10th World Conference on Lung Cancer, Vancouver, British Columbia, Canada, August 10-14, 2003; the American Society of Clinical Oncology Annual Meetings on May 12-15, 2001 (37th; San Francisco, CA), May 18-21, 2002 (38th; Orlando, FL), and May 31-June 3, 2003 (39th; Chicago, IL); and the 43rd Annual Meeting of the American Society for Therapeutic Radiology and Oncology, San Francisco, CA, November 4-8, 2001.

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