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Originally published as JCO Early Release 10.1200/JCO.2005.00.414 on June 6 2005 © 2005 American Society of Clinical Oncology. Study of Paclitaxel, Etoposide, and Cisplatin Chemotherapy Combined With Twice-Daily Thoracic Radiotherapy for Patients With Limited-Stage Small-Cell Lung Cancer: A Radiation Therapy Oncology Group 9609 Phase II StudyFrom the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Radiation Therapy Oncology Group; University of Pennsylvania Medical Center; Thomas Jefferson University Hospital; Fox Chase Cancer Center, Philadelphia, PA; Cedars Sinai Medical Center, Los Angeles, CA; Greater Dayton Cancer Center, Kettering, OH; and Medical College of Wisconsin, Milwaukee, WI Address reprint requests to David S. Ettinger, MD, Alex Grass Professor of Oncology, Associate Director for Clinical Research, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, 1650 Orleans St, Rm G88, Baltimore, MD 21231-1000; e-mail: ettinda{at}jhmi.edu PURPOSE: To determine the response rate, progression-free survival and overall survival, and toxicity of paclitaxel, etoposide, and cisplatin combined with accelerated hyperfractionated thoracic radiotherapy in patients with limited-disease (LD) small-cell lung cancer (SCLC).
PATIENTS AND METHODS: LD-SCLC patients with measurable disease, Karnofsky performance score of RESULTS: Fifty-five patients were enrolled onto the study, and 53 were assessable. The major toxicities included grade 3 and 4 acute neutropenia (32% and 43%, respectively) and grade 3 and 4 esophagitis (32% and 4%, respectively). Two patients died as a result of therapy (one died of acute respiratory distress syndrome, and one died of sepsis). There was one late fatal pulmonary toxicity. The median survival time was 24.7 months. The 2-year survival rate was 54.7%. The median progression-free survival time was 13 months, with a 2-year progression-free survival rate of 26.4%. CONCLUSION: Although this therapeutic regimen is effective in the treatment of patients with LD-SCLC, it is unlikely that the three-drug combination with thoracic radiation therapy will improve the survival times compared with the etoposide plus cisplatin chemotherapy regimen with thoracic radiation therapy in LD-SCLC patients. Supported by grant Nos. CA21661, CA37423, and CA32115 from the National Cancer Institute, Bethesda, MD. Presented at the 36th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, May 20-23, 2000. The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. Authors' disclosures of potential conflicts of interest are found at the end of this article.
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Copyright © 2005 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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70, and adequate organ function who were previously untreated were eligible for the study. Treatment was as follows. In cycle 1 of chemotherapy, concurrent thoracic radiation therapy was administered. In cycles 2 to 4, chemotherapy was administered alone. In cycle 1, chemotherapy consisted of paclitaxel 135 mg/m2 intravenous over 3 hours on day 1, etoposide 60 mg/m2 intravenous on day 1 and 80 mg/m2 orally on days 2 and 3, and cisplatin 60 mg/m2 intravenous on day 1. In cycles 2 to 4, the paclitaxel dose was increased to 175 mg/m2, with the etoposide and cisplatin doses remaining the same as in cycle 1. The thoracic radiation therapy consisted of 1.5 Gy in 30 fractions (total dose, 45 Gy) administered 5 days a week for 3 weeks. 
