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Originally published as JCO Early Release 10.1200/JCO.2008.17.7840 on November 10 2008 © 2008 American Society of Clinical Oncology. Phase III Study of Cisplatin, Etoposide, and Concurrent Chest Radiation With or Without Consolidation Docetaxel in Patients With Inoperable Stage III Non–Small-Cell Lung Cancer: The Hoosier Oncology Group and U.S. Oncology
From the Indiana University Melvin and Bren Simon Cancer Center; Hoosier Oncology Group, Indianapolis; Michiana Hematology Oncology, South Bend; Ball Memorial Hospital Cancer Center, Muncie; Center for Cancer Care at Goshen Health System, Goshen; Cancer Care Center, Inc, New Albany; Ft Wayne Medical Oncology and Hematology; Radiation Oncology Associates PC, Ft Wayne, IN; Kansas City Cancer Centers, Overland Park, KS; U.S. Oncology, Houston; Texas Cancer Center, Abilene; Tyler Cancer Center, Tyler; Mid Cities Oncology, Bedford, TX; Chandler Medical Center, Lexington, KY; New York Oncology Hematology PC, Albany, NY; Ocala Oncology Center, Ocala, FL; and Washington University Siteman Cancer Center, St Louis, MO Corresponding author: Nasser Hanna, MD, Indiana University Melvin and Bren Simon Cancer Center, 535 Barnhill Dr, RT 473, Indianapolis, IN 46202; e-mail: nhanna{at}iupui.edu Purpose Concurrent chemoradiotherapy is standard treatment for patients with inoperable stage III non–small-cell lung cancer (NSCLC). A phase II study by the Southwest Oncology Group using consolidation docetaxel after cisplatin (P), etoposide (E), and radiation (XRT) resulted in a median survival time (MST) of 26 months. This randomized phase III trial evaluated whether consolidation docetaxel was responsible for this improved survival.
Patients and Methods Eligible patients had stage IIIA or IIIB NSCLC, baseline performance status of 0 to 1, forced expiratory volume in 1 second Results On the basis of evidence of futility, a data and safety monitoring board recommended early termination after an analysis of the initial 203 patients. Patient characteristics (n = 203) were as follows: 34% female; median age, 63 years; 39.4% stage IIIA; and 60.6% stage IIIB. One hundred forty-seven (72.4%) of 203 patients were randomly assigned to docetaxel (n = 73) or observation (n = 74). Grade 3 to 5 toxicities during docetaxel included febrile neutropenia (10.9%) and pneumonitis (9.6%); 28.8% of patients were hospitalized during docetaxel (v 8.1% in observation arm), and 5.5% died as a result of docetaxel. The MST for all patients (n = 203) was 21.7 months; MST was 21.2 months for docetaxel arm compared with 23.2 months for observation arm (P = .883). Conclusion Consolidation docetaxel after PE/XRT results in increased toxicities but does not further improve survival compared with PE/XRT alone in patients with stage III inoperable NSCLC. published online ahead of print at www.jco.org on November 10, 2008. Supported by Sanofi-aventis, Bridgewater, NJ. Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL, and the 12th World Conference on Lung Cancer, September 2-6, 2007, Seoul, South Korea. Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article. Clinical trial information can be found for the following: NCT00216125 [ClinicalTrials.gov] .
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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1 L, and less than 5% weight loss. Patients received P 50 mg/m2 intravenously (IV) on days 1, 8, 29, and 36 and E 50 mg/m2 IV on days 1-5 and 29-33 concurrently with chest XRT to 59.40 Gy. Patients who did not experience progression were randomly assigned to docetaxel 75 mg/m2 IV every 21 days for three cycles versus observation. The primary end point was to compare overall survival (Kaplan-Meier analysis). 
