Originally published as JCO Early Release 10.1200/JCO.2005.09.108 on April 18 2005

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Belani, C. P. Articles by Mehta, M. Search for Related Content PubMed PubMed Citation Articles by Belani, C. P. Articles by Mehta, M.

Phase III Study of the Eastern Cooperative Oncology Group (ECOG 2597): Induction Chemotherapy Followed by Either Standard Thoracic Radiotherapy or Hyperfractionated Accelerated Radiotherapy for Patients With Unresectable Stage IIIA and B Non–Small-Cell Lung Cancer

From the University of Pittsburgh Cancer Institute, Pittsburgh; Hershey Medical Center, Hershey, PA; Dana- Farber Cancer Institute, Boston, MA; Vanderbilt University, Nashville, TN; University of Wisconsin, Madison, WI; Mayo Clinic, Rochester, MN

Address reprint requests to Chandra P. Belani, MD, University of Pittsburgh Medical Center Cancer Pavilion, 5150 Centre Avenue, Pittsburgh, PA 15232; e-mail: belanicp{at}upmc.edu

PURPOSE: To compare once-daily radiation therapy (qdRT) with hyperfractionated accelerated radiation therapy (HART) after two cycles of induction chemotherapy.

PATIENTS AND METHODS: Eligible patients were treatment naive, and had stage IIIA and B unresectable non-small-cell lung cancer, Eastern Cooperative Oncology Group performance status 0/1, and normal organ function. Induction chemotherapy consisted of two cycles of carboplatin area under time-concentration curve 6 mg/mL · min plus paclitaxel 225 mg/m² on day 1. RT consisted of arm 1 (qdRT), 64 Gy (2 Gy/d), versus arm 2 (HART), 57.6 Gy (1.5 Gy tid for 2.5 weeks). A total of 388 patients were needed to detect a 50% increase in median survival from 14 months of qdRT to 21 months of HART; accrual was not achieved and the study closed prematurely.

RESULTS: Of 141 patients enrolled, 83% were randomly assigned after chemotherapy to qdRT (n = 59) or HART (n = 60). Median survival was 20.3 and 14.9 months for HART and qdRT, respectively (P = .28). Overall response was 25% and 22% for HART and qdRT, respectively (P = .69). Two- and 3-year survival was 44% and 34% for HART, and 24% and 14% for qdRT, respectively. Grade 3 toxicities included esophagitis in 14 v nine patients, and pneumonitis in 0 v 6 patients for HART and qdRT, respectively. Any subsequent trials of the HART regimen must address the issues that led to early closure, including slow accrual, logistics of HART, mucosal toxicity, and the fact that concurrent chemoradiotherapy now seems more effective than sequential treatment.

CONCLUSION: After two cycles of induction chemotherapy with carboplatin-paclitaxel, HART is feasible with an acceptable toxicity profile. Although statistical significance was not achieved and the study closed early, there was a positive statistical trend suggesting a survival advantage with the HART regimen.

Supported in part by Public Health Service grant Nos. 5U10 CA39229 18, CA23318, CA66636, CA21115, CA49957, CA73590, CA21076, and CA13650, and from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not represent the official views of the National Cancer Institute. This study was conducted by the Eastern Cooperative Oncology Group (Robert L. Comis, MD).

Presented at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

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

This article has been cited by other articles:

				M. J. Edelman, M. Suntharalingam, W. Burrows, K. F. Kwong, N. Mitra, Z. Gamliel, M. Riley, L. B. Cooper, N. L. Kennedy, S. Buskirk, et al. Phase I/II Trial of Hyperfractionated Radiation and Chemotherapy Followed by Surgery in Stage III Lung Cancer Ann. Thorac. Surg., September 1, 2008; 86(3): 903 - 910. [Abstract] [Full Text] [PDF]

				J. P. van Meerbeeck, S. Meersschout, R. De Pauw, I. Madani, and W. De Neve Modern Radiotherapy as Part of Combined Modality Treatment in Locally Advanced Non-Small Cell Lung Cancer: Present Status and Future Prospects Oncologist, June 1, 2008; 13(6): 700 - 708. [Abstract] [Full Text] [PDF]

				B. Jeremic and C. Koning Induction Chemotherapy Before Chemoradiation in Locally Advanced Non-Small-Cell Lung Cancer: Failure After Failure, Again and Again J. Clin. Oncol., April 1, 2008; 26(10): e1 - e2. [Full Text] [PDF]

				L. A. Robinson, J. C. Ruckdeschel, H. Wagner Jr, and C. W. Stevens Treatment of Non-small Cell Lung Cancer-Stage IIIA: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition) Chest, September 1, 2007; 132(3_suppl): 243S - 265S. [Abstract] [Full Text] [PDF]

				J. R. Jett, S. E. Schild, R. L. Keith, and K. A. Kesler Treatment of Non-small Cell Lung Cancer, Stage IIIB: ACCP Evidence-Based Clinical Practice Guidelines (2nd Edition) Chest, September 1, 2007; 132(3_suppl): 266S - 276S. [Abstract] [Full Text] [PDF]

				D. H. Johnson, V. W. Rusch, and A. T. Turrisi Scalpels, Beams, Drugs, and Dreams: Challenges of Stage IIIA-N2 Non-Small-Cell Lung Cancer J Natl Cancer Inst, March 21, 2007; 99(6): 415 - 418. [Full Text] [PDF]

				T. E. Stinchcombe, D. Fried, D. E. Morris, and M. A. Socinski Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer Oncologist, July 1, 2006; 11(7): 809 - 823. [Abstract] [Full Text] [PDF]

				E. E. Vokes Optimal Therapy for Unresectable Stage III Non-Small-Cell Lung Cancer J. Clin. Oncol., September 1, 2005; 23(25): 5853 - 5855. [Full Text] [PDF]