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Thoracic Radiation Therapy Alone Compared with Combined Chemoradiotherapy for Locally Unresectable Non-Small Cell Lung Cancer: A Randomized, Phase III Trial

Roscoe F. Morton, MD; James R. Jett, MD; William L. McGinnis, MD; John D. Earle, MD; Terry M. Therneau, PhD; James E. Krook, MD; Thomas E. Elliott, MD; James A. Mailliard, MD; Robert A. Nelimark, MD; Andrew W. Maksymiuk, MD; Ronald G. Drummond, MD; John A. Laurie, MD; John W. Kugler, MD; and Richard T. Anderson, MD
[+] Article, Author, and Disclosure Information

Presented in part at the annual meeting of the American Society of Clinical Oncology, New Orleans, Louisiana, on 25 May 1988.

Grant Support: In part by Public Health Services Grants CA-25224, CA-35101, CA-35103, CA-35113, CA-35269, CA-35272, and CA-37417 from the National Cancer Institute.

Requests for Reprints: James R. Jett, MD, Division of Medical Oncology, 7Mayo Clinic, Rochester, MN 55905.

Current Author Addresses: Dr. Morton: Iowa Oncology Research Association CCOP, 1044 Seventh Street, Des Moines, IA 50314.

Drs. Jett, Earle, and Therneau: Mayo Clinic, 200 First Street, S.W., Rochester, MN 55905.

Dr. McGinnis: Suite 210, Methodist Medical Plaza, 1212 Pleasant, Des Moines, IA 50309.

Drs. Krook and Elliott: The Duluth Clinic CCOP, 400 East Third Street, Duluth MN 55805.

Dr. Mailliard: Nebraska Oncology Group—Creighton University, University of Nebraska Medical Center and Associates, Omaha, NE 68131.

Dr. Nelimark: Sioux Community Cancer Consortium CCOP, Central Plains Clinic Ltd., Suite 2000, 1000 East 21 Street, Sioux Falls, SD 57105.

Dr. Maksymiuk: Saskatoon Cancer Clinic, University of Saskatchewan Campus, 200 Campus Drive, Saskatoon, Saskatchewan, S7N 4H4.

Dr. Drummond: Rapid City Regional Oncology CCOP, Cancer Treatment Center, Radiology Associates, 2880 Fifth Street, Rapid City, SD 57701.

Dr. Laurie: Grand Forks Clinic Ltd., 1000 South Columbia Road, Grand Forks, ND 58201.

Dr. Kugler: Illinois Oncology Research Association CCOP, Suite 780, 900 Main Street, Peoria, IL 61603.

Dr. Anderson: Department of Pathology, Methodist Medical Center of Illinois, 221 Northeast Glen Oak Avenue, Peoria, IL 61636.

Additional participating institutions include Quain and Ramstad Clinic, Bismarck, ND 58502 (D. M. Pfeifle, MD); St. Luke's Hospital CCOP, Fargo, ND 58123 (R. Levitt, MD); Billings Clinic, Billings, MT 59103 (D. I. Twito, MD); Cedar Rapids Oncology Project, Cedar Rapids, IA 52403 (M. Wiesenfeld, MD); and Alton Ochsner Medical Foundation CCOP, New Orleans, LA 70121 (C. G. Kardinal, MD).

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;115(9):681-686. doi:10.7326/0003-4819-115-9-681
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Objective: To compare the survival of patients with medically inoperable or unresectable stage III non-small cell lung cancer treated with thoracic radiotherapy alone or in combination with chemotherapy.

Design: Randomized, prospective phase III trial.

Setting: Multi-institutional cooperative oncology group.

Patients: A total of 121 patients were enrolled in the study, of whom 7 (5.8%) were ineligible. All patients were ambulatory and had measurable or evaluable disease. Before they were randomized, patients were stratified by ECOG performance score, histologic type, maximum tumor diameter, and NCCTG institution.

Interventions: Radiotherapy consisted of a total of 5000 cGy in 5 weeks with a 1000 cGy boost in 5 fractions to a small tumor field. Combined modality therapy was MACC which is intravenous methotrexate, intravenous doxorubicin, intravenous cyclophosphamide, and oral lomustine (CCNU), on day 1 and 28. Chemotherapy was followed by identical thoracic radiotherapy 4 weeks after the second cycle of chemotherapy. Four weeks after thoracic radiotherapy was completed, patients received another two cycles of identical chemotherapy. Patients who had progression of disease after chest irradiation only were treated with MACC chemotherapy.

Main Results: Major clinical responses were observed in 31 of 56 (55%; 95% Cl, 42% to 68%) patients treated with combination therapy and 37 of 58 (64%; Cl, 51 % to 76%) treated with radiation only (P > 0.2). The median time to progression was 192 days with radiotherapy only compared with 199 days for combined modality therapy (P > 0.2). The median survival time was 313 days compared with 317 days, respectively (P > 0.2). The 1-, 2-, and 5-year survival rates after thoracic radiation only were 45% (Cl, 32% to 58%), 16% (Cl, 6% to 25%), and 7%. With chemoradiotherapy, the survival rates were 46% (Cl, 33% to 60%), 21% (Cl, 11% to 32%), and 5%, respectively. Myelosuppression was significantly greater for the combined modality therapy arm (P = 0.002).

Conclusion: Chemotherapy with MACC, in combination with thoracic radiotherapy, did not result in significant survival advantage compared with radiation alone (P > 0.2) in patients with medically inoperable or unresectable stage III non-small cell lung cancer.





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