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* From the LDS Hospital Radiation Therapy, Salt Lake City, UT (Dr. Sause); RTOG Headquarters, Philadelphia, PA (Ms. Kolesar); Illinois Masonic Cancer Center, Chicago, IL (Dr. Taylor); Radiation Oncology, Vanderbilt Clinic, Nashville, TN (Dr. Johnson); University of Washington Medical Center, Seattle, WA (Dr. Livingston); Division of Radiation Oncology, MD Anderson Center, Houston, TX (Dr. Komaki); Department of Radiotherapy, Edward Hines VA Hospital, Hines, IL (Dr. Emami); Department of Radiation Oncology, Thomas Jefferson University Hospital/Bodine Treatment Center, Philadelphia PA (Dr. Curran); Department of Radiation Oncology, Zablocki VA Hospital, Milwaukee, WI (Dr. Byhardt); London Regional Cancer Center, London, Ontario, Canada (Dr. Dar); and Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC (Dr. Turrisi) Supported by NIH grants U10 CA21661, CCOP U10 CA37422, and STAT U10 CA32115 to the RTOG (Dr. Sause, Ms. Kolesar, Drs. Taylor, Komaki, Emami, Curran, Byhardt, and Dar); CA 21115 and STAT CA23318 to the ECOG (Drs. Johnson and Turrisi); and U10 CA58861 to the Southwest Oncology Group (Dr. Livingston).
Correspondence to: William Sause, MD, FCCP, LDS Hospital Radiation Therapy, 400 C St, Salt Lake City, UT 84143
Study objectives: The purpose of this phase III clinical trial was to test whether chemotherapy followed by radiation therapy resulted in superior survival to either hyperfractionated radiation or standard radiation in surgically unresectable non-small cell lung cancer.
Design: Patients were prospectively randomized to 2 months of cisplatin, vinblastine chemotherapy followed by 60 Gy of radiation at 2.0 Gy per fraction or 1.2 Gy per fraction radiation delivered twice daily to a total dose of 69.6 Gy, or 2.0 Gy per fraction of radiation once daily to 60 Gy. Patients were enrolled from January 1989 through January 1992, and followed for a potential minimum period of 5 years.
Setting: This trial was an intergroup National Cancer Institute–funded trial within the Radiation Therapy Oncology Group, the Eastern Cooperative Oncology Group, and the Southwest Oncology Group.
Patients: Patients with
surgically unresectable non-small cell lung cancer, clinical stage II,
IIIA, and IIIB, were required to have a Karnofsky Performance Status of
70 and a weight loss of < 5% for 3 months before study entry.
Four hundred ninety patients were registered on trial, of which 458
patients were eligible.
Conclusion: Overall survival was statistically superior for the patients receiving chemotherapy and radiation vs the other two arms of the study. The twice-daily radiation therapy arm, although better, was not statistically superior in survival for those patients receiving standard radiation. Median survival for standard radiation was 11.4 months; for chemotherapy and irradiation, 13.2 months; and for hyperfractionated irradiation, 12 months. The respective 5-year survivals were 5% for standard radiation therapy, 8% for chemotherapy followed by radiation therapy, and 6% for hyperfractionated irradiation.
Key Words: chemotherapy • hyperfractionated radiation • lung cancer • phase III trial • radiation
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