Journal of Clinical Oncology, Vol 17, Issue 9
(September), 1999: 2681
© 1999 American Society for Clinical Oncology
Phase III Comparison of Twice-Daily Split-Course Irradiation Versus Once-Daily Irradiation for Patients With Limited Stage Small-Cell Lung Carcinoma
James A. Bonner,
Jeff A. Sloan,
Thomas G. Shanahan,
Burke J. Brooks,
Randolph S. Marks,
James E. Krook,
James B. Gerstner,
Andrew Maksymiuk,
Ralph Levitt,
James A. Mailliard,
Henry D. Tazelaar,
Shauna Hillman,
James R. Jett
From the Mayo Clinic and Mayo Foundation, Rochester, and Duluth Community Clinical Oncology Program, Duluth, MN; Carle Cancer Center Community Clinical Oncology Program, Urbana, and Illinois Oncology Research Association Community Clinical Oncology Program, Peoria, IL; Oschner Community Clinical Oncology Program, New Orleans, LA; Saskatchewan Cancer Foundation (Saskatoon Cancer Centre, Saskatoon, and Allan Blair Cancer Centre, Regina, Saskatchewan, Canada); Meritcare Hospital Community Clinical Oncology Program, Fargo, ND; and Nebraska Oncology Group (Creighton University, University of Nebraska Medical Center, and Associates), Omaha, NE.
Address reprint requests to James A. Bonner, MD, University of Alabama at Birmingham, Department of Radiation Oncology, 619 South 19th St, WTI 105, Birmingham, AL 35233-6832
PURPOSE: Because small-cell lung cancer is a rapidly proliferating tumor, it was hypothesized that it may be more responsive to thoracic irradiation (TI) given twice-daily than once-daily. This hypothesis was tested in a phase III trial.
PATIENTS AND METHODS: Patients with limited-stage small-cell lung cancer were entered onto a phase III trial, and all patients initially received three cycles of etoposide (130 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). Subsequently, patients who did not have progression to a distant site (other than brain) were randomized to twice-daily thoracic irradiation (TDTI) versus once-daily thoracic irradiation (ODTI) given concomitantly with two additional cycles of etoposide (100 mg/m2 x 3) and cisplatin (30 mg/m2 x 3). The irradiation doses were TDTI, 48 Gy in 32 fractions, with a 2.5-week break after the initial 24 Gy, and ODTI, 50.4 Gy in 28 fractions. After thoracic irradiation, the patients received a sixth cycle of etoposide/cisplatin, followed by prophylactic cranial irradiation (30 Gy/15 fractions) if they had a complete response.
RESULTS: Of 311 assessable patients enrolled in the trial, 262 underwent randomization to TDTI or ODTI. There were no differences between the two treatments with respect to local-only progression rates, overall progression rates, or overall survival. The patients who received TDTI had greater esophagitis ( grade 3) than those who received ODTI (12.3% v 5.3%; P = .05). Although patients received thoracic irradiation encompassing the postchemotherapy volumes, only seven of 90 local failures were out of the portal of irradiation.
CONCLUSION: When TI is delayed until the fourth cycle of chemotherapy, TDTI does not result in improvement in local control or survival compared with ODTI.
This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by United States Public Health Service grants no. CA15083, CA25224, CA37404, CA35269, CA35113, CA37417, CA63849, CA35415, CA35195, CA52352, CA35103, CA35448, CA35272, CA35101, CA60276, CA63848, and CA63826 from the National Cancer Institute, Department of Health and Human Services.
Presented at the American Society of Clinical Oncology Annual Meeting, Los Angeles, CA, May 16-19, 1998.
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