High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538.

Autor:	Bogart J; State University of New York Upstate Medical University, New York, NY., Wang X; Alliance Statistics and Data Management Center, Duke University, Durham, NC., Masters G; Delaware/Christiana Care NCORP, Helen Graham Cancer Center, Newark, DE., Gao J; Alliance Statistics and Data Management Center, Duke University, Durham, NC., Komaki R; MD Anderson Cancer Center, University of Texas, Houston, TX., Gaspar LE; University of Colorado Denver Health Science Center, Denver, CO.; University of Colorado School of Medicine, Aurora, CO., Heymach J; MD Anderson Cancer Center, University of Texas, Houston, TX., Bonner J; University of Alabama, Birmingham, AL., Kuzma C; Southeast Clinical Oncology Research Consortium NCORP, FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, NC., Waqar S; Washington University-Siteman Cancer Center, St Louis, MO., Petty W; Wake Forest University Health Sciences, Winston-Salem, NC., Stinchcombe TE; Duke Cancer Institute, Duke University Medical Center, Durham, NC., Bradley JD; Winship Cancer Institute, Emory University, Atlanta, GA., Vokes E; University of Chicago Comprehensive Cancer Center, Chicago, IL.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 May 01; Vol. 41 (13), pp. 2394-2402. Date of Electronic Publication: 2023 Jan 09.
DOI:	10.1200/JCO.22.01359
Abstrakt:	Purpose: Although level 1 evidence supports 45-Gy twice-daily radiotherapy as standard for limited-stage small-cell lung cancer, most patients receive higher-dose once-daily regimens in clinical practice. Whether increasing radiotherapy dose improves outcomes remains to be prospectively demonstrated. Methods: This phase III trial, CALGB 30610/RTOG 0538 (ClinicalTrials.gov identifier: NCT00632853), was conducted in two stages. In the first stage, patients with limited-stage disease were randomly assigned to receive 45-Gy twice-daily, 70-Gy once-daily, or 61.2-Gy concomitant-boost radiotherapy, starting with either the first or second (of four total) chemotherapy cycles. In the second stage, allocation to the 61.2-Gy arm was discontinued following planned interim toxicity analysis, and the study continued with two remaining arms. The primary end point was overall survival (OS) in the intention-to-treat population. Results: Trial accrual opened on March 15, 2008, and closed on December 1, 2019. All patients randomly assigned to 45-Gy twice-daily (n = 313) or 70-Gy once-daily radiotherapy (n = 325) are included in this analysis. After a median follow-up of 4.7 years, OS was not improved on the once-daily arm (hazard ratio for death, 0.94; 95% CI, 0.76 to 1.17; P = .594). Median survival is 28.5 months for twice-daily treatment, and 30.1 months for once-daily treatment, with 5-year OS of 29% and 32%, respectively. Treatment was tolerable, and the frequency of severe adverse events, including esophageal and pulmonary toxicity, was similar on both arms. Conclusion: Although 45-Gy twice-daily radiotherapy remains the standard of care, this study provides the most robust information available to help guide the choice of thoracic radiotherapy regimen for patients with limited-stage small-cell lung cancer.
Databáze:	MEDLINE
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