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

Authors

Jeffrey Bogart
Xiaofei Wang
Gregory Masters
Junheng Gao
Ritsuko Komaki
Laurie E Gaspar
John Heymach
James Bonner
Charles Kuzma
Saiama Waqar
William Petty
Thomas E Stinchcombe
Jeffrey D Bradley
Everett Vokes

Publication Date

5-1-2023

Journal

Journal of Clinical Oncology

Abstract

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;

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.

Keywords

Humans, Lung Neoplasms, Small Cell Lung Carcinoma, Radiotherapy Dosage, Antineoplastic Combined Chemotherapy Protocols

Comments

PMID: 36623230

DOI

10.1200/JCO.22.01359

PMID

36623230

PMCID

PMC10150922

PubMedCentral® Posted Date

January 2023

PubMedCentral® Full Text Version

Post-print

Published Open-Access

yes