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

Publication: 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; 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.

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Study Protocol

The following protocol information is provided solely to describe how the authors conducted the research underlying this article. The information provided may not reflect the complete protocol or any previous amendments or modifications. As described in the Information for Contributors, JCO requests only specific elements of the most recent version of the protocol. The protocol information is not intended to replace good clinical judgment in selecting appropriate therapy and in determining drug doses, schedules, and dose modifications. The treating physician or other health care provider is responsible for determining the best treatment for the patient. ASCO and JCO assume no responsibility for any injury or damage to persons or property arising out of the use of this protocol material or due to any errors or omissions. Readers seeking additional information about the protocol are encouraged to consult the corresponding author directly.

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Disclaimer

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health (https://acknowledgments.alliancefound.org).

Prior Presentation

Presented in part at the Oral Lung Session, Chicago, IL, June 6, 2021.

Support

Supported by the National Cancer Institute of the National Institutes of Health under Award Nos. U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), UG1CA189824, UG1CA189819, UG1CA189858, UG1CA233253, UG1CA233324, UG1CA233327, UG1CA233329, UG1CA233339, and U10CA180868 (NRG Oncology).

Clinical Trial Information

Information & Authors

Information

Published In

Journal of Clinical Oncology
Pages: 2394 - 2402
PubMed: 36623230

History

Published online: January 09, 2023
Published in print: May 01, 2023

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Authors

Affiliations

State University of New York Upstate Medical University, New York, NY
Xiaofei Wang, MD
Alliance Statistics and Data Management Center, Duke University, Durham, NC
Delaware/Christiana Care NCORP, Helen Graham Cancer Center, Newark, DE
Alliance Statistics and Data Management Center, Duke University, Durham, NC
Ritsuko Komaki, MD
MD Anderson Cancer Center, University of Texas, Houston, TX
Laurie E. Gaspar, MD
University of Colorado Denver Health Science Center, Denver, CO
University of Colorado School of Medicine, Aurora, CO
MD Anderson Cancer Center, University of Texas, Houston, TX
James Bonner, MD
University of Alabama, Birmingham, AL
Charles Kuzma, MD
Southeast Clinical Oncology Research Consortium NCORP, FirstHealth of the Carolinas-Moore Regional Hospital, Pinehurst, NC
Saiama Waqar, MD
Washington University—Siteman Cancer Center, St Louis, MO
William Petty, MD
Wake Forest University Health Sciences, Winston-Salem, NC
Thomas E. Stinchcombe, MD https://orcid.org/0000-0002-3595-8011
Duke Cancer Institute, Duke University Medical Center, Durham, NC
Winship Cancer Institute, Emory University, Atlanta, GA
University of Chicago Comprehensive Cancer Center, Chicago, IL

Notes

Jeffrey Bogart, MD, Department of Radiation Oncology, State University of New York, Upstate Medical University, 750 East Adams St, Syracuse, NY 13210; e-mail: [email protected].

Author Contributions

Conception and design: Jeffrey Bogart, Xiaofei Wang, Gregory Masters, Ritsuko Komaki, Laurie E. Gaspar, James Bonner, Everett Vokes
Administrative support: Thomas E. Stinchcombe
Provision of study materials or patients: Gregory Masters, Ritsuko Komaki, John Heymach, Saiama Waqar, William Petty, Thomas E. Stinchcombe
Collection and assembly of data: Jeffrey Bogart, Xiaofei Wang, Gregory Masters, Junheng Gao, Charles Kuzma, William Petty, Thomas E. Stinchcombe, Jeffrey D. Bradley, Everett Vokes
Data analysis and interpretation: Jeffrey Bogart, Xiaofei Wang, Gregory Masters, Junheng Gao, Laurie E. Gaspar, John Heymach, Saiama Waqar, William Petty, Thomas E. Stinchcombe, Jeffrey D. Bradley, Everett Vokes
Manuscript writing: All authors
Final approval of manuscript: All authors
Accountable for all aspects of the work: All authors

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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
Journal of Clinical Oncology 2023 41:13, 2394-2402

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