Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 May 1;41(13):2394-2402.
doi: 10.1200/JCO.22.01359. Epub 2023 Jan 9.

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

Jeffrey Bogart  1 , Xiaofei Wang  2 , Gregory Masters  3 , Junheng Gao  2 , Ritsuko Komaki  4 , Laurie E Gaspar  5   6 , John Heymach  4 , James Bonner  7 , Charles Kuzma  8 , Saiama Waqar  9 , William Petty  10 , Thomas E Stinchcombe  11 , Jeffrey D Bradley  12 , Everett Vokes  13
Affiliations
Clinical Trial

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

Jeffrey Bogart et al. J Clin Oncol. .

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.

PubMed Disclaimer

Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Figures

FIG 1.
FIG 1.
CONSORT diagram. AE, adverse event; CB, concomitant-boost.
FIG 2.
FIG 2.
(A) OS and (B) investigator-assessed PFS in the intention-to treat population. P values are from stratified log-rank test. HR, hazard ratio; OS, overall survival; PFS, progression-free survival.
See this image and copyright information in PMC

References

    1. Govindan R, Page N, Morgensztern D, et al. : Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: Analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 24:4539-4544, 2006 - PubMed
    1. Zelen M: Keynote address on biostatistics and data retrieval. Cancer Chemother Rep 3 4:31-42, 1973 - PubMed
    1. Turrisi AT III, Kim K, Blum R, et al. : Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med 340:265-271, 1999 - PubMed
    1. Farrell MJ, Yahya JB, Degnin C, et al. : Radiation dose and fractionation for limited-stage small-cell lung cancer: Survey of US radiation oncologists on practice patterns. Clin Lung Cancer 20:13-19, 2019 - PubMed
    1. Bogart JA, Herndon JE II, Lyss AP, et al. : 70 Gy thoracic radiotherapy is feasible concurrent with chemotherapy for limited-stage small-cell lung cancer: Analysis of Cancer and Leukemia Group B study 39808. Int J Radiat Oncol Biol Phys 59:460-468, 2004 - PubMed

Publication types

MeSH terms

Associated data