Short Communication: Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on CALGB 30610 (Alliance) / RTOG 0538

Wang, Xiaofei; Masters, Gregory A.; Gao, Junheng; Komaki, Ritsuko; Gaspar, Laurie E.; Heymach, John V.; Dobelbower, M.C.; Kuzma, Charles; Stinchcombe, Thomas E.; Vokes, Everett E.

doi:10.1016/j.lungcan.2021.04.016

Cited by 10 publications

(6 citation statements)

References 8 publications

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“…Between March 15, 2008, and December 1, 2019, 731 patients were randomly assigned (Fig 1). A planned interim toxicity analysis resulted in discontinuation of the 61.2-Gy concomitant-boost arm in March 2013, 10 leaving 638 patients randomly assigned to 45-Gy twice-daily radiotherapy (n = 313) or 70-Gy once-daily radiotherapy (n = 325) for primary analysis. The distributions of the baseline covariates were comparable between study (Table 1), and treatment details were similar in both cohorts (Table 2).…”

Section: Resultsmentioning

confidence: 99%

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

Wang

Masters

Gao

et al. 2023

JCO

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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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Section: Resultsmentioning

confidence: 99%

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

Wang

Masters

Gao

et al. 2023

JCO

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“…Patients were randomized to 45 Gy BID or 70 Gy QD in the CALGB 30610/RTOG 0538 phase III trial; however, the 61.2 Gy concomitant boost arm was terminated early after the interim analysis due to unfavorable toxicity compared with 70 Gy [ 18 ]. Subsequently, no direct comparison was made between the doses of 61.2 Gy and 70 Gy [ 5 , 19 ]. Therefore, our study is an important academic data as one of the few studies to compare QD doses.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Once-Daily Thoracic Radiotherapy Dose According to the Underlying Lung Disease in Patients with Limited-Stage Small Cell Lung Cancer Undergoing Concurrent Chemoradiotherapy

et al. 2023

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In the treatment of concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer, the optimal once-daily radiotherapy (RT) dose/fractionation remain unclear although it is the most frequently used. Therefore, this study aimed to compare the treatment outcomes and toxicities of modest dose RT (≤54 Gy) with those of standard dose RT (>54 Gy) and investigate the benefit of the high dose based on patient factors. Materials and MethodsSince 2004, our institution has gradually increased the thoracic RT dose. Among the 225 patients who underwent CCRT, 84 patients (37.3%) received >54 Gy. Because the patients treated with RT > 54 Gy were not randomly assigned, propensity score matching (PSM) was performed. ResultsThe proportion of patients treated with >54 Gy increased over time (p=0.014). Multivariate analysis revealed that the overall tumor stage and dose > 54 Gy (hazard ratio 0.65, p=0.029) were independent prognostic factors for overall survival (OS). PSM confirmed that thoracic RT doses of >54 Gy showed significantly improved progression-free survival (3-year 42.7% vs 24.0%, p < 0.001) and OS (3-year 56.2% vs 38.5%, p=0.003). Sensitivity analysis also showed that 60 Gy resulted in better survival than 54 Gy. However, in patients with underlying lung disease, OS benefit from >54 Gy was not observed but considerable rates of severe pulmonary toxicities were observed (p=0.001). ConclusionOur analysis supports that the 60 Gy RT dose should be considered in the once-daily regimen of CCRT for limited-stage small cell lung cancer without underlying lung disease, but RT dose > 54 Gy did not seem to benefit for patients with chronic obstructive pulmonary disease or interstitial lung disease. Further study is needed to validate these results.

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“…Although TNM staging is prognostic, in clinical practice, the Veterans Administration Lung Study Group classification is most used to guide decision making for initial treatment for patients with LS-SCLC. 67 The treatment regimen for LS-SCLC has remained the same with the standard of care therapy consisting of four cycles of PE concurrent with TRT given once or twice daily, with 5-year OS of approximately 25% to 30% [68][69][70][71] Despite multiple studies, there has not been significant gain in survival with lower dose, twice-daily, and high-dose once-daily concurrent chemoradiotherapy. 72 Increased lung cancer screening may identify earlier stage SCLC, and, if found early enough, surgery followed by adjuvant PE is recommended.…”

Section: Limited-stage Sclcmentioning

confidence: 99%

Advancing immunotherapy in small cell lung cancer

Carlisle,

Leal

2023

Cancer

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Small cell lung cancer (SCLC) is a rapidly progressive neuroendocrine carcinoma that, until recently, had a very small armamentarium of effective treatments. Advances in DNA sequencing and whole transcriptomics have delineated key subtypes; therefore, SCLC is no longer viewed as a homogeneous cancer. Chemoimmunotherapy with PD1 blockade is now the standard of care for advanced disease, and ongoing research efforts are moving this strategy into the limited stage setting. Combination strategies of immunotherapy with radiation are also under active clinical trial in both limited and extensive stage disease.Plain Language Summary Small cell lung cancer (SCLC) is a rapidly progressive neuroendocrine carcinoma that, until recently, had a very small armamentarium of effective treatments. Chemoimmunotherapy with immune check point inhibitors is now the standard of care for advanced disease. This comprehensive review provides an overview of current treatment strategies for SCLC, unmet needs in this patient population, and emerging treatment strategies incorporating immunotherapy that will hopefully further improve outcomes for patients.

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Short Communication: Interim toxicity analysis for patients with limited stage small cell lung cancer (LSCLC) treated on CALGB 30610 (Alliance) / RTOG 0538

Cited by 10 publications

References 8 publications

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

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

Analysis of Once-Daily Thoracic Radiotherapy Dose According to the Underlying Lung Disease in Patients with Limited-Stage Small Cell Lung Cancer Undergoing Concurrent Chemoradiotherapy

Advancing immunotherapy in small cell lung cancer

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