Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer: A Multicenter, Phase II, Randomized Trial

Qiu, Bo; Li, Qiwen; Liu, Junling; Huang, Yan; Pang, Qingsong; Zhu, Zhengfei; Yang, Xi; Wang, Bin; Chen, li; Fang, Jiafeng; Lin, Mang; Jiang, Xiaobo; Guo, Shu; Guo, Jin; Wang, Daquan; Liu, FangJie; Chu, Chu; Huang, Xiaoyan; Xie, Chengsong; Liu, Hui

doi:10.1016/j.ijrobp.2021.05.003

Cited by 28 publications

(29 citation statements)

References 34 publications

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“…The observed 26.2 months median OS from 45 BID is comparable with previous trials (22.6–33.6 mo) and population-based series (21.5–27 mo). 10 , 11 , 12 , 14 , 22 , 23 , 33 , 39 , 40 , 41 The observed 19.6 months median OS among patients receiving 42 OD is also similar to previous reports (clinical trials: 18.8–21.2 mo, population-based series: 14.7–28.1 mo). 11 , 39 , 42 , 43 , 44 , 45 The 6.6 months benefit in median OS favoring 45 BID is comparable with the 6.3 months difference in our previous trial, 11 and results from a retrospective single institution study (5 mo benefit in median OS from 45 BID versus 40 OD).…”

Section: Discussionsupporting

confidence: 90%

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Thoracic Radiotherapy in Limited-Stage SCLC—a Population-Based Study of Patterns of Care in Norway From 2000 Until 2018

Graabak

Grønberg

Sandvei

et al. 2022

JTO Clinical and Research Reports

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Introduction Twice-daily (BID) thoracic radiotherapy (TRT) of 45 Gy per 30 fractions is recommended for limited-stage (LS) SCLC, but most patients are treated with once-daily (OD) schedules owing to toxicity concerns and logistic challenges. An alternative is hypofractionated OD TRT of 40 to 42 Gy per 15 fractions. A randomized trial by our group indicated that TRT of 45 Gy per 30 fractions is more effective than TRT of 42 Gy per 15 fractions, and because it was not more toxic, 45 BID replaced 42 OD as the recommended schedule in Norway. The aims of this study were to evaluate to what extent BID TRT has been implemented in Norway and whether this practice change has led to improved survival. Methods Data on all patients diagnosed with LS SCLC from 2000 until 2018 were collected from the Cancer Registry of Norway, containing nearly complete data on cancer diagnosis, radiotherapy, and survival. Results A total of 2222 patients were identified; median age was 69 years, 51.8% were women, and 87.1% had stage II to III disease. Overall, 64.6% received TRT. The use of BID TRT increased from 1.8% (2000–2004) to 83.2% (2015–2018). Median overall survival among patients receiving curative TRT improved significantly during the study period (2000–2004: 17.9 mo, 2015–2018: 25.0 mo, p = 0.0023), and patients receiving 45 BID had significantly longer median overall survival than patients receiving 42 OD (BID: 26.2 mo, OD: 19.6 mo, p = 0.0015). Conclusions BID TRT has replaced hypofractionated OD TRT as the standard treatment of LS SCLC in Norway which has led to a significant ( p = 0.0023) and clinically relevant survival improvement.

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Section: Discussionsupporting

confidence: 90%

“…However, a recent Chinese randomized phase 2 trial (n = 182) suggests that high-dose hypofractionated OD TRT of 65 Gy per 26 fractions improve progression-free survival compared with 45 BID. 40 …”

Section: Discussionmentioning

confidence: 99%

Thoracic Radiotherapy in Limited-Stage SCLC—a Population-Based Study of Patterns of Care in Norway From 2000 Until 2018

Graabak

Grønberg

Sandvei

et al. 2022

JTO Clinical and Research Reports

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“…This is the first randomized trial of LS SCLC to show a significant survival improvement in more than 20 years. Objectively assessed toxicity did not reveal any significant differences between the treatment arms, and the proportion of patients who experienced severe radiotoxicity was lower than in older trials and similar to other, recent trials of TRT in LS SCLC [5,6,[8][9][10].…”

Section: Introductionsupporting

confidence: 75%

“…There were no comparable studies included in a systematic review of HRQoL-data in SCLC [28]. We are aware of three other randomized trials of highdose TRT in LS SCLC and hitherto, none have reported patient reported outcomes [6,9,10].…”

Section: Discussionmentioning

confidence: 99%

Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

et al. 2022

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“…A total of 4,212 records were searched, and 40 records were screened to quality assessment. Among the 40 records, 3 records (40,49,50) were excluded for high risk of bias and 37 records, consisting of 15 phase III RCTs (4, 5, 13-25), 12 phase II (27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38), and 10 retrospective studies (39,(41)(42)(43)(44)(45)(46)(47)(48)51), were finally included for analysis (Supplementary Figure 1). Long-term survival data of three single-arm phase II studies (35)(36)(37) were updated in another report (52).…”

Section: Study Characteristicsmentioning

confidence: 99%

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

Yang

Wang

et al. 2022

Front. Oncol.

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PurposeTo investigate whether progression-free survival (PFS) or time to progression (TTP) could be a valid surrogate endpoint for overall survival (OS) in patients with limited-stage small-cell lung cancer (LS-SCLC) receiving combined chemoradiotherapy.MethodsLiterature searching was performed in PubMed, Embase, and The Cochrane Library up to 2021. Prediction models were firstly established using data from phase III randomized controlled trials (RCTs) and then externally validated in phase II and retrospective studies. Correlation analysis was evaluated by a weighted linear regression model at both trial and arm levels. Cross-validation was performed to assess the consistency and robustness of the established models.Results37 studies, including 15 phase III RCTs, 12 phase II studies, and 10 retrospective studies, were selected in the final analysis. In trial-level surrogacy, a very good correlation was observed between hazard ratios (HRs) of PFS/TTP and OS (R2 = 0.783, 95% CI 0.771–0.794). In arm-level surrogacy, very good correlations were also observed between 2-year (R2 = 0.823, 95% CI 0.814–0.832), 3-year (R2 = 0.843, 95% CI 0.833–0.850), 5-year (R2 = 0.852, 95% CI 0.843–0.859) PFS/TTP, and 5-year OS. An excellent correlation was observed between 4-year PFS/TTP and 5-year OS (R2 = 0.906, 95% CI 0.901–0.910). Cross-validation demonstrated reasonable overall consistency. External validation in phase II and retrospective studies showed good agreement (R2, 0.728–0.824).ConclusionsPFS/TTP was a valid surrogate endpoint for OS in patients with LS-SCLC receiving combined chemoradiotherapy. The finding provides high-level evidence to support PFS/TTP as the primary endpoint in clinical trials so as to speed up introducing novel agents to the treatment of LS-SCLC.

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Moderately Hypofractionated Once-Daily Compared With Twice-Daily Thoracic Radiation Therapy Concurrently With Etoposide and Cisplatin in Limited-Stage Small Cell Lung Cancer: A Multicenter, Phase II, Randomized Trial

Cited by 28 publications

References 34 publications

Thoracic Radiotherapy in Limited-Stage SCLC—a Population-Based Study of Patterns of Care in Norway From 2000 Until 2018

Thoracic Radiotherapy in Limited-Stage SCLC—a Population-Based Study of Patterns of Care in Norway From 2000 Until 2018

Patient-reported health-related quality of life from a randomized phase II trial comparing standard-dose with high-dose twice daily thoracic radiotherapy in limited stage small-cell lung cancer

Progression-Free Survival and Time to Progression as Potential Surrogate Endpoints for Overall Survival in Chemoradiotherapy Trials in Limited-Stage Small-Cell Lung Cancer: A Systematic Review and Meta-Analysis

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