Martin Reck , Rafal Dziadziuszko , Shunichi Sugawara , Steven Kao , Maximilian Hochmair , Florian Huemer , Gilberto de Castro Jr , Libor Havel , Reyes Bernabé Caro , György Losonczy , Jong-Seok Lee , Dariusz M. Kowalski , Zoran Andric , Raffaele Califano , Andrea Veatch , Gregory Gerstner , Marta Batus , Stefanie Morris , Monika Kaul , Vaikunth Cuchelkar , Stephen V. Liu
{"title":"III 期 IMpower133 研究和 III 期 IMbrella A 扩展研究中接受阿特珠单抗治疗的广泛期小细胞肺癌患者的五年生存率","authors":"Martin Reck , Rafal Dziadziuszko , Shunichi Sugawara , Steven Kao , Maximilian Hochmair , Florian Huemer , Gilberto de Castro Jr , Libor Havel , Reyes Bernabé Caro , György Losonczy , Jong-Seok Lee , Dariusz M. Kowalski , Zoran Andric , Raffaele Califano , Andrea Veatch , Gregory Gerstner , Marta Batus , Stefanie Morris , Monika Kaul , Vaikunth Cuchelkar , Stephen V. Liu","doi":"10.1016/j.lungcan.2024.107924","DOIUrl":null,"url":null,"abstract":"<div><h3>Objectives</h3><p>IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech–sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A.</p></div><div><h3>Materials and Methods</h3><p>IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A.</p></div><div><h3>Results</h3><p>Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %–21 %), 13 % (8 %–18 %), and 12 % (7 %–17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism).</p></div><div><h3>Conclusion</h3><p>This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone.</p><p>NCT03148418.</p></div>","PeriodicalId":18129,"journal":{"name":"Lung Cancer","volume":"196 ","pages":"Article 107924"},"PeriodicalIF":4.5000,"publicationDate":"2024-08-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study\",\"authors\":\"Martin Reck , Rafal Dziadziuszko , Shunichi Sugawara , Steven Kao , Maximilian Hochmair , Florian Huemer , Gilberto de Castro Jr , Libor Havel , Reyes Bernabé Caro , György Losonczy , Jong-Seok Lee , Dariusz M. Kowalski , Zoran Andric , Raffaele Califano , Andrea Veatch , Gregory Gerstner , Marta Batus , Stefanie Morris , Monika Kaul , Vaikunth Cuchelkar , Stephen V. Liu\",\"doi\":\"10.1016/j.lungcan.2024.107924\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objectives</h3><p>IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech–sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A.</p></div><div><h3>Materials and Methods</h3><p>IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A.</p></div><div><h3>Results</h3><p>Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %–21 %), 13 % (8 %–18 %), and 12 % (7 %–17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism).</p></div><div><h3>Conclusion</h3><p>This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone.</p><p>NCT03148418.</p></div>\",\"PeriodicalId\":18129,\"journal\":{\"name\":\"Lung Cancer\",\"volume\":\"196 \",\"pages\":\"Article 107924\"},\"PeriodicalIF\":4.5000,\"publicationDate\":\"2024-08-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Lung Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0169500224004586\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Lung Cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0169500224004586","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study
Objectives
IMbrella A is a Phase III extension study that allowed rollover from Roche/Genentech–sponsored atezolizumab trials, including IMpower133, a Phase I/III trial of first-line atezolizumab or placebo plus carboplatin/etoposide in extensive-stage small cell lung cancer. We report outcomes from an exploratory analysis of IMpower133 with extended time-to-event data for patients who rolled over to IMbrella A.
Materials and Methods
IMpower133 patients could roll over to IMbrella A to receive atezolizumab 1200 mg intravenously every three weeks if they continued to receive atezolizumab at IMpower133 closure or were in survival follow-up after atezolizumab discontinuation. Overall survival and safety were assessed; only serious adverse events and AEs of special interest were collected in IMbrella A.
Results
Eighteen of 26 eligible patients rolled over to IMbrella A. At clinical cutoff (March 16, 2023), median follow-up in the atezolizumab plus carboplatin/etoposide arm (IMpower133 and IMbrella A) was 59.4 months. The three-, four-, and five-year overall survival (95 % CI) estimates were 16 % (11 %–21 %), 13 % (8 %–18 %), and 12 % (7 %–17 %), respectively. In IMbrella A, serious adverse events occurred in three patients (16.7 %), and one adverse event of special interest was reported (grade two hypothyroidism).
Conclusion
This long-term analysis of patients from IMbrella A previously enrolled in IMpower133 provides the first report of five-year overall survival outcomes in patients with extensive-stage small cell lung cancer treated with first-line cancer immunotherapy and chemotherapy. While limited by small patient numbers and lack of long-term data for the IMpower133 control arm, exploratory overall survival analyses in patients treated with atezolizumab plus carboplatin/etoposide compared favorably with historical data with chemotherapy alone.
期刊介绍：
Lung Cancer is an international publication covering the clinical, translational and basic science of malignancies of the lung and chest region.Original research articles, early reports, review articles, editorials and correspondence covering the prevention, epidemiology and etiology, basic biology, pathology, clinical assessment, surgery, chemotherapy, radiotherapy, combined treatment modalities, other treatment modalities and outcomes of lung cancer are welcome.
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