Anderley Gordon, David Cunningham, Zayn Rajan, Caroline Fong, Clare Peckitt, Laura Satchwell, Susan Cromarty, Shannon Kidd, Katarzyna Piadel, Becky Leamon, Oleg Zhitkov, Michael Davidson, Joyce Thompson, Nicholas Maisey, Suzanne Darby, Tom Waddell, Carys Morgan, Alexander Bradshaw, Russell Petty, Charlotte Fribbens, Sheela Rao, Naureen Starling, Ian Chau
{"title":"晚期食管胃腺癌患者一线化疗后卡培他滨+ Ramucirumab的维持性治疗：来自随机平台研究的结果","authors":"Anderley Gordon, David Cunningham, Zayn Rajan, Caroline Fong, Clare Peckitt, Laura Satchwell, Susan Cromarty, Shannon Kidd, Katarzyna Piadel, Becky Leamon, Oleg Zhitkov, Michael Davidson, Joyce Thompson, Nicholas Maisey, Suzanne Darby, Tom Waddell, Carys Morgan, Alexander Bradshaw, Russell Petty, Charlotte Fribbens, Sheela Rao, Naureen Starling, Ian Chau","doi":"10.1200/OA-24-00073","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>PLATFORM is an adaptive phase II study assessing maintenance therapies in advanced esophagogastric adenocarcinoma (OGA). We evaluated the role of capecitabine plus a vascular endothelial growth factor receptor 2 inhibitor ramucirumab (cape-ram) in these patients.</p><p><strong>Methods: </strong>Human epidermal growth factor receptor 2 (HER2)-negative patients with advanced OGA with stable or responding disease after 18 weeks of induction platinum-based chemotherapy were randomly assigned 1:1 to surveillance or cape-ram. The primary end point was progression-free survival (PFS), and key secondary end points were overall survival (OS) and safety. Recruitment to the cape-ram arm closed prematurely because of industry support withdrawal. A one-sided log-rank test with a 2.5% significance level was considered significant.</p><p><strong>Results: </strong>Between April 2019 and November 2022, 25 surveillance and 22 cape-ram patients were contemporaneously randomly assigned. Median follow-up was 24.4 months. Compared with surveillance, cape-ram significantly prolonged PFS (hazard ratio [HR], 0.33 [95% CI, 0.17 to 0.63], <i>P</i> < .001; median PFS: 2.5 months with surveillance versus 5.5 months with cape-ram; 6-month PFS rate: 4% [95% CI, 0.3% to 17.0%] <i>v</i> 42.9% [95% CI, 21.9% to 62.3%], respectively) and OS (HR, 0.51 [95% CI, 0.26 to 1.00], <i>P</i> = .023; median OS: 7.1 months with surveillance <i>v</i> 14.4 months with cape-ram; median OS from start of induction chemotherapy was 12.1 months <i>v</i> 19.5 months, respectively). Of 10 cape-ram patients with measurable disease, 1 had an incremental partial response. Grade ≥3 adverse events (AEs) were seen in 32% surveillance and 57% cape-ram patients. Six cape-ram patients had grade 3 treatment-related AEs, and no new safety signals were identified.</p><p><strong>Conclusion: </strong>Maintenance cape-ram after induction chemotherapy for patients with HER2-negative OGA significantly improved survival compared with surveillance. To our knowledge, this is the first randomized maintenance study demonstrating survival benefit and provides support for maintenance treatment.</p>","PeriodicalId":520350,"journal":{"name":"JCO oncology advances","volume":"2 1","pages":"e2400073"},"PeriodicalIF":0.0000,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053389/pdf/","citationCount":"0","resultStr":"{\"title\":\"Maintenance Capecitabine Plus Ramucirumab After First-Line Chemotherapy in Patients With Advanced Esophagogastric Adenocarcinoma: Results From the Randomized PLATFORM Study.\",\"authors\":\"Anderley Gordon, David Cunningham, Zayn Rajan, Caroline Fong, Clare Peckitt, Laura Satchwell, Susan Cromarty, Shannon Kidd, Katarzyna Piadel, Becky Leamon, Oleg Zhitkov, Michael Davidson, Joyce Thompson, Nicholas Maisey, Suzanne Darby, Tom Waddell, Carys Morgan, Alexander Bradshaw, Russell Petty, Charlotte Fribbens, Sheela Rao, Naureen Starling, Ian Chau\",\"doi\":\"10.1200/OA-24-00073\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>PLATFORM is an adaptive phase II study assessing maintenance therapies in advanced esophagogastric adenocarcinoma (OGA). We evaluated the role of capecitabine plus a vascular endothelial growth factor receptor 2 inhibitor ramucirumab (cape-ram) in these patients.</p><p><strong>Methods: </strong>Human epidermal growth factor receptor 2 (HER2)-negative patients with advanced OGA with stable or responding disease after 18 weeks of induction platinum-based chemotherapy were randomly assigned 1:1 to surveillance or cape-ram. The primary end point was progression-free survival (PFS), and key secondary end points were overall survival (OS) and safety. Recruitment to the cape-ram arm closed prematurely because of industry support withdrawal. A one-sided log-rank test with a 2.5% significance level was considered significant.</p><p><strong>Results: </strong>Between April 2019 and November 2022, 25 surveillance and 22 cape-ram patients were contemporaneously randomly assigned. Median follow-up was 24.4 months. Compared with surveillance, cape-ram significantly prolonged PFS (hazard ratio [HR], 0.33 [95% CI, 0.17 to 0.63], <i>P</i> < .001; median PFS: 2.5 months with surveillance versus 5.5 months with cape-ram; 6-month PFS rate: 4% [95% CI, 0.3% to 17.0%] <i>v</i> 42.9% [95% CI, 21.9% to 62.3%], respectively) and OS (HR, 0.51 [95% CI, 0.26 to 1.00], <i>P</i> = .023; median OS: 7.1 months with surveillance <i>v</i> 14.4 months with cape-ram; median OS from start of induction chemotherapy was 12.1 months <i>v</i> 19.5 months, respectively). Of 10 cape-ram patients with measurable disease, 1 had an incremental partial response. Grade ≥3 adverse events (AEs) were seen in 32% surveillance and 57% cape-ram patients. Six cape-ram patients had grade 3 treatment-related AEs, and no new safety signals were identified.</p><p><strong>Conclusion: </strong>Maintenance cape-ram after induction chemotherapy for patients with HER2-negative OGA significantly improved survival compared with surveillance. To our knowledge, this is the first randomized maintenance study demonstrating survival benefit and provides support for maintenance treatment.</p>\",\"PeriodicalId\":520350,\"journal\":{\"name\":\"JCO oncology advances\",\"volume\":\"2 1\",\"pages\":\"e2400073\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-04-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12053389/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JCO oncology advances\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1200/OA-24-00073\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JCO oncology advances","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1200/OA-24-00073","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
Maintenance Capecitabine Plus Ramucirumab After First-Line Chemotherapy in Patients With Advanced Esophagogastric Adenocarcinoma: Results From the Randomized PLATFORM Study.
Purpose: PLATFORM is an adaptive phase II study assessing maintenance therapies in advanced esophagogastric adenocarcinoma (OGA). We evaluated the role of capecitabine plus a vascular endothelial growth factor receptor 2 inhibitor ramucirumab (cape-ram) in these patients.
Methods: Human epidermal growth factor receptor 2 (HER2)-negative patients with advanced OGA with stable or responding disease after 18 weeks of induction platinum-based chemotherapy were randomly assigned 1:1 to surveillance or cape-ram. The primary end point was progression-free survival (PFS), and key secondary end points were overall survival (OS) and safety. Recruitment to the cape-ram arm closed prematurely because of industry support withdrawal. A one-sided log-rank test with a 2.5% significance level was considered significant.
Results: Between April 2019 and November 2022, 25 surveillance and 22 cape-ram patients were contemporaneously randomly assigned. Median follow-up was 24.4 months. Compared with surveillance, cape-ram significantly prolonged PFS (hazard ratio [HR], 0.33 [95% CI, 0.17 to 0.63], P < .001; median PFS: 2.5 months with surveillance versus 5.5 months with cape-ram; 6-month PFS rate: 4% [95% CI, 0.3% to 17.0%] v 42.9% [95% CI, 21.9% to 62.3%], respectively) and OS (HR, 0.51 [95% CI, 0.26 to 1.00], P = .023; median OS: 7.1 months with surveillance v 14.4 months with cape-ram; median OS from start of induction chemotherapy was 12.1 months v 19.5 months, respectively). Of 10 cape-ram patients with measurable disease, 1 had an incremental partial response. Grade ≥3 adverse events (AEs) were seen in 32% surveillance and 57% cape-ram patients. Six cape-ram patients had grade 3 treatment-related AEs, and no new safety signals were identified.
Conclusion: Maintenance cape-ram after induction chemotherapy for patients with HER2-negative OGA significantly improved survival compared with surveillance. To our knowledge, this is the first randomized maintenance study demonstrating survival benefit and provides support for maintenance treatment.
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