Antonio González-Martín, María Jesús Rubio, Florian Heitz, René Depont Christensen, Nicoletta Colombo, Toon Van Gorp, Margarita Romeo, Isabelle Ray-Coquard, Lydia Gaba, Alexandra Leary, Luis Miguel De Sande, Coriolan Lebreton, Andrés Redondo, Michel Fabbro, Maria-Pilar Barretina Ginesta, Philippe Follana, J Alejandro Pérez-Fidalgo, Manuel Rodrigues, Ana Santaballa, Renaud Sabatier, Maria José Bermejo-Pérez, Jean-Pierre Lotz, Beatriz Pardo, Gloria Marquina, Luisa Sánchez-Lorenzo, María Quindós, Purificación Estévez-García, Eva Guerra Alía, Luis Manso, Victoria Casado, Stefan Kommoss, Germana Tognon, Stéphanie Henry, Ilan Bruchim, Ana Oaknin, Frédéric Selle
{"title":"阿特珠单抗联合铂类和尼拉帕利治疗无铂期大于 6 个月的复发性卵巢癌：ENGOT-OV41/GEICO 69-O/ANITA III 期试验。","authors":"Antonio González-Martín, María Jesús Rubio, Florian Heitz, René Depont Christensen, Nicoletta Colombo, Toon Van Gorp, Margarita Romeo, Isabelle Ray-Coquard, Lydia Gaba, Alexandra Leary, Luis Miguel De Sande, Coriolan Lebreton, Andrés Redondo, Michel Fabbro, Maria-Pilar Barretina Ginesta, Philippe Follana, J Alejandro Pérez-Fidalgo, Manuel Rodrigues, Ana Santaballa, Renaud Sabatier, Maria José Bermejo-Pérez, Jean-Pierre Lotz, Beatriz Pardo, Gloria Marquina, Luisa Sánchez-Lorenzo, María Quindós, Purificación Estévez-García, Eva Guerra Alía, Luis Manso, Victoria Casado, Stefan Kommoss, Germana Tognon, Stéphanie Henry, Ilan Bruchim, Ana Oaknin, Frédéric Selle","doi":"10.1200/JCO.24.00668","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer.</p><p><strong>Methods: </strong>The multicenter placebo-controlled double-blind randomized phase III ENGOT-OV41/GEICO 69-O/ANITA trial (ClinicalTrials.gov identifier: NCT03598270) enrolled patients with measurable high-grade serous, endometrioid, or undifferentiated recurrent ovarian cancer who had received one or two previous CT lines (most recent including platinum) and had a treatment-free interval since last platinum (TFIp) of >6 months. Patients were stratified by investigator-selected carboplatin doublet, TFIp, <i>BRCA</i> status, and PD-L1 status in de novo biopsy and randomly assigned 1:1 to receive either atezolizumab or placebo throughout standard therapy comprising six cycles of a carboplatin doublet followed (in patients with response/stable disease) by maintenance niraparib until progression. The primary end point was investigator-assessed progression-free survival (PFS) per RECIST v1.1.</p><p><strong>Results: </strong>Between November 2018 and January 2022, 417 patients were randomly assigned (15% <i>BRCA-</i>mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% previous poly [ADP-ribose] polymerase inhibitor after frontline CT, and 53% previous bevacizumab). Median follow-up was 28.6 months (95% CI, 26.6 to 30.5 months). Atezolizumab did not significantly improve PFS (hazard ratio, 0.89 [95% CI, 0.71 to 1.10]; <i>P</i> = .28). Median PFS was 11.2 months (95% CI, 10.1 to 12.1 months) with atezolizumab versus 10.1 months (95% CI, 9.2 to 11.2 months) with standard therapy. Subgroup analyses generally showed consistent results, including analyses by PD-L1 status. The objective response rate (ORR) was 45% (95% CI, 39 to 52) with atezolizumab and 43% (95% CI, 36 to 49) with standard therapy. The safety profile was as expected from previous experience of these drugs.</p><p><strong>Conclusion: </strong>Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"4294-4304"},"PeriodicalIF":42.1000,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.\",\"authors\":\"Antonio González-Martín, María Jesús Rubio, Florian Heitz, René Depont Christensen, Nicoletta Colombo, Toon Van Gorp, Margarita Romeo, Isabelle Ray-Coquard, Lydia Gaba, Alexandra Leary, Luis Miguel De Sande, Coriolan Lebreton, Andrés Redondo, Michel Fabbro, Maria-Pilar Barretina Ginesta, Philippe Follana, J Alejandro Pérez-Fidalgo, Manuel Rodrigues, Ana Santaballa, Renaud Sabatier, Maria José Bermejo-Pérez, Jean-Pierre Lotz, Beatriz Pardo, Gloria Marquina, Luisa Sánchez-Lorenzo, María Quindós, Purificación Estévez-García, Eva Guerra Alía, Luis Manso, Victoria Casado, Stefan Kommoss, Germana Tognon, Stéphanie Henry, Ilan Bruchim, Ana Oaknin, Frédéric Selle\",\"doi\":\"10.1200/JCO.24.00668\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer.</p><p><strong>Methods: </strong>The multicenter placebo-controlled double-blind randomized phase III ENGOT-OV41/GEICO 69-O/ANITA trial (ClinicalTrials.gov identifier: NCT03598270) enrolled patients with measurable high-grade serous, endometrioid, or undifferentiated recurrent ovarian cancer who had received one or two previous CT lines (most recent including platinum) and had a treatment-free interval since last platinum (TFIp) of >6 months. Patients were stratified by investigator-selected carboplatin doublet, TFIp, <i>BRCA</i> status, and PD-L1 status in de novo biopsy and randomly assigned 1:1 to receive either atezolizumab or placebo throughout standard therapy comprising six cycles of a carboplatin doublet followed (in patients with response/stable disease) by maintenance niraparib until progression. The primary end point was investigator-assessed progression-free survival (PFS) per RECIST v1.1.</p><p><strong>Results: </strong>Between November 2018 and January 2022, 417 patients were randomly assigned (15% <i>BRCA-</i>mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% previous poly [ADP-ribose] polymerase inhibitor after frontline CT, and 53% previous bevacizumab). Median follow-up was 28.6 months (95% CI, 26.6 to 30.5 months). Atezolizumab did not significantly improve PFS (hazard ratio, 0.89 [95% CI, 0.71 to 1.10]; <i>P</i> = .28). Median PFS was 11.2 months (95% CI, 10.1 to 12.1 months) with atezolizumab versus 10.1 months (95% CI, 9.2 to 11.2 months) with standard therapy. Subgroup analyses generally showed consistent results, including analyses by PD-L1 status. The objective response rate (ORR) was 45% (95% CI, 39 to 52) with atezolizumab and 43% (95% CI, 36 to 49) with standard therapy. The safety profile was as expected from previous experience of these drugs.</p><p><strong>Conclusion: </strong>Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.</p>\",\"PeriodicalId\":15384,\"journal\":{\"name\":\"Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"4294-4304\"},\"PeriodicalIF\":42.1000,\"publicationDate\":\"2024-12-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1200/JCO.24.00668\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/18 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1200/JCO.24.00668","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/18 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Atezolizumab Combined With Platinum and Maintenance Niraparib for Recurrent Ovarian Cancer With a Platinum-Free Interval >6 Months: ENGOT-OV41/GEICO 69-O/ANITA Phase III Trial.
Purpose: To evaluate atezolizumab combined with platinum-based chemotherapy (CT) followed by maintenance niraparib for late-relapsing recurrent ovarian cancer.
Methods: The multicenter placebo-controlled double-blind randomized phase III ENGOT-OV41/GEICO 69-O/ANITA trial (ClinicalTrials.gov identifier: NCT03598270) enrolled patients with measurable high-grade serous, endometrioid, or undifferentiated recurrent ovarian cancer who had received one or two previous CT lines (most recent including platinum) and had a treatment-free interval since last platinum (TFIp) of >6 months. Patients were stratified by investigator-selected carboplatin doublet, TFIp, BRCA status, and PD-L1 status in de novo biopsy and randomly assigned 1:1 to receive either atezolizumab or placebo throughout standard therapy comprising six cycles of a carboplatin doublet followed (in patients with response/stable disease) by maintenance niraparib until progression. The primary end point was investigator-assessed progression-free survival (PFS) per RECIST v1.1.
Results: Between November 2018 and January 2022, 417 patients were randomly assigned (15% BRCA-mutated, 36% PD-L1-positive, 66% TFIp >12 months, 11% previous poly [ADP-ribose] polymerase inhibitor after frontline CT, and 53% previous bevacizumab). Median follow-up was 28.6 months (95% CI, 26.6 to 30.5 months). Atezolizumab did not significantly improve PFS (hazard ratio, 0.89 [95% CI, 0.71 to 1.10]; P = .28). Median PFS was 11.2 months (95% CI, 10.1 to 12.1 months) with atezolizumab versus 10.1 months (95% CI, 9.2 to 11.2 months) with standard therapy. Subgroup analyses generally showed consistent results, including analyses by PD-L1 status. The objective response rate (ORR) was 45% (95% CI, 39 to 52) with atezolizumab and 43% (95% CI, 36 to 49) with standard therapy. The safety profile was as expected from previous experience of these drugs.
Conclusion: Combining atezolizumab with CT and maintenance niraparib for late-relapsing recurrent ovarian cancer did not significantly improve PFS or the ORR.
期刊介绍：
The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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