Alice Boilève, Franck Audemar, Eric Dupont-Bierre, Samuel Le Sourd, Ayhan Ulusakarya, Marion Chauvenet, Asmahame Benmaziame, Mathilde Wagner, Diane Goere, Clarisse Dromain, Maximiliano Gelli, Veronica Pezzella, Baptiste Bonnet, Marie-Laure Tanguy, Valérie Boige
{"title":"在系统性诱导化疗后仍不能切除的仅肝结直肠癌患者中，肝动脉输注化疗加强治疗：来自过早关闭的多中心随机II期研究的探索性发现：SULTAN UCGI 30/PRODIGE 53 （NCT03164655）。","authors":"Alice Boilève, Franck Audemar, Eric Dupont-Bierre, Samuel Le Sourd, Ayhan Ulusakarya, Marion Chauvenet, Asmahame Benmaziame, Mathilde Wagner, Diane Goere, Clarisse Dromain, Maximiliano Gelli, Veronica Pezzella, Baptiste Bonnet, Marie-Laure Tanguy, Valérie Boige","doi":"10.1245/s10434-025-18570-5","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Hepatic arterial infusion (HAI) oxaliplatin represents a promising treatment option in patients with unresectable liver-only colorectal metastases (CRLM).</p><p><strong>Methods: </strong>In this randomized phase II study, we evaluated the efficacy of an intensification strategy based on HAI oxaliplatin combined with systemic chemotherapy (sys-CT) as a salvage treatment in patients with CRLM still unresectable after first-line induction sys-CT. The primary objective was conversion to resection/ablation (CTR). A real-life retrospective cohort of consecutive patients treated with HAI oxaliplatin + sys-CT in the same setting was also analyzed.</p><p><strong>Results: </strong>The study was stopped prematurely because of slow enrollment. Among 26 patients (13 men [50%]; median age 60 years) enrolled in 2018-2021, 11 were randomized in arm A (HAI + sys-CT, percutaneously placed catheters) and nine in arm B (sys-CT). CRLM were synchronous in 89% of patients, and 55% had RAS mutations. The CTR was 64% (7/11) in arm A and 22% (2/9) in arm B (odds ratio 0.16; 95% confidence interval 0.02-1.2; p = 0.09). Objective tumor response was 80% (8/10) in arm A and 11% (1/9) in arm B. Median overall survival was not reached in arm A versus 16.6 months in arm B (p = 0.008). Progression-free survival was significantly longer in arm A (12.6 vs. 4.37 months, p = 0.002). In the retrospective cohort of 35 patients, objective tumor response and CTR were 64% and 34%, respectively. Overall, HAI-related toxicity was manageable.</p><p><strong>Conclusions: </strong>Because the number of enrolled patients was lower than expected, our study could not confirm that salvage HAI combined with sys-CT improved CTR and survival outcomes compared with Sys-CT alone. However, these encouraging exploratory results warrant further prospective studies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.</p>","PeriodicalId":8229,"journal":{"name":"Annals of Surgical Oncology","volume":" ","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Treatment Intensification with Hepatic Arterial Infusion Chemotherapy in Patients with Liver-Only Colorectal Metastases Still Unresectable After Systemic Induction Chemotherapy: Exploratory Findings From a Prematurely Closed Multicenter Randomized Phase II Study: SULTAN UCGI 30/PRODIGE 53 (NCT03164655).\",\"authors\":\"Alice Boilève, Franck Audemar, Eric Dupont-Bierre, Samuel Le Sourd, Ayhan Ulusakarya, Marion Chauvenet, Asmahame Benmaziame, Mathilde Wagner, Diane Goere, Clarisse Dromain, Maximiliano Gelli, Veronica Pezzella, Baptiste Bonnet, Marie-Laure Tanguy, Valérie Boige\",\"doi\":\"10.1245/s10434-025-18570-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Hepatic arterial infusion (HAI) oxaliplatin represents a promising treatment option in patients with unresectable liver-only colorectal metastases (CRLM).</p><p><strong>Methods: </strong>In this randomized phase II study, we evaluated the efficacy of an intensification strategy based on HAI oxaliplatin combined with systemic chemotherapy (sys-CT) as a salvage treatment in patients with CRLM still unresectable after first-line induction sys-CT. The primary objective was conversion to resection/ablation (CTR). A real-life retrospective cohort of consecutive patients treated with HAI oxaliplatin + sys-CT in the same setting was also analyzed.</p><p><strong>Results: </strong>The study was stopped prematurely because of slow enrollment. Among 26 patients (13 men [50%]; median age 60 years) enrolled in 2018-2021, 11 were randomized in arm A (HAI + sys-CT, percutaneously placed catheters) and nine in arm B (sys-CT). CRLM were synchronous in 89% of patients, and 55% had RAS mutations. The CTR was 64% (7/11) in arm A and 22% (2/9) in arm B (odds ratio 0.16; 95% confidence interval 0.02-1.2; p = 0.09). Objective tumor response was 80% (8/10) in arm A and 11% (1/9) in arm B. Median overall survival was not reached in arm A versus 16.6 months in arm B (p = 0.008). Progression-free survival was significantly longer in arm A (12.6 vs. 4.37 months, p = 0.002). In the retrospective cohort of 35 patients, objective tumor response and CTR were 64% and 34%, respectively. Overall, HAI-related toxicity was manageable.</p><p><strong>Conclusions: </strong>Because the number of enrolled patients was lower than expected, our study could not confirm that salvage HAI combined with sys-CT improved CTR and survival outcomes compared with Sys-CT alone. However, these encouraging exploratory results warrant further prospective studies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.</p>\",\"PeriodicalId\":8229,\"journal\":{\"name\":\"Annals of Surgical Oncology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-10-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of Surgical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1245/s10434-025-18570-5\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of Surgical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1245/s10434-025-18570-5","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
Treatment Intensification with Hepatic Arterial Infusion Chemotherapy in Patients with Liver-Only Colorectal Metastases Still Unresectable After Systemic Induction Chemotherapy: Exploratory Findings From a Prematurely Closed Multicenter Randomized Phase II Study: SULTAN UCGI 30/PRODIGE 53 (NCT03164655).
Background: Hepatic arterial infusion (HAI) oxaliplatin represents a promising treatment option in patients with unresectable liver-only colorectal metastases (CRLM).
Methods: In this randomized phase II study, we evaluated the efficacy of an intensification strategy based on HAI oxaliplatin combined with systemic chemotherapy (sys-CT) as a salvage treatment in patients with CRLM still unresectable after first-line induction sys-CT. The primary objective was conversion to resection/ablation (CTR). A real-life retrospective cohort of consecutive patients treated with HAI oxaliplatin + sys-CT in the same setting was also analyzed.
Results: The study was stopped prematurely because of slow enrollment. Among 26 patients (13 men [50%]; median age 60 years) enrolled in 2018-2021, 11 were randomized in arm A (HAI + sys-CT, percutaneously placed catheters) and nine in arm B (sys-CT). CRLM were synchronous in 89% of patients, and 55% had RAS mutations. The CTR was 64% (7/11) in arm A and 22% (2/9) in arm B (odds ratio 0.16; 95% confidence interval 0.02-1.2; p = 0.09). Objective tumor response was 80% (8/10) in arm A and 11% (1/9) in arm B. Median overall survival was not reached in arm A versus 16.6 months in arm B (p = 0.008). Progression-free survival was significantly longer in arm A (12.6 vs. 4.37 months, p = 0.002). In the retrospective cohort of 35 patients, objective tumor response and CTR were 64% and 34%, respectively. Overall, HAI-related toxicity was manageable.
Conclusions: Because the number of enrolled patients was lower than expected, our study could not confirm that salvage HAI combined with sys-CT improved CTR and survival outcomes compared with Sys-CT alone. However, these encouraging exploratory results warrant further prospective studies.
期刊介绍：
The Annals of Surgical Oncology is the official journal of The Society of Surgical Oncology and is published for the Society by Springer. The Annals publishes original and educational manuscripts about oncology for surgeons from all specialities in academic and community settings.
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