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).
1/5 보강
PICO 자동 추출 (휴리스틱, conf 2/4)
유사 논문P · Population 대상 환자/모집단
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).
I · Intervention 중재 / 시술
추출되지 않음
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.
[BACKGROUND] Hepatic arterial infusion (HAI) oxaliplatin represents a promising treatment option in patients with unresectable liver-only colorectal metastases (CRLM).
- p-value p = 0.09
- p-value p = 0.008
APA
Boilève A, Audemar F, et al. (2026). 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).. Annals of surgical oncology, 33(2), 1460-1469. https://doi.org/10.1245/s10434-025-18570-5
MLA
Boilève A, et al.. "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).." Annals of surgical oncology, vol. 33, no. 2, 2026, pp. 1460-1469.
PMID
41118066 ↗
Abstract 한글 요약
[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.
[TRIAL REGISTRATION] ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.
[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.
[TRIAL REGISTRATION] ClinicalTrials.gov, (NCT03164655). Trial registration date: 11th May 2017. https://clinicaltrials.gov/ct2/show/NCT03164655.
🏷️ 키워드 / MeSH 📖 같은 키워드 OA만
- Humans
- Male
- Female
- Middle Aged
- Liver Neoplasms
- Colorectal Neoplasms
- Infusions
- Intra-Arterial
- Antineoplastic Combined Chemotherapy Protocols
- Oxaliplatin
- Hepatic Artery
- Survival Rate
- Aged
- Induction Chemotherapy
- Retrospective Studies
- Follow-Up Studies
- Salvage Therapy
- Prognosis
- Adult
- Early Termination of Clinical Trials
- Colorectal cancer
- Hepatic arterial infusion
- Liver metastases
- Liver resection
같은 제1저자의 인용 많은 논문 (4)
- Lung-only metastatic pancreatic cancer: Differences in patients 'characteristics, molecular profile and survival.
- The increasing burden of early-onset pancreatic and biliary tract cancers: a review of risk factors.
- Organoids for Functional Precision Medicine in Advanced Pancreatic Cancer.
- Role of molecular biology in the management of pancreatic cancer.
🏷️ 같은 키워드 · 무료전문 — 이 논문 MeSH/keyword 기반
- A Phase I Study of Hydroxychloroquine and Suba-Itraconazole in Men with Biochemical Relapse of Prostate Cancer (HITMAN-PC): Dose Escalation Results.
- Self-management of male urinary symptoms: qualitative findings from a primary care trial.
- Clinical and Liquid Biomarkers of 20-Year Prostate Cancer Risk in Men Aged 45 to 70 Years.
- Diagnostic accuracy of Ga-PSMA PET/CT versus multiparametric MRI for preoperative pelvic invasion in the patients with prostate cancer.
- Association of patient health education with the postoperative health related quality of life in low- intermediate recurrence risk differentiated thyroid cancer patients.
- Early local immune activation following intra-operative radiotherapy in human breast tissue.