Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial
| العنوان: | Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases - the multicenter randomized controlled PUMP trial |
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| المؤلفون: | Jasper Emmering, Rutger-Jan Swijnenburg, Roel J. Bennink, W W Te Riele, Marjolein Y.V. Homs, Florian E. Buisman, Elisabeth G. Klompenhouwer, M.I. D'Angelica, Joris I. Erdmann, Marnix G.E.H. Lam, Adriaan Moelker, Maria Kuiper, Jeanine M.L. Roodhart, E. Oomen-de Hoop, L. van Doorn, Cecile Grootscholten, Nils Kok, Maarten Vermaas, Koert F. D. Kuhlmann, B. Groot Koerkamp, Nikki S. IJzerman, Pieter J. Tanis, Marc G. Besselink, Maarten L. Donswijk, W.F. Filipe, M.W.J. Versleijen, O.M. van Delden, Rutger C G Bruijnen, M. J. Weterman, Cees Verhoef, Pascal G. Doornebosch, T.P. Kingham, Warner Prevoo, Dirk J. Grünhagen, Andrea Cercek, C.J.A. Punt, S. Koolen, Ron H.J. Mathijssen, I. H. M. Borel Rinkes, Nancy E. Kemeny, Jeroen Hagendoorn, F. P. Veuger |
| المساهمون: | Surgery, Medical Oncology, Radiology & Nuclear Medicine, Radiology and Nuclear Medicine, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, AGEM - Digestive immunity, AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and Quality of Life, ACS - Amsterdam Cardiovascular Sciences, Oncology |
| المصدر: | BMC Cancer, 19(1). BioMed Central BMC Cancer, Vol 19, Iss 1, Pp 1-9 (2019) Buisman, F E, Homs, M Y V, Grünhagen, D J, Filipe, W F, Bennink, R J, Besselink, M G H, Borel Rinkes, I H M, Bruijnen, R C G, Cercek, A, D’Angelica, M I, van Delden, O M, Donswijk, M L, van Doorn, L, Doornebosch, P G, Emmering, J, Erdmann, J I, IJzerman, N S, Grootscholten, C, Hagendoorn, J, Kemeny, N E, Kingham, T P, Klompenhouwer, E G, Kok, N F M, Koolen, S, Kuhlmann, K F D, Kuiper, M C, Lam, M G E, Mathijssen, R H J, Moelker, A, Oomen-de Hoop, E, Punt, C J A, te Riele, W W, Roodhart, J M L, Swijnenburg, R J, Prevoo, W, Tanis, P J, Vermaas, M, Versleijen, M W J, Veuger, F P, Weterman, M J, Verhoef, C & Groot Koerkamp, B 2019, ' Adjuvant hepatic arterial infusion pump chemotherapy and resection versus resection alone in patients with low-risk resectable colorectal liver metastases-the multicenter randomized controlled PUMP trial ', BMC Cancer, vol. 19, no. 1, 327 . https://doi.org/10.1186/s12885-019-5515-6Test BMC Cancer, 19(1):327. BioMed Central BMC Cancer BMC Cancer, 19(1):327. BioMed Central Ltd. BMC cancer, 19(1):327. BioMed Central |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Cancer Research, Survival, Antimetabolites, Colorectal cancer, Antimetabolites, Antineoplastic/administration & dosage, medicine.medical_treatment, law.invention, Study Protocol, 0302 clinical medicine, Randomized controlled trial, Antineoplastic/administration & dosage, law, Clinical endpoint, Neoplasm Recurrence, Local/prevention & control, Medicine, Multicenter Studies as Topic, Infusion Pumps, Netherlands, Randomized Controlled Trials as Topic, Liver Neoplasms, Infusion Pumps, Implantable, Floxuridine/administration & dosage, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Progression-Free Survival, Phase III as Topic, Oncology, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Local/prevention & control, Implantable, Colorectal Neoplasms, Adult, Infusions, Antimetabolites, Antineoplastic, medicine.medical_specialty, Chemotherapy, Adjuvant/instrumentation, lcsh:RC254-282, 03 medical and health sciences, Young Adult, Hepatic arterial infusion, Intra-Arterial/instrumentation, SDG 3 - Good Health and Well-being, Genetics, Journal Article, Chemotherapy, Infusions, Intra-Arterial, Hepatectomy, Humans, Clinical Trials, Progression-free survival, Retrospective Studies, business.industry, Liver Neoplasms/mortality, Infusions, Intra-Arterial/instrumentation, Retrospective cohort study, medicine.disease, Resection, Colorectal Neoplasms/mortality, Surgery, Adjuvant chemotherapy, Neoplasm Recurrence, 030104 developmental biology, Clinical Trials, Phase III as Topic, Adjuvant/instrumentation, Neoplasm Recurrence, Local, Floxuridine, business, Colorectal liver metastasis |
| الوصف: | BACKGROUND: Recurrences are reported in 70% of all patients after resection of colorectal liver metastases (CRLM), in which half are confined to the liver. Adjuvant hepatic arterial infusion pump (HAIP) chemotherapy aims to reduce the risk of intrahepatic recurrence. A large retrospective propensity score analysis demonstrated that HAIP chemotherapy is particularly effective in patients with low-risk oncological features. The aim of this randomized controlled trial (RCT) --the PUMP trial-- is to investigate the efficacy of adjuvant HAIP chemotherapy in low-risk patients with resectable CRLM.METHODS: This is an open label multicenter RCT. A total of 230 patients with resectable CRLM without extrahepatic disease will be included. Only patients with a clinical risk score (CRS) of 0 to 2 are eligible, meaning: patients are allowed to have no more than two out of five poor prognostic factors (disease-free interval less than 12 months, node-positive colorectal cancer, more than 1 CRLM, largest CRLM more than 5 cm in diameter, serum Carcinoembryonic Antigen above 200 μg/L). Patients randomized to arm A undergo complete resection of CRLM without any adjuvant treatment, which is the standard of care in the Netherlands. Patients in arm B receive an implantable pump at the time of CRLM resection and start adjuvant HAIP chemotherapy 4-12 weeks after surgery, with 6 cycles of floxuridine scheduled. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival, hepatic PFS, safety, quality of life, and cost-effectiveness. Pharmacokinetics of intra-arterial administration of floxuridine will be investigated as well as predictive biomarkers for the efficacy of HAIP chemotherapy. In a side study, the accuracy of CT angiography will be compared to radionuclide scintigraphy to detect extrahepatic perfusion. We hypothesize that adjuvant HAIP chemotherapy leads to improved survival, improved quality of life, and a reduction of costs, compared to resection alone.DISCUSSION: If this PUMP trial demonstrates that adjuvant HAIP chemotherapy improves survival in low-risk patients, this treatment approach may be implemented in the standard of care of patients with resected CRLM since adjuvant systemic chemotherapy alone has not improved survival.TRIAL REGISTRATION: The PUMP trial is registered in the Netherlands Trial Register (NTR), number: 7493 . Date of registration September 23, 2018. |
| وصف الملف: | image/pdf; application/pdf |
| اللغة: | English |
| تدمد: | 1471-2407 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::686310046653dad4c908b51a2aaf3abbTest https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85063963854&origin=inwardTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....686310046653dad4c908b51a2aaf3abb |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 14712407 |
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