1. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer
- Author
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Versteijne, E., Suker, M., Groothuis, K., Akkermans-Vogelaar, J.M., Besselink, M.G., Bonsing, B.A., Buijsen, J., Busch, O.R., Creemers, G.J.M., Dam, R.M. van, Eskens, F.A.L.M., Festen, S., Groot, J.W.B. de, Koerkamp, B.G., Hingh, I.H. de, Homs, M.Y.V., Hooft, J.E. van, Kerver, E.D., Luelmo, S.A.C., Neelis, K.J., Nuyttens, J., Paardekooper, G.M.R.M., Patijn, G.A., Sangen, M.J.C. van der, Vos-Geelen, J. de, Wilmink, J.W., Zwinderman, A.H., Punt, C.J., Eijck, C.H. van, Tienhoven, G. van, Dutch Pancreatic Canc Grp, Graduate School, Radiotherapy, CCA - Cancer Treatment and Quality of Life, Surgery, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Gastroenterology and Hepatology, Oncology, Epidemiology and Data Science, APH - Methodology, Radiotherapie, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), and Medical Oncology
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Cancer Research ,medicine.medical_specialty ,FOLFIRINOX ,MULTICENTER ,DUCTAL ADENOCARCINOMA ,THERAPY ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,ADJUVANT CHEMOTHERAPY ,SDG 3 - Good Health and Well-being ,Randomized controlled trial ,Borderline resectable ,law ,FULL-DOSE GEMCITABINE ,NEOADJUVANT CHEMORADIATION ,Pancreatic cancer ,medicine ,Carcinoma ,Humans ,business.industry ,Dose fractionation ,ORIGINAL REPORTS ,Chemoradiotherapy ,CONCURRENT RADIATION ,medicine.disease ,OPEN-LABEL ,Neoadjuvant Therapy ,Surgery ,Pancreatic Neoplasms ,Clinical trial ,Oncology ,030220 oncology & carcinogenesis ,SURVIVAL ,030211 gastroenterology & hepatology ,business - Abstract
PURPOSE Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven. PATIENTS AND METHODS In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat. RESULTS Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% ( P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery ( P < .001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% ( P = .096). CONCLUSION Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.
- Published
- 2020
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