Riccardo Casadei1, Mariacristina Di Marco2, Claudio Ricci3, Donatella Santini4, Carla Serra5, Lucia Calculli6, Marielda D'Ambra3, Alessandra Guido7, Antonio Maria Morselli-Labate3, Francesco Minni3. 1. Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. riccardo.casadei@aosp.bo.it. 2. Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale (DIMES), Oncologia Medica-Biasco, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. 3. Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Chirurgia Generale-Minni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. 4. Anatomia Patologica-Grigioni, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. 5. Medicina Interna-Morelli, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. 6. Radiologia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy. 7. Radioterapia-Zompatori, Alma Mater Studiorum - University of Bologna, Policlinico S.Orsola-Malpighi, Via Massarenti n.9, 40138, Bologna, Italy.
Abstract
OBJECTIVE: The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer. METHODS: A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group. RESULTS: The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively. CONCLUSIONS:Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.
RCT Entities:
OBJECTIVE: The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer. METHODS: A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A (surgery alone) and arm B (neoadjuvant chemoradiation and surgery). The primary endpoint was R0 resection; the secondary endpoints were toxicity; number of patients who completed the neoadjuvant therapy; radiological and pathological response after chemoradiation; and pTNM stage, postoperative morbidity, mortality, and overall and disease-free survival. A sample size of 32 patients was required for each group. RESULTS: The study was terminated early, and 38 patients were randomized: 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups (intention-to-treat, OR = 1.91, P = 0.489). Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases (77.8 %) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases, respectively. CONCLUSIONS: Neoadjuvant chemoradiation was feasible, safe, and efficacious, although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients. Additional multicenter RCTs are needed in the future.
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