Background: We compare neoadjuvant chemoradiation therapy plus surgery versus surgery alone in patients with resectable pancreatic adenocarcinoma (RPA) in a prospective, controlled, randomized study. The primary end-point was to evaluate the R0 resection rate in the two groups and secondary was safety/efficacy of neoadjuvant therapy, postoperative mortality, morbidity, lymph node-ratio and pTNM stage. Methods: Patients with RPA were randomized to receive either neoadjuvant therapy plus surgery (group A) or surgery alone (group B). In group A, patients received gemcitabine (1,000 mg/m2) on days 1,8 every 21, followed by radiation therapy (45 Gy plus boost of 9 Gy) plus gemcitabine 50 mg/m2 biweekly, for 6 weeks. A CT scan restaging was performed before surgery. Results: From March 2007 we enrolled 19 consecutive patients (9 male and 8 female). Seventeen among the eligible patients 7 (41%) were randomized in group A and 10 (59%) in group B. After neoadjuvant therapy one patient (14.3%) had a progression of disease, 4 had stable disease (57.2%) and 2 (28.5%) had partial response. Consequently 6 patients in group A, underwent surgery (85.7%) and 4 of these (66.6%) experienced a successful resection. In group B surgical resection was performed in 9 patients (90%). R0 resection rate was 75% (3/4) in group A and 30% (2/9) in group B without statistically significant difference (p = 0.217). Regarding to safety myelotoxicity (57.1%), asthenia, weight loss (28.5%) and gastrointestinal toxicity (57.1%) were reported in group A patients. Overall postoperative mortality was 1 (11.1%) without significantly difference in the two groups (p = 1.000); overall postoperative morbidity was 0% in group A and 44.4% in group B (p = 0.093). There was no difference regarding pTNM stage (p = 0.364). Mean total number of lymph node removed with surgical specimen was similar in the two group (A: 29.5 vs. B: 27, p = 0.636). Mean number of lymph node metastasis was lesser in group A (p = 0.035). Conclusions: Despite the small number of patients, preliminary data suggest that neoadjuvant chemoradiation therapy plus surgery increases the R0 resection rate, reduces the lymph nodes ratio and allows a better postoperative course

Neoadjuvant therapy for resectable pancreatic adenocarcinoma: An interim report of a prospective randomized study

DI MARCO, MARIACRISTINA;MACCHINI, MARINA;DI CICILIA, ROBERTO;CASADEI, RICCARDO;BARBIERI, ENZA;CALCULLI, LUCIA;PANTALEO, MARIA ABBONDANZA;BIASCO, GUIDO
2010

Abstract

Background: We compare neoadjuvant chemoradiation therapy plus surgery versus surgery alone in patients with resectable pancreatic adenocarcinoma (RPA) in a prospective, controlled, randomized study. The primary end-point was to evaluate the R0 resection rate in the two groups and secondary was safety/efficacy of neoadjuvant therapy, postoperative mortality, morbidity, lymph node-ratio and pTNM stage. Methods: Patients with RPA were randomized to receive either neoadjuvant therapy plus surgery (group A) or surgery alone (group B). In group A, patients received gemcitabine (1,000 mg/m2) on days 1,8 every 21, followed by radiation therapy (45 Gy plus boost of 9 Gy) plus gemcitabine 50 mg/m2 biweekly, for 6 weeks. A CT scan restaging was performed before surgery. Results: From March 2007 we enrolled 19 consecutive patients (9 male and 8 female). Seventeen among the eligible patients 7 (41%) were randomized in group A and 10 (59%) in group B. After neoadjuvant therapy one patient (14.3%) had a progression of disease, 4 had stable disease (57.2%) and 2 (28.5%) had partial response. Consequently 6 patients in group A, underwent surgery (85.7%) and 4 of these (66.6%) experienced a successful resection. In group B surgical resection was performed in 9 patients (90%). R0 resection rate was 75% (3/4) in group A and 30% (2/9) in group B without statistically significant difference (p = 0.217). Regarding to safety myelotoxicity (57.1%), asthenia, weight loss (28.5%) and gastrointestinal toxicity (57.1%) were reported in group A patients. Overall postoperative mortality was 1 (11.1%) without significantly difference in the two groups (p = 1.000); overall postoperative morbidity was 0% in group A and 44.4% in group B (p = 0.093). There was no difference regarding pTNM stage (p = 0.364). Mean total number of lymph node removed with surgical specimen was similar in the two group (A: 29.5 vs. B: 27, p = 0.636). Mean number of lymph node metastasis was lesser in group A (p = 0.035). Conclusions: Despite the small number of patients, preliminary data suggest that neoadjuvant chemoradiation therapy plus surgery increases the R0 resection rate, reduces the lymph nodes ratio and allows a better postoperative course
JOURNAL OF CLINICAL ONCOLOGY
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M. Di Marco; M. Macchini; R. di Cicilia; S. Vecchiarelli; R. Casadei; E. Barbieri; L. Calculli; M. A. Pantaleo; G. Biasco
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11585/95080
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