BACKGROUND: Success of surgical treatment for pancreatic and periampullary cancer is often limited due to locoregional recurrence and/or the development of distant metastases. OBJECTIVE: The survival benefit of celiac axis infusion (CAI) and radiotherapy (RT) versus observation after resection of pancreatic or periampullary cancer was investigated. METHODS: In a randomized controlled trial, 120 consecutive patients with histopathologically proven pancreatic or periampullary cancer received eitheradjuvant treatment consisting of intra-arterial mitoxantrone, 5-FU, leucovorin, and cisplatinum in combination with 30 x 1.8 Gy radiotherapy (group A) or no adjuvant treatment (group B). Groups were stratified for tumor type (pancreatic vs. periampullary tumors). RESULTS: After surgery, 120 patients were randomized (59 patients in the treatment group, 61 in the observation group). The median follow-up was 17 months. No significant overall survival benefit was seen (median, 19 vs. 18 months resp.). Progressive disease was seen in 86 patients: in 37 patients in the CAI/RT group, and in 49 patients in the observation group (log-rank P < 0.02). Subgroup analysis showed significantly less liver metastases after adjuvant treatment in periampullary tumors (log-rank P < 0.03) without effect on local recurrence. Nonetheless, there was no significant effect on overall survival in these patients (log-rank P = 0.15). In patients with pancreatic cancer, CAI/RT had no significant effect on local recurrence (log-rank P = 0.12) neither on the development of liver metastases (log-rank P = 0.76) and consequently, no effect on overall survival. CONCLUSION: This adjuvant treatment schedule results in a prolonged time to progression. For periampullary tumors, CAI/RT induced a significant reduction in the development of liver metastases, with a possible effect on overall survival. Especially in these tumors, CAI/RT might prove beneficial in larger groups and further research is warranted.
RCT Entities:
BACKGROUND: Success of surgical treatment for pancreatic and periampullary cancer is often limited due to locoregional recurrence and/or the development of distant metastases. OBJECTIVE: The survival benefit of celiac axis infusion (CAI) and radiotherapy (RT) versus observation after resection of pancreatic or periampullary cancer was investigated. METHODS: In a randomized controlled trial, 120 consecutive patients with histopathologically proven pancreatic or periampullary cancer received either adjuvant treatment consisting of intra-arterial mitoxantrone, 5-FU, leucovorin, and cisplatinum in combination with 30 x 1.8 Gy radiotherapy (group A) or no adjuvant treatment (group B). Groups were stratified for tumor type (pancreatic vs. periampullary tumors). RESULTS: After surgery, 120 patients were randomized (59 patients in the treatment group, 61 in the observation group). The median follow-up was 17 months. No significant overall survival benefit was seen (median, 19 vs. 18 months resp.). Progressive disease was seen in 86 patients: in 37 patients in the CAI/RT group, and in 49 patients in the observation group (log-rank P < 0.02). Subgroup analysis showed significantly less liver metastases after adjuvant treatment in periampullary tumors (log-rank P < 0.03) without effect on local recurrence. Nonetheless, there was no significant effect on overall survival in these patients (log-rank P = 0.15). In patients with pancreatic cancer, CAI/RT had no significant effect on local recurrence (log-rank P = 0.12) neither on the development of liver metastases (log-rank P = 0.76) and consequently, no effect on overall survival. CONCLUSION: This adjuvant treatment schedule results in a prolonged time to progression. For periampullary tumors, CAI/RT induced a significant reduction in the development of liver metastases, with a possible effect on overall survival. Especially in these tumors, CAI/RT might prove beneficial in larger groups and further research is warranted.
Authors: Brett L Ecker; Charles M Vollmer; Stephen W Behrman; Valentina Allegrini; John Aversa; Chad G Ball; Courtney E Barrows; Adam C Berger; Martha N Cagigas; John D Christein; Elijah Dixon; William E Fisher; Mollie Freedman-Weiss; Francisco Guzman-Pruneda; Robert H Hollis; Michael G House; Tara S Kent; Stacy J Kowalsky; Giuseppe Malleo; Ronald R Salem; Roberto Salvia; Carl R Schmidt; Thomas F Seykora; Richard Zheng; Amer H Zureikat; Paxton V Dickson Journal: JAMA Surg Date: 2019-08-01 Impact factor: 14.766
Authors: Adriana Romiti; Viola Barucca; Angelo Zullo; Ida Sarcina; Roberta Di Rocco; Chiara D'Antonio; Marco Latorre; Paolo Marchetti Journal: World J Gastrointest Oncol Date: 2012-03-15
Authors: Joris I Erdmann; Marjolein J M Morak; Hugo J Duivenvoorden; Herman van Dekken; Geert Kazemier; Niels F M Kok; Casper H J van Eijck Journal: HPB (Oxford) Date: 2015-03-20 Impact factor: 3.647
Authors: Jin He; Nita Ahuja; Martin A Makary; John L Cameron; Frederic E Eckhauser; Michael A Choti; Ralph H Hruban; Timothy M Pawlik; Christopher L Wolfgang Journal: HPB (Oxford) Date: 2013-03-08 Impact factor: 3.647