BACKGROUND: There have been few randomized controlled clinical trials until now to determine the effectiveness of adjuvant treatments for pancreatic cancer, and the results reported so far are inconsistent. METHODS:Patients with invasive ductal pancreatic cancer who underwent radical surgery with clear histological margins at 11 Japanese institutions were enrolled and randomly assigned to one of two groups: surgery-alone group (no further treatment after surgery) and the surgery + chemotherapy group [two courses of postoperative adjuvant systemic chemotherapy with cisplatin (80 mg/m(2), Day 1) and 5-fluorouracil (500 mg/m(2)/day, Days 1-5)]. Patients with a positive resectional margin or with resected distant metastases were excluded from the trial in order to minimize the influence of residual cancer. RESULTS:Between 1992 and 2000, 89 patients were randomized into the two arms of the trial (45 patients to the surgery + chemotherapy arm and 44 patients to the surgery-alone arm). Four patients in total were found to be ineligible (three in the surgery + chemotherapy group and one in the surgery-alone group). The baseline characteristics were comparable between the two groups. In the surgery + chemotherapy group, four patients did not receive the adjuvant treatment because of patient refusal. Toxicity was minor and acceptable among the eligible patients in the surgery + chemotherapy group. The estimated 5-year survival rates were 26.4% in the surgery + chemotherapy group and 14.9% in the surgery-alone group, and the median duration of survival was 12.5 months and 15.8 months, respectively. The recurrence rates at 5 years were 73.6 and 80.8%, respectively, in the surgery + chemotherapy and the surgery-alone groups. The differences in the survival and recurrence rates between the two groups were not statistically significant. CONCLUSIONS: Postoperative adjuvant chemotherapy using cisplatin and 5-fluorouracil was safe and well tolerated; however, no clear survival benefit could be demonstrated.
RCT Entities:
BACKGROUND: There have been few randomized controlled clinical trials until now to determine the effectiveness of adjuvant treatments for pancreatic cancer, and the results reported so far are inconsistent. METHODS:Patients with invasive ductal pancreatic cancer who underwent radical surgery with clear histological margins at 11 Japanese institutions were enrolled and randomly assigned to one of two groups: surgery-alone group (no further treatment after surgery) and the surgery + chemotherapy group [two courses of postoperative adjuvant systemic chemotherapy with cisplatin (80 mg/m(2), Day 1) and 5-fluorouracil (500 mg/m(2)/day, Days 1-5)]. Patients with a positive resectional margin or with resected distant metastases were excluded from the trial in order to minimize the influence of residual cancer. RESULTS: Between 1992 and 2000, 89 patients were randomized into the two arms of the trial (45 patients to the surgery + chemotherapy arm and 44 patients to the surgery-alone arm). Four patients in total were found to be ineligible (three in the surgery + chemotherapy group and one in the surgery-alone group). The baseline characteristics were comparable between the two groups. In the surgery + chemotherapy group, four patients did not receive the adjuvant treatment because of patient refusal. Toxicity was minor and acceptable among the eligible patients in the surgery + chemotherapy group. The estimated 5-year survival rates were 26.4% in the surgery + chemotherapy group and 14.9% in the surgery-alone group, and the median duration of survival was 12.5 months and 15.8 months, respectively. The recurrence rates at 5 years were 73.6 and 80.8%, respectively, in the surgery + chemotherapy and the surgery-alone groups. The differences in the survival and recurrence rates between the two groups were not statistically significant. CONCLUSIONS: Postoperative adjuvant chemotherapy using cisplatin and 5-fluorouracil was safe and well tolerated; however, no clear survival benefit could be demonstrated.
Authors: Francesco A D'Angelo; Laura Antolino; Mara La Rocca; Niccolò Petrucciani; Paolo Magistri; Paolo Aurello; Giovanni Ramacciato Journal: Med Oncol Date: 2016-02-17 Impact factor: 3.064
Authors: Jordan M Cloyd; Matthew H G Katz; Laura Prakash; Gauri R Varadhachary; Robert A Wolff; Rachna T Shroff; Milind Javle; David Fogelman; Michael Overman; Christopher H Crane; Eugene J Koay; Prajnan Das; Sunil Krishnan; Bruce D Minsky; Jeffrey H Lee; Manoop S Bhutani; Brian Weston; William Ross; Priya Bhosale; Eric P Tamm; Huamin Wang; Anirban Maitra; Michael P Kim; Thomas A Aloia; Jean-Nicholas Vauthey; Jason B Fleming; James L Abbruzzese; Peter W T Pisters; Douglas B Evans; Jeffrey E Lee Journal: J Gastrointest Surg Date: 2016-10-24 Impact factor: 3.452
Authors: M Hidalgo; A Abad; E Aranda; L Díez; J Feliu; C Gómez; A Irigoyen; R López; F Rivera; C Rubio; J Sastre; J Tabernero; E Díaz-Rubio Journal: Clin Transl Oncol Date: 2009-05 Impact factor: 3.405