Phase II trial of postoperative adjuvant gemcitabine and cisplatin chemotherapy followed by chemoradiation with gemcitabine in patients with resected pancreatic cancer.

Abstract

4094 Background: Despite potentially curative resection for pancreatic carcinoma the 5-year survival in these patients is less than 20%. Progression of disease can occur both locally and in distant sites. Effective multimodality adjuvant treatment protocol is needed for these patients receiving curative resection. Methods: Patients with curatively resected pancreatic adenocarcinoma (stage IB ~ IIB, AJCC 6th ed.), ECOG PS of 0-2, and no prior chemo- or radiotherapy were eligible. Treatment consisted of chemotherapy with gemcitabine (GEM) 1,200mg/m2 (D1,8) and CDDP 60mg/m2 (D1) every 3 weeks for 2 cycles. Subsequently, patients without progression received chemoradiotherapy (CRT) (50.4 Gy/ 28 Fx) with concurrent weekly gemcitabine (300mg/m2/week). GEM 1,200mg/m2 were given on day 1, 8 every 3 weeks for 4 cycles after CRT. The primary endpoint was to evaluate one year disease free survival (DFS) rate. The secondary endpoints were median DFS, overall survival (OS), and safety. Results: From Oct. 2005 to Sep. 2009, we enrolled 74 patients with curatively resected pancreas cancer (median age 61, M:F = 48:26 ). At the median follow up duration of 45 months (range 10.2 ~ 64.6 months), six patients withdrew consent, 11 patients confirmed disease progression during treatment and 57 patients completed CRT followed by systemic chemotherapy. One-year DFS rate was 62.1%. Fifty-two patients (70.3%) were diagnosed with recurrence. Most of the recurrences were systemic disease (49 patients, 66.2% of all patients). Median DFS was 17.4 months and median OS was 33.6 months in all patients. The stage (73.3% in IIA, 55.6% in IIB, p<0.001) and the nodal status (71.0% in N0, 55.6% in N1, p=0.01) at the time of diagnosis were significantly related with DFS. Toxicities were generally tolerable, 53 events of grade 3 or 4 hematologic toxicity were reported and four patients experienced febrile neutropenia. Conclusions: Adjuvant GEM-CDDP chemotherapy followed by GEM-RT and maintenance GEM showed promising efficacy and good tolerability in curatively resected pancreatic cancer.