Greater than 3-year follow-up of concomitant gemcitabine, capecitabine, and radiation therapy in locally advanced or incompletely resected pancreatic cancer.

Abstract

e14708 Background: When either gemcitabine (G) or capecitabine (X) are combined with RT, the median survival is less than 12 months. Approximately 30% of patients progress during the 9 week period of treatment and re-assessment. The benefit of RT in the post-op setting has been questioned. Co-administration of G and X is synergistic against pancreatic cancer cells and both are radiation sensitizers. They were combined with RT. Methods: A retrospective analysis was done on 48 patients treated with GTX (G, docetaxel (T) and X) followed by radiation therapy with concomitant G and X. RT was delivered by conformal fields or IMRT in 180 cGy fractions to 5040 cGy. X, 1,000 mg/m2 was given days 1 to 10 and days 16 to 25 of RT and G, 750 mg/m2 over 90 minutes, was given on days 5, 10, 20 and 25 of RT. The end-points were toxicity and local disease control. Results: 14 patients with positive margin of resection were treated adjuvantly and 34 patients with arterial involvement were treated neo-adjuvantly. No patient developed evidence of metastasis within the 9 weeks after starting RT. There were no bowel perforations, pancreatitis or delayed strictures. The therapy was well tolerated. Grade 3/4 toxicities were: thrombocytopenia 29%, leucopenia 38%, anemia 43%, enteritis 10% and infection 8%. 2 patients had GI bleeding from telangectasias more than 6 months after completing RT. The group of 14 treated adjuvantly had survival of 100% at 1 year, 86% at 2 years. 7 (57%) are beyond 3 years and have not relapsed. 34 patients treated neo-adjuvantly had one year survival of 85%. Of the 34 patients, 16 (47%) are alive with a median survival of 24 months (95% CI 20.7, 31.7.) 22 had resections with a median OS of 25.7 M (range 8.8 to 74.8 M.) 13 have not relapsed (13.6 to 74.8 M.) On pathology, there were 3 CR’s (14%,) 6 (27%) with scattered microscopic disease and 13 (59%) with macroscopic residual disease. Conclusions: G and X can be combined safely with radiation therapy to achieve local control of pancreatic cancer. Our results suggest that the aforementioned therapy, when combined with surgery, increases the long-term disease-free survival over results reported in the literature.