Background & objective: Advanced,unresectable pancreatic cancer is an extremely aggressive disease. Systemic chemotherapy is the most frequently administered treatment for the patients with advanced pancreatic cancer. This clinical trial was designed to compare the efficacy, clinical benefit response (CBR), and toxicity profile of three regimens in treating advanced pancreatic cancer (APC).
Methods: From February 2000 to April 2001,74 patients of pathologically advanced pancreatic cancer were analyzed retrospectively. Of 74 APC patients, 26 received 5-fluorouracil+leucovorin+cisplatin (Arm A), 23 received gemcitabine (Arm B) and 25 treated with gemcitabine+5-fluorouracil+leucovorin (Arm C). Kaplan-Meier method was used for analysis of survival rate and Cox regression model was used for analysis of prognostic factors.
Results: The overall response rates and CBRs were 7.69% and 19.23% in Arm A, 17.39% and 47.83% in Arm B, 24.0% and 60.0% in Arm C. There was no significant difference in the overall response rate(P=0.261,Chi-square test) and a significant difference in CBR among three groups(P< 0.05, Chi-square test). The median survival time were 6.5 months for Arm A(95%CI 5.00,7.99 months),8.03 months for Arm B(95%CI 6.72,9.35 months) and 8.79 months for Arm C (95%CI 7.31,10.26 months). There were significant differences among three groups in the median survival time(Breslow=8.85,P=0.0119). There was no significant difference in the incidence of hematological and nonhematological toxicity among three groups.
Conclusion: The combination of gemcitabine,5-fluorouracil and leucovorin is a moderatedly active treatment with tolerable side effects. It has definite response rate and also significantly improve the quality of life in patients. Its treatment value is worth further studying.