INTRODUCTION - Pancreatic cancer is the 5th leading cause of cancer in the U.S. Because of poor survival, chemoradiation has been advocated for patients with locally unresectable and resectable disease. In the past three years, gemcitabine (GEM) has been recommended as a radiosensitizer and a chemotherapeutic agent to replace or augment 5-flurouracil (5-FU) in the treatment of these patients. However, the combined effect of GEM and 5-FU are unknown. Therefore we tested the hypothesis that GEM plus 5-FU would be well tolerated and improve survival.
METHODS - Fifty-eight patients with resected (71%) or unresected (29%) pancreatic cancer were treated with chemoradiation. Forty-two patients (72%) received either bolus (46%) or continuous infusion (26%) 5-FU while 16 patients (28%) received GEM plus continuous infusion 5-FU. The 5-FU and GEM + 5-FU groups did not differ with respect to age, gender, type of surgical resection, tumor stage or radiation dose. Common criteria for gastrointestinal (GI) and hematologic toxicity, necessity for a break in chemotherapy or radiation (XRT) and survival were recorded. Mann-Whitney, Fischer Exact, and Chi-Squared tests were performed as appropriate.
RESULTS - Data on toxicity, requirement for a break in treatment and hospital admission during treatment, and survival in resected patients are presented in the table.
CONCLUSION - These data indicate that pancreatic cancer patients treated with gemcitabine, 5-flurouracil and radiation have 1) increased gastrointestinal toxicity, 2) increased need for a break in chemotherapy and admission due to toxicity, and 3) no increase in survival compared to patients treated with 5-FU and radiation. We conclude that the addition of gemcitabine to 5-FU is associated with increased toxicity without survival benefit in patients with pancreatic cancer.
Group GI toxicity (3) Break in Chemo Break in XRT Admitted Survival 1-yr Survival (days)
5-FU 17% 17% 26% 14% 74% 463
GEM + 5-FU 60%* 88%* 39% 38% 64% 511
* p<0.01, p=0.07, median days