Phase-II Trial Using Gemcitabine as Monochemotherapy in Patients with Metastasized Pancreatic Carcinoma

Abstract

BACKGROUND: The aim of this phase-II study was to evaluate the efficacy of gemcitabine monochemotherapy in patients with metastasized pancreatic carcinoma known to have a poor overall tumor response rate to chemotherapy in order to achieve an improvement in the quality of life. METHODS: In 28 patients with metastasized pancreatic carcinoma (mean age, 63.7 years; range, 37 to 77 years; sex ratio, 13 males, 15 females), systemic chemotherapy with gemcitabine (dose, 1000 mg/m2) was administered on day 1, 8 and 15. After one further week (day 29), the cycle was repeated. After each 2nd cycle, extension of tumor growth (restaging) including radiological imaging (ultrasound, computed tomography, plain film of the thorax) and laboratory analysis (tumor marker) was performed. Frequency, severity and spectrum of side effects were assessed according to WHO grading prior to each treatment. Quality of life was evaluated using standardized questionnaires. RESULTS: All in all, 106 chemotherapeutic cycles were administered in 28 patients (range, 1–18 cycles; mean, 3.78). While in no patient complete remission was observed, 2 out of 28 patients showed partial remission (7.2 %). In 11 out of 28 patients, stable tumor disease was detected (39.2 %). Fifteen out of 28 patients (53.6 %) showed progressive tumor growth. Four out of 28 patients lived longer than 1 year (1-year survival rate, 14.3 %). Side effects of the chemotherapy were only moderate. Only in 26 of 106 cycles (26.5 %), side effects were documented. Significant improvement in the quality of life was reported in 25 % of the treated patients. CONCLUSIONS: Chemotherapy using gemcitabine is a well tolerable treatment option with a minimal rate of side effects in the case of metastasized pancreatic carcinoma. However, overall response rate is low. Even considering the acceptable median survival time of 9.1 months most likely caused by second-line chemotherapy, optimization of gemcitabine monotherapy appears to be required using a combination with a further potential cytostatic drug.