Article
Can Gemcitabine Improve the Treatment Results of Radiochemotherapy in Pancreatic Cancer? Results of Two Consecutive Monoinstutional Studies
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Published: | March 20, 2006 |
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Purpose: In locally advanced pancreatic cancer combined radiochemotherapy has been established as a standard treatment.
Methods: 1/1994 to 12/2003, a total of 125 patients with locally advanced irresectable pancreatic adenocarcinoma, histologically proven, were included in the study.
Two different treatment schemes have been consecutively used: 1/1994 and 12/2001 all patients (n = 110) received a combined radiochemotherapy, consisting of hyperfractionated accelerated conformal radiotherapy and simultaneous application of 5-fluorouracil (5-FU) and folinic acid (FA). A total tumor dose of 44.8 Gy was applied in two daily fractions of 1.6 Gy. On days 1-3 of radiotherapy, 600 mg/m2 5-FU and 300 mg/m2 FA were given. Chemotherapy was repeated monthly in in non-progressive patients.
From 1/2002 to 2/2005, in another 32 consecutive patients chemotherapy regimen was changed to gemcitabine (Gem) (300 mg/m²) and cisplatinum (Cis) (30 mg/m²), followed by gemcitabine (1000 mg/m²) every 2 weeks in all non-progressive patients.
Results: Median overall survival of the 5-FU/FA group was 10.3 months. The actuarial 1-year survival was 46.6%, the 2-year survival 20.1%, the 3-year survival 15.5%. Median time to progression (TTP) was 8.6 months. In the Gem/Cis group median survival was 13.5 months with a 1-year-survival of 54.9% and a 2-year-survival of 24.4%. Median time to progression was 11.1 months. The progression-free survival was 40.0% after one year and 18.8% after two years. The overall survival and the progression-free survival was significantly superior in the Gem/Cis group (p = 0.03, resp. 0.048).
Concerning tumor response, evaluated 3 months after the end of radiotherapy by imaging procedures, 7 patients (6.4%) of the 5-FU/FA group achieved a complete response (CR), 26 patients (23.6%) a partial response (PR), 32 patients (29.1%) had no significant change (NC) of their disease, and 45 patients (40.9%) a progression of their disease (PD). In the Gem/Cis group 3 patients (9.4%) achieved a CR, 11 patients (34.4%) a PR, 14 patients (43.8%) had NC, and 4 patients (12.4%) a PD.
There was comparable feasibility in both groups with a slight tendency towards more severe side effects in the Gem/Cis group.
Conclusion: Radiochemotherapy is an effective and well tolerable treatment. The integration of gemcitabine in the multimodality treatment seems to improve the treatment results.