[Radiochemotherapy with gemcitabine and cisplatin in pancreatic cancer -- feasible and effective].

BACKGROUND

Concomitant radiotherapy and chemotherapy with gemcitabine appears to be a promising tool for the treatment of pancreatic cancer since gemcitabine -- applied as single or combination therapy -- proved to have better efficacy in pancreatic cancer than 5-FU containing schemes and furthermore offers radiosensitizing potential. In the present paper our pilot data of concomitant and sequential chemoradiation with gemcitabine and cisplatin are presented.

PATIENTS AND METHODS

A total of 57 patients (f/m 23/34) with pancreatic cancer was treated, of whom 33 patients had irresectable tumors, 19 patients following resection (R1 and/or pN+) and five patients with local recurrent disease. Radiotherapy was delivered in 25 fractions up to a total dose of 45.0 Gy specified according to ICRU reference point (50 patients, 1.8 Gy/fraction) respectively 50.0 Gy to gross tumor volume (seven patients; 45.0 Gy in locoregional lymphatic pathways; 2.0/1.8 Gy/fraction). Concomitant with radiotherapy cisplatin (30 mg/m(2)) and gemcitabine (300 mg/m(2)) were applied on days 1, 8, 22 and 29. After simultaneous chemoradiation two sequential cycles gemcitabine and cisplatin (1000 mg/m(2) and 50 mg/m(2) d 1, 15) were applied.

RESULTS

With a median follow-up of 8.2 months the median survival time was 14.8 months (irresectable patients: 10.3 months, postoperative patients, 15.1 months). Within 33 irresectable patients 19 and four partial and complete remissions, respectively, were observed. In 14 patients a secondary resection was possible. Using leveled antiemetics with ondansetron and dexamethasone no gastrointestinal toxicities grade III or IV were observed. Hematologic toxicities were the most grave side effects (leukocytopenia III/IV in 29/five patients and thrombocytopenia III/IV in 21/eight patients), however with minor clinical relevancy (one neutropenic infection, one thrombopenic epistaxis).

CONCLUSION

The presented treatment scheme using concomitant and sequential gemcitabine and cisplatin with radiation is feasible with justifiable side effects. To evaluate the promising remission and survival rates, randomized trials of neoadjuvant and primary chemoradiation are started.