Treatment of unresectable, locally advanced pancreatic adenocarcinoma withcombined radiochemotherapy with 5-fluorouracil, leucovorin and cisplatin

The aim of the study was to evaluate the effectiveness and safety of a comb ined treatment modality including systemic chemotherapy with 5-fluorouracil (FU), leucovorin, cisplatin and external beam radiotherapy in patients wit h locally advanced pancreatic cancer. Systemic chemotherapy consisted of FU 400 mg m(-2) and leucovorin 20 mg m-2 both given as intravenous bolus inje ction on days 1-4, plus cisplatin 20 mg m-2 administered as 90-min infusion on days 1-4. Treatment courses were repealed every 4 weeks x 6 unless prio r evidence of progressive disease. Radiation therapy using megavolt irradia tion of greater than or equal to 6 MV photons with a 3- or 4-field techniqu e was delivered during the second and third chemotherapy course, that was r educed in dose by 25%, Between October 1994 and July 1996, a total of 38 pa tients were entered onto this trial, ail of whom were assessable for toxici ty and survival. Eighteen of these (47%) had objective remissions to combin ed radiochemotherapy, including four CR (11%), 13 (34%) had stable disease and seven patients (18%) showed tumour progression during treatment. The me dian progression-free interval of the entire study population was 10 months (range 3-32), and median overall survival was 14.0 months (range 3-45+ mon ths), 53% of all patients were alive at 12 months, and 18% of patients were alive at 24 months respectively Severe haematological side-effects compris ed neutropenia in 18%, thrombocytopenia in 8% and anaemia in 11%. The most frequent non-haematological side-effects were nausea/vomiting (WHO grade 3: 18%), and diarrhoea (grade 3: 13%). This combined radiochemotherapy regime n was tolerable and effective in patients with locally advanced pancreatic cancer. Since therapeutic results, in fact, compare favourably with other s eries, including surgical treatment of potentially resectable tumours, furt her evaluation of combined treatment modalities in the neoadjuvant setting seems warranted. (C) 2000 Cancer Research Campaign.