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PHASE II TRIAL OF HIGH DOSE ADJUVANT CHEMO-RADIOTHERAPY (55 GY IN 5 WKS + 5FU CONTINUOUSLY) AFTER RESECTION OF PANCREATIC ADENOCARCINOMA.
J. Balosso, P. Hammel, T. André, B. Roullet, Ch. Louvet, A. Botton, M. Flesch, D. Jaubert, B. Vie, and the GERCOR.
Background: Radiotherapy (Rth) of 45 Gy or equivalent, with 5FU bolus infusion is the usual adjuvant treatment scheme for resected adenocarcinoma of the pancreas. This work intends to demonstrate the feasibility of a higher dose of Rth with continuous 5FU infusion.
Methods: Inclusion criteria were any adenocarcinoma of the pancreas or Ampulla of Vater completely resected with negative or positive microscopic margins, age < 75 years. Adjuvant treatment began when possible, without limited delay, at least 4 weeks after surgery. Pts received 55 Gy of chemo-Rth: 45 Gy in 25 fract (median vol. = 2000 ml), 5 d/wk combined with 5FU continuously infused 250 mg/m2/d during the 5 wks; a 10 Gy concomitant boost (median vol. = 1000 ml) was given in celiac axis and tumor bed in 8 fract during wks 4 & 5, six hours apart the large volume irradiation. All pts gave writing consent. Endpoints were tolerance, relapse free survival and overall survival.
Results: From Oct 1998 to March 2001, 80 pts have been included, aged 34 to 75 years, sex ratio was balanced, 76 were adenocarcinoma of the pancreas and 4 cases were ampulla of Vater. Most of the tumors were pT2-T3 and pN0-N1, median diameter was 30 mm. All the pts completed the treatment, 72% without any delay in the Rth schedule, 83% without any delay in chemotherapy and with the total planned dose. Only five pts required hospitalization during a mean duration of 3 wks. Maximal toxicities (OMS) were grade 2-3 leucopenia in 6 pts, grade 2 anemia in 2 pts, grade 2-3 diarrhea in 12 pts, grade 2-3 nausea-vomiting in 19 pts, grade 2 mucositis in 5 pts, two delayed gastro-intestinal bleeding without any related death. 45% of the pts had stable body weight. Fifty one relapses happened until July 2003, forty one have been at least radiologically documented: 51% were metastatic diseases only, 20% were local relapse only and 29 % were local and metastatic relapse. Median relapse free survival is 9.7 months and median overall survival is 20.3 months. The 3 years overall survival is 36 %.
Conclusion: This chemo-Rth with 10 Gy above the classical adjuvant scheme of 45 Gy is clearly safe and feasible. The very low toxicity and the persistence of many local relapses urge to study a more effective scheme.
Communication
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