CONCOMITANT INTRAARTERIAL CISPLATIN, INTRAVENOUS 5-FLUOROURACIL, AND SPLIT-COURSE RADIATION-THERAPY FOR LOCALLY ADVANCED UNRESECTABLE PANCREATIC ADENOCARCINOMA - A PHASE-II STUDY OF THE PUGET-SOUND-ONCOLOGY-CONSORTIUM (PSOC-703)

A Gastrointestinal Tumor Study Group (GITSG) protocol showed a surviva l benefit for patients with locally advanced unresectable pancreatic a denocarcinoma when treated with split-course radiation therapy and bol us intravenous (i.v.) 5-fluorouracil (5-FU) as compared with survival achieved with radiation alone. In an attempt to improve these results, a phase II trial using intraarterial (i.a.) cisplatin, systemic-infus ional 5-FU, and concomitant split-course radiation therapy was conduct ed. Sixteen previously untreated patients with unresectable pancreatic adenocarcinoma (5 with American Joint Committee on Cancer [AJCC] stag e I-II, 11 with stage III) disease were treated with i.a. cisplatin 10 0 mg/m(2) by selective celiac arteriography followed by i.v. infusiona l 5-FU 1,000 mg/m(2)/day for 4 days, and concomitant split-course exte rnal beam photon radiation therapy at 2.0 Gy for 10 days in a 12-day p eriod. After a planned 14-day interval, the identical chemoradiation t reatment was repeated; finally, after a second 2-week interval, a thir d cycle of chemotherapy with a final 10 Gy radiation was administered. All 16 patients were evaluable for response; there were two partial r esponses(PR: 12%) and five minor responses (31%). Median follow-up per iod was 77 months. Median time to progression was 6 months(range 1-12 months), and median survival was 9 months (range 4-94 months). Nausea/ vomiting was the major toxicity. There were no treatment-related fatal ities. This regimen of concomitant i.a. cisplatin, i.v. infusional 5-F U, and split-course external beam photon radiation is well tolerated b ut has minimal activity in the treatment of locally advanced unresecta ble pancreatic adenocarcinoma. Future combined-modality protocols for this disease should explore alternative chemoradiation schemes.