Reoperative surgery results for GERD are satisfactory. A variety of operative approaches proved equally effective. Poorer results were observed in patients with more advanced disease.
Purpose: To review early outcomes for patients enrolled on our institution's protocol (PC01) for patients with unresectable pancreatic cancer, and to test whether the serious adverse event rate could be reduced from 15% (expected) to ,5%. Patients and Methods: Twelve patients were enrolled, but only 11 patients are reported in this analysis. Pathology on all patients was reviewed at University of Florida Health Medical Center in Jacksonville to confirm the diagnosis of pancreatic adenocarcinoma. Unresectability was defined by radiographic evidence of encasement of the celiac axis and/or superior mesenteric artery or by occlusion of the superior mesenteric vein, portal vein, or both confluences. Patients received proton therapy to a planning target volume dose of 59.4 Gy (relative biological effective) at 1.8 Gy (relative biological effective) per fraction over 7 weeks with concomitant oral capecitabine (1000 mg orally twice-daily, 5 days/week on radiation treatment days only). Only gross disease was targeted. Results: Median follow-up for all patients was 14 months (range, 5 to 25 months). Median follow-up for surviving patients was 23 months (range, 8 to 25 months). Median age was 68 years (range, 51 to 86 years). One-and 2-year overall survival, progression-free survival, distant metastasis-free survival, and freedom from local progression rates were 61% and 31% (median, 18.4 months), 55% and 14%, 68% and 27%, and 86% and 69%, respectively. No patient experienced a grade 3 or greater toxicity during treatment or follow-up. Grade 2 toxicity was limited to a single patient experiencing grade 2 fatigue. Median weight loss over the course of treatment was 1.7 kg (range, loss of 5.7 to gain of 4.9 kg). Four patients had an adequate radiographic response to radiation therapy to justify surgical exploration. Conclusion: Proton therapy with concomitant capecitabine as delivered on the PC01 protocol was well-tolerated with no grade 2 or greater gastrointestinal toxicities. The
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