Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer
Background and purpose: To investigate the efficacy and toxicity of a short intensive Uracil/Tegafur (UFT) based chemoradiotherapy scheme combined with celecoxib in locally advanced pancreatic cancer. Material and methods: The Academic Medical Centre, Amsterdam and the Erasmus Medical Centre, Rotterdam enrolled 83 eligible patients with unresectable pancreatic cancer in a prospective multicentre phase II study. Median age was 62 years, median tumour size 40 mm and the majority of the patients (85%) had pancreatic head cancers. Treatment consisted of 20 × 2.5 Gy radiotherapy combined with UFT 300 mg/m2 per day, leucovorin (folinic acid) 30 mg and celecoxib 800 mg for 28 days concomitant with radiotherapy. Four patients were lost to follow-up. Results: Full treatment compliance was achieved in 55% of patients, 80% received at least 3 weeks of treatment. No partial or complete response was observed. Median survival was 10.6 months and median time to progression 6.9 months. Toxicity was substantial with 28% grades III and IV gastro-intestinal toxicity and two early toxic deaths. Conclusions: Based on the lack of response, the substantial toxicity of mainly gastro-intestinal origin and the reported mediocre overall and progression free survival, we cannot advise our short intensive chemoradiotherapy schedule combined with celecoxib as the standard treatment.
|Keywords||COX-II inhibitor, Chemoradiotherapy, Locally advanced pancreatic cancer, Phase II clinical trial, UFT, adult, aged, anorexia, article, blood toxicity, cancer growth, cancer radiotherapy, cancer survival, celecoxib, diarrhea, drug efficacy, fatigue, female, fever, folinic acid, human, inoperable cancer, major clinical study, male, mucosa inflammation, multicenter study, multimodality cancer therapy, nausea, pain, pancreas cancer, patient compliance, phase 2 clinical trial, priority journal, progression free survival, vomiting|
|Persistent URL||dx.doi.org/10.1016/j.radonc.2010.10.016, hdl.handle.net/1765/23416|
Morak, M.J.M, Richel, D.J, van Eijck, C.H.J, Nuyttens, J.J.M.E, van der Gaast, A, Verwenne, W.L, … van Tienhoven, G. (2011). Phase II trial of Uracil/Tegafur plus leucovorin and celecoxib combined with radiotherapy in locally advanced pancreatic cancer. Radiotherapy & Oncology, 98(2), 261–264. doi:10.1016/j.radonc.2010.10.016