Results of a Prospective Phase II Clinical Trial of Induction Gemcitabine/Capecitabine Followed by Stereotactic Ablative Radiotherapy in Borderline Resectable or Locally-advanced Pancreatic Adenocarcinoma

Publication date: Available online 7 October 2017
Source:Practical Radiation Oncology
Author(s): Kimmen Quan, Philip Sutera, Karen Xu, Mark E. Bernard, Steven A. Burton, Rodney E. Wegner, Herbert Zeh, Nathan Bahary, Ronald Stoller, Dwight E. Heron
PurposeStereotactic ablative radiotherapy's (SABR) great conformity and short duration, has become an attractive treatment modality. We report a phase II clinical trial to evaluate efficacy and safety of induction chemotherapy (ICT) followed by SABR, in patient (pts) with borderline resectable (BR) and locally-advanced (LA) pancreatic ductal adenocarcinoma (PDAC).Methods and MaterialsPts with biopsy-proven BR or LA PDAC were treated with four 21-day cycles of IV gemcitabine, and PO capecitabine. Pts were re-staged within 4weeks after ICT by CT, and treated by 3-fraction SABR if no metastasis or progressive disease was identified. Pts were re-staged 4weeks following SABR to determine resectability. Tumor response was assessed with CA19–9.Results35 pts. (19 BR/16 LA) were enrolled. The median age was 71. 8 yo (range: 50.6–81.1 yo). ICT was completed in 91. 4% (n=32) of pts. All pts. who completed ICT completed SABR. Of those 32 pts., 34.3% (n=12: 10 BR, 2 LA) underwent pancreaticoduodenectomy and 11/12 (91. 7%) received R0 resection. Median overall survival (OS) 18.8, 28.3, and 14.3months for the entire cohort, BR, and LA respectively. 2-yr. local progression-free survival (LPFS) was 44.9%, 40%, and, 52% for the entire cohort, BR, and LA respectively. For BR pts., multivariate analysis showed surgery was associated with better OS and LPFS. 1-yrLPFS for pts. with surgery was 80% and 44% without surgery. Within the 15.4month follow up, no grade 3+ toxicity from SABR was observed No significant Quality of Life change was observed before and after ICT, SABR or surgery for BR or LA pts.ConclusionThis is the first prospective phase II study to investigate the feasibility and efficacy of a 12-week gemcitabine/capecitabine ICT followed by SABR for BR or LA PDAC. The results suggest excellent tolerability, high R0 resection rates and acceptable post-treatment complications.SummaryWe report the very first prospective phase II clinical study to investigate the feasibility, efficacy and safety of a 12-week gemcitabine/capecitabine induction chemotherapy course followed by stereotactic ablative radiotherapy for borderline resectable or locally-advanced pancreatic adenocarcinoma. The results suggest excellent tolerability, acceptable toxicities and high R0 resection rates.



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