Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 4630
© 2008 American Society of Clinical Oncology

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Abstract

Preoperative gemcitabine (gem) and bevacizumab (bev)-based chemoradiation for resectable pancreatic adenocarcinoma

University of Texas M. D. Anderson Cancer Center, Houston, TX

4630

Background: Over 80% of pts who undergo potentially curative pancreaticoduodenectomy (PD) for pancreatic adenocarcinoma (PC) develop local or distant recurrence. Preoperative therapy maximizes the no. of pts who receive multimodality therapy and undergo a complete (R0) resection. Our phase I study using bev and capecitabine based chemoradiation for locally advanced PC was well tolerated. We hypothesized that gem and bev with RT in pts with resectable PC may allow more pts to undergo PD and improve the rate of R0 resections. Methods: Pts with biopsy proven, stage I/II adenoca of the pancreatic head or uncinate process received 6 wkly infusions of gem (400 mg/m²) and 3 infusions of bev (10 mg/kg, every 2 wks) with concomitant RT, 50.4 Gy at 1.8 Gy/fr. Pts were restaged 4–6 wks after the last dose of radiation. Those without disease progression and with good PS underwent surgery. Pts with adequate recuperation received bev (10mg/kg) every 2 weeks for 3 months starting 6 wks after surgery. Results: This study has enrolled 11 pts. Median age is 64 yrs; all pts had ECOG-PS 0–1. Median CA19–9 was 52. Of the 11 pts who finished chemoradiation, 10 underwent restaging and 1 pt died from cardiac arrest before restaging. At restaging, 1 pt. had metastatic disease, and 9 (90 %) went to surgery and underwent a successful (R0) PD. Pathologic PR rate (>50 % tumor kill) was 56 %. Preoperative grade 3–4 toxicities were infrequent and included stent related cholangitis (1), gastrointestinal toxicity (1), neutropenia (4), hypertension (1), and PE (1). Major postop complications occurred in 5 of the 9 pts (56%) who underwent PD including wound dehiscence (3) requiring reoperation, large ventral hernia related to fascial dehiscence (1) and biliary anastomotic leak (1). Conclusions: This study was planned to build on our previous gem-based preop chemoradiation program with an estimated accrual of 31 pts. However, interim analysis after accrual of 11 pts suggests that the rate of major postop complications was unforeseen and significant. The combined use of bevacizumab with radiation or gemcitabine (or both) may have contributed to poor wound healing. Optimal use of anti-VEGF therapy in the preop setting requires further refinement.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration GenentechTM BioOncology

Abstract presentation from the 2008 ASCO Annual Meeting