Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial

Alice C. Wei, Fang Shu Ou, Qian Shi, Xiomara Carrero, Eileen M. O’Reilly, Jeffrey Meyerhardt, Robert A. Wolff, Hedy L. Kindler, Douglas B. Evans, Vikram Deshpande, Joseph Misdraji, Eric Tamm, Dushyant Sahani, Malcolm Moore, Elliot Newman, Nipun Merchant, Jordan Berlin, Laura W. Goff, Peter Pisters, Mitchell C. Posner

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Background: There is considerable interest in a neoadjuvant approach for resectable pancreatic ductal adenocarcinoma (PDAC). This study evaluated perioperative gemcitabine + erlotinib (G+E) for resectable PDAC. Methods: A multicenter, cooperative group, single-arm, phase II trial was conducted between April 2009 and November 2013 (ACOSOG Z5041). Patients with biopsy-confirmed PDAC in the pancreatic head without evidence of involvement of major mesenteric vessels (resectable) were eligible. Patients (n = 123) received an 8-week cycle of G+E before and after surgery. The primary endpoint was 2-year overall survival (OS), and secondary endpoints included toxicity, response, resection rate, and time to progression. Resectability was assessed retrospectively by central review. The study closed early due to slow accrual, and no formal hypothesis testing was performed. Results: Overall, 114 patients were eligible, consented, and initiated protocol treatment. By central radiologic review, 97 (85%) of the 114 patients met the protocol-defined resectability criteria. Grade 3+ toxicity was reported in 60% and 79% of patients during the neoadjuvant phase and overall, respectively. Twenty-two of 114 (19%) patients did not proceed to surgery; 83 patients (73%) were successfully resected. R0 and R1 margins were obtained in 67 (81%) and 16 (19%) resected patients, respectively, and 54 patients completed postoperative G+E (65%). The 2-year OS rate for the entire cohort (n = 114) was 40% (95% confidence interval [CI] 31–50), with a median OS of 21.3 months (95% CI 17.2–25.9). The 2-year OS rate for resected patients (n = 83) was 52% (95% CI 41–63), with a median OS of 25.4 months (95% CI 21.8–29.6). Conclusions: For resectable PDAC, perioperative G+E is feasible. Further evaluation of neoadjuvant strategies in resectable PDAC is warranted with more active systemic regimens.

Original languageEnglish (US)
Pages (from-to)4489-4497
Number of pages9
JournalAnnals of surgical oncology
Volume26
Issue number13
DOIs
StatePublished - Dec 1 2019

ASJC Scopus subject areas

  • Surgery
  • Oncology

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    Wei, A. C., Ou, F. S., Shi, Q., Carrero, X., O’Reilly, E. M., Meyerhardt, J., Wolff, R. A., Kindler, H. L., Evans, D. B., Deshpande, V., Misdraji, J., Tamm, E., Sahani, D., Moore, M., Newman, E., Merchant, N., Berlin, J., Goff, L. W., Pisters, P., & Posner, M. C. (2019). Perioperative Gemcitabine + Erlotinib Plus Pancreaticoduodenectomy for Resectable Pancreatic Adenocarcinoma: ACOSOG Z5041 (Alliance) Phase II Trial. Annals of surgical oncology, 26(13), 4489-4497. https://doi.org/10.1245/s10434-019-07685-1