P-185 - Randomized phase III trial of nab-paclitaxel (nab-P) plus gemcitabine (Gem) vs Gem alone as adjuvant therapy for patients with resected pancreatic c...

Date 04 July 2015
Event WorldGI 2015
Session Posters
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Margaret A. Tempero
Citation Annals of Oncology (2015) 26 (suppl_4): 1-100. 10.1093/annonc/mdv233
Authors M.A. Tempero1, P.A. Philip2, H. Riess3, D. Cardin4, A. Biankin5, D. Goldstein6, M. Moore7, E. O'Reilly8, T. Macarulla9, L. Yung10, M. Li11, B. Lu10
  • 1San Francisco/US
  • 2Detroit/US
  • 3Charité-Universitätsmedizin Berlin, Berlin/DE
  • 4Nashville, Nashville/US
  • 5University of Glasgow, Glasgow/UK
  • 6Prince of Wales Hospital, Sydney/AU
  • 7Princess Margaret Hospital, Toronto/CA
  • 8New York, New York/US
  • 9Vall d'Hebron University Hospital, Barcelona/ES
  • 10Summit/US
  • 11Basking Ridge/US

Abstract

Introduction

Adjuvant chemotherapy with Gem has been shown to decrease disease recurrence and increase survival following surgery in patients with resected pancreatic cancer. However, disease recurrence is common, suggesting a need for improved regimens. In the phase III MPACT trial, nab-P + Gem demonstrated significantly longer overall survival (OS; primary endpoint) than Gem alone in patients with metastatic pancreatic cancer (median, 8.7 vs 6.6 months; HR 0.72; P < 0.001). Toxicities were manageable and consistent with those in previous studies. The findings of the MPACT trial supported the investigation of nab-P + Gem vs Gem alone as adjuvant therapy in the phase III APACT study of patients with resected pancreatic cancer.

Methods

Approximately 800 patients will be enrolled. Eligibility criteria include histologically confirmed pancreatic cancer with macroscopic complete resection (R0 or R1); stage T1-3, N0-1, M0; Eastern Cooperative Oncology Group performance status 0 or 1; acceptable hematologic/blood chemistry levels; and CA19-9 < 100 U/mL within 14 days of randomization. Patients who have neuroendocrine tumors, presence or history of metastatic pancreatic cancer, any other malignancy within 5 years of randomization, HIV infection, hepatitis B or C infection, or prior neoadjuvant treatment or radiation therapy for pancreatic cancer are ineligible. Study treatment should begin as early as adequate recovery from surgery will allow but no later than 12 weeks postsurgery. Patients will be randomized to receive 6 cycles of either nab-P 125 mg/m2 plus Gem 1000 mg/m2 or Gem alone 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle. The study design is summarized in Table 1. Two dose reductions are allowed for hematologic and other toxicities. Patients will be discontinued from the study if more than 2 dose reductions are required. The planned enrollment of 800 patients will allow 90% power to detect an HR for disease-free survival of 0.74 at a 2-sided significance level of 0.05. One interim safety analysis is planned after 100 patients are treated for at least 2 cycles. Two interim efficacy analyses (the first for futility and the second for both futility and superiority) will be performed. Over 100 patients were enrolled as of February 2015. Patient enrollment is ongoing. ClinicalTrials.gov: NCT01964430.

Table: P-185. Study Design