722P - A pilot trial of gemcitabine in combination with capecitabine or erlotinib compared to gemcitabine alone in patients with advanced pancreatic cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer Agents
Pancreatic Cancer
Therapy
Biological Therapy
Presenter Jae Yong Cho
Authors J.Y. Cho1, J.Y. Lim1, S.J. Lee2, D.K. Lee2, J.S. Park3, D.S. Yoon3, Y.H. Min4
  • 1Medical Oncology, Gangnam Severance Hospital, Yonsei University College of Medicine, 135-720 - Seoul/KR
  • 2Gastroeneterology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul/KR
  • 3Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul/KR
  • 4Hematology, Severance Hospital, Seoul/KR

Abstract

Aims

This pilot study was designed to compare the survival benefit of gemcitabine plus capecitabine (GEM-X) or gemcitabine plus erlotinib (GEM-T) over gemcitabine alone (GEM) in patients with locally advanced or metastatic pancreatic cancer.

Methods

Patients with previously untreated locally advanced or metastatic carcinoma of the pancreas were recruited. Patients were assigned to GEM, GEM-T, or GEM-X. The primary end points were the overall survival (OS) and response rate.

Results

A total of 127 patients were assigned to receive GEM (n = 47), GEM-T (n = 44), and GEM-X (n = 36). GEM-X significantly improved the objective response rate (21.2% vs. 12.7% and 15.9%) and the overall disease control rate (partial response plus stable disease; 72.7% vs. 63.8% and 59.1%) compared to GEM and GEM-T, respectively. Progression-free survival was significantly prolonged in the GEM-X group compared to the GEM and GEM-T groups (median, 8.9 months vs. 5.2 and 3.9 months, respectively; P < 0.001). GEM-X significantly reduced the hazard of progression compared with other groups (Hazard ratio [HR] 0.46, 95% confidence interval[CI] 0.27-0.79, p = 0.005 in GEM-X vs. GEM; HR 0.36, 95% CI 0.20-0.64, p = 0.001 in GEM-X vs. GEM-T). The median survival with GEM-X treatment was prolonged upto 12.1 months, compared with 10.4 and 9.9 months for GEM and GEM-T. GEM-X reduced the hazard of death compared to each group (HR 0.52, 95% CI 0.28-0.94, p = 0.033 in GEM-X vs. GEM; HR 0.52, 95% CI 0.28-0.96, p = 0.037 in GEM-X vs. GEM-T). The 1-year OS rates were 51% for GEM-X, 33.7% for GEM, and 40.6% for GEM-T. The incidence of adverse events was not significantly different among groups.

Conclusions

GEM-X is plausible first-line treatment for locally advanced and metastatic pancreatic cancers. GEM-X was superior to GEM and GEM-T accompanying acceptable levels of toxicity, and GEM-T showed similar efficacy to GEM. It is of clinical value to perform a phase III trial to compare gemcitabine plus capecitabine and gemcitabine plus erlotinib in pancreatic cancer patients.

Disclosure

All authors have declared no conflicts of interest.