755 - Oxaliplatin, irinotecan, bevacizumab followed by docetaxel, bevacizumab in inoperable gastric cancer. A multicenter phase II trial (AGMT GASTRIC-3)...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Cytotoxic agents
Gastric Cancer
Therapy
Biological therapy
Presenter Ewald Wöll
Authors E. Wöll1, F. Keil2, J. Thaler3, B. Gruenberger4, M. Hejna5, W. Eisterer6, M.A. Fridrik7, F. Romeder8, R. Greil8
  • 1Internal Medicine, St. Vinzenz Krankenhaus Zams, A6511 - Zams/AT
  • 2Internal Medicine, Hanusch Krankenhaus, Vienna/AT
  • 3Internal Medicine, Klinikum Wels Grieskirchen, Wels/AT
  • 41 Medical Oncology, Krankenhaus der Barmherzigen Br, AT-1020 - Vienna/AT
  • 5Internal Medicine, Medical University Vienna, Vienna/AT
  • 6Department Of Internal Medicine I, University Hospital Innsbruck, AT-6020 - Innsbruck/AT
  • 7Internal Medicine 3, Allgemeines Krankenhaus Linz, AT-4020 - Linz/AT
  • 8Internal Medicine Iii, University Hospital Salzburg, Salzburg/AT

Abstract

Background

In previous phase II trials (AGMT-Gastric-1 and AGMT Gastric-2) we could show efficacy of oxaliplatin and irinotecan as well as oxaliplatin, irinotecan and cetuximab in advanced gastric cancer. Time to progression however was short suggesting acquired chemotherapy resistance. To address this problem sequential chemotherapy combined with bevacizumab is investigated in the presented Gastric-3 trial.

Methods

Oxaliplatin 85 mg/m2 biweekly (q2w) and irinotecan 125 mg/m2 q2w are administered for the first three months followed by docetaxel 50mg/m2 q2w for subsequent three months. Chemotherapy is combined with bevacizumab 5 mg/kg q2w which is administered until progression. For this abstract 36 pt. with histologically proven unresectable and/or metastatic gastric adenocarcinoma treated in a first line setting have been evaluated. Median age: 62.5 years (range 26-80 years), PS 0: 25 patients, PS 1: 10 patients, missing: 1 patients, single metastatic site: 24 patients, multiple metastases: 10 patients, missing: 2.

Results

Frequently reported adverse events (more than 20% of pts.) were predominantly grade 1 or 2 and included diarrhea (25/36, 69%), polyneuropathy (17/36, 47%), nausea (17/36, 47%), fatigue (15/36, 42%), neutropenia (13/36, 36%), abdominal pain (11/36, 31%), hypokalemia (9/36, 25%). Grade 3 and 4 toxicities included neutropenia (6/36, 17%), diarrhea (3/36, 8%), hypokalemia (3/36, 8%), anemia in (2/36, 6%), leucopenia (2/36, 6%), thrombocytopenia (1/36, 3%), nausea in (1/36, 3%). Weight loss Grade 1 was initially documented in 1/36 pts., (3%). Objective response rate after 3 cycles was available in 25 patients: CR 1/25 (4%), PR 14/25 (56%), SD 8/25 (32%), PD 2/25 (8%). After 6 cycles there were 12 evaluable patients with CR 2/12 (16.7%), PR 5/12 (41.7%), SD 4/12 (33.3%) and PD 1/12 (8.3%). Median time to progression was 24 weeks, median overall survival was 48 weeks. Progression total was 12/36 (33%).

Conclusions

The combination of oxaliplatin and irinotecan with bevacizumab followed by docetaxel with bevacizumab is feasible and active in advanced gastric cancer.

Disclosure

All authors have declared no conflicts of interest.