Multicenter phase II study of gemcitabine and oxaliplatin (GEMOX) as
second-line chemotherapy in colorectal cancer patients pretreated with
5-fluorouracil plus irinotecan
Purpose: To evaluate the efficacy and tolerance of the
gemcitabine/oxaliplatin (GEMOX) combination as second-line chemotherapy
for patients with advanced colorectal cancer (CRC) pretreated with an
irinotecan (CPT-11)/5-fluorouracil (5-FU)/leucovorin (LV) regimen.
Patients and Methods: Patients with documented disease progression
during or after first-line treatment with CPT-11 and 5-FU/LV were
enrolled. Gemcitabine (1,000 mg/m(2) days 1 and 8) and oxaliplatin (100
mg/m2 day 1) were administered every 3 weeks. Results: Partial responses
were observed in 6 of the 34 (17.7%) patients enrolled
(intention-to-treat analysis; overall response rate: 17.7%; 95%
confidence interval 4.8-30.5%). Eight (23.5%) patients experienced
disease stabilization and 20 (59%) disease progression (tumor growth
control rate = 41.2%). The median duration of response was 5.5 months,
and the median time to tumor progression 2.7 months. The median overall
survival was 9.1 months (1-year survival rate: 44.0%). Grade 3
neutropenia and thrombocytopenia occurred in 18 and 15% of the
patients, respectively. Other severe non-hematologic toxicities were
rare. Conclusion: The interesting tumor growth control rate and the
favorable toxicity profile of the GEMOX regimen in pretreated patients
with advanced CRC strongly suggest that this regimen may provide an
alternative therapeutic option for this group of patients. Copyright (c)
2006 S. Karger AG, Basel
