Multicenter Phase II Study of Gemcitabine and Oxaliplatin (GEMOX) as Second-Line Chemotherapy in Colorectal Cancer Patients Pretreated with 5-Fluorouracil plus Irinotecan

Abstract

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/m² days 1 and 8) and oxaliplatin (100 mg/m² day 1) were administered every 3 weeks. Results: Partialresponses 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.

Dose-finding study and pharmacogenomic analysis of fixed-rate infusion of gemcitabine, irinotecan and bevacizumab in pretreated metastatic colorectal cancer patients

“…Although it is a heterogeneous group, with most patients receiving the regimen as second line and some as an even later line, if we take into account the type of previous systemic therapies and the high percentage of patients considered to have a truly resistant or refractory disease, our results seem to be encouraging and compare favourably with other irinotecan-based regimens in oxaliplatin-pretreated mCRC (Recchia et al , 2004; Tournigand et al , 2004; Bidard et al , 2009). Furthermore, they overlap with those achieved when bevacizumab is combined with a more active partner than 5-FU (Giantonio et al , 2007; Lievre et al , 2009) and with other reported GMB-based schedules (Correale et al , 2004, 2005; Ziras et al , 2006; Lopes et al , 2007; Bitossi et al , 2008; Merl et al , 2009). Although 27% of the patients underwent a consolidative procedure, this finding should be viewed with caution, as the trial was not specifically designed to rule out the resectability rate achieved with this combination.…”

Randomized phase 2 sequencing and pharmacokinetic study of gemcitabine and oxaliplatin in advanced non‐small cell lung cancer

“…[14][15][16][17][18] Foremost amongst these is pancreatic cancer, for which there is now phase 3 evidence supporting oxaliplatin and gemcitabine as an alternative to single agent gemcitabine. 19 A number of studies have been carried out in patients with NSCLC.…”

Mitomycin‐C, 5‐fluorouracil, and leucovorin as a salvage therapy in patients with metastatic colorectal adenocarcinoma

“…The result from the study with gemcitabine and oxaliplatin showed a response rate of 17.7 percent and stable disease of 23.5 percent in metastatic colorectal cancer patients previously treated with 5FU/LV and irinotecan. 24 After the failure of oxaliplatin or irinotecan-containing chemotherapies, or both, gemcitabine and 5-FU infusion have been evaluated in 37 metastatic colorectal cancer patients. This study reported a partial response in 10.8 percent and disease stabilization in 62.2 percent.…”