FOLFOXIRI (irinotecan, oxaliplatin
, and infusional 5-FU/LV) in combination with bevacizumab (BV) in the first-line treatment of metastatic colorectal cancer (mCRC): a phase II study by the G.
One group received combination therapy with oxaliplatin
, fluorouracil, and leucovorin--a regimen called FOLFOX; another group received a combination of fluorouracil and leucovorin (FU-LV also known as 5FU-LV); the third group received oxaliplatin
APP currently markets Oxaliplatin
for Injection (lyophilized) under a previously approved ANDA for Fresenius Kabi Oncology Limited (NSE: FKONCO, BSE: 532545).
and fluoropyrimidine combination was well tolerated and the dermatological toxicity (acneiform rash) was the typical adverse effect seen using anti-EGFR biological agents.
The study aimed to establish the potential use of Xeloda (X) and oxaliplatin
(O) in previously untreated patients
The combination of oxaliplatin
(Eloxatin), 5-fluorouracil, and leucovorin resulted in a greater number of patients with tumor shrinkage and delay in the resumption of cancer growth in patients who had either a relapse or progression of cancer while on or shortly after treatment with irinotecan, bolus 5-fluorouracil, and leucovorin.
In 2007, APP and Fresenius Kabi filed ANDAs seeking approval to market generic oxaliplatin
Pooled analysis of safety and efficacy of oxaliplatin
plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer.
By demonstrating that Xeloda in combination with oxaliplatin
was as effective as FOLFOX-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer.
A dose-limiting toxicity for oxaliplatin
was defined as any grade 3 or higher hematologic or nonhematologic adverse event (J.
Sanofi-Aventis has also sued the FDA seeking to rescind all approvals granted to date for Oxaliplatin
Injection pending resolution of the outstanding appeal.
The combination of all cytotoxic drugs in one regimen [5-fluorouracil, leucovorin, oxaliplatin
and irinotecan (FOLFOXIRI)] increased the response rate and resection rate in a randomised study , and adding cetuximab to irinotecan- or oxaliplatin
-based chemotherapy also increases the response rates.