GRONINGEN, The Netherlands- Oxaliplatin(Drug information on oxaliplatin) (Eloxatin) added
to a standard bolus fluorouracil(Drug information on fluorouracil)/folinic
acid (5-FU/FA) regimen apparently
increases response and progressionfree
survival time in patients with metastatic
colorectal cancer (abstract
The oxaliplatin-containing combination
was associated with less grade
3/4 diarrhea and mucositis vs 5-FU/
FA in the randomized, phase III trial.
Median overall survival time was approximately
14 months in patients
treated with standard therapy or with
the regimen containing oxaliplatin.
"Despite a low treatment cross-over
rate, overall survival in both groups
was comparable," according to the
Dutch Oxaliplatin Study Group. Reporting
on behalf of the group were
Geke Hospers, MD, PhD, University
Hospital Groningen, and Michael
Schaapveld, MD, Comprehensive
Cancer Center North Netherlands,
Compared to Standard Tx
The study included 302 patients with metastatic colorectal cancer enrolled between July 1999 and August 2002. As first-line treatment, patients received either:
- standard bolus administration of 5-FU 425 mg/m2 on days 1 to 5, and FA 20 mg/m2 on days 1 to 5 q4 wk; or
- oxaliplatin 85 mg/m2 as a 2-hour infusion, FA 200 mg/m2 as a 1-hour infusion, and 5-FU 2,600 mg/m2 as a 24-hour infusion on day 1 q2wk.
Stomatitis/diarrhea was much more common in the standard 5-FU/FA arm, 22 cases vs 6 cases in the oxaliplatin/ 5-FU/FA arm (P < .001). There was a low (less than 10%) incidence of grade 3/4 vomiting and hematologic toxicity in both groups. Grade 3/4 sensory neuropathy, related to oxaliplatin, was seen in 10% of patients in the oxaliplatin/5-FU/FA arm. There was one toxic death, from septicemia, in the standard 5-FU/FA arm. "Immunologic side effects deserve attention," the investigators noted. In the oxaliplatin arm, 5% had grade 3/4 immunologic events; two cases were classical anaphylaxis and five were atypical, with thrombocytopenia, hemolysis, pulmonary and renal dysfunction, and the one toxic death. Second-line treatment was not specified in the study protocol, but about 14% of patients on standard therapy crossed over to treatment with oxaliplatin. Overall, about 60% of patients in either arm went on to receive second-line treatment.