Cetuximab Improves Efficacy of Cisplatin/Vinorelbine in EGFR-Positive NSCLC Patients

BARCELONA-Adding cetuximab(Erbitux) improves the efficacyof cisplatin/vinorelbine (Navelbine)for first-line treatment of advancednon-small-cell lung cancer (NSCLC)in patients whose tumors express epithelialgrowth factor receptor (EGFR),according to Rafael Rosell, MD, of theCatalan Institute of Oncology, Barcelona,Spain. Dr. Rosell reported thatdata from a randomized phase II studyalso showed that development of askin rash is predictive of response andthat the toxicity of the regimen wasnot increased substantially by addingcetuximab (abstract 7012).Cetuximab is an IgG1 monoclonalantibody targeting the EGFR. Dr.Rosell said that combinations of cetuximaband chemotherapy have beenshown to be effective and safe in otherEGFR-expressing tumors such ascolorectal and head and neck cancers.PredominantlyStage IVThe primary study endpoint wasobjective response rate. Ninety percentof the patients in this study hadstage IV disease.All patients were treated with threecycles of cisplatin 80 mg/m² on day 1and vinorelbine 25 mg/m² on days 1and 8. Patients were then randomizedto receive either additional treatmentwith cetuximab 400 mg/m² on week 1and 250 mg/m² weekly thereafter (armA, n = 43), or no additional treatment(arm B, n = 43). Ninety percent (101of 122 patients screened) had EGFRexpressing tumors. A total of 86 patientswere enrolled, 43 in each of thetwo treatment arms.One-year survival was 32% withcetuximab plus chemotherapy vs 29%with placebo plus chemotherapy, butDr. Rosell emphasized that only fivepatients are still alive. Survival at 18months was 14% with cetuximab vs 0on the comparison arm. "The longestsurvival was 24 months," he said.The patients who were treated withcetuximab had more grade 3 or 4 astheniaand fatigue (19% vs 2%).Complete/PartialResponsesFor patients under age 60 years, theunconfirmed complete response/partialresponse rate was 63% for patientstreated with cetuximab vs 2% for controls.In the same population, confirmedcomplete/partial responseswere 14% with cetuximab, 0 withoutcetuximab. For patients over age 60years, the unconfirmed completeresponse/partial response rate was31% with cetuximab vs 36% withoutcetuximab. Dr. Rosell said that theresponse rate was 25% in patients whodeveloped any type of skin toxicity."Cetuximab can safely be added tothe regimen of cisplatin and vinorelbine,with evidence suggesting enhancementof activity," Dr. Rosellconcluded.