Nimotuzumab-gemcitabine combo improves survival in metastatic pancreatic cancer patients
The combination of nimotuzumab and gemcitabine is safe and well tolerated in the treatment of patients with locally advanced or metastatic pancreatic cancer, significantly improving 1-year overall survival (OS) and progression-free survival (PFS) rates especially in those with KRAS wild-type tumours, according to a study.
A total of 192 patients with previously untreated, unresectable, locally-advanced or metastatic pancreatic cancer were randomly assigned to receive gemcitabine (1,000 mg/m2, administered as a 30-minute infusion once weekly for 3 weeks, followed by a 1-week rest) plus either nimotuzumab (fixed dose of 400 mg as a 30-minute infusion) or placebo. Treatment was given until progression or unacceptable toxicity.
Of the patients, 186 (average age 63.6 years) were evaluated for efficacy and safety. The primary endpoint of OS was markedly higher in the nimotuzumab vs the placebo group (median, 8.6 vs 6.0 months; hazard ratio [HR], 0.69; p=0.0341). PFS was similarly better in the group receiving nimotuzumab (median, 5.1 vs 3.4 months; HR, 0.68; p=0.0163).
The corresponding 1-year OS and PFS were 34 and 22 percent for the gemcitabine plus nimotuzumab group vs 19 and 10 percent for the gemcitabine plus placebo group (HR for OS, 0.69; p=0.03; HR for PFS, 0.68; p=0.02).
Of note was the significantly better OS observed among patients with KRAS wild-type tumours than those with KRAS mutations (11.6 vs 5.6 months; p=0.03).
In terms of safety, very few grade 3/4 toxicities were reported. Commonly reported adverse events in the gemcitabine plus nimotuzumab group included chills, fatigue and pyrexia.
Nearly always fatal, pancreatic cancer has a 5-year survival rate of below 5 percent. Palliative chemotherapy remains the treatment of choice, given that most patients present with advanced disease. [Ann Oncol 2013;24:792-800; Ther Adv Med Oncol 2015;7:68-84; Oncology (Williston Park) 2014;28:70-74]