Pemetrexed in combination with cisplatin versus cisplatin monotherapy in patients with recurrent or metastatic head and neck cancer
Urba S et al. – Pemetrexed–cisplatin compared with placebo–cisplatin did not significantly improve survival for the intent–to–treat population. However, in a prespecified subgroup analysis, pemetrexed–cisplatin showed overall survival (OS) and progression–free survival (PFS) advantage for patients with performance status 0 or 1 or oropharyngeal cancers.Methods
- In a double–blind phase 3 trial, patients with recurrent or metastatic SCCHN and no prior systemic therapy for metastatic disease were randomized to pemetrexed (500mg/m2) plus cisplatin (75mg/m2; n=398) or placebo plus cisplatin (75mg/m2; n=397) to assess overall survival (OS) and secondary endpoints.
- Median OS was 7.3months in the pemetrexed–cisplatin arm and 6.3months in the placebo–cisplatin arm (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.75–1.02; P=.082).
- Median progression–free survival (PFS, months) was similar in both treatment arms (pemetrexed–cisplatin, 3.6; placebo–cisplatin, 2.8; HR, 0.88; 95% CI, 0.76–1.03; P=.166).
- Among patients with performance status 0 or 1, pemetrexed–cisplatin (n=347) led to longer OS and PFS than placebo–cisplatin (n=343; 8.4 vs 6.7months; HR, 0.83; P=.026; 4.0 vs 3.0months; HR, 0.84; P=.044, respectively).
- Among patients with oropharyngeal cancers, pemetrexed–cisplatin (n=86) resulted in longer OS and PFS than placebo–cisplatin (n=106; 9.9 vs 6.1months; HR, 0.59; P=.002; 4.0 vs 3.4months; HR, 0.73; P=.047, respectively).
- Pemetrexed–cisplatin toxicity was consistent with studies in other tumors.