Quality of life scores as prognostic factors of overall survival in advanced head and neck cancer: Analysis of a phase III randomized trial of pemetrexed plus cisplatin versus cisplatin monotherapy

SummaryObjectives: We examined the prognostic factors (clinical, demographic, and health-related quality of life [HRQoL]) of overall survival (OS) and progression-free survival (PFS) in patients with recurrent/metastatic head and neck cancer (HNC) who were treated with pemetrexed plus cisplatin versus cisplatin in a phase III, multinational, randomized trial.Materials and Methods: Five subscales of the Functional Assessment of Cancer Therapy-Head and Neck Cancer (FACT-H&N), modified to score from 0 to 100, measured HRQoL at baseline and during treatment. Univariate and multivariate Cox proportional hazards models were used on data pooled from both treatment arms to assess the effect of baseline prognostic factors on OS and PFS.Results: Of 795 patients randomized, 704 completed a baseline FACT-H&N and were included in the analysis. Age (<65 versus ⩾65; HR = 0.74, 95% CI: 0.61–0.90), race (Caucasian versus non-Caucasian; HR = 0.83, 95% CI: 0.70–0.98 per table), Eastern Cooperative Oncology Group performance status (ECOG PS; 0/1 versus 2; HR = 0.44, 95% CI: 0.35–0.56), prior surgery/radiotherapy in the last 6 months (no versus yes; HR = 0.74, 95% CI: 0.61–0.90), and primary site of disease (oral cavity versus other; HR = 1.37, 95% CI: 1.15–1.63) were significantly prognostic of OS in univariate models, as were baseline scores on four FACT-H&N subscales (physical well-being, emotional well-being, functional well-being, additional concerns-H&N; HRs = 0.82–0.94; all P ⩽ 0.002). In multivariate models, significant prognostic factors were age (HR = 0.78); race (HR = 0.76 per table); ECOG PS (HR = 0.56); prior surgery/radiotherapy (HR = 0.76); and baseline scores of the FACT-H&N subscales of physical well-being, social/family well-being, and additional concerns-H&N (HRs = 0.89–0.94; all P ⩽ 0.014 per table).Conclusions: The results suggest that baseline HRQoL scores are prognostic indicators of OS in recurrent/metastatic HNC in addition to other known clinical and demographic indicators. HRQoL might be considered as a stratification factor in randomized clinical trials of recurrent/metastatic HNC.