There is limited information about prognostic factors in RM HNC pts receiving first-line platinum-based chemotherapy and cetuximab. Moreover, we lack survival data in a real-world population, without the selection bias affecting pts enrolled in clinical trials.
We evaluated all consecutive pts treated from 1/2007 to 12/2016 in 6 Italian Centres. The following baseline prognostic factors were investigated: sex, age, site of disease, tumor grading, HPV status for oropharyngeal cancer, performance status (PS), weight loss in the previous 3 months (less/more than 5%), comorbidities (according to ACE-27), residual tumor at primary site, previous chemotherapy or cetuximab in curative setting, previous radiotherapy, platinum type (cisplatin/carboplatin, CBDCA), chemotherapy schedule (weekly/3-weekly), platinum and cetuximab doublet or with a third drug (i.e. 5FU or paclitaxel).
For each potential predictor variable, Kaplan-Meier curves for OS and PFS were estimated, and a Log-rank test was used to compare survivorship in different levels of the variable. A Cox proportional hazard model was run including only predictors characterized by a significant (p < 0.05) Log-rank test.
We analyzed 340 pts, with a median PFS/OS of 5.0/10.6 months. The 1-year and 3-year OS rate for all pts was 44.2% (CI: 39.1-50.0) and 7.8% (CI: 5.1-12.0). Only one out of two pts received a second-line therapy. In univariate analysis lower OS was associated with PS > 0 (p < 0.001), residual tumor at primary site (p < 0.001) and CBDCA use (p = 0.012) while lower PFS was associated with paranasal sinus site (p = 0.008), PS > 0 (p = 0.001), CBDCA use (p = 0.035) and residual tumor at primary site (p < 0.001). All these predictors except for platinum type remained significant at multivariate analysis. Pts with clinical response to treatment carried a more favorable prognosis, while progressive disease as best response had a dismal median OS of 5.8 months.
In non-selected RM HNC pts, we obtained a median PFS and OS of 5.0 and 10.6 months, very similar to 5.6 and 10.1 months reported in Extreme trial (Vermorken et al. 2008). At baseline, PS and residual tumor at primary site could be used to define pt prognosis.
Clinical trial identification
Legal entity responsible for the study
Has not received any funding.
P. Bossi, D. Ferrari, R. Depenni, G. Azzarello: Advisory board: Merck Serono. L.F. Licitra: Advisory board and research support: Merck Serono. All other authors have declared no conflicts of interest.