Exploring new potentials and generating hypothesis for management of locally advanced head neck cancer: Analysis of pooled data from two phase II trials

Abstract

Background: To study the long term results of two phase II concurrent chemoradiotherapy protocols and conduct pooled data analysis with special emphasis on nodal density. Materials and Methods: In the period from April 2001 to May 2003, phase II Mitomycin C (MMC) and late chemo-intensification (LCI) protocols were started in the same institute, enrolling 69 and 74 patients respectively. Long term results for these individual trials are reported along with pooled data analysis. Results: Median follow-up time for whole group, MMC protocol and LCI protocol was 43.8 months (SD619.8), 55 months (SD 618.5) and 47.5 months (SD 620.9) respectively. LRFS, DFS and OS at five years for whole group was 59.4, 43.5 and 47.1% respectively, for MMC protocol was 59.9, 45.5 and 49.5% respectively and for LCI, protocol was 53.6%, 41.5% and 44.4% respectively. Subgroup analysis revealed that MMC protocol was more effective than LCI protocol in terms of DFS and OS in patients with hypo dense nodes while opposite was true for Isodense nodes. Multivariate analysis revealed nodal density as an independent variable that had an impact on treatment outcome. Risk of death in patients with hypo dense nodes was 2.91 times that of Isodense nodes. Conclusions: Innovative and pragmatic approach is required to address locally advanced head neck cancer. Long term results for MMC and LCI protocols are encouraging. Integrating the basic concepts of these protocols may help develop new protocols, which will facilitate the search for the optimal solution