Khalid Al Saleh, Reham Safwat, Ahmed Bedair, Mustafa El-Sherify, Jitendra Shete, Amany AL Basmy.
Kuwait cancer control center
Kuwait
Background:
This is an update of a randomized study comparing the use of cetuximab versus platinum based chemotherapy with concurrent hyperfractionated radiation therapy (HRT) in locally advanced non metastatic head and neck carcinoma. Acute and late toxicity as well as progression free survival (PFS) were set as primary end points, while overall survival (OS) was set as secondary end point.
Methods:
Between December 2009 and August 2013, 37 patients were randomly assigned to HRT consisting of 120 cGy twice daily, to a total of 69.6-75.6 Gys in 58-63 fractions over 6 weeks, plus either platinum-based chemotherapy (Arm A: 22 patients) or weekly cetuximab (Arm B: 15 patients). The overall radiation dose was the same for the two groups. The median follow up time of the whole group was 19.3 months (IQR: 6.1- 37.1 ms).
Results:
The mean Overall treatment time was 62 days in both arms (p= 0.93). Skin toxicity (Grade >3) was experienced in 36.4% of patients in arm A and 40% in arm B (p= 0.82). Mucositis (Grade >3) was 54.5% in arm A and 60% in arm B (p=0.74). Hematologic toxicity of (Grade >3) occurred in 18.2% and 13.3% of the cases respectively (p= 0.9). The mean percent of weight loss was (9.2%, SD=5.8) in group A, and (13 %, SD=6) in group B respectively (p=0.06). Complete response was observed in 16 patients (72.7%) and 8 patient (53.3%) of arm A and B respectively p= 0.23. Partial response was achieved in 2 (9.1%) patients in arm A and in 6 (40%) in arm B. The 1-year PFS for the whole group, arm A, & arm B were 67.6%, 63.9% & 75% respectively (p= 0.37).The 2-year O.S was 88.9% and 90% for arm A and B respectively.
Conclusions:
When HRT is used, both platinum-based and cetuximab concomitant regimens seem to have equivalent PFS and OS. Moreover, the toxicity profile for both regimens is largely similar although a trend for less haematological but more skin and mucosa toxicities were noticed in the cetuximab arm. A larger patient’s cohort and longer follow up period is required to validate our findings.
