A phase 2 randomized study to compare short course palliative radiotherapy with short course concurrent palliative chemotherapy plus radiotherapy in advanced and unresectable head and neck cancer

Abstract

BackgroundTreatment of unresectable HNSCC is not well defined and has a poor outcome. This study has been designed to address the unmet needs of such groups of patients with primary end points of (a) proportion of patients eligible for radical treatment in each arm (b) loco-regional disease control at 6months between two arms. Materials and methodsLocally advanced and unresectable HNSCC patients (except Nasopharynx and Larynx) unfit for radical treatment were randomized to arm A [short course RT alone (4Gy/#/day for 5days)] or arm B [RT as arm A+concurrent cisplatin at 6mg/m2/day IV bolus for 5days]. Those with at least PR were taken for further RT to complete biological equivalent dose of 70Gy, in both the arms. In arm B, concurrent CDDP at a dose of 40mg/m2/week was administered. Results114 patients (57 in each arm) were randomized but 111 were analyzable. 15 (27.27%) patients in arm A and 28 (50%) patients in arm B had ⩾PR (p=0.01) however patients taken for FRT were 14 (25.45%) and 26 (46.42%) in arms A and B respectively (p=0.02). Locoregional control i.e. (CR+PR) at 6months was 16.36% in arm A versus 32.14% in arm B (p=0.15). Median PFS (arm A – 3.2months, arm B – 6.2months; p=0.02) and OS (arm A – 5.9months, arm B – 10.1months; p=0.03) was significantly more in arm B. There was relative improvement in quality of life for most parameters in arm B. ConclusionConcurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.