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. Issue 1 (October 2015)

• Record Type: Journal Article
• Authors: Kumar, Arvind; Sharma, Atul; Mohanti, Bidhu Kalyan; Thakar, Alok; Shukla, Nootan Kumar; Thulkar, Sanjay P.; Sikka, Kapil; Bhasker, Suman; Singh, Chirom Amit; Vishnubhatla, Sreenivas
• Is Part Of: Radiotherapy and oncology. Volume 117:Issue 1(2015:Oct.)
• Page Start: 145
• Page End: 151
• Publication Date: 2015-10
• Subjects: Advanced and incurable HNSCC -- Palliative -- RT -- CTRT -- C15-PAL -- HN-35 questionnaire; Oncology -- Periodicals; Radiotherapy -- Periodicals; Tumors -- Periodicals; Medical Oncology -- Periodicals; Neoplasms -- radiotherapy -- Periodicals; Radiotherapy -- Periodicals; Radiothérapie -- Périodiques; Cancérologie -- Périodiques; Tumeurs -- Périodiques; Electronic journals; 616.9940642
• DOI: 10.1016/j.radonc.2015.07.026
• Languages: English
• ISSNs: 0167-8140

Abstract

Abstract: Background: Treatment 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 6 months between two arms. Materials and methods: Locally advanced and unresectable HNSCC patients (except Nasopharynx and Larynx) unfit for radical treatment were randomized to arm A [short course RT alone (4 Gy/#/day for 5 days)] or arm B [RT as arm A + concurrent cisplatin at 6 mg/m 2 /day IV bolus for 5 days]. Those with at least PR were taken for further RT to complete biological equivalent dose of 70 Gy, in both the arms. In arm B, concurrent CDDP at a dose of 40 mg/m 2 /week was administered. Results: 114 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 6 months was 16.36% in arm A versus 32.14% in arm B ( p = 0.15). Median PFS (arm A – 3.2 months, arm B – 6.2 months; p = 0.02) and OS (arm A – 5.9 months, arm B – 10.1 months; p = 0.03) was significantly more in arm B. There was relative improvement in quality of life for most parameters in arm B. Conclusion: Concurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.