Arvind Kumar1, Atul Sharma2, Bidhu Kalyan Mohanti3, Alok Thakar4, Nootan Kumar Shukla5, Sanjay P Thulkar6, Kapil Sikka4, Suman Bhasker3, Chirom Amit Singh4, Sreenivas Vishnubhatla7. 1. Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India. 2. Department of Medical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences (AIIMS), New Delhi, India. Electronic address: atul1@hotmail.com. 3. Department of Radiotherapy, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India. 4. Department of Otorhinolaryngology, All India Institute of Medical Sciences, New Delhi, India. 5. Department of Surgical Oncology, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India. 6. Department of Radiology, Dr BRA IRCH, All India Institute of Medical Sciences, New Delhi, India. 7. Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.
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 6months 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 (4Gy/#/day for 5days)] or arm B [RT as arm A+concurrent cisplatin at 6mg/m(2)/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/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 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. CONCLUSION: Concurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.
RCT Entities:
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 6months 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 (4Gy/#/day for 5days)] or arm B [RT as arm A+concurrent cisplatin at 6mg/m(2)/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/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 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. CONCLUSION: Concurrent low dose CTRT can be an effective treatment modality in advanced and incurable HNSCC. However, a larger phase III trial is required.
Authors: Nadia Hindi; Irene Carrasco García; Alberto Sánchez-Camacho; Antonio Gutierrez; Javier Peinado; Inmaculada Rincón; Johanna Benedetti; Pilar Sancho; Paloma Santos; Paloma Sánchez-Bustos; David Marcilla; Victor Encinas; Sara Chacon; Cristobal Muñoz-Casares; David Moura; Javier Martin-Broto Journal: Cancers (Basel) Date: 2020-12-12 Impact factor: 6.639
Authors: Vidisha Tuljapurkar; Harsh Dhar; Aseem Mishra; Swagnik Chakraborti; Pankaj Chaturvedi; Prathamesh S Pai Journal: South Asian J Cancer Date: 2016 Jul-Sep