ICHNO-ECHNO 2022 - Abstract Book

S8

ICHNO-ECHNO 2022

OC-0014 Results from CompARE phase III RCT: Dose Escalated Chemoradiation vs control in oropharyngeal cancer

P. Sanghera 1 , W. Liu 2 , P. Gaunt 2 , C. Firth 2 , I. Humphreys 2 , A. Hartley 1 , M. Sen 3 , A. Kong 4 , D. Srinivasan 5 , R. Moleron 6 , K. Geropantas 7 , A. Chan 8 , L. O'Toole 9 , H. Booz 10 , M. Sivaremalingam 11 , J. Lester 12 , B. Foran 13 , C. Fong 1 , T. Roques 14 , R. Simoes 15 , Z. Nabi 15 , H. Mehanna 16 1 University Hospitals Birmingham NHS Trust, Oncology, Birmingham, United Kingdom; 2 Institute of Cancer and Genomic Sciences, University of Birmingham, Cancer Research Clinical Trials Unit, Birmingham, United Kingdom; 3 St. James's Institute of Oncology, Clinical Oncology, Leeds, United Kingdom; 4 Kings College London, Comprehensive Cancer Centre, London, United Kingdom; 5 Edinburgh Cancer Centre, Clinical Oncology, Edinburgh, United Kingdom; 6 Aberdeen Royal Infirmary, Clinical Oncology, Aberdeen, United Kingdom; 7 Norfolk & Norwich University Hospitals NHS FT, Oncology, Norwich, United Kingdom; 8 University Hospitals Coventry and Warwickshire, Arden Cancer Centre, Coventry, United Kingdom; 9 Queen’s Centre for Oncology, Clinical Oncology, Cottingham, Hull, United Kingdom; 10 University Hospitals Bristol NHS Foundation Trust, Oncology, Bristol, United Kingdom; 11 Royal Preston Hospital, Oncology, Preston, United Kingdom; 12 Weston Park Hospital, Sheffield Teaching Hospital NHS Foundation Trust, Clinical Oncology, Sheffield , United Kingdom; 13 Weston Park Hospital, Sheffield Teaching Hospital NHS Foundation Trust, Clinical Oncology, Sheffield, United Kingdom; 14 Norfolk & Norwich University Hospitals NHS FT, Clinical Oncology, Norwich, United Kingdom; 15 National Radiotherapy Trials Quality Assurance Group (RTTQA), Radiotherapy Physics, Mount Vernon Cancer Centre, Middlesex, United Kingdom; 16 Institute of Cancer and Genomic Sciences, University of Birmingham, Institute of Head and Neck Studies and Education, Birmingham, United Kingdom Purpose or Objective CompARE is a phase III randomised controlled trial using an adaptive, multi-arm multi-stage design to evaluate alternative regimes for escalating treatment of intermediate and high risk oropharyngeal cancer (OPC). This paper presents the first results of the investigational arm evaluating biological effective dose escalated accelerated hypofractionated chemoradiation. Materials and Methods Patients with Intermediate-risk OPC (HPV positive N2b or above disease and greater than 10 pack year history of smoking), or high-risk OPC (HPV negative), aged 16-70 years with ECOG PS 0-1 and suitability for concurrent chemoradiotherapy were randomised (2:1) to standard therapy in arm 1 using 70Gy in 35 fractions with concurrent cisplatin or one of several experimental arms. Arm 3 reported here evaluated 64Gy in 25 fractions with concurrent cisplatin delivered over 5 weeks. All centres participated in a central radiotherapy quality assurance programme and all patients had central HPV evaluation. Primary outcome was overall survival (OS) with an interim outcome of event free survival (EFS). 72 control arm events are required to perform the first interim analysis. Secondary outcome measures included toxicity (CTCAEv4.0), QoL, swallowing using MDADI questionnaire and gastrostomy dependence. Analysis was by intention to treat. Results 257 patients (172 in Arm 1 and 85 in Arm 3) were recruited across 27 centres and eligible for this analysis. Recruitment was suspended to this comparator arm in advance of planned interim analyses due to a SAE. Baseline characteristics were well balanced between the arms with 80% of patients having intermediate risk OPC and 20% with high risk. 97% patients received radiotherapy as planned for each arm. Overall median length of follow up was 36.7 months (95% CI. 27.6, 37.5). Three-year EFS rate was 72% (95%CI 64-78%) in arm 1 and 68% (95% CI 56-78%) in arm 3, (p=0.98). Adjusted hazard ratio for arm 3 versus 1 was 1.00 (95/% CI 0.62, 1.62). Three-year OS rate was 79% (95%CI 71-86%) in arm 1 and 74% (95%CI 62-83%) in arm 3, (p=0.59). Adjusted hazard ratio for arm 3 versus 1 was 1.17 (95% CI 0.66, 2.05). The proportional-hazards model was not violated. Rates of gastrostomy tube use at 2 years were 5% and 9% in arms 1 and 3 respectively (p=0.35). Conclusion Biological effective dose escalated chemoradiation did not appear to demonstrate any benefit over standard therapy in patients with intermediate and high risk OPC. The CompARE trial continues to recruit and evaluate other regimes. S. Ghosh Laskar 1 , D. Chaukar 2 , A. Chatterjee 3 , S. Chakraborty 4 , J.P. Agarwal 3 , P. Chaturvedi 2 , M. Deshpande 5 , T. Gupta 6 , V. Murthy 6 , A. Budrukkar 3 , P. Pai 2 , G. Pantvaidya 2 , A. Deshmukh 2 , D. Nair 7 , S. Nair 7 , K. Prabhash 8 , A. Joshi 9 , A.K. DCruz 10 1 Tata Memorial Hospital, Radiation Oncology, Mumbai, India; 2 Tata Memorial Hospital, Head and Neck Surgical Oncology, Parel Mumbai, India; 3 Tata Memorial Hospital, Radiation Oncology, Parel Mumbai, India; 4 Tata Medical Centre, Radiation Oncology, Kolkata, India; 5 Kokilaben Dhirubhai Ambani Hospital, Surgical Oncology, Mumbai, India; 6 Advanced Centre for Treatment Research and Education in Cancer, Radiation Oncology, Mumbai, India; 7 Advanced Centre for Treatment Research and Education in Cancer, Head and Neck Surgical Oncology, Mumbai, India; 8 Tata Memorial Hospital, Medical Oncology, Parel Mumbai, India; 9 Advanced Centre for Treatment Research and Education in Cancer, Medical Oncology, Parel Mumbai, India; 10 Apollo Cancer Hospital, Surgical Oncology, Mumbai, India Purpose or Objective Locally advanced Oral Cavity Squamous Carcinoma (OCSCC) is associated with poor outcomes and warrant some form of adjuvant treatment intensification even after complete resection. This Phase III Randomized Controlled Trial (NCT00193843) (OCAT) endeavoured to test the intensification of adjuvant therapy either by accelerating radiotherapy (6D- RT) or by adding concurrent chemotherapy (CTRT) in optimally resected locally advanced OCSCC. Reporting of the outcomes of harms and quality of life are the subject of a separate abstract to this meeting. OC-0016 Intensifying adjuvant therapy in advanced Oral Cavity Carcinoma: Results of a randomized study.