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Abstract
Purpose To report the results of the Trans Tasman Radiation Oncology Group randomized phase III trial designed to determine whether the addition of concurrent chemotherapy to postoperative radiotherapy (CRT) improved locoregional control in patients with high-risk cutaneous squamous cell carcinoma of the head and neck. Patients and Methods The primary objective was to determine whether there was a difference in freedom from locoregional relapse (FFLRR) between 60 or 66 Gy (6 to 6.5 weeks) with or without weekly carboplatin (area under the curve 2) after resection of gross disease. Secondary efficacy objectives were to compare disease-free survival and overall survival. Results Three hundred twenty-one patients were randomly assigned, with 310 patients commencing allocated treatment (radiotherapy [RT] alone, n = 157; CRT, n = 153). Two hundred thirty-eight patients (77%) had high-risk nodal disease, 59 (19%) had high-risk primary or in-transit disease, and 13 (4%) had both. Median follow-up was 60 months. Median RT dose was 60 Gy, with 84% of patients randomly assigned to CRT completing six cycles of carboplatin. The 2- and 5-year FFLRR rates were 88% (95% CI, 83% to 93%) and 83% (95% CI, 77% to 90%), respectively, for RT and 89% (95% CI, 84% to 94%) and 87% (95% CI, 81% to 93%; hazard ratio, 0.84; 95% CI, 0.46 to 1.55; P = .58), respectively, for CRT. There were no significant differences in disease-free or overall survival. Locoregional failure was the most common site of first treatment failure, with isolated distant metastases as the first site of failure seen in 7% of both arms. Treatment was well tolerated in both arms, with no observed enhancement of RT toxicity with carboplatin. Grade 3 or 4 late toxicities were infrequent. Conclusion Although surgery and postoperative RT provided excellent FFLRR, there was no observed benefit with the addition of weekly carboplatin.

Author information

Porceddu SV1, Bressel M1, Poulsen MG1, Stoneley A1, Veness MJ1, Kenny LM1, Wratten C1, Corry J1, Cooper S1, Fogarty GB1, Collins M1, Collins MK1, Macann AMJ1, Milross CG1, Penniment MG1, Liu HY1, King MT1, Panizza BJ1, Rischin D1.
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Sandro Virgilio Porceddu, Michael Geoffrey Poulsen, Lizbeth Moira Kenny, and Benedict James Panizza, University of Queensland; Sandro Virgilio Porceddu, Adam Stoneley, Howard Yu-hao Liu, and Benedict James Panizza, Princess Alexandra Hospital; Michael Geoffrey Poulsen, Radiation Oncology Mater Centre; Lizbeth Moira Kenny, Royal Brisbane and Women's Hospital, Brisbane; Michael Kevin Collins, Townsville Cancer Centre and James Cook University, Townsville, Queensland; Mathias Bressel, June Corry, Marnie Collins, and Danny Rischin, Peter MacCallum Cancer Centre; June Corry and Danny Rischin, University of Melbourne, Melbourne, Victoria; Michael John Veness, Westmead Cancer Care Centre, Westmead; Michael John Veness, Christopher Gerard Milross, and Madeleine Trudy King, University of Sydney; Stephen Cooper and Gerald Blaise Fogarty, Genesis Cancer Care, St Vincent's Hospital; Gerald Blaise Fogarty, University of Technology Sydney; Christopher Gerard Milross, Royal Prince Alfred Hospital, Sydney; Chris Wratten, Calvary Mater Newcastle, Waratah; Chris Wratten, University of Newcastle, Newcastle, New South Wales; Michael Gordon Penniment, Royal Adelaide Hospital and University of Adelaide, Adelaide, South Australia, Australia; and Andrew Martin John Macann, Auckland City Hospital, Auckland, New Zealand.