John F Gleason1, Mahesh Kudrimoti1, Emily M Van Meter2, Mohammed Mohiuddin3, William F Regine4, Joseph Valentino5, Daniel Kenady6, Susanne M Arnold7. 1. Department of Radiation Medicine, University of Kentucky, Markey Cancer Center, Lexington, KY, USA. 2. Division of Cancer Biostatistics, University of Kentucky, Markey Cancer Center, Lexington, KY, USA. 3. King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. 4. Department of Radiation Oncology, University of Maryland, Baltimore, MD, USA. 5. Department of Otolaryngology HNS, University of Kentucky, Markey Cancer Center, Lexington, KY, USA; Department of Surgery, University of Kentucky, Markey Cancer Center, Lexington, KY, USA. 6. Division of General Surgery, Department of Surgery, University of Kentucky, Markey Cancer Center, Lexington, KY, USA. 7. Division of Medical Oncology, Department of Internal Medicine, Markey Cancer Center, cc445, 800 Rose Street, Lexington, KY 40536, USA.
Abstract
OBJECTIVE: This study aims to report the long-term outcomes of a novel treatment approach utilizing induction low-dose fractionated radiation therapy (LDFRT) and chemotherapy for locally advanced squamous cell carcinoma of head and neck (SCCHN). METHODS: We prospectively enrolled 40 patients with locally advanced SCCHN (77 % stage IV) on a phase II clinical trial and treated with induction paclitaxel (225 mg/m2), carboplatin (AUC 6), and LDFRT (80 cGy BID on days 1 and 2) every 21 days for two cycles. RESULTS: Forty patients enrolled; 39 were evaluable. The acute toxicity and response data have been previously reported; overall response rate (RR) was 82 %. After induction, definitive therapy was concurrent chemoradiation (CRT) in 51 %, XRT alone in 39 %, surgery in 5 %, and surgery and XRT in 5 %. The long-term outcomes are now reported with a median follow-up of 83 months. Locoregional control (LRC) is 80 % and distant control (DC) is 77 %. Five-year overall survival (OS), disease-specific survival, and progression-free survival (PFS) are 62 %, 66 %, and 58 %, respectively. CONCLUSION: Induction chemotherapy with LDFRT has a high initial RR, comparable toxicity to two-drug induction regimens, but adds a third novel and effective agent, LDFRT. Five-year follow-up shows favorable outcomes compared to historical controls and excellent compliance with definitive therapy. This novel treatment approach is now planned for phase 3 trial evaluation.
OBJECTIVE: This study aims to report the long-term outcomes of a novel treatment approach utilizing induction low-dose fractionated radiation therapy (LDFRT) and chemotherapy for locally advanced squamous cell carcinoma of head and neck (SCCHN). METHODS: We prospectively enrolled 40 patients with locally advanced SCCHN (77 % stage IV) on a phase II clinical trial and treated with induction paclitaxel (225 mg/m2), carboplatin (AUC 6), and LDFRT (80 cGy BID on days 1 and 2) every 21 days for two cycles. RESULTS: Forty patients enrolled; 39 were evaluable. The acute toxicity and response data have been previously reported; overall response rate (RR) was 82 %. After induction, definitive therapy was concurrent chemoradiation (CRT) in 51 %, XRT alone in 39 %, surgery in 5 %, and surgery and XRT in 5 %. The long-term outcomes are now reported with a median follow-up of 83 months. Locoregional control (LRC) is 80 % and distant control (DC) is 77 %. Five-year overall survival (OS), disease-specific survival, and progression-free survival (PFS) are 62 %, 66 %, and 58 %, respectively. CONCLUSION: Induction chemotherapy with LDFRT has a high initial RR, comparable toxicity to two-drug induction regimens, but adds a third novel and effective agent, LDFRT. Five-year follow-up shows favorable outcomes compared to historical controls and excellent compliance with definitive therapy. This novel treatment approach is now planned for phase 3 trial evaluation.
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