Randomized phase II trial of concomitant CT/RT versus TPF followed by concomitant CT/RT in locally advanced squamous cell carcinoma of the head and neck (LASCCHN)

• DOI: 10.1200/jco.2006.24.18_suppl.5518
• Publication Date: 2020-03-09T19:54:11Z
• Authors: A. Paccagnella; A. Buffoli; H. Koussis; P. D’Amanzo; L. Loreggian; A. Bonetti; F. Valduga; A. Gava; A. Ardizzoia; C. Sguotti
• Keywords: Concomitant; Mucositis; Clinical endpoint

5518 Background: Concomitant CT/RT is the standard treatment for LASCCHN. Induction chemotherapy followed by vs alone have not yet been compared. The feasibility of TPF has evaluated in a previous study (Int J Rad Oncol Biol Phys 2004, 59:481). Methods: Pts with inoperable stage III-IVa, PS 0–1, were randomized to [2 cycles Cisplatin 20 mg/sqm days 1–4, 5FU 800 96 hours c.i. weeks 1 and 6 during RT (66–70 Gy)] (Arm A) or 3 neoadjuvant (Docetaxel 75mg/sqm day1, 80mg/sqm 800mg/sqm c.i) same B). stratified according tumor site, T nodal status. Neck dissection was performed N2-N3 patients pathological CR on primary tumor. planned sample size pts detect difference (primary endpoint) up 15% favour arm B. radiological responses an internal committee RECIST criteria. Results: Preliminary data are available 84/96 (42 A, 42 Pts/tumor characteristics well balanced two arms. Toxicities induction consisted primarily G3–4 granulocytopenia 56% (febrile neutropenia: 7.5%). Grade 3–4 toxicities A B mucositis (42% 26%), dysphagia (20% 9%), skin reaction (12% 8.6%), asthenia (5% 3%); G3 weight loss (2% 3%), dry-mouth (0% 3%). Duration equivalent: 6.1 wks (4.2–8.7) 6.3 (3.8–9.5) At end CT/RT, 82 evaluable efficacy, 20% (95% CI 8–37%) 64% 45–80%) Conclusions: Three feasible don’t compromise subsequent concomitant comparable toxicity pattern. sequence serious adverse events 31% 34% 40% justifies following phase III study. Final results including pCR DFS will be presented at meeting. [Table: see text]