Wanebo H J, Lee J, Burtness B A, Ridge J A, Ghebremichael M, Spencer S A, Psyrri D, Pectasides E, Rimm D, Rosen F R, Hancock M R, Tolba K A, Forastiere A A
Department of Surgery, Landmark Medical Center, Woonsocket.
Department of Biostatistics & Computational Biology, Dana Farber Cancer Institute, Boston.
Ann Oncol. 2014 Oct;25(10):2036-2041. doi: 10.1093/annonc/mdu248. Epub 2014 Jul 9.
E2303 evaluated cetuximab, paclitaxel, and carboplatin used as induction therapy and concomitant with radiation therapy in patients with stage III/IV head and neck squamous cell carcinoma (HNSCC) determining pathologic complete response (CR), event-free survival (EFS), and toxicity.
Patients with resectable stage III/IV HNSCC underwent induction therapy with planned primary site restaging biopsies (at week 8 in clinical complete responders and at week 14 if disease persisted). Chemoradiation (CRT) began week 9. If week 14 biopsy was negative, patients completed CRT (68-72 Gy); otherwise, resection was carried out. p16 protein expression status was correlated with response/survival.
Seventy-four patients were enrolled; 63 were eligible. Forty-four (70%) were free of surgery to the primary site, progression, and death 1-year post-treatment. Following induction, 41 (23 CR) underwent week 8 primary site biopsy and 24 (59%) had no tumor (pathologic CR). Week 14 biopsy during chemoradiation (50 Gy) in 34 (15 previously positive biopsy; 19 no prior biopsy) was negative in 33. Thus 90% of eligible patients completed CRT. Overall survival and EFS were 78% and 55% at 3 years, respectively. Disease progression in 23 patients (37%) was local only in 10 (16%), regional in 5 (8%), local and regional in 2 (3%), and distant in 5 patients (8%). There were no treatment-related deaths. Toxicity was primarily hematologic or radiation-related. p16 AQUA score was not associated with response/survival.
Induction cetuximab, paclitaxel, and carboplatin followed by the same drug CRT is safe and induces high primary site response and promising survival.
NCT 00089297.
E2303评估了西妥昔单抗、紫杉醇和卡铂作为诱导治疗药物，并与放射治疗联合用于III/IV期头颈部鳞状细胞癌（HNSCC）患者，以确定病理完全缓解（CR）、无事件生存期（EFS）和毒性。
可切除的III/IV期HNSCC患者接受诱导治疗，并计划在原发部位进行分期活检（临床完全缓解者在第8周进行，疾病持续者在第14周进行）。第9周开始放化疗（CRT）。如果第14周的活检结果为阴性，患者完成CRT（68 - 72 Gy）；否则，进行手术切除。p16蛋白表达状态与反应/生存情况相关。
共纳入74例患者；63例符合条件。44例（70%）在治疗后1年未接受原发部位手术、疾病无进展且未死亡。诱导治疗后，41例（23例CR）在第8周进行了原发部位活检，24例（59%）无肿瘤（病理CR）。在放化疗（50 Gy）期间第14周进行活检的34例患者（15例之前活检为阳性；19例之前未活检）中，33例结果为阴性。因此，90%符合条件的患者完成了CRT。3年总生存率和EFS分别为78%和55%。23例患者（37%）出现疾病进展，仅局部进展的有10例（16%），区域进展的有5例（8%），局部和区域均进展的有2例（3%），远处转移的有5例（8%）。无治疗相关死亡。毒性主要为血液学毒性或与放疗相关的毒性。p16 AQUA评分与反应/生存情况无关。
诱导使用西妥昔单抗、紫杉醇和卡铂，随后进行相同药物的CRT是安全的，可诱导原发部位产生高反应率，并具有良好的生存前景。
NCT 00089297。
