Rayan Amal, Shahine Mohammed S, Rezk Khalid, Zahran Asmaa M, Aboshanif Mohamed Modather, Gamal Doaa A
Clinical Oncology Department, Faculty of Medicine, Assiut University, Assiut 71515, Egypt.
https://orcid.org/0000-0001-5995-9177.
Ecancermedicalscience. 2023 Oct 9;17:1611. doi: 10.3332/ecancer.2023.1611. eCollection 2023.
We aimed from the current study to explore the treatment results of cetuximab in combination with a weekly carboplatin and paclitaxel regimen in advanced squamous cell carcinoma of head and neck (HNSCC) after failure of radiotherapy and chemotherapy.
This study was a non-randomised, single arm, phase 2 efficacy study conducted in two oncology centres in upper Egypt, we recruited 31 patients with recurrent HNSCC previously treated with concurrent chemoradiation ± surgery to receive weekly cetuximab, carboplatin and paclitaxel for 18 weeks followed by maintenance cetuximab every 2 weeks for 12 months. All patients underwent intention to treat analysis.
The current study revealed a significant reduction of the size of recurrent primary lesion ( < 0.001), without comparable significant reduction of regional lymph nodes (LNs) ( = 0.06), the current overall response rate (ORR) was 83.9%, ≥1-year progression-free survival (PFS) was 58.1%, also surgical intervention was succeeded to salvage 32.3% who did not achieve complete response to the current protocol, the median PFS was 12 months which was significantly affected by tumour site ( = 0.012), programmed death ligand-1 (PDL-1) expression ( = 0.01) and overall response rate (ORR) ( < 0.001).
Based on favourable treatment outcomes, including high ORR and disease control rate, improved median PFS and tolerable toxicity profile, the current weekly cetuximab, carboplatin and paclitaxel with 1 year maintenance cetuximab in responding patients is considered a feasible and effective regimen.
我们开展本研究旨在探索西妥昔单抗联合每周一次的卡铂和紫杉醇方案，用于治疗放疗和化疗失败后的晚期头颈部鳞状细胞癌（HNSCC）的疗效。
本研究是一项非随机、单臂、2期疗效研究，在埃及上埃及的两个肿瘤中心进行。我们招募了31例复发性HNSCC患者，这些患者先前接受过同步放化疗±手术治疗，接受每周一次的西妥昔单抗、卡铂和紫杉醇治疗18周，随后每2周给予西妥昔单抗维持治疗12个月。所有患者均接受意向性分析。
本研究显示复发性原发灶大小显著缩小（<0.001），但区域淋巴结（LNs）无类似显著缩小（=0.06），当前总体缓解率（ORR）为83.9%，≥1年无进展生存期（PFS）为58.1%，对于当前方案未达到完全缓解的患者，手术干预成功挽救了32.3%，中位PFS为12个月，其受肿瘤部位（=0.012）、程序性死亡配体-1（PDL-1）表达（=0.01）和总体缓解率（ORR）（<0.001）的显著影响。
基于良好的治疗效果，包括高ORR和疾病控制率、改善的中位PFS以及可耐受的毒性特征，当前对于有反应的患者采用每周一次的西妥昔单抗、卡铂和紫杉醇联合1年西妥昔单抗维持治疗被认为是一种可行且有效的方案。
