Tiwari S, Goel V, John M C, Patnaik N, Doval D C
Department of Medical Oncology, Jawaharlal Nehru Cancer Hospital and Research Centre, Bhopal, Madhya Pradesh, India.
Department of Medical Oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India.
Indian J Cancer. 2016 Oct-Dec;53(4):487-492. doi: 10.4103/ijc.IJC_7_17.
In squamous cell carcinoma of the head and neck (SCCHN), epidermal growth factor receptor is expressed at very high levels. Hence, we have done this study to assess the response and tolerability of cetuximab and platinum-based chemotherapy in recurrent and metastatic (R/M) head and neck squamous cell cancer (HNSCC) in view of paucity of data from the Indian subcontinent.
In this prospective study, patients of R/M SCCHN were randomly enrolled from September 2012 to April 2015. Chemotherapy (cisplatin/carboplatin/5-fluorouracil) and cetuximab-based treatment were administered up to 6 cycles or unacceptable toxicity. The response rates (RRs), progression-free survival (PFS), and overall survival (OS) were analyzed.
In total, fifty patients were enrolled. The median age was 51.0 years. A total of 255 cycles of treatment were administered (median = 6 cycles/patient). Four patients (8.0%) experienced complete response and 21 (42.0%) experienced partial response. Twenty-one patients (42.0%) had stable disease and four patients (8.0%) experienced progressive disease. The disease control rate was 92.0%. Median PFS was 5.3 months (95% confidence interval [CI]: 4.52-6.14 months). Median OS was 9.933 months (95% CI: 8.58-11.28 months). There was statistically significant correlation between overall response and Eastern Cooperative Oncology Group performance status (P = 0.014), site of tumor (P = 0.027), and histological grade of tumor (P = 0.001). The main Grade 3/4 side effects seen were hematological in 44 (88%) and gastrointestinal in 28 (56%) patients.
The RR of cetuximab plus chemotherapy of> 45% and the promising PFS rates are strong arguments for clinically testing this combination and this treatment schedule further in R/M HNSCC.
在头颈部鳞状细胞癌（SCCHN）中，表皮生长因子受体呈高表达。因此，鉴于印度次大陆相关数据匮乏，我们开展了本研究，以评估西妥昔单抗和铂类化疗药物对复发和转移性（R/M）头颈部鳞状细胞癌（HNSCC）的疗效及耐受性。
在这项前瞻性研究中，2012年9月至2015年4月期间随机纳入R/M SCCHN患者。给予化疗（顺铂/卡铂/5-氟尿嘧啶）和基于西妥昔单抗的治疗，最多6个周期或直至出现不可接受的毒性反应。分析缓解率（RRs）、无进展生存期（PFS）和总生存期（OS）。
共纳入50例患者。中位年龄为51.0岁。共进行了255个周期的治疗（中位值 = 6个周期/患者）。4例患者（8.0%）完全缓解，21例（42.0%）部分缓解。21例患者（42.0%）疾病稳定，4例（8.0%）疾病进展。疾病控制率为92.0%。中位PFS为5.3个月（95%置信区间[CI]：4.52 - 6.14个月）。中位OS为9.933个月（95%CI：8.58 - 11.28个月）。总体缓解与东部肿瘤协作组体能状态（P = 0.014）、肿瘤部位（P = 0.027）及肿瘤组织学分级（P = 0.001）之间存在统计学显著相关性。主要的3/4级副作用中，44例（88%）为血液学方面，28例（56%）为胃肠道方面。
西妥昔单抗联合化疗的RR>45%且PFS率良好，有力支持在R/M HNSCC中进一步对该联合方案及治疗方案进行临床测试。
