Chaturvedi Anushree, Sehrawat Amit, Mopidevi Trivikrama Rao, Parthasarthy K M, Gupta Deni, Singh Anuj
National Institute of Medical Science and Research, Jaipur, Rajasthan India.
All India Institute of Medical Sciences, Rishikesh, Uttarakhand India.
Indian J Otolaryngol Head Neck Surg. 2025 Jan;77(1):356-370. doi: 10.1007/s12070-024-05190-w. Epub 2024 Nov 11.
Patients with squamous cell carcinoma of the head and neck (HNSCC) often present with advanced locoregional disease. Combined modality treatment with definitive concurrent chemoradiotherapy (CTRT) has become the standard of care for these cancers. We compared the efficacy and toxicity profile of weekly cisplatin regime compared to a three-weekly cisplatin regime in the setting of definitive CTRT for locally advanced HNSCC (LAHNSCC). 51 patients were enrolled in the study between May 2016 and June 2019. In arm A, 25 patients (n = 25) were given three weekly cisplatin at dose of 100 mg/m on days 1, 22 and 43 (D1, D22, D43) concurrent with radiotherapy. In arm B, 26 patients (n = 26) were given weekly cisplatin at dose of 35 mg/m. Primary end points of the study were locoregional control (LRC), distant metastasis free survival (DMFS) and disease free survival (DFS). Adverse effects / toxicity was the secondary end point. Out of the 51 total patients, 49 patients underwent response evaluation at 3-month follow up, after completion of definitive CTRT. Two patients expired in the 3 weekly cisplatin arm before response assessment. On MRI, total 29 patients had complete clinicoradiologic response (cCR), 14 in weekly cisplatin arm and 15 in three weekly cisplatin arm. Only these 29 patients showing cCR were eligible for evaluation of LRC, DMFS and DFS at 2 years. Median follow up period was 20 months. At the time analysis 1 patient in 3 weekly arm and 2 patients in weekly arm expired. All of them had disease relapse during follow up. After 2 years of follow up, overall 89.7% (n = 26) patients had LRC. 92.86% (n = 13) in 3 weekly arm and 86.15% (n = 13) in weekly arm had LRC after 2 years. DMFS at 2 years was 86.15% (n = 13) in 3 weekly arm in comparison to 78.57% (n = 11) in weekly arm. DFS at 2 years was 77.92% (n = 11) in 3 weekly arm versus 66.67% (n = 10) in weekly arm. LAHNSCC patients with ECOG PS of 0-2, should be offered 3 weekly cisplatin regime in the setting of definitive CTRT as preferred regime in comparison to weekly cisplatin in view of trend favoring better response in terms of LRC, DMFS and DFS. Acute toxicities are more common in 3 weekly cisplatin arm as compared to weekly cisplatin arm but most of the toxicities are grade 1 or 2 which can be easily managed. This is a pilot study and randomized trials are needed to confirm the findings.
头颈部鳞状细胞癌（HNSCC）患者常表现为局部晚期疾病。确定性同步放化疗（CTRT）的综合治疗模式已成为这些癌症的标准治疗方法。我们比较了在局部晚期HNSCC（LAHNSCC）的确定性CTRT中，每周一次顺铂方案与每三周一次顺铂方案的疗效和毒性特征。2016年5月至2019年6月期间，51例患者纳入该研究。A组25例患者（n = 25）在第1、22和43天（D1、D22、D43）接受三次每周一次的顺铂治疗，剂量为100mg/m²，同时进行放疗。B组26例患者（n = 26）接受每周一次的顺铂治疗，剂量为35mg/m²。该研究的主要终点是局部区域控制（LRC）、无远处转移生存期（DMFS）和无病生存期（DFS）。不良反应/毒性是次要终点。在51例患者中，49例在完成确定性CTRT后的3个月随访时进行了疗效评估。2例在每三周一次顺铂组的患者在疗效评估前死亡。在MRI上，共有29例患者有完全临床放射学缓解（cCR），每周一次顺铂组14例，每三周一次顺铂组15例。只有这29例显示cCR的患者有资格在2年时评估LRC、DMFS和DFS。中位随访期为20个月。在分析时，每三周一次组有1例患者和每周一次组有2例患者死亡。他们在随访期间均有疾病复发。随访2年后，总体89.7%（n = 26）的患者有LRC。每三周一次组2年后LRC为92.86%（n = 13），每周一次组为86.15%（n = 13）。每三周一次组2年时的DMFS为86.15%（n = 13），而每周一次组为78.57%（n = 11）。每三周一次组2年时的DFS为77.92%（n = 11），每周一次组为66.67%（n = 10）。ECOG PS为0 - 2的LAHNSCC患者，在确定性CTRT中，考虑到在LRC、DMFS和DFS方面有更好反应的趋势，与每周一次顺铂相比，应首选每三周一次的顺铂方案。与每周一次顺铂组相比，每三周一次顺铂组的急性毒性更常见，但大多数毒性为1级或2级，易于处理。这是一项试点研究，需要进行随机试验来证实这些发现。
