Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiotherapy in head and neck cancer patients with low skeletal muscle mass

Cisplatin dose limiting toxicity (CDLT) occurs often and impedes obtaining the planned cumulative cisplatin dose. A cumulative cisplatin dose of 200 mg/m2 or more is warranted for better survival and locoregional control. Patients with a low skeletal muscle mass (SMM) have a three-fold higher risk of developing CDLT than patients with a normal SMM. SMM can be assessed through measurements on routinely performed diagnostic head and neck CT- or MRI-scans. A weekly regimen of 40 mg/m2 body surface area cisplatin is proposed as a less toxic schedule, which possibly decreases the risk of developing CDLT and enables reaching a higher cumulative cisplatin dose. The aim of this multicenter randomized clinical trial (NL76533.041.21, registered in the Netherlands Trial Register) is to identify whether a regimen of weekly cisplatin increases compliance to the planned chemotherapy scheme in HNSCC patients with low SMM. The primary outcome is the difference in compliance rate, defined as absence of CDLT, between low SMM patients receiving either the weekly or triweekly regimen. Secondary outcomes consist of toxicities, the cumulative cisplatin dose, time to recurrence, incidence of recurrence at two years of follow-up, location of recurrence, 2-year overall, disease free and disease specific survival, quality of life, patient’s experiences, and cost-effectiveness.

The data are sensitive since they involve personal information of patients. There are also restrictions on use by commercial parties, and on sharing openly based on (inter)national laws and regulations and written informed consent. Therefore these data (and additional clinical data) are only available upon signing a Data Sharing Agreement (see Terms of Access) and within a specially designed environment provided by the UMC Utrecht.

顺铂剂量限制性毒性（Cisplatin dose limiting toxicity, CDLT）的发生率较高，常阻碍患者达到计划的顺铂累积给药剂量。为获得更佳生存获益与局部区域控制效果，需给予顺铂累积剂量≥200 mg/m²。骨骼肌量（Skeletal Muscle Mass, SMM）低下患者发生CDLT的风险较骨骼肌量正常者高3倍。骨骼肌量可通过常规开展的头颈部诊断CT或MRI扫描进行评估。有研究提出每周给予40 mg/m²体表面积顺铂的给药方案，该方案毒性更低，或可降低CDLT发生风险并帮助患者达到更高的顺铂累积给药剂量。本项多中心随机临床试验（荷兰试验注册库注册号：NL76533.041.21）旨在明确，对于骨骼肌量低下的头颈部鳞状细胞癌（Head and Neck Squamous Cell Carcinoma, HNSCC）患者，每周顺铂给药方案是否能提升患者对计划化疗方案的依从性。该试验的主要终点为：接受每周给药方案与每三周给药方案的骨骼肌量低下患者中，以无CDLT定义的依从率差异。次要终点包括不良反应发生率、顺铂累积给药剂量、复发时间、随访2年时的复发发生率、复发部位、2年总生存率、无病生存率、疾病特异性生存率、生活质量、患者体验以及成本效益。
本数据集涉及患者个人信息，属于敏感数据。同时根据国际及国内法律法规与书面知情同意要求，商业机构对本数据集的使用以及公开共享均存在限制。因此，本数据集（及附加临床数据）仅可在签署数据共享协议（详见访问条款），并在乌得勒支大学医学中心（UMC Utrecht）提供的专用环境中使用。