Journal Article

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: The CISLOW-study protocol

de Boer, Jan Paul, Schaeffers, Anouk W. M. A., van Gils, Carla H., Voortman, Jens, Smid, Ernst J., Dankbaar, Jan Willem, Frederix, Geert W. J., Slingerland, Marije, de Bree, Remco, Devriese, Lot A., Hendriks, Mathijs P.

2023

Overview

Chemoradiotherapy with cisplatin in a triweekly regimen of 100 mg/m2 body surface area, is used to treat locally advanced head and neck squamous cell carcinoma (HNSCC) with curative intent. 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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Analysis / Antineoplastic Agents - adverse effects / Cancer / Cancer patients / Care and treatment / Chemoradiotherapy - adverse effects / Chemoradiotherapy - methods / Chemotherapy / Cisplatin / Cisplatin - adverse effects / Complications and side effects / CT imaging / Head and neck cancer / Head and Neck Neoplasms - chemically induced / Head and Neck Neoplasms - drug therapy / Humans / Multicenter Studies as Topic / Muscle, Skeletal - diagnostic imaging / Muscles / Oncology, Experimental / Patient compliance / Patient outcomes / Quality of Life / Randomized Controlled Trials as Topic / Squamous cell carcinoma / Squamous Cell Carcinoma of Head and Neck - drug therapy