Pearl
The standard of care first line chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) consists of a platinum (carboplatin or cisplatin) in combination with fluorouracil (5-FU), given as a continuous infusion over 4 days, and pembrolizumab
This regimen may create logistical complications for patients, in addition to 5-FU’s associated side effects including mucositis and cardiotoxicity which can be challenging in this population that often has multiple comorbidities
Results of the KEYNOTE-B10 trial have provided valuable data for the use of paclitaxel as a substitute for patients who may not be candidates for 5-FU
This study was an open-label, single arm study in ~100 patients with recurrent or metastatic HNSCC. Patients received pembrolizumab 200 mg + carboplatin AUC 5 + paclitaxel 175 mg/m2 every 3 weeks (or 100 mg/m2 on Day 1 and 8).
The primary endpoint was objective response rate (ORR)
Patients were relatively healthy at baseline with an ECOG score of 0 or 1 and most were white males that were <65 years old
The ORR was 49%, although it was driven by partial responses at 42% with only 7% having a complete response - 27% had stable disease and 15% progressed
75% of patients had a grade 3+ adverse event, most commonly, and not surprisingly, being neutropenia and anemia
Not an earth shattering study, but it does provide data for the use of paclitaxel as a substitute for patients who may not be candidates for 5-FU |