Cetuximab in platinum-ineligible patients with locally advanced squamous cell carcinoma of the head and neck: Consensus from India

Abstract Locally advanced squamous cell carcinomas of the head and neck (LA-SCCHN) are one of the most common cancers globally and in India. Though many treatment options are available for LA-SCHHN, chemotherapy administered concurrently with radiotherapy (CCRT) is the most common treatment modality. Cisplatin-based CCRT is the guideline-recommended standard of care (SoC) in definitive and adjuvant settings. However, cisplatin-based CCRT often fails or cannot be administered due to toxicity. Hence, 60% of LA-SCCHN patients experience locoregional recurrence, and 20% experience distant metastasis. Many of these patients are cisplatin-ineligible/unfit due to absolute or relative contraindications; thus, continued cisplatin-based CCRT is unsuitable for them. Hence, alternative treatment strategies have been suggested for cisplatin-unfit LA-SCCHN patients and include docetaxel, carboplatin, and cetuximab-based regimens. Of these, docetaxel and carboplatin-based regimens have an unfavorable toxicity profile when compared with cetuximab-based regimens. Additionally, cetuximab-based regimens have demonstrated good locoregional control (LRC), improved disease-free survival (DFS), and OS (including 5-year OS) in LA-SCCHN patients. Therefore, Indian and international guidelines recommend cetuximab-based regimens for cisplatin-ineligible/unfit LA-SCCHN patients, Cetuximab is a costly drug for Indian patients. However, with the availability of cetuximab biosimilars, it has become possible to extend the drug’s benefits to cisplatin-ineligible/unfit LA-SCCHN patients in India. Hence, this Expert opinion from India was organized, and nine consensus statements were drafted to highlight the various clinical settings where cetuximab-based regimens can benefit cisplatin-ineligible/unfit LA-SCCHN patients. An attempt was also made to understand the burden and causes of cisplatin ineligibility and toxicity in Indian patients.