CHICAGO -- Triple oral metronomic chemotherapy combined with ultra-low-dose immunotherapy (TMC-I) may be a promising first-line treatment for patients in low-resource countries with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), an open-label phase III trial suggested.

TMC-I extended median overall survival (OS), the primary endpoint, to 10.3 months from 6.2 months in patients randomized to paclitaxel plus carboplatin, corresponding to a 43% lower risk of death (HR 0.565, 95% CI 0.439-0.728; P<0.001), Minit Jalan Shah, MBBS, MD, of the Tata Memorial Centre in Mumbai, India, reported at a press conference during the American Society of Clinical Oncology (ASCO) annual meeting.

The survival benefit of TMC-I was consistent across subgroups, with a greater benefit observed in those with oral cavity cancer and those who used or had used tobacco, Shah added. There also were fewer serious adverse events in patients randomized to TMC-I.

The findings could allow patients from low-resource countries to access immunotherapy at a fraction of the cost of the standard dosages used in higher-resource settings, Shah noted.

TMC-I "offers a practical, scalable, and globally relevant first-line treatment option for advanced head and neck squamous cell carcinoma," he said. The cost of TMC-I is approximately $2,700 per year, compared with about $12,000 per year for chemotherapy plus standard-dose immunotherapy, and about $30,000 per year for cetuximab (Erbitux)-based therapy, he observed.