For patients with oligometastatic head and neck cancer, the omission of chemotherapy in the frontline setting resulted in lower toxicity rates while maintaining survival rates and quality of life, according to a phase 2 study.

These results were presented by Juliette Thariat, MD, PhD, Centre Francois Baclesse Centre for Cancer, Caen, France, at the 2023 ESMO Congress in Madrid, Spain.

“We now have radiotherapy techniques, like ablative radiotherapy, that can be directed at metastases… There are some stereotactic ablative radiotherapy (SABR) trials, but head and neck carcinomas are underrepresented and no trial has yet investigated SABR alone vs chemotherapy and SABR in head and neck cancers,” explained Dr Thariat during her presentation.

The GORTEC 2014-04 trial aimed to assess the impact of omitting frontline chemotherapy in patients with oligometastatic head and neck cancer by using SABR alone. The primary end point was overall survival (OS) rate without definitive health-related quality of life score deterioration at 1 year in patients treated with SABR alone (experimental arm) vs chemotherapy plus SABR. Secondary end point included progression-free survival (PFS), definitive quality of life deterioration, and toxicity.

A total of 69 patients from 11 treatment center were enrolled in the trial between 2016 and 2022. The median baseline quality of life score was 66.7. The 1-year OS without quality of life score deterioration among 57 eligible patients was equivalent in both treatment arms. However, Kaplan-Meier estimates of physical functioning & cough score deterioration-free survival were better with SABR alone.

Among all 69 patients, the 1-year and median survival were 63.4 (95% confidence interval [CI], 47.6 to 84.5) and 47.2 months with SABR alone and 61.7 (95% CI, 46.2 to 82.4) and 42.3 months with chemotherapy plus SABR. Median follow-up was 55.3 (95% CI, 42.5 to 72.1) months in the SABR alone arm vs 45.4 (95% CI, 36.7 to 69.1) months in the chemotherapy plus SABR arm. The 1-year PFS rates were 38.2% and 53.3%, respectively.

There were a total of 58 relapse events among 48 patients. Following relapse, 16 (10 in the chemotherapy plus SABR arm and 6 in the SABR alone arm) new out-of-field lesions and 1 in-field (in SABR-arm) metastases were retreated with SABR alone (17/58, 29.3%).

The rates of all grade toxicities were 43/69 (62.3%) with 10/34 (29.4%) in the SABR alone arm and 33/35 (94.3%) in the chemo plus SABR arm. The rates of severe grade 3 to 4 toxicities were 24/69 (34.8%) with 2/34 (5.9%) and 21/35 (60%) in each group, respectively.

“Omission of frontline chemotherapy in patients with oligometastatic head and neck cancer led to lower severe toxicity rates, similar rates of survival & 1-year OS without quality of life deterioration,” Dr Thariat and colleagues concluded.

Source:

Thariat J, Bosset M, Falcoz A, et al. OMITting frontline chemotherapy in head and neck cancer (HNSCC) patients with 1-3 oligometastases using stereotactic ablative radiotherapy (SABR), the GORTEC 2014-04 “OMET” randomized phase II trial. Presented at 2023 ESMO Annual Congress; October 20-24, 2023; Madrid, Spain. 853O.