Patients with recurrent or metastatic squamous cell carcinoma of the head and neck treated with the checkpoint inhibitor nivolumab were able to maintain baseline levels of quality of life in contrast to clinically meaningful deteriorations seen in patients assigned to investigator’s choice of treatment, according to results of the CheckMate 141 trial published recently in Lancet Oncology.
“In view of the major unmet need in this population and the importance of maintaining or improving quality of life for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, these data support nivolumab as a new standard of care option in this setting,” wrote researcher Kevin J. Harrington, PhD, of the Institute of Cancer Research/Royal Marsden Hospital in the United Kingdom, and colleagues.
CheckMate 141 randomized 361 patients with recurrent or metastatic squamous cell carcinoma of the head and neck 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator’s choice of methotrexate, docetaxel, or cetuximab. All patients had progressed within 6 months after platinum-based chemotherapy. Previously published data showed assignment to nivolumab resulted in improved overall survival compared with investigator’s choice.
In this analysis, the researchers analyzed patient reported outcomes (PRO), which were assessed at baseline, week 9, and every 6 weeks thereafter.
“Patients with squamous cell carcinoma of the head and neck rank the ability to speak, swallow, and perform daily tasks in the absence of pain as very high priorities,” the researchers wrote. “Patients with recurrent or metastatic squamous cell carcinoma of the head and neck face a dismal prognosis with poor quality of life, including more severe social and psychological problems than those with other cancers.”
The PRO assessment included 129 patients from the nivolumab arm and 36 from the investigator’s choice arm. A clinically meaningful difference was defined as a change detectable by patients that might require a change in disease management—a score difference of 10 points or more for all domains on both questionnaires used.
No domain assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Core 30 showed clinically meaningful deterioration from baseline to week 15 for patients assigned nivolumab. However, more than one-half (53%) of the domains assessed in the investigator’s choice arm had clinically meaningful deterioration.
Similarly, using the EORTC head and neck cancer–specific module (QLQ-H&N35) 44% of patients assigned to investigator’s choice had clinically meaningful worsening at week 15 in comparison to no worsening in patients assigned nivolumab.
At week 9 and 15, differences between the two treatments group were significant and clinically meaningful in favor of nivolumab for role functioning, social functioning, fatigue, dyspnea, and appetite loss.
Finally, the median time to deterioration as measured by the European Quality of Life–5 Dimensions questionnaire was significantly longer for patients assigned nivolumab compared with investigator’s choice for 37% of the 35 domains assessed across all of the questionnaires.
“The clinical benefit, as measured by these validated PRO measures, indicates that patients experienced improved quality of life in addition to prolonged survival, higher response rate, and fewer high-grade toxicities relative to investigator’s choice,” the researchers wrote. “These results are consistent with studies of nivolumab in melanoma, non–small-cell lung cancer, and renal cell carcinoma, which showed stable or improved quality of life with nivolumab compared with dacarbazine, docetaxel, and everolimus, respectively.”