Immunotherapy Agent Improves Quality of Life in Head and Neck Cancer

Patients with head and neck squamous cell carcinoma (HNSCC) saw an improvement or stabilization in quality of life when they were treated with Opdivo.
BY JASON HARRIS
PUBLISHED: JULY 14, 2017
Quality of life (QOL) was either improved or stabilized for patients with head and neck squamous cell carcinoma (HNSCC) who were treated with Opdivo (nivolumab) as a single agent, according to recent results from a study published in Lancet Oncology.

In contrast, patients assigned to investigator’s choice of treatment saw clinical meaningful declines, defined as a decrease in 10 percent or more from baseline, across eight of 15 (53 percent)domains on the EORTC QLQ-C30 questionnaire.

“The results of CheckMate-141 suggest that nivolumab is the first PD-1 inhibitor, to our knowledge, to show a significant improvement in overall survival, with better tolerability and a quality-of-life benefit, compared with standard therapy for platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck,” investigators wrote. “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.”

Investigators evaluated statistical differences in patient-reported adjusted mean changes from baseline between treatment groups as assessed by the EORTC QLQ-C30, EORTC QLQ-H&N35 and EQ-5D-3L at each time point, and the time to clinically meaningful deterioration per each individual scale’s criteria.

Patient assessments were conducted before treatment initiation, at week nine, and then every six weeks during the treatment period using the EORTC QLQ-C30, EORTC QLQ-H&N35 and EQ-5D-3L questionnaires. Posttreatment assessments were made at follow-up visits one and two (35 days give or take seven days after the last treatment dose, and 80 days give or take seven days after follow-up visit 1). The EQ-5D-3L questionnaire was also administered at survival follow-up visits (every three months give or take seven days after follow-up visit two). Patients completed their assessments at each time point before physician contact, treatment dosing, or any procedures.

Thirty-six patients assigned to investigator’s choice of treatment with platinum-based chemotherapy and 93 patients assigned to Opdivo completed 15 weeks of QoL assessment.

Adjusted mean differences between the treatment groups were significant and clinically meaningful, defined as a difference of 10 points or greater, in favor of Opdivo for role functioning, social functioning, fatigue, dyspnea, and appetite loss at both weeks nine and 15. Investigators also observed significant and clinically meaningful differences favoring Opdivo for diarrhea week nine, and at week 15 for physical functioning, cognitive functioning and insomnia.

Opdivo significantly delayed median time to deterioration compared with investigator’s choice for pain, sensory problems, social contact problems, and mouth opening problems on the EORTC QLQ-H&N35 questionnaire. Patients in the Opdivo group reached median time to clinically meaningful increase in weight, but not in the investigator’s choice group.


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