Nivolumab may improve patient-reported outcomes in HNSCC

Issue: November 25, 2016

COPENHAGEN, Denmark — Patient-reported outcomes and symptoms stabilized or improved in patients with recurrent or metastatic head and neck squamous cell carcinoma treated with nivolumab compared with patients treated with investigator’s choice of therapy, according to analysis of quality-of-life data from the CheckMate 141 trial presented at the European Society for Medical Oncology Congress.

Perspective from Sandrine Faivre, MD, PhD

Patients treated with nivolumab (Opdivo, Bristol-Myers Squibb) experienced less fatigue, pain and dyspnea, results showed.

“Patients living with this form of advanced head and neck cancer often experience debilitating physiological effects as well as emotional and social challenges brought on by the condition despite current treatment options,” Kevin Harrington, MD, PhD, professor in biological cancer therapies at The Institute of Cancer Research in London and a consultant clinical oncologist at The Royal Marsden NHS Foundation Trust in London, said in a company-issued press release. “These patient-reported outcomes are encouraging, as they help us understand the potential for [nivolumab] to impact important quality-of-life measures for this patient population.”

The open-label, randomized phase 3 CheckMate 141 trial included 361 patients with platinum-refractory recurrent or metastatic HNSCC assigned to receive nivolumab or investigator’s choice of methotrexate, docetaxel or cetuximab (Erbitux, Eli Lilly).

Harrington and colleagues administered the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire (EORTC QLQ-C30), Head and Neck Cancer module (QLQ-H&N35) and 3-level EQ-5D questionnaire (EQ-5D) at baseline, week 9 and then every 6 weeks thereafter during treatment.

Researchers considered a 10-point change or difference from baseline to be clinically relevant.

Eighty percent of patients treated with nivolumab and 75% of patients treated with investigator’s choice completed baseline assessments. Overall, baseline and follow-up quality-of-life data were available from 129 patients.

Results showed nivolumab doubled the median time to deterioration for global health status (7.7 months vs. 3 months), physical functioning (7.8 months vs. 3.6 months), role functioning (8.6 months vs. 3.8 months), cognitive functioning (7.8 months vs. 3.3 months) and social functioning (7.7 months vs. 3 months).

At 15 weeks, patients treated with investigator’s choice of therapy demonstrated significant worsening of physical, role and social functioning (P < .001); fatigue (P < .001); dyspnea (P < .001) and appetite loss (P = .004). Patients assigned nivolumab demonstrated a 50% less likely to experience a clinically meaningful deterioration in fatigue, insomnia and dyspnea scores (P = .008).

Responses to the QLQ-H&N35 questionnaire showed that patient-reported outcomes remained stable in patients treated with nivolumab but worsened for patients treated with investigator’s choice with regard to pain (P = .022), sensory problems (P < .001) and social contact problems (P = .001).

Nivolumab conferred a 74% reduction in rate of clinically meaningful deterioration in pain (P < .001), 62% in sensory problems (P = .002) and 51% in mouth opening problems (P = .029).

Data from EQ-5D showed patients assigned nivolumab experienced stable health status, whereas health status significantly worsened at 15 weeks in patients treated with investigator’s choice of therapy (P = .037). Median time to deterioration of health status was 9.1 months for patients assigned nivolumab vs. 3.3 months for patients assigned investigator’s choice of therapy.

Due to low complete rates in the control arm, researchers were unable to compare outcomes after week 15. – by Alexandra Todak

Reference:

Harrington K, et al. Abstract LBA4. Presented at: European Society for Medical Oncology Congress; Oct. 7-11, 2016; Copenhagen, Denmark.

Disclosure: The study was funded by Bristol-Myers Squibb. Harrington reports personal fees from Bristol-Myers Squibb during the conduct of the study, as well as fees paid to his institution from Amgen, AstraZeneca, Merck and Pfizer outside the current study. Please see the abstract for a list of all other researchers’ relevant financial disclosures.

Perspective

Sandrine Faivre, MD, PhD

This study assessed symptoms and quality of life using several questionnaires, including one specifically designed for patients with head and neck cancer. This is important because these tumors have particular consequences. A tumor mass in the neck, for example, is painful and may impair eating and speaking functions. It is also visible and can lead to social isolation.
This is the first study to show that an immunotherapy is superior to classical treatment options for improving quality of life and symptoms, on top of prolonging survival. I can now explain to my patients that nivolumab (Opdivo, Bristol-Myers Squibb) may help them to feel and function better in daily life.
Nivolumab works in approximately one-third of patients with advanced head and neck cancer. We need biomarkers or biological criteria to identify patients most likely to benefit from this treatment so that unnecessary side effects and costs are avoided.

Sandrine Faivre, MD, PhD

Beaujon University Hospital

Disclosures: HemOnc Today could not confirm Faivre’s relevant financial disclosures at the time of reporting.