The Lynx Group

Nivolumab Improves Quality of Life versus Chemotherapy in Patients with Head and Neck Cancer

November 2016, Vol 7, No 10

Copenhagen, Denmark—In recent years, the personal experience of patients with cancer has been recognized as an important factor in determining the value of a treatment. According to patient-reported outcomes from the CheckMate-141 clinical trial presented at the 2016 European Society for Medical Oncology (ESMO) Congress, patients’ quality of life (QOL) remained stable with the immunotherapy nivolumab (Opdivo), whereas it significantly deteriorated with chemotherapy.

This phase 3 study of platinum-refractory, recurrent, metastatic head and neck cancer was the only study of patient-reported outcomes to be singled out for the Presidential Symposium (which highlights abstracts ESMO considers to contain practice-changing results). In this study, the results are clinically meaningful, because treatments for head and neck cancer are among the most painful and difficult to tolerate for patients.

In the main CheckMate-141 clinical trial, nivolumab significantly (P = .01) improved overall survival by a median of 2.5 months compared with chemotherapy (investigator’s choice of methotrexate, docetaxel, or cetuximab) in 361 patients with platinum-refractory head and neck cancer.

The initial results of patient-reported outcomes from the CheckMate-141 study, including functional capacity and symptoms, were presented at ESMO and were published online to coincide with the presentation (Ferris RL, et al. N Engl J Med. 2016 Oct 9. Epub ahead of print).

“Squamous-cell cancer of the head and neck and its treatment may alter physical appearance and physical ability, impacting functional status and well-­being,” said lead investigator Kevin Harrington, MBBS, MRCP, PhD, FRCP, FRCR, Division of Radiotherapy and Imaging, Institute of Cancer Research, London. “We found on all measures used that patients taking nivolumab remained stable over 15 weeks, while those taking chemotherapy significantly worsened, and this was clinically meaningful.”

Nivolumab Outperforms Chemotherapy in Quality-of-Life Measures

The QOL analysis was based on 129 patients who completed QOL and symptom questionnaires at baseline, 9 weeks, and 15 weeks.

At week 15, 50% to 68% of patients completed parts of the questionnaires. A 10-point difference from baseline in the EORTC-QLQ-C30 questionnaire was deemed clinically relevant.

The nivolumab group had stable outcomes in physical function, role function, and social function, whereas the chemotherapy group had a significant and clinically meaningful worsening in all these domains across the 15 weeks of analysis.

“It is important that patients taking chemotherapy were unable to go about their daily lives, fulfill their roles, and socialize with family and friends,” Dr Harrington emphasized.

Symptom burden, fatigue, dyspnea, and appetite loss remained stable for 15 weeks for patients receiving nivolumab, whereas those receiving chemotherapy fared significantly worse from baseline.

Time to deterioration in symptoms favored nivolumab across all measures, with the exception of financial burden, which was similar in both treatment arms.

A similar pattern was observed on the EORTC-QLQ Head and Neck Cancer Module. Patients receiving nivolumab remained stable on measures of symptom burden for 15 weeks, but those receiving the investigator’s choice of chemotherapy had significant and clinically meaningful deterioration on all measures of pain, sensory problems, and social contact problems.

PD-L1 expression levels in patients’ tumors made no difference in responses on either of the EORTC QOL instruments.

On the EuroQol-5 dimensions questionnaire visual analog scale (a generic measure of health status) patients receiving nivolumab were stable, but those receiving chemotherapy were significantly and clinically worsened.

“Taking the positive results of nivolumab in improving survival in these patients, and considering the patient-reported outcomes we heard today, nivolumab should be considered standard second-line therapy for recurrent or metastatic squamous-cell carcinoma of the head and neck,” stated formal discussant Anthony T.C. Chan, MD, The Chinese University of Hong Kong.

Related Articles

Subscribe to
Value-Based Cancer Care

Stay up to date with personalized medicine by subscribing to recieve the free VBCC print publication or weekly e‑Newsletter.

I'd like to recieve: