November 2016 VOL 7, NO 10

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ESMO 2016

Quality of Life Improved with Nivolumab versus Chemotherapy

In recent years, the cancer patient’s experience has been recognized as an important factor in determining the value of a treatment. According to patient reports, their quality of life (QOL) remained stable on the immunotherapy nivolumab, whereas it significantly deteriorated on chemotherapy, as shown in an analysis of a phase 3 study of platinum-refractory, recurrent, metastatic head and neck cancer.

This is the only study of patient-reported outcomes to be singled out for the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2016 Congress. Results are clinically meaningful, because treatments for head and neck cancer are among the most difficult and painful for patients to tolerate.

In the main CheckMate 141 trial, nivolumab significantly 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 (P = .01).

The first patient-reported outcomes from CheckMate 141 were presented at ESMO, including functional capacity and symptoms, and included in results published online to coincide with the presentation at ESMO (N Engl J Med. 2016; DOI: 10.1056/NEJMoa1602252).

“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 coauthor Kevin Harrington, MD, Royal Marsden Hospital, London, UK. “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.”

The QOL analysis was based on 129 patients who completed QOL and symptom questionnaires at baseline, 9 weeks, and then at 6-week intervals during treatment.

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

The nivolumab group experienced stable outcomes in physical function, role function, and social function, whereas the chemotherapy group had a statistically significant and clinically meaningful worsening in all 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 over 15 weeks for nivolumab-treated patients, whereas those on chemotherapy fared significantly worse from baseline.

Time to deterioration in symptoms favored nivolumab across all measures, with the exception of financial symptoms, which were similar.

On the EORTC QLQ-H&N35 (a cancer-specific QOL measure), a similar pattern was observed. Patients on nivolumab remained stable on measures of symptom burden over 15 weeks, but those on investigator’s choice of chemotherapy experienced statistically significant and clinically meaningful deterioration on all measures of pain, sensory problems, and social contact problems.

Programmed death-1 ligand 1 expression levels in patients’ tumors did not make any difference in responses on either of the EORTC QOL instruments.

On the EQ-5D visual analogue scale, a generic measure of health status, nivolumab-treated patients were stable, whereas patients receiving investigator’s choice of chemotherapy experienced a statistically significantly as well as clinically worsened outcome.

The study was funded by Bristol-Myers Squibb.

“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, Chinese University of Hong Kong.

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