Standard treatment for advanced head and neck cancer—including chemotherapy and radiation—causes painful side effects that impair quality of life, as well as the ability to socialize and engage in daily life activities. A new study of patients with platinum-refractory recurrent, metastatic head neck cancer shows that nivolumab (Opdivo) did not compromise quality of life on a variety of scales, whereas chemotherapy was associated with significant deterioration on all measures.
This study is clinically meaningful, as results were based on patient-reported outcomes reflecting patients’ own experience. The first results of the patient-reported outcomes from the CheckMate 141 trial including functional capacity and symptoms, were presented at the 2016 European Society for Medical Oncology (ESMO) Congress.1
In CheckMate 141, nivolumab significantly improved overall survival by a median of 2.5 months compared with chemotherapy (investigator’s choice between methotrexate, docetaxel, or cetuximab [Erbitux]) in 361 patients with platinum-refractory cancer of the head and neck (P = .01).2 In addition to a survival benefit, patients’ quality of life during treatment for head and neck cancer is also a consideration when selecting treatment.
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.— Kevin Harrington, MD
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“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 author Kevin Harrington, MD, of the 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 study Dr. Harrington presented was based on 129 patients enrolled in the trial who completed quality-of-life and symptom questionnaires at baseline, 9-week, and 6-week intervals during treatment. The instruments used included the European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30, as well as a cancer-specific questionnaire EORTC-QLQ-H&N35. The goal was to assess changes from baseline in symptoms and function, compare the changes between the two treatment arms, and evaluate the time to deterioration in symptoms and health status between the two treatments.
Over time, the proportion of patients who filled out the questionnaires declined until at week 15, completion rates ranged from 50% to 68%. A 10-point difference from baseline was considered relevant for the EORTC-QLQ-C30, Dr. Harrington noted.
Patients taking nivolumab experienced stable outcomes in physical function, role function, and social function, whereas those taking chemotherapy experienced 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.
Although patients who had programmed cell death ligand 1 (PD-L1)-positive disease had a numerically greater improvement on the EORTC-QLQ-C30 with nivolumab compared with those with lower PD-L1 expression, this difference was not statistically significant.
Looking at symptom burden, fatigue, dyspnea, and appetite loss all 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 in both arms.
For the head and neck cancer–specific questionnaire—EORTC-QLQ-H&N35—the same pattern was evident. For measures of symptom burden, patients on nivolumab remained stable over 15 weeks, whereas 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.
Patients also responded to the EQ-5D (EuroQol 5 dimensions) visual analog scale, a generic measure of health status. For this instrument, a 7-point change is considered clinically relevant. At week 15, nivolumab-treated patients were stable, and those on investigator’s choice of chemotherapy were statistically significantly worsened as well as clinically worsened.
A similar pattern was observed when results were analyzed according to PD-L1 status as was seen for EORTC-QLQ-C30 responses, with no statistically significant differences according to PD-L1 levels of expression. “Nivolumab delivered benefits to PD-L1–positive and PD-L1–negative tumors,” Dr. Harrington noted. ■
Disclosure: The study was funded by Bristol-Myers Squibb. Dr. Harrington received personal and institutional fees from Bristol-Myers Squibb during the study; institutional fees from AstraZeneca and Pfizer; and personal and institutional fees from Merck and Amgen outside the submitted work.
1. Harrington K, Ferris RL, Shaw J, et al: Patient-reported outcomes in recurrent or metastatic squamous cell carcinoma of the head and neck treated with nivolumab or investigator’s choice: CheckMate 141. 2016 ESMO Congress. Abstract LBA4_PR. Presented October 9, 2016.
All clinical trials should include patient-reported outcomes.— Anthony T.C. Chan, MD
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These results showed nivolumab (Opdivo) to be the clear winner in this trial from the patients’ perspective, according to formal discussant Anthony T.C. Chan, MD,...!-->!-->