The immunotherapy Opdivo (nivolumab) is less aggressive than standard-of-care chemotherapy for patients with recurrent or metastatic head and neck cancer, and has less of an impact on patients’ quality of life, according to a major Phase 3 trial.
The findings from the study, “Nivolumab versus standard, single-agent therapy of investigator’s choice in recurrent or metastatic squamous cell carcinoma of the head and neck (CheckMate 141): health-related quality-of-life results from a randomised, phase 3 trial,” were published in The Lancet Oncology.
Science has made great advances in the development of new therapies targeting cancer cells. Still, many treatment regimens have severe effects on patients’ lives, which often lead to generalized distress and a potentially severe impact on patients’ physical states as well as their mental health.
In the case of head and neck cancer, available therapies have been shown to affect patients’ ability to speak, breath, eat, and drink, which severely affects their overall well-being.
“When immunotherapies first hit the clinic, there were concerns over side-effects and the fact that they didn’t work for everyone. But in only two or three years we have become very good at managing the side-effects they cause, and we are better able to select patients in whom these treatments are most likely to be effective,” Kevin Harrington, professor of Biological Cancer Therapies at The Institute of Cancer Research in London, and consultant clinical oncologist at The Royal Marsden NHS Foundation Trust, said in a news release.
“We now need to test if we can move away from resorting to traditional chemotherapies, which come with far too much collateral damage, and see these smarter, kinder therapies used as a first-line treatment to replace chemotherapy altogether,” Harrington said.
The ongoing CheckMate 141 Phase 3 trial (NCT02105636), is sponsored by Bristol-Myers Squibb (BMS) and led by researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust. The trial is evaluating BMS’ Opdivo compared to standard chemotherapies such as Erbitux (cetuximab), methotrexate, and Taxotere (docetaxel).
A total of 361 patients with recurrent or metastatic squamous cell carcinoma of the head and neck were included in the study. In April 2016, results from the trial demonstrated that Opdivo improved patients’ survival compared to other tested therapies. After one year, 36 percent of patients receiving Opdivo were still alive, compared to 17 percent in the chemotherapy arm. Opdivo’s beneficial effect was also favored by fewer treatment-related adverse effects.
More recently, the researchers analyzed the impact of these therapies in patients’ quality of life. Among all participants, 129 patients — 93 from the Opdivo group and 36 from the chemotherapy group — responded to questionnaires covering physical symptoms, mental health, and general well-being.
“Our research has found that [Opdivo] really is a game-changing treatment for patients with head and neck cancer,” Harrington said. “Not only does it extend survival — we have now shown that patients feel much better in the extra time that the drug grants them.”
The results of the questionnaires showed that those who received Opdivo were less affected by the treatment compared to their counterparts. Indeed, at nine weeks of treatment, Opdivo-treated patients reported less pain, sensory problems, appetite loss, tiredness, and breathing problems.
This trend was maintained at 15 weeks of treatment, with patients receiving Opdivo having fewer complaints of nausea, insomnia, and weight loss than standard chemotherapy-treated patients.
“Creating cancer treatments that can not only extend life but also minimize the impact of the disease on patients’ lives is a major aim of researchers worldwide. So it’s great news that this trial has found that as [Opdivo] greatly extends life among these patients it also gives marked improvements in quality of life compared with current treatment options,” said Prof. Paul Workman, chief executive of The Institute of Cancer Research in London.
Opdivo was approved by the European Commission to treat advanced squamous cell cancer of the head and neck in May 2017. It is currently under evaluation by the National Institute for Health and Care Excellence (NICE) for a final decision on its use in the U.K. after an initial rejection due to cost was announced in April 2017.
“I hope that this drug will be now approved very soon for use on the NHS so that this group of patients, who badly need new treatment options, can see the benefit,” Workman said.