Treatment of relapsed squamous cell head and neck cancer with Pembrolizumab is…complicated. I will break down the study linked below as simply and completely as I can.
A little background. According to wikipedia, “Head and neck cancer is a group of cancers that starts in the mouth, nose, throat, larynx, sinuses, or salivary glands. In 2015, head and neck cancers globally affected more than 5.5 million people (mouth 2.4 million, throat 1.7 million, and larynx 1.4 million), and it has caused over 379,000 deaths (mouth 146,000, throat 127,400, larynx 105,900). The average 5 year survival following diagnosis in the developed world is 42-64%.”
The KEYNOTE study focuses on head and neck cancer that has relapsed and compare relapsed H/N patients who take the standard of care chemo regimens with those relapsed patients who take immunotherapy-Pembrolizumab.
When comparing the standard of care therapy to a challenger, the three most important functions of a cancer clinical trial are to compare 1) overall survival of the two 2) how adverse events or treatment side effects compare and finally, any treatment related deaths from either the new or old regimen.
The KEYNOTE study documented a “meaningful” increase in overall survival (OS) or length of life- “pembrolizumab yielded median OS of 8.4 months vs. 6.9 months with standard-of-care therapy.” While an increase in a patient’s life of, on average, a month and a half might not look like much, it may be when you only have an average of 6.9 months left.
The KEYNOTE study then cited fewer serious treatment-related adverse events with those head and neck patients who underwent pembrolizumab compared to the standard chemotherapy regimen. And finallly, 4 patients undergoing immunotherapy died of treatment related adverse events and only two patients died of the standard treatment adverse events.
Keep in mind that there are evidence-based integrative and complimentary therapies shown to both fight H/N cancer itself as well as reduce or eliminate the side effects from either therapy.
Have you been diagnosed with head and neck cancer? What symptoms? What is your therapy plan? Please scroll down the page, post a question or comment and I will reply to you ASAP.
“Pembrolizumab provided a clinically meaningful OS extension compared with standard-of-care therapy among patients with recurrent head and neck squamous cell carcinoma, according to results from the randomized phase 3 KEYNOTE-040study published in The Lancet…
Researchers compared the safety and efficacy of pembrolizumab with standard-of-care treatment among 495 patients (median age, 60 years; range, 54-66) with head and neck squamous cell carcinoma that either advanced during or after platinum-containing treatment for recurrent or metastatic disease or recurred or progressed within 3 to 6 months of prior multimodal, platinum-containing treatment for locally advanced disease…
OS in the intention-to-treat population served as the study’s primary endpoint. Researchers assessed safety in the as-treated population.
Median follow-up was 7.5 months, including 8.4 months in the pembrolizumab group and 7.1 months in the standard-of-care group.
By data cutoff on May 15, 2017, 181 patients (73%) in the pembrolizumab group and 207 patients (83%) in the standard-of-care group had died (HR for death = 0.8; 95% CI, 0.65-0.98).
Among the intention-to-treat population, pembrolizumab yielded median OS of 8.4 months vs. 6.9 months with standard-of-care therapy.
Twelve-month survival reached 40% in the pembrolizumab group and 26% in the standard-of-care group.
Researchers reported 300 deaths among the 387 study participants with a PD-L1 combined positive score of 1 or higher, including 138 in the pembrolizumab group and 162 in the standard-of-care group.
Fewer patients in the pembrolizumab group experienced grade 3 or worse treatment-related adverse events compared with the standard group (13% vs. 36%).
The most common treatment-associated adverse events were hypothyroidism (n = 33; 13%) in the pembrolizumab group and fatigue (n = 43; 18%) the standard-of-care group.
Four patients in the pembrolizumab group died of causes related to treatment
compared with two treatment-related deaths in the standard of care group