Around 2,100 women in the United Kingdom who are diagnosed with advanced uterine cancer are set to benefit from a groundbreaking new treatment option, following our recommendation of pembrolizumab (Keytruda®; Merck & Co/Merck Sharp & Dohme) in final draft guidance published by National Institute for Health and Care Excellence (NICE).
The approval by NICE marks the first time immunotherapy has been combined with chemotherapy as a first-line treatment for the whole group of patients with primary advanced or recurrent endometrial cancer.
Endometrial cancer is the sixth most common cancer among women around the world, and according to data from International Agency for Research on Cancer, the incidence has, over the past two decades, increased dramatically. [1] In the United Kingdom. endometrial cancer is the most common gynecological cancer, with around 9,700 people diagnosed each year. Advanced or recurrent endometrial cancer severely impacts life expectancy and health related Quality of Life (hrQoL). On averagem only 15% of people diagnosed with stage 4 disease are surviving 5 years or longer.
Not just a postmenopausal disease
Although endometrial cancer is mainly a postmenopausal disease, with the average age patients being diagnosed with this disease around 60 years, an estimated 14% to 20% of patients are premenopausal when diagnosed.
However, in contrast to older, postmenopausal women, younger, premenopausal women have a more favorable histology with better prognosis. Younger women are generally diagnosed in the early stages of cancer with less involvement of myometrium and the absence of lymphatic vascular invasion.*[3]
Race and ethnicity
Although the incidence rates for endometrial cancers are rising across all racial/ethnic groups, the economic status, level of education, awareness of comorbidities, access to healthcare, and the histological type of the tumor are the most important causes of observed disparities.[4]
The incidence of endometrial cancer is the highest in European (white) women and the lowest in African (black) women. This difference factors in the role obesity, metabolic syndrome, hormone therapy, genetic predisposition like as Lynch syndrome and population aging, which all contribute to a statistical difference.[4][5]
However, in contrast to the incidence, studies have shown that more black women may die from endometrial cancer. This may be the result of barriers that hinder access to care, an increased incidence of comorbidities among black women, inequalities in surgical care, adjuvant chemotherapy and radiation treatment. In addition, studies have shown that a number of underlying biological differences are associated with a more aggressive tumor which often develop in black women, including, but not limited to papillary serous carcinoma of the endometrium.[6]
What makes these health related disparities more complex – and explain some of the disparities seen between white and black women is – the fact that the biological differences of the kinds of cancer that are generally more common in Black women are not as well targeted by current treatment options. Hence, an improved understanding of the causative factors associated with racial disparities in endometrial cancer outcome really needed to facilitate efforts aimed at correcting this, and providing individualized care to those at highest risk for poor outcome.[6]
Innovative dual approach
The treatment approved by NICE in the United Kingdom combines pembrolizumab with chemotherapy drugs carboplatin (Paraplatin®, Bristol-Myers Squibb) and paclitaxel (Taxol®; Bristol-Myers Squibb).
Pembrolizumab, an immunotherapy, helps the immune system recognize and attack cancer cells, while chemotherapy damages cancer cells to prevent them from growing and dividing. This dual approach harnesses the body’s immune system alongside conventional chemotherapy to deliver improved outcomes for people facing this challenging diagnosis.
Additional time and improved quality of life
Clinical trials show that adding pembrolizumab to chemotherapy reduces the risk of death by 26% compared with chemotherapy alone. Clinical trials also show that adding pembrolizumab to chemotherapy can slow down cancer progression, offering people valuable additional time with improved quality of life.
Treatment continues for up to 2 years, or is stopped earlier if the cancer progresses or side effects become unmanageable, allowing for personalized care based on individual patient response.
“For people with advanced endometrial cancer, this innovative combination offers a powerful new treatment option. It marks a major step forward, and we’re pleased to recommend it as part of our commitment to getting the best care to people, fast, while ensuring value for the taxpayer,” noted Helen Knight, Director of Medicines Evaluation at NICE.
Note * Also known as lymphovascular invasion (LVI) or lymphovascular space invasion.
Highlights of prescribing information
Pembrolizumab (Keytruda®; Merck & Co/Merck Sharp & Dohme) [Prescribing Information]
Carboplatin (Paraplatin®, Bristol-Myers Squibb) [Prescribing Information]
Paclitaxel (Taxol®; Bristol-Myers Squibb). [Prescribing information]
Reference
[1] Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID: 33538338.
[2] Passarello K, Kurian S, Villanueva V. Endometrial Cancer: An Overview of Pathophysiology, Management, and Care. Semin Oncol Nurs. 2019 Apr;35(2):157-165. doi: 10.1016/j.soncn.2019.02.002. Epub 2019 Mar 11. PMID: 30867105.
[3] Abdol Manap N, Ng BK, Phon SE, Abdul Karim AK, Lim PS, Fadhil M. Endometrial Cancer in Pre-Menopausal Women and Younger: Risk Factors and Outcome. Int J Environ Res Public Health. 2022 Jul 25;19(15):9059. doi: 10.3390/ijerph19159059. PMID: 35897440; PMCID: PMC9330568.
[4] Cote ML, Ruterbusch JJ, Olson SH, Lu K, Ali-Fehmi R. The Growing Burden of Endometrial Cancer: A Major Racial Disparity Affecting Black Women. Cancer Epidemiol Biomarkers Prev. 2015 Sep;24(9):1407-15. doi: 10.1158/1055-9965.EPI-15-0316. Epub 2015 Aug 19. PMID: 26290568.
[5] Allard JE, Maxwell GL. Race disparities between black and white women in the incidence, treatment, and prognosis of endometrial cancer. Cancer Control. 2009 Jan;16(1):53-6. doi: 10.1177/107327480901600108. PMID: 19078930.
[6] Karia PS, Huang Y, Tehranifar P, Wright JD, Genkinger JM. Racial and ethnic differences in type II endometrial cancer mortality outcomes: The contribution of sociodemographic, clinicopathologic, and treatment factors. Gynecol Oncol. 2023 Jan;168:119-126. doi: 10.1016/j.ygyno.2022.11.015. Epub 2022 Nov 23. PMID: 36434946; PMCID: PMC9797437.
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