New developments in gynecologic cancer

Pharmacists are an important part of the interdisciplinary medical team that treats gynecologic cancer patients, provides screening education, and navigates changes in treatment options.

Endometrial cancer

The endometrium is the most common type of uterine cancer.² On April 22, 2021, the FDA received dostarlimab-gxly (Jemperli; GlaxoSmithKline) and immunotherapy for the treatment of relapsed or advanced endometrial cancer that progressed during or after pretreatment with platinum-containing chemotherapy. Granted expedited approval for the patient. Cancer patients with a specific genetic feature known as mismatch repair deficiency (dMMR), as determined by approved tests.^4-6

The Ventana MMR RxDx Panel is the first companion diagnostic to identify patients with endometrial cancer who are eligible for treatment with dostarlimab-gxly, giving pharmacists an important role in pharmacological genomics and personalized medicine for tumor treatment. Offers.⁷ Dostarlimab-gxly is a treatment for unmet needs because approximately 25% to 30% of patients with advanced endocardial cancer have dMMR tumors and the options available after treatment with a platinum-containing regimen are limited. Provide.^Four

In a news release, Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the FDA’s Center for Drug Evaluation and Research’s Oncology Diseases Office, said: [dostarlimab-gxly] This is evidence of the FDA’s progress in applying precision medicine to expand treatment options for cancer patients. “^Four

Accelerated approval was granted based on positive results from an ongoing GARNET study (NCT02715284) with an overall response rate of 42%. 93% of respondents responded for more than 6 months. Continued approval is subject to confirmatory trials demonstrating clinical benefit.^Five Dostarlimab-gxly is administered
Inject intravenously over 30 minutes with the following dosing schedule: 500 mg every 3 weeks from dosing 1 to 4, and 1000 mg every 6 weeks starting 3 weeks after dosing 4 (after dosing 5).⁶

Common side effects (AEs) include fatigue, nausea, diarrhea, anemia, and constipation. 6 Immune-mediated AE affects a variety of organ systems, causing inflammation of the lungs, colon, liver, endocrine glands, and kidneys. Patients who experience a serious or life-threatening reaction associated with fluids should stop taking dostarlimab-gxly. 6 In addition, pregnant or lactating individuals should not use dostarlimab-gxly.⁶

Cervical cancer

Pharmacists need to continue to educate patients about the importance of cervical cancer screening, especially during the COVID-19 pandemic, as screening has declined.³ In July 2020, the Camaro for a Cause published the latest screening guidelines for individuals with an average risk of cervical cancer8. The new guidelines recommend screening for cervical cancer every 5 years with only the human papillomavirus (HPV) test. For patients aged 25 to 65 years with no cervical damage, the test should be done every 3 years. Previously, the recommended screening age was 21 years and older.^8,9

If only the HPV test is available, individuals can be screened with the HPV / Pap test every 5 years or the Pap test every 3 years. There is evidence that the HPV test is more accurate and reliable than the Pap test.⁹ Therefore, the HPV test is more effective in ruled out the disease and does not need to be repeated as often as the Pap test.⁹ Patients vaccinated with the HPV vaccine should continue to be screened for cervical cancer.⁹

Pharmacists should continue to recommend HPV vaccines that can prevent cervical cancer and other cancers. A recent CDC report found that the HPV infections targeted by the vaccine have decreased since the vaccine was introduced in 2014.^Ten In fact, the report provides evidence that unvaccinated females are indirectly protected through the effects of herds in these age groups.^Ten

Ovarian cancer

On April 29, 2020, the FDA approved niraparib (Zejula; GlaxoSmithKline) as first-line maintenance therapy for advanced ovarian cancer. First-line platinum-based chemotherapy.^11,12 Approval was based on positive results from a double-blind, placebo-controlled PRIMA trial (NCT02655016).^11,13

Niraparib can be used in patients with or without mutations.¹³ The recommended dose of niraparib for first-line maintenance therapy for advanced ovarian cancer is based on body weight and platelet count (Table).^11,12 In addition, patients should begin treatment with niraparib within 12 weeks of a regimen containing the latest platinum product.¹²

The most common AEs experienced by patients in the PRIMA trial are thrombocytopenia, anemia, nausea, fatigue, constipation, neutropenia, muscle pain, abdominal pain, vomiting, loss of appetite, leukopenia, headache, and sleeplessness. Symptoms, respiratory distress, dizziness, cough, high blood pressure, elevated liver enzymes, and acute liver injury.^12,13

Jennifer Garshman, PharmD, CPh, Is a pharmaceutical information pharmacist living in South Florida and a contributor to Pharmacy Times®.

Reference materials

1. Recognition of gynecologic cancer. CDC. Review on August 19, 2020. Accessed on May 1, 2021. https://www.cdc.gov/Cancer/dcpc/resources/features/gynecologiccancers/
2. Get the facts about gynecologic cancer. CDC. Revised in April 2017. Accessed on May 1, 2021. https://www.cdc.gov/cancer/knowledge/pdf/cdc_gyn_comprehensive_brochure.pdf
3. Cancer Facts and Numbers 2021. Special Section: COVID-19 and Cancer. American Cancer Society. Accessed on May 1, 2021. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/special-section-covid19-and-Cancer- 2021.pdf
4. The FDA has approved immunotherapy for endometrial cancer using certain biomarkers. news release. FDA; April 22, 2021. Accessed on May 2, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-endometrial-cancer-specific-biomarker
5. The FDA grants accelerated approval of GSK’s Jemperli (dostarlimab-gxly) for women with relapsed or advanced dMMR endometrial cancer. news release. GlaxoSmithKline; April 22, 2021. Accessed on May 2, 2021. https://www.gsk.com/en-gb/media/press-releases/fda-grants-accelerated-approval-for-gsk-s-jemperli-dostarlimab-gxly-for-women-with-recurrent-or- Advanced dmmr-endometrial cancer / #
6. Jemperi. Prescription information. GlaxoSmithKline; access 2021.xxxx, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761174s000lbl.pdf
7. Roche has received FDA approval as the first companion diagnostic to identify patients with endometrial cancer who are eligible for immunotherapy. news release. Roche; April 23, 2021. Accessed on May 2, 2021. https://www.roche.com/media/releases/med-cor-2021-04-23.htm
8. Fonsom ETH, Wolf AMD, Church TR, etc. Cervical Cancer Screening for Average Risk Individuals: Camaro for a Cause 2020 Guidelines Update. CA Cancer J Clinic. 2020; 70 (5): 321-346. doi: 10.3322 / caac.21628
9. NCI staff. The latest ACS screening guidelines for cervical cancer are described. National Cancer Institute. September 18, 2020. Accessed on May 3, 2021. https://www.cancer.gov/news-events/cancer-currents-blog/2020/cervical-cancer-screening-hpv-test-guideline
10. Rosenblum HG, Lewis RM, Gargano JW, Querec TD, Unger ER, Markowitz LE. Decreased prevalence of human papillomavirus vaccine-type infections in women after vaccination – United States, 2003-2018. MMWR Morb Mortal Wkly representative2021; 70 (12): 415-420. Doi:10.15585 / mmwr.mm7012a2Published fixes will appear in MMWR Morb Mortal Wkly representative 2021; 70 (13): 502.
11. The FDA has approved niraparib as the first-line treatment for advanced ovarian cancer. FDA. April 29, 2020. Accessed on May 3, 3021. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-niraparib-first-line-maintenance-advanced-ovarian- Cancer
12. Zejura. Prescription information. GlaxoSmithKline; 2021. 2021 Access to xxxxx. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208447s019s020lbl.pdf
13. González-Martin A, Pothuri B, Vergote I and more. PRIMA / ENGOT-OV26 / GOG-3012 Investigator. Niraparib in patients newly diagnosed with advanced ovarian cancer. New England Journal of Medicine. 2019; 381 (25): 2391-2402. doi: 10.1056 / NEJMoa1910962