Tisotumab vedotin-tftv, an antibody-drug conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, demonstrated clinically meaningful and durable responses with a manageable safety profile in the pivotal phase II innovaTV 204 clinical trial. Based on the proposed mechanism of action of tisotumab vedotin, experience from clinical trials, and the US prescribing information, certain adverse events (AEs) including ocular AEs, peripheral neuropathy, and bleeding have been identified as AEs of interest. This article highlights practical considerations and provides recommendations to support the management of selected AEs associated with tisotumab vedotin. Central to monitoring of patients on tisotumab vedotin is a comprehensive care team comprised of oncologists, advanced practice providers (including nurse practitioners, physician assistants, and pharmacists), and other specialists such as ophthalmologists. As ocular AEs may be less familiar to gynecologic oncology practitioners, adherence to the “Premedication and Required Eye Care” section outlined in the US prescribing information, as well as the incorporation of ophthalmologists into the oncology care team, can help provide timely and appropriate eye care for patients receiving tisotumab vedotin.
5561 Background: Health disparities exist in gynecologic cancers, with data revealing lower survival among certain racial/ethnic groups. Studies suggest underrepresented patients of color with gynecologic cancers may not receive guideline-concordant care to adequately manage their disease, including molecular testing. We conducted a patient preferences survey evaluating treatment choices and provider interactions influencing adherence to guideline-based care. Methods: From July 7 to August 18, 2021, a survey was sent to women with gynecologic cancers who participate in the SMART Patients advocacy group. Survey questions covered topics of preparedness to discuss care with provider, biomarker testing specific to gynecologic tumor type, patients’ considerations informing treatment choices, and confidence to work with providers to improve their clinical and survival outcomes. Information regarding cancer diagnosis, stage, race, ethnicity, treatment, and genetic testing was obtained. Survey responses between non-Hispanic White patients (W) versus non-White (NW) underrepresented patients of color were compared and analyzed using descriptive statistics. Results: A total of 89 women with gynecologic cancers (67% ovarian, fallopian tube, and peritoneal; 21% endometrial; 9% vulvar or vaginal; and 2% cervical) participated in the patient survey. Amongst responders, 55% had localized disease while 36% indicated they had metastatic disease, and 9% did not know. Overall, 86.5% were W and 13.5% were NW (Asian, Black/African American, Native American or Pacific Islander, Hispanic, or mixed race). A higher proportion of NW compared to W patients said they were not at all prepared to discuss cost of treatment (18.2% vs 9.5%), treatment options (12.5% vs 4.5%), and side effects of treatment (20% vs 0%) with their provider; 31% of W patients discussed genetic testing and received resources from their provider compared with only 16.7% of NW patients, and a higher proportion of NW compared to W patients (37.5% vs 28.1%) indicated they were not confident in their ability to work with providers to improve their cancer treatment outcome. Conclusions: While a limitation of this study was low participation from diverse populations, the findings indicate that underrepresented NW patients felt less prepared to discuss treatment-related issues compared to W patients. Moreover, a large proportion of all patients with OC were not informed and/or aware about genetic testing, and approximately a third of participants were not confident in their ability to interact with provider to improve their outcomes. The results highlight opportunities to enhance health care provider education and community outreach to reduce gaps in care delivery.
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