Clinical Research: Phase 1 - Phase 4

Addressing the Challenges and Opportunities in Gynecologic Cancer Research

Gynecologic cancers continue to be a significant cause of female morbidities and mortality worldwide. Significant unmet needs exist in diagnosis and treatment. These cancers are often detected at later stages when therapeutic options are limited, and advanced or recurrent disease leads to a poor prognosis. Earlier diagnosis and more effective treatments will enhance the quality of life and, ideally, extend progression-free and overall survival for patients.

The challenges of cancer detection and treatment

All women are at risk for the five major gynecologic cancers: ovarian, uterine, cervical, vaginal, and vulvar. Specific risk factors include family history, human papillomavirus (HPV) infections (cervical cancer), genetic mutations such as BRCA1 and BRCA2 (ovarian cancer), hormone replacement therapy, and increasing age.

Vaccines and screening tests are available only for cervical cancers, which, in addition to vaginal and vulvar cancers, are linked to persistent HPV infections. HPV vaccination can reduce infections and prevent cervical cancer, though unequal access to HPV vaccines and pap tests is an ongoing problem contributing to 4000-5000 unnecessary deaths each year. However, even if the disease does develop, routine screening and management of precancerous lesions often result in a good outcome.

Advanced ovarian and endometrial carcinomas present the most significant challenge and account for the most deaths annually. Ovarian cancer is typically diagnosed at a later stage, as there are at present no commercially-available screening tests to improve early detection. The standard-of-care first-line treatments are debulking surgery and perioperative platinum-based chemotherapy. Although the initial response rate is high, most patients eventually relapse, which is driving an unmet need for maintenance therapies. In recent years, endometrial cancer cases have also been rising, and those patients have faced recurrence, progression, and a poor prognosis following conventional treatment. Despite the limited diagnostic and treatment options to date, recent progress in endometrial and ovarian cancer research has improved our understanding of these diseases and led to developing novel targeted therapies that advance patient care and outcomes.

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