FDA ALERT REGARDING RISKS ASSOCIATED WITH OVARIAN CANCER SCREENING TESTS

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Ovarian cancer is the sixth most commonly diagnosed cancer worldwide. Second, only to uterine cancer, it is a leading cause of gynecologic cancers and causes more deaths per year than any other cancer of the female reproductive system. [1] Worldwide 23900 new cases were diagnosed in 2012 with the UK alone having 4271 deaths annually.  The etiology of this disease is poorly understood despite such a high incidence and mortality rates.  Five-year survival rates are over 90% for the early-stage tumors, but only 43% overall. [2]

Previously known as the ‘silent killer’, ovarian cancer is associated with non-specific symptoms like distension and loss of appetite, bloating, unexplained loss of weight, etc. which make it a challenging diagnosis. It is detected in only 1 of 3 women through primary care referral with patients routinely presenting in the advanced stages (stages III or IV). National Institute for Health and Care Excellences has set guidelines that recommend sequential testing of CA 125 and routine ultrasound in primary care. However, these diagnostics tests show limited sensitivity and specificity. [2]

The FDA has warned women and physicians regarding the lack of sensitivity of the routinely used screening tests for ovarian cancer and has emphasized on their unreliability. Despite several companies marketing tests that claim to screen and detect ovarian cancer, a high number of inaccurate results have been obtained over the years.  Currently, there are no foolproof tests for diagnosing the condition without accompanying large numbers of incorrect results, raising concerns about treatments based on such results.[2,3]

The chief known risk factors for ovarian cancer include the following:

  • a family history of cancer
  • Age of the person
  • Smoking
  • Alcohol consumption
  • Post-menopausal hormone replacement therapy
  • Inherited mutations in BRAC1/BRAC2 gene in women
  • Lynch syndrome
  • Infertility
  • Endometriosis

The protective factors include the following:

  • Oral contraceptives
  • Incremental Parity
  • Oophorectomy
  • Lactation
  • Incomplete pregnancies
  • Hysterectomy
  • Tubal ligation
  • In a nulliparous woman, infertility [1]

A high risk for ovarian cancer was determined in Ashkenazi Jewish women who have inherited mutations in the tumor suppressor genes BRCA1 and BRCA2. The lifetime risk of ovarian cancer is 55 to 65% for BRCAI and 45% for BRCA2 mutation carriers. [2] Because survival prediction and treatment plan depends on the stage of diagnosis, early detection is critical in improving the clinical outcome. Existing screening techniques (CA125 and transvaginal ultrasound) have not shown a reduction in mortality rates or cancer-related morbidity. Except for oral contraceptive pills, no other chemoprotective agents are currently available for ovarian cancer. [4]

FDA is concerned about such women with high risks of cancer and physicians that may be misled by claims of screening tests for ovarian cancer by diagnostic centers and that they may rely upon the false positive results. Research based on FDA’s review of all the available clinical data, from the screening of ovarian cancer to recommendations of healthcare professionals, demonstrates that the current screening tests for ovarian cancer are unreliable. [5]

FDA recommendations:

  • Better methods to detect ovarian cancer, like screening tests, particularly in high-risk women, are urgently needed [4]
  • Women should be aware that no safe and effective ovarian cancer screening test is available till date[3]
  • Physicians should also not recommend tests that claim to screen for ovarian cancer but are unreliable. It is better to refer women at a high risk of developing ovarian cancer to a genetic counselor or gynecologic oncologist. [3]
Copyright © 2016 BorderlessAccess
Credit: Dr. Rachita on behalf of Borderless Access

Reference Sources:

  1. http://link.springer.com/protocol/10.1007/978-1-60327-492-0_20
  1. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet
  1. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519540.htm
  2. http://www.gynecologiconcology-online.net/article/S0090-8258(03)00254-3/abstract
  3. http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-detection

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