Olaparib shows improved survival in Phase 3 trial, FDA approval granted

"FDA Approves Olaparib for First-Line Maintenance of BRCA-Mutated, Advanced Ovarian Cancer

https://tinyurl.com/yayx3drb

On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germ-line or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

The FDA also approved BRACA analysis CDx to be used by health-care professionals to identify patients with advanced ovarian cancer who have a germ-line BRCA mutation and are eligible for olaparib following response to platinum-based chemotherapy

Lynparza (olaparib), a poly ADP-ribose polymerase (PARP) inhibitor, co-developed by AstraZeneca and Merck (known as MSD outside the US and Canada), has succeeded in a phase 3 trial (SOLO-3) held in patients with relapsed BRCA-mutated (BRCAm) advanced ovarian cancer by meeting the primary endpoint.

https://tinyurl.com/y9fcbckz

SOLO-3 is the first Phase 3 trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed".

(The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug. This trial phase recruits a large group of people with the disease or condition, usually ranging from 1,000 to 3,000 participants. The Food and Drug Administration (FDA) reviews results from Phase 3 trials when considering a drug for approval.)

Does opportunistic salpingectomy save lives and money?

 

The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction

https://tinyurl.com/ybevpsa4

Opportunistic salpingectomy is a cost-effective strategy recommended for ovarian cancer risk reduction at the time of gynecologic surgery in women who have completed childbearing.

https://tinyurl.com/y79oseav

We aimed to evaluate the cost-effectiveness of opportunistic salpingectomy compared to standard tubal ligation (TL) during cesarean delivery.

In 10,000 women desiring sterilization with cesarean, opportunistic salpingectomy would result in 17 fewer ovarian cancer diagnoses, 13 fewer ovarian cancer deaths, and 25 fewer unintended pregnancies compared to TL.

In women undergoing cesarean with sterilization, opportunistic salpingectomy is likely cost-effective and may be cost saving in comparison to TL for ovarian cancer risk reduction.

Well, it’s Christmas!

 “Dietary fiber intake and reduced risk of ovarian cancer: a meta-analysis

https://nutritionj.biomedcentral.com/articles/10.1186/s12937-018-0407-1

To the best of our knowledge, this is the first meta-analysis to summarize evidence between total dietary fiber intake and different types or sources of dietary fiber intake and risk of ovarian cancer. The risk of ovarian cancer was reduced by 22% in the group of highest dietary fiber intake compared with the lowest”

http://www.eatingwell.com/recipes/17938/holidays-occasions/christmas/

'We bring gifts of gold, myrrh, and ovarian cancer treatment'

https://lra.le.ac.uk/handle/2381/39946

Extracts from Boswellia sp. (Frankincense), used for centuries as herbal medicine in Asia, have known anti-inflammatory properties and anti-cancer potential alone or in combination with other chemotherapies. This suggests that frankincense may be useful for overcoming drug resistance, and it could also lead to an improved survival rate for patients with late-stage ovarian cancer”.

“A Perspective on Ovarian Cancer Biomarkers: Past, Present and Yet-To-Come

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5373023/

As one year closes and another begins, I find myself reflecting on ovarian cancer diagnostics. It is truly humbling how little we have accomplished in this field over the last half-century. So let us awake on a future Christmas morning with newfound clarity. Let us transform how we categorize ovarian cancer, how we identify ovarian cancer, how we treat ovarian cancer, and possibly how we screen for cancer in general. It did not take long for the Nuclear Age to change our worldview or for the Information Age to profoundly alter our daily lives; with any luck, it will not take long to revisit our approach to early diagnostics for ovarian cancer. If Ebenezer Scrooge can change his ways…”

Women of faith more often present with advanced ovarian cancer.

“Effect of Cultural Folk and Religious Beliefs and Practices on Delays in Diagnosis of Ovarian Cancer in African American Women

https://doi.org/10.1089/jwh.2018.7031

An individual's beliefs have the potential to affect cancer outcomes both positively and negatively. Religious practices and cultural/folk beliefs may be especially relevant for African Americans (AAs) with cancer. AAs are more likely than whites to have a religious affiliation and more likely to report praying, regardless of whether they identify with a specific religious affiliation.

We conducted analyses among AA women in a multicenter case control study of ovarian cancer. Because many cultural/folk beliefs are intertwined with religious beliefs, our analyses evaluated specific cultural/folk beliefs as well as measures of participation in religious practices. We examined whether these beliefs and practices were associated with delays in ovarian cancer diagnosis as indicated by a later stage at diagnosis or longer symptom duration before diagnosis.

This case only analysis comprised of 599 AA women with ovarian cancer from the African American Cancer Epidemiology Study. Participants completed an interviewer administered telephone survey that obtained risk factor information, including reproductive history, medical history, socio-demographic factors, and lifestyle characteristics. Stage at diagnosis was derived from pathology and medical records, and categorized as stage I–II versus III–IV.

Responses to questions on religiosity showed that a large majority of the women regularly participated in religious services and prayers. Religiosity showed a significant association with stage at diagnosis. There was a twofold increase in the odds of stage III–IV disease for women who reported attending religious services >1 × /week (OR = 1.98, 95% CI 1.11–3.53) and those who considered themselves very religious (OR = 2.35, 95% CI 1.07–5.18).

Our analyses showed that women who reported greater religiosity were more likely to have higher stage ovarian cancer, whereas there was no clear association with symptom duration before diagnosis. Endorsement of cultural/folk beliefs related to cancer or health showed little association with either stage at diagnosis or symptom duration”.

Chemotherapy issues

“Current Chemotherapy of Ovarian Cancer

https://tinyurl.com/yans2wcg

Optimal primary chemotherapy of advanced ovarian cancer has not substantially changed over the last few years, in spite of the extensive evaluation of new cytotoxic agents and diverse treatment strategies. The rapid development of drug resistance remains a major clinical challenge for the majority of patients

While the combination of carboplatin and paclitaxel remains a well-tolerated and effective standard treatment for newly diagnosed ovarian cancer, there is continued interest in the discovery of new targets, as well as new approaches for inhibiting old targets

When patients undergo complete surgical clearance and have a tumor that is limited to the ovary with the finding of clear cell histology, cure would be expected in the vast majority of cases. In contrast, early-stage serous tumors are often high-grade and have a greater risk of recurrence and are perhaps more likely to benefit from adjuvant chemotherapy.

The dominant pattern of chemotherapy resistance observed in ovarian cancer is related to platinum compounds (cisplatin and carboplatin). Currently, there are no compounds with the ability to specifically target platinum-resistant tumors in the clinical setting.

The integration of emerging biologic principles with the development of molecular-targeted reagents is starting to achieve meaningful results, especially with regard to inhibition of angiogenesis and interference with PARP-mediated DNA repair. This single-agent treatment strategy is well tolerated and effective in a proportion of women with BRCA1/2 mutations. However, inheritable germ-line mutations only account for perhaps 5% of all ovarian cancers”.

Medical Radiation and ovarian cancer.

“Nuclear Medicine Procedures in Women: Unappreciated Risks to Reproductive Organs?

https://doi.org/10.1148/radiol.2018172344

Radiation exposure in imaging include CT, PET, and an increasing number of newer diagnostic and therapeutic radio-pharmaceuticals, used primarily in cancer diagnosis, staging, and treatment are associated with a theoretical increase in the risk of secondary cancer, with younger patients at higher risk than the elderly.

Women are particularly vulnerable to medical imaging radiation exposure, although the nature and extent of this vulnerability vary over time and depend on what type of imaging was performed. Accumulating evidence suggests that hormonal changes associated with the menstrual cycle are an underappreciated but avoidable source of vulnerability and risk to female reproductive organs, specifically ovaries, endometrium, and breasts.

While it can be argued that the risks of diagnostic nuclear medicine procedures using relatively short-lived isotopes could be viewed as mostly hypothetical, this is definitely not the case for radio-pharmaceuticals in use and under development for targeted radionuclide therapy, which use high-energy nuclides with longer half-life and are specifically designed to inflict direct cell damage.

Clinical and research nuclear medicine procedure on young women should be performed in the least susceptible phase of the menstrual cycle to improve the safety and the diagnostic accuracy of nuclear medicine procedures in women. 

There is a need for new guidelines for radiotracer development and use, which are responsive to the greater risk to reproductive organs inherent in exposing reproductively competent women to administered radiopharmaceuticals”.