Today is World Cancer Research Day: A call to action by ASCO- Don’t Stand Still. We Won’t

September 24th is  World Cancer Research Day. American Society of Clinical Oncology (ASCO)calls upon to continue and heighten research in areas of cancer prevention and treatment, along with discovering new drugs. World Cancer Research Day is a global initiative that aims to raise awareness about the critical importance of cancer research.

It is estimated that by 2030 cancer will be the leading cause of death worldwide with new cases expected to increase to 21.6 million each year. According to the GLOBOCAN report, in 2012 there were 14 million new cases diagnosed and 8.2 million cancer-related deaths worldwide.

Life years and productivity loss, together with disabilities resulting from cancer account for the largest economic cost on a global scale, compared to other causes of death including infectious diseases.

One of the most important areas is to support and promote research on the causes, prevention and early detection of cancer as a key element in controlling the disease. This will lead us towards the discovery of a cure for cancer or transforming the disease into a chronic illness, both approaches translating into higher survival rates.

Some of the important research paper on Obstetrics and Gynecological cancer published recently are:

USPSTF simplifies cervical cancer screening recommendations: Dual testing no longer advised

The US Preventive Services Task Force (USPSTF) has issued new draft recommendations for cervical cancer screening with a major change that it recommends either cervical cytology (CC) or high-risk HPV (hrHPV) test as a screening procedure every 3 years for women aged 30-65 years, and not both ( Grade A)  

https://obgynupdated.blogspot.com/2017/09/uspstf-simplifies-cervical-cancer.html

Magseed, a minimally invasive breast marker for cancer localization during surgery receives clearance in Europe

Endomag, a surgical guidance company received CE clearance for Sentimag+Magseed breast cancer diagnostic system, that guides surgeon for precise location of impalpable tumor during breast lumpectomy. It improves outcome and reduces the amount of radioactive exposure for patients.

https://obgynupdated.blogspot.com/2017/09/magseed-minimally-invasive-breast.html

FDA clears first 2D digital mammography system that allows patients to control the compression

GE Healthcare announced today FDA 510(k) clearance of an industry-first, patient-assisted mammography system, Senographe Pristina Duetathat makes mammography experience more comfortable by putting the control in patients’ own hands.

https://obgynupdated.blogspot.com/2017/09/fda-clears-first-2d-digital-mammography.html

FDA approves world’s first pioneering gene therapy for cancer

The U.S.Food and Drug Administration in its landmark and historic action today approved the world’s first gene therapy, Novartis' Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

This opens a new frontier in treatment of cancer and other serious and life-threatening diseases.

https://obgynupdated.blogspot.com/2017/09/fda-approves-worlds-first-pioneering.html

Are you dense? What every woman and her healthcare provider needs to know.

Nearly 20 plus years of research have provided sufficient evidence to link dense breast tissue and increased risk of missing cancer diagnosis by screening mammography. As the breast density increases, the reliability of mammogram as a screening tool for picking up breast malignancy decreases.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

https://obgynupdated.blogspot.com/2017/08/are-you-dense-what-every-woman-and-her.html

Now Ovarian Tissue paper to support normal hormonal production: Breakthrough in Regenerative Medicine

An accidental Spill has sparked a breakthrough in the field of regenerative medidicne. Scientists and engineers at the Northwestern Medicine have invented a range of bioactive “tissue papers” made from organs combined with a polymer to make them so pliable.

These new “tissue papers” are so thin and pliable that they can be folded into an origami bird. Their clinical application is for wound healing and aid in natural hormone production in young cancer patients.

https://obgynupdated.blogspot.com/2017/08/now-ovarian-tissue-paper-to-support.html

Adjunct Metformin helps reversal of atypical endometrial hyperplasia

Adjunct metformin treatment help reversal of atypical endometrial hyperplasia (AEH) and improves overall survival in endometrial cancer reports the result of a systematic review and meta-analysis published ahead of print in Journal of Gynecologic Oncology.

https://obgynupdated.blogspot.com/2017/08/adjunct-metformin-helps-reversal-of.html

FDA Approves PARP inhibitor Zejula for treatment of recurrent ovarian cancer.

The U.S.Food and Drug Administration today approved Zejula (niraparib) for the maintenance treatment of epithelial ovarian, fallopian tube or primary peritoneal cancer in adult patients who have already responded well to platinum-based chemotherapy.

https://obgynupdated.blogspot.com/2017/03/fda-approves-parp-inhibitor-zejula-for.html

Here is an interesting video about importance of research on World Cancer Research Day 2017

FDA approves first single dose oral secnidazole (Solosec) for Bacterial Vaginosis

The US Food and Drug Administration (FDA) approved first and only single dose oral therapy, secnidazole 2 gms (Solosec, Symbiomix Therapeutics) for treatment of women with bacterial vaginosis (BV), the most common U.S. gynecologic infection in women aged 14 to 49 years, according to the Centers for Disease Control and Prevention.

The antibiotic is manufactured by Symbiomix Therapeutics, Newark, NJ.

The single dose 2 gm secnidazole comes in the form of packaged granules, the entire contents of the packet should be sprinkled onto applesauce, yogurt or pudding and consumed once within 30 minutes without chewing or crunching the granules. It cannot be consumed by dissolving it in any liquid.

The current treatment regimen is prescribed for at least twice a day for 7 days, which has resulted in only 50% of the patient taking the full course of antibiotics. Incomplete treatment of BV leads put the patient at high risk of contracting other sexually transmitted diseases like chlamydia, gonorrhea, herpes, trichomaniasis and HIV. It also results in preterm births and low birth weight.

David L. Stern, CEO of Symbiomix, “The FDA’s approval of this first-of-its-kind treatment is an important milestone for Symbiomix and most importantly, millions of women suffering from BV. The approval of Solosec™ represents a critical moment in our efforts to bring innovative medicines to the women’s health market. Solosec is the first new oral antibiotic to treat BV in more than a decade and will provide women with a new treatment option. We look forward to making this treatment available to patients in the first quarter of 2018.”

The FDA’s approval comes in wake of successful results of two pivotal clinical trials involving a total of 333 nonpregnant women up to age 54. The patients were assessed based on 3 endpoints namely: clinical responder, therapeutic responder and Nugent score cure (Nugent score < 3).

In both the trials significant more number of patients attained clinical and therapeutic cure as compared to placebo. Adverse effects were mild or moderate and includes Vulvovaginal candidiasis, headache, nausea, dysgeusia, vomiting, abdominal pain and diarrhea. The drug label warns that Vulvovaginal candidiasis may require antifungal treatment.

The FDA designated Solosec as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec eligible for priority review and at least 10 years of U.S. market exclusivity.

The label also warns against chronic use, animal studies have demonstrated its carcinogenic potential after long use. It is also contraindicated in pregnancy and lactation.

The FDA Drug label.

New release by Symbiomix Therapeutics

Nearly 10% of young women worldwide prefer Cesarean section to vaginal birth as delivery option

One in ten young women prefers cesarean section to vaginal birth as her choice of delivery in a seemingly healthy pregnancy, because of fear of uncontrollable labor pains and physical damage says the result of large study published in Journal of Reproductive Health.

All attempts to bring down cesarean section rates in middle income and developed countries have mostly focused on educating the physicians and midwives, changing hospital policies and environment and less on patient education and knowledge about benefits of vaginal births.

It is estimated that 6.2 million unnecessary cesarean sections (CS) are performed worldwide each year and most countries that participated in this study exceeds the optimal limit between 10-19%.

Recently, psychological indication of Cesarean Section has emerged as an important contributing in increasing the global cesarean rate. A survey of 6000 European found that 16.7% of primiparas and 31.7% of multiparas had a CS without medical indications because of severe fear of childbirth.

The current study recruited student from Universities and Schools across 8 OECD countries (Australia, Canada, Chile, England, Germany, Iceland, New Zealand, United States.

Childless young men and women who plan to have one child in near future were sent online questionnaire, of which 6571 completed the survey.

During the final analysis, overall 10.8% of women wanted to have a CS in a healthy future pregnancy, with the highest rate of 16.0% in Australia.

The most common reason cited was fear of labor pains and maintain vaginal integrity, the other being CS is well planned and good for mother’s health.

Regression analysis showed that students who studied health science had significant less fear and lower odds of preferring CS.

Epidural analgesia might theoretically appear a lucrative solution, but it increased the rates of instrumental delivery and created a lasting negative impression in long term.

All women expressed a significant interest in knowing more about anatomy and process of childbirth.

The authors concluded, “Education sessions delivered online, through social media, and face-to-face using drama and stories told by peers (young women who have recently had babies) or celebrities could be designed to maximize young women’s capacity to understand the physiology of labor and birth, and the range of methods available to support them in coping with labor pain and to minimize invasive procedures, therefore reducing fear of pain, bodily damage, and loss of control. The most efficacious designs and content for such education for young women and girls remains to be tested in future studies.”

Abstract, Full Text.