Tubal re-anastomosis or IVF? A difficult choice to make when seeking reversal

Courtesy: Mayo Clinic 

Surgical re-anastomosis is an effective option, especially for younger women, whereas IVF is more cost effective for older women when seeking reversal of tubal ligation says the results of a systematic review published in current issue of Human Reproduction Update.

Female sterilization is one of the most common method of contraception used worldwide, with nearly 19% of women opting for it. The percentage is higher in Asia and Latin American countries (~ 25%) and lowest in European countries (3.8%).

In the United States, it is second most common method of contraception.  

But, circumstances and relationship change or a personal loss may aspire the women to desire future pregnancies. According to a statistic, up to 14.3% of women request reversal of sterilization. The categorical options are either tubal re-anastomosis or IVF.

Choosing between the two options is difficult decision to make and profoundly affected by many factors like age of women, time elapsed since sterilization, cost and desire for multiple children.

This systematic review looked at factors affecting the success of reversal, compared different methods of tubal re-anastomosis and how these methods fared compared to IVF.

The researchers searched the literature for randomized and non- randomized trials comparing fertility outcomes of various surgical methods and also looked at trails comparing re-anastomosis with IVF.

Women who have earlier suffered from tubal factor infertility were excluded from the analysis.

A total of 37 studies, with 10 689 women was included in the final analysis.  The pooled pregnancy rate after reversal was 42–69%, with variation in rate seen across different methods. About 4-8% of women had ectopic pregnancy after the surgery.

Age of the women at reversal of surgery was the only factor affecting the success rate of the procedure. The way the surgery was done i.e. laparoscopically, robotic and laparotomy using microscope did not play any part in achieving pregnancy.

Rates were lower in macroscopic laparotomic technique, which is currently not in much use.

IVF was better choice for women who were older, but no direct comparison data was available nor any cut-off age limit could be established.

The authors stressed the need of larger, randomized trials in future to compare re-anastomosis vs IVF in terms of  pregnancy rates and cost of procedures.  

FDA drug panel unanimously approves Avastin and Herceptin Biosimilars

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) today unanimously voted to recommend the approval of biosimilar versions of two of Genentech’s top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab).

Herceptin®, is used in treatment of HER2-positive breast cancer in the metastatic and adjuvant settings while Avastin is used in colorectal, ovarian, cervical, brain and renal cell cancers.

In the morning session, the ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar ABP 215, for six of 8 originally approved indications for Avastin, as they are covered by orphan drug exclusivity until 2021 and 2023.

In the afternoon session, ODAC members voted 16-0 in favor of approving Mylan's Herceptin biosimilar candidate, MYL-1401O, for all of Herceptin's indications, including an indication for metastatic gastric cancer, which is protected by orphan drug exclusivity through 20 October 2017.

For both the drugs the FDA and committee members felt that there were no clinically meaningful differences between the reference products and the biosimilars. However, some members were worried about extrapolating the data from studies pertaining to single disease to multiple indications in actual clinical application.

Courtney J. Preusse, MA, ODAC's consumer representative and a research administrator at Fred Hutchinson Cancer Research Center in Seattle said, “I would like to strongly applaud the sponsor for equivalence results that were very solid and for what appears to be the first proposal for a biosimilar for a drug that's been on the market for almost three decades.”

To gain the approval, Mylan has submitted clinical trial data comparing MYL-14010 and European Union trastuzumab. The trial recruited 458 patients with untreated metastatic breast cancer, who were randomized to receive MYL-14010 or EU-trastuzumab in combination with a taxane, for a minimum of eight cycles.

Those patients whose disease was stabilized were put on single agent MYL-14010 or EU-trastuzumab for a period until the disease progressed or drug toxicity developed.

In an intention to treat analysis, overall similar response was achieved with both the drugs. No difference was observed in safety analysis also.

The FDA and ODAC report concluded that the clinical trials have  shown "that there are no clinically meaningful differences between MYL-14010 and US-Herceptin in terms of the safety, purity, and potency of the product."

Photo courtesy: Genentech

Ranked as one of the top 100 Obgyn Blogs on the web

This is not an Ob/Gyn blog post but, I just want to thank you all, my friends and colleagues who have read and commented on my articles since last 1.5 years. Today I received a notification that my blog has been selected by Feedlist panelist as one of the Top 100 Obgyn Blogs on the web.( I am 44^th on the list)

http://blog.feedspot.com/obgyn_blogs/

I really appreciate your taking time off to read my blog posts. 

These blogs are ranked based on following criteria:

Google reputation and Google search ranking

Influence and popularity on Facebook, twitter and other social media sites

Quality and consistency of posts.

Feedspot’s editorial team and expert review

Thank you all once again and looking forward to sharing the most recent, practice oriented and best articles in Ob/Gyn and Women’s Health.

Best,

Dr. Anjali Vyas