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Clinical Trial Decisions- No trial necessary - FDA approves treatment

Fridays Child
Posts: 74
Joined: Jul 2019

Some of you all have done clinical trials and some of you have chosen against them.  I now find myself in the position of having to make this decision.

Brief synopsis:  Diagnosed in 2012, Stage Ia, Grade 1 endometrial cancer.  Surgery followed by brachytherapy.  CT scan for hip pain two years later, negative.  After six years, MRI shows pelvic wall/hip tumor; PET reveals lung metastases.  Low dose Carbo/Taxol during five weeks of radiation, followed by six full dose Carbo/Taxol treatments.  Good response.  Started letrozole after that, and scans showed continued shrinking for about a year, then disease progression.

The clinical trial, should I get on the study drug arm, would be Keytruda and Lenvima.  The side effects for Lenvima look pretty rough.   If I choose another treatment now, I will not be eligible for the study in the future. Of course, if another treatment works, that's a good thing!  If I do the study now, the other options will still be there if it doesn't help.  There are a number of  things I had planned for this fall which, depending on the side effects, I might have to give up.  If it buys me time, maybe it's worth it.

How did you all go about making this decision?  It's a tough one for sure!

Northwoodsgirl
Posts: 546
Joined: Oct 2009

Hi Friday’s Child,

First let me say I am sorry to hear that the cancer came back after all this time.

I can only imagine what a tough decision you are trying to make. I haven’t had to make a clinical trial decision but others who have will share their decision making processes with you soon.

I have faith that your decision will be the best for you. I will keep you in my prayers. 

Lori

MAbound
Posts: 874
Joined: Jun 2016

Having cancer can be such a lonely place when you are faced with having to make a decision you really aren't qualified to make. We're not the experts in any part of this and having choices rather than a clear cut path to follow just doesn't help us to help you. I'm so sorry to hear that you are in this position. I have no similar experience to draw from except from what I've read over time here from others.

Whatever you decide to do, you are always going to wonder if you made the right choice unless you have absolutely miraculous results a la Jimmy Carter. We've seen here from others that taking Keytruda alone may only work for a while rather than indefinitely, but it doesn't seem too difficult to take by itself. Your trial adds something else to the mix and maybe that will be a plus and give you longer lasting remission, but it sounds like it will be a rougher road than just taking Keytruda. I don't know what those side effects you are talking about are, but I wonder if they are like other drug side effects you get told about where they are possible but not necessarily certain to occur. Chemo and radiation scare us all before we go through it because we just don't know how we will react to it, but we risk it anyway because the worst of those potential side effects don't happen to all. Some breeze through, and others really suffer, you just don't know until you are in the midst of it.

If I were in your shoes, I'd give a long, hard look at those side effects and weigh how permanent or not they were going to be. Quality of life matters as much, if not more than quantity in my mind. That said, I think I could put up with a lot if I knew it wouldn't be forever or if there were things that could be done to deal with them after the fact. It's the big stuff that I couldn't change, ever, that would propably make me decide to refuse a treatment. It's a scary decision to need to make and I wish the best for you whatever path you choose to follow.

DM_K's picture
DM_K
Posts: 51
Joined: Mar 2018

I made my decision based on not wanting any regrets.  I knew if I didn't try I would feel I should have when it was too late.  If my clinical trial doesn't work I will go into a another one.  I tested positive for a protein that makes me eligible for another clincial trial.  Just keep in mind, if the side effects get too bad you can always leave the study.

 

Keep up posted.

Donna Faye's picture
Donna Faye
Posts: 255
Joined: Jan 2017

Friday's Child, I was asked to join a clinical trial 20 years ago for my Stage3 BC. It involved a stem cell transplant and was the third phase. I did quite a bit of research, talked to the doctor doing the trial and also to 2 patients that had gone through it in the second phase. I decided not to do it for the following reasons. It would require a long hospital stay and then a long recovery period. My 3 children had just begun their own lives and I had no one that had the time to care for me.  I was 55 and the research showed that chemo, radiation, and tamoxifen had a good result for my cancer. I wanted more time, but I wanted quality time as my first grandson was on the way, my daughter was planning a wedding and so I decided to throw the dice and not do the trial. For me, it worked as I am now 79. So each of us has to weigh the pros and cos and live with our choice. The tamoxifen, however, did result in my uterine cancer in 2017, so I did not get away scot-free, but I had 20 good years and so far am NED after the last go-round. I hope you find lots of good advice and make the decision that works best for you. 

jan9wils's picture
jan9wils
Posts: 69
Joined: Mar 2017

MAbound said it well, we are indeed in a very lonely place.

I was in a clinical trial for three months before contracting hypothyroidism which turned out to be life threatening (who knew?). Now I am waiting to see if they are going to cover the costs of my care as indicated in the consent I signed. I am off of the trial, not because of my thyroid, but because my disease is progressing.  

I wish you peace as you make your decision. 

 

DM_K's picture
DM_K
Posts: 51
Joined: Mar 2018

Hi Jan,

I also aquired hypothyroidism, mine happened after 6 doses of carbo and taxol.  My docs are trying to stablize it but it's all over the place, right now I'm in hyper.  I don't feel any affects from it, fortunately. 

I'm sorry about your disease progressing, maybe there is another study you're eligible for?  Months after having genetic tumor testing they were able to find out that I was eligible for another study for a protein my cancer carries, an immunotherapy was created to go after that protein.  Since my cancer is stablizing with the clinical trial I'm currently in, I'm going to stay in this one but at least it's nice to know there is an alternative if my cancer increases.

Keeping you in my thoughts and prayers, hugs.

Fridays Child
Posts: 74
Joined: Jul 2019

Thank you all for sharing your experiences and thoughts. It is a difficult decision to make.  It does help to read your thoughts and perspectives.

The thyroid issue is one that is a risk of both of the study drugs, so the combination is a concern for me. There also can be sudden and severe high blood pressure and all its attendant risks.

Those of you having treatments, I wish you all well in your next treatment and hope that it is easy on you and most of all successful. Those who are clear, may you stay that way forever!

 

NoTimeForCancer's picture
NoTimeForCancer
Posts: 2597
Joined: Mar 2013

I want to say THANK YOU.  To all of you who can do a clinical trial, it is so generous of yourselves, it is humbling.  We have treatments today because of those who participated in trials.  We truly stand on the shoulders of those who are able to participate.  

MoeKay
Posts: 217
Joined: Feb 2004

My childhood friend had to make the decision on whether to participate in a clinical trial or not.  Her gyn-onc made her decision process much easier by giving her the statistics that she would benefit from traditional chemotherapy (relatively low) and advising her that preliminary results for the trial drug looked "promising."  The gyn-onc told my friend that knowing what he knew, if he were in her situation, he would participate in the trial. 

Since you are concerned about potential side effects, I thought it would be helpful if you could get some input on the side effects experienced by earlier trial participants.  Therefore, I'm providing a link to an Abstract that discusses interim results from phase 2 of a Keytruda and Lenvima trial:  https://www.ncbi.nlm.nih.gov/pubmed/30922731.  If you haven't already seen this information, I thought it might be helpful for discussions with your treatment team.

Best of luck to you in making this difficult decision!

MAbound
Posts: 874
Joined: Jun 2016

Moekay, you are such an amazing researcher and come up with some of the most helpful and practical information when someone is in a tough spot like this. I am so glad you are on this board!

Fridays Child
Posts: 74
Joined: Jul 2019

Wow, MoeKay, that is so kind of you to find that information for me.  I will have to wait until tomorrow to read it, but I am truly grateful for your work in finding it.

MoeKay
Posts: 217
Joined: Feb 2004

Thanks for the kind words, MAbound.  And you're very welcome, Friday's Child.  When I was diagnosed back in 1999, I had a tremendous "need to know" about the details of my endometrial cancer, which had some unusual twists and turns.  I can't tell you how much time I spent researching, and how many lunch hours I spent at the medical school library reading and copying the entire studies for the Abstracts I had found online.  Keep in mind that the link I've provided is only to the study Abstract.  If you want to read the study in its entirety, there are instructions in the upper right-hand corner on obtaining a full-text copy, or if you have a medical school library in your area, you can visit or contact them for help in getting a copy of the entire study published in The Lancet.  Also, assuming you're interested, I should think that your oncologist who discussed this clinical trial with you would have a copy of the full text of this journal article that he/she could share with you.  

Hope this information is helpful!

 

Feelingalone74
Posts: 236
Joined: Jun 2019

Best of luck in your decision of a clinical trial. I hope whatever u decide u feel well and wishing u good health and  to all of the sweet ladies on this site.

From all that I'm reading it does scare me. Because  it's sounding like endometrial cancer after treatment  some time down the road comes back in some form. If anyone has  not experienced reoccurrence I love to hear your story 

I have had 2 treatments of carbo/taxol. In 2 weeks I'm to being radiation with cisplatin.  My gyno oncologist suggested 1 day a week cisplatin each week  with the 5 day radiation for 5 weeks. The Center closer to to my home where I'm being treated the oncologist there says there's a new clinical trial that showed no difference in giving cisplatin only on weeks 1 and 4 rather every week. Spoke to my gyno oncologist and he's leaving decision up to me. Ugh! I dont anything about any of this and not in the right frame of mind to make that kind if decision.  He and the radiologist dont agree either. Radiologist says I need the standard brachytherapy following radiation. my gyno oncologist says I do not because of where the cancer was found. 

So I can understand your struggle in making a decision.  I'm not sure why they put it on the patients whom dont have any knowledge of "C" treatment. 

Fridays Child
Posts: 74
Joined: Jul 2019

There are many, many women who don't have a recurrence, but most of them are off living their lives and not coming here to talk about it.  Some have stuck around to help others, but many of the women here are in active treatment, whether for the first diagnosis or a recurrence.  I hope and pray you will be done with treatment and not have to think about it any more ever!

Feelingalone74
Posts: 236
Joined: Jun 2019

Fridays Child , Best wishes to you in the decision you make! I hope it brings you to good health! I will be thinking of you.

Thank you for you prayers for me. 

I'm relieved to hear that many women dont have reoccurence. I wish they would come back here to the discussion board to share their success with us all. although I do respect that they probably just want to put this all behind them.  At the same time I am so grateful for all of you that continue on this board to give advice, suggestions , encouragement and just be an ear to those of us just begining this sccary health journey. I wish you and everyone on this board strength and good health! 

Soup52's picture
Soup52
Posts: 902
Joined: Jan 2016

So far no reoccurance so far. Diagnosed 2015 with surgery October 2015. I had internal and external radiation followed by six rounds of carbo/taxol. So I’m still being followed now every 6 months.

Fridays Child
Posts: 74
Joined: Jul 2019

Well, the drug combination received approval:

https://investors.merck.com/news/press-release-details/2019/FDA-Approves-KEYTRUDA-pembrolizumab-plus-LENVIMA-lenvatinib-Combination-Treatment-for-Patients-with-Certain-Types-of-Endometrial-Carcinoma/default.aspx

 

 

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the U.S. Food and Drug Administration (FDA) approved the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available kinase inhibitor discovered by Eisai, for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This marks the first U.S. approval for the combination of KEYTRUDA plus LENVIMA and the first time an anti-PD-1 therapy is approved in combination with a kinase inhibitor for advanced endometrial carcinoma in the U.S. Following submission on June 17, this is an accelerated approval reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to improve the efficiency of the review process for applications to ensure that treatments are available to patients as early as possible. This approval is based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial. According to the FDA, this review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.

derMaus's picture
derMaus
Posts: 561
Joined: Nov 2016

Wonderful news, thank you for posting it.

Fridays Child
Posts: 74
Joined: Jul 2019

Good to hear from you and hope you're beginning to feel better.  I hope this treatment will be effective for many women!

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