Clinical Trial Decisions- No trial necessary - FDA approves treatment

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.

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. 

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!

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 , 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! 

jan9wils said:

I was just in a clinical trial

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. 

 

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 said:

New drug combination approved

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.

Wonderful news, thank you for posting it.