› Forums › Cutaneous Melanoma Community › Need help fast Carbo/Taxol vs Yervoy
- This topic has 26 replies, 4 voices, and was last updated 13 years, 5 months ago by
Banu.
- Post
-
- June 30, 2011 at 6:14 pm
Hello everybody. I want to extend my best wishes to all of you who are courageously fighting melanoma. There are many advances in the field and I am glad to hear that some of you are benefiting from them.
Hello everybody. I want to extend my best wishes to all of you who are courageously fighting melanoma. There are many advances in the field and I am glad to hear that some of you are benefiting from them.
Here is my question and dilemma. My father had been diagnosed as stage IV in December of 2009 with 2 mets in the lung, larger one about 30 mm, and a small thoracic spot. He is now 75 years old. Before we started therapy, we consulted with 2 doctors. One of them said that since my father is quite healthy and strong and the disease seems to be slow progressing, we should start with ipi first and give it a try for longer term benefits. The other one suggested to start with MEK inhibitor, because my father was BRAF positive. They did not have PLX4032 available in the trials at that time. The doctor said that ipi has a low response rate and we still have time to try it, if we fail MEK inhibitor which is directly targeting the tumors. My father started the MEK inhibitor trial around April 2010 and did very well on it until February 2011 with tolerable side effects, a lot of energy and up to 30% shrinkage in lung tumors. In January 2011, he found a bump getting larger in the groin area and on February 4th, we found out that he has four small lesions in the brain. He was taken off MEK. He started corticosteroids and had SRS for the lesions in the brain. The plan was to start ipi as soon as steroids were discontinued. In the meantime, we also tried PLX4032 which did not help much as at least 10 subcutaneous lesions and other smaller lesions are visible in the CT involving pancreas, small bowel, stomach etc. This was from the May 16 scan. The doctor prescribed Yervoy, however, the FDA approval worked against us. We have been waiting for approval and have been denied and appealed in the last six weeks. If ipi was still in compassionate use, we could have accessed it 6 weeks ago. The oncologist said that he never thought the FDA approval would actually cause such an access problem and felt really bad that we could not have access to it in a timely manner. In the meantime my father lost more weight. Since February, he lost about 25 lbs. His energy levels are down and he moves very slowly. I forgot to mention, that his follow up MRI showed one brain lesion smaller, the other 3 larger and 6 more smaller lesions for a total of 10. The radiation oncologist said the 6 new lesions were probably microscopic in the first MRI. So, my father had WBR the first two weeks in June to get rid of any other mircroscopic melanoma and shrink others. The plan was to get Yervoy at the same time, which did not happen. Now, his doctor wants to give him carbo/taxol as a bridge therapy until Yervoy becomes available. I told him that we have an opportunity to have access to ipi in compassionate use in Europe and asked him, if we should go that route. Even though he originally wanted to start my father on ipi/Yervoy after PLX4032, now he says that my father is deteriorating fast and he wants to stop the tumor growth and hope for shrinkage. He said that it takes a long time for Yervoy to work (months) and we may get a faster result with chemo (weeks). He also added that Yervoy works best when the patient is at his strongest, which does not apply to my father anymore.
My questions are:
1) Should we start carbo/taxol combo? Does anybody have experience with it? I am concerned that chemo may suppress my father's immune system further, but I also heard that sometimes chemo or even the flu may wake up the immune system? Any thoughts?
2) Should we start Yervoy or is it too risky considering the long wait and my father's condition?
3)Are there any other suggestions?
I now regret not having tried ipi at the very beginning and opting for MEK inhibitor instead. At least, we would have known whether my father is a responder or not. I have to admit that I feel responsible since I was helping my father make decisions. We thought that we still had time, if and when we failed the inhibitors, but FDA approval got in the way. At the time, we discussed that ipi is going to be around and most likely FDA approved, but we did not know whether or not MEK will be available in the future, so we decided to try MEK while we had an opportunity to do so. I find it very unfortunate that patients cannot have access to drugs when they most need it.
I would appreciate your feedback.
Many thanks.
- Replies
-
-
- June 30, 2011 at 6:41 pm
I had two brain mets treated with gamma knife and then a met showed up on my right adrenal gland. My onc wanted to see if she could shrink it before surgery so I went into a drug trial combining carbo/taxol and temodar.
For me it worked fantastic with more than 50% shrinkage after just one infusion. By the end of the six month trail, I was 'No Evidence of Disease'. My first set of post trial scans are on 7/11 and of course we are praying I am still NED!
The chemo wasn't fun but I got through it without a lot of trouble. I am a 58 year old woman and in good health and physical conditon otherwise. I didn't have any trouble with nausea and actually gained weight between each infusion right up until the last two.
Besides the expected fatigue and shortness of breath, the most difficult part was the intense muscle and joint pain from the taxol that would start on the 2nd or 3rd day after the infusion. The body pain only lasted about two days though so it was easy to get through.
Also, my white cell count stayed within normal ranges through the whole treatment so at least for me, it wasn't a problem for my immune system and I had no infections or problems of that nature at all.
I still have really bad neuropathy but if I stay NED it will be worth it.
I hope that helps – if you want to ask me any specific questions, please do. You might want to see if this trial would be available to you because temodar does cross the brain/blood barrier. Here is the link:http://clinicaltrials.gov/ct2/show/NCT01009515
-
- June 30, 2011 at 6:41 pm
I had two brain mets treated with gamma knife and then a met showed up on my right adrenal gland. My onc wanted to see if she could shrink it before surgery so I went into a drug trial combining carbo/taxol and temodar.
For me it worked fantastic with more than 50% shrinkage after just one infusion. By the end of the six month trail, I was 'No Evidence of Disease'. My first set of post trial scans are on 7/11 and of course we are praying I am still NED!
The chemo wasn't fun but I got through it without a lot of trouble. I am a 58 year old woman and in good health and physical conditon otherwise. I didn't have any trouble with nausea and actually gained weight between each infusion right up until the last two.
Besides the expected fatigue and shortness of breath, the most difficult part was the intense muscle and joint pain from the taxol that would start on the 2nd or 3rd day after the infusion. The body pain only lasted about two days though so it was easy to get through.
Also, my white cell count stayed within normal ranges through the whole treatment so at least for me, it wasn't a problem for my immune system and I had no infections or problems of that nature at all.
I still have really bad neuropathy but if I stay NED it will be worth it.
I hope that helps – if you want to ask me any specific questions, please do. You might want to see if this trial would be available to you because temodar does cross the brain/blood barrier. Here is the link:http://clinicaltrials.gov/ct2/show/NCT01009515
-
- June 30, 2011 at 7:59 pm
I am not sure I am following you about Yervoy and approval. Are you saying that your father's insurance won't cover it? If that is the case I encourage you to go to the companies reiumbursement site and get them to help you. I think they have been very successful in securing reimbursement. And if that doesn't work they have programs to help people have access to the drug outside normal reimbursement programs. They site is here:
http://www.destinationaccess.com/
Regarding which treatment to choose, this is a major challenge, as you know all too well. What drugs do you try? Which do you try first? No-one can tell you what to do on this. Several approaches have the potential to work, but no approach is guaranteed to work.
Yervoy has a higher response rate than any other approach out there, except the BRAF inhibitors. Some people do take months to respond, but the more typical response is much shorter than that.
Genentech has recently opened a trial for people who have developed resistance to vemurafenib (PLX4032). This trial is a BRAF/MEK combination. I don't know if the prior treatment with MEK alone would exclude your father, but it is worth exploring. And, Glaxo SmithKline has some other combination studies they are working on.
Please keep everyone posted on this.
Tim–MRF
-
- July 1, 2011 at 12:01 am
Tim,
My understanding is that the GSK BRAF/MEK trial has now closed for new applicants. My husband was up for that trial, originally washed out because of liver function numbers, and then after his chemo made him better, we were told this trial had closed.
(Unless it is only closed in our city?)
Michelle
-
- July 1, 2011 at 12:01 am
Tim,
My understanding is that the GSK BRAF/MEK trial has now closed for new applicants. My husband was up for that trial, originally washed out because of liver function numbers, and then after his chemo made him better, we were told this trial had closed.
(Unless it is only closed in our city?)
Michelle
-
- July 1, 2011 at 5:55 am
Hi Tim, thank you for your response and all the wonderful information. I was not aware of the Genentech trial and will look into it.
My father's oncologist has already submitted an application to Destination Access, but BMS asked to submit the prescription to insurance for appeal again. I guess they can help only after several attempts and several denials. I will keep you updated. Thanks again for your guidance.
-
- July 7, 2011 at 7:00 pm
I contacted BMS about the Destination Access person and was able to reach a senior person there. If you are still interested in Yervoy approval she can facilitate. Send an email to me directly and I will put you in touch with her: [email protected]
This may no longer be an issue if your father has started another treatment approach, but thought I would offer.
Tim–MRF
-
- July 7, 2011 at 7:00 pm
I contacted BMS about the Destination Access person and was able to reach a senior person there. If you are still interested in Yervoy approval she can facilitate. Send an email to me directly and I will put you in touch with her: [email protected]
This may no longer be an issue if your father has started another treatment approach, but thought I would offer.
Tim–MRF
-
- July 1, 2011 at 5:55 am
Hi Tim, thank you for your response and all the wonderful information. I was not aware of the Genentech trial and will look into it.
My father's oncologist has already submitted an application to Destination Access, but BMS asked to submit the prescription to insurance for appeal again. I guess they can help only after several attempts and several denials. I will keep you updated. Thanks again for your guidance.
-
- July 1, 2011 at 5:56 am
Hi Tim, thank you for your response and all the wonderful information. I was not aware of the Genentech trial and will look into it.
My father's oncologist has already submitted an application to Destination Access, but BMS asked to submit the prescription to insurance for appeal again. I guess they can help only after several attempts and several denials. I will keep you updated. Thanks again for your guidance.
-
- July 1, 2011 at 5:56 am
Hi Tim, thank you for your response and all the wonderful information. I was not aware of the Genentech trial and will look into it.
My father's oncologist has already submitted an application to Destination Access, but BMS asked to submit the prescription to insurance for appeal again. I guess they can help only after several attempts and several denials. I will keep you updated. Thanks again for your guidance.
-
- June 30, 2011 at 7:59 pm
I am not sure I am following you about Yervoy and approval. Are you saying that your father's insurance won't cover it? If that is the case I encourage you to go to the companies reiumbursement site and get them to help you. I think they have been very successful in securing reimbursement. And if that doesn't work they have programs to help people have access to the drug outside normal reimbursement programs. They site is here:
http://www.destinationaccess.com/
Regarding which treatment to choose, this is a major challenge, as you know all too well. What drugs do you try? Which do you try first? No-one can tell you what to do on this. Several approaches have the potential to work, but no approach is guaranteed to work.
Yervoy has a higher response rate than any other approach out there, except the BRAF inhibitors. Some people do take months to respond, but the more typical response is much shorter than that.
Genentech has recently opened a trial for people who have developed resistance to vemurafenib (PLX4032). This trial is a BRAF/MEK combination. I don't know if the prior treatment with MEK alone would exclude your father, but it is worth exploring. And, Glaxo SmithKline has some other combination studies they are working on.
Please keep everyone posted on this.
Tim–MRF
-
- June 30, 2011 at 11:58 pm
My husband is halfway through his 2nd Carbo/Taxol cycle. He is 46 and was in good health before discovering the infected lymph nodes on April 1st. His melanoma spread at a wildfire rate and he was upgraded to stage 4 before April was done. The melanoma spread from the right underarm area to bones all through the torso, his liver and lungs.
Chemo was never our planned method of attack. My husband had tested positive for the BRAF mutation and he was to get into the GSK BRAF/MEK trial. Unfortunately, the mel was progressing in his liver so quickly that he didn't qualify due to liver function. Carbo/Taxol was offered to Don as a hopeful stopgap…something, anything to try and slow down the cancer's growth and hopefully improve his liver function enough to get him into a compassionate use trial.
It was unspoken but understood that Yervoy was not an option because it would take too long.
When he went back for his follow up visit 2 1/2 weeks later, we discovered that the softball sized tumor under his arm had shrunk to marble sized and the LDH reading (one of the tests used to determine tumor burden) had dropped 75%.
His doctor was shocked and amazed at his response. So amazed, in fact, that he kept him on the chemo rather than put him into the trial (saving that for a rainy day, would rather stay with what's definitely working).
His side effects were not that bad the first round; he had more issues this second round. He experienced some nasty muscle aches from the Taxol (they gave him a 2nd round of steroids and that took care of it). He also had brutal motion-induced vomiting for about 4 days. But any and all of it is worth it for the response he's had.
We have been told that this amount of response to chemo is unusual, so keep that in mind. But, based on what you've said about your father, it sounds like time is definitely a factor.
Even if the chemo works a little and the radiation can help a bit more, it might open up other treatment options for him that he doesn't currently have.
Wishing you the best of luck; I hope he gets better soon!
Michelle, wife of Don
-
- July 1, 2011 at 6:22 am
Michelle, thank you very much for sharing your experience. I hope that my father will have similar response and I hope that your husband will continue doing well. 75% reduction in LDH is quite amazing. I know that this response is not typical, but it sure gives hope. Thank you for your time and guidance. Best wishes. Banu
-
- July 1, 2011 at 6:22 am
Michelle, thank you very much for sharing your experience. I hope that my father will have similar response and I hope that your husband will continue doing well. 75% reduction in LDH is quite amazing. I know that this response is not typical, but it sure gives hope. Thank you for your time and guidance. Best wishes. Banu
-
- June 30, 2011 at 11:58 pm
My husband is halfway through his 2nd Carbo/Taxol cycle. He is 46 and was in good health before discovering the infected lymph nodes on April 1st. His melanoma spread at a wildfire rate and he was upgraded to stage 4 before April was done. The melanoma spread from the right underarm area to bones all through the torso, his liver and lungs.
Chemo was never our planned method of attack. My husband had tested positive for the BRAF mutation and he was to get into the GSK BRAF/MEK trial. Unfortunately, the mel was progressing in his liver so quickly that he didn't qualify due to liver function. Carbo/Taxol was offered to Don as a hopeful stopgap…something, anything to try and slow down the cancer's growth and hopefully improve his liver function enough to get him into a compassionate use trial.
It was unspoken but understood that Yervoy was not an option because it would take too long.
When he went back for his follow up visit 2 1/2 weeks later, we discovered that the softball sized tumor under his arm had shrunk to marble sized and the LDH reading (one of the tests used to determine tumor burden) had dropped 75%.
His doctor was shocked and amazed at his response. So amazed, in fact, that he kept him on the chemo rather than put him into the trial (saving that for a rainy day, would rather stay with what's definitely working).
His side effects were not that bad the first round; he had more issues this second round. He experienced some nasty muscle aches from the Taxol (they gave him a 2nd round of steroids and that took care of it). He also had brutal motion-induced vomiting for about 4 days. But any and all of it is worth it for the response he's had.
We have been told that this amount of response to chemo is unusual, so keep that in mind. But, based on what you've said about your father, it sounds like time is definitely a factor.
Even if the chemo works a little and the radiation can help a bit more, it might open up other treatment options for him that he doesn't currently have.
Wishing you the best of luck; I hope he gets better soon!
Michelle, wife of Don
-
Tagged: cutaneous melanoma
- You must be logged in to reply to this topic.