Hey 3-50!
Sorry you are dealing with all this. I'm not entirely sure what you are asking…but I'll give it a go. The truth of the matter is that neither ipi nor the ipi/nivo combo are "new" in melanoma world. Then again…when you consider that all current treatment for melanoma has only been FDA approved since 2011…maybe they are. They ARE "new" as far as their use in folks who are Stage III.
Here's the down and dirty. 2010 – none of the current effective treatments for melanoma of any flavor were FDA approved. 2011 – saw the approval of ipi for Stage IV patients. Average 15% response rate. Pretty significant side effects. (Anything that your immune system can rev up is at risk when you take 'immunotherapy': colitis, rash, fatigue, pneumonitis, arthritis, thyroiditis, etc) But, it was an amazing gift to those of us who were facing nothing!!! 2014 – saw the approval of both anti-PD-1 products (nivolumab/opdivo and pembrollizumab/keytruda). Also both categorized as immunotherapy. Both with similar side effects and response profile. Response rate – about 40% in Stage IV patients. Side effects in the same category as ipi, but less aggressive in that regard. 2015 – FDA approves ipi/nivo combo for Stage IV melanoma. Side effects are a bit greater with the combo than with either product alone. Most side effects are due to the bad boy ipi. Response rates in Stage IV patients = 50% +. 2015 was also the year that ipi was approved as adjuvant for folks who are Stage III with resected nodes.
In regard to immunotherapy, we know that folks with the lowest disease burden respond best. In melanoma, we know that it is a sneaky beast, that may well have ugly cells floating about just waiting to do us harm. However, when you are Stage III, sometimes it is a reasonable choice to watch and wait…with the plan to treat when/if you advance to Stage IV…though at that point you may have lost your advantage of a low tumor burdern
Then there is you: Your lesion was considered large. Ulceration and multiple positive nodes are, unfortunately, not positive prognostic signs.
You are correct. Clinical trials are not for everyone. I am a rattie, so I know from which I speak. I entered a nivolumab trial in 2010 after having been diagnosed with a smaller tumor than yours, no ulceration and only one microscopically positive node in 2003…after progression to brain and lung mets in 2010. Lung met removed. Brain met zapped with radiation left me NED. (No evidence of disease.) Good news, right? Well in 2010…not so much. There were no meds available. I was offered nivo in an NED vs active disease arm for Stage IV patients. I knew ipi was coming on line soon. I asked my doc…."Why shouldn't I wait for that, rather than participate in your experiment?" He said, "Because I think anti-PD-1 will work better with fewer side effects." I decided to believe. He was right. I took it for 2 1/2 years. My last dose was in June of 2013. I remain NED.
I cannot tell you what you SHOULD do. You can only do what feels right for you. You will still be a rattie because, like my cohort….we were "NED"…albeit Stage IV vs Stage III. It takes longer to tell what the precise response is…in those of us who had no measureable disease when we enter treatment and who may have never advanced/progressed or at least not for some time with no treatment at all. There is this…that might be important for you: http://chaoticallypreciselifeloveandmelanoma.blogspot.com/2015/09/sequential-nivo-then-ipi-orr-of-41-ipi.html
The bottom line of that abstract is this: Sequential nivo then ipi = ORR of 41%. Ipi followed by nivo = ORR of 20%!!!!
To make matters slightly more complicated….I think that there are some Stage III trials in process using BRAF inhibitors for folks whose tumors are BRAF positive. (Something that you should have your tumor tested for…if only for future information.)
Things that have served me best when deciding how to deal with my melanoma treatment choices: (1) Make sure you are seeing a melanoma specialist. (2) Ask, "Which of these options would you choose for yourself, your dad, your brother?"
Hope this helps. I wish you well. There is a fair amount of data regarding all of the above and Stage III melanoma on my blog. Just use the top left search bubble if you are interested. Celeste
.
