Clinical Trial - LSZ102 with Ribociclib

Cycle 2/Day 15 – June 29

Study visit with labs, EKGs and vital signs.

So far everything is going great.  My WBC and Neutrophils are staying in the low end of normal.  My WBC and Neutrophils never tanked while I was on Ibrance/Palbociclib but they did dip below normal while on that protocol.  So I'm happy to see that my counts are higher on Kisqali/Ribociclib.   All of my blood work is normal with the exception of that pesky EGFR (Estimated Glomerular Filtration Rate) dropped below 60 again.  Greater than 60 is normal.  Below 60 could mean kidney damage but not necessarily.  My EGFR was at 54 and in two prior labs it was 53 and 52.  It bounced back to >60 in the labs I had two weeks ago.  However a low EGFR alone isn't enough to indicate kidney damage and the measurements of 52, 53 and 54 would only mean mild to moderate decrease in kidney function.  The other factors in determining EGFR is serum creatinine levels, age, sex, body size.  My Creatinine level is normal.  The Trial Team doesn't seem at all concerned about it so I won't either.  But I will continue to research it. 

Here is an update on the side effects I have been experiencing:

• First I'd just like to say that in general I feel better on this protocol than I did on Ibrance and Letrozole.  I am not as tired.  I definitely have more energy.
• I can continue to report that my hair shedding has nearly stopped since I started this protocol.  I think it is just normal shedding now.  No more handfuls of hair in the shower.
• There may be slight constipation.  I'm always constipated to some extent so it's hard to tell.
• No Diarrhea while taking the Ribociclib but I did have it on the off week of Ribo.  I'm heading into my next off week from Ribo so I'm waiting to see if the diarrhea returns during that week. 
• The "nausea" has subsided.  My stomach still feels a little funky at times during the day but I'm not nauseous and the feeling passes with time.
• The change in my sense of taste continues but hasn't worsened.  I'm just getting used to the way things taste now.  Sweets continue to taste too sweet.
• I am feeling a little bit of insomnia.  I've always been a really good sleeper so I do eventually fall asleep.  I just feel too awake when I first get into bed.  I read or do crossword puzzles to wind down.  That doesn't always work and I still feel too awake but like I said I do overcome it and fall asleep. 
• Still feeling some bone pain in my hips and back.  It's never to the point that I have to take anything to relieve the pain and it doesn't last long.  But I do notice it.
  
• My appetite seems to be back to normal.
• Hot flashes have all but disappeared.  I can't recall that last one I had.
• My skin gets a little itchy if I take a long shower or if I'm out in the sun for more than 15 minutes. 
• I'm still experiencing a small amount of vaginal discharge.  It is not daily, it does not itch and it is clear. 

I have next week off from any study visits!  Yay!

The following week, on Tuesday July 11, I have my first set of surveillance scans since being on the trial.  I cannot wait to see the results.  I am soooooo hoping for no progression! 

Hope everyone has a wonderful 4th of July weekend. 

Thanks for following.

Cathy

Cycle 3/Day 1
– July 13

Okay here I am beginning cycle 3.  That means I had good news from my scans on Tuesday, July 11.  I am stable!  No progression!  I will take that!  My bones are stable and the liver lesion that sent me to this new treatment has neither grown nor reduced in size.  It remains exactly 13mm as it was in my last scans.  Would I rather have heard that it shrunk?  Of course.  But it didn't grow and in this game that is a victory. 

If I continue to remain stable (or dare I hope regress) then I will be one happy camper and a huge advocate of this treatment.  This protocol has been very very tolerable.  I feel pretty damn good!   My hair stopped shedding which I am thrilled about.  I have energy again.  Don't get me wrong, I still need to rest.  I'm not back to my pre-cancer energy level but I am not as tired and lethargic as when I was on Ibrance and Letrozole.  The hot flashes have all but disappeared.   I did not get diarrhea this time on my off week from the Ribo/Kisqali so I'm hoping that was just a one time thing.  The side effects that I do have are not bad at all.  There is some vaginal discharge but as I have reported it is minimal and it doesn't itch or burn.  My sense of taste has been altered but I'm getting used to it.  It's not metallic or bad.  Some foods just taste different.  I've noted that chocolate tastes richer.  I get a little sick when I eat it.  That's actually a good thing.  My thighs really don't need the extra calories! [edited to add that I still have some stomach upset in general but's it's been manageable].

In my last post I mentioned that my blood work is terrific with the exception of the EGFR (Estimated Glomerular Filtration Rate) which remains under 60.  Above 60 is good and normal.  Below 60 could indicate a decrease in kidney function.  So I mentioned this to my oncologist and he looked at my creatinine levels which is one of the measurements used to determine the EGFR and those levels are normal.  However he looked deeper and showed me my creatinine levels since my diagnosis in 2014 and it was clear that they were trending up.  Still well within normal but slowly creeping upward.  That means it's something to watch but it also means it is not related to this treatment.  He believes it is more likely from the zometa.  So that will be another discussion for the future.  We will continue to monitor my kidney function numbers but not really be concerned about them unless they are elevated beyond normal.

So all in all I am very pleased.  The hard part and time consuming part of the trial is behind me and the side effects are insignificant.  I don't have another appointment until August 10.  WOW! 

I'll keep you guys posted!  Thanks for following!

Just some thoughts:

One odd thing about being on a trial - you don't know how others on the trial are doing.  It's not like we're all together in the same room when we have our study visits.  One time someone on the trial team mentioned that at least one other person on the trial was also experiencing one of the symptoms I was reporting (the vaginal discharge).  But that was pretty much the only time I heard about another participant.  I think I will ask at my next visit in August.  I am interested in knowing if I am sailing through this treatment but others are having a hard time with the side effects.  That would be helpful for you all to know too.  My experience may be unique - I'm hoping it's not too unique.  I know we all respond differently to treatments and that is important to keep in mind when hearing about my experience on the trial in terms of side effects.  Others on the trial may be having a rough time.  I hope not...

Happiness2 -  I wouldn't worry about the time delay in taking your meds, especially since it was less than 90 minutes the first time.  I was told there is a 6 hour window either before or after your "scheduled" time.  I try to stay consistent but you can't be perfect.  When I start a new cycle I have to wait to take my next dose until after I've had blood work done and then the pharmacy prepares the prescription.  On those days I'm definitely off my scheduled time by 3 or more hours.  If that were a problem I think they would coordinate it better.  I think you are fine.

Are you having PET scans?  I don't get PET scans.  I get CT scans on Abdomen, Pelvis and Chest.  I also get a bone scan.  I think there are different arms of the trial where some people get PET scans and other have CTs and Bone scans.  I'm not sure why.  I'm scheduled for my next scans right after labor day (Sept. 5).  Do you have mets anywhere else besides your bones?  You mentioned that you will be having a second biopsy on the same bone met as the first biopsy.  Was that because that bone met was a progression from your previous treatment?  I have bone mets and 1 pesky liver met.  For the trial they biopsied the Liver Met twice because that was the progression met.  

NKB - yes I'm noticing a lot of regrowth now.  It makes my hair very difficult to style but I'm not complaining.  I have hair to style so I'll take the challenge.  

So I've been kind of slow to update my status on the clinical trial.  I've been in a funk for a while and have been experiencing abdominal distress (burning, nausea, bloating) for the last couple of months which just puts me in a foul mood.  I've also gained some weight which I'm pretty sure I can ascribe to the trial drugs. That also puts me in a foul mood.  sigh...  Anyway, until the last couple of months I was doing very well on this protocol but alas it looks like the honeymoon is over in terms of side effects.  

A couple of weeks ago the burning, mild nausea and bloating in my stomach was too upsetting and I met with my oncologist.  I was worried about ascites but it wasn't that.  My oncologist decided to take me off the trial drugs until we could identify the cause of my stomach issues.  And of course one cause could be the trial drugs themselves.  He also wanted met to try Ativan, Reglan and then Nexium (40mg prescription strength).  Not all at the same time but one at a time depending on the success of any one of them.  I started with Ativan because I was also having some anxiety at night and having trouble sleeping.  I'm usually a great sleeper so it is very unusual for me to not be able to fall asleep.  My MO also thought that the Ativan may help relax my stomach which may resolve my nausea, burning and bloating.  He thinks I may have a sluggish stomach, meaning it doesn't digest food quickly and takes a long to for gastric emptying.  I've suspected I have had that for years.  I did not like the Ativan at all.  It took too long to kick in, about 90 minutes.  So what's the point in taking it if it doesn't help me fall asleep.  In addition once I did fall asleep, I slept well but I felt druggy the rest of the day.  I tried it for two or three nights and just didn't like it at all and I got no relief from it.  So then I tried the Reglan which helps with nausea and helps stimulate the stomach to digest food but also relax the pyloric sphincter to allow smooth gastric emptying to the small intestine.  The Reglan did help with the nausea and burning but not the bloating.  I used it for a couple of days (you take it 30 minutes before you eat) and I felt a little better but still bloated.  By this time I had been off my trial drugs for a week and was getting a bit nervous about that.  Meanwhile, I had not followed up on my prescription for Nexium because I was busy with the other drugs.  But now I wanted to start taking the Nexium 40 mg prescription.  When I did follow up with the pharmacy I was told that the insurance company wouldn't approve it and the Dr wasn't responding to the pharmacy's faxes.  So I called my trial team and long story short they suggested I use the OTC Nexium which is 20mg but take 2 instead of 1 to get the 40mg.  I was skeptical about he Nexium because I have been on PPI (Proton Pump Inhibitors) before and they didn't really do much.  It can take 1 to 4 days before you feel any relief from the Nexium so I gave it some time.  Much to my surprise the Nexium did work well.  So the nausea, burning and bloating improved quite a bit over the next few days.  By the time I met with my MO this past Thursday I was happy to report that I was feeling much better. However, since this all took place while I was off the trial drugs we don't know for sure if the Nexium worked or the trial drugs are the cause.  

Another symptom has also reared its ugly head - mid back pain.  It is a different kind of back pain than I have ever experienced before.  I've always had back problems - but usually it is related to something physical I was doing and it was more of a muscular pull from the my left side.  This new pain is more in line with my spine and I feel very stiff in the middle of my back.  I am also feeling tightness around my ribs and tenderness below my rib cage.  My MO looked at my last scans and we can correlate the pain to a met I have in spine in terms of location but that met isn't very big and isn't pressing on anything.  He's hoping that once I get back on treatment the back pain will resolve.  If not we'll have to do more investigating and testing.

As of Thursday (Nov. 2)  I started back on my treatment protocol (Cycle 7).  I also had my Zometa infusion.  Not feeling wonderful right now.  Zometa sometimes makes me sluggish so I'll give myself a couple of days to hydrate.

I am scheduled to follow up with my MO in two weeks (Nov. 16) and let him know if my stomach issues have returned and if my back has improved.  If the stomach issues return then it looks like the trial drugs are the culprit and we'll discuss either lowering the dose or changing the treatment.  Also if my back does not improve we'll look closely at the my next set of scans which are scheduled for Nov. 27 and see if there is progression.

I'm sure I've left something out but for now that is where I'm at.

Hi Z - I've been following the discussions on the other threads regarding probiotics.  I'm going to look closer at what I can try to keep my gut happy.  Because other than the bloating, burning and nausea the other side effects are minimal and tolerable.

I've been following your treatment in Japan.  You are amazing!  I am a huge fan!!!