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All TopicsForum: Stage IV and Metastatic Breast Cancer ONLY → Topic: Ribociclib, exemestane, everolimus clinicial trial

Topic: Ribociclib, exemestane, everolimus clinicial trial

Forum: Stage IV and Metastatic Breast Cancer ONLY —

A place for those managing the ups & downs of a Stage IV/metastatic breast cancer diagnosis. Please respect that this forum is for Stage IV members only. There is a separate forum For Family and Caregivers of People with a STAGE IV Diagnosis.

Posted on: Feb 14, 2017 09:23PM

Davenport1 wrote:

Bones met for 2 years, just went off ibrance + Letrozole (which worked great for 2 years by the way) due to progression, wondering if anyone has been on clinical trial for this new combination of Ribociclib, exemestane and everolimus? Would love to hear anything about this combo of drugs.

Thanks,

Davenport

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Feb 28, 2017 08:14AM Mama2twinsplus2 wrote:

Thanks for checking in ladies!! I have to re-check a cbc today and then we will decide where to go from here. We want to be careful because I am taking my daughter to Disneyland this weekend and even though its the happiest place on earth, it is also the germiest!! My rash has morphed into a life of its own!! I don't think it is drug related though. I am allergic to adhesive, and they left the EKG pads on me all 8 hours I was there on friday. I am guessing that is the culprit. So glad to have a few more of you to compare notes with. Also. still no mouth sores, just the tip of my tongue is sensitive. I wrap the pills in marshmellow and stay on top of the mouth wash. Hope everyone is having a great Tuesday!!

Alissa

Dx 7/8/2015, IDC, Left, 6cm+, Stage IV, metastasized to liver, Grade 2, ER+/PR+, HER2- Surgery 8/14/2015 Prophylactic ovary removal Targeted Therapy 2/8/2017 Afinitor (everolimus)
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Feb 28, 2017 02:31PM dlb823 wrote:

Following. This trial (TRINITI-1) was just proposed to me yesterday as an option. My gut says "no" -- partly b'cuz I live a good 3 to 5 hrs. from UCLA, depending on traffic, and not enthused about the time & travel commitment when I have other logical options. But I'm still gathering every bit of info I can find, so very happy to see this discussion.

For anyone who chose the TRINITI-1 trial over a more standard option, could you share what influenced your thoughts? Thanks so much. Deanna

Deanna "The soul would have no rainbow if the eyes had no tears" Native American proverb Dx 2/1/2008, 1cm, Stage IIA, Grade 3, 1/16 nodes, ER+/PR+, HER2- Dx 1/3/2014, Stage IV
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Feb 28, 2017 08:23PM Davenport1 wrote:

Well THAT would be nice for a change! I finish all the testing on Monday. Not sure when I would start first dosing....



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Feb 28, 2017 08:53PM Davenport1 wrote:

Deanna,

My next option with my Onc was to just exemestane and in fact he's the one that sent me off to this trial. He said he had heard it was getting good results and he thought it might prolong this stage for me. I, too, have gone back and forth trying to decide what to do... I'm a bit weary of 3 drugs at once but supposedly they have worked out the dosing.

Alissa,

Thanks for the update and the marshmallow tip! And have fun at Disneyland! Hoping to pop over to Walt Disney World in Florida myself to visit Pandora (once it opens at the end of May) and Harry Potter at Universal.... I was going to head to Cali for Harry Potter but Pandora made up my mind to head east instead of west! But I do love Disneyland as well!

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Mar 1, 2017 06:17PM pajim wrote:

Deanna, I can tell you what decided me. The next step for me is A/A on it's own (or Xeloda). With the study I'm on I get all three drugs. It's not a randomized trial.

There's been enough research on palbociclib to convince me that it'll prolong the length of time A/A will work.

On the other hand I can drive to the cancer center in 20 minutes or walk from my office in 5. If I had to drive 3 hours each way no way would I do it.

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 2, 2017 02:03PM - edited Mar 2, 2017 02:14PM by dlb823

Thanks so much for your comments, Pam. I've just PM'd you with a few more questions.

Alissa, I really appreciate your comments and updates too. Can I ask you how far you have to drive? And if you had to drive at least 3 hrs. o/w, depending on traffic -- knowing what you do now about the need for EKGs, blood work, etc, would you still be willing to do the trial? That is one of my biggest concerns -- living that driving distance from UCLA. Just don't know if the stress will be a factor!

Davenport, same question for you... Would a 3-hr drive impact your thoughts on doing the trial, especially with the pre-testing, etc., you've described?

Deanna "The soul would have no rainbow if the eyes had no tears" Native American proverb Dx 2/1/2008, 1cm, Stage IIA, Grade 3, 1/16 nodes, ER+/PR+, HER2- Dx 1/3/2014, Stage IV
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Mar 2, 2017 09:52PM GG27 wrote:

Deanna, I was sorry to read today about your progression. I'm not on this trial, but wanted to throw my 2 cents into the travel thing. I travel 6 hours each way for the trial I'm on plus I have to go there for all scans & even labs. Yes, 12 hours travel for one tube of blood. It's doable. I know, it's not LA traffic, but it's Vancouver, BC traffic which is bad too especially when you live somewhere that doesn't even have a single traffic light! good luck with your decision,

cheers, dee

Dx 10/2008, IDC, Both breasts, 3cm, Stage IIB, Grade 2, 3/9 nodes, mets, ER+/PR+, HER2- Surgery 1/8/2009 Lymph node removal; Mastectomy: Left, Right Chemotherapy 2/1/2009 Other Radiation Therapy 7/5/2009 Whole-breast: Breast, Lymph nodes Hormonal Therapy 9/6/2009 Tamoxifen pills (Nolvadex, Apo-Tamox, Tamofen, Tamone) Dx 5/14/2014, IDC, Both breasts, Stage IV, metastasized to bone, 9/20 nodes, mets, ER+/PR+, HER2- Hormonal Therapy 5/19/2014 Arimidex (anastrozole) Radiation Therapy External: Bone Hormonal Therapy Femara (letrozole) Targeted Therapy Ibrance (palbociclib)
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Mar 2, 2017 10:23PM - edited Mar 2, 2017 10:40PM by nancyartcrafts

Davenport1: you asked about being on the three drugs of Ribociclib, exemestane and everolimus so thought I would chime in with a question. After being on Ibrance and letrizole since August, I am moving on to everolimus and exemestane daily with Herceptin infusion every three weeks. The everolimus should come tomorrow and I will start the two oral drugs on Saturday

IT took ten days to get approval from insurance to cover the $13K per month cost of everolimus, so I cannot imagine that any insurance would cover the cost of ribociclib at $10 K per month in addition to the cost of the everolimus. Do others have any experience in getting this financial issue covered, or is it paid for because of it being a clinical trial? I am not on a trial. I would appreciate hearing about others experiences with this,


Nanc

"Joy does not simply happen to us. We have to choose joy and keep choosing it every day." ~Henri Nouwen Dx 6/2003, ILC, Left, 5cm, Stage IIB, 0/23 nodes, ER+/PR+, HER2+ (FISH) Surgery 7/1/2003 Lumpectomy: Left; Lymph node removal: Left, Underarm/Axillary; Mastectomy: Left, Right; Prophylactic mastectomy: Right; Reconstruction (left): Saline implant, Tissue expander placement; Reconstruction (right): Saline implant, Tissue expander placement Dx 7/15/2016, ILC, 5cm, Stage IV, metastasized to bone, Grade 2, ER+/PR+, HER2- (IHC) Hormonal Therapy 7/27/2016 Femara (letrozole) Targeted Therapy 8/9/2016 Ibrance (palbociclib) Radiation Therapy 10/17/2016 Bone Hormonal Therapy Radiation Therapy Hormonal Therapy Aromasin (exemestane)
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Mar 2, 2017 11:14PM Davenport1 wrote:

Nanc - On trial the drugs are at no cost. I had no idea that everolimus cost that much..wow. No I can't imagine any insurance covering the cost of those 2 drugs simultaneously. Ibrance was charged to my insurance at half cost and my cost was $10.00 with card....I would think if Ribociclib got approved they would have to run it the same to compete? not sure though ( Ribo is a Novartis product and Ibrance is a Pfizer product) and they would be competing at least combined with Letrozole. (I am going to ask the folks at the Huntsman about these costs on Monday when I am there...glad you brought this up...I'll let you know what I find out).

Deanna - I am 1 1/2 hours one way from my clinic so a little travel time but not 3 to 5 each way! That would be a hard decision. Looking at my paperwork after 1 full day of testing if you qualify...you have the first day of dosing...then you return 2 times in the first months, 2 times in the second month and then once a month after that so your condition can be monitored. Imaging (CT/MRI/Bone Scan) is required every 8 weeks for the first year of study then after that every 12....this imaging cost is charged to your insurance. I believe they said I could do my imaging up at my local hospital if wanted but I need to follow up on that.

Tamera

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Mar 2, 2017 11:20PM - edited Mar 9, 2017 11:29AM by zarovka

At the moment, triplet therapy with a CDK 4/6 inhibitor could be hard get covered. There are no robust clinical trial results proving its efficacy. Ribociclib is not approved yet, so it would never be covered today. Doctors could try to make a case for "off label" use of ibrance with exemestane and everolimus now. That argument may work if there is no reasonable alternative.

It should be relatively easy to get the triplet therapy approved by insurance if this trial is completed and successful and Ribociclib is FDA approved. I agree there will be push back from insurance companies, but they generally have to approve protocols that have been demonstrated effective. The real question is when the price of ribociclib and ibrance will drop. They seem very similar and therefore directly competing with each other. Also, they have priced themselves out of all markets outside the US.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 9, 2017 12:44AM Davenport1 wrote:

Spent Monday having CT Scan, Bone Scan, ECG and giving lots of blood. Today they called and said everything looks good for the study. I just have to meet with my study doc and then on to my first dose. Still a little part of me isn't sure. I learned I will only be the second one at this location on this study. They are looking at one other but they are planning on 6 of us. I think since Ibrance is pretty new itself and it is a pre-condition of this study...timing here may be part of that. Would love to hear how everyone is doing!


Tamera

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Mar 9, 2017 11:30AM zarovka wrote:

Good luck Tamera - It's a powerful combination. Should knock your mets to the curb. You have approached this very thoughtfully, I think you should be confident in your decision. Let us know how you are doing.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 9, 2017 12:39PM Davenport1 wrote:

Thanks for the encouragement Z! I'm hoping it does just that! The mets in my skull are pushing on nerves and my chin, lip and front teeth have now gone numb. They have checked my jaw bone, teeth and spinal fluid to make sure no activity there so they attribute it to skull mets. Hoping this clears this up. Dislike waking up everyday with numb chin to be reminded of my condition...

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Mar 9, 2017 06:10PM zarovka wrote:

yes. It is very important to forget you have cancer as much as possible.

Looking forward to good news from you on your next scan ... keep us in the loop.

Z

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 9, 2017 06:56PM dlb823 wrote:

Tamera, congrats on getting approved for the study! I'm going to keep this thread bookmarked, so that I can follow your progress, which I'm sure will be great! I decided against pursuing this study myself because the time commitment was just too demanding for me, living as far from UCLA as I do. No way could I run back and forth for extra labs, for example, if needed, and the initial evaluation and follow up screenings would have necessitated several overnight stays. But thank you for doing it and hopefully helping us to have access to this combo in the near future!

Deanna "The soul would have no rainbow if the eyes had no tears" Native American proverb Dx 2/1/2008, 1cm, Stage IIA, Grade 3, 1/16 nodes, ER+/PR+, HER2- Dx 1/3/2014, Stage IV
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Mar 9, 2017 09:34PM pajim wrote:

I've been at this ten days. 125 Ibrance, 25mg Aromasin and 5 mg Affinitor (half the usual dose). No problems whatsoever. I suspect it's because I'm only on half the dose of Affinitor. I won't know for a while whether it's working.

When I saw the nurses and said I was on the placebo arm they gave me the incredulous stare. Maybe it's too early and the effects will appear over time.

What I'm getting at is, don't be afraid. It might be easy. [Or it might not but don't borrow trouble]

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 9, 2017 10:33PM zarovka wrote:

Pajim - The placebo comment is a joke, correct? If this is the study you are on, there is no placebo, right? In any case, I think the magic trick here is the low dose of afinitor. I definitely warming up to this combo as I hear how well you are doing. Hope it continues and the mets melt away.

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 10, 2017 05:27PM pajim wrote:

No placebo arm. But it feels that way. Which is great. Hoping it keeps up.

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 10, 2017 11:03PM ShetlandPony wrote:

I did not notice any side effects with 5 mg Afinitor for four weeks. On the study, do they give you the dexamethasone mouth wash to go with the Afinitor? I used it three times per day with my 5 mg, and now four times a day with 10 mg. (I am not in the study.)

2011 Stage I ILC ER+PR+ Her2- 1.5 cm grade 1, ITCs sn . Lumpectomy, radiation, tamoxifen. 2014 Stage IV ILC ER+PR+Her2- grade 2, mets to breast , liver. Taxol NEAD. 2015,2016 Ibrance+letrozole. 2017 Faslodex+Afnitor; Xeloda
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Mar 11, 2017 12:16PM Davenport1 wrote:

Pajim, glad to hear you are having no issues! Hoping that continues for you. I think that Ibrance is quite a promising drug.

ShetlandPony, On the Triniti1 trial we will be on 2.5mg Afinitor a day...so we shall see. Will be using the mouthwash 3 times a day. OF course I'm hoping for few side effects....

Tamera


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Mar 11, 2017 09:10PM pajim wrote:

No mouthwash here. They suggested a saline rinse wither after each meal or morning/evening but I decided to wait to see what happens. Next week (week three of palbociclib) will tell the tale.

If mouth sores appear and are bad they will give me the magic mouthwash but they also agreed to wait and see what happens.

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 14, 2017 08:50AM Mama2twinsplus2 wrote:

Good morning ladies. I realized I had not checked in in quite awhile. Davenport, I am the only one on the Huntsman TRINITI_1 trial right now, that's me!! When I was in on Friday I learned that while they want 6 people, the national study is almost full. Once the numbers have been reached, they won't be able to enroll anyone else. I have started my 2nd cycle. The Affinitor is at 2.5mg as stated above and you are issued a mouth wash. I have had one tiny sore on the tip of my tongue and it is gone. I made it 15 days and had to hold drug for a week to allow my counts to come back up. I never had to do that once with Ibrance. The Dr assured me that this is very normal. I am back on all the drugs and still feel good. I noticed that ribo was FDA approved yesterday. I had asked how this would impact the trial and was told that I would be allowed to remain on it as long as it benefited me. Longer appointments, but the drug company is paying for the drugs!! I hope everyone is feeling well and having a good day!!

Alissa

Dx 7/8/2015, IDC, Left, 6cm+, Stage IV, metastasized to liver, Grade 2, ER+/PR+, HER2- Surgery 8/14/2015 Prophylactic ovary removal Targeted Therapy 2/8/2017 Afinitor (everolimus)
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Mar 14, 2017 09:53AM pajim wrote:

Right there with Alissa. Day 14 I show up for the blood draw and barely escaped the panic button. Very low neutrophils. I'm to stop taking Ibrance for the rest of the cycle while we see what's what. I've also been told not to get sick, LOL. [They issued antibiotics just in case]

Never had this problem on Ibrance/Faslodex/Femara. Guess the Afinitor combination is a count killer.

Still no side-effects that I notice.

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 14, 2017 11:39AM zarovka wrote:

Thanks for the updates ladies!

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 20, 2017 06:13PM pajim wrote:

On to Day 22 of the Cycle 1. Now not only do I have no neutrophils (only a few more than last week) but I have quite low platelets. Sigh.

I am officially off all meds for the week. If the platelets don't rise by Thursday they will transfuse.

Will be interested to hear whether it's just me or whether this combination just does everyone in.

I still feel fine. Maybe a little tired but after all, it's Monday. Fun times!

Dx 4/20/2008, IDC, Right, 4cm, Stage IIIA, Grade 2, 1/15 nodes, ER+/PR+, HER2- Dx 2/1/2013, IDC, Stage IV, metastasized to bone, mets, ER+/PR+, HER2- Hormonal Therapy 2/26/2013 Femara (letrozole) Hormonal Therapy 4/21/2013 Faslodex (fulvestrant) Targeted Therapy 2/24/2016 Ibrance (palbociclib) Chemotherapy 6/18/2017 Xeloda (capecitabine)
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Mar 20, 2017 09:09PM zarovka wrote:

hang in there! Thanks for the update.

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 21, 2017 09:55AM Mama2twinsplus2 wrote:

I am on day 12 of cycle #2. I will have my next trial visit on 03/27. I was told if my counts are low again, we take another med break. You then have 7 days to bring your neutrophills back up. If you can't do it in 7 days, then we will dose reduce. It took me 9 days last time, but I had my blood drawn further apart than normal to take my daughter to Disneyland. So far, I feel the side effects are not too bad. I have fatigue, but I am also the mother of 4 kids 7 and under!!! I have a tender spot on my tongue, but it is not a sore yet. I guess I should ask what dose everyone is on? I am 300 of ribo, and 2.5 Afinitor, I need to check the Aromasin. Pajim, sending good vibes for your counts. I will look at my last cycle blood work when I leave work. I need to look at see what my platelets were. Hope everyone is having a good day!!

Alissa

Dx 7/8/2015, IDC, Left, 6cm+, Stage IV, metastasized to liver, Grade 2, ER+/PR+, HER2- Surgery 8/14/2015 Prophylactic ovary removal Targeted Therapy 2/8/2017 Afinitor (everolimus)
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Mar 21, 2017 11:20AM zarovka wrote:

Alissa - good to hear from you. Thanks for the update. Not on this trial, but following ...

>Z<

Ibrance/Letrozol Feb '16 -Sep '17. Adoptive Cell Therapy Oct 2017. Jan 2018 SBRT to sternum met and liver mets. Jan 2018 start Faslodex. Dx 12/28/2015, IDC, Left, 4cm, Stage IV, metastasized to bone/liver, Grade 3, ER+/PR-, HER2- Hormonal Therapy 1/17/2016 Femara (letrozole) Targeted Therapy 2/2/2016 Ibrance (palbociclib)
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Mar 21, 2017 12:08PM dlb823 wrote:

I'm also following this thread and very much appreciate the updates, ladies!

Deanna "The soul would have no rainbow if the eyes had no tears" Native American proverb Dx 2/1/2008, 1cm, Stage IIA, Grade 3, 1/16 nodes, ER+/PR+, HER2- Dx 1/3/2014, Stage IV
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Mar 21, 2017 09:52PM Davenport1 wrote:

Oh my goodness, blood count issues all around! Thanks for the updates ladies...wishing you better numbers soon. I have ANOTHER CT scan and Doc visit tomorrow. This scan to get exact measurements on my skull lesions I guess. Supposed to have first dose on Friday. A little nervous!

Tamera

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