STIVARGA (Regorafenib) - ONGOING PATIENT EXPERIENCES

[Misha]

My mom got back from MDA yesterday and the Stivarga appears to be working. At the time of her scans she was midway through her second cycle. Her liver mets shrunk and her big large multilobulated growth in the lower abdomen is stable. I wish this big tumor would shrink because it is causing her great discomfort. The doctors were a little worried about the weight she has lost (loss of appetite) and her loss of strength. They prescribed marijuana pills (one tablet a day). Hopefully, that will help. She still has a lot of fatigue from stivarga.

My dad said that although the doctors were pleased with her progress they didn't seem too positive about the overall effectiveness of stivarga in most patients...

ETA: CEA went up during treatment, but onc said that he is only concerned with scans which showed shrinkage...

[Ashlee H.]

Today I just started my second cycle of Stivarga. My doctor told me Stivarga will not get rid of the tumors, but may keep me stable. The drug is even surprising him. Seems it takes about 3 months to see any improvement, if there is going to be improvement. I hear many people give up after two months. Either the dose seems to be too high or they stop due to progression. I'm beginning to see it is not unusual to have some progression, and then some improvement. I'll have my cancer markers tested again this week. Will let you all know if my CEA is still stalled out.

[janeandrea]

Ashlee, can I ask how you are doing on the Stivarga now? I should be starting it this week sometime. Anyone else currently on it who want to give an update, that would be great as well.

Thanks,
Jane

[Ashlee H.]

I'm day 5 days into my 2nd cycle. Still better than all the other chemos. I'll get labs this week to see if anything has changed. My ONC really says it takes 3 months before we will know. I'm still only on 3 pills a day, but I think after I see my ONC this week, I'll be alternating one day 3 pills, the next 4 pills. I'm really trying to stay off my feet, and so far they are doing ok for this cycle. My voice still is with me. I did have a little gut pain last night, but minor. I'll have really good days, and then some so-so days. My quality of life is much better on Stivarga than FOLFIRI or FOLFOX. I have lost a little weight, but just because my tastebuds are off and I don't do the nibbling and noshing I used to do. I can easily afford to lose some weight, so not upset about this. I am eating, I just don't get the pleasure from it that I used to. I'll report back when I get my lab results.
Oh...and I am taking the pills at night with a low fat dinner instead of a breakfast. I'm sleeping when the drug is most active.

[janeandrea]

Thanks, Ashlee. Another question: how soon did you feel side effects after you started it for the first time? I ask because I am going to be leaving in a couple of weeks to spend a month and a half in Chicago. I have "pre-decided" that if the drug makes me really crappy feeling I won't do it and just let what happens happen. There are things I want to be doing, and I don't want something that may only give me a few extra months to prevent me from living until I am truly dying.

[Ashlee H.]

The first five days I had a hoarse voice, body aches, and a bad headache. At that point my ONC took me off it for 5 days and then started up again. He told me he has found if side effects come up too rapidly that is when things seem to go bad quickly. When the drug was reintroduced, I still had the body aches and then started to get sore feet - felt like walking on hot rocks. This went away on my week off and hasn't come back yet, but I've really been trying to stay off my feet. I've heard people get extremely fatigued, but for me it hasn't been nearly as bad as the other chemos. I do try to get a lot of rest, eat a lot of protein, and stay hydrated. My ONC also did labs every week on me for the first month, checking mostly on liver function. My skin is also very dry...but again, nothing I haven't had with the other chemos.

[Sharona]

Jane, I, too, am starting Stivarga thia week. I saw the onc last Monday and she prescribed it. Finally heard from the pharmaceutical company last Friday Who informed me that my insurance okayed it, but when they told me the copay I flipped out! The social worker called me for some information to apply for a grant and she said that I was in the limits. Hope to talk to them tomorrow to finalIze.
I will be starting on three pills a day. I'm glad to know that Ashlee takes it at night rather than with breakfast.
Thanks for your updates, Ashlee. I'm anxious to hear how it works for you Jane.
Thinking of both of you.
Sharon

[janeandrea]

Hi Sharon - I still am not entirely sure when I will be starting it; my onc was on vacation and will be back tomorrow. I've been worried about the copay too. When I was on Xeloda, I was on a charitable program the pharmacy found so I either payed nothing or $5, and it didn't even go to my insurance. But now I'm on Medicare, and if I can't get someone to pay for the whole thing, then I will pretty immediately be in what they call the "donut hole," when you max out your prescription benefits and have to pay for all of your drugs, or 90% of them or something. The donut hole starts somewhere around $2800 for the whole year max payout, so I am probably already close even without Stivarga.

Well, fingers crossed for both of us!! What was your copay to be, just curious?

Jane

[Ashlee H.]

If you go to the Stivarga website, they have a "Reach" program that helps with co-payments. I'm very lucky to have a low co-pay so I haven't checked into the program.

[Ashlee H.]

Well, I told you all I'd keep you posted - so here is the update. Saw my ONC today. I'm feeling pretty good and he said to have a scan in 4 weeks and he'd see me in 5 weeks. I wasn't crazy about not having labs for 5 weeks, but welcomed the break. A few hours later he called me and said my CEA had only gone up 4 points...but my liver enzymes are crazy high (in the 500's). I'm not jaundice or anything, but he said this is a sign of liver damage. So, I'm off Stivarga for now and will start retesting every week again. He said we might be able to start Stivarga again. The other options I'm not crazy about - go back on FOLFIRI + Avastin which gives me no quality of life. Go on Gemzar + Xeloda - I've known no one who was helped by Gemzar and Xeloda hurts my heart - combo of the FOLFIRI/FOLFOX - I don't think so, or trial studies. Wish the news had been more encouraging.

[Sharona]

Oh, Ashlee, I am so sorry to hear this. Stivarga can be hard on the liver. Praying that things get better and that you can start again.
Jane, I was told that my copay would be $2830. Needless to say, I was slightly shocked, especially since this is for three weeks worth of pills. The good news is that when I objected, the nice person I was talking to offered to have a social worker call me regarding a grant for financial aid. I did qualify, not surprising since I had to retire when diagnosed. Whew! No telling when it will arrive.
Let' keep going for that quality of life!
Sharon

[Sharona]

Heard from the pharmacy this evening. Stivarga should be delivered Monday and I will start Tuesday.
Jane and Ashlee, thinking of both of you!
Sharon

[Busymamaof3]

Ugh Ashlee so sorry to hear that. So crazy frustrating that chemo can kill us faster than cancer! Or a lack of chemo options... I am trying the trial route first - saving the dreaded Folfox as back up if I have lots of growth. Stigarvia was an option too but I would rather take a gamble at this point. It is all so unbelievably frustrating as I feel relatively good but have limited chemo options which means a short life span barring a miracle or new discovery. Argh!!!!

[Ashlee H.]

Bilirubin was normal 3 days ago when other liver enzymes were up...it went from .8 to 5. Being admitted to the hospital tonight. ONC said I haven't peaked yet, so it is basically for observation. I'm off Stivarga.

[Maia]

The other options I'm not crazy about - go back on FOLFIRI + Avastin which gives me no quality of life. Go on Gemzar + Xeloda - I've known no one who was helped by Gemzar and Xeloda hurts my heart.

Gemzar would be off label... since your onc is willing to go the off label route, what about Nexavar (sorafenib)? They do have results with Nexavar + Xeloda (with Xeloda at lower doses, your heart may be fine...). They feel Nexavar + Xeloda could be an alternative to Stivarga. I'll copy an old post (for when you're back form your mini stay at the big house : ):


Combining SOR and CAP increases survival in advanced colorectal cancer

Monday Feb 03, 2014 | Reuters

"We studied 92 patients with advanced colorectal cancer (metastatic or with an unresectable local recurrence) who had received every single or combined medication available for this condition," explained Dr. Alain Hendlisz, lead researcher and head of the GI unit in the Medical Oncology Department at the Institut Jules Bordet in Brussels.

CAP [= capecitabine = Xeloda] was given at 1700 mg/m²/day (D), for two out of three weeks; SOR [sorafenib] was administered at 600mg/D for the first cycle, then at 800mg/D until progression or unacceptable toxicity.

"Based on earlier trials, we should have expected that only 30-35% of the patients would be alive after six months, if the treatment had no activity in this disease. However, 71% of the patients included in the trial were alive at six months, which is a remarkable achievement," Hendlisz told Reuters.
(...)
"This could be another active regimen for a group of patients that is ready for more treatment," Dr. Krishnamurthi said. "It's hard to show an improvement in survival for colorectal cancer, and this study did it, however, it is a small study and the results are not definitive. Regorafenib [Stivarga], which has gone through Phase III studies, is very similar. Further study of the SOR-CAP combination is needed to know if it could eventually replace regorafenib [Stivarga]."

More: http://www.newsdaily.com/health/34231f6 ... tal-cancer

These previous news come from Brussels (Belgium); this is an older article about the phase 1 of that trial: Safety and Pharmacokinetics of Sorafenib Combined With Capecitabine in Patients With Advanced Solid Tumors: Results of a Phase 1 Trial (pubished online 12 MAR 2013).
But there is also this ongoing trial at the University of Florida, with the same agents: Sorafenib Plus Capecitabine (SorCape) in Previously Treated Metastatic Colorectal Cancer and, from that trial, these are the results presented at the 2013 Gastrointestinal Cancers Symposium Phase II study of sorafenib and capecitabine (SorCape) in previously treated metastatic colorectal cancer (mCRC): NCT01471353