AUGH - what next? Stivarga, is it worth it?

[hurnik]

I don't remember all the details, but mom's last CT scan showed no reduction in her localized tumor spreading, and some new, small ones (4mm) either around/near/at involving lymph nodes, after 6 months of Irinotecan + Avastin.

She was diagnosed with Stage 2 colon cancer in 2011 I think (sorry I don't remember exactly, I'm not concentrating really well right now). Everything in that testing came back really well except she wasn't in that 15% group with the "good" mutation, and there was slight penetration into the colon wall, but everything else was good (20 lymph nodes, all clean, etc.) We even did the Oncotype testing. Unfortunately everything indicated "borderline" (ie, don't know whether to do chemo or not).

She opted no chemo. Surgical removal of tumor and part of colon (8" ?)

CT Scans every 6 months were clean until 18th month post surgery, where 1 or 2 (?) small tumors just underneath the abdominal wall were found (but not in colon, nothing in lungs/liver). PET scan also done, cancer.

Started FOLFOX + Avastin, had severe diahreah (most difficult word to spell I'm sure I did it wrong) and all her hair fell out after 2 days. That's where I found the DPD deficiency stuff, told her to get tested, they did the test, came back fine (ie, not lacking the gene). She was supposed to have treatments every other week. She ended up having to wait a month before blood counts were high enough for treatment #2, they cut the dose 30% (?), round 2 did a number on her again, had to wait another 4 weeks, we made her to go Denver to see an actual colon cancer specialist. He said classic symptoms of 5FU toxicity (you can still have the gene, but your body doesn't make enough of the DPD enzyme). Did another PET scan and said if stable/decrease, they'd drop the dose another 20-25%, if tumors had gotten larger, would do Irinotecan.

Fortunately after only 2 treatments, things had shrunk by 50% or more.

Every 3 weeks she had a treatment, but then white cells were too low, so they started Neulasta. After 3(rd) Neulasta (once/treatment) she had adverse reaction (hives, etc.). Switched to Neupogen, but bone pain really really bad. I want to say about a year later, (again, I'm all mental right now), after 10 treatments (she should've had 12 in 6 months, but she doesn't tolerate anything well so far), they put her on maintenance dosing, which I believe was just Folfox every 3 weeks. I cant' remember if Avastin was in or not.

CT/PET scans every 6 months. I want to say 6 months or 12 months later, found another tumor below abdomen, decided to stop chemo and do 5 weeks of radiation (once/day for 5 days/week for 5 weeks). After that, maybe 20% reduction in tumor? We went on vacation, when she got back, they started up FOLFOX again. Had a mild reaction to something, so on treatment #2, they pre-dosed her with whatever, and she had a severe allergic reaction (almost died). They're fairly certain it was the Oxaloplatin, but apparently they can't test for things like that (not sure why, but they can't). Had to wait 3-4 more weeks before doing anything as it totally wiped her out. So they started up Irinotecan only for 2-3 treatments, but not typical 3-week cycle. Instead, one dose 1 week, one dose week #2, and then week #3 off, instead of one dose and 2 weeks off. I believe they actually gave her 50% dose, spread over 2 weeks, so in reality 25% week 1, 25% week 2. Gradually increased to 70 or 80% level and added Avastin again. Her white cells went low again, more neupogen, massive amounts of bone pain. 6 months of that (January to now). CT scan showed no improvement in the tumors that are there (3 I think). One is near the kidney, but not on the kidney, and some 4mm or smaller ones either around or near the lymph nodes. I will have to ask if they were actually spread to the lymph nodes.

Now they want to do Stivarga.

But with mom being allergic/sensitive to every single thing so far, I am very concerned about Stivarga, especially given the 45%+ adverse reaction with hand/foot whatever and such.

Obviously not my decision but I can't seem to find much, and obviously everyone is different (some people respond well to stuff, others do not). 1.7 months "extra" with Stivarga doesn't seem worth it, IMO. But maybe I'm reading the literature wrong.

Doc says tumors are slow growing, but I don't know. I mean how do they know that the 6 months of Irinotecan with no improvement didn't actually keep things from spreading/growing fast?

Very frustrated and disheartened at this point.

[midlifemom]

So sorry to hear of moms troubles.
I know nothing about stivarga but did want to offer one piece of advice.
If they want her to continue with neupogen, ask if they can prescribe a pain killer for those days.
Good luck with the stivarga question.

[Pita]

Sorry hurnik I too do not know anything about Stivarga, just wanted to wish the best for your Mother.

[jhocno197]

Some people on stivarga are doing well still 18+ months out.(I think there's someone in this group, but I might be confusing it with another group)

I was terrified for my husband to take it. However, as long as he is not taking the full dose (4 pills a day) he feels better on Stivarga than he did on folfox or folfiri. He takes 3 pills a day. His oncologist says nobody can stand 4 pills a day. I would talk to the docs about a low starting dose - maybe even just one a day - to see how it goes. When my husband did take the full dose briefly, he got nasty mouth sores & his surgical wound stopped healing & started regressing. He will sometimes have nausea or a random painful foot twinge on 3 pills a day. His CEA was either 8 or 12 at dx; it was 223 when he started Stivarga in February; CEA last month was back down to 12. It has shrunk his tumor only a very tiny bit (from 10.4 cm x 9.8 cm to 9.8 cm x 9.4 cm), but, at least it's not growing.

[ebv60]

My DW has been on stivarga now for one cycle (4 pills each day) on her one week break now..start back on Tue ..doing "ok" so far on side effect ..No test yet to see if it`s helping..

[JJ2212]

Sorry your mom is going through this. Deciding on the next steps is never easy...

Stivarga has been working for me for 19 months and counting. Unfortunately, like any other treatment, it's far from a sure thing for everyone but it is possible to get more than 2 months progression free. I second the suggestion of starting at a lower dose. With your mom's history, her onc shouldn't be too hard to convince that a lower dose is a good idea to start off with.

Take care,

Janie

[hurnik]

Thanks everyone for the words of encouragement.

The doc is going to start her on a half dose basically. I believe full dose is 160 mg/day, so she's going to take (2) 40 mg pills/day. but they are waiting for Medicare approval and then, depending on the co-pay situation, apply for REACH through the manufacturer of Stivarga.

Plus she's told the doc she won't start until after my visit next week because she wants to feel good.

My co-worker's mother is going through almost the same thing, except she was initially diagnosed at Stage IV (mom was initial at Stage 2). And my co-worker's mom is like 80 something years old (eesh, to go through all that).

I'm glad to see at least someone is still around after 18 months, that's encouraging.

[hurnik]

OK, mom's doc just got back from some big oncology/cancer forum thingy. Something like 25,000 oncologists were there. Anyway, apparently nobody can withstand the 4 pills on Stivarga and most of the results were end of life type of thing (hence the FDA studies where it extended life by like 1.5 months).

The doc says her tumors are slow growing at this point, and with that in mind, they're going to start her on ONE pill/day for a week, and then a week off. Do labs, etc. and then possibly increase to 2 pills/day for a week, see how that goes, then do 2 weeks @ 2 pills/day.

Now, Medicare supposedly approved it, but they have $3,000 co-pay (I thought medicare had a $2600 donut hole, not $3K) per month.

Unfortunately Bayer's website says REACH assistance not available if you have any government insurance (I pity anyone on Obamacare then), but the lady I work with says her mom got approved for $0 co-pay and she's on Medicare.?

I told 'em to fill out the form anyway and see what happens.

[jhocno197]

My husband has healthcare thru the marketplace & has a $0 copay for Stivarga.

I am so glad to hear they decided to put her on only 1 pill a day!!!

[jhocno197]

Also, is there not an oncology social worker at her oncologist's office? At our local place there's a lady who does all that sort of paperwork (for financial/copay assistance); she did our stuff for us.

[hurnik]

Sorry for the delay. So yes, there is a person who works with the patients and insurance to get things squared away. Sure enough, REACH paid for ALL the drug. $0 copay. Even on Medicare.

So for those of you, don't listen to the REACH website (although technically it says the $0 co-pay isn't available if on Medicare/government insurance, but doesn't say that "low co-pay" isn't available).

So that's the good news. She started 1 pill/day on Sunday. Her schedule will be:

1 week on
1 week off
If labs are good
2 pills for 1 week on, 1 week off.
If labs are good, then
2 pills for 2 weeks on, 1 week off.

[jhocno197]

Hoping it goes well!!!

[fumaros]

Dont know anything about Stivarga (sorry). But Claritin and Aleve helped with my bone pain when I take neulasta. I hope your mom gets better with this new treatment.

[ebv60]

Just an up date on my wife 10 days into the second cycle of Stivarga (4 pills) stopped because of liver bilirubin count high ..dr. order an ultrasound test for the liver ..said bile duct may be plug??? See the Dr next Wednesday for test results?? not sure where to now with her treatment?????

[hurnik]

Just an up date on my wife 10 days into the second cycle of Stivarga (4 pills) stopped because of liver bilirubin count high ..dr. order an ultrasound test for the liver ..said bile duct may be plug??? See the Dr next Wednesday for test results?? not sure where to now with her treatment?????

Supposedly the oncology conference my mom's doc went to (25k+ oncologists I believe), none of them had any success with 4 pills/day on Stivarga (meaning the patients couldn't tolerate it).

My understanding is that if your liver levels are within a certain threshold, they will modify treatment, but once they drop below a different threshold, they permanently withold Stivarga. I could be wrong (I have to re-read the literature and studies).

Liver problems are very real with Stivarga, based upon my reading (you can go to the Stivarga website and there's some PDFs you can download that list things in more detail like actual percentages, etc.), so that's probably why the doc is concerned.

I'm not sure, but I believe Stivarga is considered 3rd line chemo? And after that, they may do Lonsurf (4th line?). But Lonsurf, AFAIK also requires certain blood results to be consistent within a threshold (I think neutrophiles and platelets) in order to be considered for it.

I believe there's an 800# you can call for Bayer (makers of Stivarga) to ask questions about the drug, but not sure what info they can give.

My co-workers mom is on 3 pills/day and so far, doing well. But I think she has her lab work drawn this week or early next week to check liver levels and whatnot. Mom's on 1 pill/day and so far hasn't noticed any side effects. I think next week she has her blood work drawn.

Hoping things clear up for your wife!