CSN Login
Members Online: 2

Need Advice - RCC Stage 3 - Adjuvant therapy - Clinical Trial - Pazopanib v/s Active Monitoring - Any Vaccines ? Options

livealive's picture
livealive
Posts: 127
Joined: Feb 2012

Diagnosed 11/2011 - Open Partial 01/2012 - Pt3a - 2.5 cm clear cell, Fuhrman grade 2, renal vein invasion, am a high risk - with prognosis of 40% recurrence probability - Early 40's, with generally OK health (some back pain from a disc herniation - well managed, asthma - well managed)

Options being given to me are

(1) Monitor with ultrasound + xray every 6 months - I am saying this is not adequate, but they tell me - that is standard monitoring protocol. When I asked for monitoring by CT, I was told "we don't want to expose you to so much radiation (but they can on the blind trial ???)"

(2) Blind clinical trial of Pazopanib for 1 year - 2 hour trip 1 way for doctor visits, will need several during trial, CT at month 5, 9, and 12, blood tests for liver function (I suppose there are serious side effects ?)

Pros -
-- Monitoring,
-- "Maybe" the drug helps prevent recurrence, "maybe' delays it ? That's what they are testing for
-- Clinical trial led by one of the best RCC doctors in the NY area

Cons -

-- Blind Trial - They won't tell me if they give me drug or placebo
-- Side Effects of drug - hypertension, diarrhea, nausea, vomiting, liver damage (10%), Possibility of heart failure(rare),
-- Side Effects - They are in phase 1 of Study To Assess Long Term Safety Of Pazopanib - ClinicalTrials.gov Identifier: NCT00387205
-- For placebo, what use is it to me ?
-- Resistance to drug - should there be a recurrence
-- Drug only proven for PFS by 12 months in metastatic patients - we really don't know if it prevents formation of tumors or spread

(3) I could - not sure yet, but go on Pazopanib directly,

-- they say it's not approved for stage 3, (but OK to give under blind trial ???),
-- may have to pay directly, about $8000/month, which is very pressing
-- resistance possibility should recurrence occur
-- I don't know whether I will need it, but am told I am high risk due to the renal vein invasion
-- They tell me tumor size was small,
-- I did not remove the kidney, they had margin, I don't understand the path report, but frozen section states cortical neoplasm < 1 mm from benign margin - and 1 doc says that is very little, consider removing the kidney, except the surgeon here is the best in NY - every doctor has attested to his capability

Questions / Requests

(1) Does anyone know of any adjuvant therapy ? Experiences ?
(2) Knowledge of vaccines ? I did find this - if anyone cares - http://kidney-cancer-journal.com/rini_v9n4.pdf

I meet all the doctors again this week, but, I am thinking, for weeks, what do I do ? I have consulted various oncologists, tired of thinking, prayed, and forgive me for saying this (should there be a god, listening) tired of praying, scared (very, when I think of the magnitude of what's happened over the last 3 months since November 28, 2011).

I want to do every single thing I can to help myself, at-least while I can. I did read the median is not the message, and I am reading the book "AntiCancer A new way of life", but the real question is, has this "Tangibly" helped other people, the diet, the exercise ?

Soliciting Concrete specific proven recommendations. Please write if you have any. I am not sure - but doctors look at this in an abstract manner, I believe the real people here feel what I feel.

Many thanks, and my best wishes.

angec's picture
angec
Posts: 717
Joined: Mar 2012

TW.. do you have a personal email? I wanted to forward you something from the dr. i have been speaking about. If not i understand. You can send it to me at hnachan@aol.com. I think he may be able to help alot of others on this board. Especially those who are stage one and thinking about trials with bad side affects.

angec's picture
angec
Posts: 717
Joined: Mar 2012

Please email me at hnachan@aol.com.. I have something for you I am totally sure of! Angela

Texas_wedge's picture
Texas_wedge
Posts: 2807
Joined: Nov 2011

Angela, in order that people don't have to reveal their email addresses here, ACS makes a special facility available, which you can access by clicking on "CSN email" which you'll find in the brown box on the left of the window, under the heading CSN. Do try that. By the way, I've looked at the homeopathy site you mentioned quite thoroughly in the past and have it bookmarked. I look forward to hearing from you.

angec's picture
angec
Posts: 717
Joined: Mar 2012

Ok. I see the email sight but don't know how to send mail to you... But if you have seen the site then that is good. I was going to forward the email where he says that most of his patients live many years longer and have a better life with less pain and suffering just taking his meds. I felt much better to hear that. I am hoping he can help someone else because this disease is fierce. Texas maybe you should write to him as well. It wouldn't hurt to see what he can offer you. He is very, very low cost as well so no problems there. A few hundred dollars i pay every six months and i have him at my fingertips whenever i have a new issue come or and i usually get a response within 24 hours or more immediate if it is an emergency. Just want to let you know and keep the hope alive. Thanks for all of your help. Let's see if i figure out this email thingy now.. lol By the way, i hope your mother in law is doing well.

Ree_Maryland's picture
Ree_Maryland
Posts: 66
Joined: May 2014

Hi i alos had stage 1b RCC kidney removed. I am iinterested in the Homeyphatic infor ,where do I find that infor? thanks

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

I'm moving this thread back up to the top. I'm not clear what was decided and who has done this trail?

2 years ago I did the Everest trial (1 year on everolimus/placebo). I finished a year ago. Just had a recurrence in my adrenal gland and had that removed weeks ago. Now my oncologist wants to offer me this drug trial. It's a year on pazopanib/placebo.

I'd think 3 years out, they'd have some results by now. I'm surprised this trial isn't over yet.

Does anybody know the results of this trial? This may be a new trial for people like me that have had a surgically resected recurrence (as opposed to 1 initial kidney tumor treated by nephrectomy).

Can anyone tell me if they know if this drug has helped delay/avoid recurrence when you have NED?

Anybody done this trial?

I'm having exactly the same difficulty deciding as the discussion here and also that I had when I decided to do the Everest trial.

My uncle (a retired oncologist) isn't pushing me one way or the other, but is saying that it's hard to know if a drug will prevent recurrence altogether in an adjuvant study and if that's not a better use of the drug than waiting for it to come back and using it later to prolong survival. He basically said we don't know, and that's the reason for the trial.

However, I'd think since it's been 3 years since they started a trial like this, they'd have results already by now.

Comments?

Todd

sblairc's picture
sblairc
Posts: 320
Joined: Feb 2014

There was a good discussion/presentation about this at the Cedars Sinai Kidney Cancer Patient Survivor conference. You should see if he KCA website has the link. I believe they said that data is coming from 2 large adjuvant studies soon?? 

I don't have my notes but I bet you can get a copy of the presentation if you emailed somebody associated with the Kidney Cancer Association or Dr. Figlin himself. Check out the agenda online and maybe you can email the presenter directly. 

 

Hope that helps. 

MMondi1
Posts: 19
Joined: Jun 2013

Hello Todd,

I've been trying to search all over for this answer along with the recurrence rate of small stage 3 tumors.

I did find one presentation where a Doctor said its possible that a subset of patients with a certain staining has shown some benefit however I've seen others that said it has shown no benefit and some that even said it could possibly have a negative benefit (more beneficial to wait).  

I completed a year of adjuvant therapy at the recommendation of two oncologists however neither one were very good at pointing me to any information on this.   My one doctor did say that it was tough to recruit for the study as people who are NED really start to question a study without data once the side effects hit. 

  

 

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

Which drug study did you participate in? How did you do on it? Any idea if you got the drug or a placebo?

Thanks,

Todd

MMondi1
Posts: 19
Joined: Jun 2013

Todd,

 

I did the votrient/placebo trial. I def got the drug as I had several side effects (hair turned white, thyroid, liver enzymes, blood pressure, ect.).  Overall I did ok.  I am currently a  little over a year out from the trial.  I def understand both sides for and against.  

sblairc's picture
sblairc
Posts: 320
Joined: Feb 2014

Dr. Kevin Scher gave the talk. It's the results of the ASSURE trial that are supposed to be ready mid 2015. This is the largest adjuvant study. If you email him ask for his power point. It had good info. 

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

I wasn't able to attend that conference, but had planned to. Dr. Figlin's nurse emailed me and said that there would be a video of the talks on the KCA website soon after the conference, but I haven't been able to find a link to any of them. I may not know where to look.

Todd

LynninNC
Posts: 16
Joined: Jul 2013

Hi Todd. I participated in the pazopanib/votrient blind placebo trial. I was at Duke and took the trial drug (or not) for a year 12/12 to 12/13. I had an open nephrectomy 10/12, 9 cm 3Tb. I am pretty certain that I got the active drug.....I had enough of the side effects....but I tolerated it well enough. So far my 6 month follow up scans have been NED. I know that Duke is no longer enrolling new trial participants. In December I asked how people are doing and the general sense I got was that only 1 had actually had a distant met while on the meds.  I was crushed to see you that you had a recurrence....if I remember correctly  you had surgery about the same time as me. I am still hyper-vigilant about aches and pains and am glad that you acted on your pain. Periodically I have pretty significant adhesion pains. It is like my guts are twisting up inside me. But once I can make myself relax they ease up. Back to the trial: I feel good about taking part in it. It did get me into a fabulous medical facility and gave me some sense of doing everything I could. I struggled with the loss of control when this all happended out of the blue. Signing up for the trial gave me that sense of control.  When I enrolled it was restricted to patients that had NOT had a met and were less than 3 months post surgery. Maybe the goal of the study is changing. Good luck with your decision.  Positve vibes.   L~

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

I'm not sure if there is more than 1 study or if this is the same study. The one I'm looking at is for anyone who has had RCC but has had all disease resected. You have to enter within 3 months of having surgery (which sounds the same as your study).

I found out today that I had the placebo on the EVEREST trial. It completely shocked me. I'd been so sure that all the times I hadn't felt well that year was due to the drug, and I was never on a drug. It's making it harder to decide whether to do another one or not.

This may very well be a different study. The title mentions pazopanib versus placebo following metastatectomy. The other one was probably following nephrectomy. That one is probably closed.

I wonder why they would think the result would be different....

I'll probably do it.

I'd like to just ignore all of this and live my life as if it never happened. I don't think that's an option for me.

Todd

GailN
Posts: 9
Joined: Dec 2013

Todd, I suppose the metastatectomy trial is for RCC that has definitely escaped the kidney via the blood/lymph system whereas the adjuvant trial was for RCC that probably hadn't left the building!! There is likely a greater risk of recurrence for tumour that has already metastasized and therefore a chance that the trial may be able to detect a difference......liken it to finding a needle in a hay stack assuming of course that the needle does exist in the first place.

I took Sunitinib as an adjuvnt for 12 months after a nephrectomy in Feb 2012 for a 5.8cm stage 3a, grade 4, ccRCC. Currently, it has been 3 years and still NED. That does not say that this NED status is due to the sunitinib as it may never had recurred anyway. But I had an aggressive tumour with other risk factors such as necrosis and was keen to take any measure that may prevent recurrence. Other adjuvant trial results seem to be leaning towards benefit for high risk groups of which unfortunately I am a member. If I was only stage 1, grade 1 with a 3cm tumour, I would not bother with adjuvant therapy as the benefits do not outweigh any potential harm from the TKI. Further, I take supplements of maitake mushrooms, liposomal curcumin, drink cups of green tea and use fresh culinary herbs/spices in my cooking. Not sure if any of this helps but my cooking tastes a lot better!!.......regards

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

That's exactly the difference.

I suppose you don't know if you had the real drug or a placebo if it was a trial?

I was also Stage 3 and Grade 3. My tumor was 6.8cm. Had a similar concern.

If you think those things help, I might just try them. Fresh herbs and spices are great regardless!

The only supplements I take are D3 (I was deficient before the nephrectomy but got worse after, and now it's normal taking 4000 iu per day), B12 and a multi-vitamin and a B complex + C. I also tested low on B12.

Do you take a supplement  made of the mushrooms? What's the difference between liposomal curcumin and just turmeric? Are they the same? Can you get that from just using curry powder in your food?

Todd

 

MMondi1
Posts: 19
Joined: Jun 2013
Footstomper's picture
Footstomper
Posts: 289
Joined: Dec 2014

Well THAT's a depressing survey!

MMondi1
Posts: 19
Joined: Jun 2013

Yes its disappointing but hopefully the trial will still show to have some benefit to a subset of patients. It seems a lot of doctors have been hinting at this.  It also does point out, the trial didnt worsen the outcome.

Footstomper's picture
Footstomper
Posts: 289
Joined: Dec 2014

My mrs is a research viral oncologist and pointed out that these studies are only about localised cancers, NOT metastatic ones. So not a great study, but not a terrible one either.

todd121's picture
todd121
Posts: 802
Joined: Dec 2012

My gut feeling was that VEGF drugs weren't going to make a difference in adjuvant settings. This makes me doubt I'll do the study. Actually, I'm not going to do the study. I've changed my mind after seeing this. I don't think there's a significant difference between the efficacy of votrient and these two other VEGF drugs they tested. Votrient has been popular mainly because of reduced side effects and not because of increased efficacy (somebody correct me if I'm wrong about this).

Appreciate the information.

Todd

MMondi1
Posts: 19
Joined: Jun 2013

The only thing Ive seen hinted at is there might be a subset of patients who could benefit from this but I have not come across anything that explains who the subset could be and if its true.  

I was disappointed to see these results. 

My doctor said its the combination therapies in clinical trials that are the ones to get excited about.

 

 

Subscribe with RSS
About Cancer Society

The content on this site is for informational purposes only. It is not a substitute for professional medical advice. Do not use this information to diagnose or treat a health problem or disease without consulting with a qualified healthcare provider. Please consult your healthcare provider with any questions or concerns you may have regarding your condition. Use of this online service is subject to the disclaimer and the terms and conditions.

Copyright 2000-2015 © Cancer Survivors Network