CSN Login
Members Online: 17

Previous scans

tacyarts
Posts: 73
Joined: Apr 2012

The scans that I had two weeks ago from my mdx 1106 / sutent trial finally received the % of shrinkage. The overall shrinkage of my tumors was 12 % over the first 6 weeks. It took over 2 weeks to get the results. Such a blessing!!

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

Good stuff - keep it up.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

That's great news and, hopefully, only the first of many more reductions! I'm really happy for you. YES YES YES!!!

foxhd's picture
foxhd
Posts: 1876
Joined: Oct 2011

Thats FANTASTIC! I've had bumps and bruises that are still present after 6 weeks! Keep going! Even stable is good news. 12% is awesome. I've been told sometimes it takes 2-3 infusions before changes.

Max Power's picture
Max Power
Posts: 60
Joined: Sep 2012

Great news, glad to hear it.

I was on PD-1 (MDX-1106) (no Sutent) from May2011 to Jan 2012. No side effects. My notes say results are usually seen after 1st or 2nd scan. Side-effects, if at all, take 1-3mo. I had to leave the trial due to slight progression.

But I was quite content to have 7 months of side-effect free stability!

I'm on sutent now.
May you keep shrinking!
Max

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

Max, you seem to have a well-balanced attitude so I'm happy to ask you about the rationale for the exit from the trial.

I'm not so cynical as to suppose that it's designed to manipulate the apparent success figures of the trial! I imagine that the exit criteria are ethically based on factors such as toleration (the cure being worse than the disease) or progression, suggesting that it hasn't worked/has stopped working and accordingly trying something else is now in the patient's best interests. Is this correct?

Both of those criteria seem problematical and I presume medical science is, necessarily, feeling its way with these new therapies. Switching, however, seems a good idea on several grounds. First, it may wrong-foot the cancer in its endeavour to adadpt and survive (I'm using a teleological description here just as shorthand rather than with tacit assumptions).

Next, a break from a given therapy may not be permanent - sometimes success is enjoyed on a re-visit to an earlier therapy, the patient having had a refractory period in which to recover from side-effects. Then, again, we may not yet know enough, for certain, about the latencies to benefits and to side-effects - the information you give above is probably the best guess so far but we are all so different and there may be delayed benefits for some patients that we don't yet know about and that may be camouflaged by the change of regimen.

I'd be interested in your thoughts on the above (and the rationale of the decision) but, in any case, I take the opportunity to wish you every success on Sutent. Though not as new as the PD1, it's still pretty new and all indications are that it can be very effective.

Max Power's picture
Max Power
Posts: 60
Joined: Sep 2012

I guess my onc summed it up best: If you are progressing on [whatever] you don't want to be taking it.

My dim impression is that switching due to side-effects is often a decision of the patient (though I was told if I lose any more weight... or if my BP goes any higher...) whereas even the slightest progression (mine was miniscule) is more objective and defined by the drug co (for trials).

It is also my dim impression that once I leave a clinical trial, the drug won't be avail to me to try again until/unless it is FDA released.

Max Power's picture
Max Power
Posts: 60
Joined: Sep 2012

I haven't asked, but sometimes I think that, because I'm asymptomatic, the objective is to simply keep the lesions as small as possible. As of today, if I were to stop taking any drug, I would feel great for awhile at least. That is an enviable state compared to some the docs have seen.

To wait a bit to see if the new drug will take hold is against that philosophy.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Tex / Max,

Interesting discussion. Thanks for having it.

“I'm not so cynical as to suppose that it's designed to manipulate the apparent success figures of the trial!” An AHA moment for me!

Being green and relatively new to the trial world, it’s not something that would have occurred to me. But thought and possibility is probably something to keep in the back of mind.

Tex-thanks for mentioning it even if not supposing it.

ClaraW
Posts: 64
Joined: Jun 2012

That's why there is intention-to-treat analysis in biostatistics. So RCT that use ITT analysis is more transparent

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

Clara, before I get back to you re the brilliant research work you've done on my behalf, a quick question:

Have you come across and if so would you recommend a book from 2010 - James Penston's Stats.con: How We've Been Fooled by Statistics-Based Research in Medicine?

ClaraW
Posts: 64
Joined: Jun 2012

Sorry, I haven't come across this book. I guess if you'd like to know how to critically appraise a trial, there's better tools (guidelines) out there which are only a couple of pages to read. I rarely read big books nowadays =). I've read very little on statistics and know hardly anything about research, thus my understanding in this area is very very superficial.

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

Clara, fortunately, for that purpose all I need to do is ask my Wife who was recently in an IT contract designing systems for the UK body (N.I.H.R.) re drug trials. [Also, in an earlier career she published research papers in various medical fields and some original papers in statistics.]

I came across the reference to that particular book in this item that will probably interest you:-

The International Journal of Person Centered Medicine
841 The International Journal of Person Centered Medicine
Volume 1 Issue 4 pp 841-842
LETTER
An unattractive hypothesis – RCTs’ descent to non-science
Clifford G. Miller BSc ARCS
Solicitor, Supreme Court of England & Wales and former Lecturer in Law, Imperial College, London, UK
Correspondence address
Mr. Clifford G. Miller, Burnhill House, 50 Burnhill Road, Beckenham, Kent, BR3 3LA, UK.
E-mail: cgmiller@cliffordmiller.com
Accepted for publication: 14 October 2011
To the Editor

Eyal Shahar’s essay review [1] of James Penston’s remarkable book [2] seems more inspired playful academic provocation than review or essay, expressing dramatic views of impossible validity. The account given of modern biostatistical causation reveals the slide from science into the intellectual confusion and non-science RCTs have created:
“…. the purpose of medical research is to estimate the magnitude of the effect of a causal contrast, for example the probability ratio of a binary outcome …”
But Shahar’s world is simultaneously not probabilistic, but of absolute uncertainty: “We should have no confidence in any type of evidence ….. We should have no confidence at all”. Shahar’s "Causal contrast" is attractive. It seems to make sense, but bypasses in two words the means of establishing causation by the scientific method. This phrase assumes a numeric statistically significant “contrast” is causal rather than a potential correlation requiring further investigation.
The concept of “causal contrast” is a slippery slope from sense into biostatistical non-science. This can be illustrated with an hypothetical RCT where 100% of interventions exhibit a posited treatment effect and 0% of placebo controls. Internal validity is seemingly quite reasonably assumed satisfied (common-sense dictating the likelihood of an awesome magnificent fraud, bias or plain error of the magnitude required is infinitesimal). Scientific method appears satisfied. The RCT demonstrates: (1) strict regularity of outcome in the presence of posited cause; (2) the absence of outcome in its absence and (3) an intervention (experiment) showing the direction of causation is from posited cause to posited effect.
Now travel further down the slope from science. Assume 50% of interventions and 0% of controls are positive. We compromise scientific method, but justify this by assuming a large subgroup which we say surely must on these figures be exhibiting the posited treatment effect. But what of 10% of interventions and 9% of placebo controls exhibiting the posited treatment effect? Our biostatistician says the 1% “causal contrast” is statistically significant. But we have: (1) minimal evidence of regularity; (2) the posited outcome irrespective of presence of posited cause and (3) our intervention is at the highest equivocal in demonstrating any form of causation. This is not science. It is, however, where biostatistics has unthinkingly taken us, as Penston has shown comprehensively [2].
We, the audience of published medical research, are now for the 10% / 9% example well down the slope from science.
An unattractive hypothesis results requiring numerous assumptions similar to these:-
"There is a 'contrast' which is ‘causal’, albeit the method employed is not scientific. An effect of the intervention has been observed in a very small subgroup. This subgroup is susceptible to treatment. The similar number of placebo controls exhibiting the outcome sought is irrelevant, because the 1% difference between intervention and controls is statistically significant. The statistical analysis is valid and reliable. The RCT’s internal validity is sufficiently satisfied. No funding or bias or fraud has affected the results or their analysis.”
As Penston notes:
“Confirming and refuting the results of research is crucial to science …. But … there’s no way of testing the results of any particular large-scale RCT or epidemiological study. Each study … is left hanging in the air, unsupported.”
It gets worse. To identify a rare serious adverse reaction of a frequency of 1:10,000 can require a trial of 200,000 or larger split between controls and interventions. This is not done. But for every 100 who prospectively
Miller Letter
842 The International Journal of Person Centered Medicine
Volume 1 Issue 4 pp 841-842
benefit from the intervention, 9,900 also receive it. And for every 100 benefiting one person (who likely gains no benefit) will suffer a serious unidentified adverse reaction. This is also without taking account of more common adverse reactions whether serious or otherwise.
References
[1] Shahar, E. (2011) Research and medicine: human conjectures at every turn. International Journal of Person Centered Medicine 1 (2), 250-253.
[2] Penston, J. (2010). stats.con: How we’ve been fooled by statistics-based research in medicine. London: The London Press, UK.

pjune127's picture
pjune127
Posts: 127
Joined: Dec 2011

Max, was your tumor sample checked for the receptor for PDL? That is a recent addition to the criteria for acceptance into the trial. I just began a trial with 20 mgs/kgs of PDL. Hope I get a durable response, but glad Sutent is working for you. No side effects right now, but just had the infusion yesterday.

Max Power's picture
Max Power
Posts: 60
Joined: Sep 2012

I'm seeing my onc in 2 days, I'll ask 'im.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Tac - just wondering if any of the pain has subsided with reduction?

tacyarts
Posts: 73
Joined: Apr 2012

Yes I have had some pain flare ups in the chest stop happening. A few times a day my chest would hurt drastically but haven't had them since 3 weeks into trial. The leg pain is unchanged since no reduction there. Alice, I didn't know if you had seen that Monica told me wrong on dosage that I was receiving , I am getting 5 mg dose.

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Yes I did see that. I believe that's the highest dosage now (at Hopkins). The maximum dosage started out at 10 mg but then was changed to 5 mg (remember John signing an addendum reducing the max dosage from 10 mg to 5 mg even though it did not directly impact him.) He's on 2 mg, what they refer to as the active dose. He too has been told the bone mets are much slower to respond. He has his next scan on Wednesday, 10/24/12. Keeping our fingers crossed.

I assume you're still unable to work. What kind of work do you do?

angec's picture
angec
Posts: 621
Joined: Mar 2012

Alice, just wondering. Did they give John radiation for the bone mets? I hear radiation really helps them disappear faster and greatly helps the pain. If they didnt' offer it to him for the bones, is there a possibility of asking for it? Fox has done well with it! All my best to you and John!

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

They did briefly mention it at one point but then quickly dismissed the idea, saying it was off protocol for the trial.

Since he has done pretty well managing with pain oxy***es, he hasn't pushed the issue. He also attributes the oxycodone/oxycontin to his NOT experiencing the diarrhea that often accompanies of use of Votrient, since the oxy***s are basically immodium with opiates.

angec's picture
angec
Posts: 621
Joined: Mar 2012

I understand. I was on heavy pain meds at one point, and the runs are not the culprit.. The constipation is another thing! LOL I guess it might have done good for John to get the radiation, it would probably work quicker on eliminating the bone mets and it would be ideal to not have to take those pain meds for too long. But i guess he has to be the good patient and take what they give him. Does that mean that as long as he is on the trial his treatment regimen cannot change? I wonder if they are aware that others on very similar trials are in fact getting the radiation(like our FOX). Thank you Alice for sharing. xxoo much love to you!

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

Hi Ange - I don't know for sure if this will continue to be the only way they treat his pain or not. John doesn't want to do anything to jeopardize his treatments. He is a slave to the details and doesn't want to forego a single infusion or miss a single dose of Votrient if its in his control. Right now, with the controled pain he experiences, he lives pretty normally (minus golf) which is I know is a bigger deal for some more than others.

On the last scan, there was a small reduction in the shoulder met, but also a hairline fracture. The doctor noted it COULD reflect shrinkage and the met pulling away from the bone, thus causing the fracture, but the jury is still out on this. He has his next scan on Wednesday, the 24th with prayers for continued reduction.

I know you're right about long term use of the pain killers, and his doctor has already told him he will need to be weaned from the oxyees when the time comes. The trial itself is a year long, and we're at the five month point now. In my mind, if reduction/stabilization continues, they will not do anything as far as radiation until after the trial. If the MDX stops working, then I see other measures being taken. But that's just guesswork at this juncture. Thanks for sharing your concern; I'm with you.

Love U back!

tacyarts
Posts: 73
Joined: Apr 2012

I've owned a restaurant named The Stray Cat Cafe for 17 years now in Moorefield WV. I am putting so much exta work on my wife's shoulders by me being sick, she is a trooper!!

tacyarts
Posts: 73
Joined: Apr 2012

I've owned a restaurant named The Stray Cat Cafe for 17 years now in Moorefield WV. I am putting so much exta work on my wife's shoulders by me being sick, she is a trooper!!

alice124's picture
alice124
Posts: 860
Joined: Mar 2012

I'm sure she is, but it shows she knows you're worth it. Just keep your head up, your postivity tuned to high, and kick cancer butt! You and your wife sound like a great team that can make it happen.

garym's picture
garym
Posts: 1651
Joined: Nov 2009

for shrinkage...Way to go Tacy!!!

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 2000-2014 © Cancer Survivors Network