Immunotherapy Treatment Xilonix for CRC

[joe7777777]

http://immuno-oncologynews.com/2016/07/ ... treatment/

[midlifemom]

Joe, wonderful news.

Question - now that phase 3 is complete will the trial shut down? Clinical Trials .gov still says recruiting.

My concern - what if I want to go on xilonix in the next few weeks/months. But if the trial is over,fda approval still needed? Then a push to get insurances to cover it? I could be out of luck.

Can anyone provide some education, along with consequences, for what happens at this point in the trial?

[Maddielolo]

Haven't heard to much about this trial, other than a comment or two. Dk37, grouseman, rp -- any thoughts on this one?

[DH2Sleen]

While I don't have the pedigree that DK37 and Grouseman have, I can see some problems with this report.

First of all, this is a report from Europe and has no bearing on the US trial that is ongoing.

Second, it is somewhat misleading in the way it was reported. The actual endpoint of the study was not "overall survival" but rather "a predictor of overall survival" (which was quoted from the chairman of the study). After that paragraph, the reporter interpreted that statement to mean an increase in overall survival with reduced fatigue and pain and better appetite, but in fact, the study found no increase in overall survival and was not looking for it (according to another report: https://www.thestreet.com/story/1362832 ... utiny.html).

I'm no expert, but I think the jury is still out on this one.

[aja1121]

My husband is going on this trial at the suggestion of his oncologist. It will be a couple of months before husband can try Avastin (very small open wound from APR is almost healed) so this is kind of a can't hurt/might help scenario. 66% chance of getting Xilonix, 33% chance of placebo. Scan 8 weeks after trial starts, and they will pull him off if there's any progression. At that point, next step will be to try FOLFOX/Avastin or look at another clinical trial.

[midlifemom]

My husband is going on this trial at the suggestion of his oncologist. It will be a couple of months before husband can try Avastin (very small open wound from APR is almost healed) so this is kind of a can't hurt/might help scenario. 66% chance of getting Xilonix, 33% chance of placebo. Scan 8 weeks after trial starts, and they will pull him off if there's any progression. At that point, next step will be to try FOLFOX/Avastin or look at another clinical trial.

Aja, please keep us informed. I'm rather interested in this trial.

[Nik Colon]

While I don't have the pedigree that DK37 and Grouseman have, I can see some problems with this report.

First of all, this is a report from Europe and has no bearing on the US trial that is ongoing.

Second, it is somewhat misleading in the way it was reported. The actual endpoint of the study was not "overall survival" but rather "a predictor of overall survival" (which was quoted from the chairman of the study). After that paragraph, the reporter interpreted that statement to mean an increase in overall survival with reduced fatigue and pain and better appetite, but in fact, the study found no increase in overall survival and was not looking for it (according to another report: https://www.thestreet.com/story/1362832 ... utiny.html).

I'm no expert, but I think the jury is still out on this one.

From the link you posted. This statement makes no sense at all to me, unless I am reading it wrong.....

Responding colon cancer patients -- Xilonix or placebo, doesn't matter -- lived an average of 11.5 months! That's way better than the non-responding patients, who lived only an average of 4.2 months, XBiotech said.

Huh???!!! Am I missing something?

Is placebo used different here? So the drug AND placebo are equal. Non responders? To both? Huh? What are the placebo people responding to?

[midlifemom]

While I don't have the pedigree that DK37 and Grouseman have, I can see some problems with this report.

First of all, this is a report from Europe and has no bearing on the US trial that is ongoing.

Second, it is somewhat misleading in the way it was reported. The actual endpoint of the study was not "overall survival" but rather "a predictor of overall survival" (which was quoted from the chairman of the study). After that paragraph, the reporter interpreted that statement to mean an increase in overall survival with reduced fatigue and pain and better appetite, but in fact, the study found no increase in overall survival and was not looking for it (according to another report: https://www.thestreet.com/story/1362832 ... utiny.html).

I'm no expert, but I think the jury is still out on this one.

From the link you posted. This statement makes no sense at all to me, unless I am reading it wrong.....

Responding colon cancer patients -- Xilonix or placebo, doesn't matter -- lived an average of 11.5 months! That's way better than the non-responding patients, who lived only an average of 4.2 months, XBiotech said.

Huh???!!! Am I missing something?

Is placebo used different here? So the drug AND placebo are equal. Non responders? To both? Huh? What are the placebo people responding to?

Nik,
Not sure if I understand your question or the study, BUTT my initial understanding of this drug xilonix was to improve well being - reduce fatigue, nausea, improve appetite and well being. I believe some initial findings did unexpectedly show improved overall survival. What I think this is saying is that while OS was not improved, QOL was improved during those final months.

[Nik Colon]

While I don't have the pedigree that DK37 and Grouseman have, I can see some problems with this report.

First of all, this is a report from Europe and has no bearing on the US trial that is ongoing.

Second, it is somewhat misleading in the way it was reported. The actual endpoint of the study was not "overall survival" but rather "a predictor of overall survival" (which was quoted from the chairman of the study). After that paragraph, the reporter interpreted that statement to mean an increase in overall survival with reduced fatigue and pain and better appetite, but in fact, the study found no increase in overall survival and was not looking for it (according to another report: https://www.thestreet.com/story/1362832 ... utiny.html).

I'm no expert, but I think the jury is still out on this one.

From the link you posted. This statement makes no sense at all to me, unless I am reading it wrong.....

Responding colon cancer patients -- Xilonix or placebo, doesn't matter -- lived an average of 11.5 months! That's way better than the non-responding patients, who lived only an average of 4.2 months, XBiotech said.

Huh???!!! Am I missing something?

Is placebo used different here? So the drug AND placebo are equal. Non responders? To both? Huh? What are the placebo people responding to?

Nik,
Not sure if I understand your question or the study, BUTT my initial understanding of this drug xilonix was to improve well being - reduce fatigue, nausea, improve appetite and well being. I believe some initial findings did unexpectedly show improved overall survival. What I think this is saying is that while OS was not improved, QOL was improved during those final months.

I seen that mentioned, but I was just confused by the statement I posted as it didn't make sense to me. Yes, qol is important.

[aja1121]

Midlifemom, my husband signed the forms on Wednesday. First step is to have a DEXA Scan to assess his lean body mass. Once that is done, he will be scheduled for an infusion. Study is double-blinded, so not even the oncologist or nurses know whether he is getting Xilonix or placebo. Labs will be run before each treatment and at differing times after each treatment. He will also fill out some forms on how he's feeling re: different QOL measures. This is a separate trial from the one in the recent news coverage; I believe enrollment is supposed to be complete by December 2016. The research nurse told us there is no specific endpoint for this trial, and if my husband does not have growth/progression while on Xilonix, he can continue to receive it indefinitely.

Nik, there has been some discussion online about the non-traditional measurements used in the study (e.g., QOL measures as opposed to overall survival). I read that the placebo survival rates were not available because they gave every patient in the trial Xilonix after eight weeks. Some experts argue that the overall survival still could have been tracked before the 8-week mark. Numbers are not my thing, so I can't comment on that.

I'm not expecting miracles from this trial. It's just good timing for my husband. If he gets the placebo, he should still feel much better than when he's on FOLFOX; if he gets Xilonix, hopefully it will help even more. Either way, it gives a little more time for his wound to heal.

[LeonW]

Congrats for having been accepted.
Best wishes for good results.
L

[aja1121]

It took a couple of weeks to get all the details in order, but my husband started the trial today. The infusion is complete; now we wait for an hour and he gets labs repeated before going home. He said he feels sleepy and his face is a little flushed, but his stomach is fine (nausea and diarrhea reported by about 20% of patients receiving Xilonix in earlier phases of the trial).

[midlifemom]

It took a couple of weeks to get all the details in order, but my husband started the trial today. The infusion is complete; now we wait for an hour and he gets labs repeated before going home. He said he feels sleepy and his face is a little flushed, but his stomach is fine (nausea and diarrhea reported by about 20% of patients receiving Xilonix in earlier phases of the trial).

Thanks for keeping us updated Aja.
Let's hope he has good results.

[aja1121]

My husband has now had 4 infusions on the trial. He gets saline, then the trial drug or saline placebo, then more saline for a one-hour observation period. We believe he is getting the drug, because his face became flushed all four times only after they hung the "trial" bag on his IV, and remained that way until they switched back to saline for the last hour. Otherwise the only side effect has been a bit of diarrhea about four hours after the infusion.

He had an MRI after 2 infusions; we pushed for this because his last MRI had been done pre-APR surgery and we wanted a new baseline, but we also knew it would give us a hint of what was happening on Xilonix. MRI showed cancer was stable/consistent compared to CT performed 5 weeks prior.

The 8-week CT required by the trial is happening next week, which will provide an exact comparison. I believe the plan is to stick with the trial as long as growth is controlled; if more cancer is seen next step is Xeloda and Avastin.

Overall, he feels great. After his failed surgery in February, the oncologists told us he could have as few as six months to live. While I can't say for sure if the trial is what's working for him, I'm so very grateful that we have more time.

Please know that even if I don't post often, I am ALWAYS thinking of the board members/families fighting this awful fucking disease.

[aja1121]

CT scan is STABLE. Moving forward with Xilonix trial for another 8 weeks