Husband started CO-1686 trial on June 22nd. He is not new to being DM type-2. His sugars usually range before Clovis in the 130-160 range, controlled on Metformin. However, his sugars have been climbing and just this past week beginning Tuesday night he started to experience extreme fatigue/weakness, muscle cramps, nausea, worsening of his GERD symptoms. Also, experiencing fevers with chills. He's still taking Metformin. His sugars have climbed as high as 400. Today I took him to the ER because of the sugar being 400, seemed to be dehydrated and had trouble focusing, no strength. Clovis was discontinued yesterday until his sugars are better controlled and they figure out why he's spiking temps. His dose was 250 mg, 2 in the AM and 2 in PM so 1000 mg a day. He is staying the night in the hospital which is the best for him so they can monitor him. The hospital got his sugar down to 91 and his temps are down as well.
My question: 1) Should we give up on this trial drug now due to all the problems he's having? I'm thinking it might not be worth it and maybe it's best to try another chemo. 2) If we were to go with the more traditional chemo, does the patient have a right to request a milder dose of that chemo rather than the shotgun approach?
Thanks,
Kate
Reply # - July 12, 2015, 09:53 AM
Hi Kate,
Hi Kate,
I'm sorry to hear about the problems your husband is experiencing. It seems that the decision to be made, in consultation with his own doctor and the trial staff, is whether to try the trial drug one more time before abandoning it. Of course, if you and your husband don't feel you want to go through this again, the decision is yours.
In terms of chemo dosage, when new drugs are tested in clinical trials, phase I trials help determine the maximum dose tolerated by most patients, then that dosage is tested in phase II/III trials for efficacy. This process doesn't determine whether a lower dose will be effective, so although it is possible to choose such a dose, there is no way to know whether that dose is of sufficient strength to produce good results.
One significant downside to choosing a lower dose initially is that if the drug proves ineffective, the standard course of action would be to move on to a different therapy. You could increase the dose, but since it is entirely possible that the particular patient's cancer simply does not respond to this drug, you may be wasting time on further use of an ineffective therapy.
For that reason, patients typically start at the standard dosage and if side effects become onerous, either holding back treatment for a week or two or reducing the dose are the usual choices. If you can manage to get in a couple of cycles, then you can scan to determine if therapy has been effective. But once again, the ultimate choice belongs to the patient and his family
Good luck with whichever path is chosen.
JimC
Forum moderator
Reply # - October 28, 2015, 04:33 PM
NSCLC -EGFR, Exon 21, T790M
NSCLC -EGFR, Exon 21, T790M
My husband is on the Clovis trial; however, met with the oncologist (Cycle 7) who said he's stable from lung standpoint; however there is a very small spot on the liver (new 6 mm), the oncologist said she's worried about this. So there seems to be progression. My husband will be getting gamma knife again. He is staying on Clovis until the next scan which will be in 6 weeks.
1. Would the spot on the liver be biopsied? Would it be a different mutation?
2. Is this common to spread to the liver?
3. What would the kinds of treatment be to treat the liver?
The oncologist mentioned "immunotherapy" and I am wondering which one she is thinking about. I mentioned afatinib and AZD; however, she said they would not be as effective as Clovis so therefore I think she feels they would not be effective next time.
Can I have your opinions on this?
Kate
Reply # - October 29, 2015, 08:14 AM
Hi Kate,
Hi Kate,
I'm so sorry your husband is going through this, and you as well. The liver is a common site for lung cancer to metastasize however a biopsy can't be done to a nodule that has been radiated. Not all sites of progression are biopsied if it's overwhelmingly thought to be a met (if it looks like a duck and quacks like a duck it is a duck). Most often a site of progression such as the liver is treated with systemic therapy such as chemo, tki and most recently, immunotherapies. The big and new HOWEVER to this is, it appears that with egfr tki's at least there is often only one or 2 sites of progression that are being treated with focal treatment like gamma knife radiation treatment. This often takes care of the renegade, newly mutated cancer for sometimes a very long time. It makes sense for your team to make this plan. Dr. West wrote this a couple of years ago and has only picked up more steam. http://cancergrace.org/lung/2013/01/23/acquired-resistance-algorithm/ and more recently, http://cancergrace.org/lung/2015/10/27/gcvl_lu_egfr_tki_therapy_continu…
Afitinib has not panned out to be as good a treatment option as was first hoped. It's known to cause quite a bit of toxicity without lots of benefit. The 3rd generation drugs such as Rociletinib (CO-1686) and azd9291 are showing more efficacy. There is no data to show whether giving both rociletinib then azd9291 is beneficial, they are very much alike and the drugs are too new to have that info.
I hope your husband does well for a very long time.
Janine
Reply # - October 31, 2015, 09:01 AM
Janine:
Janine:
Not really sure if this is indeed a liver met. The Impression from the radiologist reads:
"stable low-attenuation hepatic lesions, likely benign. A low-attenuation lesion in segment 8 is faintly visible on the July 2015 scan, but not clearly seen in November 2013. This can be followed on subsequent exams".
So, if I am understanding you correctly, treatment option for the liver met (if in fact it is), could be GK? Have you heard of "Radiofrequency Ablation?"
He is getting gamma knife for the 2nd time on his brain soon. The oncologist is recommending this over WBR due to with WBR he would have to be without Clovis for a couple weeks and since she's not sure of progression or not she thought GK would be the better option for now.
Thanks,
Kate
Reply # - November 1, 2015, 07:47 AM
Hi Kate,
Hi Kate,
With a history of metastases to both brain and bones, a local treatment to the possible liver mets, such as surgery, focused radiation or RFA, would not normally be recommended. For lung cancer cells to have reached these varied sites, they must have entered the bloodstream. Without effective systemic treatment (chemotherapy, targeted therapy or immunotherapy) metastases are likely to continue to appear outside the lungs. Since they are small, it may be recommended that these mets be watched over time, and if progression in the liver or elsewhere becomes significant, a change in systemic therapy would be warranted.
Dr. West discusses this in detail in this GRACE FAQ.
JimC
Forum moderator