I'm sorry to hear about the progression, although it seems there is also some good news too.
I would think that your mom's doctor would have some fairly recent blood work, along with historical results, on which he/she is basing the decision and dosing of these supplements, and will keep an eye on those levels with future blood work.
Yes, I would expect that if Xgeva is started, then Fosamax (alendronate) would be discontinued. If nothing else, insurance likely would not pay for both.
EGF816 appears to be in phase I/II trials, so probably a little early to say much about how promising it may be.
Good luck with the new plan.
<p>I began visiting GRACE in July, 2008 when my wife Liz was diagnosed with lung cancer, and became a forum moderator in January, 2010. My beloved wife of 30 years passed away Nov. 4, 2011 after battling stage IV lung cancer for 3 years and 4 months</p>
Calcium and vitamin D are routinely recommended with denosumab, though there is no evidence-based work to say how much. And yes, alendronate would be discontinued with the start of denosumab.
I also don't have any insight to offer on the new Novartis drug, but AZD9291 and CO-1686 also started out with no real information about them not that long ago. The trial with EGF816 may well be a fine alternative to pursue. In the meantime, it sounds like the plan for her is very appropriate.
Dr. Howard (Jack) West
City of Hope Cancer Center
Founder & President
Global Resource for Advancing
Hello Jim and Dr. West,
Thank you for your replies, they are very helpful! Currently, we are waiting for a date to be scheduled for a biopsy for the CO-1686 trial. Although the prescription for Xgeva was given the other day, I was told by the research nurse today that she was unsure whether or not the sponsor company would allow Xgeva to be used concurrently with the Clovis agent, since CO-1686 is a monoclonal antibody and apparently antibody therapies are not allowed in the study? We are currently waiting for a reply from the sponsor company and I was told that they might take a while to respond back.
In the meantime we are given the option to choose ourselves whether we want to take the injection now or wait until we hear back from the sponsor company. At first I thought it might be a good idea to just start the xgeva now and it will be at least another month or so (biopsy, mutation testing, screening, etc) before my mom can actually start the trial (if she's lucky enough to have the mutation); at that time if the sponsor company says she can not take xgeva on the trial then we can always be off the xgeva in interest of going on the trial.
But then I was thinking again that maybe it might be a good idea to just wait until we hear back to not jeopardize our chances. Just wondering if you have any insight on this matter? For instance, Dr. West, do you know of anyone or are currently treating any patient who is on the CO-1686 trial and on xgeva concurrently? Do you presume it to be a problem? We'd like to start the xgeva asap but unsure what to do.
I did some searching on the clinicaltrials.gov site and didn't see any instances of the use of xgeva being listed as an exclusion. That being said, the exclusion listings are at times incomplete so I would contact the trial staff for the trial you're considering and ask them whether concurrent or prior, recent use of xgeva would be a problem. If prior use is a problem, ask what the washout period is. They are usually quite helpful.
Thanks a lot for your reply! We actually heard back from the company today stating that Xgeva is allowed while on CO-1686, which is excellent news. My mom will be having the injection later today administered by her family doc.
In other news biopsy is scheduled for next Thursday.
I'll try to keep you updated on how things play out.
I just re-read my previous post and realized that the questions are either too specific or are similar to questions I have already asked in my previous posts. In this event, please disregard my previous post.
I do have a general question I want to get your opinion on at the moment. I was wondering if you think that there is any difference in terms of yield, adequate tissue sample, etc. between obtaining tissue for mutation testing by way of either Fine Needle Aspiration biopsy or Core Needle biopsy when the target lesion is in the supraclavicular lymph node? I'm just trying to understand the rationale between choosing one method over another method because as you know this would be the second biopsy done because the first procedure resulted in mainly scar tissue collected when the site was the pleura.
I read that core biopsies use a thicker needle and can collect more tissue to sample and be tested, whereas FNA biopsies uses a thinner needle, so is easier to tolerate than core biopsies but unfortunately less tissue is collected. Of course either procedure would be done through ultrasound guidance.
A core biopsy would definitely be preferred. More tissue is better, and sampling from a supraclavicular node under ultrasound guidance isn't quite risk free (no invasive procedure is), but it's very low risk.
Hello Dr. West,
Thank you very much for your quick response. It is very helpful in the discussion I had with my clinical trial nurse today. I have another follow up question to ask you.
I was just informed by the research nurse that we are booked for tomorrow for an ultrasound guided FNA biopsy, and when asked if there is a possibility to have a core biopsy instead we were told that this would require a longer wait time to book the appointment. We were given the option to either go ahead with tomorrow's FNA and we should get results back within a week to see if there is sufficient tissues in the sample to ship off for the mutation test (which by the way would take another 1 week to get mutation results back) OR to cancel the appointment tomorrow and see if it is possible to book an appointment for a core biopsy at a later date, but this second option would take us probably to sometime end of January-early February to get a booking. We were told this is completely up to us in terms of what we wanted to do.
I was wondering what your thoughts are on this situation and if you could offer your opinion on what you think would be the best course of action here, all in the interest of saving time of course. Looking forward to hearing back from you.
Sorry, but that is entirely a question of medical judgment and recommendation -- there is no evidence I can use to speak to it, so I need to leave that question to you, your mom, and her oncologist. All I can say is that the yield is higher with a core biopsy.
Thank you for the reply Dr. West. In the interest of saving time, since the biopsy is already scheduled for tomorrow we will go through with it and hope for the best. I'll be sure to follow up with you if any other questions come up along the way. Again, I can't thank you enough for the value of having your opinion and for creating this website.
So currently mom had biopsy and waiting on results to be available in the next couple of weeks for the trial. In the meantime I just have a question for you and would like to get your opinion if possible.
Around christmas of 2014, mom had a T8 compression fracture from new mets that developed. She had a lot of pain, especially with transfers in and out of bed and was prescribed oxycodone, referred for radiation and possible surgical kyphoplasty. Radiation oncologist mentioned that radiation is used solely to treat mets pain and kyphoplasty would only treat pain related to fracture.
Last friday my mom started her first dose of xgeva and on Monday (Jan. 12) she started to feel better, meaning less pain and easier with transfer activities. The pattern since Monday for this past week is improvement, although there is of course still pain but she would report probably 60-70% better.
We have met with the neuroradiologist and was told that it was entirely up to us whether we would like to proceed with the kyphoplasty. Currently we have decided to put radiation on hold but are still contemplating the idea of kyphoplasty.
We were just wondering what your thoughts are in terms of kyphoplasty in a patient who presents like my mom. Back in October she had a T1 compression fracture, pain for 2-3 weeks then complete resolution. We were thinking that if we do not proceed with the surgery, perhaps my mom would have this same natural history. Having said that, we also was informed that this is a very low risk procedure (outpatient day surgery) and would not compromise her ability to enter the trial. We are just wondering if you think in this situation, would you generally have your patients hold off on kyphoplasty and radiation since the general pattern is improvement? Or would you say kyphoplasty is still warranted in this setting as it could prevent future fracture at the same site T8? I'm thinking xgeva may have pulled some weight in (continued...)
...slowing down or stopping further bone degradation from mets.
As always, thank you very much for your candid and helpful reply!
I consider kyphoplasty a very minor surgical procedure that often produces very good and sometimes immediate pain control. I would be less convinced that her pain control from denosumab is going to be consistent and long-lasting -- her response is better than most, and I would have confidence that it will improve further -- it may worsen again.
The lower the risk of a small procedure, the lower the barrier needs to be to pursue it.
Thank you Dr. West for your helpful reply! I needed to re-read your ending quote several times to completely understand it but I think I get it now. We will proceed with the procedure and keep you updated if any other questions come up. Have a great weekend!
Hope your weekend is going well so far. I wanted to give you an update on my mom and ask a question. We were told that mutation test results should come in by middle or so this coming week (fingers crossed). Mom had a T8 kyphoplasty done on Thursday, January 29th and the neuroradiologist mentioned that he was satisfied with the procedure and there was no apparent complications during the procedure.
Immediately after the procedure mom had more pain than usual (pre-op 3/10, post-op 5-6/10) especially in the rib area (not the vertebrae). She has been taking percocets for the pain 2-3 per day. The next day on Friday she had more pain on transferring but the percocets seem to help. Today she is in more pain than usual especially with transferring to and from bed. She seems to be experiencing tachycardia with a HR of 110+, SPO2 95% (her normal is 97-98%), respiratory rate seems to be above 20. No apparent fever, but then the percocets contain acetaminophen which might mask a fever. I am unsure if this is a normal presentation of a patient 2 days post-op from a kyphoplasty or whether it is abnormal and she should seek medical attention? I have read that a possible complication from the surgery could be cement pumonary embolism, which could explain the tachy, and lowered oxygen saturation. I am just wondering what your thoughts are on this situation? I'm not sure if her metastasis is also playing a role in her symptom presentation. Looking forward to hearing back from you.
Hi Will, I can imagine your last few weeks of worry that your mom is getting everything she needs. I hope she or possibly you are in touch with her neuroradiologist to make sure he is satisfied with how she's doing now. It's important to stay in touch with those who are caring for your mom and let them know of your concerns. I hope you understand we can't say whether one should or shouldn't seek medical attention that's is solely for her, her caregivers at home and her healthcare providers should decide. A call to them with these questions is more that appropriate.
Please let us know how she fairs and I hope she finds comfort soon.
Thank you for the reply. I am sorry for posing my question the way I did, what I was really trying to understand was whether or not what my mom was experiencing is what a typical patient would experience few days post-op from a kyphoplasty; so that in the event that it was not typical, we would then consider seeking medical attention. Having said that, taking your advice we contacted the neuroradiologist's office this morning and was given the option of setting dates for scans to see what might be going on. Since we were going to have new sets of scans (for the trial purposes) this week anyways, the neuroradiologist will just have a look at those scans when they are ready. Thank you again for your help!
Thanks for the explanation. We want to be helpful but your mom's team will always be her first line of defense just as Dr. West's patients are his primary focus. I think either medical oncologist would refer her to the person who performed the kyphoplasty.
I hope you never hesitate to call your mom's doctors for matters about her immediate health, it's what they're paid to do. We're here to help you understand how and why.
Hello Janine, Jim, and Dr. West,
Thank you for all your helpful replies. To give an update, mom was officially enrolled into the phase 2 CO-1686 trial after 4 months of wait and took her first dose last week. Her symptoms seem to have stabilized and she is also experiencing less pain only after taking it for a few days. I hope the trend is continual improvement and that no dramatic side effects present itself. I'll be sure to stay in touch should we have any questions along this journey.
We learned about options beyond first generation TKIs through this website and without it wouldn've gone with our onc's initial proposal after Iressa, which was chemotherapy. We are very grateful that we are able to hopefully delay chemo and reserve it for later, as well as for having access to this invaluable website! Keep up the great work!
That's great to hear that your mom got into the trial and wonderful that her symptoms have improved.
Continued best wishes for improvement, good response to treatment and freedom from bothersome side effects. Glad to hear that we have helped you.
That's great to hear Will! I hope your mom continues to improve and for a very long time
Thanks guys! So I wanted to ask a question in regards to new issue that came up with mom. So for the past week or so prior to her starting the trial she had started to develop some problems with appetite. Specifically, she started to have taste changes, not finding food as appealing, not feeling hungry, and if and when she eats the portions are very small. Having said that when she started the trial, although she was still feeling this way, her appetite actually improved a few days into the trial, which unfortunately was short-lived. After several days of decent appetite, she once again lost her appetite and is back to not wanting to eat much food, feeling the urge to regurgitate swallowed food, and not finding any food appealing whatsoever etc. As a result she has been losing weight slowly. She was around 105lbs down to around 103 lbs, yesterday she was 100lbs and tonight 99 lbs.
I lightly addressed my concern in regards to her lack of appetite with the trial nurse the other day and she mentioned to have her eat small portioned foods and try meal supplements in addition to regular food. She also mentioned that they don't like giving patients synthetic meds to stimulate appetite as patients tend to only gain water weight and not lean mass. Having said that I have read that losing weight is associated with a poorer prognosis and possibly an indicator that the cancer is progressing and not being well controlled. The good news is that she seems to have less pain while on this trial med, but the down side is that she is currently battling weight and appetite issues. I'm just curious as to your thoughts on this issue?
I have read megace and/or cannabinoids may help stimulate appetite, do you think this is something worth discussing with the team? We won't see the onc for another 2 weeks, and I really aren't sure if we should push to set up an appointment to speak with him sooner in light of new issues? Just thought I'd get your expert opinions on the situation first.
Dr. West wrote a thorough post on weight loss and lack of appetite which you may find helpful: http://cancergrace.org/cancer-treatments/2009/02/16/acs-mgmt/
I think it is always a good idea to address these questions with your medical team sooner rather than later so that if an intervention is recommended it can be started soon.
Good luck in finding a resolution to these issues.
Thank you Jim for the reply. Mom was prescribed dexamethasone today for her anorexia-cachexia related symptoms. According to the post by Dr. West, it seems as though Megace is a better choice? It is my understanding that long term use of corticosteroids may have unwanted side effects such as degradation of the muscles and bones. Since mom isn't doing too well in that department, I was just wondering if you think it might be worth asking the onc to consider giving mom megace instead in this clinical setting? I'm not sure if cost might be a factor that onc considered in this situation, but if it is and megace is the better choice then we are okay putting up the extra money for it. Looking forward to hearing back.
Magace as I recall is very expensive but it has a generic my husband get's in the U.S. that is very affordable. If your mom has health insurance or under a national health system magace should be covered. It's a standard treatment for appetite loss and it worked very well for my husband, still does when he needs a boost.
Just an FYI, if your mom is taking the steroid on an ongoing basis and is taken off it she do it gradually and the schedule the doctor gives can and usually does need modified for the individual. So a conversation about that is usually helpful plus we have lots of those discussions on the forums as well.
Best of luck to you and your mom,
Thank you Janine for your reply. Although we have the prescription for the steroids today, mom has not taken any yet because we fear the side effects of the steroids (muscle and bone degradation, suppressed immune system, etc). My grandma had brain cancer and was given corticosteroids, after a few weeks she went through an episode of pneumonia that strictly weakened her and she passed away. Hence, if megace or another agent is found to be more beneficial and with a less severe side effect profile we are certainly interested in pursuing that option instead.
I was wondering if either Dr. West and/or another oncologist/health care professional could please make a comment on this question. Thank you and looking forward to hearing back.
Will do Will.
Having had several patients on CO-1686/rociletinib over the past few months, I have come to conclude that it's not as trivially easy to tolerate as I might have hoped and expected based on the early reports. Specifically, I have a patient who experienced diminished appetite, weight loss, nausea, etc. to the point of needing urgent care for fluids and then a dose reduction. She's doing better, and her pulmonary symptoms clearly related to her cancer have clearly improved on the study drug, but she's still having a bit of a challenge with GI issues even after a dose reduction.
I mention this to say that it may be helpful to take a break from the drug, particularly if her symptoms get bad enough. She may feel much better with a brief break, which will clarify the cause-effect relationship, and then may do better with a dose reduction.
Worth keeping in good communication with her oncologist about this.
Thank you for your reply and sharing your clinical experience with us. Your suggestions are well taken and we will certainly discuss with the onc regarding this possibility of rociletinib-induced anorexia. I was just wondering though, mom actually started to manifest lack of appetite symptoms a week prior to starting the Clovis agent (started Feb 9, 2015), these symptoms improved 3 days after taking the study drug, then took another turn and gradually worsened. Since she already started presenting these symptoms prior to starting the study drug, do you think it is likely that the anorexia-cachexia is cancer related and is only worsening and not being controlled by the study drug, or is the study drug actually compounding the lack of appetite symptoms further? A good sign is that her spine and rib related pain has improved, she is no longer on pain meds (previously 1-3 oxycodone).
Since she is prescribed dexamethasone today (she has not taken it for fear of side effects), we were wondering if you could comment on dexamethasone vs. megace in treating cancer related anorexia-cachexia, which I think mom is experiencing currently (i.e., she was around 103-105 lbs in past few weeks, last night was 97 lbs), in terms of side effects. We are afraid of the musculoskeletal and immune suppressing side effect of long term corticosteroid use.
Thank you very much and looking forward to hearing back from you.