Hi wadvocator:

Welcome to GRACE and I’m so sorry to read of your wife’s diagnosis. I personally have not heard of this agent that you have written about and anxiously await hearing if our faculty members have anything to add here. In terms of “other actions” to “stack the cards in your wife’s favor” – - I think that being here on GRACE definitely qualifies. In my opinion, being an informed patient/caregiver dramatically heightens the level of communication between the doctor and the patient/patient advocate. Conversations/consultations become much more detailed and a little less stressful because you know what the options are that exist out there before you walk into the room. That’s just my opinion. . .

Anyway, let’s wait and see what the faculty and other members have to say about this. . .

Laya

Hi wadvocator. I wonder if this is the trial your wife is on?
http://www.clinicaltrials.gov/ct2/show/NCT01221077.
I am sorry to hear that she had problems with side-effects. Are you able to say more about these? It might be helpful for others who are considering the same trial. I’m glad you were able to reduce the dose and hope she is now more comfortable.
The factor that may work most strongly in your wife’s favour is the EGFR mutation, which hopefully will predispose her cancer to show a good and lasting response to Tarceva. All best.

I wanted to provide a bit of a notice to everyone, which is that Dr. Aggarwal is a new faculty member with an expertise in lung cancer who is just now starting to work with us. I hadn’t had the chance to formally introduce her, but I’ll do that in a separate post very soon.

Second, to wadvocator, my center is also participating in the same trial, and there have been some concerns about OSI-906, which is an oral inhibitor of both insulin-like growth factor-1 receptor (IGF-1R) and insulin receptor (IR). Another agent that works as an inhibitor of IGF-1R, called figitumumab, was part of a negative trial that raised some concerns about potentially significant side effects in some of the patients who had received this agent, primarily high blood sugar levels and some kidney problems, occasionally also liver problems as well (there was a trend toward worse survival in the recipients of figitumumab compared with the placebo arm). There are some concerns that these side effects may be seen in people who receive other IGF-1R inhibitors as well, as a “class effect”, so that is certainly one of the reasons there is heightened concern about side effects with OSI-906.

As Dr. Aggarwal indicated, the concept is that the combination of OSI-906 with EGFR tyrosine kinase inhibitor (TKI) may prolong the time that a person remains sensitive to the beneficial effects of EGFR TKI therapy in patients with an activating EGFR mutation. It remains to be seen whether this will be borne out in the clinical trial.

-Dr. West

I haven’t heard of this side effect before, but it sounds very concerning. I certainly understand why you would be wary about this.

I hope you’ll keep us informed about how things are going.

-Dr. West

Hello wadvocator, and welcome to GRACE! I wanted to chime in on your earliest question and support what Laya said about how to “stack the cards” in your favor as to manage your wife’s disease.

Finding this website was the single most important thing I did after finding an outstanding medical team. It made it possible for me ask questions (initially by using the search function) just to build up my “fluency” on my condition. I started by going onto the website at least once a day (as a constructive act when my thoughts turned to my recent diagnosis) and typing in a keyword or phrase…I know there are hundreds of those being thrown at you now. That approach led me to faculty discussions of broader topics and patient/caregiver posts that described their own treatment plans and symptom management strategies. It also showed me how many different treatment options are available as you move through this journey and showed me that it is possible to survive for years by working closely with your medical team and being well informed. I didn’t post a question or comment for months because the wealth of information was so helpful to me.

My first treatment was with Tarceva and it is a VERY dehydrating medicine. I also participated in a EGFR resistance clinical trial and that was even MORE dehydrating. I’m not sure it’s possible to hydrate enough to keep you skin moist — you’ll need lotions and creams for that — but I found that I couldn’t be without a 32 ounce cup of something with me at all times.

We often talk about being well informed and a good advocate with our medical team, but it is just as important to be well informed and “advocate” with yourself, paying close attention to your body and taking care of it. You’ll notice all kinds of odd little things that you didn’t ever notice before. Trust your instincts and take very good care of yourself. It sounds like you are already well along on that road for you and your wife.

My very best wishes to you and your wife. I’ll be watching to see how things go from here. And thank you for being willing to enroll in this trial. It’s this kind of research that makes me feel hopeful that we can find a way to interrupt and defeat this cancer sooner rather than later.

• This reply was modified 90 days ago by  blue skies.
• This reply was modified 90 days ago by  blue skies.

Hi Dr. West, I looked up the Tarceva and OSI 906 clinical study in Swedish Cancer Institute website and learned that you are the primary investigator for the study and that the study has been halted temporarily. May I ask why? Thanks!

Thank you Blue Sky for the advice. We are learning to develop new habits that are more healthy for our body, spirit and soul. Developing those new habits provide us a sense of self empowerment.

Hi Blue Sky,

Please help me better understand: “My first treatment was with Tarceva and it is a VERY dehydrating medicine. I also participated in a EGFR resistance clinical trial…..”

1. Was Tarceva your first line treatment?
2. Did you combined Tarceva with other study drug to assess whether it prolongs the effectiveness of Tarceva?

Hi Drs,

Is it commom that the safety assessment done in phase 1 study no longer hold true with phase 2 study results?

wadvocator,

It’s most typical for the phase I work to give a fairly accurate picture of the side effect profile, but that work is usually based on just a dozen people or a few more more patients than that. Obviously, that’s so limited that it’s absolutely not that unusual to see new safety signals in phase II work (as, for instance, was seen with bleeding complications from Avastin (bevacizumab) in patients with squamous cell carcinoma in an approximately 100-patient phase II study that changed the course of this agent’s development) or phase III trials (as was seen with the IGF-1R inhibitor figitumumab, which demonstrated a worse outcome than the placebo arm when combined with chemo in a phase III trial, due to greater side effects). And of course, every few years a drug comes off the market, like Vioxx (rofecoxib) after being found to be associated with a higher proportion of cardiac events only after being evaluated in thousands and thousands of patients.

So while phase I trials are meant to provide a very efficient summary of key side effect issues, there are obviously limitations in what you can draw from just a dozen patients compared with the greater accuracy that you get from assessing a drug in much larger numbers of patients, especially when the safety issue of concern is actually infrequent but very serious.

-Dr. West