Not just a clarification but an apology to Steph and anyone who read what I posted to her down the page here about the response rates of Temodar/Xeloda.

And and and....I can't remember if I posted this info before. very large <<sigh>> here.

ok. here it is and you can especially note the "RESULTS:" ( CR= complete response PR= partial response SD= stable disease MD=mixed response )

SABCS ABSTRACT: [San Antonio Breast Cancer Symposium] [1079] Phase I
study of capecitabine © in combination with temozolomide (T) in the
treatment of patients with brain metastases from breast carcinoma.


Rivera E, Valero V, Francis D, Brewster A, Royce M, Esteva F, Murray JL,
Pusztai L, Hortobagyi GN.. The University of Texas M.D. Anderson Cancer
Center, Houston, TX



Background: T is an oral alkylating agent that is currently being used
for the treatment of primary brain tumors due to its ability to cross
the blood-brain barrier. C has been approved for use in the treatment of
metastatic breast cancer patients who have failed anthracyclines and
taxanes. It is well known that C crosses the blood-brain barrier and has
activity in the brain. Options are limited for patients with brain
metastases.


Materials and Methods: We evaluated the activity of both drugs in
combination for the treatment of brain metastases not amenable to
surgery. Patients were allowed in the study if they had new onset brain
metastases from breast cancer, had declined radiation therapy, and were
neurologically stable. They were also eligible if they had evidence of
recurrence or progression of brain metastases after whole brain or
stereotactic radiation therapy. C was started at 1800
mg/m2 in 2 divided doses. T was given at a starting dose of 75 mg/m2 in
one daily dose. Each drug was given concomitantly every day for 5
days (day 1-5) followed by 2 days of rest and restarted again for an
additional 5 days (days 8-12). Each cycle was repeated every 21
days. We have enrolled a total of 16 pts — 6 pts at dose level 0
(C/T — 1800/75), 6 pts at dose level 1 (C/T — 1800/100), and 4 pts
at dose level 2
(n/T — 2000/100).


Results: Five pts had recurrent brain metastases and had been previously
treated with radiation therapy. The median age is 51 yrs (range, 32-77).
All pts had a Zubrod performance status < 1. Ten pts were ER and/or PR
positive. No grade 4 toxicities have been reported. Grade 3 toxicity
includes headaches (2 pts), vomiting (1 pt), constipation (2 pts),
fatigue (2 pts), nonneutropenic fever (1 pt). We have observed 1 CR, 1
PR, 6 MR, and 3 SD. Four pts did not respond to treatment. One pt was
not evaluable for response. Median duration of response in brain was
10.5 weeks (range, 6-48+ wks). Two pts with SD and 2 pts with MR had
previously received whole brain radiation therapy. Three pts were taken
off the study because of progression of disease outside the brain
including the pt who had a CR in brain but progressed systemically. Four
pts are actively being treated in the study.


Conclusions: The combination of C and T seems to be active and well
tolerated for the treatment of brain metastases from breast carcinoma.
Further studies should include the evaluation of this combination with
radiation and as adjuvant therapy in those pts who are at high risk of
developing brain metastases.


Wednesday, December 8, 2004 4:30 PM

What this means to me is that 11 out of 16 had SOME kind of response. A very small study indeed, yet...... I can be one of the responders, yes?
xoxoxopattyz

Patty,

This is from an earlier post:

Lapatinib Brain Mets trial





Warmest Regards
Joe

Patty, I know what it is to be in a small trial with very little data. The treatment you are following has even MORE results than I had when I joined a trial for aggressive, hard-to-treat mets.

You CAN be one of those responders. I found out that I was a responder, but only one of THREE in a study of 20 women. This means that there were actually three of us who had a COMPLETE RESPONSE, and a few more who had enough response to delay progression of their disease.

My med onc told me when my brain mets were discovered that only TWO of us complete responders were still in that category three years out. He did not consider my brain mets as a breakdown in my response, as chemo and herceptin do not cross the blood/brain barrier. He felt that I would beat those two tumors and be back on track.

Interesting reaction, huh?

I had no idea if I would make it when I joined that trial as the sixth patient enrolled, but I tried to have faith in my body and my treatment. I called on support from my ancestors and remembered a greatgrandmother from the 1650's who had 10 children and lived to be 90 in Connecticut! I asked that those genes be activated to give me the strength I needed.

That may sound goofy, but in times like that we want to know what we are made of! You've got some good genes, I am sure.

Steph,
Didn't sound goofy to me.......AT ALL. I love that you had this kind of history plus personality, to call on, girlfriend!

And thank you and YEA! for sharing with me your success in this small trial. If I knew before, I had forgotton...

many hugs with love,
xoxo

Well, Patty Z -
Glad I could perhaps coax a smile for you with my last message. But, what the heck - what is there to loose??
Just try everything to get your body into bigtime healing mode.
There is a lot of life to live, and I had made a promise to my mother-in-law, before my cancer showed up, on her deathbed that I would take care of her son! I even asked HER if she was letting me out of my promise - or had someone else in mind to take over.
I got my answer!

I am thinking my most powerful thoughts that your new chemos will work against those pesky mets. Get in there and Search And Destroy!

Hope you have a great weekend.

(I am working at our store as my hubby had to go back east for his cousin's funeral. Ready for my pillow now ...)