Pattz, temodar question

[Kristin]

Are you in a clinical trial to rec. temodar or can it be prescribed now for bc patients. Your response is such great news for you and others also faced with mets to the brain. I wonder how it would work for spinal mets, from the spinal fluid?

Kristen,
No, I'm not in a clinical trial. Yes, Temodar is approved for brain mets from bc.

"Spinal mets" if bone is not the same as "spinal fluid" nor the same as "spinal cord" which is the leptomeninges. And I just don't know the answer to your question. I'm sorry about that...

I have a great overworked onc who is receptive to the info I bring him, because he has taken the time to 'know' me and listen. He won't try anything just off the cuff, but relies on his experience AND the good quality info I show him. Thus, he came up with this particular Temodar/Xeloda schedule for me as an individual.

AFTER I had begun my first round, I found (and showed him) the small study reported last year at San Antonio using these two chemos for bc brain mets with good results. It was a different 'schedule'/ dosage and days, but we haven't changed what he created for me.

Thank you for your kind support!

pattyz

[Annemarie]

Hi,
I go to my oncologist on Monday and would like to present him any information about this combo. I have had brain mets 3 times. I was on Temodar and went off but will go back on next month. Do you have a link of that study? Any help would be great! And side effects from Xeloda?

Annemarie,

Did you see/keep that post I did on other chemos for brain mets? It was maybe a month ago. It was actually surprizing/hope giving to me, considering all the bbb talk etc.

No link, but have info saved on T/X combo, so will include here. Don't know if you've 'made note' of what my onc has me scheduled for, so will repeat in case you want that, too.

I am 5'4 1/2", weigh 115-118. Take 250mg Temodar for 7days once at night. Simultaneously take 2000mg Xeloda for 14 days, divided into two doses, 1000mg ea. Then two weeks off, not just one week.

4mg of Zofran is sufficiant to keep the nausea away from the Temodar. Or else! But, complicates my constipation from my MS Contin.

A very small 'meal' is enough to deal with any Xeloda sides. ( ie. 4oz fruit cup in a.m.)

I have pechecia (sp?) after the first 6? days from lowered counts, but by the end of 2nd week of chemo, they are gone. Counts good by next round. I can't honestly say that I have noticed any other side effects at these doses/timing. Yes, I have up and down days energy wise, etc, but doesn't everyone?? hugs, patty

Ok, here's the info for you (dated LAST year ):

SABCS ABSTRACT:
[San Antonio Breast Cancer Symposium]
[1079] Phase I study of capecitabine (C) 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
(C/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

Poster Session: Treatment: Chemotherapy -- New Drugs and Formulations (4:30 PM-7:00 PM)

Annemarie... oops.

I guess I should also have told you: I do take B-6 100mg twice a day, plus lotion and sock my feet every night. Hand lotion much throughout the day. Precautions.

pattyz

[Annemarie]

Does this combo make your skin dry? Also does the Xeloda cause you to lose your hair? How are you tolerating it? I remember a few years ago while on Temodar with Zofran I would still get sick. What do you take with it? Thanks.

Annemarie,
Yes, my skin is dryer on Xeloda. But managable. Was not noticably so when I was on Temodar alone.

No hair loss. YEA.

I was prescribed Zofran @ 8mg to take 30 mins before the Temodar. Because of the severe constipation, I risked cutting back to 4mg...without any negative results. I don't eat anything for two hrs before taking the Temodar. I have no problems, except the continued severe constipation the week I am on the Temodar/Zofran.

Physically, I am tolerating this regime quite well.

This can be directly related to my dosages I imagine. Anything else??

[Annemarie]

Hi,
Do you also take Herceptin? If so where in the regime? Are you NED? If so how long? I have been NED in everything EXCEPT brain mets in 5.5 years. Thanks,
Annemarie

No, I am not on Herceptin now. I opted to stop ALL tx when I became NED in body after two+ months on Herceptin/Navelbine. That was late fall of '02.

Since I had concurrant dx with brain mets and my other mets where limited to mediastinal node/s, 'spot on lung and pelvis', I was choosing QOL for the 'short term'. However, I have continued to have clear scans and tm's, except for brain.

Here is my history in a 'nutshell':

12-1999: Age 50, Dx'd Invasive Ductal & Inflammatory. Two tumors, upper and lower inside quadrants R/breast.

1-2000: Mast., 6/26 pos. nodes. ER+PR-, Heu2+++ StageIIIb - 4rnds A/C, no rads (my choice & no medical ins.)

7-2002: Dx'd mediastinal node/s mets, (surgical biopsy), 'spot' on lung and pelvis. Arimidex briefly.

9-2002: Dx'd brain mets. (mininally symptomatic) Two lesions, 1.5cm, 6mm. SRS focalized tx successful. Refused WBR.

11-2002: Navelbine/Herceptin 4rnds for systemic mets, scans show NED.

3-2003: Progression of brain mets. 14 new lesions visable. Asymptomatic. Continue to refuse WBR. "Watch and wait " approach. Treat in small batches with two more SRS, two CyberKnife procedures through 5-2004. NED in body.

3-2005: Progression brain mets - maybe 10 new lesions, asymptomatic. (otherwise NED) Again 'watch and wait' approach until...

8-2005: Dizzy 24/7 in the course of just one day. Begin Temodar/Xeloda.

9-28-2005: Following 2 rnds, MRi shows response of nearly 50% shrinkage in many brain mets, including brainstem/pons. Dizziness gone.

11-28-2005: MRi 'carbon copy' of previous, still responding. Continue Temodar/Xeloda.