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Celina, I will repaste all that I know/have here for you. Yesterday, I emailed MD Anderson with a request for a bit more information. With this holiday weekend, I think it will take more than the '48' hrs they say to respond.
This was a very small study, only phase I. If I get more info by email, I will poste to you under a new topic heading. ok?
Yes, both drugs are approved. There are a few other studies being done combining Temodar with chemo agents besides Xeloda, but are none specific for bc brain mets.
Dana Farber: A second patient with NSCLC and brain metastases who progressed after treatment with chemotherapy and WBRT was treated with temozolomide (150 mg/m(2) for 5 days in a 28-day cycle) and gemcitabine (1,000 mg/m(2) weekly for 2 weeks in a 3- week cycle). In both patients, the temozolomide regimens were extremely well tolerated and resulted in dramatic and durable responses. The combination of temozolomide with other chemotherapeutic agents represents a promising strategy for treating patients with lung cancer and recurrent brain metastases and merits further study.
and Memorial Sloan for example: The phase I part of this study will look at increasing doses of vinorelbine in combination with a fixed dose of temozolomide to determine the safest dose combination of these two drugs. Temozolomide is given orally (a pill taken by mouth), while vinorelbine is given intravenously (by vein). The phase II part of this study will determine if this drug combination is effective for treating brain metastases, as determined by tumor shrinkage on MRI and CT scans and improvement in symptoms.
hugs, patty xoxoxox
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
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