A
drug developed by Aventis Pharmaceuticals (formerly Rh?ne-Poulenc
Rorer Pharmaceuticals Inc. and Hoechst Marion Roussel, Inc.) for the
treatment of certain types of cancer,
Taxotere is
now approved in 90 countries to treat advanced breast cancer and
70 countries to treat patients with advanced non-small-cell lung
cancer.
BREAST CANCER
Taxotere is
the first anticancer agent to show a significantly higher response
rate than Adriamycin? (doxorubicin), a very active agent and widely
used chemotherapy in the first-line treatment of
metastatic breast cancer. Taxotere also is the first chemotherapy
drug as a single agent to demonstrate increased survival among patients
with advanced breast cancer compared to the combination of mitomycin
C and vinblastine, a commonly used regimen in this patient population.
Taxotere as
a single agent was compared to mitomycin C in combination with vinblastine
and showed a one-year survival rate of 49 percent among breast cancer
patients, compared to 33 percent for those treated with the combination
therapy. Fifty percent more patients treated with Taxotere were
alive one year after therapy, compared to those treated with the
combination. Median time to progression and time to treatment failure
were significantly longer for
Taxotere. The overall response rate among patients treated with
Taxotere was 28 percent vs. the combination¨s 9.5 percent.
Taxotere has
been studied extensively in more than 200 clinical trials involving
more than 85,000 patients worldwide. Approximately 10,000 breast
cancer patients worldwide have been treated with Taxotere.
In one randomized
Phase III multi-center study, Taxotere showed a 50 percent better
overall response rate compared to patients treated with Adriamycin
(45 percent for Taxotere vs. 30 percent for Adriamycin). The overall
response ate is the partial response rate (50 percent of greater
reduction in
measurable tumor size) plus the complete response rate (complete
disappearance of all clinical and radiological signs of cancer).
Median time to progression, time to treatment failure, and survival
were comparable for both agents.
Patients in
both Phase III trials were a poor prognostic group. In the study
of Taxotere versus doxorubicin, three-quarters of all patients had
disease that had spread to other internal organs, almost half had
three or more organs showing evidence of disease and approximately
half had received prior chemotherapy for metastatic disease. In
the trial of Taxotere versus mitomycin C plus vinblastine, approximately
half the patients had liver metastases, three-quarters had disease
that had spread to other internal organs, and about one-third had
received chemotherapy in both the adjuvant and metastatic setting.
LUNG CANCER
- Non-Small-Cell Lung Cancer
Taxotere is
the first chemotherapy agent shown to significantly improve survival
for patients after failure of prior platinum-based chemotherapy.
It is the first chemotherapy agent to be approved by the U.S. Food
and Drug Administration for the second-line treatment of advanced
NSCLC.
In a Phase III
clinical study involving NSCLC patients whose disease had progressed
on prior platinum-based chemotherapy, patients treated with Taxotere
75 mg/m2 plus best supportive care had a significantly higher one-year
survival rate (37 percent) compared to patients who received best
supportive care alone (12 percent).
In another study,
NSCLC patients who had undergone prior platinum-based chemotherapy
had a higher one-year survival rate when treated with Taxotere than
with either Navelbine? (vinorelbine) or Ifex? (ifosfamide), two
other chemotherapy agents. Of the patients treated with 75 mg/m2
of Taxotere, 30 percent were alive at one year, as compared to 20
percent of those treated with vinorelbine or ifosfamide.
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