Docetaxel

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Contents

Overview

Docetaxel is marketed by Sanofi Aventis under the trade mark name of Taxotere®

Taxotere® is indicated solely or in combination with another anticancer drug, according to the case, for the treatment of breast cancer in both the early stages (adjuvant treatment) and in the metastatic phase, as well as in the HER2/neu positive forms for which prognosis is very poor. Taxotere® is also indicated for the treatment of stage IV non-small cell lung cancer and for metastatic hormone-refractory prostate cancer.

Taxotere® (docetaxel) is a drug in the taxoid class, which inhibits cancer cell division by essentially “freezing” the cell’s internal skeleton, comprised of microtubules which assemble and disassemble during a cell cycle. Taxotere® promotes assembly and blocks disassembly, thereby preventing cancer cells from dividing and resulting in their death.

Taxotere® was first approved in 1995 and is currently marketed in over 100 countries in eight indications for four major forms of cancer positive forms.

In March 2006, Taxotere® received approval in the U.S. and Europe for the treatment of patients with metastatic gastric cancer. The clinical development of Taxotere® continues, including diseases for which Taxotere® is already licensed, to give patients the benefit of Taxotere®’s efficacy at every stage of disease.


For a relatively comprehensive overview of Taxotere Click Here

Details

1. Prostate cancer (hormone-refractory) - docetaxel

Docetaxel for the treatment of hormone refractory prostate cancer

Guidance type: Technology appraisal

Date issued: June 2006

We will consult on our review plans for this guidance in June 2009.

Summary

Docetaxel is recommended as a possible treatment for men with hormone-refractory metastatic prostate cancer.

  • It should be given only if the man is well enough to care for himself with occasional assistance.
  • Treatment should be stopped at the end of a planned course of up to 10 cycles (or 'rounds') of docetaxel.
  • The treatment should be stopped early if the man experiences serious side effects, or if the disease is getting worse.

N.I.C.E. does not recommend using docetaxel again if the disease comes back after the first course of treatment has finished.

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2. Prostate Cancer and Taxotere®

Androgen-Independent (Hormone-Refractory) Metastatic Prostate Cancer

Taxotere(docetaxel) Injection Concentrate in combination with prednisone is indicated for the treatment of androgen-independent (hormone-refractory) metastatic prostate cancer (AIPC). This regimen is the only treatment regimen proven to significantly prolong survival in patients with AIPC.1

In a pivotal trial comparing Taxotere® + prednisone vs. mitoxantrone + prednisone, completed in January 2006, Taxotere® + prednisone demonstrated the following benefits:

Proven prolonged survival: The Taxotere® q 3 weeks + prednisone group showed significantly longer median survival vs. mitoxantrone + prednisone (18.9 months vs. 16.5 months, respectively; P=.0094) TAX3272 Reduced risk of mortality: The Taxotere® q 3 weeks + prednisone group also showed a 24% reduced risk of mortality. High number of patients completing planned course of therapy: In the Taxotere® q 3 weeks + prednisone group, a median of 9.5 cycles out of 10 cycles were completed.

Taxotere® q 3 weeks + prednisone also was well tolerated in the elderly.1-3 Learn more about the pivotal trial demonstrating the benefits of Taxotere® in the treatment of prostate cancer.

Also, access Taxotere® dosing adjustment guidelines for prostate cancer patients, useful resources for you in your practice, and educational materials for your patients.


Taxotere is currently available on the PBS for breast cancer, ovarian cancer and non-small cell lung cancer. It has also been added in the PBS in Australia for Prostate Cancer


Articles

Ad Hoc News (KC) 15-Apr-08

MedPage (PC) 26-Feb-07

Cancer Research (PC) 15-Jul-05

References

Taxotere® Prescribing Information. Bridgewater, NJ: Sanofi Aventis U.S. LLC; Rev December 2006.

Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.

Data on file, sanofi-aventis. Clinical study report: a multicenter phase III randomized trial comparing Taxotere® administered either weekly or every three weeks in combination with prednisone versus mitoxantrone in combination with prednisone for metastatic hormone-refractory prostate cancer. Study number RP56976-V-327. 2004.

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