Difference between revisions of "Docetaxel (Taxotere)"

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==History of changes in FDA indication==
 
==History of changes in FDA indication==
 +
===[[Breast cancer]]===
 
*5/14/1996: Initial FDA approval for treatment of patients with locally advanced or metastatic [[Breast cancer | breast cancer]] who have progressed during [[:Category:Anthracyclines|anthracycline-based]] therapy or have relapsed during [[:Category:Anthracyclines|anthracycline-based]] adjuvant therapy.
 
*5/14/1996: Initial FDA approval for treatment of patients with locally advanced or metastatic [[Breast cancer | breast cancer]] who have progressed during [[:Category:Anthracyclines|anthracycline-based]] therapy or have relapsed during [[:Category:Anthracyclines|anthracycline-based]] adjuvant therapy.
*6/22/1998: Breast cancer indication revised for the treatment of patients with locally advanced or metastatic [[Breast cancer | breast cancer]] after failure of prior chemotherapy.
+
*6/22/1998: Indication revised for the treatment of patients with locally advanced or metastatic [[Breast cancer | breast cancer]] after failure of prior chemotherapy. (''no longer limited to prior anthracycline-based chemotherapy exposure'')
 +
*8/18/2004: Breast cancer indication expanded: in combination with [[Doxorubicin (Adriamycin) | doxorubicin]] and [[Cyclophosphamide (Cytoxan) | cyclophosphamide]] is indicated for the adjuvant treatment of patients with operable node-positive [[Breast cancer | breast cancer]]. (''no longer limited to the relapsed or metastatic setting'')
 +
===[[Non-small cell lung cancer]]===
 
*12/23/1999: Label expanded to include treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] after failure of prior [[:Category:Platinum_agents | platinum-based]] chemotherapy.
 
*12/23/1999: Label expanded to include treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] after failure of prior [[:Category:Platinum_agents | platinum-based]] chemotherapy.
*11/27/2002: Lung cancer indication revised:
+
*11/27/2002: Label expanded: In combination with [[Cisplatin (Platinol) | cisplatin]] is indicated for the treatment of patients with unresectable, locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] who have not previously received chemotherapy for this condition. (''no longer limited to prior chemotherapy exposure'')
** As a single agent, is indicated for the treatment of patients with locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] after failure of prior [[:Category:Platinum_agents | platinum-based]] chemotherapy.
+
===[[Prostate cancer]]===
** In combination with [[Cisplatin (Platinol) | cisplatin]] is indicated for the treatment of patients with unresectable, locally advanced or metastatic [[Non-small cell lung cancer | non-small cell lung cancer]] who have not previously received chemotherapy for this condition.
 
 
*5/19/2004: Label expanded as follows: in combination with [[Prednisone (Sterapred) | prednisone]] is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic [[Prostate cancer | prostate cancer]].
 
*5/19/2004: Label expanded as follows: in combination with [[Prednisone (Sterapred) | prednisone]] is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic [[Prostate cancer | prostate cancer]].
*8/18/2004: Breast cancer indication expanded: in combination with [[Doxorubicin (Adriamycin) | doxorubicin]] and [[Cyclophosphamide (Cytoxan) | cyclophosphamide]] is indicated for the adjuvant treatment of patients with operable node-positive [[Breast cancer | breast cancer]].
+
===[[Gastric cancer]]===
 
*3/22/2006: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the treatment of patients with advanced [[Gastric cancer | gastric adenocarcinoma]], including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.  
 
*3/22/2006: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the treatment of patients with advanced [[Gastric cancer | gastric adenocarcinoma]], including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.  
 +
===[[Head and neck cancer]]===
 
*10/17/2006: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the induction treatment of patients with inoperable locally advanced [[Head and neck cancer | squamous cell carcinoma of the head and neck (SCCHN)]].
 
*10/17/2006: Label expanded as follows: in combination with [[Cisplatin (Platinol) | cisplatin]] and [[Fluorouracil (5-FU) | fluorouracil]] is indicated for the induction treatment of patients with inoperable locally advanced [[Head and neck cancer | squamous cell carcinoma of the head and neck (SCCHN)]].
  

Revision as of 14:41, 23 July 2018

General information

Class/mechanism: Taxane; disrupts normal microtubular function. Binds to free tubulin, promotes their assembly into stable microtubules, and inhibits their disassembly, which inhibits mitosis.[1][2]
Route: IV
Extravasation: irritant, rare vesicant

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Breast cancer

  • 5/14/1996: Initial FDA approval for treatment of patients with locally advanced or metastatic breast cancer who have progressed during anthracycline-based therapy or have relapsed during anthracycline-based adjuvant therapy.
  • 6/22/1998: Indication revised for the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy. (no longer limited to prior anthracycline-based chemotherapy exposure)
  • 8/18/2004: Breast cancer indication expanded: in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with operable node-positive breast cancer. (no longer limited to the relapsed or metastatic setting)

Non-small cell lung cancer

  • 12/23/1999: Label expanded to include treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy.
  • 11/27/2002: Label expanded: In combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer who have not previously received chemotherapy for this condition. (no longer limited to prior chemotherapy exposure)

Prostate cancer

  • 5/19/2004: Label expanded as follows: in combination with prednisone is indicated for the treatment of patients with androgen independent (hormone refractory) metastatic prostate cancer.

Gastric cancer

  • 3/22/2006: Label expanded as follows: in combination with cisplatin and fluorouracil is indicated for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease.

Head and neck cancer

Also known as

  • Code names: NSC 628503, RP 56976
  • Brand names: Asodocel, Daxotel, Docefrez, Docegem, Doceglob, Docemax, Docenat, Docepar, Docetax, Docetec, Docetere, DoceXan, Docshil, Dolectran, Doxel, Doxetal, Hentaxel, Neocel, Oncodocel, Plustaxano, Sibatere, Taceedo, Taxe-RTU, Taxewell, Taxotere, Texot, Trixotene, Uvtere

References