Paclitaxel (Taxol)

General information

Class/mechanism: Taxane, promotes assembly of microtubules, stablizes microtubules, preventing depolymerization. Paclitaxel interferes with the normal dynamic reorganization of microtubules that is necessary for regular interphase/mitosis processes. It also leads to creation of abnormal bundles of microtubules. Paclitaxel is highly lipophilic/insoluble in water and needs to be dissolved in Cremophor EL (polyoxyethylated castor oil), which may cause hypersensitivity infusion reactions.
Route: IV
Extravasation: irritant (usually), vesicant (rare)

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, or the prescribing information.

Diseases for which it is established (work in progress)

• Breast cancer
• Kaposi sarcoma
• Non-small cell lung cancer
  • Non-small cell lung cancer, nonsquamous
  • Non-small cell lung cancer, squamous
• Ovarian cancer
  • Low-grade serous ovarian cancer

Diseases for which it is used

• Anal cancer
• Angiosarcoma
• Carcinoma of unknown primary
• Cervical cancer
• Cutaneous basal cell carcinoma
• Diffuse large B-cell lymphoma
• Endometrial cancer
• Esophageal cancer
  • Esophageal adenocarcinoma
  • Esophageal squamous cell carcinoma
• Gastric cancer
• Head and neck cancer
• Melanoma
• Nasopharyngeal carcinoma
• Penile cancer
• Prostate cancer
• Small cell lung cancer
• Testicular cancer
• Thymoma
• Urothelial carcinoma
  • Bladder cancer
• Vulvar cancer

Patient drug information

• Paclitaxel (Taxol) package insert
• Paclitaxel (Taxol) patient drug information (Chemocare)
• Paclitaxel (Taxol) patient drug information (UpToDate)

History of changes in FDA indication

Breast cancer

• 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer after failure of combination therapy for metastatic disease. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
• 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the treatment of breast cancer relapsed within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. (Based on Nabholtz et al. 1996)
• 1999-10-25: New indication for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. (Based on INT 0148/CALGB 9344)

Ovarian cancer

• 1992-12-29: Initial FDA approval for treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent chemotherapy. (Based on Eisenhauer et al. 1994)
• 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for first-line therapy in combination with cisplatin for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)
• 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for subsequent therapy for the treatment of advanced carcinoma of the ovary. (Based on GOG 111 & OV10)

Kaposi sarcoma

• 1998-04-09 (oldest label available at Drugs @ FDA): Indicated for the second-line treatment of AIDS-related Kaposi's sarcoma. (Based on CA139-174 & CA139-281)

Non-small cell lung cancer

• 1998-06-30: New indication added: in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy. (Based on ECOG E5592)

History of changes in EMA indication

• 1992-12-29: EURD

History of changes in PMDA indication

• 2005-05-31: New indication for the treatment of cancer of the uterus body.
• 2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic head and neck cancer.
• 2012-03-21: New additional indications and new dosages for the treatment of relapsed or metastatic esophagus cancer.
• 2012-03-21: New additional indications and new dosages for the treatment of angiosarcoma.
• 2012-03-21: New additional indications and new dosages for the treatment of advanced or relapsed cervical cancer.
• 2013-02-21: New additional indications and a new dosage for the treatment of relapsed or refractory germ cell tumors (testicular tumors, ovarian tumors, extragonadal tumors).

Also known as

• Brand names:

Synonyms
Abitaxel	Altaxel	Anzatax	Anzatec	Apealea	Asotax	Betaxel	Bristaxol
Britaxol	Clitaxel	Cytax	Daburex	Dalys	Drifen	Ebetaxel	Formoxol
Genexol	Genetaxyl	Gros	Ifaxol	Intaxel	Magytax	Medixel	Mitotax
Neotacs	Neotaxan	Neotaxl	Ofoxel	Oncotaxel	Onxol	Paclitax	Paclitaxin
Pacliteva	Pacxel	Padexol	Paklitaxfil	Panataxel	Parexel	Paxene	Paxenor
Paxus	Pazenir	Petaxel	Phyxol	Poltaxel	Praxel	Ribotax	Sindaxel
Taclipaxol	Tarvexol	Taxocris	Taxodiol	Taxol	Taxomedac	Taycovit	Unitaxel
Yewtaxan	Naveruclif