Paclitaxel (Taxol‚, Bristol-Myers Squibb, Princeton, NJ) was approved by the U.S. Food and Drug Administration (FDA) in December 1992 for use in patients with metastatic ovarian carcinoma that failed first-line or subsequent chemotherapy.

First-line ovarian carcinoma chemotherapy typically consists of a combination including cisplatin (e.g., cisplatin and cyclophosphamide), although specific agents are not specified in the FDA-approved label.

In April 1993, the FDA approved use of paclitaxel in patients with metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. The FDA labeling indicated that prior therapy should have included an anthracycline (e.g., doxorubicin), unless clinically contraindicated.

The FDA-approved label states that paclitaxel (Taxol‚) is contraindicated in patients who have a history of hypersensitivity reaction to paclitaxel or other drugs formulated in Cremophor‚ EL (polyoxyethylated castor oil). Paclitaxel should not be used in patients with a baseline neutropenia of less than1,500 cells/mm3.

Paclitaxel (Taxol‚) is medically necessary when used for its labeled indications.

Paclitaxel (Taxol‚) as first-line treatment of breast cancer or for patients with metastatic disease who are still able to undergo treatment with doxorubicin is considered investigational.

Paclitaxel (Taxol‚) is also considered investigational in the treatment of the following:

• brain cancer;
• cervical cancer;
• colon cancer;
• head and neck cancer;
• lymphoma;
• melanoma;
• non-small-cell lung cancer;
• pancreatic cancer;
• prostate cancer;
• renal cell carcinoma;
• small-cell lung cancer;
• stomach cancer.

Paclitaxel may be considered medically necessary as second-line therapy for patients with Stage IV metastatic breast cancer in whom doxorubicin therapy is contraindicated.

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Plans will need to monitor the FDA-labeled indications for changes.

ICD-9-CM codes 196.0–198.89 are applicable for the metastatic ovarian and breast carcinomas. Codes 174.0–174.9 and 175.0–175.9 and 183.0 identify primary malignant neoplasm sites.

A search of literature was completed through the MEDLINE database for the period of January 1993 through January 1995. The search strategy focused on references containing the following Medical Subject Headings:

- Paclitaxel
 
- Therapeutic Use

Research was limited to English-language journals on humans.

See also:

TEC Evaluations 1993: Tab 9

Chemotherapy, Taxol‚
Paclitaxel (Taxol‚) Chemotherapy
Taxol‚ (Paclitaxel) Chemotherapy