Paclitaxel (Taxol^®) is an injectable chemotherapy drug that is used to treat several different types of cancer. It may be used as a single agent, or in combination with another anti-cancer drug. Paclitaxel (Taxol) is an antimicrotubule, an agent that acts inside of a cell to interfere with microtubules, these are structures needed for cellular reproduction. This interference leads to cell death. As cancer cells divide faster than normal cells, they are more likely to be affected by Paclitaxel (Taxol). Individual premedication prior to the administration of Paclitaxel (Taxol) is required.

The use of Paclitaxel (Taxol) may be considered medically necessary when used in the treatment of the following condition(s):

Bladder Cancer

• Chemotherapy in combination with cisplatin (doublet chemotherapy is preferred) for:
  • Individuals who are non-cystectomy candidates
    • As adjuvant treatment for reresected clinical stage T1 disease with residual disease; or
    • Following incomplete response to intravesical therapy for cytology and bladder-biopsy positive, imaging and cystoscopy-negative recurrent or persistent clinical stage Ta, Tis, or T1 disease; or
    • With clinical stage Ta or Tis disease or high-grade clinical T1 disease following resection of recurrence post intravesical therapy (no more than two consecutive cycles); or
    • With clinical stage T2-4a disease with negative nodes as primary treatment or as adjuvant treatment if tumor is present following reassessment in individuals with no prior radiation treatment; or
    • With clinical stage Ta, Tis, or T1 disease following no response to intravesical BCG used for local recurrence or persistent disease in a preserved bladder; or
  • As primary treatment for individuals with
    • Clinical stage T2-4a disease with negative nodes for bladder preservation; or
    • Clinical stage T4b disease; or
  • For individuals with no prior radiation treatment as any one of the following: 
    • Adjuvant treatment for clinical stage T4b disease with negative nodes following Reassessment; or
    • Muscle-invasive disease with local recurrence or persistent disease following bladder preservation; or
    • Metastatic or local recurrence post cystectomy; or 
    • Metastatic disease; or
  • As adjuvant treatment for
    • Clinical stage T1; or
    •  Incomplete response to intravesical therapy for bladder positive disease; or
    •  Clinical stage Tis or Ta following resection of recurrence post intravesical  treatment; or
• Radiosensitizing chemotherapy given concurrently with conventionally fractionated radiation for palliation of metastases for pelvic recurrence after cystectomy.
• For use with clinical stage T4b or T2-4a, N1-3 disease, or for recurrence post cystectomy, or metastatic disease as
  • First-line chemotherapy in combination with gemcitabine in cisplatin ineligible individuals as an alternate regimen; or
  • Subsequent systemic therapy as
    • A single agent; or
    • In combination with gemcitabine as an alternate regimen for select individuals.

Bladder Cancer - Primary Carcinoma of the Urethra

• Chemoradiotherapy, based on the appropriate histology, in combination with cisplatin (doublet chemotherapy is preferred) as:
  • Neoadjuvant treatment for clinical stage T2 disease prior to urethrectomy; or
  • As primary treatment for
    • Clinical stage T2 disease of the female urethra; or
    • Clinical stage T3-4 disease or palpable inguinal lymph nodes (preferred for CN0 disease); or
  • A adjuvant treatment for
    • Clinical stage T2 disease with positive margins in the pendulous urethra (preferred); or
    • For pathologic stage T3-4, N1-2 disease in the bulbar urethra; or
  • For recurrence of clinical stage T2  disease; clinical stage T3-4 disease; or palpable inguinal lymph nodes; or
  • For metastatic disease.
• For recurrent or metastatic disease as based on the appropriate histology as:
  • First line chemotherapy in combination with gemcitabine in cisplatin ineligible individuals as an alternate regimen; or
  • Subsequent systemic therapy as
    • A single agent; or
    • In combination with gemcitabine as alternate regimen for select individuals.

Bladder Cancer - Upper GU Tract Tumors                  

• May be considered for metastatic disease for:
  • First-line chemotherapy in combination with gemcitabine in cisplatin ineligible individuals as an alternate regimen; or
  • Subsequent systemic therapy as:
    • A single agent; or
    • In combination with gemcitabine as an alternate regimen for select individuals.

Bladder Cancer - Urothelial Carcinoma of the Prostate                                     

• May be considered for metastatic disease for: 
  • First-line chemotherapy in combination with gemcitabine in cisplatin ineligible individuals as an alternate regimen; or
  • Subsequent systemic therapy as:
    • A single agent; or
    • In combination with gemcitabine as an alternate regimen for select individuals.

Bladder Cancer - Non-Urothelial and Urothelial with Variant Histology

• For pure squamous, and pure adenocarcinoma, including urachal, paclitaxel (Taxol) may be considered in combination with cisplatin and ifosfamide in select individuals with advanced disease; or
• In combination with carboplatin or cisplatin in select individuals with advanced disease. 

Breast Cancer – Invasive

As per the Food and Drug Administration (FDA): Paclitaxel (Taxol) is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin containing chemotherapy combination.

Paclitaxel (Taxol) is indicated for the treatment of breast cancer after the failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

• Preoperative systemic therapy for individuals with stage IIA (T2,N0,M0), IIB (T2,N1,M0 or T3,N0,M0), or stage IIIA (T3, N1, M0) disease who desire breast preservation and fulfill criteria for breast-conserving surgery except for tumor size or for locally advanced disease [stage IIIA (any T,N2,M0), IIIB, or IIIC] for:
  • Following dose-dense (doxorubicin and cyclophosphamide) (AC) as a component of a weekly or dose-dense regimen (preferred) for human epidermal growth factor receptor 2 (HER2)-negative tumors; or
  • Administered weekly following AC every 21 days regimen for HER2-negative tumors; or
  • In combination with trastuzumab with, or, without pertuzumab, following AC regimen (preferred regimen) for (HER2)-positive tumors; or  
  • In combination with trastuzumab and pertuzumab prior to or following fluorouracil, epirubicin, and cyclophosphamide (FEC) regimen for HER2-positive tumors.
• Adjuvant systemic therapy for stage I, IIA, IIB, or IIIA (T3, N1, M0) disease, or for locally advanced disease [stage IIIA (any T, N2, M0), IIIB, or IIIc]:
  • Following dose dense doxorubicin and cyclophosphamide (AC) as a component of a weekly or dose-dense regimen (preferred) for (HER2)-negative tumors; or
  • Administered weekly following AC regimen every 21 days regimen for HER2-negative tumors; or 
  • In combination with trastuzumab following AC regimen (preferred) for (HER2)-positive tumors; or
  • In combination with trastuzumab and pertuzumab following AC regimen (preferred regimen) or prior to or following FEC/(fluorouracil, epirubicin, and cyclophosphamide) regimen for HER2-positive, ≥T2 or ≥N1 early stage breast cancer if a pertuzumab-containing regimen was not used as neoadjuvant therapy.
  • In combination with trastuzumab for low risk stage I, HER2-positive tumors, especially for individuals not eligible for other standard adjuvant regimens due to comorbidities.
• Exceptions to the above include individuals with any of the following:
  • Ductal, lobular, mixed, and metaplastic HER-2 negative tumors that are ≤0.5 cm  or micro-invasive and node negative(pN0); or
  • Ductal, lobular, mixed, and metaplastic hormone receptor positive, HER2 negative tumors that are >0.5 cm with low recurrence score (<18) on gene assay; or
  • Tubular and mucinous tumors that are hormone receptor-positive and pN0 or pN1mi (≤2 mm axillary node metastasis.
  • Preferred single agent in combination with bevacizumab, or as a component of gemcitabine and paclitaxel (Taxol) (GT) regimen for recurrent or metastatic human epidermal growth factor receptor 2 (HER2)-negative disease with 
    • Symptomatic visceral disease or visceral crisis, or
    • Hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory.
  • Used for recurrent or metastatic human epidermal growth factor receptor 2-positive disease that is either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory for symptomatic visceral disease or visceral crisis:
  • As preferred first-line therapy in combination with pertuzumab and trastuzumab; or
  • In combination with trastuzumab with or without carboplatin, or

May be considered in combination with pertuzumab and trastuzumab for one line of therapy beyond first-line therapy in individuals previously treated with chemotherapy and trastuzumab in the absence of pertuzumab. 

Breast Cancer- during pregnancy

• Weekly paclitaxel (Taxol) can be used in pregnant women with confirmed breast cancer and no distant metastases if clinically indicated by disease status for:
  • Neoadjuvant chemotherapy in the second and early third trimesters; or
  • Adjuvant chemotherapy in the second and third trimesters if not used in the neoadjuvant setting.  

Cervical Cancer

• First-line therapy as a single agent, in combination with carboplatin, cisplatin or topotecan with or without bevacizumab for:
  • Local/regional recurrence; or
  • Distant metastases. 

Esophageal and Esophagogastric Junction Cancers

• Preoperative chemoradiation in combination with carboplatin as a preferred regimen, or with fluorouracil or capecitabine as primary treatment for individuals who are medically fit for surgery and have:
  • Non-cervical esophagus cT1b-T4a, N0-N+ squamous cell carcinoma; or
  • CT1b-T4a, N0-N+ adenocarcinoma (preferred option over preoperative chemotherapy,
• Definitive chemoradiation in combination with carboplatin as a preferred regimen, or with cisplatin, fluorouracil, or capecitabine for:
  • Primary treatment of individuals:
    • With cT1b-T4a, N0-N+ disease who are medically fit for surgery yet decline surgery (recommended option for cervical esophagus squamous cell carcinoma); or
    • With cT4b disease who are medically fit for surgery, or
    • Who are non-surgical candidates with cT1b-T4a, N0-N+or unresectable cT4b disease; or
  • After endoscopic resection with or without ablation for non-surgical candidates with pT1b N0 disease and poor prognostic features.
• Concurrent chemoradiation in combination with carboplatin as a preferred regimen, or with cisplatin, fluorouracil, or capecitabine for locoregional recurrence in individuals who have had esophagectomy but no prior chemoradiation.
• Palliative therapy for individuals with unresectable locally advanced recurrent, or metastatic disease and Karnofsky performance score ≥60% or ECOG performance score ≤2  as:
  • First-line therapy in combination with cisplatin or carboplatin, or as a single agent,\; or
  • Preferred second-line therapy as a single agent or for esophagogastric junction (EGJ) or esophageal adenocarcinoma in combination with ramucirumab.

Trastuzumab should be added to first-line chemotherapy for HER2 overexpressing metastatic adenocarcinoma.