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.

Gastric Cancer

• Preoperative chemoradiation in combination with carboplatin as a preferred regimen or with capecitabine or fluorouracil for resectable locoregional disease (cT2 or higher by clinical staging, any N) in medically fit individuals; or
• Primary treatment as chemoradiation in combination with carboplatin as preferred regimen or with capecitabine or fluorouracil for:
  • Surgically unresectable locoregional disease; or
  • Locoregional disease in non-surgical candidates
• First-line chemotherapy with the addition of trastuzumab for HER2 overexpressing metastatic adenocarcinoma; or
• Palliative therapy for individuals who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease and Karnofsky performance score > 60% to ECOG performance score of < 2 as:
  •  First-line therapy in combination with cisplatin or carboplatin, or as a single agent; or
  • Second-line therapy as a single agent or in combination with ramucirumab (both preferred regimens). 

Head and Neck Cancers - Cancer of the Glottic Larynx

• For induction chemotherapy in combination with cisplatin and  infusional fluorouracil for:
  • For T3, N0-3 disease requiring (amenable to) total laryngectomy; or
  • Consider for selected T4a individuals who decline surgery; or
  • For T3, N2-3 and selected T4a, or T3, N0-1 disease.
• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:
  • For T3, N0-3 disease requiring (amenable to) total laryngectomy; or
  • Consider for selected T4a individuals who decline surgery. 

Head and Neck Cancers - Cancer of the Hypopharynx

• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:
  • T1, N+; or
  • T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy; or
  • T4a, any N disease.
• Induction chemotherapy in combination with cisplatin and infusional fluorouracil for:
  • T1, N+; or
  • T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy; or
  • T4a, any N disease.

Head and Neck Cancers - Cancer of the Lip  

• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for individuals with T3-4a, N0 or for individuals with any T, N1-3 disease who are candidates for but do not receive surgery.

Head and Neck Cancers - Cancer of the Nasopharynx 

• Induction chemotherapy in combination with cisplatin and epirubicin for:
  • T1, N1-3 disease; or
  • T2-4, any N disease.
• Primary therapy in combination with cisplatin or carboplatin for any T, any N, M1 disease.

Head and Neck Cancers - Cancer of the Oropharynx 

• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:
  • T2, N1 disease; or
  • T3-4a, N0-1 disease; or
  • any T, N2-3 disease.
• Induction chemotherapy in combination with cisplatin and  infusional fluorouracil for:
  • T3-4a, N0-1 disease; or
  • any T, N2-3 disease.

Head and Neck Cancers - Cancer of the Supraglottic Larynx  

• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:
  • T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy; or
  • T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery; or
  • Consider for T4a, N0-3 individuals who decline surgery.

• Induction chemotherapy in combination with cisplatin and infusional fluorouracil for: 
  • T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy; or 
  • T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery; or
  • T4a, N0-3 individuals who decline surgery.

Head and Neck Cancers - Ethmoid Sinus Tumors

• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:
  • Newly diagnosed T3-4b disease; or
  • Individuals who decline surgery; or
  • Cancer diagnosed after incomplete excision with gross residual disease. 

Head and Neck Cancers - Maxillary Sinus Tumors 

• Consider preoperative concurrent chemoradiation in combination with cisplatin or carboplatin in select individuals with T3-4a, N0; or
• Primary concurrent chemoradiation in combination with cisplatin or carboplatin for T4b, any N.

Head and Neck Cancers - Occult Primary                               

• Initial definitive treatment for:
  • Concurrent chemoradiation for ≥N2 disease in combination with cisplatin or carboplatin; or
  • Induction chemotherapy in combination with cisplatin and fluorouracil. 

Head and Neck Cancers - Advanced, Recurrent, Persistent             

• Primary concurrent chemoradiation for non-nasopharyngeal cancer in combination with cisplatin or carboplatin for individuals:
  • Newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases,  for those who are unfit for surgery; or
  • Unresectable locoregional recurrence without prior radiation therapy (RT) and performance status (PS) 0-2; or
  • Metastatic (M1) disease at initial presentation or recurrent/persistent disease with distant metastases and PS 0-1; or
  • Resectable locoregional recurrence without prior RT; or
  • Unresectable locoregional recurrence or second primary with prior RT.
• Induction chemotherapy for non-nasopharyngeal cancer in combination with cisplatin and fluorouracil in individuals with performance status 0-1 for:
  • Newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, or individuals unfit for surgery; or
  • Unresectable locoregional recurrence in individuals who have not received prior radiation therapy.
• Induction chemotherapy for nasopharyngeal cancer in combination with cisplatin and epirubicin in individuals:
  • With performance status 0-1 for newly diagnosed T4b, and N, Mo disease, unresectable nodal disease with no metastases, or  who are unfit for surgery.
• Therapy as:
  • A single agent for individuals with newly diagnosed T4b, any N, M0 disease, unresectable nodal disease with no metastases, or individuals unfit for surgery and performance status (PS) 3; or
  • A single agent in PS 0-2 individuals or in combination (PS 0-1) with cisplatin or carboplatin with (non-nasopharyngeal cancer) or without cetuximab for metastatic (M1) disease at initial presentation, recurrent/persistent disease with distant metastases, or unresectable locoregional recurrence or second primary with prior RT; or

A single agent for non-nasopharyngeal cancer with unresectable locoregional recurrence without prior RT and PS 3.

Kaposi sarcoma – AIDS related

• Paclitaxel (Taxol) is indicated for the second-line treatment of AIDS-related Kaposi’s sarcoma. 

Kidney Cancer

• May be used for relapse or stage IV disease in combination with carboplatin for collecting duct or medullary subtypes. 

Melanoma

• As a single agent, or in combination with carboplatin, in cytotoxic therapy for metastatic or unresectable disease as second-line, or subsequent therapy for disease progression, after maximum clinical benefit from BRAF (the gene for B-type Raf kinase) targeted therapy for individuals with performance status 0-2. 

Non-Small Cell Lung Cancer (NSCLC)

• Indicated for first-line treatment in combination with cisplatin for individuals who are not candidates for potentially curative surgery and/or radiation therapy.
• Preoperative concurrent chemoradiation in combination with carboplatin for individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Resectable or possibly resectable superior sulcus tumors (T3 invasion or T4 extension, N01); or
  • T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum.
• In combination with carboplatin for individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Use as induction chemotherapy for:
    • Operable stage IB (peripheral T2a, N0); or
    •  Stage I (central T1ab-2a, N0); or
    •  Stage II (T1ab-2ab, N1 or T2b, N0); or
    •  Stage IIB (T3, N0); or
    •  Stage IIIA (T3, N1) with negative mediastinal nodes as an alternative for    likely to receive adjuvant chemotherapy, or
  • Neoadjuvant chemotherapy for :
    • T3 invasion;  or
    • Resectable T4 extension; or
    • N0-1 disease in the chest wall, proximal airway, or mediastinum, or
  • Induction chemotherapy
    • With or without radiation for T1-2 or T3 (other than invasive), N2, M0, or
    • For T1-3, N0-1 (including T3 with multiple nodules in the same lobe) as an alternative for individuals likely to receive adjuvant chemotherapy.
• Initial treatment as definitive concurrent chemoradiation in combination with carboplatin (with or without an additional two cycles of paclitaxel (Taxol) and carboplatin after concurrent chemoradiation) for individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Medically inoperable stage IB (peripheral T2a, N0), or
  • Stage I (central T1ab-2a, N0); or
  • Stage II (T1ab-2ab, N1 or T2b, N0); or
  • Stage IIB (T3, N0); or
  • Stage IIIA (T3,N1) with negative mediastinal nodes and N1 disease; or
  • Unresectable superior sulcus tumors (T4 extension, N0-1); or
  • Unresectable stage IIIA (T4, N0-1); or
  • T1-2 or T3 (other than invasive), N2 nodes positive, M0; or
  • T3 invasion, N2 nodes positive, M0; or
  • Stage IIIB (T1-3, N3 positive, M0); or
  • Contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3) or
  • Stage IV, M1b disease and limited non-brain metastases confirmed, if definitive therapy for thoracic disease is feasible.
• Adjuvant chemotherapy in combination with carboplatin for individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Consider following definitive radiation therapy in medically inoperable high-risk stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or stage IIB (T3, N0) or stage IIIA (T3,N1) with negative mediastinal nodes and N0 disease; or
  • For high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0); or
  • For margin-positive stage IB (T2a, N0) and IIA (T2b, N0); or
  • For margin-positive stage IIA (T2b, N0) following radiation; or
  • For stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or
  • For margin-negative stage IIIA (T1-3, N2; T3, N1); or
  • For resectable superior sulcus tumors (T3 invasion, T4 extension, N0-1) , or
  • For T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment; or
  • For clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3nodes on mediastinal biopsy and negative margins post-surgery; or
  • For clinical stage IIIA disease (T1-2, T3 other than invasive, N2 nodes positive, M0) with no apparent progression or local progression; or
  • For separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N0-1; or  
  • For margin-negative or margin-positive, R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2.
• Adjuvant concurrent chemoradiation in combination with carboplatin with or without an additional 2 cycles of paclitaxel (Taxol) and carboplatin after concurrent chemoradiation)for:
  • Margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or
  • Margin-positive stage IIIA (T1-3, N2; T3, N1); or
  • Margin-positive T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment; or
  • Clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on mediastinal biopsy and positive margins post-surgery; or
  • Margin-positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2.
• Sequential chemoradiation in combination with carboplatin for:
  • Initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), or
    • Stage I (central T1ab-2a, N0); or
    • Stage II (T1ab-2ab, N1 or T2b, N0); or
    • Stage IIB (T3, N0) with negative mediastinal nodes and N1 disease; or
    • Stage IIIA (T3, N1) with negative mediastinal nodes and N1 disease.
  • Adjuvant therapy for margin-positive
    • R1 stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or
    • R1 stage IIIA (T1-3, N2; T3, N1); or
    • R1 T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment;or
    • R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral non-primary lobe (T4), N2; or
  • Adjuvant therapy for margin-negative T1-3, N2; or
  • Adjuvant treatment for clinical stage IIIA disease (T1-3, including T3 with multiple nodules in the same lobe) that was clinically N2 but has negative N2, N3 nodes on  mediastinal biopsy and R1 positive margins post-surgery;or
  • Definitive therapy, if feasible, for thoracic disease in individuals with stage IV, M1b disease and limited non-brain metastases confirmed.
• Concurrent chemoradiation in combination with carboplatin (with or without an additional two cycles of palcitaxel and carboplatin after concurrent chemoradiation) if radiation not previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction.
• Treatment for recurrence or metastasis as a single agent for individuals with performance status (PS) 2, in combination with cisplatin for (PS) 0-1 or in combination with carboplatin for (PS) 0-2
  • Frst-line therapy for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS1, and programmed death ligand 1 (PD-L1) negative or unknown, or
  • Subsequent therapy for:
    • Sensitizing EGFR mutation-positive tumors and prior erlotinib, afatinib, gefitinib, or osimertinib therapy; or
    • ALK rearrangement-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
    • ROS1 rearrangement-positive tumors and prior crizotinib therapy; or
    • PD-L1 expression-positive (> 50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy.
• Treatment in combination with bevacizumab and carboplatin for recurrence or metastasis in individuals with performance status (PS) 0-1, tumors of nonsquamous cell histology, and no history of recent:
  • First-line therapy for EGFR, ALK, ROS1, and PD-L1 negative or unknown; or
  • Subsequent therapy for:
    • Sensitizing EGFR mutation-positive tumors and prior erlotinib, agatinib, gefitinib, or osimertinib therapy; or
    • ALK rearrangement-positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or
    • ROS1 rearrangement-positive tumors and prior crizotinib therapy; or
    • PD-L1 expression-positive (> 50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy. 

Occult Primary

• Chemoradiation in combination with carboplatin with or without etoposide in symptomatic individuals with performance status (PS) 1-2 or asymptomatic individuals with PS 0 and aggressive disease for localized disease or inguinal nodal involvement; or
• Used in combination with carboplatin with or without etoposide in symptomatic with performance status (PS) 1-2 or asymptomatic individuals with PS 0 and aggressive disease for:
  • Axillary involvement in men if clinically indicated; or
  • Lung nodules or breast marker-negative pleural effusion; or
  • Resectable liver disease; or
  • Peritoneal mass or ascites with nonovarian histology; or
  • Retroperitoneal mass of non-germ cell histology in selected individuals; or
  • Unresectable liver disease or disseminated metastases.
• Used in combination with carboplatin or cisplatin in symptomatic individuals with performance status (PS) 1-2 or asymptomatic individuals with PS 0 and aggressive disease for:
  • Chemoradiation in individuals with axillary or inguinal nodal involvement; or
  • Chemotherapy in individuals with multiple lung nodules, pleural effusion, or disseminated metastases. 

Ovarian Cancer – Borderline and Low-Grade (Grade 1), Serous/Endometroid Epithelial Carcinoma

• As approved by the FDA, paclitaxel (Taxol) is indicated for use as subsequent therapy for the treatment of advanced carcinoma of the ovary, or in combination with cisplatin as first-line therapy.  
• As adjuvant treatment in combination with:
  • Carboplatin for pathologic stage IC-IV low grade disease or borderline epithelial tumors with invasive implants; or
  • Bevacizumab and carboplatin for pathological stage III-IV low grade disease or borderline epithelial tumors with invasive implants; or       
• Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel (Taxol) and IP cisplatin or carboplatin for less than 1 cm optimally debulked stage II and III low grade disease or borderline epithelial tumors with invasive implants. 

Ovarian Cancer –  Carcinosarcoma (Malignant Mixed)

• As adjuvant treatment:
  •  In combination with carboplatin with or without bevacizumab for pathologic stage I-IV disease; or
  • As (preferred) intraperitoneal (IP) chemotherapy in combination with IV paclitaxel (Taxol) and IP cisplatin or carboplatin for less than 1 cm optimally debulked stage II and III disease; or
  • In combination with ifosfamide for pathologic stage I-IV disease. 

Ovarian Cancer – Clear Cell Carcinoma of the Ovary

·         As adjuvant treatment:

o    In combination with carboplatin for pathologic stage IA-IV disease; or

o    In combination with bevacizumab and carboplatin for pathological stage II-IV disease.

·        Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel (Taxol) and IP cisplatin or carboplatin for less than 1 cm optimally debulked stage II and III disease.

Ovarian Cancer – Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer                                                             

• Neoadjuvant chemotherapy in combination with carboplatin with or without bevacizumab  for bulky stage III-IV disease or poor surgical candidates; or

• Used in combination with carboplatin with or without bevacizumab for primary treatment for: 
  • Individuals with incomplete previous surgery and/or staging with suspected stage IA-IB, grade 2-3 or clear cell, or stage IC and no suspected residual disease; or
  • Individuals with incomplete previous surgery and/or staging with stage II-IV and suspected unresectable residual disease; or
  • Primary adjuvant treatment for pathologic stage IA-IB (grades 2 serous/endometrioid or grade 3 stage IC (grades 1-3), or stage II-IV disease.
• Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel (Taxol) and IP cisplatin  or carboplatin for less than 1 cm optimally debulked stage II and III disease; or
• Postremission chemotherapy as a single agent for stage II-IV individuals in complete clinical remission following primary treatment; or
• In combination with carboplatin with or without bevacizumab for rising CA-125 levels or clinical relapse in individuals who have received no prior chemotherapy; or
• Therapy for persistent disease or recurrence for:
  • As preferred therapy,
    • If platinum-sensitive in combination with carboplatin; or
    • If platinum resistant;
    • In combination with bevacizumab  in individuals who have not previously received bevacizumab; or
    • Using weekly dosing in combination with pazopanib, or
  • If platinum sensitive, in combination with carboplatin and bevacizumab in individuals who have not previously received bevacizumab; or
  • As a single agent.

Ovarian Cancer - Malignant Germ Cell Tumors

• Used as a component of TIP (paclitaxel (Taxol), ifosfamide, and cisplatin) regimen as follow-up treatment for individuals with persistently elevated markers (alpha-fetoprotein and/or beta-human chorionic gonadotrophin) following initial treatment for:
  • Embryonal tumor; or
  • Endodermal sinus tumor; or
  • Stage II-IV dysgerminoma; or
  • Stage I (grade 2-3) or stage II-IV immature teratoma; or
• Used in combination with carboplatin (palliative therapy only), or in TIP regimen for recurrent or residual disease; or
• Used as a single agent or in combination with ifosfamide or gemcitabine for recurrent disease as palliative therapy. 

Ovarian Cancer - Malignant Sex Cord-Stromal Tumors

• Initial treatment in combination with carboplatin for:
  • Intermediate- and high-risk stage I disease; or
  • Stage II-IV disease.
• Single agent or in combination with carboplatin or ifosfamide for clinical relapse in individuals with stage II-IV disease. 

Ovarian Cancer – Mucinous Carcinoma   

• As adjuvant treatment in combination with:
  • Carboplatin for pathologic stage IC-IV disease; or
  • Bevacizumab and carboplatin for pathologic stage II-IV disease.
• Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel (Taxol) and IP cisplatin or carboplatin for less than 1 cm optimally debulked stage II and III disease.

Penile Cancer

• Used in combination with cisplatin and ifosfamide (preferred) for: 
  • Adjuvant chemotherapy for:
    • Pathologic N2-3 disease following inguinal lymph node dissection (ILND) in individuals with palpable non-bulky unilateral inguinal lymphnodes (s) < 4 cm (mobile); or
    •  Individuals with ≥ 2nodes positive or extranodal extension following ILND for biopsy positive palpable bulky unilateral inguinal lymph nodes ≥4 cm (mobile) Iif chemotherapy not already given); or
    • Pathological N2-3 disease following ILND in individuals with local recurrence in the inguinal region with a single, mobile , < 4 cm lymph node; or
  • Neoadjuvant chemotherapy for:
    • Biopsy positive palpable bulky unilateral inguinal lymph nodes ≥ 4 cm (mobile); or
    • Biopsy positive palpable bulky unilateral inguinal lymph nodes (fixed) or bilateral inguinal lymph nodes (fixed or mobile); or
    • Potentially resectable enlarged biopsy positive pelvic lymph nodes; or
  • As chemotherapy for local recurrence in the inguinal region in individuals that received prior inguinal lymphadenectomy or radiotherapy; or
  • Systemic chemotherapy for metastatic disease.
• For considered use in individuals as a single agent as subsequent-line systemic chemotherapy for metastatic disease.

Small Cell Lung Cancer (SCLC)

• Subsequent chemotherapy for individuals with performance status 0-2 as a single agent for:
  • Relapse within 6 months following complete or partial response or stabile disease with initial treatment; or
  • Primary progressive disease. 

Soft Tissue Sarcoma – Angiosarcoma

• Used as a single agent for angiosarcoma. 

Testicular Cancer

• As a component of TIP (paclitaxel (Taxol), ifosfamide, and cisplatin) regimen as:
  • Second-line conventional –dose chemotherapy for:
    • Stage IIA, IIB, IIC, or III pure seminoma that is residual, progressive or recurrent following first-line chemotherapy; or
    • Any stage nonseminoma with progressive disease or unresectable residual cancer following first-line chemotherapy.
  • Treatment of residual embryonal, yolk sac, choriocarcinoma, or seminoma elements following surgical resection of all residual masses postchemotherapy; or
• In combination with ifosfamide followed by carboplatin and etoposide as high-dose chemotherapy for:
  • Stage II or III; pure seminima that is residual, progressive or recurrent following first-, second-, or third-line chemotherapy; or
  • Any stage nonseminoma with progressive disease or unresectable residual cancer after having received first first-, second-, or third-line chemotherapy.
• As palliative chemotherapy in combination with gemcitabine with or without oxaliplatin after second-line or high-dose chemotherapy regimens. 

Thymomas and Thymic Carcinomas

• Postoperative treatment in combination with carboplatin and radiation therapy for:
  • Thymic carcinoma after R1 or R2 resection; or
  • Thymoma after R2 resection; or
• First-line therapy in combination with carboplatin (preferred regimen for thymic carcinoma) for:
  • Locally advanced disease; or
  • Solitary metastasis or ipsilateral pleural metastasis; or
  • Extrathoracic metastatic disease.
• Second-line therapy as a single agent. 

Thyroid Carcinoma - Anaplastic Carcinoma

• Used as a single agent or in combination with carbopatlin for:
  • Unresectable or incomplete (R2) resection of locoregional disease; or
  • Adjuvant therapy for locoregional disease following R0 or R1 resection; or
  • Aggressive therapy for metastatic disease. 

Uterine Neoplasms - Endometrial Carcinoma

• Primary treatment as a single agent or in combination with cisplatin and doxorubicin or with carboplatin for:
  • Use with or without  sequential external beam radiation therapy (EBRT) and brachytherapy for disease not suitable for primary surgery in individuals with suspected or gross cervical involvement; or
  • May be considered preoperatively for intra-abdominal disease; or
  • Use with or without sequential EBRT and, or, brachytherapy for extrauterine pelvic disease; or
  • With or without EBRT and, or, hormonal therapy for extra abdominal or liver disease.
• Adjuvant  treatment for surgically staged individuals as a single agent or in combination with cisplatin and doxorubicin or with carboplatin:
  • With sequential EBRT and, or, vaginal brachytherapy in individuals with stage IB disease and histologic grade 3 tumors with adverse risk factors; or
  • Use with sequential EBRT with or without vaginal brachytherapy in individuals with stage II disease with histologic grade 3 tumors; or
  • With sequential EBRT with or without vaginal brachytherapy for stage III disease; or
  • Use with or without sequential EBRT and vaginal brachytherapy for stage IV disease.
• Single agent or in combination with cisplatin and doxorubicin or with carboplatin for:
  • Consideration for isolated masses; or
  • Disseminated metastases that have progressed on hormonal therapy; or
  • Use with or without sequential palliative external beam radiation therapy (EBRT) for symptomatic, grade 2-3, or large-volume disseminated metastases or local/regional  recurrence in individuals with gross upper abdominal residual disease; or
  • Use with sequential EBRT with or without brachytherapy for local /regional  recurrence in individuals with disease confined to the vagina or in pelvic lymph nodes; or
  • Use with sequential EBRT for local/regional recurrence in individuals with disease in para-aortic or common iliac lymph nodes; or
  • Use with or without sequential tumor-directed EBRT for local/regional recurrence in individuals with microscopic residual upper abdominal or peritoneal disease; or
  • For local/regional recurrence in individuals who have received prior EBRT to site of recurrence.
• Adjuvant therapy as a single agent or in combination with xisplatin and doxorubicin or with carboplatin and with or without:
  • Vaginal brachytherapy for stage 1A disease; or
  • Sequential EBRT with or without vaginal brachytherapy for stage IB-IV disease.
• Adjuvant therapy in combination with ifosfamide with or without:
  • Vaginal brachytherapy for stage 1A disease; or
  • Sequential EBRT with or without vaginal brachytherapy for stage IB-IV disease. 

Vulvar Cancer

• Single agent or in combination with cisplatin or carboplatin
  • As additional treatment for unresectable locally advanced disease clinically positive for residual tumor at the primary site and, or, nodes; or
  • As additional treatment for locally advanced disease with positive margins following resection; or
  • As primary treatment for metastatic disease beyond the pelvis; or
  • For isolated groin/pelvic recurrence if prior EBRT, or
  • For clinical nodal or distant recurrence with multiple pelvic nodes, distant metastasis, or prior pelvic EBRT.

The use of paclitaxel (Taxol) for all other indications is considered experimental/investigational, and therefore, non-covered. Peer reviewed literature does not support the use of paclitaxel (Taxol) for any indications other than those listed on this medical policy.

NOTE: Dosage recommendations per the FDA label.