Docetaxel (Taxotere®) is an antimitotic, injectable drug that is used in the treatment of different types of cancerous disease. The drug 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 docetaxel.

Docetaxel (Taxotere) may be considered medically necessary for ANY of the following conditions:

Bladder Cancer

·         For recurrent or metastatic disease, as subsequent systemic therapy as:

o    A first-line alternative therapy, single agent for T4b or T2-4a, N1-3 disease or; for recurrence post cystectomy, or for metastatic disease as subsequent system therapy; or

·         As radiosensitizing chemotherapy given concurrently with radiation for palliation of metastases or for pelvic recurrence after cystectomy.

Bladder Cancer - Primary Carcinoma of the Urethra

·         Used as a single agent for subsequent systemic therapy for recurrent or metastatic disease, for recurrence of clinical stage T3-T4 disease or palpable inguinal lymph nodes.

Bladder Cancer – Upper GU Tract Tumors

·         Used as a single agent as subsequent systemic therapy for metastatic disease.

Bladder Cancer – Urothelial Carcinoma of the Prostate

·         Used as a single agent for subsequent systemic therapy for metastatic disease.

Bone Cancer – Ewing’s Sarcoma Family of Tumors

·         Used with growth factor support in combination with gemcitabine with or without vincristine:

o    With or without radiation therapy for relapse; or

o    For progressive disease following primary treatment; or

o    As second-line therapy for metastatic disease.
 

Bone Cancer – Osteosarcoma

·         As a second-line therapy in combination with gemcitabine with growth factor support, or

·         Dedifferentiated chondrosarcoma and for high-grade undifferentiated pleomorphic sarcoma.

Breast Cancer – Invasive

·         As treatment for individuals with locally advanced, or, metastatic breast cancer following a failure of prior chemotherapy, or

·         As a preoperative systemic therapy for individuals with stage IIA (T2, N0, M0),  IIB T2, N1, M0 or T3),  or IIIA(T2, 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, IIIB, or IIIC):

o    For use in human epidermal growth factor receptor 2(HER2) negative tumors as follows:

§  As a component with cyclophosphamide (TC) preferred regimen; or

§  After doxorubicin and cyclophosphamide (AC) regimen; or

§  As a component with docetaxel, doxorubicin, and cyclophosphamide (TAC) regimen.

o    For use in HER2 positive tumors as follows:

§  As a component with docetaxel, carboplatin, and trastuzumab TCH (preferred regimen) with or without pertuzumab; or

§  In combination with trastuzumab with or without pertuzumab following AC regimen: or

§  In combination with cyclophosphamide and trastuzumab; or

§  In combination with trastuzumab and pertuzumab prior to or following fluorouracil, epirubicin, and cyclophosphamide (FEC/CEF) regimen.

·         As an adjuvant systemic therapy for stage I, IIA, IIB, or IIIA disease (T3, N1, M0), or for locally advanced disease (stage IIIA, IIIB, or IIIC):

o    For use in human epidermal growth factor receptor 2(HER2) negative tumors as follows:

§  As a component with cyclophosphamide (TC) preferred regimen; or

§  Following doxorubicin and cyclophosphamide (AC) regimen; or

§  As a component with doxorubicin, and cyclophosphamide (TAC) regimen; or

o    For use in HER2 positive tumors as follows:

§  In combination with trastuzumab after AC regimen: or

§  If a pertuzumab containing treatment was not used as a neoadjuvant therapy, as

·         A component of TCH regimen in combination with pertuzumab (preferred regime) ≥ T2 or N1 early stage or locally advanced breast cancer; or

·         In combination with trastuzumab and pertuzumab following an AC regimen, or prior to , or following an FEC regimen for ≥ T2 or ≥N1 early stage or locally advanced breast cancer; or

·         In combination with cyclophosphamide and trastuzumab.

o    Following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen; or

·         Exceptions include individuals with:

o    Ductal, lobular, mixed, and metaplastic HER2-negative tumors that are ≤0.5 cm or microinvasive and node negative (pN0); or

o    Ductal, lobular, mixed, and metaplastic hormone receptor-positive, HER2-negative tumors >0.5 cm with low recurrence score on gene assay; or

o    Tubular and mucinous tumors that are hormone receptor-positive and pN0 or pN1mi (≤2 mm axillary node metastasis).

·         As a single agent or in combination with capecitabine for recurrent or metastatic human epidermal growth factor receptor 2-negative disease that is:

o    Hormone receptor-positive or hormone receptor negative and endocrine therapy refractory; or

o    With symptomatic visceral disease or visceral crisis.

·         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:

o    As a preferred first-line therapy in combination with pertuzumab and trastuzumab; or

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

o    In combination with trastuzumab.

Cervical Cancer

·         As a second-line therapy, single agent for

o    Local/regional recurrence; or

o    Distant metastases.

Esophageal and Esophagogastric Junction Cancers

·         In combination with cisplatin as definitive chemoradiation for:

o    The primary treatment of medically fit individuals who are candidates for surgery with

§  CT1b-T4a, N0-N+ disease, and decline a surgical procedure (the recommended option for cervical esophagus squamous cell carcinoma); or

§  CT4b disease.

o    Individuals who are non-surgical candidates:

§  After endoscopic resection with or without ablation with pT1b, NO disease and poor prognostic features; or

§  As primary treatment for non-surgical candidates with cT1b-T4a, NO-N+ or unresectable cT4b disease.

·         Concurrent chemoradiation in combination with cisplatin for individuals with locoregional recurrence after esophagectomy, without prior chemoradiation.

·         As palliative therapy for individuals with unresectable locally advanced, recurrent, or metastatic disease and Karnofsky performance score ≥60% or ECOG performance score ≤2 as:

o    First-line treatment as a component of modified docetaxel, cisplatin, and fluorouracil (DCF); or docetaxel, oxaliplatin, and fluorouracil; or docetaxel, carboplatin and fluorouracil) preferred regimens; or

o    In combination with cisplatin;  or

o    As a single agent; or

o    First-line therapy with the addition of trastuzumab for HER2 overexpressing metastatic adenocarcinoma (not recommended for use with anthracyclines); or

o    Second-line therapy as a preferred single agent, or in combination with irinotecan.

Gastric Cancer

·         As a primary treatment with:

o    Cisplatin and fluorouracil for individuals with advanced gastric adenocarcinoma, including that of the gastroesophageal junction, who have not received prior chemotherapy for advanced disease; or

o    The addition of trastuzumab to first-line therapy for HER2 overexpressing metastatic adenocarcinoma (use with anthracyclines is not recommended).

·         As a palliative therapy for individuals who are non-surgical candidates or have locally advanced, non-resectable, recurrent, or metastatic disease with a Karnofsky performance score of  ≥60% or ECOG performance score ≤2 as:

o    First-line treatment as a component of: docetaxel, cisplatin, and fluorouracil (DCF) regimen; or

o    Modified regimens (docetaxel, oxaliplatin, and fluorouracil) or (docetaxel, carboplatin, and fluorouracil) in combination with cisplatin; or

o    As single agent; or

o    Second-line therapy as a preferred single agent; or

§  In combination with irinotecan.

Head and Neck Cancers – Very Advanced

·         As induction chemotherapy for non-nasopharyngeal cancer in combination with cisplatin and fluorouracil, or, in combination with cisplatin without fluorouracil, in individuals with an ECOG performance status 0-1 for:

o    Newly diagnosed T4b, any N disease, M0 disease, unresectable nodal disease with no metastases; or

o    Individuals unfit for surgery; or

o    Individuals with unresectable locoregional recurrence who have not received prior radiation therapy.

·         For single agent therapy in individuals that demonstrate

o    An ECOG performance status of  3 with any of the following:

§  Newly diagnosed T4b, and N, MO disease, unresectable nodal disease with no metastases; or

§  With non-nasopharyngeal cancer with unresectable locoregional recurrence without prior radiation therapy; or

§  Are deemed not fit for surgery.

o    An ECOG performance status of 0-2.

·         In combination therapy with cisplatin for individuals with an ECOG performance status of 0-1; or

o    With 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 radiation therapy.

Head and Neck Cancers – Cancer of the Glottic Larynx

·         As induction chemotherapy in combination with cisplatin and fluorouracil for:

o    T3, N0-3 disease requiring (amenable to) total laryngectomy; or

o    Selected T4a individuals who decline surgery.

Head and Neck Cancers – Cancer of the Hypopharynx

·         As induction chemotherapy in combination with cisplatin and fluorouracil for:

o    T1, N+; or

o    T2-3, any N disease requiring (amenable to) pharyngectomy with partial or total laryngectomy; or

o    T4a, any N disease.

Head and Neck Cancers – Cancer of the Nasopharynx

·         As induction chemotherapy in combination with cisplatin with or without fluorouracil for:

o    T1, N1-3 disease; or

o    T2-4, any N disease; or

·         Primary therapy in combination with cisplatin or carboplatin for any T, any N, M1 disease.

Head and Neck Cancers – Cancer of the Oropharynx

·         As induction chemotherapy in combination with cisplatin and fluorouracil for:

o    T3-4a, N0-1 disease; or

o    Any T, N2-3 disease.

Head and Neck Cancers – Cancer of the Supraglottic Larynx

·         As induction chemotherapy in combination with cisplatin and fluorouracil for:

o    T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy; or

o    T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation) surgery; or

o    T4a, N0-3 individuals who decline surgery.

Head and Neck Cancer – Occult Primary

·         Initial definitive treatment as induction chemotherapy in combination with cisplatin and fluorouracil.

Head and Neck Cancer - Squamous Cell Carcinoma

·         Induction therapy in combination with cisplatin and fluorouracil in locally advanced disease.

Non-Small Cell Lung Cancer (NSCLC)

·         As a single agent for the treatment of individuals with locally advanced or metastatic non-small cell lung cancer after failure of prior platinum-based chemotherapy; or

·         In combination with cisplatin is indicated for the treatment of individuals with unresectable, locally advanced, or metastatic non-small cell lung cancer who have not previously received chemotherapy (for this disease) as follows:

o    When used in combination with cisplatin as:

§  Neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, 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

§  May be used as induction chemotherapy for T1-3, N0-1 (including T3 with multiple nodules in the same lobe) as an alternative for individuals likely to receive adjuvant chemotherapy; or

§  May be used as induction chemotherapy for operable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), stage IIB (T3, N0), or stage IIIA (T3, N1) with negative mediastinal nodes as an alternative for individuals likely to receive adjuvant chemotherapy.

·         As an adjuvant chemotherapy in combination with cisplatin:

o    Following definitive radiation therapy in medically inoperable high-risk disease as found in stage IB (peripheral T2a, N0), stage I (central T1ab- 2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), stage IIB (T3, N0), stage IIIA (T3, N1) with negative mediastinal nodes and N0 disease; or

o    For high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0); or

o    For margin-positive stage IB (T2a, N0) and IIA (T2b, N0); or

o    For margin-positive stage IIA (T2b, N0) following radiation; or

o    For stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or

o    For margin-negative stage IIIA (T1-3, N2; T3, N1); or

o    For resectable superior sulcus tumors (T3 invasion, T4 extension, N0-1); or

o    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

o    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 negative margins post-surgery; or

o    For clinical stage IIIA disease (T1-2, T3 other than invasive, N2 nodes positive, M0) with no apparent progression or local progression after induction chemotherapy, or

o    Separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N0-1; or

o    For margin-negative or margin-positive, R1 separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2; or

·         Therapy 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 or gemcitabine for (PS) 0-2 as:

o    First line therapy for anaplastic lymphoma kinase (ALK), epidermal growth factor receptor (EGFR),  proto-oncogene receptor tyrosine kinase (ROS1), and programmed death ligand-1 (PD-L1) negative or unknown; or

o    Subsequent therapy for sensitizing (EGFR) mutation-positive tumors and prior erlotinib, afatinib, gefitinib, or osimertinib therapy; or

o    Subsequent therapy for ALK- rearrangement positive tumors and prior crizotinib, ceritinib, or alectinib therapy; or

·         Subsequent therapy for ROS1 rearrangement-positive tumors and prior crizotinib therapy; or

·         Subsequent therapy for PD-L1 expression-positive (>50%) and EGFR, ALK, and ROS1 negative tumors and prior pembrolizumab therapy; or

·         As a single-agent switch maintenance for recurrence or metastasis of squamous cell histology for individuals with performance status 0-2 who achieve tumor response or stable disease following chemotherapy.

·         Subsequent therapy (if not already given) as a single agent or in combination with ramucirumab for metastatic disease in individuals with performance status 0-2:

o    Following progression on a first-line cytotoxic regimen; or

o    For further progression on a systemic immune checkpoint inhibitor or other systemic therapy.

Occult Primary

·         When used as chemoradiation in combination with carboplatin, cisplatin, or gemcitabine in symptomatic individuals with performance status (PS) 1-2 or asymptomatic individuals with PS 0 and aggressive disease for localized disease with axillary or inguinal nodal involvement; or

·         When used in combination with carboplatin, cisplatin, or gemcitabine in symptomatic individuals with performance status (PS) 1-2 or asymptomatic individuals with PS 0 and aggressive disease for:

o    Axillary involvement in men (if clinically warranted); or

o    Lung nodules or breast marker-negative pleural effusion; or

o    Resectable liver disease; or

o    Peritoneal mass or ascites with nonovarian histology, or retroperitoneal mass of nongerm cell histology in selected individuals; or

o    Unresectable liver disease or disseminated metastases.

·         When used in combination with cisplatin or carboplatin, or with cisplatin and fluorouracil in symptomatic individuals with performance status (PS) 1-2, or asymptomatic individuals with PS 0 and aggressive disease for:

o    Chemoradiation in individuals with axillary or inguinal nodal involvement; or

o    Chemotherapy in individuals with multiple lung nodules, pleural effusion, or disseminated metastases.

Ovarian Cancer – Clear cell Carcinoma of the Ovary

·         As adjuvant treatment in combination with carboplatin for pathology staged IA-IC disease.

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

·         As a neoadjuvant chemotherapy in combination with carboplatin for bulky stage III-IV disease in poor surgical candidates; or

·         Used in combination with carboplatin as:

o    A 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

o    A primary treatment for individuals with incomplete previous surgery and/or staging with stage II-IV and suspected unresectable residual disease

o    A primary adjuvant treatment for pathologic stage IA-IB (grades 2-3 or high grade and stage IC (all grades); or

·         Used in combination with carboplatin as:

o    A primary treatment for incompletely staged (stage II-IV) individuals with suspected unresectable residual disease; or

o    A primary adjuvant treatment for pathologic stage II-IV disease following completion surgery in selected individuals.

·         In combination with carboplatin for clinical relapse or recurrence as evidenced by rising CA-125 levels in individuals who have received no prior chemotherapy.

·         As a preferred single-agent therapy, if platinum-resistant, for persistent disease or recurrence.

·         As a preferred therapy, if platinum-sensitive, in combination with carboplatin for persistent disease or recurrence.

Ovarian Cancer – Malignant Germ Cell Tumors

·         Only as palliative therapy for

o    Recurrent disease, as a single agent; or 

o    Recurrent or residual disease, in combination with carboplatin.

Ovarian Cancer – Malignant Sex Cord-Stromal Tumors

·         As a single agent for clinical relapse in individuals with stage II-IV disease.

Ovarian Cancer – Mucinous Carcinoma of the Ovary

·         As adjuvant treatment in combination with carboplatin for pathology staged IC-IV disease.

Pancreatic Adenocarcinoma

·         As first-line chemotherapy, or induction therapy followed by chemoradiation in select individuals without systemic metastases; or

o    For individuals with locally advanced unresectable disease and  good performance status as a component of gemcitabine, docetaxel, and capecitabine (GTX) regimen.

·         As first line therapy in individuals with metastatic disease and good performance status as a component of GTX regimen.  

Prostate Cancer

·         Used in combination with prednisone for castration-recurrent metastatic disease; or

·         Used in combination with carboplatin for treatment of distant metastases with small cell features; or

·         Used following completion of initial external beam radiation therapy in combination with androgen deprivation therapy for select individuals in the high or very high risk group who are deemed fit for chemotherapy, or

·         Used for progressive castration-naive disease in combination with androgen deprivation therapy with or without prednisone for M1 disease.

Small Cell Lung Cancer (SCLC)

·         As subsequent chemotherapy for individuals with performance status 0-2 as single agent for:

o    Relapse within six (6) months following complete or partial response or stable disease with initial treatment; or

o    Primary progressive disease.

Soft Tissue Sarcoma – Angiosarcoma

·         Used for angiosarcoma:

o    As a single agent; or

o    In combination with gemcitabine.

Soft Tissue Sarcoma – Retroperitoneal/Intra-abdominal

·         Used in combination with gemcitabine for:

o    Preoperative chemotherapy for resectable disease; or

o    Primary chemotherapy or chemoradiation for attempted downstaging of unresectable, recurrent, or metastatic disease; or

o    Palliative therapy for unresectable or progressive disease.

Soft Tissue Sarcoma – Rhabdomyosarcoma

·         As a therapy in combination with gemcitabine for pleomorphic rhabdomyosarcoma.

Soft Tissue Sarcoma of the Extremity/Superficial Trunk, Head/Neck

·         Used in combination with gemcitabine for:

o    Preoperative chemotherapy or chemoradiation for resectable stage IIB-III tumors (primary tumors or local recurrence) with acceptable functional outcomes; or

o    Primary treatment as chemotherapy or chemoradiation for stage II-III resectable disease with adverse functional outcomes or unresectable disease (primary tumors or local recurrence); or

o    Adjuvant chemotherapy for resectable stage II III disease (primary tumors or local recurrence) with acceptable functional outcomes; or

o    Treatment before or after metastasectomy with or without radiation therapy for single-organ confined, limited tumor bulk synchronous stage IV or recurrent disease that is amenable to local therapy or for recurrent isolated regional disease or isolated regional lymph nodes; or

o    Chemotherapy following regional node dissection; or

o    Palliative chemotherapy for synchronous stage IV or recurrent disease with disseminated metastases.

Thyroid Carcinoma – Anaplastic Carcinoma

·         Used in combination with doxorubicin:

o    For unresectable (R2 resection) locoregional disease; or

o    As adjuvant therapy for locoregional disease following R0 or R1 resection; or

o    As aggressive therapy for metastatic disease.

Uterine Neoplasms – Endometrial Carcinoma

·         As a primary treatment (in individuals in whom paclitaxel is contraindicated), single agent, or in combination with carboplatin:

o    With or without sequential external beam radiation therapy (EBRT) and brachytherapy extrauterine pelvic disease; or

o    With or without sequential tumor-directed external beam radiation therapy (EBRT) and brachytherapy for disease not suitable for primary surgery in individuals with suspected or gross cervical involvement; or

o    May be considered preoperatively for intra-abdominal disease; or

o    With or without RT and/or hormonal therapy for extra-abdominal or liver disease.

·         For surgically staged individuals as a single agent or in combination with carboplatin as adjuvant treatment (in individuals in whom paclitaxel is contraindicated):

o    With sequential external beam radiation therapy (EBRT) and/or vaginal brachytherapy in individuals with stage IB disease with histologic grade 3 tumors and adverse risk factors; or

o    With sequential EBRT with or without and vaginal brachytherapy in individuals with stage II disease with histologic grade 3 tumors; or

o    With sequential EBRT with or without vaginal brachytherapy for stage III disease, or

o    With or without sequential EBRT and vaginal brachytherapy for stage IV disease.

·         As a single agent or in combination with carboplatin (in individuals in whom paclitaxel is contraindicated):

o    For disseminated metastases that have progressed on hormonal therapy; or

o    With or without sequential palliative radiation therapy (RT) for symptomatic, grade 2-3, or large volume metastases or for local/regional recurrence in individuals with gross, residual upper abdominal disease; or

o    With sequential tumor-directed RT with or without brachytherapy for local recurrence in individuals with disease confined to the vagina or in pelvic lymph nodes; or

o    With or without sequential tumor-directed RT for microscopic upper abdominal or peritoneal recurrences; or

o    For local/regional recurrence in individuals who have received prior external beam RT to site of recurrence; or

o    May be considered for isolated metastases; or

o    With sequential tumor-directed RT for local/regional recurrence in individuals with disease in para-aortic or common iliac lymph nodes.

Uterine Neoplasms – Endometrial Carcinoma – Serous Cell Carcinoma 

·         As an adjuvant therapy (in individuals in whom paclitaxel is contraindicated), single agent, or in combination with carboplatin and with or without:

o    Vaginal brachytherapy for stage 1A disease; or

o    Sequential tumor-directed external beam radiation therapy (EBRT) with or without vaginal brachytherapy for stage IB - IV disease.

Uterine Neoplasm – Uterine Sarcoma

·         Used as a single agent or in combination with gemcitabine (preferred for leiomyosarcoma) for:

o    Following total hysterectomy with or without bilateral salpingo-oophorectomy (TH±BSO) for stage I-III disease; or

o    Following TH±BSO for stage IV disease; or

o    For radiologically isolated vagina/pelvic recurrence; or

o    Extrapelvic recurrence with no prior radiation therapy; or

o    Isolated metastases; consider postoperative therapy for resectable isolated metastases; or

o    Disseminated metastases; or

o    For disease that is not suitable for primary surgery.

NOTE: Dosage recommendations per the FDA label.