Carboplatin (Paraplatin®) is an anticancer drug chemotherapy drug and is classified as an alkylating agent. Alkylating agents are most active in the resting phase of the cell. These drugs are cell-cycle non-specific.

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

Bladder Cancer

• As a first line alternative therapy single agent or in combination therapy for  individuals who cannot receive cisplatin due to impaired renal function or other comorbidities, or
• As a second-line therapy single agent if not used as a first line therapy.

Bladder Cancer-Primary Carcinoma of the Urethra

• As a first line alternative therapy single agent or in combination therapy for  individuals who cannot receive cisplatin due to impaired renal function or other comorbidities, or
• As a second line therapy single agent if not used as first line therapy.

Bladder Cancer – Upper GU Tract Tumors

• As a first line alternative therapy single agent or in combination therapy for  individuals who cannot receive cisplatin due to impaired renal function or other comorbidities, or
• As a second line therapy single agent if not used as a first line therapy.

Bladder Cancer – Urothelial Carcinoma of the Prostate

• As a first line alternative therapy single agent or in combination therapy for  individuals who cannot receive cisplatin due to impaired renal function or other comorbidities, or
• As a second line therapy single agent if not used as a first line therapy.

Bone Cancer – Ewing’s Sarcoma Family of Tumors

• When used with a growth factor support in combination with etoposide and ifosfamide with or without vincristine or:
  • With or without radiation therapy for relapse, or
  • For progressive disease following primary treatment, or
  • As a second line therapy for metastatic disease.

Bone Cancer – Osteosarcoma

• As a second line therapy in combination with etoposide and ifosfamide with growth factor support.

Breast Cancer – Invasive

• As a preferred preoperative systemic therapy for  individuals with human epidermal growth factor receptor 2 (HER2), or
• Positive stage IIA, IIB, or T3, N1, M0 disease who desire breast preservation , or
• Fulfill criteria for breast-conserving surgery except for tumor size or for locally advanced disease (stage IIA, IIB, or IIC) in TCH (docetaxel, carboplatin, and trastuzumab) regimen alone or with TCH regimen with pertuzumab for >=T2 or >=N1 early stage breast cancer.
• As a single agent or in combination with gemcitabine for recurrent or metastatic disease that is:
  • Hormone receptor-positive, HER2-negative with visceral crisis, or
  • HER2-negative and wither hormone receptor –negative or hormone receptor-positive and endocrine therapy refractory, or
  • Progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease.
• Used in combination with paclitaxel and trastuzumab as a first line therapy for recurrent or metastatic HER2, positive disease or as therapy for trastuzumab, exposed HER2-positive disease that is:
  • Hormone receptor-positive with visceral crisis, or
  • Either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory with symptomatic visceral disease, or
  • Progressive with no clinical benefit after three consecutive endocrine therapy regimens or with symptomatic visceral disease.

Central Nervous System Cancers-Adult Intracranial and Spinal Ependymoma (Excluding Subependymoma)

• As a single agent treatment or as a component of platinum based regimens for disease progression.

Central Nervous System Cancers-Adult Low-Grade Infiltrative Supratentorial Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma)

• As a treatment component of platinum based regimens for recurrent or progressive disease.

Central Nervous System Cancers-Adult Medulloblastoma and Supratentorial Primitive Necroectodermal Tumors (PNET)

• As a recurrence/salvage therapy in combination with etoposide and cyclophosphamide for disease progression in individuals who have not received prior chemotherapy.

Central Nervous System Cancers-Anaplastic Gliomas

• In the treatment of recurrent disease or salvage therapy in platinum based chemotherapy regimens or in combination with bevacizumab.

Central Nervous System Cancers-Glioblastoma

• In the treatment of recurrent disease, or salvage therapy in platinum based chemotherapy regimens, or in combination with bevacizumab.

Cervical Cancer

• As a first line therapy when used as a single agent or in combination with paclitaxel for:
  • Local/regional recurrence, or
  • Distant metastases

Esophageal and Esophagogastric Junction Cancers

• For the use of locoregional disease in medically fit  individuals and in combination with paclitaxel as a preferred regimen and:
  • Definitive chemoradiation for  individuals who decline surgery and are recommended for cervical esophagus squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+ , or
  • Definitive chemoradiation for T4a.
• For medically unfit  individuals with T1b, N0 tumors with poor prognostic features, or
• As a primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for individuals who are unfit for or do not elect surgery.
• As a concurrent chemoradiation in combination with paclitaxel as a preferred regimen for locoregional recurrence in individuals who have had surgery but no prior chemoradiation.
• As palliative therapy for  individuals with Karnofsky performance score >=60%,  or ECOG performance score <=2 in combination with paclitaxel, or as a component of preferred modified DCF (docetaxel, carboplatin and fluorouracil) regimen as a first line therapy for the following:
  • T4b squamous cell carcinoma with invasion of the trachea, great vessels, heart, or
  • Macroscopic residual disease, or
  • Primary treatment for T2b, N+, T2-T4a, or unresectable T4b disease for  individuals who are unfit for or do not elect surgery, or
  • Persistent, unresectable locally advanced, locally recurrent, or metastatic disease.

Gastric Cancer

• As a preoperative chemoradiation for resectable locoregional disease. (T2 or higher by clinical staging any N) in medical fit individuals.

Head and Neck Cancers-Advanced, Recurrent, Persistent

• As a primary concurrent chemoradiation for non-nasopharyngeal cancer for:
  •  Individuals with performance status (PS) 0-2 who have newly diagnosed T4b and any N, unresectable nodal disease with no metastases, or who are unfit for surgery, or
  • Locoregional recurrence is PS 0-2 individuals who have not received prior radiation therapy.
• For sequential chemoradiation following induction chemotherapy in performance status 0-1  individuals with non-nasopharyngeal disease for :
  • Newly diagnosed T4b and any N,  or unresectable nodal disease with no metastases, or  individuals unfit for surgery, or
  • Unresectable locoregional recurrence in individuals who have not received prior radiation therapy.
• As a single agent for  individuals with performance status (PS) 3, with newly diagnosed T4b and any N, unresectable nodal disease with no metastases, or with unresectable locoregional recurrence,  no prior radiation therapy (RT), and for  individuals who are unfit for surgery, or
• As a single agent for PS-02 individuals, or in combination (PS0-1) with paclitaxel, docetaxel, or cetuximab (nasopharyngeal cancer) for the treatment of unresectable locoregional recurrence, or as a secondary primary in individuals who have received prior RT, or for distant metastases.

Head and Neck Cancers-Cancer of the Glottis Larynx

• As a primary concurrent chemoradiation in combination with paclitaxel for the treatment of:
  • T3, N0-3 disease requiring (amenable to) total laryngectomy, or
  • Considered for selected T4a individuals who decline surgery.
• For sequential chemoradiation for:
  • T3, N0-3 disease requiring (amenable to ) total laryngectomy following partial response at the primary site to induction chemotherapy, or
  • For selected T4a individuals who decline surgery following partial response at the primary site to induction chemotherapy.

Head and Neck Cancers-Cancer of the Hypopharynx

• As a primary concurrent chemoradiation in combination with paclitaxel for the treatment of:
  • T1, N+, or
  • T2-3, and any N Disease requiring (amenable to) pharyngectomy with total laryngectomy,
• For sequential chemoradiation for:
  • T1, N+ with partial response at the primary site and stable or improved disease in the neck following induction chemotherapy, or
  • T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy with partial response at the primary site and stable, or improved disease in the neck following induction chemotherapy, or
  • T4a, any N disease with partial response at the primary site and stable or improved disease in the neck following induction chemotherapy, or
  • Can be consider for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy with total laryngectomy, or for T4a, any N disease with complete response at the primary site and stable, or improved disease in the neck following induction chemotherapy.

Head and Neck Cancers-Cancer of the Lip

• As a primary concurrent chemoradiation in combination with paclitaxel 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

• As an adjuvant therapy in combination with fluorouracil following chemoradiation for:
  • T1, N1-3 disease, or
  • T2-4, any N disease.
• For sequential chemoradiation for:
  • T1, N1-3 disease
  • T2-4, and N disease.
• As a primary platinum based chemotherapy in combination with docetaxel, paclitaxel, or cetuximab for any T, any N, or M1 disease,
• As chemoradiation following platinum based chemotherapy for any T, any N, or M1 disease.

Head and Neck Cancers-Cancer of the Oropharynx

• As a primary concurrent chemoradiation in combination with paclitaxel for treatment of:
  • T2, N1 disease, or
  • T3-4a, N0-1 disease, or
  • Any T, N2-3 disease,
• For sequential chemoradiation following induction chemotherapy for:
  • T3-4a, N0-1 disease, or
  • Any T, N2-3 disease.

Head and Neck Cancers-Cancer of the Supraglottic Larynx

• As a primary concurrent chemoradiation in combination with paclitaxel 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
  • For T4a, N0-3 individuals who decline surgery.
• For sequential chemoradiation for:
  • T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy following partial response at the primary site to induction chemotherapy, or
  • T1-2, N+ and selected T3, N1 disease amenable to larynx preserving (conservation) surgery following partial response at the primary site to induction chemotherapy, or
  • T4a, N0-3 individuals who decline surgery with a partial response at the primary site to induction chemotherapy.

Head and Neck Cancers-Ethmoid Sinus Tumors

• As a primary concurrent chemoradiation in combination with paclitaxel for:
  • Newly diagnosed T3-4a disease, or
  • For  individuals who have declined surgery, or
  • For cancer diagnosed after incomplete excision with gross residual disease.

Head and Neck Cancers-Maxillary Sinus Tumors

• For preoperative concurrent chemoradiation in combination with paclitaxel in select individuals with T3-4a, or N0 disease.
• As a primary concurrent chemoradiation in combination with paclitaxel for T4b and any N disease.

Head and Neck Cancers-Occult Primary

• As the initial definitive treatment in:
  • Concurrent chemoradiation for >=N2 disease in combination with paclitaxel, or
  • As sequential chemoradiation.

Hodgkin Lymphoma-Classical Hodgkin Lymphoma

• When used as a component of GCD (gemcitabine, carboplatin and dexamethasone) or ICE (ifosfamide, carboplatin and etoposide) regimen:
  • As a second line therapy prior to autologous stem cell rescue for refractory disease, or
  • As a salvage therapy with or without ISRT prior to autologous stem cell rescue, or
  • As a second line therapy with or without ISRT for stage IA-IIA relapsed disease in  individuals with no prior RT and failure at initial sites, or
  • As a second line therapy for all other relapsed disease.

Hodgkin Lymphoma-Nodular Lymphocyte-Predominant Hodgkin Lymphoma

• As a second line therapy with or without rituximab for symptomatic refractory or relapsed disease as a component of:
  • GCD (gemcitabine, carboplatin, and dexamethasone) regimen, or
  • ICE (ifosfamide, carboplatin, and etoposide) regimen.

Kidney Cancer

• When used in combination with gemcitabine or paclitaxel for individuals with collecting duct or medullary subtypes.

Malignant Pleural Mesothelioma

• When used in combination with pemetrexed for:
  • Unresectable stage III in transit metastases, or
  • Local/satellite and/or in transit unresectable recurrence, or
  • Incompletely resected or unresectable nodal recurrence, or
  • Recurrence or metastatic disease in individuals with good performance status.

Melanoma

• When used in combination with paclitaxel for:
  • Unresectable stage III in transit metastases, or
  • Local/satellite and/or in transit unresectable recurrence, or
  • Incompletely resected or unresectable nodal recurrence, or
  • Recurrent or metastatic disease in individuals with good performance status.

Neuroendocrine Tumors-Adrenal Gland Tumors

• When used as treatment for metastatic adrenal carcinoma in combination with etoposide with or without doxorubicin or miltotane.

Neuroendocrine Tumors-Poorly Differentiated (High-Grade)/Large or Small Cell

• When used as the primary treatment for:
  • Resectable disease, or
  • Unresectable locoregional disease, or
  • Metastatic disease.

Non-Hodgkin Lymphoma (NHL)-Adult T-Cell Leukemia/Lymphoma

• When used for nonresponders to first line therapy for acute disease or lymphoma in candidates for transplant as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen.

NHL-AIDS–Related B-Cell Lymphoma

• When used as a second line therapy with or without rituximab for relapse of AIDS related diffuse large B-cell lymphoma, primary effusion lymphoma, and lymphoma associated with Castleman’s disease in  individuals with intention to proceed to high-dose therapy with autologous stem cell rescue  and as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.

NHL-Burkitt Lymphoma

• When used as a second line therapy for relapse of Burkitt lymphoma following complete response as a component of RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen with intrathecal methotrexate if not previously given.

NHL-Diffuse Large B-Cell Lymphoma

• As a second line therapy with or without rituximab for relapsed or refractory disease in  individuals with intention to proceed to high dose therapy with autologous stem cell rescue as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.
• Used to treat primary mediastinal large B-cell lymphoma as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen following RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen.

NHL-Extranodal NK/T-Cell Lymphoma, nasal type

• When used for induction therapy as a component of DeVIC (dexamethasone, etoposide, ifosfamide, and carboplatin) regimen with concurrent radiation.

NHL-Follicular Lymphoma

• When used as a second line or subsequent therapy with or without rituximab for recurrent or progressive disease in  individuals with the indications for treatment as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.

NHL-Gastric MALT Lymphoma

• When used as a second line therapy with or without rituximab for recurrent or progressive disease in  individuals with the indications for treatment as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.

NHL-Mantle Cell Lymphoma

• When used as induction therapy and a component of aggressive therapy with sequential RCHOP/RICE (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone)/ (rituximab, ifosfamide, carboplatin, and etoposide) regimen.
• As a second line therapy with or without rituximab for relapsed, refractory, or progressive disease as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen. 

NHL-Mycosis Fungoides (MF)/Sezary Syndrome (SS)

• Chemotherapy when used for tumors with histologic evidence of large cell transformation and aggressive growth rate as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen in candidates for transplant with:
  • Stage IA-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB with generalized extended tumor, transformed, and/or folliculotropic disease in combination with skin direct therapy, or
  • State IV non-Sezary or visceral disease.

NHL-Nongastric MALT Lymphoma

• As a second line therapy with or without rituximab for recurrent stage I-II disease or for progressive disease in  individuals with the indications for treatment as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen. 

NHL-Peripheral T-Cell Lymphoma

• As a first line therapy for  individuals with angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, ALK-negative anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen following CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen.
• As a second line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or enteropathy associated T-cell lymphoma in candidates for transplant as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen.

NHL-Primary Cutaneous B-Cell Lymphoma

• As a second line therapy with or without rituximab for  primary cutaneous marginal zone or follicle center lymphoma as a component of ICE (ifosfamide, carboplatin, and etoposide) or GDP (gemcitabine, dexamethasone, and carboplatin) regimen for:
  • Refractory generalized cutaneous disease, or
  • Relapsed generalized extracutaneous disease.
• Second line therapy with or without rituximab for relapsed or refractory primary cutaneous diffuse large B-cell lymphoma, leg type in  individuals with intention to proceed to high-dose therapy with autologous stem cell rescue as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.

NHL-Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

• As a component of ICE (ifosfamide, carboplatin, and etoposide) regimen for relapsed or refractory:
  • Primary cutaneous anaplastic large cell lymphoma  (ALCL) with multifocal lesions, or
  • Cutaneous ALCL with regional nodes (excludes systemic ALCL).

NHL-Splenic Marginal Zone Lymphoma

• As a second line therapy with or without rituximab for progressive disease in  individuals with the indications for treatment as a component of:
  • ICE (ifosfamide, carboplatin, and etoposide) regimen, or
  • GDP (gemcitabine, dexamethasone, and carboplatin) regimen.

Non-Melanoma Skin Cancers-Merkel Cell Carcinoma

• When used as a single agent or in combination with etoposide as:
  • A consideration for adjuvant treatment with or without radiation therapy for clinical N+ disease in select clinical circumstances, or
  • Treatment for distant metastatic disease or disseminated recurrence with or without surgery or radiation.

Non-Small Cell Lung Cancer (NSCLC)

• When used as a preoperative concurrent chemoradiation in combination with peremetrexed for  individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Resectable or possibly resectable superior sulcus tumors (T3 invasion, T4 extension, N0-1), or
  • T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or the mediastinum.
• Used as a preoperative concurrent chemoradiation in combination with paclitaxel for  individuals with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2 cycles of paclitaxel and carboplatin for T3 invasion, resectable T4 extension, N0-1 disease in the chest wall, proximal airway, or mediastinum.
• Used in combination with paclitaxel for  individuals with comorbidities or who are unable to tolerate 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 (≥7 cm), 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.
• Used for initial treatment as a definitive concurrent chemoradiation in combination with pemetrexed for  individuals with comorbidities or who are unable to tolerate cisplatin for:
  • Medically inoperable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with negative mediastinal nodes and N1 disease, or
  • Unresectable superior sulcus tumors (T4 extension, N0-1), or
  • T3 invasion, N2, M0, or
  • Contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3).
• Used for initial treatment as a definitive concurrent chemoradiation in combination with paclitaxel for  individuals with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2 cycles of paclitaxel and carboplatin for:
  • Medically inoperable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with negative mediastinal nodes and N1 disease, or
  • Unresectable superior sulcus tumors (T4 extension, N0-1), or
  • T3 invasion, N2, M0, or
  • Contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3).
• As an adjuvant chemotherapy in combination with paclitaxel for  individuals with comorbidities or who are unable to tolerate cisplatin for:
  • 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) 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 or possibly 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, and the mediastinum if not given as initial treatment, or
  • For margin negative or margin positive, R1 T1-3  (including T3 with multiple nodules in the same lobe), N2, or
  • For T1-2, T3 (≥7 cm), N2, 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.
• As an adjuvant concurrent chemoradiation in combination with paclitaxel followed by chemotherapy with 2 cycles of paclitaxel and carboplatin 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
  • Margin positive T1-3 (including T3 with multiple nodules in the same lobe), N2, or
  • Margin positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2.
• As an adjuvant concurrent chemoradiation in combination with pemetrexed 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
  • Margin positive T1-3 (including T3 with multiple nodules in the same lobe), N2, or
  • Margin positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4), N2.
• Or as a sequential chemoradiation in combination with paclitaxel as:
  • The initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with negative mediastinal nodes and N1 disease, or
  • Adjuvant therapy for margin-positive, R1 stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1), or,
  • Adjuvant therapy for margin negative T1-3, N2, or
  • Adjuvant therapy for margin positive, R1 stage IIIA (T1-3, N2; T3, N1), or
  • Adjuvant therapy for margin positive, R1 T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal airway, or mediastinum if not given as initial treatment.
• As concurrent chemoradiation in combination with pemetrexed if radiation not previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction.
  • As a first line therapy for recurrence or metastasis:
  • In combination with paclitaxel, docetaxel, gemcitabine, vinorelbine, etoposide, vinblastine, pemetrexed (nonsquamous cell  histology), or with albumin bound paclitaxel in  individuals with performance status (PS) 0-2, or the elderly , or
  • As a single agent in PS 2 or the elderly.
• As a first line therapy for recurrence or metastasis in a carboplatin based regimen in combination with bevacizumab in individuals with performance status (PS) 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis.
• As a first line therapy for recurrence or metastasis in combination with paclitaxel, docetaxel, gemcitabine, vinorelbine, etoposide, vinblastine or pemetrexed, with a nonsquamous cell histology, or with albumin bound paclitaxel in individuals with:
  • Performance status (PS) 0-2, (or the elderly), or
  • As a single agent in PS 2 (or the elderly).
• As a second line therapy for progression in individuals with multiple symptomatic systemic lesions in carboplatin based doublet therapy with or without bevacizumab:
  • With or without erlotinib for sensitizing EGFR mutation positive tumors and prior erlotinib or afatinib therapy, or
  • For ALK-positive tumors and prior crizotinib and/or ceritinib therapy.

Occult Primary

• For chemoradiation in combination with docetaxel or with paclitaxel 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 with axillary or inguinal nodal involvement.
• May be used in combination with docetaxel, or with paclitaxel with or without etoposide in symptomatic  individuals with performance status (PS) 1-2, or asymptomatic individuals with PS 0 and aggressive disease for:
  • Lung nodules or breast marker negative pleural effusion, or
  • Resectable liver disease, or
  • Peritoneal mass with non-ovarian histology or retroperitoneal mass of non-germ cell histology in selected  individuals, or
  • Unresectable liver disease or disseminated metastases.
• Used in combination with paclitaxel or docetaxel 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-Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary peritoneal Cancer

• When used as a Neoadjuvant chemotherapy in combination with paclitaxel or docetaxel for bulky stage III-IV disease in poor surgical candidates.
• Used in combination with paclitaxel or docetaxel as:
  • A primary treatment for incompletely staged (stage IA-IB, grade 2-3 or clear cell and stage IC)  individuals with no suspected residual disease, or
  • A primary adjuvant treatment for pathologic stage IA-IB (grades 2-3 or clear cell) and for stage IC (all grades).
• Used in combination with paclitaxel or with docetaxel as:
  • A primary treatment for incompletely staged (stage II-IV)  individuals with suspected unresectable residual disease, or
  • A primary adjuvant treatment for pathologic stage II-IV disease following completion surgery in selected individuals.
• In combination with paclitaxel or docetaxel for clinical relapse or recurrent disease as evidenced by rising CA-125 levels in  individuals who have received no prior chemotherapy.
• As a preferred therapy, if platinum sensitive, for persistent disease or recurrence:
  • As a single agent, or
  • In combination with docetaxel, gemcitabine, or liposomal doxorubicin, or
  • In combination with gemcitabine and bevacizumab if bevacizumab not previously received.

Small Cell Lung Cancer (SCLC)

• When used in the initial treatment and in combination with etoposide or irinotecan for extensive stage disease.
• When used in combination with etoposide in  individuals with limited stage disease who are poor candidates for cisplatin as:
  • An initial treatment with or without radiation, or
  • An adjuvant chemotherapy for pN0 disease, or
  • An adjuvant concurrent chemoradiation for pN+ disease.
• As a subsequent chemotherapy for  individuals with performance status 0-2 in combination with etoposide or irinotecan and:
  • If used as the original regimen, for relapse occurring more than 6 months following complete or partial response or stable disease with initial treatment, or
  • If not used as original regimen, for primary progressive disease.

Soft Tissue Sarcoma-Rhabdomyosarcoma

• As therapy when used in combination with etoposide for nonpleomorphic rhabdomyosarcoma.

Testicular Cancer

• As a high dose chemotherapy in combination with etoposide alone or following paclitaxel and ifosfamide for recurrent disease.
• As a primary treatment and a single agent for individuals with stage 1A-B disease.

Thymomas and Thymic Carcinomas

• When used as a postoperative treatment in combination with paclitaxel and radiation therapy for:
  • Thymic carcinoma after R1 or R2 resection, or
  • Thymoma after R2 resection.
• As a first line therapy in combination with paclitaxel for:
  • Locally advanced disease, or
  • Isolated solitary metastasis, or
  • Distant metastatic disease.

Thyroid Carcinoma-Anaplastic Carcinoma

• When used in combination with paclitaxel and:
  • In concurrent chemoradiation, or
  • As chemotherapy for unresectable local tumors with or without distant disease.

Uterine Neoplasms-Endometrial Carcinoma

• When used as a primary treatment and a single agent or in combination with paclitaxel or docetaxel when used:
  • With sequential radiation therapy (RT) and brachytherapy with or without surgery for extrauterine pelvic disease, or
  • Can be considered following palliative hysterectomy with bilateral salpingo-oophorectomy 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 paclitaxel, or with docetaxel as an adjuvant treatment:
  • With sequential pelvic radiation therapy (RT) and/or vaginal brachytherapy in individuals with stage IB disease and histologic grade 3 tumors and adverse risk factors, or
  • With sequential pelvic RT and vaginal brachytherapy in individuals with stage II disease with histologic grade 3 tumors, or
  • With or without sequential tumor directed RT for stage IIIA, IIIB, and IIIC disease, or
  • With or without sequential RT for stage IV disease, or
  • As a single agent or in combination with paclitaxel, or docetaxel as adjuvant treatment with sequential RT and vaginal brachytherapy with or without para-aortic RT for incompletely surgically staged individuals with histologic grade 3 tumors.
• Single agent or in combination with paclitaxel or docetaxel:
  • For disseminated metastases that have progressed on hormonal therapy, or
  • With or without sequential palliative radiation therapy (RT) for symptomatic, grade 2-3, or large-volume metastases, or
  • With sequential tumor directed RT with or without brachytherapy for local recurrence in individuals with disease confined to the vagina, or in the pelvic, the para-aortic, or common iliac lymph nodes, or
  • With or without sequential tumor-directed RT for microscopic upper abdominal or peritoneal recurrences, or
  • For local/regional recurrence in individuals who have received prior external beam RT to site of recurrence.
• As an adjuvant therapy single agent or in combination with paclitaxel or docetaxel and with or without:
  • Vaginal brachytherapy for stage 1A disease with no myometrial invasion, or
  • Sequential tumor directed radiation therapy for stage 1A disease with myometrial invasion or stage IB-IV disease.

Ovarian Cancer-Malignant Germ Cell Tumors

• When used in combination with docetaxel or paclitaxel for recurrent or residual disease.

Ovarian Cancer-Malignant Sex Cord-Stromal Tumors

• When used in combination with paclitaxel and:
  • Considered for initial treatment of intermediate and high-risk stage I disease, or
  • For initial treatment of stage II-IV disease, or
  • For clinical relapse in individuals with stage II-IV disease

Penile Cancer

• When used in combination with etoposide for treatment of distant metastases with small cell features.

Prostate Cancer

• When used in combination with etoposide for treatment of distant metastases with small cell feature.

NOTE: Dosage recommendations per the FDA label.