|
This information has been developed and provided by an independent third-party source. Merck & Co., Inc. does not endorse and is not responsible for the accuracy of the content, or for practices or
standards of non-Merck sources.
ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(mye toe ZAN trone)
Generic Available (U.S.)
Yes
Index Terms
Medication Guide
An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM297876.pdf, must be dispensed with this medication.
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Use: Labeled Indications
Treatment of acute nonlymphocytic leukemias (ANLL [includes myelogenous, promyelocytic, monocytic and erythroid leukemias]); advanced hormone-refractory prostate cancer; secondary progressive or relapsing-remitting multiple sclerosis (MS)
Use: Unlabeled
Treatment of Hodgkin's lymphoma, non-Hodgkin's lymphomas (NHL), acute lymphocytic leukemia (ALL), myelodysplastic syndrome, breast cancer, pediatric acute myelogenous leukemia (AML), pediatric acute promyelocytic leukemia (APL); part of a conditioning regimen for autologous hematopoietic stem cell transplantation (HSCT)
Pregnancy Risk Factor
D
Pregnancy Considerations
Adverse effects were noted in animal studies. May cause fetal harm if administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. Pregnancy should be avoided while on treatment. Women with multiple sclerosis and who are biologically capable of becoming pregnant should have a pregnancy test prior to each dose.
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Mitoxantrone is excreted in human milk and significant concentrations (18 ng/mL) have been reported for 28 days after the last administration. Because of the potential for serious adverse reactions in infants from mitoxantrone, breast-feeding should be discontinued before starting treatment.
Contraindications
Hypersensitivity to mitoxantrone or any component of the formulation
Warnings/Precautions
Boxed warnings:
• Appropriate administration: See “Other warnings/precautions” below.
• Bone marrow suppression: See “Concerns related to adverse effects” below.
• Experienced physician: See “Other warnings/precautions” below.
• Myocardial toxicity: See “Concerns related to adverse effects” below.
• Secondary malignancy: See “Concerns related to adverse effects” below.
Special handling:
• Hazardous agent: Use appropriate precautions for handling and disposal.
Concerns related to adverse effects:
• Bone marrow suppression: Treatment may lead to severe myelosuppression; unless the expected benefit outweighs the risk, use is generally not recommended in patients with pre-existing myelosuppression from prior chemotherapy. [U.S. Boxed Warning]: Usually should not be administered if baseline neutrophil count <1500 cells/mm3 (except for in the treatment of ANLL). Monitor blood counts and monitor for infection due to neutropenia.
• Hyperuricemia: Rapid lysis of tumor cells may lead to hyperuricemia.
• Myocardial toxicity: [U.S. Boxed Warning]: May cause myocardial toxicity and potentially-fatal heart failure (HF); risk increases with cumulative dosing. Effects may occur during therapy or may be delayed (months or years after completion of therapy). Predisposing factors for mitoxantrone-induced cardiotoxicity include prior anthracycline or anthracenedione therapy, prior cardiovascular disease, concomitant use of cardiotoxic drugs, and mediastinal/pericardial irradiation, although may also occur in patients without risk factors. Prior to therapy initiation, evaluate all patients for cardiac-related signs/symptoms, including history, physical exam, and ECG; and evaluate baseline left ventricular ejection fraction (LVEF) with echocardiogram or multigated radionuclide angiography (MUGA) or MRI. Not recommended for use in MS patients when LVEF <50%, or baseline LVEF below the lower limit of normal (LLN). Evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) in MS patients prior to each dose and if signs/symptoms of HF develop. Use in MS should be limited to a cumulative dose of ≤140 mg/m2, and discontinued if LVEF falls below LLN or a significant decrease in LVEF is observed; decreases in LVEF and HF have been observed in patients with MS who have received cumulative doses <100 mg/m2. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity.
• Secondary malignancy: [U.S. Boxed Warning]: Treatment with mitoxantrone increases the risk of developing secondary acute myelogenous leukemia (AML) in patients with cancer and in patients with MS; acute promyelocytic leukemia (APL) has also been observed. Symptoms of acute leukemia include excessive bruising, bleeding and recurrent infections. The risk for secondary leukemia is increased in patients who are heavily pretreated, with higher doses, and with combination chemotherapy.
Disease-related concerns:
• Hepatic impairment: Clearance is reduced in patients with hepatic impairment; use with caution; dosage adjustment recommended. Not for treatment of multiple sclerosis in patients with concurrent hepatic impairment.
• Multiple sclerosis: Not for treatment of primary progressive multiple sclerosis.
Other warnings/precautions:
• Appropriate administration: [U.S. Boxed Warning]: For I.V. administration only, into a free-flowing I.V.; may cause severe local tissue damage if extravasation occurs; do not administer subcutaneously, intramuscularly, or intra-arterially. Do not administer intrathecally; may cause serious and permanent neurologic damage. Extravasation resulting in burning, erythema, pain, swelling and skin discoloration (blue) has been reported; extravasation may result in tissue necrosis and require debridement for skin graft.
• Blue-green coloration: May cause urine, saliva, tears, and sweat to turn blue-green for 24 hours postinfusion; whites of eyes may have blue-green tinge.
• Experienced physician: [U.S. Boxed Warning]: Should be administered under the supervision of a physician experienced in cancer chemotherapy agents.
Adverse Reactions
Includes events reported with any indication; incidence varies based on treatment, dose, and/or concomitant medications
>10%:
Cardiovascular: Edema (10% to 30%), arrhythmia (3% to 18%), cardiac function changes (≤18%), ECG changes (≤11%)
Central nervous system: Fever (6% to 78%), pain (8% to 41%), fatigue (≤39%), headache (6% to 13%)
Dermatologic: Alopecia (20% to 61%), nail bed changes (≤11%), petechiae/bruising (6% to 11%)
Endocrine & metabolic: Menstrual disorder (26% to 61%), amenorrhea (28% to 53%), hyperglycemia (10% to 31%)
Gastrointestinal: Nausea (26% to 76%), vomiting (6% to 72%), diarrhea (14% to 47%), mucositis (10% to 29%; onset: ≤1 week), stomatitis (8% to 29%; onset: ≤1 week), anorexia (22% to 25%), weight gain/loss (13% to 17%), constipation (10% to 16%), GI bleeding (2% to 16%), abdominal pain (9% to 15%), dyspepsia (5% to 14%)
Genitourinary: Urinary tract infection (7% to 32%), abnormal urine (5% to 11%)
Hematologic: Neutropenia (79% to 100%; onset: ≤3 weeks; grade 4: 23% to 54%), leukopenia (9% to 100%), lymphopenia (72% to 95%), anemia/hemoglobin decreased (5% to 75%) thrombocytopenia (33% to 39%; grades 3/4: 3% to 4%), neutropenic fever (≤11%)
Hepatic: Alkaline phosphatase increased (≤37%), transaminases increased (5% to 20%), GGT increased (3% to 15%)
Neuromuscular & skeletal: Weakness (≤24%)
Renal: BUN increased (≤22%), creatinine increased (≤13%), hematuria (≤11%)
Respiratory: Upper respiratory tract infection (7% to 53%), pharyngitis (≤19%), dyspnea (6% to 18%), cough (5% to 13%)
Miscellaneous: Infection (4% to 60%), sepsis (ANLL 31% to 34%), fungal infection (9% to 15%)
1% to 10%:
Cardiovascular: CHF (≤5%), ischemia (≤5%), LVEF decreased (≤5%), hypertension (≤4%)
Central nervous system: Chills (≤5%), anxiety (5%), depression (5%), seizure (2% to 4%)
Dermatologic: Cutaneous mycosis (≤10%), skin infection (≤5%)
Endocrine & metabolic: Hypocalcemia (10%), hypokalemia (7% to 10%), hyponatremia (9%), menorrhagia (7%)
Gastrointestinal: Aphthosis (≤10%)
Genitourinary: Impotence (≤7%), sterility (≤5%)
Hematologic: Granulocytopenia (6%), hemorrhage (5% to 6%), secondary acute leukemias (≤3%; includes AML, APL)
Hepatic: Jaundice (3% to 7%)
Neuromuscular & skeletal: Back pain (6% to 8%), myalgia (≤5%), arthralgia (≤5%)
Ocular: Conjunctivitis (≤5%), blurred vision (≤3%)
Renal: Renal failure (≤8%), proteinuria (≤6%)
Respiratory: Rhinitis (10%), pneumonia (≤9%), sinusitis (≤6%)
Miscellaneous: Systemic infection (≤10%), diaphoresis (≤9%)
<1%, postmarketing, and/or case reports: Allergic reaction, anaphylactoid reactions, anaphylaxis, chest pain, dehydration; extravasation at injection site (may result in burning, erythema, pain, skin discoloration, swelling, or tissue necrosis); interstitial pneumonitis (with combination chemotherapy), hyperuricemia, hypotension, phlebitis at the infusion site, rash, sclera discoloration (blue), tachycardia, urine discoloration (blue-green), urticaria
Metabolism/Transport Effects
Inhibits CYP3A4 (weak)
Drug Interactions
ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole systemic exposure/affects with concomitant use of a weak CYP3A4 inhibitor. Decrease aripiprazole dose to 25% of the usual dose in patients receiving both a CYP3A4 and a CYP2D6 inhibitor (regardless of potencies). Risk C: Monitor therapy
BCG: Immunosuppressants may diminish the therapeutic effect of BCG. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for agranulocytosis may be increased. Risk X: Avoid combination
Coccidioidin Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioidin Skin Test. Risk C: Monitor therapy
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Risk C: Monitor therapy
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Risk D: Consider therapy modification
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Risk C: Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Herb/Nutraceutical: Avoid echinacea (may diminish the immunosuppressant effect).
Storage
Store intact vials at 15°C to 25°C (59°F to 77°F); do not freeze. Opened vials may be stored at room temperature for 7 days or under refrigeration for up to 14 days. Solutions diluted for administration are stable for 7 days at room temperature or under refrigeration, although the manufacturer recommends immediate use.
Reconstitution
Dilute in at least 50 mL of NS or D5W.
Compatibility
Stable in D5NS, D5W, NS.
Y-site administration: Compatible: Allopurinol, amifostine, cladribine, etoposide, etoposide phosphate, filgrastim, fludarabine, gemcitabine, granisetron, linezolid, melphalan, ondansetron, oxaliplatin, sargramostim, teniposide, thiotepa, vinorelbine. Incompatible: Amphotericin B cholesteryl sulfate complex, aztreonam, cefepime, doxorubicin liposome, pemetrexed, piperacillin/tazobactam, propofol. Variable (consult detailed reference): Paclitaxel.
Mechanism of Action
Related to the anthracyclines, mitoxantrone intercalates into DNA resulting in cross-links and strand breaks; binds to nucleic acids and inhibits DNA and RNA synthesis by template disordering and steric obstruction; replication is decreased by binding to DNA topoisomerase II and seems to inhibit the incorporation of uridine into RNA and thymidine into DNA; active throughout entire cell cycle (cell-cycle nonspecific)
Pharmacodynamics/Kinetics
Absorption: Oral: Poor
Distribution: Vd: 14 L/kg; Vdss: >1000 L/m2; distributes extensively into tissue (pleural fluid, kidney, thyroid, liver, heart) and red blood cells
Protein binding: >95%, 76% to 78% to albumin
Metabolism: Hepatic; pathway not determined
Half-life elimination: Terminal: 23-215 hours (median: ~75 hours); may be prolonged with hepatic impairment
Excretion: Feces (25%); urine (6% to 11%; 65% as unchanged drug)
Dosage
Details concerning dosing in combination regimens should also be consulted. I.V.:
Children: Acute nonlymphocytic leukemias:
AML consolidation phase (second course; unlabeled use): 10 mg/m2 once daily for 5 days (in combination with cytarabine) (Stevens, 1998)
APL consolidation phase (second course; unlabeled use): 10 mg/m2 once daily for 5 days (Ortega, 2005; Sanz, 2004)
Adults:
Acute nonlymphocytic leukemias:
AML induction: 12 mg/m2 once daily for 3 days (in combination with cytarabine); for incomplete response, may repeat (7-10 days later) at 12 mg/m2 once daily for 2 days (Arlin, 1990)
AML consolidation (beginning ~6 weeks after initiation of the final induction course): 12 mg/m2 once daily for 2 days (in combination with cytarabine), repeat in 4 weeks (Arlin, 1990)
APL consolidation phase (second course; unlabeled dosing): 10 mg/m2 once daily for 5 days (Sanz, 2004)
Multiple sclerosis: 12 mg/m2 every 3 months (maximum lifetime cumulative dose: 140 mg/m2; discontinue use with LVEF <50% or clinically significant reduction in LVEF)
Prostate cancer (advanced, hormone-refractory): 12-14 mg/m2 every 3 weeks (in combination with corticosteroids)
Hodgkin's lymphoma (unlabeled use): 10 mg/m2 every 28 days as part of a combination chemotherapy regimen (Phillips, 1990)
Non-Hodgkin's lymphoma (unlabeled use; as part of combination chemotherapy regimens):
CNOP regimen: 10 mg/m2 every 21 days (Bessell, 2003)
FCMR regimen: 8 mg/m2 every 28 days (Forstpointner, 2004)
FMR regimen: 10 mg/m2 every 21 days (Zinzani, 2004)
FND regimen: 10 mg/m2 every 28 days (Tsimberidou, 2002)
MINE regimen: 8 mg/m2 every 21 days (Rodriguez, 1995)
Stem cell transplantation, autologous (unlabeled use): 60 mg/m2 administered 4-5 days prior to autografting (as 3 divided doses over 1 hour each at 1-2 hour intervals on the same day; in combination with other chemotherapeutic agent[s]) (Oyan, 2006; Tarella, 2001)
Dosing adjustment for toxicity:
ANLL patients: Severe or life-threatening nonhematologic toxicity: Withhold treatment until toxicity resolves
MS patients:
Neutrophils <1500/mm3: Use is not recommended
Signs/symptoms of HF: Evaluate for cardiac signs/symptoms and LVEF
LVEF <50% or baseline LVEF below the lower limit of normal (LLN): Use is not recommended
Dosing adjustment in renal impairment: Safety and efficacy have not been established
Hemodialysis: Supplemental dose is not necessary
Peritoneal dialysis: Supplemental dose is not necessary
Elderly: Clearance is decreased in elderly patients; use with caution
Dosing adjustment in hepatic impairment: No dosage adjustment provided in the manufacturer's labeling. Clearance is reduced in hepatic dysfunction; patients with severe hepatic dysfunction (bilirubin >3.4 mg/dL) have an AUC of 3 times greater than patients with normal hepatic function. Consider dose adjustments. Note: MS patients with hepatic impairment should not receive mitoxantrone.
Dosage: Combination Regimens
Leukemia, acute myeloid:
5 + 2 (Cytarabine-Mitoxantrone) (AML Consolidation)
7 + 3 (Cytarabine-Mitoxantrone) (AML Induction)
CLAG-M (AML Induction)
MEC (AML Induction)
MEC-G (AML Induction)
Mitoxantrone-Etoposide (AML Induction)
Leukemia, acute promyelocytic: Tretinoin-Idarubicin (APL)
Lymphoma, Hodgkin:
MINE-ESHAP (Hodgkin)
VIM-D (Hodgkin)
Lymphoma, non-Hodgkin's:
CNOP
Fludarabine-Cyclophosphamide-Mitoxantrone-Rituximab
Fludarabine-Mitoxantrone
Fludarabine-Mitoxantrone-Dexamethasone (NHL)
Fludarabine-Mitoxantrone-Dexamethasone-Rituximab
Fludarabine-Mitoxantrone-Rituximab
MINE
MINE-ESHAP (NHL)
Prostate cancer:
Mitoxantrone + Hydrocortisone
Mitoxantrone-Prednisone (Prostate Cancer)
Administration: I.V.
Irritant (is considered a vesicant by some institutions). For I.V. administration only; do not administer intrathecally, subcutaneously, intramuscularly or intra-arterially. Must be diluted prior to use. Avoid extravasation; may cause severe local tissue damage if extravasation occurs. Usually administered as a short I.V. infusion over 5-15 minutes; do not infuse over less then 3 minutes.
High doses for bone marrow transplant (unlabeled use) are usually given as 3 divided doses over 1 hour each at 1-2 hour intervals on the same day (Oyan, 2006; Tarella, 2001).
Administration: I.V. Detail
pH: 3-4.5
Monitoring Parameters
CBC with differential, serum uric acid (for leukemia treatment), liver function tests; for the treatment of multiple sclerosis, obtain pregnancy test; monitor injection site for extravasation
Cardiac monitoring: Prior to initiation, evaluate all patients for cardiac-related signs/symptoms, including history, physical exam, and ECG; evaluate baseline and periodic left ventricular ejection fraction (LVEF) with echocardiogram or multigated radionuclide angiography (MUGA) or MRI. In patients with MS, evaluate for cardiac signs/symptoms (by history, physical exam, and ECG) and evaluate LVEF (using same method as baseline LVEF) prior to each dose and if signs/symptoms of HF develop. Patients with MS should undergo annual LVEF evaluation following discontinuation of therapy to monitor for delayed cardiotoxicity.
Patient Education
This drug is only administered by infusion; report any redness, swelling, burning, or pain at infusion site. Maintain adequate nutrition and hydration unless instructed to restrict fluid intake. You will be more susceptible to infection. If you have diabetes, check your glucose levels closely; may cause hyperglycemia. May cause urine, saliva, tears, sweat, and whites of eyes to turn blue-green for 24 hours postinfusion (this is normal). May cause nausea, vomiting, GI upset, mouth sores, headache, dizziness, blurred vision, or loss of hair (may be reversible). Report chest pain or palpitations, rapid or erratic heartbeat, difficulty breathing or constant cough, swelling of extremities or sudden weight gain, persistent gastrointestinal response (nausea, vomiting, diarrhea, constipation, abdominal pain), signs of opportunistic infection (eg, fever, chills, sore throat, burning on urination), or changed or decreased urine output.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Mucositis and stomatitis.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness
Mental Health: Effects on Psychiatric Treatment
May cause myelosuppression; use caution with clozapine and carbamazepine
Nursing: Physical Assessment/Monitoring
Evaluate patient carefully for use-related cautions and contraindications. Infusion site must be monitored closely to prevent extravasation, which may cause severe local tissue damage. Monitor for cardiotoxicity, hypersensitivity reactions, myelosuppression, gastrointestinal upset, and opportunistic infection with each dose and throughout therapy; dosage adjustment may be necessary. Caution patients with diabetes to monitor glucose levels closely; may cause hyperglycemia.
Oncology: Emetic Potential
Low (10% to 30%)
Oncology: Vesicant
Vesicant
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, solution [concentrate, preservative free]: 2 mg/mL (10 mL, 12.5 mL, 15 mL, 20 mL [DSC])
Novantrone®: 2 mg/mL (10 mL [DSC]) [contains sodium 0.14 mEq/mL]
Pricing: U.S. (www.drugstore.com)
Concentrate (Novantrone)
2 mg/mL (10): $1340.70
References
Arlin Z, Case DC Jr, Moore J, et al, “Randomized Multicenter Trial of Cytosine Arabinoside With Mitoxantrone or Daunorubicin in Previously Untreated Adult Patients With Acute Nonlymphocytic Leukemia (ANLL). Lederle Cooperative Group,” Leukemia, 1990, 4(3):177-83.
Bessell EM, Burton A, Haynes AP, et al, “A Randomised Multicentre Trial of Modified CHOP Versus MCOP in Patients Aged 65 Years and Over With Aggressive Non-Hodgkin's Lymphoma, Ann Oncol, 2003, 14(2):258-67.
Donelli MG, Zuchetti M, Munzone E, et al, “Pharmacokinetics of Anticancer Agents in Patients With Impaired Liver Function,” Eur J Cancer, 1998, 34(1):33-46.
Ehninger G, Schuler U, Proksch B, et al, "Pharmacokinetics and Metabolism of Mitoxantrone. A Review,"Clin Pharmacokinet, 1990, 18(5):365-80.
Faulds D, Balfour JA, Chrisp P, et al, “Mitoxantrone. A Review of Its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Potential in the Chemotherapy of Cancer,” Drugs, 1991, 41(3):400-49.
Forstpointner R, Dreyling M, Repp R, et al, “The Addition of Rituximab to a Combination of Fludarabine, Cyclophosphamide, Mitoxantrone (FCM) Significantly Increases the Response Rate and Prolongs Survival as Compared With FCM Alone in Patients With Relapsed and Refractory Follicular and Mantle Cell Lymphomas: Results of a Prospective Randomized Study of the German Low-Grade Lymphoma Study Group,” Blood, 2004, 104(10):3064-71.
Henderson IC, Allegra JC, Woodcock T, et al, “Randomized Clinical Trial Comparing Mitoxantrone With Doxorubicin in Previously Treated Patients With Metastatic Breast Cancer,” J Clin Oncol, 1989, 7(5):560-71.
Jeffrey LP, Chairman, National Study Commission on Cytotoxic Exposure. Position Statement. “The Handling of Cytotoxic Agents by Women Who Are Pregnant, Attempting to Conceive, or Breast-Feeding,” January 12, 1987.
Mandelli F, Vignetti M, Suciu S, et al, “Daunorubicin versus Mitoxantrone versus Idarubicin as Induction and Consolidation Chemotherapy for Adults With Acute Myeloid Leukemia: The EORTC and GIMEMA Groups Study AML-10,” J Clin Oncol, 2009, 27(32):5397-403.
Ortega JJ, Madero L, Martin G, et al, “Treatment With All-Trans Retinoic Acid and Anthracycline Monochemotherapy for Children With Acute Promyelocytic Leukemia: A Multicenter Study by the PETHEMA Group,” J Clin Oncol, 2005, 23(30):7632-40.
Oyan B, Koc Y, Ozdemir E, et al, “High Dose Sequential Chemotherapy and Autologous Stem Cell Transplantation in Patients With Relapsed/Refractory Lymphoma,” Leuk Lymphoma, 2006, 47(8):1545-52.
Petrylak DP, Tangen CM, Hussain MH, et al, “Docetaxel and Estramustine Compared With Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer,” N Engl J Med, 2004, 351(15):1513-20.
Phillips JK, Spearing RL, Davies JM, et al, “VIM-D Salvage Chemotherapy in Hodgkin's Disease,” Cancer Chemother Pharmacol, 1990, 27(2):161-3.
Pratt CB, Vietti TJ, Etcubanas E, et al, “Novantrone® for Childhood Malignant Solid Tumors. A Pediatric Oncology Group Phase II Study,” Invest New Drugs, 1986, 4(1):43-8.
Rodriguez MA, Cabanillas FC, Velasquez W, et al, “Results of a Salvage Treatment Program for Relapsing Lymphoma: MINE Consolidated With ESHAP,” J Clin Oncol, 1995, 13(7):1734-41.
Sanz MA, Martin G, Gonzalez M, et al, “Risk-Adapted Treatment of Acute Promyelocytic Leukemia With All-Trans-Retinoic Acid and Anthracycline Monochemotherapy: A Multicenter Study by the PETHEMA Group,” Blood, 2004, 103(4):1237-43.
Scott LJ and Figgitt DP, "Mitoxantrone: A Review of its Use in Multiple Sclerosis," CNS Drugs, 2004, 18(6):379-96.
Stevens RF, Hann IM, Wheatley K, et al, “Marked Improvements in Outcome With Chemotherapy Alone in Paediatric Acute Myeloid Leukemia: Results of the United Kingdom Medical Research Council's 10th AML Trial: MRC Childhood Leukaemia Working Party,” Br J Haematol, 1998, 101(1):130-40.
Tannock IF, de Wit R, Berry WR, et al, “Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer,” N Engl J Med, 2004, 351(15):1502-12.
Tarella C, Zallio F, Caracciolo D, et al, “High-Dose Mitoxantrone + Melphalan (MITO/L-PAM) as Conditioning Regimen Supported by Peripheral Blood Progenitor Cell (PBPC) Autograft in 113 Lymphoma Patients: High Tolerability With Reversible Cardiotoxicity,” Leukemia, 2001, 15(2):256-63.
Toledano A, Azria D, Garaud P, et al, “Phase III Trial of Concurrent or Sequential Adjuvant Chemoradiotherapy After Conservative Surgery for Early-Stage Breast Cancer: Final Results of the ARCOSEIN Trial,” J Clin Oncol, 2007, 25(4):405-10.
Tsimberidou AM, McLaughlin P, Younes A, et al, “Fludarabine, Mitoxantrone, Dexamethasone (FND) Compared With an Alternating Triple Therapy (ATT) Regimen in Patients With Stage IV Indolent Lymphoma,” Blood, 2002, 100(13):4351-7.
Vitolo U, Chiappella A, Angelucci E, et al, “Dose-Dense and High-Dose Chemotherapy Plus Rituximab With Autologous Stem Cell Transplantation for Primary Treatment of Diffuse Large B-Cell Lymphoma With a Poor Prognosis: A Phase II Multicenter Study,” Haematologica, 2009, 94(9):1250-8.
Weiss M, Maslak P, Feldman E, et al, “Cytarabine With High-Dose Mitoxantrone Induces Rapid Complete Remissions in Adult Acute Lymphoblastic Leukemia Without the Use of Vincristine or Prednisone,” J Clin Oncol, 1996, 14(9):2480-5.
Wierzbowska A, Robak T, Pluta A, et al, “Cladribine Combined With High Doses of Arabinoside Cytosine, Mitoxantrone, and G-CSF (CLAG-M) is a Highly Effective Salvage Regimen in Patients With Refractory and Relapsed Acute Myeloid Leukemia of the Poor Risk: A Final Report of the Polish Adult Leukemia Group,” Eur J Haematol 2008; 80(2):115-26.
Zinzani PL, Pulsoni A, Perrotti A, et al, “Fludarabine Plus Mitoxantrone With and Without Rituximab Versus CHOP With and Without Rituximab as Front-Line Treatment for Patients With Follicular Lymphoma,” J Clin Oncol, 2004, 22(13):2654-61.
Zinzani PL, Tani M, Pulsoni A, et al, “Fludarabine and Mitoxantrone Followed by Yttrium-90 Ibritumomab Tiuxetan in Previously Untreated Patients With Follicular Non-Hodgkin Lymphoma Trial: A Phase II Non-Randomised Trial (FLUMIZ),” Lancet Oncol, 2008, 9(4):352-8.
International Brand Names
Lexi-Comp.com
Last full review/revision April 2012
|
