Cabazitaxel, a semisynthetic taxoid derived from the major natural taxoid (10-deacetyl baccatin III) extracted from the needles of various species of yew trees ( Taxus species), is an antineoplastic agent.1, 9, 13
Cabazitaxel is used in combination with prednisone for the treatment of hormone-refractory metastatic prostate cancer in patients with disease that has progressed following prior treatment with docetaxel-based therapy.1, 2, 3, 4
The current indication for cabazitaxel is based principally on the results of a randomized, multicenter, phase 3 study (TROPIC) in 755 men with hormone-refractory metastatic prostate cancer who had experienced disease progression during or after completion of a docetaxel-containing regimen.1, 2 Approximately 92% of patients had received a cumulative docetaxel dose of at least 225 mg/m2 at time of study entry.2 Patients with measurable disease who were enrolled in the study had disease progression documented by Response Evaluation Criteria in Solid Tumors (RECIST) with at least one visceral or soft-tissue metastatic lesion, while those with nonmeasurable disease were required to have either rising serum prostate specific antigen (PSA) concentrations or the presence of at least one new radiographic lesion.2 Patients were randomized to receive either cabazitaxel and prednisone or mitoxantrone and prednisone.2 Treatment consisted of cabazitaxel 25 mg/m2 administered IV over 1 hour or mitoxantrone 12 mg/m2 administered IV over 15-30 minutes on day 1 of each 21-day treatment cycle; prednisone 10 mg daily (or an equivalent dosage of prednisolone) was administered orally throughout both treatment courses.1, 2 Patients receiving cabazitaxel were premedicated with an antihistamine, a histamine H2-receptor antagonist (excluding cimetidine), and a corticosteroid at least 30 minutes prior to cabazitaxel administration.2 Treatment duration in both groups was limited to 10 cycles to minimize the risk of mitoxantrone-induced cardiotoxicity.1, 2 Prophylactic use of granulocyte colony-stimulating factors was not permitted during the first cycle of treatment, but use of these agents was allowed after the first occurrence of prolonged neutropenia (i.e., lasting 7 days or longer) or neutropenia associated with fever or infection.2
At a median follow-up of 12.8 months, patients receiving cabazitaxel and prednisone had longer median overall survival (15.1 versus 12.7 months) and progression-free survival (2.8 versus 1.4 months) compared with those receiving mitoxantrone and prednisone.1, 2 A subset analysis of overall survival based on prognostic features at baseline consistently favored the cabazitaxel regimen over the mitoxantrone regimen.2 Patients receiving cabazitaxel and prednisone also had higher objective tumor response rates (14.4 versus 4.4%) and PSA response rates (39.2 versus 17.8%) and longer median times to tumor progression (8.8 versus 5.4 months) and PSA progression (6.4 versus 3.1 months), but had similar times to pain progression, compared with those receiving mitoxantrone and prednisone.1, 2 In both treatment groups, the most common reason for drug discontinuance was disease progression;2 discontinuance because of disease progression was more common (71 versus 48%) in patients receiving mitoxantrone and prednisone, whereas discontinuance because of adverse effects was more common (18 versus 8%) in patients receiving cabazitaxel and prednisone.1, 2
Higher frequencies of severe (grade 3 or greater) neutropenia (82 versus 58%), severe febrile neutropenia (7 versus 1%), diarrhea (47 versus 11%, severe in 6 versus less than 1%), and peripheral neuropathy (13 versus 3%) were observed in patients receiving cabazitaxel and prednisone compared with those receiving mitoxantrone and prednisone.1, 2 The frequency of peripheral edema was similar in both treatment groups (9%).1, 2 About 5% of cabazitaxel-treated patients compared with 2% of mitoxantrone-treated patients died within 30 days of the last dose of the drug;2 disease progression was the most common cause of early death among patients receiving mitoxantrone, whereas adverse reactions, including neutropenic complications and renal failure, were the most frequent causes of early death among patients receiving cabazitaxel.1, 2, 6
Cabazitaxel should administered under the supervision of a qualified clinician experienced in therapy with cytotoxic agents; appropriate diagnostic and treatment facilities should be readily available for the management of treatment-related complications.1
To minimize the risk and/or severity of hypersensitivity reactions, patients should be premedicated with an IV antihistamine (diphenhydramine hydrochloride 25 mg or equivalent), IV histamine H2-receptor antagonist (ranitidine 50 mg or equivalent [except cimetidine]), and IV corticosteroid (dexamethasone 8 mg or equivalent) at least 30 minutes prior to each cabazitaxel infusion.1, 2, 5
Antiemetic prophylaxis, administered orally or IV as needed, also is recommended in patients receiving cabazitaxel.1
Cabazitaxel is administered by IV infusion over 1 hour.1
Caution should be exercised when preparing and handling cabazitaxel solutions, and the use of protective equipment (e.g., gloves) is recommended.1 If the drug (as a concentrate or diluted solution) comes into contact with mucous membranes, the affected area should be flushed immediately and thoroughly with water.1 Skin accidentally exposed to the drug should be washed immediately and thoroughly with soap and water.1
Cabazitaxel injection concentrate must be diluted prior to IV infusion .1 First, the cabazitaxel injection concentrate is diluted to prepare the initial diluted cabazitaxel solution and then the initial diluted cabazitaxel solution is further diluted to prepare the final dilution of cabazitaxel solution for infusion.1 Both the cabazitaxel injection concentrate and diluent vials contain an overfill to compensate for the loss of liquid during preparation.1
For preparation of the initial diluted solution, the entire contents of the diluent vial supplied by the manufacturer (approximately 5.7 mL of 13% [w/w] ethanol in water for injection) is withdrawn and transferred to a vial labeled as containing cabazitaxel 60 mg in 1.5 mL; the resultant solution contains cabazitaxel 10 mg/mL.1 The diluent should be directed toward the wall of the vial and injected slowly to minimize foaming.1 The vial should be inverted repeatedly for at least 45 seconds to fully mix the injection concentrate and diluent; the vial should not be shaken.1 The solution should be allowed to stand for a few minutes to let any foam dissipate; then preparation may continue even if some foam remains.1 The initial diluted cabazitaxel solution should be further diluted within 30 minutes of preparation.1
For preparation of the final diluted cabazitaxel solution, the required amount of the initial diluted cabazitaxel solution (cabazitaxel 10 mg/mL) should be injected into a 250-mL non-PVC infusion bag or bottle containing 0.9% sodium chloride injection or 5% dextrose injection to produce a final solution with a cabazitaxel concentration of 0.1-0.26 mg/mL.1 If the required dose exceeds 65 mg, the volume of IV solution should be increased accordingly so that a cabazitaxel concentration of 0.26 mg/mL is not exceeded.1 The final diluted cabazitaxel solution for infusion should be mixed thoroughly by gently inverting the bag or bottle.1 Infusion of the final diluted cabazitaxel solution should be completed within 8 hours if stored at room temperature or within 24 hours if stored under refrigeration.1 The infusion solution should be at room temperature for administration.1 Any unused portion should be discarded.1 Cabazitaxel should not be admixed with other drugs.1
Because both the initial and final diluted cabazitaxel solutions are supersaturated, crystallization may occur over time.1 Diluted solutions of the drug should be inspected visually for particulate matter, including crystals, and discoloration; the drug should be discarded if either the initial or final diluted solution is cloudy or contains a precipitate.1 Cabazitaxel should be administered through a 0.22-µm in-line filter.1
Cabazitaxel injection concentrate contains polysorbate 80, which can cause leaching of diethylhexyl phthalate (DEHP) from PVC containers.1, 7 PVC infusion containers and polyurethane administration sets should not be used during preparation or administration of the drug.1, 5, 7
The recommended adult dosage of cabazitaxel for the treatment of hormone-refractory metastatic prostate cancer in patients previously treated with a docetaxel-containing regimen is 25 mg/m2 administered as a 1-hour IV infusion every 3 weeks.1, 2 Prednisone (10 mg orally once daily) is administered continuously throughout cabazitaxel treatment.1, 2 In the phase 3 clinical trial supporting use of cabazitaxel for this indication, treatment duration was limited to 10 cycles because of the potential for cumulative cardiotoxicity with the comparator regimen (mitoxantrone).2, 3, 5 Although no cumulative dose-limiting toxicities have been described with cabazitaxel use, the manufacturer states there are no data to support use of the drug beyond 10 cycles.5
Dosage Modification for Toxicity
Dosage Modification for Hematologic Toxicity
Complete blood cell counts should be monitored weekly during the first cycle of cabazitaxel therapy and prior to each treatment cycle thereafter.1 In patients who experience severe prolonged neutropenia (i.e., grade 3 or greater neutropenia lasting longer than one week) despite appropriate use of a granulocyte colony-stimulating factor (e.g., filgrastim, pegfilgrastim), cabazitaxel therapy should be interrupted until the neutrophil count exceeds 1500/mm3; upon resumption of therapy, the cabazitaxel dosage should be reduced to 20 mg/m2 every 3 weeks.1 In patients who experience an episode of febrile neutropenia, therapy should be interrupted until improvement or resolution occurs and the neutrophil count exceeds 1500/mm3; upon resumption of therapy, the cabazitaxel dosage should be reduced to 20 mg/m2 every 3 weeks.1 The manufacturer recommends use of a granulocyte colony-stimulating factor for secondary prophylaxis in patients who have experienced severe prolonged neutropenia or an episode of febrile neutropenia.1 Cabazitaxel therapy should be discontinued if severe prolonged neutropenia or febrile neutropenia recurs following reduction of the cabazitaxel dosage to 20 mg/m2 every 3 weeks.1
Dosage Modification for GI Toxicity
In patients who experience severe diarrhea (grade 3 or greater) or persistent diarrhea despite use of appropriate medical therapy (e.g., antidiarrheals, fluid and electrolyte replacement), cabazitaxel therapy should be interrupted until the diarrhea improves or resolves; upon resumption of therapy, the cabazitaxel dosage should be reduced to 20 mg/m2 every 3 weeks.1 Cabazitaxel therapy should be discontinued if severe or persistent diarrhea recurs following reduction of the cabazitaxel dosage to 20 mg/m2 every 3 weeks.1
The manufacturer makes no special population dosage recommendations at this time.1 The manufacturer states that cabazitaxel should not be used in patients with hepatic impairment (serum AST and/or ALT concentrations of 1.5 or more times the upper limit of normal [ULN] or total serum bilirubin concentrations at or above the ULN).1 (See Specific Populations under Cautions: Warnings/Precautions.)
Known severe hypersensitivity reaction to cabazitaxel or other formulations containing polysorbate 80.1
Baseline neutrophil count of 1500/mm3 or less.1
Neutropenia, including fatal neutropenic episodes, have been reported in patients receiving cabazitaxel.1 In the TROPIC study in patients with prostate cancer, grade 3 or 4 neutropenia was reported in 82% and febrile neutropenia was reported in 7% of patients receiving cabazitaxel and prednisone.1 Five deaths due to sepsis or septic shock were reported with this regimen in the TROPIC study; all 5 patients had severe (grade 4) neutropenia, and one patient had febrile neutropenia.1 One additional death was attributed to neutropenia without documented infection.1
Granulocyte colony-stimulating factors (G-CSF) (e.g., filgrastim, pegfilgrastim) may be used to reduce the risk of neutropenic complications associated with cabazitaxel.1, 3 The manufacturer recommends that primary prophylaxis with G-CSF be considered in patients with high-risk clinical features that could potentially increase the risk of complications associated with prolonged neutropenia, including patients older than 65 years of age and those with poor performance status, prior episodes of febrile neutropenia, extensive prior radiation, poor nutritional status, or other serious comorbidities.1, 3 The manufacturer recommends that therapeutic use of G-CSF and secondary prophylaxis be considered in all patients at increased risk for neutropenic complications.1
Complete blood cell counts should be monitored weekly during the first treatment cycle and prior to each treatment cycle thereafter.1 After administration of the recommended dosage for the initial cycle, dosage for each subsequent cycle should be adjusted as needed based on hematologic recovery.1 Cabazitaxel should not be administered until neutrophil counts exceed 1500/mm3.1 In patients who experience severe prolonged neutropenia despite appropriate treatment (e.g., G-CSF) or febrile neutropenia, temporary interruption of cabazitaxel therapy followed by dosage reduction or discontinuance of cabazitaxel therapy may be required.1 (See Dosage Modification for Hematologic Toxicity under Dosage: Dosage Modification for Toxicity, in Dosage and Administration.)
Cabazitaxel can cause severe hypersensitivity reactions (e.g., generalized rash/erythema, hypotension, bronchospasm), and all patients receiving the drug should be premedicated to minimize the risk and/or severity of these reactions.1 (See Dosage and Administration: General.) Patients should be observed closely for hypersensitivity reactions, especially during the first and second infusions of the drug.1, 3 Appropriate facilities and equipment for the treatment of hypotension and bronchospasm should be readily available, since hypersensitivity reactions may occur within minutes following initiation of a cabazitaxel infusion.1 If a severe hypersensitivity reaction develops, the infusion should be discontinued immediately and appropriate supportive treatment instituted.1 Cabazitaxel injection concentrate contains polysorbate 80 and should not be used in patients with a history of severe hypersensitivity to cabazitaxel or to other formulations containing polysorbate 80.1
Other Warnings and Precautions
Cabazitaxel can cause nausea, vomiting, and severe diarrhea.1 Death related to diarrhea and associated dehydration and electrolyte imbalance has been reported in a patient who received the drug.1, 2 Antiemetic prophylaxis, administered orally or IV as needed, is recommended in patients receiving cabazitaxel.1 Rehydration therapy and antidiarrheal and antiemetic agents should be used as needed; intensive measures may be required for the management of severe diarrhea and electrolyte imbalance.1 In patients with severe or persistent diarrhea, temporary interruption of therapy followed by dosage reduction, or discontinuance of cabazitaxel therapy, may be required.1 (See Dosage Modification for GI Toxicity under Dosage: Dosage Modification for Toxicity, in Dosage and Administration.)
Renal failure, sometimes fatal, has been reported in patients receiving cabazitaxel,1, 2 generally in association with sepsis, dehydration, or obstructive uropathy; some deaths due to renal failure did not have a clear etiology.1 If renal failure develops during cabazitaxel therapy, appropriate measures should be taken to identify the cause and the renal failure should be treated aggressively.1
Fetal/Neonatal Morbidity and Mortality
Cabazitaxel may cause fetal harm if administered to pregnant women; the drug has been shown to be embryotoxic, fetotoxic, and abortifacient in animals.1 Pregnancy should be avoided during therapy.1 If cabazitaxel is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential fetal hazard.1
Category D.1 (See Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Other Warnings and Precautions, in Cautions.) (See Users Guide.)
Cabazitaxel or its metabolites are distributed into milk in lactating rats.1 It is not known whether cabazitaxel or its metabolites are distributed into human milk.1 Because of the potential for serious adverse reactions to cabazitaxel in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.1
Safety and efficacy of cabazitaxel have not been established in pediatric patients.1
In the TROPIC study in patients with prostate cancer, 65% of patients receiving cabazitaxel and prednisone were 65 years of age or older, while 19% were 75 years of age or older.1 Although no substantial differences in efficacy or pharmacokinetics of cabazitaxel were observed between individuals 65 years of age or older and younger adults, reported frequencies of neutropenia, fatigue, asthenia, pyrexia, dizziness, urinary tract infection, and dehydration were at least 5 percentage points higher in patients 65 years of age or older compared with younger adults.1 In addition, 6% of patients 65 years of age or older, compared with 2% of patients younger than 65 years of age, died within 30 days of the last cabazitaxel dose from a cause other than disease progression.1
Safety and efficacy of cabazitaxel have not been established in patients with hepatic impairment.1 Patients with serum transaminase (AST, ALT) concentrations of 1.5 or more times the upper limit of normal (ULN) or serum bilirubin concentrations at or above the ULN were excluded from the TROPIC study.1
Because cabazitaxel is extensively metabolized in the liver, hepatic impairment is expected to result in increased serum concentrations of the drug.1 Hepatic impairment increases the risk of severe or life-threatening complications of other taxanes (e.g., docetaxel).1, 14 The manufacturer states that cabazitaxel should not be used in patients with hepatic impairment (i.e., AST and/or ALT concentrations of 1.5 or more times the ULN or total serum bilirubin concentrations at or above the ULN).1
Safety and efficacy of cabazitaxel in patients with renal impairment have not been studied specifically to date.1 Only minimal amounts of cabazitaxel (3.7%) are excreted as unchanged drug or metabolites in urine.1 A population pharmacokinetic analysis indicated that mild to moderate renal impairment (creatinine clearance of 30 to less than 80 mL/minute) did not substantially alter cabazitaxel clearance.1 However, no data are available for patients with severe renal impairment (creatinine clearance less than 30 mL/minute) or end-stage renal disease, and the manufacturer states that cabazitaxel should be used with caution in patients with severe renal impairment or end-stage renal disease.1
Adverse effects reported in 10% or more of patients receiving cabazitaxel in combination with prednisone include neutropenia,1, 2 leukopenia,1, 2 anemia,1, 2 thrombocytopenia,1, 2 diarrhea,1, 2 fatigue,1, 2 nausea,1, 2 vomiting,1, 2 constipation,1, 2 asthenia,1, 2 abdominal pain,1, 2 anorexia,1 back pain,1, 2 hematuria,1, 2 peripheral neuropathy,1, 2 pyrexia,1, 2 dyspnea,1, 2 cough,1 dysgeusia,1 arthralgia,1, 2 and alopecia.1 Serious (grade 3 or 4) adverse effects reported in 5% or more of patients receiving cabazitaxel in combination with prednisone include neutropenia,1, 2 leukopenia,1, 2 anemia,1, 2 febrile neutropenia,1, 2 diarrhea,1, 2 fatigue,1, 2 and asthenia.1, 2
No formal drug interaction studies have been performed to date.1
The manufacturer states that cabazitaxel is unlikely to inhibit multidrug resistance proteins MRP1 and MRP2, the efflux transporter P-glycoprotein (P-gp, ABCB1), or breast cancer resistance protein (BCRP) in vivo following administration of the drug at a dose of 25 mg/m2.1 In vitro data indicate that cabazitaxel does not inhibit MRP1 or MRP2; although in vitro inhibition of P-gp transport and BCRP has been observed, inhibition occurred at concentrations at least 38 times those achieved clinically.1
In vitro data indicate that cabazitaxel is a substrate of P-gp, but not a substrate of MRP1, MRP2, or BCRP.1
Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes
Because cabazitaxel is extensively metabolized by cytochrome P-450 (CYP) isoenzyme 3A (CYP3A), potent inhibitors or inducers of this isoenzyme are expected to alter the drug's pharmacokinetics.1 Cabazitaxel does not induce CYP isoenzymes in vitro.1 In vitro data also indicate that cabazitaxel is unlikely to inhibit metabolism of drugs that are substrates of CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5.1
Concomitant use of cabazitaxel with potent inhibitors of CYP3A (e.g., atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) is expected to result in increased plasma cabazitaxel concentrations and should be avoided.1, 4 Moderate CYP3A inhibitors should be used concomitantly with caution.1
Concomitant use of cabazitaxel with potent inducers of CYP3A (e.g., carbamazepine, phenobarbital, phenytoin, rifampin, rifabutin, rifapentine) is expected to result in decreased plasma cabazitaxel concentrations and should be avoided.1, 4 Concomitant use of St. John's wort ( Hypericum perforatum ) also should be avoided.1
Administration of prednisone or prednisolone at a dosage of 10 mg daily did not affect the pharmacokinetics of cabazitaxel.1
Cabazitaxel, a semisynthetic taxoid derived from the major natural taxoid (10-deacetyl baccatin III) extracted from the needles of various species of yew trees ( Taxu s species), is an antimicrotubule antineoplastic agent.1, 4, 9, 10, 13 Cabazitaxel is the 7,10-dimethoxy analog of docetaxel.5 Like other taxanes (e.g., docetaxel, paclitaxel), cabazitaxel binds to β-tubulin subunits on microtubules and stabilizes and suppresses microtubule activity, thereby resulting in mitotic arrest and cell death.1, 3, 4, 9, 10, 11, 12, 13
In preclinical studies, cabazitaxel was active against some cell lines that are resistant to other antineoplastic agents, including anthracyclines, vinca alkaloids, and other taxanes (i.e., docetaxel, paclitaxel).1, 3, 10, 11 Cabazitaxel, a weak substrate for the efflux transporter P-glycoprotein (P-gp), has demonstrated activity in cell lines with acquired resistance to docetaxel resulting from P-gp overexpression and in cell lines with primary resistance to taxanes resulting from increased expression of the multidrug resistance (MDR) gene and its product P-gp.9, 10, 11, 13 Cabazitaxel has demonstrated activity against some taxane-resistant tumors in vivo, including activity against docetaxel-resistant prostate cancer.2, 10, 11
Evidence from animal studies suggests that cabazitaxel may cross the blood-brain barrier to a greater extent than docetaxel or paclitaxel, possibly because of cabazitaxel's lower affinity for P-gp, which is expressed in the blood-brain barrier.9, 10, 11, 12, 13 Animal data suggest that P-gp-mediated transport across the blood-brain barrier can be saturated, resulting in nonlinear accumulation of the drug in the brain.12, 13 The clinical relevance of these findings to neurotoxicity or antitumor effects of the drug in humans is unknown.12
Cabazitaxel is extensively metabolized in the liver, primarily by cytochrome P-450 (CYP) isoenzyme 3A4/5 and to a lesser extent by CYP isoenzyme 2C8.1, 4 About 76% of a dose of cabazitaxel is eliminated in feces as metabolites, and about 3.7% is eliminated in urine as unchanged drug or metabolites; about 20 metabolites of the drug have been identified in urine or feces.1 The terminal elimination half-life of cabazitaxel is 95 hours.1
Risk of hypersensitivity reactions.1 Importance of informing clinician immediately if manifestations of severe hypersensitivity (e.g., rash, itching, dizziness or faintness, difficulty breathing, chest or throat tightness, facial swelling) occur.1 Importance of informing clinician of any history of hypersensitivity to cabazitaxel or other formulations containing polysorbate 80.1
Risk of infection, including severe or potentially fatal infection.1 Importance of routine monitoring of blood cell counts.1 Importance of patients monitoring their temperature frequently and immediately notifying their clinician if fever or other manifestations of infection (e.g., cough, burning on urination, myalgia) occur.1
Risk of dehydration and renal failure.1 Importance of informing clinician if substantial vomiting or diarrhea occurs, decreased urine output occurs, or edema develops.1
Importance of informing geriatric patients that certain adverse effects may be more frequent or severe in older patients.1 (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)
Importance of taking the oral prednisone component of the cabazitaxel/prednisone regimen for prostate cancer as directed.1 Importance of informing clinician if not adherent to the oral prednisone regimen.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Apprise patient of potential hazard to the fetus if used during pregnancy; women of childbearing potential should avoid becoming pregnant.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Additional Information
Overview® (see Users Guide). For additional information on this drug until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. For further information on the handling of antineoplastics agents, see the ASHP Guidelines on Handling Hazardous Drugs at [Web].
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection concentrate, for IV infusion only | 40 mg/mL (60 mg) | Jevtana® (with water for injection containing alcohol 13% w/w diluent) |
AHFS® Drug Information. © Copyright, 1959-2026, Selected Revisions September 9, 2011. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, MD 20814.
1. Sanofi-Aventis. Jevtana® (cabazitaxel) injection prescribing information. Bridgewater, NJ; 2010 Jun.
2. de Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet . 2010; 376:1147-54. [PubMed 20888992]
3. Pal SK, Twardowski P, Sartor O. Critical appraisal of cabazitaxel in the management of advanced prostate cancer. Clin Interv Aging . 2010; 5:395-402. [PubMedCentral][PubMed 21152241]
4. . New treatments for metastatic prostate cancer. Med Lett Drugs Ther . 2010; 52:69-70.
5. Sanofi-Aventis, Bridgewater, NJ: Personal communication.
6. Froehner M, Wirth MP. Cabazitaxel for castration-resistant prostate cancer. Lancet . 2011; 377:121-2; author reply 122-3. [PubMed 21215875]
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9. Kurata T, Shimada Y, Tamura T et al. Phase I and pharmacokinetic study of a new taxoid, RPR 109881A, given as a 1-hour intravenous infusion in patients with advanced solid tumors. J Clin Oncol . 2000; 18:3164-71. [PubMed 10963645]
10. Mita AC, Denis LJ, Rowinsky EK et al. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res . 2009; 15:723-30. [PubMed 19147780]
11. Pivot X, Koralewski P, Hidalgo JL et al. A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol . 2008; 19:1547-52. [PubMed 18436520]
12. Cisternino S, Bourasset F, Archimbaud Y et al. Nonlinear accumulation in the brain of the new taxoid TXD258 following saturation of P-glycoprotein at the blood-brain barrier in mice and rats. Br J Pharmacol . 2003; 138:1367-75. [PubMedCentral][PubMed 12711638]
13. Bouchet BP, Galmarini CM. Cabazitaxel, a new taxane with favorable properties. Drugs Today (Barc) . 2010; 46:735-42. [PubMed 21076710]
14. Sanofi-Aventis. Taxotere® (docetaxel) injection concentrate prescribing information. Bridgewater, NJ; 2010 May.