Written by: Alyson Leonard, PharmD, BCPS,BCOP Cone Health
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Cabazitaxel is indicated for treatment of patients with metastatic castration-resistant prostate (mCRPC) cancer previously treated with a docetaxel-containing treatment regimen in combination with prednisone.1 The purpose of this PQI is to provide guidance for initiating cabazitaxel.
Background
Cabazitaxel was FDA approved in 2010 based on information from the phase 3 trial TROPIC that compared cabazitaxel plus prednisone to mitoxantrone in patients with mCRPC previously treated with a docetaxel-based treatment.2 The recommended dose of cabazitaxel is now 20mg/m2 every 3 weeks, the higher dose of 25mg/m2 can be used at provider discretion for select patients.1,3
In 2019, the CARD study evaluated the use of cabazitaxel as a third line option for patients with mCRPC previously treated with docetaxel and an androgen- signaling -targeted inhibitor (abiraterone or enzalutamide) who progressed within 12 months. The study compared cabazitaxel to initiation of another androgen- signaling -targeted inhibitor not previously used. The median imaging-based progression-free survival was 8 months with cabazitaxel and 3.7 months with androgen- signaling -targeted inhibitors (HR 0.54, p<0.0001). When comparing median overall survival, cabazitaxel had a longer overall survival compared to androgen-signaling-targeted inhibitor, 13.6 months vs 11 months. Overall, cabazitaxel was associated with a 36% risk of death reduction. Secondary objectives of improvement in PFS, pain response, and time to symptomatic skeletal events favored cabazitaxel.4
PQI Process:
- Review the medical record
- Review past treatments for documentation of previous docetaxel administration.
- If docetaxel was not previously given, evaluate the reason for non-use. Per guidelines, patients who are not candidates for docetaxel can still be considered for cabazitaxel. (e.g. pre-existing mild neuropathy prevented docetaxel use)5
- Review labs for a recent CBC. Cabazitaxel is contraindicated in patients with neutrophil counts currently ≤1,500 cells/mm1
- Review past treatments for documentation of previous docetaxel administration.
- Review treatment plan: 1
- Verify pre-medication orders:
- Antihistamine: diphenhydramine 25 mg or equivalent antihistamine
- Corticosteroid: dexamethasone 8 mg or equivalent steroid
- H2antagonist: famotidine 20 mg or equivalent H2 antagonist
- Verify Cabazitaxel dosing: 20 mg/m2administered every three weeks as a one-hour intravenous infusion
- Dose adjustments needed for hepatic impairment; no adjustment necessary for renal impairment
- If provider is starting dosing as 25 mg/m2, consider G-CSF and CINV prophylaxis, incidence of grade 3-4 nausea at this dose was 2% and grade 3-4 vomiting was 2%1
- Verify a prescription for prednisone has been entered
- Verify a prescription or order for antiemetic: prophylaxis recommended as needed (PO or IV)
- Evaluate the need for primary prophylaxis with G-CSF
- Recommended for patient with high risk clinical features such as previous episodes of febrile neutropenia, older patients, extensive prior radiation, poor performance or nutritional status, or other serious comorbidities
- Verify pre-medication orders:
- Monitoring1
- CBC: baseline, weekly during cycle one, then before each treatment cycle
- Preparation1
- Cabazitaxel requires two dilutions for preparation
- Mix cabazitaxel vial with the entire contents of the included 5.7 mL diluent vial
- Withdrawal the patient specific dose of cabazitaxel
- Inject dose into a 250 mL PVC-free container of 0.9% sodium chloride (NS) or 5% dextrose (D5W)
- If dose is >65mg use a larger volume solution so the concentration is ≤0.26 mg/mL
- Mix the final infusion solution by gently inverting the bag
- Administration1
- IV over hour with a 0.22-mcm nominal pore size inline filter
Patient Centered Activities:
- Patient Education
- Review the risk of infusion reactions, with cabazitaxel they are most likely to occur during first or second infusion. Signs of a reaction may include rash/itching, feeling dizzy, chest or throat tightness, breathing problems, face swelling
- Instruct patient to report any adverse events, such as fever, diarrhea, nausea/vomiting, numbness/tingling of the hands or feet, or fatigue
- Ensure patient has access to supportive medications
- Anti-nausea: (ex. 5-HT3 receptor antagonist, metoclopramide, or prochlorperazine)
- Anti-diarrheal: (ex. loperamide)
- Provide written information to patient on medication
Supplemental Information
- CareASSIST Patient Support Program6
- Program can assist eligible patients with no insurance coverage or who lack coverage for the prescribed therapy
- *Medicare Part B patients with no supplemental insurance coverage may be eligible
- Program can assist eligible patients with no insurance coverage or who lack coverage for the prescribed therapy
- CareASSIST Copay Program5
- Available to commercial insurance patient to help decrease out of pocket cost
References:
- Jevtana (cabazitaxel) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; March 2020
- 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(9747):1147-1154.
- Eisenberger M, Hardy-Bessard AC, Kim CS, et al. Phase III Study Comparing a Reduced Dose of Cabazitaxel (20 mg/m2) and the Currently Approved Dose (25 mg/m2) in Postdocetaxel Patients With Metastatic Castration-Resistant Prostate Cancer-PROSELICA. J Clin Oncol. 2017;35(28):3198-3206.
- de Wit R, de Bono J, Sternberg CN, et al. Cabazitaxel versus Abiraterone or Enzalutamide in Metastatic Prostate Cancer. N Engl J Med. 2019;381(26):2506-2518.
- National Comprehensive Cancer Network. Prostate Cancer (Version 2.2020). https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Accessed August 22, 2020
- CareASSIST by Sanofi Genzyme, https://www.sanoficareassist.com/hcp/jevtana.
