Written by: Alyson Leonard, PharmD, BCPS, BCOP Cone Health
Download Here
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
The CARD trial evaluated the use of cabazitaxel with prednisone/prednisolone and G-CSF for patients with mCRPC previously treated with docetaxel and an androgen- signaling -targeted inhibitor (abiraterone or enzalutamide) who had progressed within 12 months. The study compared cabazitaxel to initiation of another androgen- signaling -targeted inhibitor not previously used. The median radiographic progression-free survival was 8 months with cabazitaxel + prednisone/prednisolone + G-CSF and 3.7 months with abiraterone + prednisone/prednisolone or enzalutamide (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.1,4
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. (ex. 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, strongly 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
- Withdraw 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
- 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; December 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.
