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A - Regimen Name

BICA Regimen
Bicalutamide


Disease Site
Genitourinary - Prostate

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses

Treatment of metastatic prostate (D2) cancer in combination with surgical or medical castration


Supplementary Public Funding

bicalutamide
ODB - General Benefit (bicalutamide) (ODB Formulary )

 
B - Drug Regimen

bicalutamide
50 mg PO Daily

(Outpatient prescription in multiples of 50mg tablets)

 

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C - Cycle Frequency

CONTINUOUS TREATMENT

Until disease progression or unacceptable toxicity.

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Not applicable

Patients should be advised to avoid direct exposure to excessive sunlight and may consider the use of sunscreens.

 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs.

Bicalutamide should be started at the same time as the LHRH analogue for patients who have not had surgical castration. Bicalutamide doses of 150 mg/day should not be used as this increases mortality (phase III localized prostate trials).

Dosage with toxicity

Toxicity Action
Myelosuppression No adjustment required
Pneumonitis Hold; investigate.  If confirmed, discontinue.
Cardiac failure, arterial or venous thromboembolism Discontinue
Grade 3 or 4 LFT increases Discontinue



Hepatic Impairment

No adjustment required in the presence of mild hepatic impairment. Caution should be exercised in moderate to severe hepatic impairment, as bicalutamide is extensively metabolized in the liver. Elimination is lower in subjects with severe hepatic impairment, leading to increased accumulation.


Renal Impairment

No adjustment required.


Dosage in the Elderly

No adjustment required.

 


 
F - Adverse Effects

Refer to bicalutamide drug monograph(s) for additional details of adverse effects


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Androgen deprivation symptoms (may be severe)
  • Musculoskeletal pain
  • Abdominal pain
  • Nausea, vomiting
  • Constipation 
  • Diarrhea
  • Fatigue
  • Edema
  • Anemia
  • Infection
  • Urinary symptoms
  • Cough, dyspnea (may be severe)
  • Dizziness
  • Arrhythmia
  • Arterial thromboembolism
  • Venous thromboembolism
  • Cardiotoxicity
  • Increased LFTs
  • Hyperglycemia
  • GI hemorrhage
  • GI obstruction
  • Hypersensitivity
  • Pneumonitis
  • Photosensitivity 
 
G - Interactions

Refer to bicalutamide drug monograph(s) for additional details


  • Monitor INR closely with warfarin and adjust warfarin dose accordingly
  • Caution with QT prolonging drugs
  • Caution with CYP3A4 substrates with a narrow therapeutic range
 
H - Drug Administration and Special Precautions

Refer to bicalutamide drug monograph(s) for additional details


Administration:

  • Outpatient prescription for home administration
  • May be taken with or without food


Contraindications:

  • Patients with hypersensitivity to the drug or any of its components
  • Localized prostate cancer patients undergoing ”watchful waiting”
  • Females and children.

Precautions:

  • contains lactose; use should be carefully considered in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
  • results in fluid retention and should be used with caution in patients with cardiac disease as well as in patients at risk for prolonged QTc

Pregnancy and lactation:

  • CONTRAINDICATED in pregnancy and breastfeeding. Patients and their partners should use adequate contraception for at least 130 days after the last dose.
  •  Fertility effects: Probable. Male fertility impairment may be reversible.

 

 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • Liver function tests; baseline and regular
  • Electrolytes; baseline, also during treatment for patients at risk of electrolyte abnormality and QT prolongation
  • ECG; baseline; also during treatment for patients at risk of QT prolongation
  • Blood glucose; especially in diabetic patients; baseline and regular
  • Bone density; as clinically indicated
  • INR, for patients on warfarin; as clinically indicated
  • Clinical assessment for fluid retention, pneumonitis, androgen withdrawal effects, cardiovascular, hepatic effects and thromboembolism; at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Hemoglobin; baseline and as clinically indicated

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J - Administrative Information
Outpatient prescription for home administration

 
K - References
Bicalutamide drug monograph, Cancer Care Ontario.
 
Denis LJ, Griffiths K. Endocrine treatment in prostate cancer. Semin Surg Oncol. 2000;18:52-74
 
Goa KL, Spencer CM. Bicalutamide in advanced prostate cancer. Drugs & Aging 1998 May; 12(5): 401-22.
 
Prostate Cancer Trialists’ Collaborative Group. Maximum androgen blockade in advanced prostate cancer: an overview of the randomized trials. Lancet. 2000 Apr 29; 355(92140: 1491-8.
 
Schellhammer P, Sharafi, R, Block N, et al. Clinical benefits of bicalutamide compared with flutamide in combined androgen blockade for patients with advanced prostatic carcinoma: final report of a double-blind, randomized, muticenter trial. Urology 1997; 50(3): 330-336.
 
Schellhammer P, Sharifi R, Block N et al. A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Urology. May 1995; 45(5): 745-52.

May 2019 Updated emetic risk category


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.