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A - Regimen Name

 

BICABSRL Regimen
Bicalutamide-Buserelin

 

 

Disease Site
Genitourinary - Prostate

 

 

Intent
Neoadjuvant
Adjuvant
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
  • for cytoreduction before brachytherapy
  • in combination with radiotherapy for the treatment of high-risk localized prostate cancer
  • for palliative treatment of recurrent, progressive or metastatic prostate cancer

 

 

 

 

 

 

 

Supplementary Public Funding

buserelin
ODB - General Benefit (buserelin) (

ODB Formulary

)
 

 

bicalutamide
ODB - General Benefit (bicalutamide) (

ODB Formulary

)
 

 

 

 
B - Drug Regimen

 

buserelin
 

6.3 mg               SC depot                 EVERY 2 MONTHS
OR
9.45mg              SC depot                 EVERY 3 MONTHS
(Outpatient prescription in buserelin fixed-dose injection kits of 6.3mg and 9.45mg implant)

bicalutamide
 
50 mgPODaily
(Outpatient prescription in multiples of 50mg tablets)
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C - Cycle Frequency

 

Duration of therapy is dependent on the indication.

  • Neoadjuvant - Generally up to 6 months in duration
  • Adjuvant - Generally up to 3 years
  • Palliative - Continue until disease progression

 

 
D - Premedication and Supportive Measures
 
Antiemetic Regimen:

Not applicable

 
E - Dose Modifications

Dosage with toxicity

 

Buserelin:  No dose adjustment required in myelosuppression.        (Continued on next page)

Bicalutamide:

Toxicity Action
Myelosuppression No adjustment required
PneumonitisHold; investigate.  If confirmed, discontinue.
Cardiac failure, arterial or venous thromboembolismDiscontinue
Grade 3 or 4 LFT increasesDiscontinue

 

 

Hepatic Impairment

Hepatic impairment
Bicalutamide
Buserelin
Mild
No adjustment required

No adjustment required; no studies conducted.

Moderate

Caution as extensively metabolized by liver; lower elimination may lead to accumulation

Severe
 

Renal Impairment

Buserelin:  No adjustment required; no studies conducted.

Bicalutamide:  No adjustment required.
 
F - Adverse Effects
Refer to buserelin, bicalutamide drug monograph(s) for additional details of adverse effects
 

Most Common Side Effects

Less Common Side Effects, but may be Severe or Life-Threatening

  • Hypogonadism and symptoms of ↓ testosterone
  • Disease flare – may be severe (may use short-term antiandrogen therapy for blockade of testosterone flare)
  • Urinary symptoms
  • Insomnia
  • Hypertension
  • Glucose intolerance
  • Hyperlipidemia
  • Anemia
  • Fatigue
  • Edema
  • Musculoskeletal pain
  • Injection site reactions
  • Cough, dyspnea (may be severe)
  • Heart failure
  • Arrhythmia (including  ↑ QTc)
  • Cardiovascular risk
  • Arterial thromboembolism
  • Venous thromboembolism
  • Osteoporosis
  • Pituitary adenoma
  • Hypersensitivity
  • Pneumonitis
  • ↑ LFTs
  • GI obstruction/hemorrhage
  • Depression, mood changes
 
 
 
G - Interactions

Refer to buserelin, bicalutamide drug monograph(s) for additional details

 

 
H - Drug Administration and Special Precautions

Refer to buserelin, bicalutamide drug monograph(s) for additional details

 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Blood pressure monitoring in patients with hypertension; regular
  • Electrolytes, including calcium and magnesium; baseline, also regularly in patients at risk
  • Blood glucose monitoring in diabetic patients or patients at risk of hyperglycemia; baseline and regular
  • Liver function tests; baseline and regular
  • Clinical toxicity assessment for depression, disease flare, osteoporosis, symptoms of hypogonadism, injection site reactions, fluid retention, pneumonitis, thromboembolism, cardiovascular effects, hypersensitivity or local reactions; regular
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • ECG at baseline for patients at risk of QTc prolongation
  • Hemoglobin; baseline and regular
  • Monitoring of bone and prostatic lesions; periodic

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J - Administrative Information
Outpatient prescription; Buserelin depot administration at Cancer Centre or physician's office
 
 
 
K - References

Crook JM, O'Callaghan CJ, Duncan G, et al.  Intermittent androgen suppression for rising PSA levels after radiotherapy.  N Engl J Med 2012;367:895-903.

Denham JW, Steigler A, Lamb DS, et al.  Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial.  Lancet Oncol 2011;12(5):451-9.

Heidenreich A, Bellmunt J, Bolla M, et al. EAU Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Treatment of Clinically Localised Disease. European Urology 2011;59:61-71.

Loblaw DA, Virgo KS, Nam R, et al. Initial Hormonal Management of Androgen-Sensitive Metastatic, Recurrent, or Progressive Prostate Cancer: 2006 Update of an American Society of Clinical Oncology Practice Guideline. J Clin Oncol 2007; 25: 1596-605.

Mottet N, Bellmunt J, Bolla M, et al  EAU guidelines on prostate cancer.  Part II:  Treatment of advanced, relapsing, and castration resistant prostate cancer.  European Urology 2011:59;572-83.

October 2017 Replaced regimen category with evidence-informed

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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.