Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
CISPGEMC
Adjuvant
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.
- Neoadjuvant treatment of transitional cell carcinoma of the bladder*
- Adjuvant treatment of deep muscle-invasive transitional cell carcinoma of the bladder*
Standard schedule:
gemcitabine | 1000 mg /m² | IV | Days 1, 8 and 15 |
CISplatin | 70 mg /m² | IV | Day 1 |
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gemcitabine | 1000-1250 mg /m² | IV | Days 1 and 8 |
CISplatin | 70 mg /m² | IV | Day 1 |
Standard Schedule: REPEAT EVERY 28 DAYS
Alternative Schedule: REPEAT EVERY 21 DAYS
Neoadjuvant / Adjuvant: For 3 to 4 cycles unless disease progression or unacceptable toxicity occurs
High (D1)
Low (D8, 15)
Moderate
Other Supportive Care:
Standard regimens for Cisplatin premedication and hydration should be followed. Refer to institutional guidelines.
Also refer to CCO Antiemetic Recommendations.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Dose on Day 1 of Cycle:
Worst Toxicity in Previous Cycle
|
Gemcitabine
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Cisplatin
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||
Non-Hematologic
(related organ)
|
|
Hematologic
|
% Full Dose*
|
% Full Dose*
|
Grade 3 |
or
|
Febrile neutropenia, thrombocytopenic bleeding |
75%
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75%
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Grade 4
|
|
|
Consider discontinuing, or ↓ to 75%
|
Consider discontinuing, or ↓ to 75% |
Day 8 or 15 holds in > 1 cycle |
75%
|
100%
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||
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Discontinue
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Discontinue
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Dose on Day 8 and 15 (if applicable) of Cycle:
Toxicity on Day 8 or 15 of cycle
|
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||||
Non-hematologic
(related organ)
|
|
Hematologic
|
Gemcitabine
(% Full Dose)
|
||
AGC
(x 106/L)
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Platelets
(x 106/L)
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|||
≤ grade 2 |
and
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> 1000 |
and
|
> 100,000 |
100%
|
≤ grade 2 |
and
|
500-1000
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or
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50,000-100,000
|
Consider Omit*, or ↓ to 75% |
Grade 3 or 4 |
or
|
< 500 |
or
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< 50,000 |
Omit*, ↓ to 75% at restart (if applicable) for non-hematologic toxicity
|
Pneumonitis, HUS, SJS, TEN, CLS |
|
-
|
|
-
|
Discontinue
|
Hepatic Impairment
Bilirubin
|
|
AST/ALT
|
Gemcitabine
(% previous dose)
|
Cisplatin
(% previous dose)
|
1-2 x ULN
|
and/ or
|
<2 x ULN
|
100%
|
100%
|
2-4 x ULN
|
2-5 x ULN
|
Caution
|
100%
|
|
> 4 x ULN
|
> 5 x ULN
|
Caution, consider ↓
|
Caution, consider↓
|
Renal Impairment
Creatinine Clearance (mL/min) |
Gemcitabine
(% previous dose)
|
Cisplatin
(% previous dose)
|
> 60
|
100%
|
100%
|
>45-60
|
Caution
|
75%
|
30-45
|
Caution
|
50%
|
< 30
|
Consider discontinuing or ↓
|
Discontinue
|
Refer to gemcitabine, CISplatin drug monograph(s) for additional details of adverse effects
Most Common Side Effects |
Less Common Side Effects, but may be Severe or Life-Threatening |
|
|
Refer to gemcitabine, CISplatin drug monograph(s) for additional details
Recommended Clinical Monitoring
- CBC; baseline and before each cycle
- Electrolytes, including magnesium, sodium, potassium, phosphate and calcium; baseline and regular
- Liver function tests; baseline and regular
- Renal function tests; baseline and regular
- Audiogram; baseline as clinically indicated
- Clinical toxicity assessment (infection, bleeding, flu-like symptoms, lethargy, dyspnea, rash, nausea/vomiting and other GI effects, neurotoxicity, ototoxicity); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
INR for patient receiving warfarin; Baseline and as clinically indicated
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Cisplatin, gemcitabine drug monographs, Cancer Care Ontario.
Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol 2005;48(2):202-5.
Booth CM, Siemens DR, Li G, et al. Perioperative chemotherapy for muscle-invasive bladder cancer: A population-based outcomes study. Cancer 2014;120(11):1630-8.
Fléchon A, Fizazi K, Gourgou-Bourgade S, et al. Gemcitabine and cisplatin after radical cystectomy for bladder cancer in an adjuvant setting: feasibility study from the Genito-Urinary Group of the French Federation of Cancer Centers. Anticancer Drugs 2006;17(6):705-8.
Herchenhorn D, Dienstmann R, Peixoto FA, et al. Phase II trial of neoadjuvant gemcitabine and cisplatin in patients with resectable bladder carcinoma. Int Braz J Urol 2007;33(5):630-8.
Yeshchina O, Badalato GM, Wosnitzer MS, et al. Relative efficacy of perioperative gemcitabine and cisplatin versus methotrexate, vinblastine, adriamycin, and cisplatin in the management of locally advanced urothelial carcinoma of the bladder. Urology 2012 Feb;79(2):384-90.
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.
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