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regimen-monograph

A - Regimen Name

CISPGEMC Regimen
Gemcitabine-CISplatin (Neoadjuvant)
(Neoadjuvant)


Disease Site
Genitourinary - Bladder

Intent
Neoadjuvant

Regimen Category
Emergent :

Regimens that may eventually be ‘evidenced informed’, but are still undergoing review.  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
Neoadjuvant treatment of transitional cell carcinoma of the bladder.
 
B - Drug Regimen

gemcitabine

(Round to nearest 10mg)
1000 mg /m² IV Days 1, 8 & 15*
CISplatin

(Round to nearest 1mg)
70 mg /m² IV Day 1 or 2

*Some centres use a q21day schedule with gemcitabine 1000-1250 mg/m2 on days 1 and 8, and cisplatin 70 mg/m2 on day 1.

 

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C - Cycle Frequency

REPEAT EVERY 28 DAYS

Usually 3 to 4 cycles

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (Day 1 or 2 - with cisplatin)
Low (Days 1 (if gemcitabine only), 8 and 15)

Other Supportive Care:

Standard regimens for Cisplatin premedication and hydration should be followed. Refer to Cisplatin monograph
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated. The following recommendations are in use at some centres.

Dosage with toxicity

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Dose on Day 1 of Cycle:

Worst Toxicity in Previous Cycle
 
Gemcitabine
 
Cisplatin
 
Non-Hematologic
(related organ)
 
Hematologic
 
% Full Dose*
 
% Full Dose*
Grade 3
or
Febrile neutropenia, thrombocytopenic bleeding 
 
 
75%
 
75%.
           Grade 4
 
 
 
 
Consider discontinuing,
or ↓ to 75%
 
Consider discontinuing,
or ↓ to 75%
 
Day 8 holds in > 1 cycle
 
75%
 
100%
 
Pneumonitis or HUS
 
 
Discontinue
 
Discontinue
 

* Do not restart until ANC ≥ 1500x 106/L, platelets ≥ 100,000 x 106/L and non-hematologic toxicity ≤ grade 2 

Dose on Day 8 of Cycle:  

Toxicity on Day 8 of cycle
 
Non-hematologic
(related organ)
 
Hematologic
Gemcitabine
(% Full Dose)
AGC
(x 106/L)
 
Platelets
(x 106/L)
≤ grade 2
and
> 1000
and
> 100,000
100%
≤ grade 2
and
500-1000
 
or
50,000-100,000
Consider Omit,
or ↓ to 75%
Grade 3 or 4
or
< 500
or
< 50,000
Omit
Pneumonitis, Hemolytic Uremic Syndrome
 
-
 
-
Discontinue
If the Q28day protocol is used, these modifications apply to day 15 gemcitabine as well.



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%
40-60
100%
75%
20-40
Caution
50%
< 20
Consider discontinuing or ↓
Discontinue

 
F - Adverse Effects
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

  • Myelosuppression ± infection
  • Fatigue and flu-like symptoms
  • Nausea and vomiting
  • Increase in bilirubin/LFTs
  • Neurotoxicity (including ototoxicity)
  • Nephrotoxicity (may be severe, includes SIADH / electrolyte abnormalities)
  • Diarrhea, stomatitis
  • Edema
  • Anorexia
  • Rash

       

  • Hemolytic Uremic Syndrome
  • Hemolytic anemia, thrombotic microangiopathy
  • Pneumonitis, ARDS
  • Myocardial infarction, arrhythmia
  • Arterial, venous thromboembolism
 
G - Interactions
Refer to gemcitabine, CISplatin drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to gemcitabine, CISplatin drug monograph(s) for additional details
 
I - Recommended Clinical Monitoring

Recommended Clinical Monitoring

  • Clinical toxicity assessment (including fatigue, neurotoxicity, ototoxicity, rash, edema, infection, bleeding, pulmonary). 
  • CBC before each cycle and on day 8. Interim counts should be done in first cycle and repeated if dose modifications necessary
  • Baseline and regular renal function tests (including electrolytes and magnesium) and urinalysis
  • Baseline and regular liver function tests
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

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J - Administrative Information

Approximate Patient Visit
Day 1: 4 to 5 hours; Gemcitabine only day: 0.75 hour
 
K - References
Dash A, Pettus JA, Herr HW, et al. A Role for Neoadjuvant Gemcitabine Plus Cisplatin in
Muscle-Invasive Urothelial Carcinoma of the Bladder: A Retrospective Experience. Cancer 2008;113:2471–7.
 
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 Sep-Oct;33(5):630-8. 
 


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L - Other Notes
December 2011:  Modified section F
 
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.
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Last Updated: July 21, 2026