Gem Carbo NHS

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GEMCITABINE AND CARBOPLATIN

Advanced or metastatic bladder cancer, ureteric cancer or renal pelvis carcinoma, where renal function poor or
patient not fit for cisplatin
Neo-adjuvant or adjuvant use in transitional cell carcinoma in high-risk patients not suitable for cisplatin-based
treatment

Drug / Dosage: Gemcitabine 1000mg/m2 IV Day 1 and Day 8


Carboplatin AUC 5 IV Day 1

Carboplatin dose should be calculated using the Calvert formula:


Dose = Target AUC x (25 + GFR)

It is mandatory for the carboplatin dose to be based on the EDTA result, when available.
Checks should always be made by the prescriber and the screening pharmacist to confirm
whether an EDTA result is available at the start of treatment.

If the EDTA result is not available this should be documented on ARIA, by the prescriber,
before prescribing carboplatin using the Cockcroft & Gault formula to predict creatinine
clearance.
When using Cockcroft & Gault, a “cap” of 125 ml/min should be used for carboplatin dose
calculations.
Carboplatin dose should be re-calculated using the EDTA result, once available, for
subsequent cycles (do not “cap”).

EDTA should only be repeated if there is a 30% change in serum creatinine.

Administration: Gemcitabine diluted in 250 ml 0.9% sodium chloride and infused over 30 minutes
Carboplatin diluted in 250 ml 5% glucose and infused over 30 - 60 minutes

Frequency: 3 weekly cycle


Neo-adjuvant use: 3 – 4 cycles
Palliative use: 6 cycles
Adjuvant use: up to 6 cycles, at discretion of Consultant

Main Toxicities: myelosuppression; erythematous rash; flu-like syndrome;


peripheral oedema (mild-moderate & reversible); infertility / ovarian failure

Anti- emetics: Day 1: highly emetogenic


Day 8: mildly emetogenic

Extravasation: non-vesicants

Regular FBC Day 1 and Day 8


Investigations: U&Es Day 1
LFTs Day 1
EDTA Prior to 1st cycle

Reason for Update: new EDTA statement added Approved by Consultant: C Mikropoulos
Version: 6 Approved by Lead Chemotherapy Nurse: E Masters
Supersedes: Version 5 Date: 23.4.20
Prepared by: S Taylor Checked by: S Seymour
Dose Modifications
Haematological Day 1:
Toxicity: Neutrophils < 1.5 x 109/l Delay treatment for 1 week. Repeat FBC and, if
or normal, proceed with treatment*.
Platelets < 100 x 109/l
*Reduce the gemcitabine dose to 75% of the original cycle initiation dose (and do not
increase this dose again) if any of the following have occurred:
 Neutrophils < 0.5 x 109/l for > 5 days
 Neutrophils < 0.1 x 109/l for > 3 days
 Febrile neutropenia
 Platelets < 25 x 109/l
 Cycle delay of more than one week due to toxicity

Day 8:

Neutrophils Platelets Gemcitabine


> 1.5 x 109/l and  100 x 109/l Give 100% of the Day 1
dose
1.0 – 1.5 x 109/l or 75 – 100 x 109/l Give 50% of the Day 1 dose

< 1.0 x 109/l or < 75 x 109/l Omit


(do not defer)

If a dose reduction to 50% of the Day 1 dose has been made on Day 8, the dose should be
increased to 100% again on Day 1 of the next cycle, providing the FBC has returned to
normal limits.

Renal Impairment: Carboplatin is contra-indicated if GFR < 20 ml/min.

If CrCl < 30ml/min, consider gemcitabine dose reduction – clinical decision

Hepatic Impairment: If bilirubin > 27 μmol/L, initiate treatment with gemcitabine 800mg/m 2

References: Bamias, A et al; Cancer 2006; 106 (2): 297 – 303


Linardou, H et al; Urology 2004; 64 (3): 479 - 484
Dogliotti, L et al; Eur Urol 2007; 52 (1):134 – 41
Haematological dose modifications advice in line with Gemzar SPC

Reason for Update: new EDTA statement added Approved by Consultant: C Mikropoulos
Version: 6 Approved by Lead Chemotherapy Nurse: E Masters
Supersedes: Version 5 Date: 23.4.20
Prepared by: S Taylor Checked by: S Seymour

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