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A - Regimen Name

CISPGEMC Regimen
Gemcitabine-CISplatin


Disease Site
Head and Neck

(Nasopharynx)


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.

 
B - Drug Regimen

gemcitabine
1000 mg /m² IV Days 1 and 8
CISplatin
70 mg /m² IV Day 1


REPEAT EVERY 21 DAYS

 

Alternative Schedule:

gemcitabine
1000 mg /m² IV Days 1, 8 and 15
CISplatin
70 mg /m² IV Day 1


REPEAT EVERY 28 DAYS

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C - Cycle Frequency

Up to 6 cycles unless disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

High (D1)
Low (D8)

Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

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 have been adapted from clinical trials or product monographs and could be considered.

Dosage with toxicity

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%
 
Non-Hematologic (related organ)   Hematologic Gemcitabine % Full Dose* Cisplatin % Full Dose*
  • Pneumonitis
  • Hemolytic Uremic Syndrome (HUS)
  • Stevens-Johnson syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Capillary Leak Syndrome (CLS)
    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 (or 15) 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; ↓ to 75% at restart  (if applicable) for non-hematolgic 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

 


Dosage in the Elderly

gemcitabine:  Clearance is lower in the elderly but no dose adjustment necessary.

 

CISplatin:  Geriatric patients may be at higher risk of developing nephrotoxicity, ototoxicity/neurotoxicity or hematologic adverse effects.

 


 
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, bleeding (may be severe)
  • Fatigue, flu-like symptoms, musculoskeletal pain
  • Edema
  • Nausea and vomiting
  • Diarrhea, anorexia
  • Elevated LFTs (may be severe)
  • Neurotoxicity and ototoxicity (may be severe)
  • Nephrotoxicity (may be severe), proteinuria
  • Electrolyte abnormalities
  • Rash (may be severe)

       

  • Hemolytic uremic syndrome, vasculitis
  • Hemolysis
  • Pneumonitis, ARDS
  • Capillary leak syndrome
  • Arrhythmia
  • Cardiotoxicity
  • Arterial thromboembolism
  • Venous thromboembolism
  • Secondary malignancy
  • Seizures
  • Hypersensitivity
 
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

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

  • CBC; baseline and at each visit
  • Electrolytes, including magnesium, sodium, potassium, phosphate and calcium; baseline and regular
  • Liver function tests; baseline and regular
  • Renal function tests; baseline and regular
  • Audiogram; 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

Audiogram; Periodic
Liver function tests; Baseline and regular
INR for patient receiving warfarin; Baseline and regular
Urinalysis; Baseline and regular


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J - Administrative Information

Approximate Patient Visit
Day 1: 4 to 5 hours; Gemcitabine only day: 0.75 hour
Pharmacy Workload (average time per visit)
31.387 minutes
Nursing Workload (average time per visit)
40.000 minutes
 
K - References

Cisplatin and gemcitabine drug monographs, Cancer Care Ontario.

Foo K-F, Tan E-H, Leong S-S, et al. Gemcitabine in metastatic nasopharyngeal carcinoma of the undifferentiated type. Ann Oncol 2002; 13: 150-156.

Ma BY, Tannock IF, Pond G, Edmonds MR, Siu LL. Chemotherapy with gemcitabine-containing regimens for locally recurrent or metastatic nasopharyngeal carcinoma. Cancer, 2002; 95: 2516-2523.

Ngan RKC, Yiu HHY, Lau WH, et al. Combination gemcitabine and cisplatin chemotherapy for metastatic or recurrent nasopharyngeal carcinoma: report of a phase II study. Ann Oncol, 2002; 13: 1252-1258.

Zhang L, Huang Y, Hong S, et al.  Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial.  Lancet 2016;388(10054):1883-92.


PEBC Advice Documents or Guidelines

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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.