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Les renseignements du Formulaire de médicaments s’adressent aux professionnels de la santé. Il ne s’agit pas d’un avis médical. Certains des renseignements, y compris ceux sur le financement des médicaments anticancéreux, ne s’appliquent pas à tous les patients. Les plans de traitement du cancer sont propres à chaque patient. Si vous êtes un patient, veuillez parler avec votre équipe soignante pour comprendre comment ces renseignements s’appliquent à vous.

A - Regimen Name

CISPETOP(RT) Regimen
CISplatin-Etoposide


Disease Site
Lung - Non-Small Cell
Lung - Small Cell

Intent
Neoadjuvant
Adjuvant
Curative
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

CISplatin
50 mg /m² IV Days 1, 8, 29, 36
etoposide
50 mg /m² IV Days 1 to 5 and 29 to 33

 

Concurrent with RADIOTHERAPY

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C - Cycle Frequency

8 WEEK CYCLE

One cycle during concurrent radiotherapy
Some centres give an additional 8-week cycle of cisplatin and etoposide after completion of radiation

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate (D1, 8, 29, 36)
Low (D2-5, 30-33)


Febrile Neutropenia Risk:

High

Consider G-CSF prophylaxis for patients at high risk of febrile neutropenia. See G-CSF recommendations.


Other Supportive Care:

Also refer to CCO Antiemetic Recommendations.

 
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

Hematologic Toxicities:  Refer to Appendix 6 for general recommendations.
 
In clinical trials,
  • Cisplatin was omitted on day 8 or 36 for grade 4 neutropenia or febrile neutropenia, during concurrent chemoradiotherapy. A break in radiation was allowed for grade 4 neutropenia.
  • Cisplatin and etoposide were delayed 1 week on day 29 for an ANC < 1.5 x 109/L or a platelet count < 100 x 109/L.
  • Etoposide was reduced to 4 days, if febrile neutropenia occurred during the previous cycle.

 

 

 

Non-Hematologic Toxicities
In clinical trials:
  • Cisplatin was omitted on day 8 or 36 for grade 4 esophagitis. A break in radiation was allowed for severe esophagitis requiring parenteral alimentation.
  • Cisplatin and etoposide were delayed 1 week on day 29 for > grade 3 non-hematological toxicity.



Hepatic Impairment

Bilirubin
Action
1. If Bilirubin 1-2 x ULN
REDUCE Etoposide to 50% dose
2. If Bilirubin 2-4 x ULN
REDUCE Etoposide to 25% dose
3. If Bilirubin > 4 x ULN
OMIT Etoposide

Renal Impairment

Creatinine Clearance
Action
1. If CrCl 10 – 50 mL/min OMIT Cisplatin* and REDUCE Etoposide to 75% dose
2. If CrCl < 10 mL/min
REDUCE Etoposide to 50% dose, and OMIT Cisplatin* dose

*In clinical trials:

Cisplatin was omitted if the serum creatinine was > 1.7 mg/dL and the calculated creatinine clearance was < 45 mL/min. After a one week delay, cisplatin was reduced to 25 mg/m2, if the serum creatinine was > 1.7 mg/dL but < 2 mg/dL and the calculated creatinine clearance was > 45 mL/min. 


 
F - Adverse Effects
Refer to CISplatin, etoposide drug monograph(s) for additional details of adverse effects

Most Frequently Occurring Adverse Effects
·         Nausea and Vomiting
·         Nephrotoxicity
·         Neurotoxicity and ototoxicity
·         Myelosuppression
·         Fatigue
 
G - Interactions
Refer to CISplatin, etoposide drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to CISplatin, etoposide 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

  • Clinical toxicity assessment (including neurotoxicity, ototoxicity); at each visit
  • CBC before each cycle. Interim counts should be done in first cycle and repeated if dose modifications necessary
  • Baseline and regular liver and renal function tests (including electrolytes and magnesium) and urinalysis
  • Blood pressure monitoring during infusion
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version


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J - Administrative Information

Approximate Patient Visit
Days 1, 8, 29, 36: 4 hours; Etoposide only: 1 hour
Pharmacy Workload (average time per visit)
13.451 minutes
Nursing Workload (average time per visit)
40.833 minutes
 
K - References

Albain KS, Swann RS, Rusch VR, et al. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer: a phase III randomised controlled trial. Lancet 2009; 374: 379-86.

Cisplatin and etoposide drug monographs, Cancer Care Ontario.

 



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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.