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A - Regimen Name

CISPTOPO Regimen
Topotecan-CISplatin


Disease Site
Gynecologic - Cervix

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.


Rationale and Uses

Patients with metastatic, recurrent cervical cancer should be offered the opportunity to participate in randomized trials. If trials are not available, cisplatin in combination with topotecan should be offered to women for whom first line treatment with chemotherapy is indicated

 
B - Drug Regimen

topotecan
0.75 mg /m² IV Days 1 to 3
(This drug is not currently publicly funded for this regimen and intent)

 

 

CISplatin
50 mg /m² IV Day 1 (give after topotecan)
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until evidence of stable disease, metastatic progression or limited by toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Moderate (D1)
Low (D2,3)

Other Supportive Care:

Standard regimens for Cisplatin premedication and hydration should be followed. Refer to Cisplatin monograph

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

See Appendix 6 for general recommendations.

Prior to the first cycle, patients must have a baseline neutrophil count of ≥ 1.5 x 109/L, a platelet count of ≥ 100 x 109/L, and a hemoglobin level of ≥ 90 g/L.

Do not retreat with topotecan and cisplatin, unless absolute neutrophil count recovers to ≥ 1.5 X 109/L and platelet count ≥ 100 X 109/L. Treatment to be delayed until blood counts have returned to acceptable levels.

Severe hematological toxicities should be managed by dose modification and the use of granulocyte-colony–stimulating factors (G-CSFs) in subsequent cycles.

At the time of retreatment, chemotherapy doses were adjusted based on nadir blood counts and interval toxicity:

Toxicity (Grade/ Counts x 109)

 

Toxicity  (Grade/
Counts x109)

Topotecan1

Cisplatin 1

Platelets 25-50

and/or

ANC 0.5-1

↓ by 20%2

↓ by 20%

Febrile Neutropenia

Platelets < 25

and/or

ANC < 0.5

↓ by 40%

↓ by 40%

Grade 2 Neurotoxicity

No change

Consider ↓

Grade 3  Neurotoxicity

No change

Hold and ↓ by 20%

Grade 3 other non-hematological

Hold and ↓ by 20%

Hold and ↓ by 20%

Grade 4 other non-hematological

Discontinue

Discontinue

1 Do not retreat until toxicity ≤ grade 2 and ANC  ≥ 1.5 X 109  /L and platelet count ≥ 100 X 109  /L. 
2 Consider growth factor support if febrile neutropenia recurs after dose ↓



Hepatic Impairment

  

Bilirubin (μmol/L)
Cisplatin (% previous dose)
Topotecan dose 
<171
No dose adjustment required
No dose adjustment required
 
171
No data found

Renal Impairment

Creatinine clearance
(mL/min)
Cisplatin (% previous dose)
Topotecan (% previous dose)
40-50
50-75%
No change
20 - <40
50%
10 - <20
OMIT
CONTRAINDICATED
<10

 
F - Adverse Effects
Refer to topotecan, 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 and bleeding (may be severe)
  • Nausea and vomiting
  • Neurotoxicity and ototoxicity
  • Nephrotoxicity ± electrolyte abnormality (may be severe)
  • Alopecia
  • Fatigue
  • Diarrhea (may be severe)
  • Rash (may be severe)
  • Stomatitis
  • Interstitial lung disease
  • Arterial thromboembolism
  • Hemolysis, thrombotic microangiopathy
 
G - Interactions
Refer to topotecan, CISplatin drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions

Refer to topotecan, 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

  • Clinical toxicity assessment (including gastrointestinal, infection, bleeding, pulmonary, skin toxicity, neurotoxicity and ototoxicity).
  • 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 (including electrolytes and magnesium) 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: 3-4 hours; Days 2-3: 0.5 hour
Pharmacy Workload (average time per visit)
17.887 minutes
Nursing Workload (average time per visit)
53.333 minutes
 
K - References

Cisplatin and topotecan drug monographs, Cancer Care Ontario.

Long HJ, III, Bundy BN, Grendys EC, et al. Randomized phase III trial of cisplatin with or without topotecan in carcinoma of the uterine cervix: a Gynecologic Oncology Group Study. J Clin Oncol. 2005;23(21):4626-33.

 


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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.