Drug Formulary information is intended for use by healthcare professionals. It is not intended to be medical advice. Some of the information, including information about funding for cancer drugs, does not apply to all patients. Cancer treatment plans are unique to each patient. If you are a patient, please speak with your healthcare team to understand how this information applies to you.
CYCLTOPO
Sarcoma - Soft Tissue
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.
| cyclophosphamide | 250 mg /m² | IV | Days 1 to 5 |
| topotecan | 0.75 mg /m² | IV | Days 1 to 5 |
Moderate
Other Supportive Care:
- Consider prophylactic growth factor support (according to local practice) especially for heavily pretreated patients.
- Ensure patient receives appropriate PO/IV hydration.
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
|
Toxicity
|
Topotecan (% previous dose)*
|
Cyclophosphamide (% previous dose)*
|
|
Grade 4 neutropenia ≥ 7 days, or
Febrile neutropenia, or
Previous delay due to neutropenia
|
↓ 20%
|
↓ 20%
|
|
Platelets ≤ 25 X 109/L or bleeding
|
↓ 20%
|
↓ 20%
|
|
Grade 3 non-hematological toxicities
|
↓ 20%
|
↓ 20%
|
|
Grade 4 non-hematological toxicities
|
Discontinue
|
Discontinue
|
|
Cystitis
|
No change
|
Consider dose reduction
|
*Do not retreat until major organ toxicities ≤ grade 2, neutrophils ≥ 1.5 X 109/L; platelets ≥ 100 X 109/L, and hemoglobin ≥ 90 g/L (after transfusion if necessary).
Hepatic Impairment
|
Topotecan
|
Cyclophosphamide
|
|
No adjustments required for bilirubin < 171 μmol/L
|
No adjustments required
|
Renal Impairment
|
Creatinine Clearance (mL/min)
|
Topotecan (% previous dose)
|
Cyclophosphamide (% previous dose)
|
|
>40
|
100%
|
100%
|
|
>30-40
|
50%
|
|
|
20-30
|
50-75%
|
|
|
10-<20
|
DISCONTINUE
|
|
|
<10
|
50% or OMIT
|
Refer to cyclophosphamide, topotecan drug monograph(s) for additional details of adverse effects
| Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
Recommended Clinical Monitoring
- Baseline and regular CBC – counts must be assessed prior to each cycle.
- Clinical toxicity assessment of infection GI, pulmonary, dermatologic, GU effects.
- Baseline and regular hepatic and renal function tests and urinalysis
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Hunold A, Weddeling N, Paulussen M, et al. Topotecan and cyclophosphamide in patients with refractory or relapsed Ewing tumors. Pediatric Blood & Cancer 2006; 47: 795–800.
Saylors RL, Stine KC, Sullivan J, et al. Cyclophosphamide plus topotecan in children With recurrent or refractory solid tumors: A Pediatric Oncology Group Phase II Study. J Clin Oncol 2001; 19: 3463-9.
June 2021 removed "unfunded" flag for topotecan
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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