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TOPO

Cancer Type: Gynecologic, Ovary  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
New Drug Funding Program
    Topotecan - Single Agent Treatment of Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer
New Drug Funding Program
    Topotecan - Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer
A - Regimen Name

TOPO Regimen
Topotecan


Disease Site
Gynecologic - Ovary

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
  • Treatment of platinum-sensitive recurrent ovarian cancer, when platinum is contraindicated (e.g. due to toxicity)
  • Treatment of platinum-resistant recurrent ovarian cancer

Supplementary Public Funding

topotecan
New Drug Funding Program (Topotecan - Single Agent Treatment of Platinum Sensitive Ovarian Fallopian Tube or Primary Peritoneal Cancer)

topotecan
New Drug Funding Program (Topotecan - Platinum-Resistant Ovarian Fallopian Tube or Primary Peritoneal Cancer)

 
B - Drug Regimen

topotecan
1.25 - 1.5 mg /m² IV Days 1 to 5
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C - Cycle Frequency

REPEAT EVERY 21 DAYS

Until evidence of disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Low

 
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.

Prior to administration of the first course of topotecan, 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.

Dosage with toxicity

Dose levels: 1.5 mg/m2, 1.25 mg/m2, 1 mg/m2

Worst Toxicity Previous Cycle

Action1

Grade 4 neutropenia ≥ 7 days

 Reduce dose by 1 dose level
OR

Use G-CSF with next cycle

Febrile neutropenia  

Cycle delay for hematologic toxicity 

 

Worst Toxicity Previous Cycle (Continued) Action1
Platelets  <25 x 109/L

Reduce dose by  1 dose level

Grade 3 GI or organ toxicity

Symptoms suggestive of pneumonitis

Hold and manage patient appropriately. Discontinue if confirmed.

Grade 4 GI or organ toxicity

 

Discontinue
1. Do not retreat until neutrophils ≥ 1 x 109/L,  platelets ≥ 100 x 109/L, hemoglobin  ≥90 g/L (after transfusion if necessary), and other toxicity ≤ grade 2.



Hepatic Impairment

No dosage adjustment is required for treating patients with bilirubin < 171 μmol/L. Total topotecan clearance in patients with hepatic impairment only decreased by about 10%, as compared to the control group of patients.


Renal Impairment

Creatinine Clearance (mL/min)
% Usual dose
20 – 39
REDUCE Topotecan to 50 % dose
< 20
CONTRAINDICATED

 
F - Adverse Effects
Refer to topotecan 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)
  • Alopecia
  • Diarrhea (may be severe)
  • Constipation, abdominal pain
  • Mucositis
  • Nausea and vomiting
  • Dyspnea/cough (may be severe)
  • Anorexia
  • Headache, pain
  • Rash (may be severe)
  • Fatigue
  • Hypersensitivity
  • GI obstruction
  • Pneumonitis
  • ↑ LFTs

 

 
G - Interactions
Refer to topotecan drug monograph(s) for additional details
 
H - Drug Administration and Special Precautions
Refer to topotecan 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


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J - Administrative Information

Approximate Patient Visit
0.5 hour
Pharmacy Workload (average time per visit)
9.692 minutes
Nursing Workload (average time per visit)
36.667 minutes
 
K - References

Gordon AN, Tonda M, Sun S, et al. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol 2004;95(1):1-8.

Gordon A, Fleagle J Guthrie D et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. J Clin Oncol 2001;19(14):3312-22.

Sehouli J, Stengel D, Oskay-Oezcelik G, et al.  Nonplatinum topotecan combinations versus topotecan alone for recurrent ovarian cancer: results of a phase III study of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group.  J Clin Oncol 2008;26(19):3176-82.

ten Bokkel Huinink W, Lane SR, Ross GA. Long-term survival in a phase III, randomised study of topotecan versus paclitaxel in advanced epithelial ovarian carcinoma. Ann Oncol 2004;15(1):100-3.

Topotecan drug monograph, Cancer Care Ontario.


PEBC Advice Documents or Guidelines

October 2017 added PEBC guideline link


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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.
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