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.
CISPPACL
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.
For the treatment of patients with advanced (stage IVB), recurrent or persistent cervical cancer.
|
PACLitaxel 1
(Round to nearest 3 mg) | 175 mg /m² | IV over 3 hours | Day 1 |
|
CISplatin
(Round to nearest 1 mg) | 50 mg /m² | IV | Day 1 (after paclitaxel) |
REPEAT EVERY 21 DAYS
For a usual total of 6 cycles unless disease progression or unacceptable toxicity occurs. (In clinical trials, patients who continued to respond to treatment may continue beyond six cycles.)
Moderate
Other Supportive Care:
- Paclitaxel: Patients should be pretreated with a corticosteroid as well as an antihistamine and a H2 blocker: For example:
- DEXAMETHASONE 20mg PO 12 & 6 hours or 20mg IV 30 minutes before paclitaxel
- DIPHENHYDRAMINE 50mg IV 30 minutes before paclitaxel
- RANITIDINE 50mg IV 30 minutes before paclitaxel
Also refer to CCO Antiemetic Summary
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.
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Dosage with toxicity
Dose levels for paclitaxel: 175, 135, 110, 90 mg/m2
Dose levels for cisplatin: 50, 37.5, 25 mg/m2
| Worst Toxicity / Counts (x 109/L) in previous cycle | Worst Toxicity / Counts (x 109/L) in previous cycle | Paclitaxel (% previous dose) | Cisplatin (% previous dose) | |
| ANC < 1.5 | or | Platelets < 100 | Hold* | Hold* |
|
Febrile Neutropenia Or ANC < 0.5 for ≥ 5-7 d |
Thrombocytopenic bleeding Or Platelets < 25 |
↓ 1 dose level and consider GCSF use next cycle | No change | |
| ANC ≥ 1.5 | or | Platelets ≥ 100 | No change | No change |
| Grade 2 neurotoxicity/ototoxicity | ↓ 2 dose levels | ↓ 2 dose levels | ||
| Grade 3 or 4 neurotoxicity/ototoxicity | Discontinue | Discontinue | ||
| Grade 3 related non-hematological/organ | ↓ 1 dose level | ↓ 1 dose level | ||
| Grade 3 hepatotoxicity | Discontinue | No change | ||
| Grade 4 related non-hematological/organ | Discontinue | Discontinue† |
Hepatic Impairment
|
Bilirubin |
|
AST/ALT |
PACLitaxel (% previous dose) |
CISplatin (% previous dose) |
|
1-2 x ULN |
|
|
no change |
no change |
|
>2-3 x ULN |
or |
2-5 x ULN |
↓ 1 dose level |
no change |
|
>3 x ULN |
or |
> 5 x ULN |
discontinue |
no change or discontinue |
Renal Impairment
In general, renal function should have normalized before patients are retreated. If continued treatment is considered to be mandatory, the following dose modifications could be considered at the physician's discretion:
|
Creatinine Clearance (mL/min) |
PACLitaxel (% previous dose) |
CISplatin (% previous dose) |
|
>60 |
no change |
no change |
|
46-60 |
no change |
75% |
|
30-45 |
no change |
50% |
|
<30 |
no change |
Discontinue |
Refer to PACLitaxel, 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 |
|
|
Refer to PACLitaxel, CISplatin drug monograph(s) for additional details
Recommended Clinical Monitoring
- CBC; baseline and before each cycle
- Electrolytes, including magnesium, phosphate and calcium; baseline and regular
- Liver function tests; baseline and regular
- Renal function tests; baseline and regular
- Clinical toxicity assessment (infection, bleeding, musculoskeletal, cardiac, arrhythmia, thromboembolism, hypersensitivity, flu-like symptoms, nausea/vomiting, neurotoxicity, ototoxicity); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Audiogram; baseline and periodic
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Cisplatin and paclitaxel drug monographs, Cancer Care Ontario.
Moore DH, Blessing JA, McQuellon RP, et al. Phase III study of cisplatin with or without paclitaxel in stage IVB, recurrent, or persistent squamous cell carcinoma of the cervix: A gynecologic oncology group study. J Clin Oncol 2004;22:3113-9.
Monk BJ, Sill MW, McMeekin DS, et al. Phase III trial of four cisplatin-containing doublet combinations in stage IVB, recurrent, or persistent cervical carcinoma: a gynecologic oncology group study. J Clin Oncol 2009;27:4649-55.
Tewari KS, Sill MW, Long HJ 3rd, et al. Improved survival with bevacizumab in advanced cervical cancer. N Engl J Med. 2014 Feb 20;370(8):734-43.
October 2017 updated drug regimen
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.