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.
DOCEGEMC
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.
Treatment of anthracycline-resistant metastatic breast cancer, as an alternative to capecitabine-docetaxel
Low
Other Supportive Care:
Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention.)
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
|
Non-Hematologic Toxicity |
|
Hematologic Toxicity
|
Gemcitabine (% Full Dose) |
Docetaxel (% full dose) |
|
|
|
Grade 4 neutropenia ≥ 7 days, or Febrile neutropenia, or Thrombocytopenic bleeding |
75%* |
75%* |
| Non-Hematologic Toxicity | Hematologic Toxicity | Gemcitabine (% Full Dose) |
Docetaxel (% full dose) |
|
|
Grade 2 neurotoxicity |
|
|
100%* |
75%* |
|
Grade 3 neurotoxicity |
|
|
100%* |
50%*, Discontinue if recurs. |
|
Grade 4 neurotoxicity |
|
|
100%* |
Discontinue |
| Any occurrence of cystoid macular edema | No change |
Hold and investigate; refer patient promptly to an ophthalmic examination. Discontinue if confirmed.
|
||
|
Other grade 3 related organ/non-hematologic |
|
|
75% * | 75% * |
|
Other grade 4 related organ/non-hematologic
|
Discontinue | Discontinue | ||
|
Day 8 holds on > 1 cycle |
Discontinue or ↓ to 75% * |
100%* |
||
|
|
|
Discontinue |
Discontinue |
*Do not restart until toxicities have recovered to ≤ grade 1 and ANC ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L.
Dose on Day 8 of Cycle:
|
Toxicity on Day 8 of cycle |
|
||||
|
Non–hematologic (related organ) |
|
Hematologic |
Day 8 Gemcitabine (% Full Dose) |
||
|
|
|
ANC (x 106/L) |
Platelets (x 106/L) |
|
|
|
≤ grade 2 |
and |
> 1000 |
and |
> 100,000 |
100% |
|
≤ grade 2 |
and |
500-1000 |
or |
50,000-100,000 |
Omit, or ↓ to 75% |
|
Grade 3 |
or |
< 500 |
or |
< 50,000 |
Omit, ↓ to 75% at restart (if applicable) for non-hematologic toxicity |
| Grade 4 related organ Pneumonitis HUS SJS TEN CLS |
|
- |
|
- |
Discontinue |
Hepatic Impairment
|
|
AST and/or ALT |
|
Alk Phosp |
|
Bilirubin |
Gemcitabine |
Docetaxel dose
|
|
Mild-moderate |
> 1.5 X ULN |
AND |
> 2.5 x ULN |
|
|
Use with caution |
Do not treat |
|
Severe |
> 3.5 x ULN |
OR |
> 6 x ULN |
OR |
> ULN |
Consider ↓ or Discontinue |
Do not treat. Discontinue if treatment already started. |
Renal Impairment
|
Drug |
Renal Impairment |
|
Gemcitabine |
Use with caution; close monitoring for occurrence of hemolytic uremic syndrome is required. No specific recommendations found |
|
Docetaxel |
No dose adjustment required |
Dosage in the Elderly
For docetaxel, no adjustment required, but caution should be exercised in elderly patients with poor performance status who are receiving docetaxel.
For gemcitabine, clearance is lower in the elderly but no dose adjustment necessary.
| Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
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
- CBC; baseline and before each visit
- Baseline and regular liver and renal function tests
- Clinical toxicity assessment (including flu-like symptoms, hypersensitivity, fluid retention, thromboembolism, ophthalmic, cardiovascular, pulmonary, musculoskeletal pain, infection, bleeding, neurotoxicity, cutaneous changes, fatigue, GI); at each visit
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- INR for patient receiving warfarin; Baseline and regular
- Urinalysis; Baseline and regular
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Chan S, Romieu G, Huober J. Phase III study of gemcitabine plus docetaxel compared with capecitabine plus docetaxel for anthracycline-pretreated patients with metastatic breast cancer. J Clin Oncol 2009; 27(11): 1753-60.
Docetaxel, gemcitabine drug monograph, Cancer Care Ontario.
Fountzilas G, Dafni U, Dimopoulos MA, et al. A randomized phase III study comparing three anthracycline-free taxane-based regimens, as first line chemotherapy, in metastatic breast cancer: a Hellenic Cooperative Oncology Group study. Breast Cancer Res Treat 2009;115(1):87-99.
Nielsen DL, Bjerre KD, Jakobsen EH, et al. Gemcitabine plus docetaxel versus docetaxel in patients with predominantly human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: a randomized, phase III study by the Danish Breast Cancer Cooperative Group. J Clin Oncol 2011;29(36):4748-54.
Seidman AD, Brufsky A, Ansari RH, et al. Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel with planned crossover to the alternate single agent in metastatic breast cancer. Ann Oncol 2011;22(5):1094-101.
August 2021 Modified Rationale and Uses section
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.