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regimen-monograph
GEMCPACL
A - Regimen Name
GEMCPACL Regimen
Gemcitabine-PACLitaxel
Disease Site
Breast
Intent
Palliative
Regimen Category
Local : A regimen not widely used by Regional Cancer Centres in this disease site.
Rationale and Uses
For the treatment of metastatic breast cancer in patients who have received prior (neo) adjuvant anthracycline therapy.
B - Drug Regimen
| PACLitaxel
(Round to nearest 3mg) |
175 mg /m² | IV over 3 hours | Day 1 |
| gemcitabine
(Round to nearest 10mg) |
1250 mg /m² | IV over 30 minutes | Days 1 and 8 |
|
|
|||
C - Cycle Frequency
REPEAT EVERY 21 DAYS
For a usual total of 6 cycles unless disease progression or unacceptable toxicity
D - Premedication and Supportive Measures
Antiemetic Regimen:
Low
Other Supportive Care:
- Paclitaxel: Patients should be pretreated with a corticosteroid as well as an antihistamine and a H2 blocker on day 1. 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
E - Dose Modifications
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.
Dosage with toxicity
Dose of Day 1 of Cycle:
Worst Toxicity in Previous Cycle |
Gemcitabine |
Paclitaxel |
||
Non Hematologic |
Hematologic |
% Full Dose* |
% Full Dose* |
|
Grade 3 |
or |
Febrile neutropenia, thrombocytopenic bleeding |
75% |
80% |
Grade 4
|
|
|
Consider discontinuing, or ↓ to 75% |
Consider discontinuing, or ↓ to 80% |
(Continued on next page)
|
||||
| Worst Toxicity in Previous Cycle | Gemcitabine | Paclitaxel | ||
| Non Hematologic | Hematologic | % Full Dose* | % Full Dose* | |
|
Day 8 holds on > 1 cycle |
Consider discontinuing, or ↓ to 75% |
100% |
||
|
|
|
Discontinue |
Discontinue |
*Do not start new cycle until ANC ≥ 1500 x 106/L, platelets ≥ 100,000 x 106/L and non-hematologic toxicity ≤ grade 2.
On Day 8 of cycle:
Toxicity on Day 8 |
|
||||
Non-hematologic |
|
Hematologic |
% Full Dose* |
||
|
|
AGC (x 106/L) |
|
Platelets (x 106/L) |
|
≤ grade 2 |
and |
≥ 1200 |
and |
> 75,000 |
100% |
≤ grade 2 |
and |
1000 - 1199 |
or |
50000 - 75000 |
75% |
≤ grade 2 |
and |
700 - 999 |
and |
≥ 50,000 |
↓ to 50% |
Grade 3 or 4 |
or |
< 700 |
or |
< 50,000 |
Omit; ↓ to 75% at restart (if applicable) for non-hematologic toxicity |
Pneumonitis |
|
- |
|
- |
Discontinue |
Other Toxicity: Refer to PACLitaxel drug monograph for management of hypersensitivity reactions.
Hepatic Impairment
| Bilirubin | PACLitaxel |
| 2-4 x ULN | Give Maximum dose of 135mg/m2 |
| > 4 x ULN | OMIT dose or Give Maximum dose of 50mg/m2 |
Gemcitabine should be used with caution in patients with hepatic impairment (cirrhosis, hepatitis, metastases, etc.); initial dose reduction should be considered if the patient is treated, especially in hyperbilirubinemia.
Renal Impairment
Gemcitabine should be used with caution in patients with renal insufficiency. For patients with pre-existing renal insufficiency, the close monitoring for occurrence of hemolytic uremic syndrome is required. No specific recommendations found.
Paclitaxel: No dose adjustment required.
F - Adverse Effects
Refer to PACLitaxel, gemcitabine drug monograph(s) for additional details of adverse effects
| Most Common Side Effects | Less Common Side Effects, but may be |
|
|
G - Interactions
Refer to PACLitaxel, gemcitabine drug monograph(s) for additional details
• Gemcitabine is a known radiosensitizer.
H - Drug Administration and Special Precautions
Refer to PACLitaxel, gemcitabine drug monograph(s) for additional details
I - Recommended Clinical Monitoring
Recommended Clinical Monitoring
- CBC; at each visit
- Liver function tests; baseline and regular
- Renal function tests; baseline and regular
- Blood pressure and pulse rate monitoring during paclitaxel infusion, cardiac monitoring with prior arrhythmia
- Clinical assessment of infection, bleeding, flu-like symptoms, fatigue, dyspnea, rash, musculoskeletal, neuropathy, hypersensitivity.
- Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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K - References
Albain KS, Nag SH, Calderillo-Ruiz G, et al. Gemcitabine Plus Paclitaxel Versus Paclitaxel Monotherapy in Patients With Metastatic Breast Cancer and Prior Anthracycline Treatment. J Clin Oncol 2008; 26: 3950-7.
PEBC Advice Documents or Guidelines
October 2017 Updated dose modifications, adverse effects and monitoring sections
L - Other Notes
- The combination of gemcitabine plus paclitaxel is superior compared to paclitaxel alone as first-line chemotherapy in metastatic breast cancer.
- Patients who received the combination regimen experienced a higher rate of neutropenia (48% versus 11%) over those treated with paclitaxel alone.
- The clinical relevance of this regimen in Ontario is questionable as docetaxel has been the standard taxane used in the metastatic setting.
Ministry of Health and Long Term Care, Ontario Public Drug Program, decided not to fund gemcitabine through Cancer Care Ontario’s New Drug Funding Program (NDFP) for the treatment of breast cancer, on the basis that efficacy and value-for money could not be established with the appropriate drug comparator. (Decision document posted July 2007)
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.
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Last Updated: July 21, 2026
