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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.

A - Regimen Name

GEMC Regimen
Gemcitabine


Disease Site
Gynecologic - Uterine Sarcoma
Sarcoma - Uterine

(Uterine leiomyosarcoma - LMS)


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.

 
B - Drug Regimen

gemcitabine
800 to 1000 mg /m² IV Days 1, 8 and 15
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C - Cycle Frequency

REPEAT EVERY 28 DAYS

Until 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. 

 

Dosage with toxicity

Doses should not be re-escalated if they are reduced for non-hematological toxicities, febrile neutropenia or thrombocytopenic bleeding.

 

Table 1 - Day 1 of Cycle

Worst Toxicity in Previous Cycle % Full Dose
Non-hematologic Grade 3** 75%*
Non-hematologic Grade 4 Consider discontinuing, or 50-75%*
Febrile neutropenia, thrombocytopenic bleeding 75%*
> 1 Occurrence of Day 8/15 holds 75%*
  • Pneumonitis
  • Hemolytic Uremic Syndrome (HUS)
  • Stevens-Johnson syndrome (SJS)
  • Toxic epidermal necrolysis (TEN)
  • Capillary Leak Syndrome (CLS)
  • Posterior reversible encephalopathy syndrome (PRES)
Discontinue

* Do not start new cycle until ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and non-hematologic toxicity ≤ grade 2.  Discontinue if non-hematological toxicities require more than a 50% dose reduction from the starting dose.

** except nausea/vomiting or alopecia

 

Other treatment days within cycle:
 

Table 2 - Non-hematologic toxicities

Toxicity Action (% Full dose)
Grade 3** HOLD; restart at 50-75%*
Grade 4 Discontinue

* Treat only if non-hematologic toxicities recover to ≤ grade 2 and hematologic parameters are met on treatment day (Table 3). Discontinue if non-hematological toxicities require more than a 50% dose reduction from the starting dose.

**except nausea/vomiting, alopecia


Table 3 - Hematologic Toxicities:

Platelets on treatment day (x 109/L)   ANC on treatment day (x 109/L) Action (% Full Dose)
>100 And > 1 100% *
50 to 100 And/or 0.5 to 1 75% or consider omit*
<50 And/or <0.5 Omit

* Treat only if above parameters are met on treatment day and non-hematologic toxicities ≤ grade 2.



Hepatic Impairment

Gemcitabine should be used with caution in patients with hepatic impairment (cirrhosis, hepatitis, alcoholism, metastases, etc.); initial dose reduction should be considered if the patient is treated, especially in hyperbilirubinemia.

 

Suggested:

Bilirubin (micromol/L) Starting dose
> 1.2 x ULN 800 mg/m2; escalate if tolerated

Renal Impairment

Gemcitabine should be used with caution in patients with renal insufficiency. There is insufficient information from clinical studies to allow clear dose recommendations for this patient population. Clinical trials with cisplatin mandated CrCl ≥ 60mL/min. For patients with pre-existing renal insufficiency, the close monitoring for occurrence of hemolytic uremic syndrome is required.

 


Dosage in the Elderly

Decreased clearance and increased half-life occurs with increasing age, however no dose adjustment is necessary.

 

Dosage based on Gender

Decreased volume of distribution and clearance are seen in women, however no dose adjustment is necessary.


 
F - Adverse Effects

Refer to gemcitabine drug monograph(s) for additional details of adverse effects

 


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

 

  • Myelosuppression ± infection, bleeding (may be severe) 
  • ↑ LFTs
  • Nausea/ vomiting (generally mild)
  • Flu-like symptoms
  • Proteinuria
  • Rash (rarely severe)
  • Edema
  • Musculoskeletal pain
  • Alopecia (generally mild)
  • Diarrhea
  • Arrhythmia
  • Arterial thromboembolism
  • Cardiotoxicity
  • Hepatotoxicity including liver failure
  • Hemolytic-uremic syndrome
  • Creatinine increased
  • Hypersensitivity
  • Injection site reaction
  • Gangrene
  • RPLS/PRES
  • ILD/ARDS
  • Capillary leak syndrome
  • Vasculitis
  • Radiosensitization
  • Toxic epidermal necrolysis (TEN)
  • Stevens Johnson syndrome (SJS))
 
G - Interactions

Refer to gemcitabine drug monograph(s) for additional details


  • No specific drug interaction studies have been conducted.
  • Monitor INR closely with concurrent warfarin use and adjust warfarin dose as needed, as gemcitabine may decrease metabolism and synthesis of clotting factors.
  • Gemcitabine is a known radiosensitizer.
 
H - Drug Administration and Special Precautions

Refer to gemcitabine drug monograph(s) for additional details


Administration

  • May dilute reconstituted drug in normal saline for IV infusion, resulting in a minimum final concentration of at least 0.1 mg/mL.

  • Gemcitabine is for IV administration only; follow local protocols for infusion time. Usual infusion time for gemcitabine is 30 minutes (some clinical trials used an infusion rate of 10mg/m2/min or infusion time of 90 minutes (when in combination with docetaxel) for soft tissue sarcoma)

  • Infusion time of > 60 minutes or dosing more frequently than once weekly may lead to increased toxicity



Contraindications

  • Patients who have a hypersensitivity to this drug or any of its components.

 

Other Warnings/Precautions

  • Use with extreme caution in patients with compromised bone marrow reserve.

  • Use with caution in patients with hepatic impairment (including concurrent liver metastases or a previous history of hepatitis, alcoholism or liver cirrhosis) and patients with renal impairment.

  • Acute shortness of breath with a temporal relationship to gemcitabine injection administration may occur.

  • Patients receiving concurrent radiation while receiving the full dose gemcitabine should be closely monitored for reactions. Exacerbation of radiation therapy toxicity including potentially life-threatening esophagitis and pneumonitis, particularly in patients receiving large volumes of radiotherapy have been observed.

 

Pregnancy/Lactation

  • Gemcitabine is not recommended for use in pregnancy.  Adequate contraception should be used by both sexes during treatment, and for at least 6 months (general recommendation) after the last dose.

  • Breastfeeding is not recommended.

  • Fertility: Observed in animal studies

    • Decreased spermatogenesis and fertility in male mice.

 
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

  • CBC; Baseline and before each dose
  • Liver function tests; Baseline, before each cycle and as clinically indicated
  • Renal function tests; Baseline, before each cycle and as clinically indicated
  • Clinical assessment of bleeding, infection, rash, diarrhea, nausea/vomiting, edema, injection site reactions, flu-like symptoms, hemolysis, signs/symptoms of capillary leak syndrome, cardiovascular, CNS and respiratory effects; At each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Urinalysis; baseline and as clinically indicated
  • INR for patient receiving warfarin; baseline and as clinically indicated

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J - Administrative Information

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

Gemcitabine drug monograph, Cancer Care Ontario.

Look KY, Sandler A, Blessing JA, et al. Gynecologic Oncology Group. Phase II trial of gemcitabine as second-line chemotherapy of uterine leiomyosarcoma: a Gynecologic Oncology Group (GOG) study. Gynecol Oncol 2004;92(2):644-7.

Maki RG, Wathen JK, Patel SR, et al.  Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: results of sarcoma alliance for research through collaboration study 002 [corrected].  J Clin Oncol 2007;25(19):2755-63

Pautier P, Floquet A, Penel N, et al. Randomized multicenter and stratified phase II study of gemcitabine alone versus gemcitabine and docetaxel in patients with metastatic or relapsed leiomyosarcomas:  a Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC) French sarcoma group study (TAXOGEM study). Oncologist 2012;17(9):1213-20.

May 2020 Updated Adverse effects, Dosage with Toxicity, Drug Administration and Special Precautions and Recommended Clinical Monitoring sections.


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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.
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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