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DOCEGEMC
Sarcoma - Soft Tissue
Sarcoma - Uterine
(Metastatic Uterine Leiomyosarcoma)
Adjuvant
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.
| gemcitabine | 900 mg /m² | IV over 30 to 90* minutes | Days 1 and 8 |
| DOCEtaxel | 100 mg /m² | IV | Day 8 |
|
(*Some clinical trials used an infusion rate of 10 mg/m2/min.) (Continued on next page) Reduce dose for patients with prior radiation therapy: |
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| gemcitabine | 650 mg /m² | IV over 30 to 65* minutes | Days 1 and 8 |
| DOCEtaxel | 75 mg /m² | IV | Day 8 |
(*Clinical trials used an infusion rate of 10 mg/m2/min)
Low
Other Supportive Care:
- Dexamethasone 8 mg bid po for 3 days starting 1 day prior to docetaxel (prevent anaphylaxis / fluid retention).
- Some clinical trials have used filgrastim on days 9 to 16. Hematological toxicity is common; consider the use of granulocyte growth factor (G-CSF). If G-CSF is not available, consider prophylactic antibiotics or dose reduction.
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
Dosing based on worst toxicity in previous cycle:
|
Non-Hematologic Toxicity
|
|
Hematologic Toxicity
|
Gemcitabine
(% Full Dose)
|
DAY 8 Docetaxel (% full dose)
|
|
Grade 3
|
or
|
Grade 4 neutropenia ≥ 7 days
or
Febrile neutropenia
or
Thrombocytopenic bleeding
|
75%*
|
75%*
Discontinue if recurs
|
|
Grade 3 neurotoxicity |
|
|
100%*
|
75%*, Discontinue if recurs
|
| Any occurrence of cystoid macular edema | No change | Hold and investigate; refer patient promptly to an ophthalmic examination. Discontinue if confirmed. | ||
|
|
|
Discontinue
|
Discontinue
|
| Non-Hematologic Toxicity (Continued) | Hematologic Toxicity (Continued) |
Gemcitabine |
Day 8 DOCEtaxel (% Full Dose) |
|
|
Grade 4 other toxicity |
|
|
Discontinue,
or ↓ to 75%*
|
Discontinue,
or ↓ to 75%*
|
|
Day 8 holds on > 1 cycle |
Discontinue,
or ↓ to 75%*
|
100%*
|
||
On Day 8 of Cycle:
|
Toxicity on Day 8 of cycle
|
|
|||||
|
Non- Hematologic
|
|
Hematologic
|
Day 8 Gemcitabine (% Full Dose)
|
Day 8 Docetaxel (% Full Dose)
|
||
|
|
|
AGC
(x 106/L)
|
|
Platelets
(x 106/L)
|
|
|
|
≤ grade 2
|
and
|
> 1000
|
and
|
> 100,000
|
100%
|
100%
|
|
≤ grade 2
|
and
|
500-1000
|
or
|
50,000-100,000
|
Omit, or ↓ to 75%
|
Omit
|
|
Grade 3 or 4
|
or
|
< 500
|
or
|
< 50,000
|
Omit, ↓ to 75%
at restart (if applicable) for non-hematologic toxicity |
Omit
|
| Pneumonitis, HUS, SJS, TEN, CLS, Grade 4 neurotoxicity |
|
-
|
|
Discontinue
|
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 gemcitabine, clearance is lower in the elderly but no dose adjustment necessary.
For docetaxel, no adjustment required, but caution should be exercised in elderly patients with poor performance status.
| Most Common Side Effects |
Less Common Side Effects, but may be |
|
|
Refer to gemcitabine, DOCEtaxel drug monograph(s) for additional details
Gemcitabine is a known radiosensitizer.
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; at each visit
- Liver function tests; baseline and regular
- Renal function tests; baseline and regular
- Clinical toxicity assessment, including infection, bleeding, neurotoxicity, fatigue, fluid retention, flu-like symptoms, hypersensitivity, cutaneous changes, thromboembolism, ophthalmic, cardiovascular, musculoskeletal pain, GI or pulmonary effects; at each visit.
-
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
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Docetaxel and gemcitabine drug monographs, Cancer Care Ontario.
Hensley ML, Blessing JA, DeGeest K, et al. Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study. Gyne Oncol 2008;109:323-8.
Hensley ML, Blessing JA, Mannel R, Rose PG. Fixed-dose rate gemcitabine plus docetaxel as first-line therapy for metastatic uterine leiomyosarcoma: a Gynecologic Oncology Group phase II trial. Gynecol Oncol 2008 Jun;109(3):329-34.
Hensley ML, Maki R, Venkatraman E, Geller G, Lovegren M, Aghajanian C, et al. Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: results of a phase II trial. J Clin Oncol 2002;20:2824-31.
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.
December 2017 added infusion time for gemcitabine
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
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