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.
GEMCPACL
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 metastatic germ cell cancer in patients:
- with disease not amenable to cure with either surgery or chemotherapy, or
- who failed initial cisplatin combination therapy with curative intent and/or failed one “salvage” regimen
- This regimen has also been studied in patients who failed high dose chemotherapy with tandem transplantation
| PACLitaxel | 100 mg /m² | IV | days 1, 8 and 15 |
| gemcitabine | 1000 mg /m² | IV | days 1, 8 and 15 |
REPEAT EVERY 28 DAYS
For a maximum of 6 cycles unless disease progression or unacceptable toxicity occurs
Low
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
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
Day 1:
|
Worst Toxicity / Counts (x 109/L) in previous cycle |
|
Worst Toxicity / Counts (x 109/L) in previous cycle |
PACLitaxel
(% previous dose)
|
gemcitabine
(% previous dose)
|
|
ANC <1.5
|
Or
|
Platelet < 75
|
Hold * |
|
|
Febrile Neutropenia
Or
ANC < 0.5 for ≥ 5-7 d
|
Or
|
Thrombocytopenic bleeding
Or
Platelets < 25
|
Hold *, then 75% |
|
|
ANC ≥ 1.5
|
And
|
Platelet ≥ 75
|
100%
|
|
|
Grade 3 related organ / non-hematologic, or omitted day 8/15 doses in multiple prior cycles |
|
|
75% * for suspect drug(s) |
|
|
Grade 4 related organ / non-hematologic |
|
|
50%* for suspect drugs or Discontinue |
|
|
Pneumonitis, Hemolytic Uremic Syndrome (HUS), Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN), Capillary Leak Syndrome (CLS) |
|
|
Discontinue
|
|
*Do not start new cycle until toxicities have recovered to ≤ grade 2, platelets ≥ 75 x 109/L, and ANC ≥ 1.5 x 109/L.
Days 8 or 15:
|
Toxicity on Day 8 or Day 15
|
|
Toxicity on Day 8 or Day 15
|
PACLitaxel #
(% Day 1 dose)
|
gemcitabine #
(% Day 1 dose)
|
|
|
ANC ≥ 1.5 |
And
|
Platelet ≥ 75 |
100%
|
||
|
ANC 1 - 1.49 |
And/or
|
Platelets 50 - 74.9 |
75%
|
||
|
ANC 0.5 - 0.99 |
And/or
|
Platelets 25 - 49.9 |
50%
|
||
|
ANC < 0.5 |
And/or
|
Platelets < 25 |
OMIT
|
||
|
Grade 3/4 hepatotoxicity |
And/or
|
Grade 4 other organ/non-hematological |
OMIT |
OMIT (if myalgia alone, 100%)
|
|
|
Grade 2 hepatotoxicity |
And/or
|
Grade 3 myalgia or other organ/non-hematological |
50% *
|
50% * (if myalgia alone, 100%)
|
|
|
Grade 4 nausea/vomiting |
And/or |
Other grade 2 organ/non-hematological toxicity |
75% * |
75% *
|
|
|
Pneumonitis |
|
|
Discontinue |
||
Paclitaxel - Hypersensitivity:
- For mild symptoms (e.g., mild flushing, rash, pruritus), attempt to complete the infusion under close supervision.
- For moderate symptoms (e.g., moderate rash, flushing, mild dyspnea, chest discomfort, mild hypotension),
- Stop the paclitaxel infusion and give diphenhydramine 25-50 mg IV and methylprednisolone 125 mg IV.
- Once symptoms have resolved, resume paclitaxel infusion at a rate of 10% of original rate for 15 minutes, then at 25% of original rate for 15 minutes, and if no further symptoms develop, continue at original rate until infusion is complete.
- For severe symptoms (e.g., one or more of: respiratory distress requiring treatment, generalized urticaria, angioedema, hypotension requiring therapy),
- Stop the paclitaxel infusion; give diphenhydramine and methylprednisolone as above. Use epinephrine or bronchodilators if indicated.
- Do not rechallenge with paclitaxel.
Hepatic Impairment
|
Bilirubin and or AST/ALT
|
PACLitaxel
|
Gemcitabine
|
|
2-4 x ULN
|
Give Maximum dose of 135mg/m2
|
Caution; no specific recommendations found |
|
> 4 x ULN
|
OMIT dose or Give Maximum dose of 50mg/m2
|
Consider dose reduction; no specific recommendations found |
Renal Impairment
Gemcitabine should be used with caution in patients with renal impairment. Patients with pre-existing renal impairment should be monitored closely for hemolytic uremic syndrome.
Paclitaxel: No dose adjustment required.
Refer to PACLitaxel, gemcitabine drug monograph(s) for additional details of adverse effects
| 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; 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; 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
Renal function tests (AIDS related Kaposi's sarcoma); Baseline and regular
Urinalysis; Baseline and regular
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Einhorn LH, Brames MJ, Juliar B, et al. Phase II study of paclitaxel plus gemcitabine salvage chemotherapy for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. J Clin Oncol. 2007 Feb 10;25(5):513-6.
Gemcitabine and paclitaxel drug monographs, Cancer Care Ontario.
Hinton S, Catalano P, Einhorn LH, et al. Phase II study of paclitaxel plus gemcitabine in refractory germ cell tumors (E9897): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2002;20(7):1859-63.
Mulherin BP, Brames MJ, Einhorn LH, et al. Long-term survival with paclitaxel and gemcitabine for germ cell tumors after progression following high-dose chemotherapy with tandem transplant. Am J Clin Oncol 2015;38(4):373-6.
January 2018 aligned dosing with QBP
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.