| Cycle length: 4 weeks. |
| Drug | Dose and route | Administration | Given on days |
| Gemcitabine | 1000 mg/m2 IV | Dilute in 250 mL normal saline (concentration no greater than 40 mg/mL) and administer over 30 minutes. | Weekly for three weeks followed by one week of rest |
| Pretreatment considerations: |
| Emesis risk | - LOW.
- Refer to UpToDate topic on "Prevention and treatment of chemotherapy-induced nausea and vomiting in adults".
|
| Infection prophylaxis | - Primary prophylaxis with granulocyte colony stimulating factors not indicated (risk of neutropenic fever <1%).
- Refer to UpToDate topic on "Use of granulocyte colony stimulating factors in adult patients with chemotherapy-induced neutropenia and conditions other than acute leukemia, myelodysplastic syndrome, and hematopoietic cell transplantation".
|
| Dose adjustment for baseline liver or renal dysfunction | - A lower starting dose may be needed for patients with liver impairment.
- Refer to UpToDate topic on "Chemotherapy hepatotoxicity and dose modification in patients with liver disease: Conventional cytotoxic agents" and "Chemotherapy hepatotoxicity and dose modification in patients with liver disease: Molecularly targeted agents".
|
| Monitoring parameters: |
- CBC with differential and platelet count weekly during treatment.
|
- Assess basic metabolic panel (including serum creatinine) and liver function prior to each cycle and otherwise as indicated during treatment.
|
| Suggested dose modifications for toxicity: |
| Myelotoxicity | - This regimen should not be initiated unless the white blood cell count is >3500 cells/microL and platelets are ≥100,000/microL.[1] During therapy, the dose of gemcitabine should be decreased by 25% if the absolute neutrophil count decreases to <1000 cells/microL but ≥500 cells/microL, or the platelets decrease to <100,000/microL and ≥50,000/microL.[2] The United States Prescribing Information recommends holding gemcitabine for an absolute neutrophil count <500 cells/microL or platelets <50,000/microL.[2]
|
| Hepatotoxicity | - Gemcitabine is commonly associated with a transient rise in serum transaminases, but these are seldom of clinical significance. There is insufficient information from clinical studies to allow clear dose recommendations in these patients.
|
| Thrombotic microangiopathy | - Thrombotic microangiopathy (TMA, also sometimes called thrombotic thrombocytopenic purpura [TTP] or hemolytic uremic syndrome [HUS]) has been associated with gemcitabine, in individuals who have received a large or small cumulative dose.[2] Consider the possibility of TMA if the patient develops Coombs-negative hemolysis, thrombocytopenia, renal failure, and/or neurologic findings. Management consists of drug discontinuation and supportive care, without plasma exchange, as long as there is high confidence in a drug-induced etiology rather than TTP.
- Refer to UpToDate topic on "Drug-induced thrombotic microangiopathy".
|
| Pulmonary toxicity | - A variety of manifestations of pulmonary toxicity have been reported. Discontinue gemcitabine immediately and permanently.
- Refer to UpToDate topic on "Pulmonary toxicity associated with antineoplastic therapy: Cytotoxic agents".
|
| If there is a change in body weight of at least 10%, doses should be recalculated. |
