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Docetaxel Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Non-Small Cell Lung Cancer

Initial dose: 75 mg/m2 IV over one hour. Courses of docetaxel may be repeated at 3 week intervals, after adequate recovery from toxicity.

When docetaxel is used as monotherapy for NSCLC treatment after failure of prior platinum based chemotherapy, the following guidelines apply: For patients who are dosed initially at 75 mg/m2 and who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or other grade 3 or 4 nonhematologic toxicities during docetaxel treatment should have treatment withheld until resolution of the toxicity and then resumed at 55 mg/m2. Patients who develop a grade 3 or greater peripheral neuropathy should have docetaxel treatment discontinued entirely.

When docetaxel is used as a part of combination chemotherapy in chemotherapy-naive NSCLC patients, the following guidelines apply: For patients who are dosed initially at 75 mg/m2 in combination with cisplatin, and whose nadir of platelet count during the previous course of therapy is less than 25,000 cells/mm3, in patients who experience febrile neutropenia, and in patients with serious nonhematologic toxicities, the docetaxel dosage in subsequent cycles should be reduced to 65 mg/m2. In patients who require a further dose reduction, a dose of 50 mg/m2 of docetaxel is recommended.

Usual Adult Dose for Breast Cancer

Locally advanced or metastatic breast cancer after failure of prior treatment:
60 to 100 mg/m2 IV over one hour. Courses of docetaxel (as a single agent) may be repeated at 3 week intervals, after adequate recovery from toxicity.

Patients who are initially dosed at 100 mg/m2 and who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions, or severe peripheral neuropathy during therapy should have their dosage decreased to 75 mg/m2. If the patient continues to experience these reactions, the dosage should either be further decreased 55 mg/m2 or treatment should be discontinued. Conversely, patients who are dosed initially at 60 mg/m2 and who do not experience the above effects may tolerate higher doses. Patients who develop a grade 3 or greater peripheral neuropathy should have docetaxel treatment discontinued entirely. Patients initiated at 60 mg/m2 who do not develop toxicity may tolerate higher doses.

Docetaxel in combination with doxorubicin and cyclophosphamide recommended as adjuvant treatment of patients with operable node-positive breast cancer:
docetaxel 75 mg/m2 intravenously administered one hour after doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 3 weeks for 6 courses. Prophylactic G-CSF may be used to mitigate the risk of hematologic toxicities.

Docetaxel in combination with doxorubicin and cyclophosphamide should be administered when the neutrophil count is greater than or equal to 1,500 cells/mm3. Patients who experience febrile neutropenia should receive G-CSF in all subsequent cycles. Patients who continue to experience this reaction should remain on G-CSF and have their docetaxel reduced to 60 mg/m2. Patients who experience severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have their dosage of docetaxel reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, treatment should be discontinued.

Patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice a day) for 3 days starting one day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

Usual Adult Dose for Prostate Cancer

Initial dose: Docetaxel 75 mg/m2 intravenously once over one hour. Prednisone 5 mg orally twice daily is administered continuously. For hormone-refractory metastatic prostate cancer, given the concurrent use of prednisone, the recommended premedication regimen is oral dexamethasone 8 mg, at 12 hours, 3 hours, and 1 hour before the docetaxel infusion. Courses of docetaxel may be repeated at 3 week intervals, after adequate recovery from toxicity.

Docetaxel should be administered when the neutrophil count is greater than or equal to 1,500 cells/mm3. Patients who experience either febrile neutropenia, neutrophils less than 500 cells/mm3 for more than one week, severe or cumulative cutaneous reactions or moderate neurosensory signs and/or symptoms during docetaxel therapy should have the dosage of docetaxel reduced from 75 mg/m2 to 60 mg/m2. If the patient continues to experience these reactions at 60 mg/m2, the treatment should be discontinued.

Usual Adult Dose for Gastric Cancer

Initial dose: Docetaxel 75 mg/m2 as a 1 hour intravenous infusion, followed by cisplatin 75 mg/m2 as a 1 to 3 hour intravenous infusion (both on day 1 only), followed by fluorouracil 750 mg/m2 per day given as a 24 hour continuous intravenous infusion for 5 days, starting at the end of the cisplatin infusion. Treatment is repeated every three weeks. Patients must receive premedication with antiemetics and appropriate hydration for cisplatin administration.

Patients should be premedicated with oral corticosteroids such as dexamethasone 16 mg per day (e.g. 8 mg twice a day) for 3 days starting one day prior to docetaxel administration in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions.

Patients treated with docetaxel in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In the study, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia, or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur, the docetaxel dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of Grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be treated with subsequent cycles of docetaxel until neutrophils recover to a level greater than 1,500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3. Treatment should be discontinued if these toxicities persist.

The recommended dose modifications for gastrointestinal toxicities in patients treated with docetaxel in combination with cisplatin and fluorouracil are as follows:

Diarrhea grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, also reduce the docetaxel dose by 20%.

Diarrhea grade 4:
For the first episode, reduce the dose of both docetaxel and fluorouracil by 20%.
For the second episode, discontinue treatment.

Stomatitis grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, stop fluorouracil only, at all subsequent cycles.
For the third episode, reduce the dose of docetaxel by 20%.

Stomatitis grade 4:
For the first episode, stop fluorouracil only, at all subsequent cycles.
For the second episode, reduce the dose of docetaxel by 20%.

Usual Adult Dose for Head and Neck Cancer

In combination with cisplatin and fluorouracil for the induction treatment of patients with inoperable locally advanced squamous cell carcinoma of the head and neck:

Initial dose: 75 mg/m2 as a 1 hour intravenous infusion
This is followed by cisplatin 75 mg/m2 intravenously over 1 hour, on day one, followed by fluorouracil as a continuous intravenous infusion at 750 mg/m2 per day for five days. This regimen is administered every 3 weeks for 4 cycles. Following chemotherapy, patients should receive radiotherapy.

Patients must receive premedication with antiemetics and appropriate hydration (prior to and after cisplatin administration). All patients on the docetaxel-containing arm of the TAX 323 study also received prophylactic antibiotics.

Patients treated with docetaxel in combination with cisplatin and fluorouracil must receive antiemetics and appropriate hydration according to current institutional guidelines. In the study, G-CSF was recommended during the second and/or subsequent cycles in case of febrile neutropenia, or documented infection with neutropenia, or neutropenia lasting more than 7 days. If an episode of febrile neutropenia, prolonged neutropenia, or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. If subsequent episodes of complicated neutropenia occur, the docetaxel dose should be reduced from 60 mg/m2 to 45 mg/m2. In case of Grade 4 thrombocytopenia, the docetaxel dose should be reduced from 75 mg/m2 to 60 mg/m2. Patients should not be treated with subsequent cycles of docetaxel until neutrophils recover to a level greater than 1,500 cells/mm3 and platelets recover to a level greater than 100,000 cells/mm3. Treatment should be discontinued if these toxicities persist.

The recommended dose modifications for gastrointestinal toxicities in patients treated with docetaxel in combination with cisplatin and fluorouracil are as follows:

Diarrhea grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, also reduce the docetaxel dose by 20%.

Diarrhea grade 4:
For the first episode, reduce the dose of both docetaxel and fluorouracil by 20%.
For the second episode, discontinue treatment.

Stomatitis grade 3:
For the first episode, reduce the dose of fluorouracil by 20%.
For the second episode, stop fluorouracil only, at all subsequent cycles.
For the third episode, reduce the dose of docetaxel by 20%.

Stomatitis grade 4:
For the first episode, stop fluorouracil only, at all subsequent cycles.
For the second episode, reduce the dose of docetaxel by 20%.

Usual Pediatric Dose for Solid Tumors

The efficacy of docetaxel in pediatric patients as monotherapy or in combination has not been established. The overall safety profile in pediatric patients receiving monotherapy or TCF was consistent with the known safety profile in adults.

Docetaxel monotherapy was evaluated in a dose-finding phase 1 trial in 61 pediatric patients (median age 12.5 years, range 1-22 years) with a variety of refractory solid tumors. The recommended dose was 125 mg/m2 as a 1-hour intravenous infusion every 21 days. The primary dose limiting toxicity was neutropenia.
The recommended dose for docetaxel monotherapy was evaluated in a phase 2 single-arm trial in 178 pediatric patients (median age 12 years, range 1-26 years) with a variety of recurrent/refractory solid tumors. Efficacy was not established with tumor response rates ranging from one complete response (CR) (0.6%) in a patient with undifferentiated sarcoma to four partial responses (2.2%) seen in one patient each with Ewing Sarcoma, neuroblastoma, osteosarcoma, and squamous cell carcinoma.

Docetaxel was studied in combination with cisplatin and 5-fluorouracil (TCF) versus cisplatin and 5-fluorouracil (CF) for the induction treatment of nasopharyngeal carcinoma (NPC) in pediatric patients prior to chemoradiation consolidation. Seventy-five patients (median age 16 years, range 9 to 21 years) were randomized (2:1) to docetaxel (75 mg/m2) in combination with cisplatin (75 mg/m2) and 5-fluorouracil (750 mg/m2) (TCF) or to cisplatin (80 mg/m2) and 5-fluorouracil (1000 mg/m2/day) (CF). The primary endpoint was the CR rate following induction treatment of NPC. One patient out of 50 in the TCF group (2%) had a complete response while none of the 25 patients in the CF group had a complete response.

Renal Dose Adjustments

Since renal excretion is minimal, the need for a dosage adjustment is unlikely.

Liver Dose Adjustments

Docetaxel is not recommended for use in patients with moderate to severe liver dysfunction. This includes patients with bilirubin greater than the upper limit of normal (ULN) or SGOT and/or SGPT greater than 1.5 times the ULN concomitant with alkaline phosphatase greater than 2.5 times the ULN. This patient population is at an increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity and toxic death. Patients with isolated elevations of transaminase greater than 1.5 times the ULN also have a higher rate of febrile neutropenia grade 4. Bilirubin, SGOT or SGPT and alkaline phosphatase values should be obtained prior to each cycle of therapy.

The following liver dysfunction guidelines are for the treatment of patients with gastric cancer: If the AST/ALT is greater than 2.5 to less than or equal to 5 times the upper limit of normal and AP is less than or equal to 2.5 times the upper limit of normal, or AST/ALT is greater than 1.5 to less than or equal to 5 times the upper limit of normal and AP is greater than 2.5 to less than or equal to 5 times the upper limit of normal, docetaxel should be reduced by 20%. If the AST/ALT is greater than 5 times the upper limit of normal and/or AP is greater than 5 times the upper limit of normal, docetaxel should be stopped.

Precautions

The incidence of treatment-related mortality associated with docetaxel therapy is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior therapy with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m2.

Neutropenia occurs in almost all patients administered a dose of 60 to 100 mg/m2. Grade 4 neutropenia occurs in almost all patients administered 100 mg/m2 and 75% to 80% of patients administered 60 to 75 mg/m2. Therapy should not be given to patients with neutrophil counts less than 1,500 cells/mm³. Frequent blood counts should be performed on all patients receiving docetaxel therapy to monitor for neutropenia.

Docetaxel should generally not be administered to patients with bilirubin greater than upper limit of normal (ULN), or to patients with SGOT and/or SGPT greater than 1.5 times ULN concomitant with alkaline phosphatase greater than 2.5 times ULN. Patients with elevations of bilirubin or abnormalities of transaminases concurrent with alkaline phosphatase are at increased risk for the development of grade 4 neutropenia, febrile neutropenia, infections, severe stomatitis, severe thrombocytopenia, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminases greater than 1.5 times ULN also had a higher rate of febrile neutropenia grade 4 but did not have an increased rate of toxic death. Bilirubin, SGOT or SGPT, and alkaline phosphatase values should be obtained prior to each cycle of docetaxel treatment and reviewed by the treating physician.

Docetaxel administered at 100 mg/m2 was associated with deaths considered possibly or probably related to treatment in 2.4% of patients with normal liver function and in 11% of patients with abnormal liver function (SGOT and/or SGPT greater than 1.5 times the upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN). Among patients dosed at 60 mg/m2, mortality related to treatment occurred in 0.6% of patients with normal liver function and in 3 of 7 patients with abnormal liver function. Approximately half of the deaths occurred during the first cycle. The majority of the deaths were due to sepsis.

Severe hypersensitivity reactions (characterized by generalized rash/erythema, hypotension and/or bronchospasm, or very rarely fatal anaphylaxis) have been reported in patients who received the recommended three day dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy. Docetaxel must not be given to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Hypersensitivity reactions have been reported within a few minutes following initiation of a docetaxel infusion. If minor reactions such as flushing or localized skin reactions occur, interruption of treatment is not required. Before administration of docetaxel, all patients should be premedicated with oral corticosteroids.

While it does not usually occur following the initial treatment, severe fluid retention has been reported following docetaxel therapy. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites). Patients with preexisting effusions should be monitored closely for possible exacerbation of effusions.

Docetaxel should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

In gastric cancer patients treated with docetaxel (Taxotere) in combination with Cisplatin and Fluorouracil (TCF), febrile neutropenia and/or neutropenic infection occurred in 12% of patients receiving granulocyte colony-stimulating factor (G-CSF) compared to 28% who did not. Patients receiving TCF should be closely monitored during the first and subsequent cycles for febrile neutropenia and neutropenic infection.

Severe neurosensory symptoms including paresthesia, dysesthesia, and pain have been observed. When these symptoms occur, the dosage should be adjusted. If symptoms persist, treatment should be discontinued.

Dialysis

Docetaxel is not removed by hemodialysis; therefore, it may be administered before or after hemodialysis.

Other Comments

Patients should be instructed to report weight gain or swelling of the feet and/or legs. Patients should be premedicated with a corticosteroid such as dexamethasone 8 mg orally twice a day for 5 days, starting 1 day prior to docetaxel therapy.

Dosages of docetaxel may vary, depending on the specific indication for its use and the choice of cytotoxic agents coadministered. Reference to specific protocols is recommended.

Contact of docetaxel with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended.

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