DOCETAXEL (Page 7 of 20)
Combination therapy with docetaxel in the adjuvant treatment of breast cancer
The following table presents treatment emergent adverse reactions observed in 744 patients, who were treated with docetaxel 75 mg/m 2 every 3 weeks in combination with doxorubicin and cyclophosphamide (see Table 6).
| Docetaxel 75 mg/m 2 + Doxorubicin 50 mg/m 2 + Cyclophosphamide 500 mg/m 2 (TAC) n=744 % | Fluorouracil 500 mg/m 2 + Doxorubicin 50 mg/m 2 + Cyclophosphamide 500 mg/m 2 (FAC) n=736 % | |||
|---|---|---|---|---|
| Adverse Reaction | Any | Grade 3/4 | Any | Grade 3/4 |
| ||||
| Anemia | 92 | 4 | 72 | 2 |
| Neutropenia | 71 | 66 | 82 | 49 |
| Fever in absence of infection | 47 | 1 | 17 | 0 |
| Infection | 39 | 4 | 36 | 2 |
| Thrombocytopenia | 39 | 2 | 28 | 1 |
| Febrile neutropenia | 25 | N/A | 3 | N/A |
| Neutropenic infection | 12 | N/A | 6 | N/A |
| Hypersensitivity reactions | 13 | 1 | 4 | 0 |
| Lymphedema | 4 | 0 | 1 | 0 |
| Fluid Retention * | 35 | 1 | 15 | 0 |
| Peripheral edema | 27 | 0 | 7 | 0 |
| Weight gain | 13 | 0 | 9 | 0 |
| Neuropathy sensory | 26 | 0 | 10 | 0 |
| Neuro-cortical | 5 | 1 | 6 | 1 |
| Neuropathy motor | 4 | 0 | 2 | 0 |
| Neuro-cerebellar | 2 | 0 | 2 | 0 |
| Syncope | 2 | 1 | 1 | 0 |
| Alopecia | 98 | N/A | 97 | N/A |
| Skin toxicity | 27 | 1 | 18 | 0 |
| Nail disorders | 19 | 0 | 14 | 0 |
| Nausea | 81 | 5 | 88 | 10 |
| Stomatitis | 69 | 7 | 53 | 2 |
| Vomiting | 45 | 4 | 59 | 7 |
| Diarrhea | 35 | 4 | 28 | 2 |
| Constipation | 34 | 1 | 32 | 1 |
| Taste perversion | 28 | 1 | 15 | 0 |
| Anorexia | 22 | 2 | 18 | 1 |
| Abdominal Pain | 11 | 1 | 5 | 0 |
| Amenorrhea | 62 | N/A | 52 | N/A |
| Cough | 14 | 0 | 10 | 0 |
| Cardiac dysrhythmias | 8 | 0 | 6 | 0 |
| Vasodilatation | 27 | 1 | 21 | 1 |
| Hypotension | 2 | 0 | 1 | 0 |
| Phlebitis | 1 | 0 | 1 | 0 |
| Asthenia | 81 | 11 | 71 | 6 |
| Myalgia | 27 | 1 | 10 | 0 |
| Arthralgia | 19 | 1 | 9 | 0 |
| Lacrimation disorder | 11 | 0 | 7 | 0 |
| Conjunctivitis | 5 | 0 | 7 | 0 |
Of the 744 patients treated with TAC, 36.3% experienced severe treatment-emergent adverse reactions compared to 26.6% of the 736 patients treated with FAC. Dose reductions due to hematologic toxicity occurred in 1% of cycles in the TAC arm versus 0.1% of cycles in the FAC arm. Six percent of patients treated with TAC discontinued treatment due to adverse reactions, compared to 1.1% treated with FAC; fever in the absence of infection and allergy being the most common reasons for withdrawal among TAC-treated patients. Two patients died in each arm within 30 days of their last study treatment; 1 death per arm was attributed to study drugs.
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