Doxorubicin Hydrochloride (Page 6 of 8)

Ocular

Conjunctivitis, keratitis, and lacrimation occur rarely.

Other

Malaise/asthenia have been reported.

Adverse Reactions in Patients with Early Breast Cancer Receiving Doxorubicin-Containing Adjuvant Therapy

Safety data were collected from approximately 2,300 women who participated in a randomized, open-label trial (NSABP B-15) evaluating the use of AC versus CMF in the treatment of early breast cancer involving axillary lymph nodes. In the safety analysis, the follow-up data from all patients receiving AC were combined (N=1,492 evaluable patients) and compared with data from patients receiving conventional CMF (i.e., oral cyclophosphamide; N=739 evaluable patients). The most relevant adverse events reported in this study are provided in Table 2.

Table 2. Relevant Adverse Events in Patients with Early Breast Cancer Involving Axillary Lymph Nodes

AC* Conventional CMF
N=1,492 N=739
Treatment administration
Mean number of cycles 3.8 5.5
Total cycles 5,676 4,068
Adverse events, % of patients
Leukopenia
Grade 3 (1,000 to 1,999 /mm 3) 3.4 9.4
Grade 4 (<1000/mm 3) 0.3 0.3
Thrombocytopenia
Grade 3 (25,000 to 49,999 /mm 3) 0 0.3
Grade 4 (<25,000 /mm 3) 0.1 0
Shock, sepsis 1.5 0.9
Systemic infection 2.4 1.2
Nausea and vomiting
Nausea only 15.5 42.8
Vomiting ≤ 12 hours 34.4 25.2
Vomiting >12 hours 36.8 12
Intractable 4.7 1.6
Alopecia 92.4 71.4
Partial 22.9 56.3
Complete 69.5 15.1
Weight loss
5 to 10% 6.2 5.7
>10% 2.4 2.8
Weight gain
5 to 10% 10.6 27.9
>10% 3.8 14.3
Cardiac function
Asymptomatic 0.2 0.1
Transient 0.1 0
Symptomatic 0.1 0
Treatment-related death 0 0

* Includes pooled data from patients who received either AC alone for 4 cycles, or who were treated with AC for 4 cycles followed by 3 cycles of CMF

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