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
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/doxorubicin-hydrochloride-4/page/6/