OGIVRI (Page 5 of 15)
Metastatic Breast Cancer Studies
The data below reflect exposure to trastuzumab in one randomized, open-label study, Study 5, of chemotherapy with (n = 235) or without (n = 234) trastuzumab in patients with metastatic breast cancer, and one single-arm study (Study 6; n = 222) in patients with metastatic breast cancer. Data in Table 4 are based on Studies 5 and 6.
Among the 464 patients treated in Study 5, the median age was 52 years (range: 25 to 77 years). Eighty-nine percent were White, 5% Black, 1% Asian and 5% other racial/ethnic groups. All patients received 4 mg/kg initial dose of trastuzumab followed by 2 mg/kg weekly. The percentages of patients who received trastuzumab treatment for ≥6 months and ≥12 months were 58% and 9%, respectively.
Among the 352 patients treated in single agent studies (213 patients from Study 6), the median age was 50 years (range 28 to 86 years), 86% were White, 3% were Black, 3% were Asian, and 8% in other racial/ethnic groups. Most of the patients received 4 mg/kg initial dose of trastuzumab followed by 2 mg/kg weekly. The percentages of patients who received trastuzumab treatment for ≥6 months and ≥12 months were 31% and 16%, respectively.
Single Agent * n = 352 | Trastuzumab + Paclitaxel n = 91 | Paclitaxel Alone n = 95 | Trastuzumab + AC † n = 143 | AC † Alone n = 135 | |
Body as a Whole | |||||
Pain | 47% | 61% | 62% | 57% | 42% |
Asthenia | 42% | 62% | 57% | 54% | 55% |
Fever | 36% | 49% | 23% | 56% | 34% |
Chills | 32% | 41% | 4% | 35% | 11% |
Headache | 26% | 36% | 28% | 44% | 31% |
Abdominal pain | 22% | 34% | 22% | 23% | 18% |
Back pain | 22% | 34% | 30% | 27% | 15% |
Infection | 20% | 47% | 27% | 47% | 31% |
Flu syndrome | 10% | 12% | 5% | 12% | 6% |
Accidental injury | 6% | 13% | 3% | 9% | 4% |
Allergic reaction | 3% | 8% | 2% | 4% | 2% |
Cardiovascular | |||||
Tachycardia | 5% | 12% | 4% | 10% | 5% |
Congestive heart failure | 7% | 11% | 1% | 28% | 7% |
Digestive | |||||
Nausea | 33% | 51% | 9% | 76% | 77% |
Diarrhea | 25% | 45% | 29% | 45% | 26% |
Vomiting | 23% | 37% | 28% | 53% | 49% |
Nausea and vomiting | 8% | 14% | 11% | 18% | 9% |
Anorexia | 14% | 24% | 16% | 31% | 26% |
Heme & Lymphatic | |||||
Anemia | 4% | 14% | 9% | 36% | 26% |
Leukopenia | 3% | 24% | 17% | 52% | 34% |
Metabolic | |||||
Peripheral edema | 10% | 22% | 20% | 20% | 17% |
Edema | 8% | 10% | 8% | 11% | 5% |
Musculoskeletal | |||||
Bone pain | 7% | 24% | 18% | 7% | 7% |
Arthralgia | 6% | 37% | 21% | 8% | 9% |
Nervous | |||||
Insomnia | 14% | 25% | 13% | 29% | 15% |
Dizziness | 13% | 22% | 24% | 24% | 18% |
Paresthesia | 9% | 48% | 39% | 17% | 11% |
Depression | 6% | 12% | 13% | 20% | 12% |
Peripheral neuritis | 2% | 23% | 16% | 2% | 2% |
Neuropathy | 1% | 13% | 5% | 4% | 4% |
Respiratory | |||||
Cough increased | 26% | 41% | 22% | 43% | 29% |
Dyspnea | 22% | 27% | 26% | 42% | 25% |
Rhinitis | 14% | 22% | 5% | 22% | 16% |
Pharyngitis | 12% | 22% | 14% | 30% | 18% |
Sinusitis | 9% | 21% | 7% | 13% | 6% |
Skin | |||||
Rash | 18% | 38% | 18% | 27% | 17% |
Herpes simplex | 2% | 12% | 3% | 7% | 9% |
Acne | 2% | 11% | 3% | 3% | < 1% |
Urogenital | |||||
Urinary tract infection | 5% | 18% | 14% | 13% | 7% |
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.