al dose of trastuzumab followed by 2 mg/kg weekly. The percentages of patientswho 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 was50 years (range 28–86 years), 86% were White, 3% were Black, 3% were Asian, and 8% in otherracial/ethnic groups. Most of the patients received 4 mg/kg initial dose of trastuzumab followed by2 mg/kg weekly. The percentages of patients who received trastuzumab treatment for ≥ 6 months and≥ 12 months were 31% and 16%, respectively.
Table 4
Per-Patient Incidence of Adverse Reactions Occurring in ≥5% of Patients in Uncontrolled Studies or atIncreased Incidence in the Trastuzumab Arm (Studies 5 and 6)
Single Agenta
n = 352
Trastuzumab +
Paclitaxel
n = 91
Paclitaxel
Alone
n = 95
Trastuzumab+
ACb
n = 143
ACb 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%
Table 4 (cont’d)
Per-Patient Incidence of Adverse Reactions Occurring in ≥ 5% of Patients in Uncontrolled Studies or atIncreased Incidence in the Trastuzumab Arm (Studies 5 and 6)
Single Agenta
n = 352
Trastuzumab +
Paclitaxel
n = 91
Paclitaxel
Alone
n = 95
Trastuzumab +
ACb
n = 143
ACb
Alone
n 135
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%
a Data for trastuzumab single agent were from 4 studies, including 213 patients from Study 6.
b Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.Metastatic Gastric Cancer
The data below are based on the exposure of 294 patients to trastuzumab in combination with afluoropyrimidine (capecitabine or 5-FU) and cisplatin (Study 7). In the trastuzumab plus chemotherapyarm, the initial dose of trastuzumab 8 mg/kg was administered on Day 1 (prior to chemotherapy)followed by 6 mg/kg every 21 days until disease progression. Cisplatin was administered at 80 mg/m2 on
Day 1 and the fluoropyrimidine was administered as either capecitabine 1000 mg/m2 orally twice a day on Days 1-14 or 5-fluorouracil 800 mg/m2
/day as a continuous intravenous infusion Days 1 |
