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.

Table 4 Per-Patient Incidence of Adverse Reactions Occurring in ≥5% of Patients in Uncontrolled Studies or at Increased Incidence in the Trastuzumab Arm (Studies 5 and 6)
*
Data for Trastuzumab single agent were from 4 studies, including 213 patients from Study 6.
Anthracycline (doxorubicin or epirubicin) and cyclophosphamide.

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%

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