Capecitabine (Page 5 of 14)

6.2 Metastatic Colorectal Cancer

Monotherapy

Table 6 shows the adverse reactions occurring in ≥5% of patients from pooling the two phase 3 trials in first line metastatic colorectal cancer. A total of 596 patients with metastatic colorectal cancer were treated with 1250 mg/m2 twice a day of capecitabine administered for 2 weeks followed by a 1-week rest period, and 593 patients were administered 5-FU and leucovorin in the Mayo regimen (20 mg/m2 leucovorin IV followed by 425 mg/m2 IV bolus 5-FU, on days 1 to 5, every 28 days). In the pooled colorectal database the median duration of treatment was 139 days for capecitabine-treated patients and 140 days for 5-FU/LV-treated patients. A total of 78 (13%) and 63 (11%) capecitabine and 5-FU/LV-treated patients, respectively, discontinued treatment because of adverse reactions/intercurrent illness. A total of 82 deaths due to all causes occurred either on study or within 28 days of receiving study drug: 50 (8.4%) patients randomized to capecitabine and 32 (5.4%) randomized to 5-FU/LV.

Table 6 Pooled Phase 3 Colorectal Trials: Percent Incidence of Adverse Reactions in ≥5% of Patients
*
Excluding vertigo

Adverse Event

Capecitabine (n=596)

5-FU/LV (n=593)

Total %

Grade 3 %

Grade 4 %

Total %

Grade 3 %

Grade 4 %

Number of Patients With > One Adverse Event

96

52

9

94

45

9

Body System/Adverse Event

GI

Diarrhea

55

13

2

61

10

2

Nausea

43

4

51

3

<1

Vomiting

27

4

<1

30

4

<1

Stomatitis

25

2

<1

62

14

1

Abdominal Pain

35

9

<1

31

5

Gastrointestinal Motility Disorder

10

<1

7

<1

Constipation

14

1

<1

17

1

Oral Discomfort

10

10

Upper GI Inflammatory Disorders

8

<1

10

1

Gastrointestinal Hemorrhage

6

1

<1

3

1

Ileus

6

4

1

5

2

1

Skin and Subcutaneous

Hand-and-Foot Syndrome

54

17

NA

6

1

NA

Dermatitis

27

1

26

1

Skin Discoloration

7

<1

5

Alopecia

6

21

<1

General

Fatigue/Weakness

42

4

46

4

Pyrexia

18

1

21

2

Edema

15

1

9

1

Pain

12

1

10

1

Chest Pain

6

1

6

1

<1

Neurological

Peripheral Sensory Neuropathy

10

4

Headache

10

1

7

Dizziness *

8

<1

8

<1

Insomnia

7

7

Taste Disturbance

6

1

11

<1

1

Metabolism

Appetite Decreased

26

3

<1

31

2

<1

Dehydration

7

2

<1

8

3

1

Eye

Eye Irritation

13

10

<1

Vision Abnormal

5

2

Respiratory

Dyspnea

14

1

10

<1

1

Cough

7

<1

1

8

Pharyngeal Disorder

5

5

Epistaxis

3

<1

6

Sore Throat

2

6

Musculoskeletal

Back Pain

10

2

9

<1

Arthralgia

8

1

6

1

Vascular

Venous Thrombosis

8

3

<1

6

2

Psychiatric

Mood Alteration

5

6

<1

Depression

5

4

<1

Infections

Viral

5

<1

5

<1

Blood and Lymphatic

Anemia

80

2

<1

79

1

<1

Neutropenia

13

1

2

46

8

13

Hepatobiliary

Hyperbilirubinemia

48

18

5

17

3

3

– Not observed

NA = Not Applicable

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