Efficacy and Safety of the All-Oral Schedule of Metronomic Vinorelbine and Capecitabine in Locally Advanced or Metastatic Breast Cancer Patients: The Phase I-II VICTOR-1 Study
Table 2
Toxicity events according to grade and level of dose, described per patient and per cycle. (a) Phase I. (b) Phase II (VRB 40 mg + CAPE 500 mg 3).
(a)
Level I VRB = 20 mg
Level II VRB 30 mg
Level III VRB 40 mg
Total
Per Pts
Per cycle
Per pts
Per cycle
Per pts
Per cycle
Per pts
Per cycle
Events G1
Abdominal pain
0
0
2
3
5
15
7
18
Nausea
1
1
2
4
1
6
4
11
Gastric pain
0
0
1
1
3
3
4
4
Diarrhea
0
0
0
0
2
4
2
4
Vomiting
0
0
0
0
1
1
1
1
Stomatitis
0
0
1
1
1
1
2
2
Asthenia
0
0
1
1
2
2
3
3
Dyspnea
1
1
0
0
1
1
2
2
Dysgeusia
0
0
0
0
1
1
1
1
Anemia
0
0
0
0
0
2
2
2
Leukopenia
0
0
0
0
0
2
2
2
Increase in transaminases
0
0
1
1
0
0
2
1
Total
2
2
8
11
17
38
32
51
Events G2
Abdominal pain
0
0
0
0
1
1
1
1
Nausea
0
0
1
2
2
2
3
4
Asthenia
0
0
1
2
3
4
4
6
Constipation
2
2
0
0
0
0
2
2
Total
2
2
2
4
6
7
10
13
(b)
Per pts
Per cycle
Events G1
Abdominal pain
3
14
Nausea-vomiting
8
20
Gastric pain
4
4
Diarrhea
5
8
Stomatitis
2
2
Asthenia
4
15
Anemia
3
4
Neutropenia
Thrombocytopenia
Leukopenia
4
11
Transaminitis
Dyspnoea
1
1
Neuropathy
3
4
Hand-foot syndrome
1
1
Nail changes
1
1
Muscular pain
3
5
Total
40
90
Events G2
Abdominal pain
4
4
Nausea-vomiting
4*
4
Diarrhea
1
Stomatitis
1*
1
Asthenia
8
10
Dysgeusia
1
1
Neutropenia
1
Anemia
1
3
Hand-foot syndrome
1
2
Nail changes
2
2
Total
22
29
Events G3
Neutropenia
1**
2
Thrombocytopenia
1
1
Leukopenia
Neuropathy
1***
2
Hand-foot syndrome
1****
1
Gamma GT increase
1
1
Total
5
7
Events G4
Neutropenia
1
1
Febrile neutropenia
1
1
Leukopenia
2
2
Total
4
4
In 1 patient vomiting and stomatitis Grade 2 determined a dose reduction of VRB at 20 mg thrice a week. In 1 patient Grade 3 neutropenia was associated to Grade 1 Leukopenia; no dose reduction was required. Grade 3 neuropathy determined a dose reduction of VRB at 20 mg thrice a week. Grade 3 hand-foot syndrome determined a dose reduction of CAPE at 500 mg twice a day, until complete recovery to Grade 1. See details in the text.
