Table 2. Treatment exposure in patients randomised to bevacizumab plus capecitabine according to development or not of HFS.
Treatment exposure | HFS (n=154) | No HFS (n=123) |
---|---|---|
Still receiving study therapy at the time of data cut-off,
n
(%) | ||
Bevacizumab | 24 (15.6) | 3 (2.4) |
Capecitabine | 23 (14.9) | 3 (2.4) |
Mean cumulative dose (s.d.) | ||
Bevacizumab, mg kg−1 | 236.9 (141.6) | 116.4 (100.8) |
Capecitabine, mg m−2 | 345 878 (194 926) | 198 233 (166 403) |
Median cumulative dose (range) | ||
Bevacizumab, mg kg−1 | 195.1 (15.0–691.4) | 90.0 (14.9–573.4) |
Capecitabine, mg m−2 | 305 202 (53 029–937 824) | 161 204 (4472–912 818) |
Median treatment duration, months (range) | ||
Bevacizumab | 8.9 (<0.1–31.3) | 3.5 (<0.1–29.2) |
Capecitabine | 9.2 (1.1–31.7) | 4.5 (0.1–26.0) |
Mean relative dose intensity, % | ||
Bevacizumab | 99 | 100 |
Capecitabine | 87 | 91 |
Patients with an AE leading to bevacizumab and/or capecitabine discontinuation, n (%)a | 36 (23.4) | 29 (23.6) |
Bevacizumab and capecitabine | 8 (5.2) | 19 (15.4) |
Bevacizumab | 17 (11.0) | 25 (20.3) |
Capecitabine | 30 (19.5) | 23 (18.7) |
Patients with an AE leading to capecitabine modification, n (%)a | 106 (68.8) | 41 (33.3) |
Interruption | 25 (16.2) | 7 (5.7) |
Dose reduction | 52 (33.8) | 10 (8.1) |
Delay | 64 (41.6) | 31 (25.2) |
Patients with HFS leading to capecitabine adaptation,
n
(%)a | ||
Discontinuation | 16 (10.4) | 0 |
Dose modification | 71 (46.1) | 0 |
Abbreviations: AE=adverse event; HFS=hand–foot syndrome.
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