Table 1.
Patients treated with sorafenib in TARGET and CALGB 80802 and patients treated with regorafenib in LCCC 1029 and Italian cohort.
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|---|---|---|---|---|
| TARGET (n=140) | CALGB 80802 (n=201) | LCCC 1029 (n=107) | Italian cohort (n=82) | |
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| Study details | ||||
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| Cancer type | mRCC | Advanced or mHCC | mCRC | mCRC |
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| Treatment | 400 mg sorafenib orally twice daily | 400 mg of sorafenib orally twice daily alone or combined with 60 mg/m2 of doxorubicin | FOLFIRI on days 1–3 and 15–17 of every 4-week cycle with 160 mg regorafenib daily | 160 mg regorafenib daily following a 3-week-on, 1-weekoff-cycle |
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| Demographics | ||||
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| Age (years)–Mean (SD) | 59.6 (9.8) | 62.3 (10.4) | 61.7 (12.2) | 61.2 (9.5) |
| Male – n (%) | 105 (75.0%) | 168 (83.6%) | 19 (17.8%) | 46 (56.1%) |
| Female – n (%) | 35 (25.0%) | 33 (16.4%) | 88 (82.2%) | 36 (43.9%) |
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| Toxicities* (n, %) | ||||
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| Hypertension | ||||
| Grade ≥2 | 12 (8.6) | 61 (29.9%) | 16 (15.0%) | 23 (28%) |
| Grade 3 | 5 (3.6) | 18 (8.8%) | 8 (7.5%) | 6 (7.3%) |
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| Diarrhea | ||||
| Grade ≥2 | 26 (18.6%) | 42 (20.6%) | 26 (24.3%) | 15 (18.3%) |
| Grade 3 | 5 (3.6%) | 15 (7.4%) | 13 (12.2%) | 7 (8.5%) |
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| Dermatologic toxicity** | ||||
| Grade ≥2 | 42 (30.0%) | 55 (27.0%) | 16 (15.0%) | 25 (29.1%) |
| Grade 3 | 15 (10.7%) | 25 (12.3%) | 6 (5.6%) | 18 (20.9%) |
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| Composite toxicity | ||||
| Grade ≥2 | 63 (45%) | 113 (55.4%) | 43 (40.2%) | 49 (59.8%) |
| Grade 3 | 24 (17.1%) | 55 (27.0%) | 24 (22.4%) | 29 (35.4%) |
CALGB: Cancer and Leukemia Group B, mRCC: metastatic renal cell carcinoma, mHCC: metastatic hepatocellular carcinoma, mCRC: metastatic colorectal cancer, SD: standard deviation, HFS: hand-foot syndrome.
*
CTCAE v3.0 for TARGET and CTCAE v4.0 for CALGB 80802, LCCC 1029 and Italian cohort
**
dermatologic toxicity in TARGET (HFS + rash or desquamation + pruritus + alopecia), CALGB 80802 (HFS), LCCC 1029 (HFS), and Italian cohort (rash).