Case Report
Copyright ©The Author(s) 2020.
World J Clin Cases. Oct 26, 2020; 8(20): 4883-4894
Published online Oct 26, 2020. doi: 10.12998/wjcc.v8.i20.4883
Table 1 Lenvatinib and sorafenib-related trials and nephrotoxicity
Trials
Study group with anti-VEGF therapy
Dosage
Median duration of follow-ups
Nephrotoxicity
Strategies during adverse effects
Brose et al[3] (DECISION trial, phase-3 trial)RAI-refractory DTC; 207 patientsSorafenib: 800 mg/d10.6 moHypertension: 40.6%/9.7% (all grades/grade ≥ 3)Dosage would be reduced to 600 mg/d, 400 mg/d or 200 mg/d
Peripheral edema: not documented
Proteinuria: not documented
Schlumberger et al[4] (SELECT trial, phase-3 trial)RAI-refractory DTC; 261 patientsLenvatinib: 24 mg/d17.1 moHypertension: 67.8%/41.8% (all grades/grade ≥ 3)Dosage would be reduced to 20 mg/d, 14 mg/d, or 10 mg/d
Peripheral edema: 11.1%/0.4% (all grades/grade ≥ 3)
Proteinuria: 31%/10% (all grades/grade ≥ 3)
Kudo et al[13] (REFLECT trial, phase-3 trial)Unresectable HCC; 476 patients with lenvatinib; and 475 patients with sorafenib1 Lenvatinib: (dosage based on whether body weights above 60 kg or not): (1) 12 mg/d: 325 patients (68%); and (2) 8 mg/d: 153 patients (32%)1 Lenvatinib: 27.7 mo1 Lenvatinib: (1) Hypertension: 42%/23% (all grades/grade ≥ 3); (2) Peripheral edema: not documented; and (3) Proteinuria: 25%/6% (all grades/grade ≥ 3)1 Lenvatinib: Dosage would be reduced to 8 mg (initially with 12 mg/d) and 4 mg/d (initially with 8 mg/d), or 4 mg every other day
2 Sorafenib: 800 mg/d2 Sorafenib: 27.2 mo2 Sorafenib: (1) Hypertension: 30%/14% (all grades/grade ≥ 3); (2) Peripheral edema: not documented; and (3) Proteinuria: 11%/2% (all grades/grade ≥ 32 Sorafenib: Dosage switch was implemented according to prescribing information in each region
Motzer et al[14] (Number NCT01136733, phase-2 trial)Metastatic RCC; 51 patients with lenvatinib plus everolimus; and 52 patients with lenvatinib1 Lenvatinib plus everolimus: Lenvatinib of 18 mg/d plus everolimus of 5 mg/d1 Lenvatinib plus everolimus: 18.5 mo1 Lenvatinib plus everolimus: (1) Hypertension: 27%/14% (all grades/grade ≥ 3); (2) Peripheral edema: 27%/0% (all grades/grade ≥ 3); and (3) Proteinuria: 18%/4% (all grades/grade ≥ 3)1 Lenvatinib plus everolimus: (1) If possibly from lenvatinib: Dosage would be reduced from 18 mg/d to 14 mg/d, 10 mg/d, and 8 mg/d; and (2) If possibly from everolimus: Dosage would be reduced from 5 mg/d to 5 mg every other day.
2 Lenvatinib: 24 mg/d2 Lenvatinib: 17.8 mo2 Lenvatinib: (1) Hypertension: 31%/17% (all grades/grade ≥ 3); (2) Peripheral edema: 15%/0% (all grades/grade ≥ 3); and (3) Proteinuria: 12%/19% (all grades/grade ≥ 3)2 Lenvatinib: Dosage would be reduced from 24 mg/d to 20 mg/d, 14 mg/d, and 10 mg/d