Correction to: Adv Ther (2020) 37:3850–3862 10.1007/s12325-020-01433-8
In the original article, there were errors published. Please see correct versions of Tables 2, 3, 4, S2 and S3 below.
Table 2.
Administration dose of lenvatinib according to the histological subtypes
| DTC | MTC | ATC | ||||
|---|---|---|---|---|---|---|
| (n = 442) | (n = 28) | (n = 124) | ||||
| Initial dose per day | ||||||
| 24 mg | 337 | (76.2) | 22 | (78.6) | 87 | (70.2) |
| 20 mg | 29 | (6.6) | 2 | (7.1) | 18 | (14.5) |
| 14 mg | 29 | (6.6) | 0 | (0.0) | 9 | (7.3) |
| 10 mg | 26 | (5.9) | 4 | (14.3) | 6 | (4.8) |
| 8 mg | 15 | (3.4) | 0 | (0.0) | 2 | (1.6) |
| 4 mg | 0 | (0.0) | 0 | (0.0) | 0 | (0.0) |
| Othersa | 6 | (1.4) | 0 | (0.0) | 2 | (1.6) |
| Mean dose, mg/day, ± SDb | 11.86 | ± 5.40 | 12.20 | ± 5.81 | 15.70 | ± 6.35 |
The total might not equal 100% owing to rounding. Data are expressed as the number and percentage unless specified
DTC differentiated thyroid cancer, MTC medullary thyroid cancer, ATC anaplastic thyroid cancer, SD standard deviation
aOthers include 18 mg, 16 mg, and 12 mg
bThe mean dose was calculated by cumulating the lenvatinib dose administered during the study period divided by the administration days
Table 3.
Adverse drug reactions according to the histological subtypes
| DTC (n = 442) | MTC (n = 28) | ATC (n = 124) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Any ADR, n (%) | 436 | (98.6) | 28 | (100.0) | 115 | (92.7) | ||||||
| ADR, n (%) | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | Any grade | Grade ≥ 3 | ||||||
| Hypertensiona | 354 | (80.1) | 267 | (60.4) | 18 | (64.3) | 11 | (39.3) | 87 | (70.2) | 58 | (46.8) |
| Proteinuria | 192 | (43.4) | 76 | (17.2) | 11 | (39.3) | 4 | (14.3) | 37 | (29.8) | 9 | (7.3) |
| Palmar-plantar erythrodysesthesia syndromeb | 178 | (40.3) | 26 | (5.9) | 14 | (50.0) | 1 | (3.6) | 32 | (25.8) | 4 | (3.2) |
| Decreased appetite | 115 | (26.0) | 20 | (4.5) | 7 | (25.0) | 1 | (3.6) | 20 | (16.1) | 6 | (4.8) |
| Platelet count decreased | 97 | (21.9) | 20 | (4.5) | 4 | (14.3) | 1 | (3.6) | 28 | (22.6) | 16 | (12.9) |
| Malaise | 88 | (19.9) | 10 | (2.3) | 3 | (10.7) | 0 | (0.0) | 24 | (19.4) | 1 | (0.8) |
| Diarrhea | 85 | (19.2) | 17 | (3.8) | 8 | (28.6) | 3 | (10.7) | 15 | (12.1) | 1 | (0.8) |
ADRs were categorized on the basis of the preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA), ver. 20.1
An ADR was counted as one event when the identical ADR was reported multiple times in 1 patient
DTC differentiated thyroid cancer, MTC medullary thyroid cancer, ATC anaplastic thyroid cancer, ADR adverse drug reactions
aHypertension included the MedDRA-preferred terms of blood pressure diastolic increased, blood pressure increased, diastolic hypertension, hypertension, systolic hypertension, and prehypertension
bPalmar-plantar erythrodysesthesia included the MedDRA-preferred terms of erythema multiforme, palmar-plantar erythrodysesthesia syndrome, palmar erythema, rash erythematous, skin reaction, and hand dermatitis
Table 4.
Assessment of the effectiveness of lenvatinib according to the histological subtypes
| DTC | MTC | ATC | ||||
|---|---|---|---|---|---|---|
| N | 442 | – | 28 | – | 124 | – |
| Overall survival, days, median (95% CI) | – | – | 101.0 | (80.0–130.0) | ||
| 12-month overall survival rate, % (95% CI) | 75.7 | (71.3–79.5) | 83.0 | (60.7–93.3) | 15.6 | (9.6–22.9) |
| Time-to-treatment failure, days, median (95% CI) | 413.0 | (375.0 to –) | 405.0 | (252.0–405.0) | 74.5 | (57.0–108.0) |
| 12-month treatment continuation, % (95% CI) | 57.0 | (52.2–61.5) | 57.1 | (35.8–73.6) | 9.4 | (4.9–15.7) |
| N | 368 | – | 20 | – | 105 | – |
| Best overall responsea, n (%) | ||||||
| Complete response | 10 | (2.7) | 1 | (5.0) | 3 | (2.9) |
| Partial response | 208 | (56.5) | 8 | (40.0) | 43 | (41.0) |
| Stable disease | 122 | (33.2) | 11 | (55.0) | 34 | (32.4) |
| Progressive disease | 25 | (6.8) | 0 | (0.0) | 25 | (23.8) |
| Not evaluable | 3 | (0.8) | 0 | (0.0) | 0 | (0.0) |
| Overall response rateb, % (95% CI) | 59.2 | (54.03–64.30) | 45.0 | (23.06–68.47) | 43.8 | (34.14–53.83) |
| Disease control ratec, % (95% CI) | 92.4 | (89.19–94.88) | 100.0 | (83.16–100.00) | 76.2 | (66.89–83.96) |
DTC differentiated thyroid cancer, MTC medullary thyroid cancer, ATC anaplastic thyroid cancer, CI confidence interval
aTumor responses for the single largest tumor were evaluated using imaging data including computed tomography (CT), and the best response during 12 months after the first administration of lenvatinib was recorded as best overall response. The responses were classified into complete response (CR), which indicated a disappearance of the tumor; partial response (PR), which indicated a ≥ 30% decrease in the tumor diameters, taking as reference the baseline diameter; stable disease (SD); progressive disease (PD), which indicated a ≥ 20% increase in the diameters, taking as reference the baseline diameter; and not evaluable (NE). Unlike the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, tumors in the current study did not need to show CR and PR at ≥ 4 weeks to be indicators of those responses. Tumor responses were recorded at the discretion of the attending physician and were not reviewed by an independent central review board
bThe overall response rate indicates the sum of the proportion of patients with CR and those with PR
cThe disease control rate indicates the sum of the proportion of patients with CR, PR, and SD
Table S2.
Adverse drug reactions of interest according to the histological subtypes
| DTC | MTC | ATC | ||||
|---|---|---|---|---|---|---|
| (n = 442) | (n = 28) | (n = 124) | ||||
| Hypertensiona | 354 | (80.1) | 18 | (64.3) | 87 | (70.2) |
| Renal disordersb | 231 | (52.3) | 12 | (42.9) | 45 | (36.3) |
| Proteinuria | 192 | (43.4) | 11 | (39.3) | 37 | (29.8) |
| Palmar-plantar erythrodysesthesia syndromec | 178 | (40.3) | 14 | (50.0) | 32 | (25.8) |
| Hematological toxicity | 126 | (28.5) | 8 | (28.6) | 42 | (33.9) |
| Hemorrhagic events excluding carotid artery hemorrhage, venous hemorrhage, and tumor hemorrhage associated with tumor shrinkage or necrosis | 111 | (25.1) | 7 | (25.0) | 25 | (20.2) |
| Increased blood-thyroid-stimulating hormone level | 81 | (18.3) | 7 | (25.0) | 33 | (26.6) |
| Hepatic disorders | 77 | (17.4) | 6 | (21.4) | 13 | (10.5) |
| Infectious diseases | 43 | (9.7) | 4 | (14.3) | 12 | (9.7) |
| Hypocalcemia | 26 | (5.9) | 2 | (7.1) | 9 | (7.3) |
| Protracted wound healing | 13 | (2.9) | 0 | (0.0) | 8 | (6.5) |
| Carotid artery hemorrhage, venous hemorrhage, and tumor hemorrhage associated with tumor shrinkage or necrosis | 7 | (1.6) | 0 | (0.0) | 10 | (8.1) |
| Thromboembolic events | 6 | (1.4) | 0 | (0.0) | 2 | (1.6) |
| Perforation of the digestive tract and gastrointestinal fistula | 5 | (1.1) | 0 | (0.0) | 4 | (3.2) |
| Cardiac dysfunction | 5 | (1.1) | 0 | (0.0) | 0 | (0.0) |
| Arrhythmia | 4 | (0.9) | 0 | (0.0) | 4 | (3.2) |
| Reversible posterior leukoencephalopathy syndrome | 1 | (0.2) | 0 | (0.0) | 0 | (0.0) |
DTC: differentiated thyroid cancer, MTC: medullary thyroid cancer, ATC: anaplastic thyroid cancer, ADR: adverse drug reactions.
Data are expressed as number and percentage. ADRs were categorized on the basis of the preferred terms used in the Medical Dictionary for Regulatory Activities (MedDRA), ver. 20.1.
aHypertension included the MedDRA-preferred terms of blood pressure diastolic increased, blood pressure increased, diastolic hypertension, hypertension, systolic hypertension, and prehypertension.
bRenal disorders included the MedDRA-preferred terms of blood creatinine increased, blood urea increased, hemoglobinuria, nephrotic syndrome, protein urine, proteinuria, renal disorder, renal failure, protein urine present, renal impairment, chronic kidney disease, acute prerenal failure, renal tubular necrosis, hypercreatininemia, and renal ischemia.
cPalmar-plantar erythrodysesthesia included the MedDRA-preferred terms of erythema multiforme, palmar-plantar erythrodysesthesia syndrome, palmar erythema, rash erythematous, skin reaction, and hand dermatitis.
Table S3.
Adverse drug reactions according to previous treatments
| Patients with a history of RAI treatment | Patients without a history of RAI and sorafenib treatment | Patients without a history of RAI treatment but with sorafenib treatment | ||||
|---|---|---|---|---|---|---|
| (n = 326) | (n = 91) | (n = 25) | ||||
| Any ADR, n (%) | 323 | (99.1) | 89 | (97.8) | 24 | (96.0) |
| ADR, n (%) | ||||||
| Hypertension | 262 | (80.4) | 68 | (74.7) | 22 | (88.0) |
| Proteinuria | 140 | (42.9) | 40 | (44.0) | 11 | (44.0) |
| Palmar-plantar erythrodysesthesia syndrome | 137 | (42.0) | 25 | (27.5) | 15 | (60.0) |
| Decreased appetite | 85 | (26.1) | 24 | (26.4) | 6 | (24.0) |
| Platelet count decreased | 76 | (23.3) | 17 | (18.7) | 4 | (16.0) |
| Malaise | 66 | (20.2) | 16 | (17.6) | 6 | (24.0) |
| Diarrhea | 69 | (21.2) | 12 | (13.2) | 3 | (12.0) |
RAI: radioactive iodine, ADR: adverse drug reactions.
ADRs were categorized on the basis of the preferred terms used in the Medical Dictionary for Regulatory Activities (MedDRA), ver. 20.1.
ADRs were counted as one event when the identical ADR was reported multiple times in one patient.