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Erschienen in: Advances in Therapy 9/2021

31.07.2021 | Correction

Correction to: Safety and Effectiveness of Lenvatinib in 594 Patients with Unresectable Thyroid Cancer in an All-Case Post-Marketing Observational Study in Japan

verfasst von: Shunji Takahashi, Makoto Tahara, Koichi Ito, Masayuki Tori, Naomi Kiyota, Katsutoshi Yoshida, Yukinori Sakata, Akira Yoshida

Erschienen in: Advances in Therapy | Ausgabe 9/2021

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Excerpt

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
Metadaten
Titel
Correction to: Safety and Effectiveness of Lenvatinib in 594 Patients with Unresectable Thyroid Cancer in an All-Case Post-Marketing Observational Study in Japan
verfasst von
Shunji Takahashi
Makoto Tahara
Koichi Ito
Masayuki Tori
Naomi Kiyota
Katsutoshi Yoshida
Yukinori Sakata
Akira Yoshida
Publikationsdatum
31.07.2021
Verlag
Springer Healthcare
Erschienen in
Advances in Therapy / Ausgabe 9/2021
Print ISSN: 0741-238X
Elektronische ISSN: 1865-8652
DOI
https://doi.org/10.1007/s12325-021-01829-0

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