Published in:
01-02-2006 | Erratum to
Erratum to: Phase I clinical study of the recombinant antibody-toxin scFv(FRP5)-ETA specific for the ErbB2/HER2 receptor in patients with advanced solid malignomas
Published in: Breast Cancer Research | Issue 1/2006
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Following publication of the data presented by von Minckwitz and colleagues [1] it has been brought to our attention that some patients should be scored differently. Stable disease was seen in three of the eighteen patients instead of two of the eighteen patients: one patient with transitional cell carcinoma treated at 4 μg/kg scFv(FRP5)-ETA per day, and two breast cancer patients treated at 4 and 12.5 μg/kg scFv(FRP5)-ETA per day. Disease progression occured in 9 of the eighteen patients evaluated (see corrected Table 2 overleaf). This does not affect the conclusions of our study. In addition we would like to correct the following errors: patient IDs for patients U01 and U02 in the original Table 2 were interchanged. In addition, patient N03 had a grade 3 elevation of gamma-glutamyl transferase, and not grade 2 (see corrected Table 2 overleaf).
Table 2
Study summary
|
Patient
|
Dose level (μg/kg)
|
Course of therapy
|
Toxicities ≥ grade 1
|
Dose-limiting toxicity
|
Neutralizing antibodies
|
Clinical response
|
|---|---|---|---|---|---|---|
|
N01
|
2
|
According to plan
|
GGT grade 2
|
No
|
No
|
Progression
|
|
U01
|
2
|
Stopped on day 10
|
Cholestasis due to liver metastasisa
|
No
|
n.d.
|
n.d.
|
|
U02
|
2
|
According to plan
|
None
|
No
|
n.d.
|
Progression
|
|
N03
|
4
|
According to plan
|
GGT grade 2
|
No
|
No
|
Stable disease
|
|
N04
|
4
|
According to plan
|
ALT grade 1
|
No
|
No
|
Stable disease
|
|
N05
|
4
|
According to plan
|
Hemoglobin grade 3a
|
No
|
No
|
Progression
|
|
N06
|
10
|
According to plan
|
ALT grade 2, AST grade 1
|
No
|
+
|
Progression
|
|
N07
|
10
|
According to plan
|
ALT/AST grade 1, GGT grade 3
|
No
|
No
|
Progression
|
|
U03
|
10
|
According to plan
|
Fever and dyspnoeb
|
No
|
++
|
n.d.c
|
|
N13
|
12.5
|
According to plan
|
ALT grade 1, GGT grade 2, AP grade 1
|
No
|
No
|
Progression
|
|
N14
|
12.5
|
Stopped on day 8
|
ALT/AST grade 3, GGT grade 2, LDH grade 1
|
Yes
|
n.d.
|
n.d.
|
|
N15
|
12.5
|
According to plan
|
ALT grade 2, AST grade 1, AP grade 2
|
No
|
+
|
Progression
|
|
N17
|
12.5
|
According to plan
|
ALT/AST grade 2
|
No
|
No
|
Progression
|
|
U04
|
12.5
|
According to plan
|
Dyspnoe
|
No
|
No
|
n.d.c
|
|
U05
|
12.5
|
According to plan
|
None
|
No
|
++
|
Stable disease
|
|
N09
|
20
|
According to plan
|
ALT/AST grade 2
|
No
|
+++
|
Progression
|
|
N10
|
20
|
Stopped on day 8
|
ALT grade 4, AST grade 3, GGT grade 2
|
Yes
|
n.d.
|
n.d.
|
|
N12
|
20
|
Stopped on day 8
|
ALT grade 3, AST grade 2
|
Yes
|
n.d.
|
n.d.c
|