Abstract
Following confirmation of the appropriate dosage, safety and potential efficacy of Herceptin® (trastuzumab) in small-scale phase I and II trials involving patients with refractory disease, a large trial was conducted in 222 patients with breast cancer who had relapsed after one or two chemotherapy regimens for their metastatic disease. The results showed a positive and durable overall response rate (15% according to a response evaluation committee (REC) assessment) using trastuzumab monotherapy (initial dose 4 mg/kg intravenously (i.v.) followed by 2 mg/kg i.v. weekly). In another recently completed phase II trial, 113 patients were randomised to two dose levels (initial dose of 4 mg/kg i.v. dose followed by 2 mg/kg i.v. weekly, or initial dose of 8 mg/kg followed by 4 mg/kg i.v. weekly) of single-agent trastuzumab as first-line therapy for metastatic disease. The preliminary overall response rate was 23% based on investigator assessment, and tolerability was excellent as in previous trials; efficacy was similar in both dose groups, but the side-effects tended to be more frequent in the higher dose group. The preferred dosage is therefore the same as that currently recommended, i.e. an initial dose of 4 mg/kg i.v. followed by 2 mg/kg weekly i.v. until disease progression.
| Original language | English |
|---|---|
| Journal | European Journal of Cancer |
| Volume | 37 |
| Issue number | SUPPL. 1 |
| State | Published - Feb 22 2001 |
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Keywords
- Clinical trial
- Efficacy
- First-line
- Herceptin® (trastuzumab)
- Metastatic breast cancer
ASJC Scopus subject areas
- Cancer Research
- Hematology
- Oncology
Cite this
First-line, single-agent Herceptin® (trastuzumab) in metastatic breast cancer : A preliminary report. / Vogel, Charles; Cobleigh, M. A.; Tripathy, D.; Gutheil, J. C.; Harris, L. N.; Fehrenbacher, L.; Slamon, D. J.; Murphy, M.; Novotny, W. F.; Burchmore, M.; Shak, S.; Stewart, S. J.
In: European Journal of Cancer, Vol. 37, No. SUPPL. 1, 22.02.2001.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - First-line, single-agent Herceptin® (trastuzumab) in metastatic breast cancer
T2 - A preliminary report
AU - Vogel, Charles
AU - Cobleigh, M. A.
AU - Tripathy, D.
AU - Gutheil, J. C.
AU - Harris, L. N.
AU - Fehrenbacher, L.
AU - Slamon, D. J.
AU - Murphy, M.
AU - Novotny, W. F.
AU - Burchmore, M.
AU - Shak, S.
AU - Stewart, S. J.
PY - 2001/2/22
Y1 - 2001/2/22
N2 - Following confirmation of the appropriate dosage, safety and potential efficacy of Herceptin® (trastuzumab) in small-scale phase I and II trials involving patients with refractory disease, a large trial was conducted in 222 patients with breast cancer who had relapsed after one or two chemotherapy regimens for their metastatic disease. The results showed a positive and durable overall response rate (15% according to a response evaluation committee (REC) assessment) using trastuzumab monotherapy (initial dose 4 mg/kg intravenously (i.v.) followed by 2 mg/kg i.v. weekly). In another recently completed phase II trial, 113 patients were randomised to two dose levels (initial dose of 4 mg/kg i.v. dose followed by 2 mg/kg i.v. weekly, or initial dose of 8 mg/kg followed by 4 mg/kg i.v. weekly) of single-agent trastuzumab as first-line therapy for metastatic disease. The preliminary overall response rate was 23% based on investigator assessment, and tolerability was excellent as in previous trials; efficacy was similar in both dose groups, but the side-effects tended to be more frequent in the higher dose group. The preferred dosage is therefore the same as that currently recommended, i.e. an initial dose of 4 mg/kg i.v. followed by 2 mg/kg weekly i.v. until disease progression.
AB - Following confirmation of the appropriate dosage, safety and potential efficacy of Herceptin® (trastuzumab) in small-scale phase I and II trials involving patients with refractory disease, a large trial was conducted in 222 patients with breast cancer who had relapsed after one or two chemotherapy regimens for their metastatic disease. The results showed a positive and durable overall response rate (15% according to a response evaluation committee (REC) assessment) using trastuzumab monotherapy (initial dose 4 mg/kg intravenously (i.v.) followed by 2 mg/kg i.v. weekly). In another recently completed phase II trial, 113 patients were randomised to two dose levels (initial dose of 4 mg/kg i.v. dose followed by 2 mg/kg i.v. weekly, or initial dose of 8 mg/kg followed by 4 mg/kg i.v. weekly) of single-agent trastuzumab as first-line therapy for metastatic disease. The preliminary overall response rate was 23% based on investigator assessment, and tolerability was excellent as in previous trials; efficacy was similar in both dose groups, but the side-effects tended to be more frequent in the higher dose group. The preferred dosage is therefore the same as that currently recommended, i.e. an initial dose of 4 mg/kg i.v. followed by 2 mg/kg weekly i.v. until disease progression.
KW - Clinical trial
KW - Efficacy
KW - First-line
KW - Herceptin® (trastuzumab)
KW - Metastatic breast cancer
UR - http://www.scopus.com/inward/record.url?scp=0035129498&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0035129498&partnerID=8YFLogxK
M3 - Article
C2 - 11167088
AN - SCOPUS:0035129498
VL - 37
JO - European Journal of Cancer
JF - European Journal of Cancer
SN - 0959-8049
IS - SUPPL. 1
ER -