| Title |
Efficacy and safety of leuprorelin acetate 6-month depot, TAP-144-SR (6M), in combination with tamoxifen in postoperative, premenopausal patients with hormone receptor-positive breast cancer: a phase III, randomized, open-label, parallel-group comparative study
|
|---|---|
| Published in |
Breast Cancer, March 2016
|
| DOI | 10.1007/s12282-016-0691-6 |
| Pubmed ID | |
| Authors |
Junichi Kurebayashi, Tatsuya Toyama, Shuuji Sumino, Eri Miyajima, Tsukasa Fujimoto |
| Abstract |
Leuprorelin acetate, a luteinizing hormone-releasing hormone agonist, is used worldwide in premenopausal women with hormone receptor-positive breast cancer. This study was conducted to assess the non-inferiority of the 6-month depot formulation, TAP-144-SR (6M) 22.5 mg to the 3-month depot formulation, TAP-144-SR (3M) 11.25 mg in postoperative, premenopausal patients with hormone receptor-positive breast cancer. This was a 96-week phase III, randomized, open-label, parallel-group comparative study. All patients concomitantly received oral tamoxifen (20 mg daily). The primary endpoint was the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 48. In total, 167 patients were randomized to receive TAP-144-SR (6M) (n = 83) or TAP-144-SR (3M) (n = 84) and the E2 suppression rate was 97.6 and 96.4 %, respectively. The estimated between-group difference was 1.2 % (95 % confidence interval -5.2 to 7.8). The non-inferiority of TAP-144-SR (6M) to TAP-144-SR (3M) for E2 suppression was confirmed. As for safety, common adverse events were hot flush and injection site reactions including induration, pain, and erythema in both treatment groups, which were of ≤Grade 2 in severity and not serious. No significant between-group differences in safety profiles and tolerability were observed. TAP-144-SR (6M) was not inferior to TAP-144-SR (3M) for its suppressive effect on serum E2. TAP-144-SR (6M) was also as well tolerated as TAP-144-SR (3M). |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 2 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Science communicators (journalists, bloggers, editors) | 1 | 50% |
| Members of the public | 1 | 50% |
Mendeley readers
The data shown below were compiled from readership statistics for 83 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 83 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 13 | 16% |
| Researcher | 11 | 13% |
| Other | 10 | 12% |
| Professor | 5 | 6% |
| Student > Bachelor | 5 | 6% |
| Other | 15 | 18% |
| Unknown | 24 | 29% |
| Readers by discipline | Count | As % |
|---|---|---|
| Medicine and Dentistry | 20 | 24% |
| Nursing and Health Professions | 10 | 12% |
| Pharmacology, Toxicology and Pharmaceutical Science | 7 | 8% |
| Psychology | 5 | 6% |
| Biochemistry, Genetics and Molecular Biology | 3 | 4% |
| Other | 10 | 12% |
| Unknown | 28 | 34% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 06 April 2016.
All research outputs
#16,272,032
of 23,975,976 outputs
Outputs from Breast Cancer
#303
of 614 outputs
Outputs of similar age
#184,593
of 304,399 outputs
Outputs of similar age from Breast Cancer
#9
of 21 outputs
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