Bone-Related Complications and Quality of Life in Advanced Breast Cancer: Results from a Randomized Phase III Trial of Denosumab versus Zoledronic Acid

被引：112

作者：

Martin, Miguel ^{[1
]}

Bell, Richard ^{[2
]}

Bourgeois, Hugues

Brufsky, Adam ^{[3
]}

Diel, Ingo

Eniu, Alexandru ^{[4
]}

Fallowfield, Lesley ^{[5
]}

Fujiwara, Yasuhiro ^{[6
]}

Jassem, Jacek ^{[7
]}

Paterson, Alexander H. G. ^{[8
]}

Ritchie, Diana ^{[9
]}

Steger, Guenther G. ^{[10
]}

Stopeck, Alison ^{[11
]}

Vogel, Charles ^{[12
]}

Fan, Michelle ^{[13
]}

Jiang, Qi

Chung, Karen ^{[14
]}

Dansey, Roger ^{[15
]}

Braun, Ada ^{[15
]}

机构：

[1] Univ Complutense, Madrid 28007, Spain

[2] Barwon Hlth, Andrew Love Canc Ctr, Geelong, Vic, Australia

[3] Univ Pittsburgh, Med Ctr, Pittsburgh, PA USA

[4] Inst Oncol Ion Chiricuta, Cluj Napoca, Romania

[5] Univ Sussex, Canc Res UK, Brighton, E Sussex, England

[6] Natl Canc Ctr, Tokyo, Japan

[7] Med Univ Gdansk, Gdansk, Poland

[8] Tom Baker Canc Clin, Calgary, AB, Canada

[9] Western Infirm & Associated Hosp, Beatson Oncol Ctr, Glasgow G11 6NT, Lanark, Scotland

[10] Waehringer Guertel, Div Clin Oncol, Allgemeines Krankenhaus St Georg, Vienna, Austria

[11] Univ Arizona, Arizona Canc Ctr, Tucson, AZ USA

[12] Sylvester Comprehens Canc Ctr Deerfield, Deerfield Beach, FL USA

[13] Amgen Inc, Dept Biostat, Thousand Oaks, CA 91320 USA

[14] Amgen Inc, Dept Global Hlth Econ, Thousand Oaks, CA 91320 USA

[15] Amgen Inc, Dept Global Dev, Thousand Oaks, CA 91320 USA

来源：

CLINICAL CANCER RESEARCH | 2012年 / 18卷 / 17期

关键词：

SKELETAL-RELATED EVENTS; LONG-TERM EFFICACY; DOUBLE-BLIND; SOLID TUMORS; PAMIDRONATE DISODIUM; MULTIPLE-MYELOMA; LUNG-CANCER; METASTASES; BISPHOSPHONATES; PLACEBO;

D O I：

10.1158/1078-0432.CCR-11-3310

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 [肿瘤学];

摘要：

Purpose: Denosumab was shown to be superior to zoledronic acid in preventing skeletal related events (SRE) in patients with breast cancer and bone metastases in a randomized, double-blind phase III study. We evaluated further results from this study related to skeletal complications and health-related quality of life (HRQoL). Experimental Design: Patients were randomized 1: 1 to receive subcutaneous denosumab 120 mg (n = 1,026) and intravenous placebo, or intravenous zoledronic acid 4 mg (n = 1,020) and subcutaneous placebo every 4 weeks. Analyses reported here include the proportion of patients with one or multiple on-study SREs, time to first radiation to bone, time to first SRE or hypercalcemia of malignancy, and change in HRQoL (functional assessment of cancer therapy-general). Results: Fewer patients receiving denosumab than zoledronic acid had an on-study SRE (31% vs. 36%, P = 0.006). The incidence of first radiation to bone was 12% (n = 123) with denosumab versus 16% (n = 162) with zoledronic acid. Denosumab prolonged the time to first radiation to bone by 26% versus zoledronic acid (HR, 0.74; 95% confidence interval [CI], 0.59-0.94, P = 0.012) and prolonged the time to first SRE or hypercalcemia of malignancy by 18% (HR, 0.82; 95% CI, 0.70-0.95; P = 0.007). Ten percent more patients had a clinically meaningful improvement in HRQoL with denosumab relative to zoledronic acid, regardless of baseline pain levels. Conclusions: Denosumab was superior to zoledronic acid in reducing bone-related complications of metastatic breast cancer and maintained HRQoL, providing an efficacious, well-tolerated treatment option for patients with bone metastases from breast cancer. Clin Cancer Res; 18(17); 4841-9. (C) 2012 AACR.

引用

页码：4841 / 4849

页数：9

共 39 条

[1]

Guidance on the use of bisphosphonates in solid tumours:: recommendations of an international expert panel [J].