Format

Send to

Choose Destination
J Thorac Oncol. 2012 Dec;7(12):1823-1829. doi: 10.1097/JTO.0b013e31826aec2b.

Overall survival improvement in patients with lung cancer and bone metastases treated with denosumab versus zoledronic acid: subgroup analysis from a randomized phase 3 study.

Author information

1
Department of Clinical and Biological Sciences, University of Turino, Orbassano, Italy. Electronic address: giorgio.scagliotti@unito.it.
2
Department of Oncology, McGill University Health Centre, Montreal, Canada.
3
The Falck Division of Medical Oncology, Department of Oncology, Ospedale Niguarda Ca' Granada, Milan, Italy.
4
Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, Pennsylvania.
5
Department of Oncology, Weston Park Hospital, University of Sheffield, Sheffield, United Kingdom.
6
Department of Surgery, University Medical Center Mannheim, Heidelberg University, Mannheim, Germany.
7
Centre Jean Bernard, Clinique Victor Hugo, Le Mans, France.
8
South Texas Oncology and Hematology, San Antonio, Texas.
9
The Maria Sklodowska-Curie Institute of Oncology, Warsaw, Poland.
10
Oncology Hematology Associates of Northern Illinois, Gurnee, Illinois.
11
Department of Medical Oncology, Western Hospital, Footscray, Victoria, Australia.
12
Department of Medical Oncology, Hospital Clínico San Carlos, Madrid, Spain.
13
Instituto do Cancer Arnaldo Vieira de Carvalho, University of São Paulo Medical School, Sao Paolo, Brazil.
14
Department of Medical Oncology, Tata Memorial Hospital, Mumbai, India.
15
Institutul Oncologic I. Chiricuta, Cluj-Napoca, Romania.
16
Regional Oncology Dispensary with Inpatient Sector, Plovdiv, Bulgaria.
17
Global Biostatistical Sciences, Amgen Inc., Thousand Oaks, California.
18
Clinical Development, Amgen Inc., Thousand Oaks, California.

Abstract

INTRODUCTION:

Denosumab, a fully human anti-RANKL monoclonal antibody, reduces the incidence of skeletal-related events in patients with bone metastases from solid tumors. We present survival data for the subset of patients with lung cancer, participating in the phase 3 trial of denosumab versus zoledronic acid (ZA) in the treatment of bone metastases from solid tumors (except breast or prostate) or multiple myeloma.

METHODS:

Patients were randomized 1:1 to receive monthly subcutaneous denosumab 120 mg or intravenous ZA 4 mg. An exploratory analysis, using Kaplan-Meier estimates and proportional hazards models, was performed for overall survival among patients with non-small-cell lung cancer (NSCLC) and SCLC.

RESULTS:

Denosumab was associated with improved median overall survival versus ZA in 811 patients with any lung cancer (8.9 versus 7.7 months; hazard ratio [HR] 0.80) and in 702 patients with NSCLC (9.5 versus 8.0 months; HR 0.78) (p = 0.01, each comparison). Further analysis of NSCLC by histological type showed a median survival of 8.6 months for denosumab versus 6.4 months for ZA in patients with squamous cell carcinoma (HR 0.68; p = 0.035). Incidence of overall adverse events was balanced between treatment groups; serious adverse events occurred in 66.0% of denosumab-treated patients and 72.9% of ZA-treated patients. Cumulative incidence of osteonecrosis of the jaw was similar between groups (0.7% denosumab versus 0.8% ZA). Hypocalcemia rates were 8.6% with denosumab and 3.8% with ZA.

CONCLUSION:

In this exploratory analysis, denosumab was associated with improved overall survival compared with ZA, in patients with metastatic lung cancer.

PMID:
23154554
DOI:
10.1097/JTO.0b013e31826aec2b
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center