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Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group.
J Clin Oncol. 2003 Aug 15; 21(16):3150-7.JC

Abstract

PURPOSE

To assess the efficacy and safety of zoledronic acid in patients with bone metastases secondary to solid tumors other than breast or prostate cancer.

PATIENTS AND METHODS

Patients were randomly assigned to receive zoledronic acid (4 or 8 mg) or placebo every 3 weeks for 9 months, with concomitant antineoplastic therapy. The 8-mg dose was reduced to 4 mg (8/4-mg group). The primary efficacy analysis was proportion of patients with at least one skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy to bone, and surgery to bone. Secondary analyses (time to first SRE, skeletal morbidity rate, and multiple event analysis) counted hypercalcemia as an SRE.

RESULTS

Among 773 patients with bone metastases from lung cancer or other solid tumors, the proportion with an SRE was reduced in both zoledronic acid groups compared with the placebo group (38% for 4 mg and 35% for 8/4 mg zoledronic acid v 44% for the placebo group; P =.127 and P =.023 for 4-mg and 8/4-mg groups, respectively). Additionally, 4 mg zoledronic acid significantly increased time to first event (median, 230 v 163 days for placebo; P =.023), an important end point in this poor-prognosis population, and significantly reduced the risk of developing skeletal events by multiple event analysis (hazard ratio = 0.732; P =.017). Zoledronic acid was well tolerated; the most common adverse events in all treatment groups included bone pain, nausea, anemia, and vomiting.

CONCLUSION

Zoledronic acid (4 mg infused over 15 minutes) is the first bisphosphonate to reduce skeletal complications in patients with bone metastases from solid tumors other than breast and prostate cancer.

Authors+Show Affiliations

Cancer Institute Medical Group, 11818 Wilshire Blvd, Suite 200, Los Angeles, CA 90025, USA. lrosen@cimg.org.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

12915606

Citation

Rosen, Lee S., et al. "Zoledronic Acid Versus Placebo in the Treatment of Skeletal Metastases in Patients With Lung Cancer and Other Solid Tumors: a Phase III, Double-blind, Randomized Trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 21, no. 16, 2003, pp. 3150-7.
Rosen LS, Gordon D, Tchekmedyian S, et al. Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol. 2003;21(16):3150-7.
Rosen, L. S., Gordon, D., Tchekmedyian, S., Yanagihara, R., Hirsh, V., Krzakowski, M., Pawlicki, M., de Souza, P., Zheng, M., Urbanowitz, G., Reitsma, D., & Seaman, J. J. (2003). Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 21(16), 3150-7.
Rosen LS, et al. Zoledronic Acid Versus Placebo in the Treatment of Skeletal Metastases in Patients With Lung Cancer and Other Solid Tumors: a Phase III, Double-blind, Randomized Trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. J Clin Oncol. 2003 Aug 15;21(16):3150-7. PubMed PMID: 12915606.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Zoledronic acid versus placebo in the treatment of skeletal metastases in patients with lung cancer and other solid tumors: a phase III, double-blind, randomized trial--the Zoledronic Acid Lung Cancer and Other Solid Tumors Study Group. AU - Rosen,Lee S, AU - Gordon,David, AU - Tchekmedyian,Simon, AU - Yanagihara,Ronald, AU - Hirsh,Vera, AU - Krzakowski,M, AU - Pawlicki,M, AU - de Souza,Paul, AU - Zheng,Ming, AU - Urbanowitz,Gladys, AU - Reitsma,Dirk, AU - Seaman,John J, PY - 2003/8/14/pubmed PY - 2003/9/16/medline PY - 2003/8/14/entrez SP - 3150 EP - 7 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 21 IS - 16 N2 - PURPOSE: To assess the efficacy and safety of zoledronic acid in patients with bone metastases secondary to solid tumors other than breast or prostate cancer. PATIENTS AND METHODS: Patients were randomly assigned to receive zoledronic acid (4 or 8 mg) or placebo every 3 weeks for 9 months, with concomitant antineoplastic therapy. The 8-mg dose was reduced to 4 mg (8/4-mg group). The primary efficacy analysis was proportion of patients with at least one skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, radiation therapy to bone, and surgery to bone. Secondary analyses (time to first SRE, skeletal morbidity rate, and multiple event analysis) counted hypercalcemia as an SRE. RESULTS: Among 773 patients with bone metastases from lung cancer or other solid tumors, the proportion with an SRE was reduced in both zoledronic acid groups compared with the placebo group (38% for 4 mg and 35% for 8/4 mg zoledronic acid v 44% for the placebo group; P =.127 and P =.023 for 4-mg and 8/4-mg groups, respectively). Additionally, 4 mg zoledronic acid significantly increased time to first event (median, 230 v 163 days for placebo; P =.023), an important end point in this poor-prognosis population, and significantly reduced the risk of developing skeletal events by multiple event analysis (hazard ratio = 0.732; P =.017). Zoledronic acid was well tolerated; the most common adverse events in all treatment groups included bone pain, nausea, anemia, and vomiting. CONCLUSION: Zoledronic acid (4 mg infused over 15 minutes) is the first bisphosphonate to reduce skeletal complications in patients with bone metastases from solid tumors other than breast and prostate cancer. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/12915606/Zoledronic_acid_versus_placebo_in_the_treatment_of_skeletal_metastases_in_patients_with_lung_cancer_and_other_solid_tumors:_a_phase_III_double_blind_randomized_trial__the_Zoledronic_Acid_Lung_Cancer_and_Other_Solid_Tumors_Study_Group_ L2 - https://ascopubs.org/doi/10.1200/JCO.2003.04.105?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -