ZOMETA injection - Proven Efficacy in Patients with Bone Metastases from:

	Dosing & Administration Important Safety Information

• Prostate cancer
• Breast cancer
• Multiple myeloma
• Lung and other solid tumors

The First IV Bisphosphonate Proven Effective for Patients with Documented Bone Metastases from Prostate Cancer[1,2]

In prostate cancer, ZOMETA significantly delayed bone complications vs. placebo by over 5 months (P=0.009)[3]

Patients taking ZOMETA had significantly fewer skeletal-related events.[1,2]

Prostate cancer should have progressed after treatment with at least one hormonal therapy.

Study design: Phase III, randomized, double-blind, placebo-controlled, international, multicenter (136), 15-month parallel study (039) in 422 prostate cancer patients (n=214 receiving ZOMETA, n=208 taking placebo every 3 weeks) with metastatic bone lesions and 3 consecutive rising serum PSA levels and receiving antineoplastic therapy. More than 90% of patients were >60 years of age.

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Proven Efficacy in Patients with Multiple Myeloma and Patients with Documented Bone Metastases from Breast Cancer[1,2,4]

Study design: Phase III, randomized, double-blind, double-dummy, international, multicenter, 12-month parallel study (010) in 1,122 patients stratified by cancer type and breast cancer treatment (Stage III multiple myeloma; stage IV breast cancer on chemotherapy, with or without hormonal therapy; stage IV breast cancer receiving first- or second-line hormonal therapy for metastatic disease). 564 patients received ZOMETA 4 mg, and 558 patients received pamidronate disodium 90 mg every 3 to 4 weeks; all patients were evaluated at Month 13.

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In a recent Japanese study, ZOMETA significantly reduced skeletal complications in women with bone metastases from breast cancer versus placebo.[5]

Proportion of patients with each type of skeletal-related event (SRE). Comp, compression; HCM, hypercalcemia of malignancy. (*), excluding HCM.

Study design: Women with bone metastases from breast cancer were randomized to receive 4 mg zoledronic acid (n=114) or placebo (n=114) every 4 weeks for one year.

Results: The risk of skeletal-related event (SRE), defined as pathologic fracture, spinal cord compression, and radiation or surgery to bone, was reduced 39% compared to placebo (P=.027).

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The First Bisphosphonate Proven Effective in Patients with Documented Bone Metastases from Solid Tumors*[1,2]

Solid tumor types included in study
Non-small cell lung cancer	48%
Renal	9%
Small cell lung cancer	8%
Colorectal	7%
Unknown	6%
Bladder	5%
GI (other)	4%
Head and neck	2%
Genitourinary	2%
Malignant melanoma	2%
Hepatobiliary	1%
Thyroid	1%
Sarcoma	1%
Neuroendocrine/carcinoid	<1%
Mesothelioma	<1%
Other	<1%

Study design: Phase III, randomized, double-blind, placebo-controlled, international, multicenter (141), 9-month parallel study (011) in 507 patients with any cancer other than breast, prostate or multiple myeloma, and with bone metastases; ZOMETA given with concomitant antineoplastic therapy (n=257 receiving ZOMETA, n=250 receiving placebo every 3 weeks)

In other solid tumors, including non-small cell lung cancer, ZOMETA significantly delayed bone complications vs. placebo by over two months (P=.023).[1,6]

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1. ZOMETA full prescribing information. Novartis Pharmaceuticals Corporation, 2002.
   
2. Data on file (ISE/ISS). Novartis Pharmaceuticals Corporation.
   
3. Saad F, Gleason DM, Murray R, et al. Long-term efficacy of zoledronic acid for the prevention of skeletal complications in patients with metastatic hormone-refractory prostate cancer. J Natl Cancer Inst . 2004;96(11):879-82.
   
4. Rosen LS, Gordon D, Kaminski M, et al. Zoledronic acid versus pamidronate in the treatment of skeletal metastases in patients with breast cancer or osteolytic lesions of multiple myeloma: a phase III, double-blind, comparative trial. Cancer J. 2001;7(5):377-387.
   
5. Kohno N, Aogi K, Minabi H, et al. Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. J Clin Oncol. 2005; 23: 1-8.
   
6. 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; 21:3150-7.