A controlled prospective randomized placebo-controlled trial of Zoledronic acid in bony metastatic bladder cancer patients

Zaghloul, Mohamed S.; Boutrus, Rimoun; El-Hosieny, H.; A-Kader, Y.; Elattar, Inas; Nazmy, Mohamed

doi:10.1200/jco.2008.26.15_suppl.5033

Cited by 14 publications

(10 citation statements)

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“…63 Similarly, a pilot study in patients with bone metastases from bladder cancer (N ¼ 40) demonstrated that ZOL (4 mg per month iv for 6 months) significantly reduced the risk of SRE by 58% (P ¼ .008), reduced pain scores by 1.42 units versus placebo (P ¼ .015), and improved the 1-year OS rate 6-fold (P ¼ .02) versus placebo. 64 In addition, patients with bone metastases from LC (N ¼ 144) who received standard chemotherapy and ZOL (4 mg iv every 21 to 28 days for 1 year) for bone pain had longer median survival compared with patients who received standard chemotherapy but not ZOL (578 days vs 384 days, respectively; P < .001). 65 Additional therapies may improve survival further.…”

Section: Anticancer Effects In the Advanced Disease Settingmentioning

confidence: 99%

Zoledronic acid use in cancer patients

Coleman

Cook

Hirsh

et al. 2010

Cancer

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Bone is the most common site for metastasis from solid tumors, and the majority of patients will develop bone metastases during the natural course of their disease. Bisphosphonates are an effective treatment for preventing skeletal-related events in patients with bone metastases and may preserve functional independence and quality of life. Although several bisphosphonates have been investigated in patients with solid tumors, only zoledronic acid (ZOL) is approved by the US Food and Drug Administration and the European Medicines Agency for preventing skeletalrelated events in patients across a broad range of solid tumors. In addition, bisphosphonates, notably ZOL, prevent cancer treatment-induced bone loss in breast and prostate cancer patients who are receiving endocrine therapy. It also has been demonstrated that ZOL directly and indirectly inhibits cancer cell growth in vitro and growth and tumorigenesis in animal model systems. These properties may produce clinically meaningful benefits. In recent clinical studies in patients with cancer, ZOL improved overall and prolonged disease-free survival. Ongoing clinical trials in patients with solid tumors will provide further insight into the potential of ZOL to prevent distant metastases and improve survival. Cancer 2011;117:11-23. V C 2010 American Cancer Society.KEYWORDS: adjuvant setting, bisphosphonate, bone metastases, cancer, survival, zoledronic acid.During the progression of cancer, many patients will develop distant metastases, for which a common site is bone. 1For example, an estimated 75% of patients with advanced breast cancer (BC) or prostate cancer (PC), and 40% of patients with advanced lung cancer (LC) develop bone metastases.2,3 Without bone-targeted therapies, most patients with bone metastases will experience potentially debilitating skeletal-related events (SREs), such as pathologic fractures, spinal cord compression, the need for surgery or palliative radiotherapy to bone, or hypercalcemia of malignancy.1 These SREs can have debilitating consequences and reduce quality of life and survival. 4 Moreover, declines in performance status resulting from SREs could preclude the receipt of chemotherapy and radiotherapy by patients with some solid tumors. 5Bisphosphonates, which are inhibitors of osteoclast-mediated bone resorption, currently are the standard of care for preventing SREs in patients with bone metastases.6 Several bisphosphonates currently are approved by the US Food and Drug Administration and the European Medicines Agency for preventing SREs in patients with metastatic BC and multiple myeloma (MM). In addition, the nitrogen-containing bisphosphonate (N-BP) zoledronic acid (ZOL) has received widespread regulatory approval for patients with bone involvement from PC, LC, and the entire range of other solid tumors (OSTs). 6 In randomized phase 3 trials, ZOL (4 mg intravenously [iv] every 3 to 4 weeks [monthly]) demonstrated significant efficacy in delaying the onset and reducing the risk of SREs and in palliating bone pain, reducing analges...

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Section: Anticancer Effects In the Advanced Disease Settingmentioning

confidence: 99%

Zoledronic acid use in cancer patients

Coleman

Cook

Hirsh

et al. 2010

Cancer

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“…Moreover, in a larger pilot study, zoledronic acid (4 mg monthly) signifi cantly improved 5-year overall survival (OS) from 46% to 80% compared with chemotherapy alone (P < 0.01) in patients undergoing initial chemotherapy for multiple myeloma (n = 94), a disease that colonizes the bone marrow and has a strong osteolytic component [27]. In a recent pilot study of zoledronic acid (4 mg intravenous [IV] monthly for 6 months) to reduce skeletal morbidity in patients with bone metastases from bladder cancer (n = 40), zoledronic acid was also found to improve survival compared with placebo (P = 0.02) [28]. These pilot studies suggest that the effects of BPs on bone can have important indirect benefi ts for patients with advanced cancers.…”

Section: Indirect Antitumor Effectsmentioning

confidence: 93%

Bisphosphonates as adjuvant therapy for breast cancer

Gnant

Dubsky²,

Fitzal³

et al. 2009

Curr Breast Cancer Rep

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“…ZA also consistently reduced composite pain scores compared with the placebo group. ZA has also been tested in patients with bone metastases in comparison with other solid tumors [12][13][14][15]. Strong clinical evidence of efficacy is still lacking for BPs, so the following are important open questions for future research.…”

Section: Metastatic Breast Cancermentioning

confidence: 98%

Bisphosphonates in Breast Cancer: From Metastasis to Prevention

Bosch-Barrera

Merajver

2010

Curr Breast Cancer Rep

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Bisphosphonate compounds have efficacy for the prevention and treatment of osteoporosis as they reduce the risk of fractures due to bone fragility by one third to one half. Likewise, bisphosphonates are important supportive therapies for the management of bone integrity in patients with bone metastases from breast cancer as, in this setting, they reduce the risk of skeletal-related events by one third. Bone is a common, and often the first, site of involvement from advanced breast cancer. It is thought that bisphosphonates may slow the progression of metastatic breast cancer by altering communication between tumor cells and the bone microenvironment. Although bisphosphonates have not been shown to alter overall survival in metastatic breast cancer, preclinical and clinical data suggest that bisphosphonate therapy may have a role as an anticancer strategy. Proposed general mechanisms to explain this putative antitumor activity include effects on the bone microenvironment, immune response modulation, inhibition of angiogenesis, inhibition of proliferation, and induction of apoptosis. The optimization of bisphosphonate use is being investigated. This article discusses the clinical and basic scientific data surrounding zoledronic acid, which is the most potent nitrogen-containing bisphosphonate used in patients with breast cancer.

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A controlled prospective randomized placebo-controlled trial of Zoledronic acid in bony metastatic bladder cancer patients

Cited by 14 publications

References 0 publications

Zoledronic acid use in cancer patients

Zoledronic acid use in cancer patients

Bisphosphonates as adjuvant therapy for breast cancer

Bisphosphonates in Breast Cancer: From Metastasis to Prevention

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