Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial

Amadori, Dino; Aglietta, Massimo; Alessi, Barbara; Giannì, L.; Ibrahim, Toni; Farina, Gabriella; Gaion, Fernando; Bertoldo, Francesco; Santini, Daniele; Rondena, Roberta; Bogani, Paola; Ripamonti, Carla

doi:10.1016/s1470-2045(13)70174-8

Cited by 175 publications

(171 citation statements)

References 26 publications

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“…73,74 Two other studies tested the reduction of therapy frequency from every 4 weeks to every 12 weeks after a treatment period of B1 year with ZA every 4 weeks. 75,76 Both studies reported a noninferiority of an every 12-week therapy schedule after at least 1 year of every 4-week ZA in terms of SREs; however, a significant increase in NTX-I levels from baseline in the every 12-week group was found. The meaning of this increase in the context of the longer survival of patients with bone metastases should be further studied.…”

Section: Dosing Of Btasmentioning

confidence: 98%

Bone remodeling markers and bone metastases: From cancer research to clinical implications

Ferreira¹,

Alho²,

Casimiro³

et al. 2015

BoneKEy Reports

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Bone metastasis is a frequent finding in the natural history of several types of cancers. However, its anticipated risk, diagnosis and response to therapy are still challenging to assess in clinical practice. Markers of bone metabolism are biochemical by-products that provide insight into the tumor-bone interaction, with potential to enhance the clinical management of patients with bone metastases. In fact, these markers had a cornerstone role in the development of bone-targeted agents; however, its translation to routine practice is still unclear, as reflected by current international guidelines. In this review, we aimed to capture several of the research and clinical translational challenges regarding the use of bone metabolism markers that we consider relevant for future research in bone metastasis.

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Section: Dosing Of Btasmentioning

confidence: 98%

Bone remodeling markers and bone metastases: From cancer research to clinical implications

Ferreira¹,

Alho²,

Casimiro³

et al. 2015

BoneKEy Reports

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“…The skeletal morbidity rate (SMR; number of SREs/patient/year) was the primary endpoint, and it was similar in both arms, with likewise no significant difference in the toxicity profile. The authors reported that bone resorption markers were significantly more suppressed with the monthly regimen and concluded that further follow-up is needed for a final answer [153].…”

Section: Dose Frequencymentioning

confidence: 99%

Bone health in breast cancer patients: A comprehensive statement by CECOG/SAKK Intergroup

et al. 2014

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Bone is the most common site of distant metastases in breast cancer that can cause severe and debilitating skeletal related events (SRE) including hypercalcemia of malignancy, pathologic fracture, spinal cord compression and the need for palliative radiation therapy or surgery to the bone. SRE are associated with substantial pain and morbidity leading to frequent hospitalization, impaired quality of life and poor prognosis. The past 25 years of research on the pathophysiology of bone metastases led to the development of highly effective treatment options to delay or prevent osseous metastases and SRE. Management of bone metastases has become an integral part of cancer treatment requiring expertise of multidisciplinary teams of medical and radiation oncologists, surgeons and radiologists in order to find an optimal treatment for each individual patient. A group of international breast cancer experts attended a Skeletal Care Academy Meeting in November 2012 in Istanbul and discussed current preventive measures and treatment options of SRE, which are summarized in this evidence-based consensus for qualified decision- making in clinical practice.

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“…In particular, zoledronic acid (ZA), a potent third-generation nitrogen-containing bisphosphonate, has achieved widespread clinical use in the treatment of bone metastases from solid tumors (8)(9)(10). Denosumab, a monoclonal antibody against RANKL, has been demonstrated to be superior to ZA in delaying or preventing SREs (11).…”

Section: Introductionmentioning

confidence: 99%

RANKL: A promising circulating marker for bone metastasis response

et al. 2016

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Abstract. Bone metastases are a frequent event in patients with solid tumors. Although great advances have been made in the treatment of these patients, the identification of novel, accurate indicators of bone response would greatly facilitate the clinical management of the disease. The receptor activator of nuclear factor-κB (RANK)/RANK ligand (RANKL)/osteoprotegerin (OPG) signaling pathway is significantly involved in bone metastasis formation. The main aim of the present study was to evaluate the role of circulating RANK, RANKL and OPG levels in predicting bone response. Marker accuracy was also compared with that of the conventional tumor marker N-terminal telopeptide of type I collagen (NTX). A prospective study was performed on 49 patients with bone metastases from breast, lung and prostate cancer, who were undergoing treatment with zoledronic acid. Patients were monitored for 1 year with blood tests, clinical evaluation and instrumental exams according to the response evaluation criteria of the University of Texas M. D. Anderson Cancer Center (Houston, TX, USA) and the Positron Emission Tomography Response Criteria in Solid Tumors. Circulating RANK/RANKL/OPG transcripts and NTX levels were evaluated by reverse transcription -quantitative polymerase chain reaction and immune enzymatic assay, respectively. The baseline RANKL levels differed significantly between responders and non-responders, whereas no differences in NTX levels were observed between the two groups. Receiver operating characteristic curve evaluation for all markers revealed that RANKL was the most accurate marker, with an area under the curve of 0.74 (95% confidence interval, 0.54-0.93). In addition, RANKL, which is the target of the novel monoclonal antibody denosumab, was the most accurate predictor of bone response in the present series of patients with bone metastases. Thus, the use of RANKL as a marker could potentially improve clinical practice, as current bone response evaluation is still somewhat problematic. IntroductionBone metastases are common in numerous solid cancers, including breast, prostate and lung cancer (1,2). In the USA, ~2/3 of patients who succumb to cancer each year have bone metastases, and ~20-25% of patients with neoplastic disease develop clinically evident bone metastases during the natural course of the disease (3,4).Bone metastases are responsible for high morbidity and reduced quality of life due to the frequent onset of clinical complications defined as skeletal-related events (SREs), which lead to a reduction in functional independence and quality of life, decrease survival rates and substantially increase healthcare costs (5,6).Bisphosphonates have improved the quality of life of patients with bone metastases from breast cancer by inducing both a reduction in SREs and in the risk of mortality (7). In particular, zoledronic acid (ZA), a potent third-generation nitrogen-containing bisphosphonate, has achieved widespread clinical use in the treatment of bone metastases from solid tumors (8-10). Denosumab, a ...

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Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial

Cited by 175 publications

References 26 publications

Bone remodeling markers and bone metastases: From cancer research to clinical implications

Bone remodeling markers and bone metastases: From cancer research to clinical implications

Bone health in breast cancer patients: A comprehensive statement by CECOG/SAKK Intergroup

RANKL: A promising circulating marker for bone metastasis response

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