A phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy

Clemons, Mark; Dranitsaris, George; Ooi, Wei; Cole, David E. C.

doi:10.1007/s10549-007-9583-y

Cited by 51 publications

(47 citation statements)

References 16 publications

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“…Bisphosphonates can potently reduce telopeptide levels, 32,33 which correlate well with reduced pain. 34,35 Patients in this study had already been treated with bisphosphonates for a mean duration of 15.2 months and it is possible that these patients had therefore already experienced the maximal suppression of their bone turnover. If suppression was maximal, then neither telopeptide levels nor pain scores would be expected to change as a result of a high dose of vitamin D. It should be emphasized that patients in this study were administered different bisphosphonates, and these were given both orally and intravenously.…”

Section: Discussionmentioning

confidence: 99%

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases

Amir

Simmons

Freedman

et al. 2009

Cancer

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BACKGROUND: Vitamin D deficiency has potential roles in breast cancer etiology and progression. Vitamin D deficiency has also been associated with increased toxicity from bisphosphonate therapy. The optimal dose of vitamin D supplementation is unknown, but daily sunlight exposure can generate the equivalent of a 10,000-IU oral dose of vitamin D 3 . This study therefore aimed to assess the effect of this dose of vitamin D 3 in patients with bone metastases from breast cancer. METHODS: Patients with bone metastases treated with bisphosphonates were enrolled into this single-arm phase 2 study. Patients received 10,000 IU of vitamin D 3 and 1000 mg of calcium supplementation each day for 4 months. The effect of this treatment on palliation, bone resorption markers, calcium metabolism, and toxicity were evaluated at baseline and monthly thereafter. RESULTS: Forty patients were enrolled. No significant changes in bone resorption markers were seen. Despite no change in global pain scales, there was a significant reduction in the number of sites of pain. A small but statistically significant increase in serum calcium was seen, as was a significant decrease in serum parathyroid hormone. Treatment unmasked 2 cases of primary hyperparathyroidism, but was not associated with direct toxicity. CONCLUSIONS: Daily doses of 10,000 IU vitamin D 3 for 4 months appear safe in patients without comorbid conditions causing hypersensitivity to vitamin D. Treatment reduced inappropriately elevated parathyroid hormone levels, presumably caused by long-term bisphosphonate use. There did not appear to be a significant palliative benefit nor any significant change in bone resorption. Cancer 2010;116:284-91.

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Section: Discussionmentioning

confidence: 99%

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases

Amir

Simmons

Freedman

et al. 2009

Cancer

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“…Thirty patients with metastatic breast cancer completed the study. At 12 weeks patients achieved a signifi cant improvement in pain control (OR 0.41; p = 0.028), 46% of those being a palliative response and thus clinically relevant (Clemons et al 2008). This fi nding needs further investigation in the setting of a randomized trial, however, if confi rmed, it may mean that a variety of bisphosphonates can be used through the course of a patient's disease.…”

Section: Palliation Of Symptoms With Ibandronatementioning

confidence: 99%

Use of ibandronate in the prevention of skeletal events in metastatic breast cancer

Devitt

McLachlan

2008

TCRM

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Bone metastasis from breast cancer often cause signifi cant morbidity including pain, impaired mobility, pathological fracture, and spinal cord compression. Bisphosphonates play an important role in preventing these skeletal related events and are the standard of care for patients with bone metastasis from breast cancer. Ibandronate is a highly potent bisphosphonate available in both intravenous and oral preparations. It has been shown in clinical trials to be effective in reducing skeletal complications and also signifi cantly improve quality of life up to 96 weeks. Unlike other intravenous bisphosphonates, ibandronate has minimal renal toxicity, allowing safe outpatient administration, reducing the need for hospital attendance and safety monitoring. Early trials have shown ibandronate may also be effective in high doses for palliation of opioid-resistant pain from bone metastasis, and as a second-line agent in patients developing a skeletal complication whilst receiving another bisphosphonate.

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“…Another controversial issue is switching to another bisphosphonate after SRE develops. In two phase II studies, it has been shown that patients with skeletal progression or experiencing SRE while on clodranate or pamidronate, switching to more potent bisphosphonates zoledronic acid or ibandronate, may provide pain palliation and may also reduce bone turnover markers (Clemons et al, 2006, Clemons et al, 2008. In another phase II study that evaluate switching, in patients whom urinary N-telopeptide (uNTx) levels are still elevated despite zoledronic acid treatment switching to denosumab reduced uNTx levels significantly then continuing zoledronic acid and patients in switch arm also experienced less SRE (Fizazi et al, 2009).…”

Section: Clinical Use Of Bone Modifying Agentsmentioning

confidence: 99%

Medical Treatment of Breast Cancer Bone Metastasis: From Bisphosphonates to Targeted Drugs

Erdoğan

Çiçin²

2014

Asian Pacific Journal of Cancer Prevention

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Breast cancer bone metastasis causing severe morbidity is commonly encountered in daily clinical practice. It causes pain, pathologic fractures, spinal cord and other nerve compression syndromes and life threatening hypercalcemia. Breast cancer metastasizes to bone through complicated steps in which numerous molecules play roles. Metastatic cells disrupt normal bone turnover and create a vicious cycle to which treatment efforts should be directed. Bisphosphonates have been used safely for more than two decades. As a group they delay time to first skeletal related event and reduce pain, but do not prevent development of bone metastasis in patients with no bone metastasis, and also do not prolong survival. The receptor activator for nuclear factor kB ligand inhibitor denosumab delays time to first skeletal related event and reduces the skeletal morbidity rate. Radionuclides are another treatment option for bone pain. New targeted therapies and radionuclides are still under investigation. In this review we will focus on mechanisms of bone metastasis and its medical treatment in breast cancer patients.

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A phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy

Cited by 51 publications

References 16 publications

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases

Use of ibandronate in the prevention of skeletal events in metastatic breast cancer

Medical Treatment of Breast Cancer Bone Metastasis: From Bisphosphonates to Targeted Drugs

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A phase II trial evaluating the palliative benefit of second-line oral ibandronate in breast cancer patients with either a skeletal related event (SRE) or progressive bone metastases (BM) despite standard bisphosphonate (BP) therapy

Cited by 51 publications

References 16 publications

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D3 in breast cancer patients with bone metastases

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D3 in breast cancer patients with bone metastases

Use of ibandronate in the prevention of skeletal events in metastatic breast cancer

Medical Treatment of Breast Cancer Bone Metastasis: From Bisphosphonates to Targeted Drugs

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A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases

A phase 2 trial exploring the effects of high‐dose (10,000 IU/day) vitamin D₃ in breast cancer patients with bone metastases