Real-world patient-reported outcomes of breast cancer or prostate cancer patients receiving antiresorptive therapy for bone metastases: Final results of the PROBone registry study

Jakob, Andreas; Mark-Oliver, Zahn; Nusch, Arnd; Werner, Thorsten; Schnell, Roland; Meyer, Frank; Nicole, Hamm; Däßler, Klaus-Ulrich; Losem, Christoph; Welslau, Manfred; Petra, Hoevel; Karin, Potthoff

doi:10.1016/j.jbo.2022.100420

Cited by 7 publications

(13 citation statements)

References 39 publications

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“…The management of bone metastases in patients with prostate cancer is challenging in terms of morbidity, debilitating pain, impaired function, and poor QoL [ 45 ]. Unfortunately, since 2015, there have been no new analgesic agents approved for the relief of PCIBP and so medications succinctly summarized by the World Health Organisation’s 3-Step Analgesic Ladder ([ 75 ];Fig.…”

Section: Clinically Used Analgesic/adjuvant Agents For Relief Of Pcibpmentioning

confidence: 99%

“…For patients with ‘heavy’ bone pain, FACT–BP scores improved over time Pain medication was used by 42–52% of patients and its effectiveness was reported as ‘somewhat—quite a bit). This remained stable during the 12-mth study Renal toxicity, osteonecrosis of the jaw [ 45 ] Patients with mCRPC (n = 421) who received zoledronic acid, clodronate, or etidonate compared with no treatment/placebo; a network meta-analysis of 21 trials in a Cochrane systematic review Primary 1: Proportion of patients with pain response measured at baseline, 6 mths, 1 yr, 2 yrs or longest reported follow-up Present Pain Intensity (PPI) score of 0 or ↓ of 2 points without an ↑ in analgesic score or evidence of disease progression, ↓ in analgesic score without an ↑ in PPI score; numeric & linear scales and VAS were used Little to no difference in pain response for bisphosphonates compared to placebo/no treatment None of the trials reported results for comparison with denosumab Renal events, osteonecrosis of the jaw [ 46 ] Local external beam radiation Patients with bone-predominant mCRPC with painful bone metastases (n = 6099) received local external beam radiation as a single 8 Gy) or multiple fractions; a systematic review of 26 randomized trials Primary Overall response rate of pain evoked by single versus multiple fractions of external beam radiation Overall pain responses: 70–80% of assessable patients for both single & multiple fraction arms had favourable responses Complete pain responses: ~ 20% of assessable patients for single & multiple fraction arms Bone pain flare and nausea [ 87 ] Exercise-based treatment Patients with mCRPC on ADT (n = 25); Randomized (1:1:1) to remotely monitored aerobic or resistance exercise or usual care, over a 12-wk period in the pilot CHAMP study (NCT02613273). Aerobic exercise was 20–30 min of moderate-to-vigorous intensity exercise 3–5 days/week.…”

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

“…Clinical practice guidelines, including the ESMO-endorsed Cancer Care Ontario guideline or the American Society of Clinical Oncology (ASCO) guideline, recommend starting bone-targeted agents (BTA) such as bisphosphonates (zoledronic acid (ZA), pamidronate) or the RANK inhibitor (denosumab) for treating patients with newly diagnosed mCRPC, irrespective of whether or not they are symptomatic [ 24 , 45 , 88 , 99 ]. The aim is to prevent SREs and pain progression, as well as stabilization of patient’s QoL (Table 3 ) [ 45 ]. Clinical trial comparison of 4- versus 12-weekly BTA regimens in patients with bone metastases due to mCRPC, showed equivalence for both efficacy and health-related QoL [ 23 , 42 ].…”

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

“…that produced by docetaxel alone [ 47 ]. In the PROBone study (NCT02410044) (Table 3 ), 77% of patients with bone metastases due to mCRPC had bone pain at baseline, 15% of whom rated their pain as ‘heavy’ which equated to a VAS score of 9–10 [ 45 ]. Once taking a BTA, patients with ‘heavy’ bone pain improved over the 12 month study duration (Table 3 ) [ 45 ].…”

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

“…In the PROBone study (NCT02410044) (Table 3 ), 77% of patients with bone metastases due to mCRPC had bone pain at baseline, 15% of whom rated their pain as ‘heavy’ which equated to a VAS score of 9–10 [ 45 ]. Once taking a BTA, patients with ‘heavy’ bone pain improved over the 12 month study duration (Table 3 ) [ 45 ]. Additionally, in a network meta-analysis of 21 clinical studies in men with mCRPC and bone metastases, there was little to no difference in pain responses for bisphosphates c.f.…”

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

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Prostate cancer induced bone pain: pathobiology, current treatments and pain responses from recent clinical trials

2022

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Purpose Metastatic spread of prostate cancer to the skeleton may result in debilitating bone pain. In this review, we address mechanisms underpinning the pathobiology of metastatic prostate cancer induced bone pain (PCIBP) that include sensitization and sprouting of primary afferent sensory nerve fibres in bone. We also review current treatments and pain responses evoked by various treatment modalities in clinical trials in this patient population. Methods We reviewed the literature using PubMed to identify research on the pathobiology of PCIBP. Additionally, we reviewed clinical trials of various treatment modalities in patients with PCIBP with pain response outcomes published in the past 7 years. Results Recent clinical trials show that radionuclides, given either alone or in combination with chemotherapy, evoked favourable pain responses in many patients and a single fraction of local external beam radiation therapy was as effective as multiple fractions. However, treatment with chemotherapy, small molecule inhibitors and/or immunotherapy agents, produced variable pain responses but pain response was the primary endpoint in only one of these trials. Additionally, there were no published trials of potentially novel analgesic agents in patients with PCIBP. Conclusion There is a knowledge gap for clinical trials of chemotherapy, small molecule inhibitors and/or immunotherapy in patients with PCIBP where pain response is the primary endpoint. Also, there are no novel analgesic agents on the horizon for the relief of PCIBP and this is an area of large unmet medical need that warrants concerted research attention.

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Section: Clinically Used Analgesic/adjuvant Agents For Relief Of Pcibpmentioning

confidence: 99%

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

Section: Radiotherapy and Bone-targeting Agents For Relief Of Metasta...mentioning

confidence: 99%

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Prostate cancer induced bone pain: pathobiology, current treatments and pain responses from recent clinical trials

2022

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Treatment of bone metastases from solid tumors with bone-modifying agents: a web survey of Italian oncologists investigating patterns of practice drug prescription and prevention of side effects

Fusco,

Di Maio,

Valsecchi

et al. 2024

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Purpose Optimal use of bone-modifying agents (BMAs) in patients with bone metastases from solid tumors is uncertain in some aspects: the drug choice; the planned treatment duration and long-term therapy; the prevention and management of possible side effects, including renal toxicity, hypocalcaemia, and medication-related osteonecrosis of the jaw (MRONJ). Methods Italian oncologists were invited to fulfil a 24-question web survey about prescription of BMAs for bone metastases of breast cancer, prostate cancer, and other solid tumors. Prevention and management of side effects were also investigated. Results Answers of 191 oncologists were collected. BMAs are usually prescribed at the time of diagnosis of bone metastases by 87.0% (breast cancer) and 76.1% (solid tumors except breast and prostate cancers) of oncologists; the decision is more articulated for prostate cancer (endocrine-sensitive versus castration-resistant). The creatinine level (32.3%), the availability of patient venous access (15.8%), and the type of primary neoplasm (13.6%) are the most reported factors involved in choice between bisphosphonates and denosumab. Zoledronic acid every 3 months was considered as a valid alternative to monthly administration by 94% of Italian oncologists. Oncologists reported a good confidence with measures aimed to prevent MRONJ, whereas uncertainness about prevention and management of hypocalcemia was registered. Conclusion Italian oncologists showed a high attitude in prescribing bisphosphonates or denosumab at the time of diagnosis of bone metastases, with a large application of preventive measures of side effects. Further studies are needed to investigate some controversial aspects, such as optimal drug treatment duration and long-term drug schedules.

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Castration-resistant prostate cancer with bone metastases: toward the best therapeutic choice

et al. 2022

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The treatment landscape for metastatic castration-resistant prostate cancer has evolved extremely in recent years and several drug classes are now available. Nonetheless, the lack of validated predictive biomarkers makes therapeutic choice and the best sequential approach difficult. The location of the metastatic site could be a valid criterion for choosing among the treatment options available. Although bone remains the most frequent metastatic site and a possible target for many drugs, recent data suggest a profound shift in the disease spectrum with visceral metastases increasing incidence. This review describes the presently available and ongoing therapies for patients with CRPC and bone metastases, focusing on the role of bone metastases as a possible driver for selecting therapies in these patients.

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Real-world patient-reported outcomes of breast cancer or prostate cancer patients receiving antiresorptive therapy for bone metastases: Final results of the PROBone registry study

Cited by 7 publications

References 39 publications

Prostate cancer induced bone pain: pathobiology, current treatments and pain responses from recent clinical trials

Prostate cancer induced bone pain: pathobiology, current treatments and pain responses from recent clinical trials

Treatment of bone metastases from solid tumors with bone-modifying agents: a web survey of Italian oncologists investigating patterns of practice drug prescription and prevention of side effects

Castration-resistant prostate cancer with bone metastases: toward the best therapeutic choice

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