![]() The primary aim of this open label single arm phase II study (NVALT-9, EudraCT number 2007-000885-20, NTR1602) was to establish the efficacy of intravenous loading doses of ibandronate to achieve acute bone pain relief in NSCLC patients with CIBP. Therefore, we performed a multicenter phase II study to evaluate the effect of intravenous loading doses of ibandronate on acute pain response in NSCLC patients with uncontrolled CIBP. Trials including patients with bone metastases from prostate- or breast- or lung cancer ( N = 607 of which only 1 NSCLC patient), which evaluated the effect of ibandronate (intravenous or oral) on bone pain showed pain relief within 7 days to 12 weeks after start of ibandronate ( 12– 14). However, actual data on (rapid) pain relief of bisphosphonates are scarce in NSCLC ( 11). In current guidelines, National Comprehensive Cancer Network, and National Institute for Health and Care Excellence ] bone targeted agents such as bisphosphonates are mentioned as an option to prevent skeletal related events (SREs) in NSCLC patients ( 5, 8– 10). Especially in this vulnerable population, opioid use can result in neurologic, renal, hepatic, and/or gastro-intestinal toxicity ( 7). In general, pain management, according to the World Health Organization (WHO) pain ladder ( 6), frequently results in treatment with opioids. Examples are a time delay before the maximum treatment effect is obtained, the possibility of a pain flare-up, and it is only feasible in patients with a limited number of bone metastases ( 5). Radiotherapy is an effective treatment for CIBP with a 50% chance of complete pain resolution, but it unfortunately has several drawbacks. Furthermore, bone metastases have a negative influence on quality of life (QoL) and are associated with a poorer overall survival (OS) ( 4). During the course of the disease, 24–60% of NSCLC patients are diagnosed with bone metastases and up to 80% will experience CIBP ( 1– 3). According to the stopping rule, further enrollment was halted.ĭiscussion: Ibandronate loading doses lead to insufficient pain relief in NSCLC patients with CIBP.Ĭancer induced bone pain (CIBP) is an important issue in metastasized non-small cell lung cancer (NSCLC). In 4 (22.2%), a bone pain response was observed. All completed ibandronate treatment according to protocol. Results: Of the 19 enrolled patients in the first stage, 18 were evaluable for response. Secondary endpoints: BPI score, quality of life, toxicity and World Health Organization Performance Score. Primary endpoint: bone pain response, defined as 25% decrease in worst pain score (PSc) over a 3-day period (day 5–7) compared to baseline PSc with maximum of 25% increase in mean analgesic consumption during the same period. If pain response is observed in ≤ 12 of the first 19 patients further enrollment will be stopped. Statistics: Simon's Optimal two-stage design with a 90% power to declare the treatment active if the pain response rate is ≥ 80% and 95% confidence to declare the treatment inactive if the pain response rate is ≤ 60%. Main exclusion criteria: active secondary malignancy, systemic anti-tumor treatment and radiotherapy ≤4 weeks before study start, previous bisphosphonate treatment. Patients were treated with six milligram ibandronate intravenously (day 1–3) once a day. Main inclusion criterion: bone metastasized NSCLC patients with uncontrolled CIBP ≥ 5 over last 7 days]. Methods: The NVALT-9 was an open-label, single arm, phase II, multicenter study. ![]() Introduction: Approximately 80% of non-small cell lung cancer (NSCLC) patients with bone metastases have cancer induced bone pain (CIBP). 9Department of Pulmonary Diseases, Erasmus MC, Rotterdam, Netherlands. ![]()
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