AUTHOR=Brouns Anita J. W. M. , Hendriks Lizza E. L. , van der Noort Vincent , van de Borne Ben E. E. M , Schramel Franz M. N. H. , Groen Harry J. M. , Biesma Bonne , Smit Hans J. M. , Dingemans Anne-Marie C.
TITLE=Efficacy of Ibandronate Loading Dose on Rapid Pain Relief in Patients With Non-Small Cell Lung Cancer and Cancer Induced Bone Pain: The NVALT-9 Trial
JOURNAL=Frontiers in Oncology
VOLUME=10
YEAR=2020
URL=https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2020.00890
DOI=10.3389/fonc.2020.00890
ISSN=2234-943X
ABSTRACT=Introduction: Approximately 80% of non-small cell lung cancer (NSCLC) patients with bone metastases have cancer induced bone pain (CIBP).
Methods: The NVALT-9 was an open-label, single arm, phase II, multicenter study. Main inclusion criterion: bone metastasized NSCLC patients with uncontrolled CIBP [brief pain inventory [BPI] ≥ 5 over last 7 days]. Patients were treated with six milligram ibandronate intravenously (day 1–3) once a day. Main exclusion criteria: active secondary malignancy, systemic anti-tumor treatment and radiotherapy ≤4 weeks before study start, previous bisphosphonate treatment. 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%. If pain response is observed in ≤ 12 of the first 19 patients further enrollment will be stopped. 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. Secondary endpoints: BPI score, quality of life, toxicity and World Health Organization Performance Score.
Results: Of the 19 enrolled patients in the first stage, 18 were evaluable for response. All completed ibandronate treatment according to protocol. In 4 (22.2%), a bone pain response was observed. According to the stopping rule, further enrollment was halted.
Discussion: Ibandronate loading doses lead to insufficient pain relief in NSCLC patients with CIBP.