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

Anita J.W.M. Brouns, Lizza E.L. Hendriks, Vincent van der Noort, Ben E.E.M. van de Borne, Franz M.N.H. Schramel, Harry J.M. Groen, Bonne Biesma, Hans J.M. Smit, Anne Marie C. Dingemans*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

5 Citations (Scopus)
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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.

Original languageEnglish
Article number890
JournalFrontiers in Oncology
Volume10
DOIs
Publication statusPublished - 24 Jun 2020

Bibliographical note

Funding Information:
Funding. The authors declare that this study received funding from Roche, and that Ibandronate was supplied by Roche. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication.

Publisher Copyright:
© Copyright © 2020 Brouns, Hendriks, van der Noort, van de Borne, Schramel, Groen, Biesma, Smit and Dingemans.

Research programs

  • EMC MM-04-42-02

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