Zoledronic acid in patients with stage IIIA/B NSCLC: Results of a randomized, phase III study

G. V. Scagliotti, P. Kosmidis, F. De Marinis, A. J.M. Schreurs, I. Albert, W. Engel-Riedel, D. Schallier, S. Barbera, H. P. Kuo, V. Sallo, J. R. Perez, C. Manegold

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33 Citations (Scopus)


Background: Bone metastases are common in patients with advanced non-small-cell lung cancer (NSCLC) and can have devastating consequences. Preventing or delaying bone metastases may improve outcomes. Patients and methods: This study evaluated whether zoledronic acid (ZOL) delayed disease progression or recurrence in patients with controlled stage IIIA/B NSCLC after first-line therapy. Patients received vitamin D and calcium supplementation and were randomized to i.v. ZOL (every 3-4 weeks) or no treatment (control). The primary end point was progression-free survival (PFS). Results: No significant intergroup differences were observed in PFS or overall survival (OS). Median PFS was 9.0 months with ZOL versus 11.3 months for control. Fifteen ZOL-treated (6.6%) and 19 control patients (9.0%) developed bone metastases. Estimated 1-year OS was 81.8% for each group. ZOL safety profile was consistent with previous clinical data, but with higher discontinuations versus control. Fifteen ZOL-treated (6.6%) and five control patients (2.3%) had renal adverse events. Two cases of osteonecrosis of the jaw were reported. Conclusions: ZOL did not significantly affect PFS or OS in stage IIIA/B NSCLC patients with controlled disease, with a trend toward worsening PFS in the longer-term follow-up. Few patients experienced bone metastases, possibly limiting the potential ZOL impact on disease course.

Original languageEnglish
Article numbermds128
Pages (from-to)2082-2087
Number of pages6
JournalAnnals of Oncology
Issue number8
Publication statusPublished - Aug 1 2012
Externally publishedYes


  • Adjuvant treatment
  • Non-small-cell lung cancer
  • Survival
  • Zoledronic acid

ASJC Scopus subject areas

  • Hematology
  • Oncology


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