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Ann Oncol. 2012 Aug;23(8):2082-7. doi: 10.1093/annonc/mds128. Epub 2012 Jun 22.

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

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  • 1Department of Clinical and Biological Sciences, University of Turin, Torino, Italy. giorgio.scagliotti@unito.it

Abstract

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.

PMID:
22730101
[PubMed - indexed for MEDLINE]
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