Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study
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...
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| Main Authors: | , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
22 June 2012
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| In: |
Annals of oncology
Year: 2012, Volume: 23, Issue: 8, Pages: 2082-2087 |
| ISSN: | 1569-8041 |
| DOI: | 10.1093/annonc/mds128 |
| Online Access: | Verlag, kostenfrei, Volltext: http://dx.doi.org/10.1093/annonc/mds128
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| Author Notes: | 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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| 245 | 1 | 0 | |a Zoledronic acid in patients with stage IIIA/B NSCLC |b results of a randomized, phase III study |c 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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| 520 | |a 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. | ||
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