Zoledronic acid in patients with stage IIIA/B NSCLC

• Verfasst von: Scagliotti, Giorgio V. [VerfasserIn]
• Verfasst von: Manegold, Christian [VerfasserIn]
• Titel: Zoledronic acid in patients with stage IIIA/B NSCLC
• Titelzusatz: results of a randomized, phase III study
• Verf.angabe: 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
• E-Jahr: 2012
• Jahr: 22 June 2012
• Umfang: 6 S.
• Fussnoten: Gesehen am 19.09.2018
• Titel Quelle: Enthalten in: Annals of oncology
• Ort Quelle: Amsterdam [u.a.] : Elsevier, 1990
• Jahr Quelle: 2012
• Band/Heft Quelle: 23(2012), 8, Seite 2082-2087
• ISSN Quelle: 1569-8041
• DOI: doi:10.1093/annonc/mds128
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1581102607

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.