Zoledronic acid in patients with stage IIIA/B NSCLC: results of a randomized, phase III study
| Autor: | Giorgio V. Scagliotti, V. Sallo, H.-P. Kuo, P. Kosmidis, Santi Barbera, D. Schallier, J.R. Perez, Christian Manegold, W. Engel-Riedel, F. De Marinis, A.J.M. Schreurs, I. Albert |
|---|---|
| Přispěvatelé: | Laboratory for Medical and Molecular Oncology |
| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Adult
Male Oncology medicine.medical_specialty Lung Neoplasms adjuvant treatment Bone Neoplasms survival Young Adult zoledronic acid Carcinoma Non-Small-Cell Lung Internal medicine Clinical endpoint Vitamin D and neurology Humans Medicine Progression-free survival Vitamin D Adverse effect Lung cancer Aged Neoplasm Staging Aged 80 and over Diphosphonates business.industry Imidazoles Bone metastasis Hematology Middle Aged medicine.disease Zoledronic acid non-small-cell lung cancer Dietary Supplements Calcium Female business Osteonecrosis of the jaw medicine.drug |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|