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

Research output: Contribution to journalArticle

20 Citations (Scopus)

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.

Original languageEnglish
Article numbermds128
Pages (from-to)2082-2087
Number of pages6
JournalAnnals of Oncology
Volume23
Issue number8
DOIs
Publication statusPublished - Aug 1 2012
Externally publishedYes

Fingerprint

zoledronic acid
Non-Small Cell Lung Carcinoma
Disease-Free Survival
Neoplasm Metastasis
Bone and Bones
Survival
Osteonecrosis
Jaw
Vitamin D

Keywords

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

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Scagliotti, G. V., Kosmidis, P., De Marinis, F., Schreurs, A. J. M., Albert, I., Engel-Riedel, W., ... Manegold, C. (2012). Zoledronic acid in patients with stage IIIA/B NSCLC: Results of a randomized, phase III study. Annals of Oncology, 23(8), 2082-2087. [mds128]. https://doi.org/10.1093/annonc/mds128

Zoledronic acid in patients with stage IIIA/B NSCLC : Results of a randomized, phase III study. / Scagliotti, G. V.; Kosmidis, P.; De Marinis, F.; Schreurs, A. J.M.; Albert, I.; Engel-Riedel, W.; Schallier, D.; Barbera, S.; Kuo, H. P.; Sallo, V.; Perez, J. R.; Manegold, C.

In: Annals of Oncology, Vol. 23, No. 8, mds128, 01.08.2012, p. 2082-2087.

Research output: Contribution to journalArticle

Scagliotti, GV, Kosmidis, P, De Marinis, F, Schreurs, AJM, Albert, I, Engel-Riedel, W, Schallier, D, Barbera, S, Kuo, HP, Sallo, V, Perez, JR & Manegold, C 2012, 'Zoledronic acid in patients with stage IIIA/B NSCLC: Results of a randomized, phase III study', Annals of Oncology, vol. 23, no. 8, mds128, pp. 2082-2087. https://doi.org/10.1093/annonc/mds128
Scagliotti GV, Kosmidis P, De Marinis F, Schreurs AJM, Albert I, Engel-Riedel W et al. Zoledronic acid in patients with stage IIIA/B NSCLC: Results of a randomized, phase III study. Annals of Oncology. 2012 Aug 1;23(8):2082-2087. mds128. https://doi.org/10.1093/annonc/mds128
Scagliotti, G. V. ; Kosmidis, P. ; De Marinis, F. ; Schreurs, A. J.M. ; Albert, I. ; Engel-Riedel, W. ; Schallier, D. ; Barbera, S. ; Kuo, H. P. ; Sallo, V. ; Perez, J. R. ; Manegold, C. / Zoledronic acid in patients with stage IIIA/B NSCLC : Results of a randomized, phase III study. In: Annals of Oncology. 2012 ; Vol. 23, No. 8. pp. 2082-2087.
@article{5ca9e47bacc747d7801c47f69e796d72,
title = "Zoledronic acid in patients with stage IIIA/B NSCLC: Results of a randomized, phase III study",
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.",
keywords = "Adjuvant treatment, Non-small-cell lung cancer, Survival, Zoledronic acid",
author = "Scagliotti, {G. V.} and P. Kosmidis and {De Marinis}, F. and Schreurs, {A. J.M.} and I. Albert and W. Engel-Riedel and D. Schallier and S. Barbera and Kuo, {H. P.} and V. Sallo and Perez, {J. R.} and C. Manegold",
year = "2012",
month = "8",
day = "1",
doi = "10.1093/annonc/mds128",
language = "English",
volume = "23",
pages = "2082--2087",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "8",

}

TY - JOUR

T1 - Zoledronic acid in patients with stage IIIA/B NSCLC

T2 - Results of a randomized, phase III study

AU - Scagliotti, G. V.

AU - Kosmidis, P.

AU - De Marinis, F.

AU - Schreurs, A. J.M.

AU - Albert, I.

AU - Engel-Riedel, W.

AU - Schallier, D.

AU - Barbera, S.

AU - Kuo, H. P.

AU - Sallo, V.

AU - Perez, J. R.

AU - Manegold, C.

PY - 2012/8/1

Y1 - 2012/8/1

N2 - 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.

AB - 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.

KW - Adjuvant treatment

KW - Non-small-cell lung cancer

KW - Survival

KW - Zoledronic acid

UR - http://www.scopus.com/inward/record.url?scp=84864955288&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84864955288&partnerID=8YFLogxK

U2 - 10.1093/annonc/mds128

DO - 10.1093/annonc/mds128

M3 - Article

VL - 23

SP - 2082

EP - 2087

JO - Annals of Oncology

JF - Annals of Oncology

SN - 0923-7534

IS - 8

M1 - mds128

ER -