volume 29 issue 33 pages 4442-4451

Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer

Jean-Charles Soria 1
Zsuzsanna Márk 1
Petr Zatloukal 1
Barna Szima 1
Istvan Albert 1
Erzsébet Juhász 1
Jean Louis Pujol 1
Jerzy Kozielski 1
Nigel Baker 1
Dominic Smethurst 1
Yong-Jiang Hei 1
Avi Ashkenazi 1
Howard Stern 1
Lukas Amler 1
Yang Pan 1
Fiona Blackhall 1
Publication typeJournal Article
Publication date2011-11-20
scimago Q1
wos Q1
SJR11.205
CiteScore38.9
Impact factor41.9
ISSN0732183X, 15277755
Cancer Research
Oncology
Abstract
Purpose

To evaluate the efficacy and safety of dulanermin combined with paclitaxel and carboplatin (PC) and bevacizumab (PCB) as first-line treatment for advanced or recurrent non–small-cell lung cancer (NSCLC).

Patients and Methods

Patients with squamous NSCLC and/or CNS metastases received PC every 3 weeks alone (arm 1) or with dulanermin 8 mg/kg for 5 days (arm 2). Patients with nonsquamous NSCLC received PCB alone (arm 3) or with dulanermin 8 mg/kg for 5 days (arm 4) or 20 mg/kg for 2 days (arm 5). The primary end point was the objective response rate (ORR).

Results

Overall, 213 patients were randomly assigned (arm 1, n = 41; arm 2, n = 39; arm 3, n = 42; arm 4, n = 40; arm 5, n = 41). The ORR in arms 1 to 5 was 39% (95% CI, 24% to 56%), 38% (95% CI, 24% to 54%), 50% (95% CI, 35% to 65%), 40% (95% CI, 25% to 56%), and 40% (95% CI, 25% to 56%), respectively. The odds ratio for ORR was 1.04 (P = 1.000) for arm 1 versus arm 2, 1.53 (P = .391) for arm 3 and versus arm 4, and 1.53 (P = .391) for arm 3 versus arm 5. The most common grade ≥ 3 adverse events were neutropenia, asthenia, anemia, thrombocytopenia, and hemoptysis. Of 161 available serum samples, a trend toward increased caspase-cleaved cytokeratin-18 was observed after dulanermin treatment in cycles 1 and 2. Among 84 patients evaluated for GalNT14 expression, there was a trend toward favorable progression-free survival and overall survival with dulanermin treatment in those with high GalNT14 expression.

Conclusion

The addition of dulanermin to PC and PCB did not improve outcomes in unselected patients with previously untreated advanced or recurrent NSCLC.

Found 
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GOST |
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GOST Copy
Soria J. et al. Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer // Journal of Clinical Oncology. 2011. Vol. 29. No. 33. pp. 4442-4451.
GOST all authors (up to 50) Copy
Soria J., Márk Z., Zatloukal P., Szima B., Albert I., Juhász E., Pujol J. L., Kozielski J., Baker N., Smethurst D., Hei Y., Ashkenazi A., Stern H., Amler L., Pan Y., Blackhall F. Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer // Journal of Clinical Oncology. 2011. Vol. 29. No. 33. pp. 4442-4451.
RIS |
Cite this
RIS Copy
TY - JOUR
DO - 10.1200/jco.2011.37.2623
UR - https://doi.org/10.1200/jco.2011.37.2623
TI - Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer
T2 - Journal of Clinical Oncology
AU - Soria, Jean-Charles
AU - Márk, Zsuzsanna
AU - Zatloukal, Petr
AU - Szima, Barna
AU - Albert, Istvan
AU - Juhász, Erzsébet
AU - Pujol, Jean Louis
AU - Kozielski, Jerzy
AU - Baker, Nigel
AU - Smethurst, Dominic
AU - Hei, Yong-Jiang
AU - Ashkenazi, Avi
AU - Stern, Howard
AU - Amler, Lukas
AU - Pan, Yang
AU - Blackhall, Fiona
PY - 2011
DA - 2011/11/20
PB - American Society of Clinical Oncology (ASCO)
SP - 4442-4451
IS - 33
VL - 29
PMID - 22010015
SN - 0732-183X
SN - 1527-7755
ER -
BibTex |
Cite this
BibTex (up to 50 authors) Copy
@article{2011_Soria,
author = {Jean-Charles Soria and Zsuzsanna Márk and Petr Zatloukal and Barna Szima and Istvan Albert and Erzsébet Juhász and Jean Louis Pujol and Jerzy Kozielski and Nigel Baker and Dominic Smethurst and Yong-Jiang Hei and Avi Ashkenazi and Howard Stern and Lukas Amler and Yang Pan and Fiona Blackhall},
title = {Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer},
journal = {Journal of Clinical Oncology},
year = {2011},
volume = {29},
publisher = {American Society of Clinical Oncology (ASCO)},
month = {nov},
url = {https://doi.org/10.1200/jco.2011.37.2623},
number = {33},
pages = {4442--4451},
doi = {10.1200/jco.2011.37.2623}
}
MLA
Cite this
MLA Copy
Soria, Jean-Charles, et al. “Randomized Phase II Study of Dulanermin in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Advanced Non–Small-Cell Lung Cancer.” Journal of Clinical Oncology, vol. 29, no. 33, Nov. 2011, pp. 4442-4451. https://doi.org/10.1200/jco.2011.37.2623.