The DOI matches its Crossref record; 38 of the 38 references it cites were found in a registry or an index.
Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine/Cisplatin Plus Bevacizumab or Placebo in Patients With Malignant Mesothelioma
Open accessAbstract
Purpose: Gemcitabine plus cisplatin is active in malignant mesothelioma (MM), although single-arm phase II trials have reported variable outcomes. Vascular endothelial growth factor (VEGF) inhibitors have activity against MM in preclinical models. We added the anti-VEGF antibody bevacizumab to gemcitabine/cisplatin in a multicenter, double-blind, placebo-controlled randomized phase II trial in patients with previously untreated, unresectable MM. Patients and Methods: Eligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and no thrombosis, bleeding, or major blood vessel invasion. The primary end point was progression-free survival (PFS). Patients were stratified by ECOG performance status (0 v 1) and histologic subtype (epithelial v other). Patients received gemcitabine 1,250 mg/m 2 on days 1 and 8 every 21 days, cisplatin 75 mg/m 2 every 21 days, and bevacizumab 15 mg/kg or placebo every 21 days for six cycles, and then bevacizumab or placebo every 21 days until progression. Results: One hundred fifteen patients were enrolled at 11 sites; 108 patients were evaluable. Median PFS time was 6.9 months for the bevacizumab arm and 6.0 months for the placebo arm (P = .88). Median overall survival (OS) times were 15.6 and 14.7 months in the bevacizumab and placebo arms, respectively (P = .91). Partial response rates were similar (24.5% for bevacizumab v 21.8% for placebo; P = .74). A higher pretreatment plasma VEGF concentration (n = 56) was associated with shorter PFS (P = .02) and OS (P = .0066), independent of treatment arm. There were no statistically significant differences in toxicity of grade 3 or greater. Conclusion: The addition of bevacizumab to gemcitabine/cisplatin in this trial did not significantly improve PFS or OS in patients with advanced MM.
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Cites
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
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Paclitaxel–Carboplatin Alone or with Bevacizumab for Non–Small-Cell Lung Cancer
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Self-citationPaclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer
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Cited by
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Zalcman, G., Mazieres, J., Margery, J., Greillier, L., Audigier-Valette, C., Moro-Sibilot, D., Molinier, O., Corre, R., Monnet, I., Gounant, V., et al. (2016) · The Lancet · doi:10.1016/s0140-6736(15)01238-6 · Cited by 968
Systems biology of cisplatin resistance: past, present and future
Galluzzi, L., Vitale, I., Michels, J., Brenner, C., Szabadkai, G., Harel-Bellan, A., Castedo, M., & Kroemer, G. (2014) · Cell Death & Disease · doi:10.1038/cddis.2013.428 · Cited by 782
Nalluri, S. R., Chu, D., Keresztes, R., Zhu, X., & Wu, S. (2008) · JAMA · doi:10.1001/jama.2008.656 · Cited by 771
Zhu, X., Wu, S., Dahut, W. L., & Parikh, C. R. (2007) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2006.11.039 · Cited by 632
Metadata
- Authors
- Kindler, H. L., Karrison, T. G., Gandara, D. R., Lu, C., Krug, L. M., Stevenson, J. P., Jänne, P. A., Quinn, D. I., Koczywas, M. N., Brahmer, J. R., Albain, K. S., Taber, D. A., Armato, S. G., Vogelzang, N. J., Chen, H. X., Stadler, W. M., & Vokes, E. E.
- Venue
- Journal of Clinical Oncology
- Published
- 2012-07-10
- Volume
- 30
- Issue
- 20
- Pages
- 2509-2515
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2167527173
- Cited by
- 257
- References
- 38
- FWCI
- 20.63
- Type
- journal article
- Language
- en
- Open access
- green
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- Kindler, H. L., Karrison, T. G., Gandara, D. R., Lu, C., Krug, L. M., Stevenson, J. P., Jänne, P. A., Quinn, D. I., Koczywas, M. N., Brahmer, J. R., Albain, K. S., Taber, D. A., Armato, S. G., Vogelzang, N. J., Chen, H. X., Stadler, W. M., & Vokes, E. E. (2012). Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase II Trial of Gemcitabine/Cisplatin Plus Bevacizumab or Placebo in Patients With Malignant Mesothelioma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.41.5869
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.