Pillai, Rathi N.;
Fennell, Dean A.;
Kovcin, Vladimir;
Ciuleanu, Tudor-Eliade;
Ramlau, Rodryg;
Kowalski, Dariusz;
Schenker, Michael;
Yalcin, Ilker;
Teofilovici, Florentina;
Vukovic, Vojo M.;
Ramalingam, Suresh S.
Randomized Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel Versus Docetaxel in Advanced Non–Small-Cell Lung Cancer (GALAXY-2)
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Medientyp:
E-Artikel
Titel:
Randomized Phase III Study of Ganetespib, a Heat Shock Protein 90 Inhibitor, With Docetaxel Versus Docetaxel in Advanced Non–Small-Cell Lung Cancer (GALAXY-2)
Beteiligte:
Pillai, Rathi N.;
Fennell, Dean A.;
Kovcin, Vladimir;
Ciuleanu, Tudor-Eliade;
Ramlau, Rodryg;
Kowalski, Dariusz;
Schenker, Michael;
Yalcin, Ilker;
Teofilovici, Florentina;
Vukovic, Vojo M.;
Ramalingam, Suresh S.
Erschienen:
American Society of Clinical Oncology (ASCO), 2020
Beschreibung:
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Ganetespib, a highly potent heat shock protein 90 inhibitor, blocks multiple oncogenic pathways, resulting in antitumor activity. We evaluated the combination of ganetespib and docetaxel for second-line therapy of patients with advanced adenocarcinoma of the lung. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> In this international phase III trial, patients with stage IIIB or IV adenocarcinoma diagnosed > 6 months before study entry and 1 prior systemic therapy were randomly assigned (1:1) to ganetespib 150 mg/m<jats:sup>2</jats:sup> on days 1 and 15 with docetaxel 75 mg/m<jats:sup>2</jats:sup> on day 1 of a 21-day cycle or to docetaxel alone. The primary end point was overall survival (OS). </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Of 677 enrolled patients, 335 were randomly assigned to ganetespib and docetaxel and 337 were assigned to docetaxel. The trial was stopped early as a result of futility at a planned interim analysis. The median OS time was 10.9 months (95% CI, 9.0 to 12.3 months) in the ganetespib and docetaxel arm compared with 10.5 months (95% CI, 8.6 to 12.2 months) in docetaxel arm (hazard ratio [HR], 1.11; 95% CI, 0.899 to 1.372; P = .329). Median progression-free survival was 4.2 months in the ganetespib and docetaxel arm and 4.3 months in the docetaxel arm (HR, 1.16; 95% CI, 0.96 to 1.403; P = .119). The addition of ganetespib did not improve outcomes compared with docetaxel alone for any secondary end point, including survival in the elevated lactate dehydrogenase or EGFR and ALK wild-type populations. The most common grade 3 or 4 adverse event in both arms was neutropenia (30.9% with ganetespib and docetaxel v 25% with docetaxel). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> The addition of ganetespib to docetaxel did not result in improved survival for salvage therapy of patients with advanced-stage lung adenocarcinoma. </jats:p></jats:sec>