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Sökning: onr:"swepub:oai:lup.lub.lu.se:c4f8636a-87de-4e9b-aacc-3e287c1ffe06" > Double-blind, place...

Double-blind, placebo-controlled, randomized phase III trial evaluating pertuzumab combined with chemotherapy for low tumor human epidermal growth factor receptor 3 mRNA-Expressing platinum-resistant ovarian Cancer (PENELOPE)

Kurzeder, Christian (författare)
Kliniken Essen-Mitte
Bover, Isabel (författare)
Hospital Son Llàtzer
Marḿe, Frederik (författare)
University Hospital Heidelberg
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Rau, Joern (författare)
Philipp University of Marburg
Pautier, Patricia (författare)
Institut Gustave Roussy
Colombo, Nicoletta (författare)
European Institute of Oncology
Lorusso, Domenica (författare)
Istituto Nazionale dei Tumori
Ottevanger, Petronella (författare)
Radboud University Nijmegen
Bjurberg, Maria (författare)
Lund University,Lunds universitet,Tumörmikromiljö,Sektion I,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Tumor microenvironment,Section I,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital,Nordic Society of Gynecological Oncology
Marth, Christian (författare)
Medical University of Innsbruck
Barretina-Ginesta, Pilar (författare)
Catalan Institute of Oncology
Vergote, Ignace (författare)
University Hospitals Leuven
Floquet, Anne (författare)
Institut Bergoníe
Campo, Josep M Del (författare)
Vall d'Hebron University Hospital
Mahner, Sven (författare)
University Medical Center Hamburg-Eppendorf
Bastíere-Truchot, Lydie (författare)
F. Hoffmann-La Roche AG
Martin, Nicolas (författare)
F. Hoffmann-La Roche AG
Oestergaard, Mikkel Z. (författare)
F. Hoffmann-La Roche AG
Kiermaier, Astrid (författare)
F. Hoffmann-La Roche AG
Schade-Brittinger, Carmen (författare)
Philipp University of Marburg
Polleis, Sandra (författare)
Arbeitsgemeinschaft Gynäkologische Onkologie
Bois, Andreas Du (författare)
Kliniken Essen-Mitte
Gonzalez-Martin, Antonio (författare)
GEICO
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 (creator_code:org_t)
American Society of Clinical Oncology, 2016
2016
Engelska 10 s.
Ingår i: Journal of Clinical Oncology. - : American Society of Clinical Oncology. - 0732-183X. ; 34:21, s. 25-2516
  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Purpose The AGO-OVAR 2.29/ENGOT-ov14/PENELOPE prospectively randomized phase III trial evaluated the addition of pertuzumab to chemotherapy in patients with platinum-resistant ovarian carcinoma with low tumor human epidermal growth factor receptor 3 (HER3)mRNA expression. We report the results of the primary efficacy analysis. Patients and Methods Eligible patients had ovarian carcinoma that progressed during or within 6 months of completing four or more platinum cycles, centrally tested low tumor HER3 mRNA expression (concentration ratio # 2.81 by quantitative reverse transcriptase polymerase chain reaction on cobas z480 [Roche Molecular Diagnostics, Pleasanton, CA]), and no more than two prior lines of chemotherapy. After investigators selection of the chemotherapy backbone (single-agent topotecan, weekly paclitaxel, or gemcitabine), patientswere randomly assigned to also receive either placebo or pertuzumab (840-mg loading dose followed by 420 mg every 3 weeks). Stratification factors were selected chemotherapy, prior antiangiogenic therapy, and platinum-free interval. The primary end point was independent review committee-assessed progression-free survival (PFS). Additional end points included overall survival, investigator-assessed PFS, objective response rate, safety, patient-reported outcomes, and translational research. Results Overall, 156 patientswere randomly assigned. Adding pertuzumab to chemotherapy did not significantly improve independent review committee-assessed PFS for the primary analysis (stratified hazard ratio, 0.74; 95% CI, 0.50 to 1.11; P = .14; median PFS, 4.3 months for pertuzumab plus chemotherapy v 2.6 months for placebo plus chemotherapy). Sensitivity analyses and secondary efficacy end point results were consistent with the primary analysis. The effect on PFS favoring pertuzumab was more pronounced in the gemcitabine and paclitaxel cohorts. No new safety signals were seen. Conclusion Although the primary objective was not met, subgroup analyses showed trends in PFS favoring pertuzumab in the gemcitabine and paclitaxel cohorts, meriting further exploration of pertuzumab in ovarian cancer.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine (hsv//eng)

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