Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients
In the single-arm non-interventional OTILIA study, patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IIIB–IV ovarian cancer received bevacizumab (15 mg/kg every 3 weeks for up to 15 months) and standard carboplatin–paclitaxel. The primary aim was to ass...
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MDPI AG
2021-09-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/13/19/4739 |
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| author | Jalid Sehouli Alexander Mustea Guelten Oskay-Özcelik Maren Keller Rolf Richter Oliver Tomé Hannah Woopen Ann-Katrin Sommer-Joos Jacek P. Grabowski Robert Armbrust Pauline Wimberger |
| author_facet | Jalid Sehouli Alexander Mustea Guelten Oskay-Özcelik Maren Keller Rolf Richter Oliver Tomé Hannah Woopen Ann-Katrin Sommer-Joos Jacek P. Grabowski Robert Armbrust Pauline Wimberger |
| author_sort | Jalid Sehouli |
| collection | DOAJ |
| description | In the single-arm non-interventional OTILIA study, patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IIIB–IV ovarian cancer received bevacizumab (15 mg/kg every 3 weeks for up to 15 months) and standard carboplatin–paclitaxel. The primary aim was to assess safety and progression-free survival (PFS). Subgroup analyses according to age were prespecified. The analysis population included 824 patients (453 aged <70 years, 371 aged ≥70 years). At data cutoff, the median bevacizumab duration was 13.8 months. Grade ≥3 adverse events (AEs), serious AEs, and AEs leading to bevacizumab discontinuation were more common in older than younger patients, whereas treatment-related AEs were less common. Median PFS was 19.4 months, with no clear difference according to age (20.0 vs. 19.3 months in patients <70 vs. ≥70 years, respectively). One-year OS rates were 92% and 90%, respectively. Mean change from baseline in global health status/quality of life showed a clinically meaningful increase over time. In German routine oncology practice, PFS and safety were similar to reported randomized phase 3 bevacizumab trials in more selected populations. There was no notable reduction in effectiveness and tolerability in patients aged ≥70 years; age alone should not preclude use of bevacizumab-containing therapy. ClinicalTrials.gov: NCT01697488. |
| first_indexed | 2024-03-10T07:05:25Z |
| format | Article |
| id | doaj.art-0f2530a3a50843669c5f8d14e633daf8 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-10T07:05:25Z |
| publishDate | 2021-09-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-0f2530a3a50843669c5f8d14e633daf82023-11-22T15:51:39ZengMDPI AGCancers2072-66942021-09-011319473910.3390/cancers13194739Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 PatientsJalid Sehouli0Alexander Mustea1Guelten Oskay-Özcelik2Maren Keller3Rolf Richter4Oliver Tomé5Hannah Woopen6Ann-Katrin Sommer-Joos7Jacek P. Grabowski8Robert Armbrust9Pauline Wimberger10Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité—Universitätsmedizin Berlin, 13353 Berlin, GermanyDepartment of Gynecology, Greifswald Medical University, 17489 Greifswald, GermanyPraxisklinik Krebsheilkunde für Frauen, 13597 Berlin, GermanyNord-Ostdeutsche Gesellschaft für Gynäkologische Onkologie (NOGGO) e.V., Schwedenstraße 9, 13359 Berlin, GermanyDepartment of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité—Universitätsmedizin Berlin, 13353 Berlin, GermanySt Vincentius-Kliniken, 76135 Karlsruhe, GermanyDepartment of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité—Universitätsmedizin Berlin, 13353 Berlin, GermanyRoche Pharma AG, D-79639 Grenzach-Wyhlen, GermanyDepartment of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité—Universitätsmedizin Berlin, 13353 Berlin, GermanyDepartment of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Charité—Universitätsmedizin Berlin, 13353 Berlin, GermanyDepartment of Gynecology, Carl Gustav Carus University Dresden, Technische Universität Dresden, 01307 Dresden, GermanyIn the single-arm non-interventional OTILIA study, patients with newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) stage IIIB–IV ovarian cancer received bevacizumab (15 mg/kg every 3 weeks for up to 15 months) and standard carboplatin–paclitaxel. The primary aim was to assess safety and progression-free survival (PFS). Subgroup analyses according to age were prespecified. The analysis population included 824 patients (453 aged <70 years, 371 aged ≥70 years). At data cutoff, the median bevacizumab duration was 13.8 months. Grade ≥3 adverse events (AEs), serious AEs, and AEs leading to bevacizumab discontinuation were more common in older than younger patients, whereas treatment-related AEs were less common. Median PFS was 19.4 months, with no clear difference according to age (20.0 vs. 19.3 months in patients <70 vs. ≥70 years, respectively). One-year OS rates were 92% and 90%, respectively. Mean change from baseline in global health status/quality of life showed a clinically meaningful increase over time. In German routine oncology practice, PFS and safety were similar to reported randomized phase 3 bevacizumab trials in more selected populations. There was no notable reduction in effectiveness and tolerability in patients aged ≥70 years; age alone should not preclude use of bevacizumab-containing therapy. ClinicalTrials.gov: NCT01697488.https://www.mdpi.com/2072-6694/13/19/4739bevacizumabovarian canceranti-angiogenicplatinum–taxanechemotherapy |
| spellingShingle | Jalid Sehouli Alexander Mustea Guelten Oskay-Özcelik Maren Keller Rolf Richter Oliver Tomé Hannah Woopen Ann-Katrin Sommer-Joos Jacek P. Grabowski Robert Armbrust Pauline Wimberger Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients Cancers bevacizumab ovarian cancer anti-angiogenic platinum–taxane chemotherapy |
| title | Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients |
| title_full | Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients |
| title_fullStr | Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients |
| title_full_unstemmed | Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients |
| title_short | Bevacizumab Combined with Platinum–Taxane Chemotherapy as First-Line Treatment for Advanced Ovarian Cancer: Results of the NOGGO Non-Interventional Study (OTILIA) in 824 Patients |
| title_sort | bevacizumab combined with platinum taxane chemotherapy as first line treatment for advanced ovarian cancer results of the noggo non interventional study otilia in 824 patients |
| topic | bevacizumab ovarian cancer anti-angiogenic platinum–taxane chemotherapy |
| url | https://www.mdpi.com/2072-6694/13/19/4739 |
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