PMID- 34638225 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211016 IS - 2072-6694 (Print) IS - 2072-6694 (Electronic) IS - 2072-6694 (Linking) VI - 13 IP - 19 DP - 2021 Sep 22 TI - 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. LID - 10.3390/cancers13194739 [doi] LID - 4739 AB - 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. FAU - Sehouli, Jalid AU - Sehouli J AD - Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Charite-Universitatsmedizin Berlin, 13353 Berlin, Germany. FAU - Mustea, Alexander AU - Mustea A AD - Department of Gynecology, Greifswald Medical University, 17489 Greifswald, Germany. FAU - Oskay-Ozcelik, Guelten AU - Oskay-Ozcelik G AUID- ORCID: 0000-0001-7302-1409 AD - Praxisklinik Krebsheilkunde fur Frauen, 13597 Berlin, Germany. FAU - Keller, Maren AU - Keller M AD - Nord-Ostdeutsche Gesellschaft fur Gynakologische Onkologie (NOGGO) e.V., Schwedenstrasse 9, 13359 Berlin, Germany. FAU - Richter, Rolf AU - Richter R AUID- ORCID: 0000-0003-2965-8730 AD - Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Charite-Universitatsmedizin Berlin, 13353 Berlin, Germany. FAU - Tome, Oliver AU - Tome O AD - St Vincentius-Kliniken, 76135 Karlsruhe, Germany. FAU - Woopen, Hannah AU - Woopen H AD - Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Charite-Universitatsmedizin Berlin, 13353 Berlin, Germany. FAU - Sommer-Joos, Ann-Katrin AU - Sommer-Joos AK AD - Roche Pharma AG, D-79639 Grenzach-Wyhlen, Germany. FAU - Grabowski, Jacek P AU - Grabowski JP AD - Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Charite-Universitatsmedizin Berlin, 13353 Berlin, Germany. FAU - Armbrust, Robert AU - Armbrust R AD - Department of Gynecology with Center for Oncological Surgery, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Charite-Universitatsmedizin Berlin, 13353 Berlin, Germany. FAU - Wimberger, Pauline AU - Wimberger P AUID- ORCID: 0000-0002-7380-577X AD - Department of Gynecology, Carl Gustav Carus University Dresden, Technische Universitat Dresden, 01307 Dresden, Germany. LA - eng SI - ClinicalTrials.gov/NCT01697488 GR - n/a/Roche Pharma AG/ PT - Journal Article DEP - 20210922 PL - Switzerland TA - Cancers (Basel) JT - Cancers JID - 101526829 PMC - PMC8507543 OTO - NOTNLM OT - anti-angiogenic OT - bevacizumab OT - chemotherapy OT - ovarian cancer OT - platinum-taxane COIS- Jalid Sehouli reports honoraria from AstraZeneca, Clovis Oncology, Eisai, Johnson & Johnson, MSD Oncology, Olympus Medical Systems, Pfizer, PharmaMar, Tesaro, Teva; consulting/advisory roles for AstraZeneca, Clovis Oncology, Lilly, Merck, MSD Oncology, Pfizer, PharmaMar, Tesaro; research funding from AstraZeneca, Bayer, Clovis Oncology, Merck, MSD Oncology, Pfizer, PharmaMar, Tesaro-all to institution; and travel/accommodation/expenses from AstraZeneca, Clovis Oncology, MSD Oncology, PharmaMar, Roche Pharma AG, Tesaro. Alexander Mustea reports consulting/advisory roles for AstraZeneca, Roche. Guelten Oskay-Ozcelik reports honoraria from Roche, Novartis, AstraZeneca, Amgen, Riemser, MSD; and consulting/advisory role for Roche, Novartis, AstraZeneca, MSD. Hannah Woopen reports travel/accommodation/expenses from Medac. Ann-Katrin Sommer-Joos is an employee of Roche Pharma AG and holds a share in Roche. Jacek P. Grabowski reports honoraria from AstraZeneca, Clovis Oncology, Pfizer, Riemser, Roche, Tesaro; consulting/advisory role for AstraZeneca, Clovis Oncology, Pfizer, Riemser, Roche, Tesaro; research funding from AstraZeneca, MSD, Riemser, Tesaro-all to institution; and travel/accommodation/expenses from Molecular Health, Tesaro. Pauline Wimberger reports honoraria from Roche, AstraZeneca, Clovis Oncology, Eisai, Novartis, Amgen, MSD, Merck Oncology, Pfizer, PharmaMar, Tesaro, Teva; research funding from Amgen, Novartis, Roche; and consulting/advisory roles for Roche, MSD, Tesaro, Novartis, Amgen, Clovis, Pfizer, AstraZeneca, Eisai. Maren Keller, Rolf Richter, Oliver Tome, and Robert Armbrust report no conflict of interest. EDAT- 2021/10/14 06:00 MHDA- 2021/10/14 06:01 PMCR- 2021/09/22 CRDT- 2021/10/13 01:01 PHST- 2021/08/18 00:00 [received] PHST- 2021/09/15 00:00 [revised] PHST- 2021/09/16 00:00 [accepted] PHST- 2021/10/13 01:01 [entrez] PHST- 2021/10/14 06:00 [pubmed] PHST- 2021/10/14 06:01 [medline] PHST- 2021/09/22 00:00 [pmc-release] AID - cancers13194739 [pii] AID - cancers-13-04739 [pii] AID - 10.3390/cancers13194739 [doi] PST - epublish SO - Cancers (Basel). 2021 Sep 22;13(19):4739. doi: 10.3390/cancers13194739.