No abstract

PurposeThe OVA-YOND study is the first prospective, non-interventional trial designed to evaluate trabectedin (1.1 mg/m2) plus PLD (30 mg/m2) in patients with platinum-sensitive recurrent ovarian cancer (ROC), given according to the marketing authorization in real-life clinical practice across Germany.MethodsEligible patients were adults with platinum-sensitive ROC, pretreated with ≥ 1 platinum-containing regimen/s. The primary endpoint was to assess safety/tolerability of the combination.ResultsSeventy-seven patients with platinum-sensitive relapse from 31 sites were evaluated. Patients received a median of 6 cycles (range 1–21) with 39 patients (50.6%) receiving ≥ 6 cycles. Median treatment duration was 4.2 months (range 0.7–18.8), mostly on an outpatient basis (88.3% of patients). Most common grade 3/4 trabectedin-related adverse events (AEs) were leukopenia (18.2%), neutropenia (15.6%), thrombocytopenia (9.1%), alanine (7.8%) and aspartate aminotransferase (6.5%) increase, and nausea/vomiting (5.2% each). Neutropenia (18.2%), leukopenia (15.6%), thrombocytopenia (10.4%), and nausea/vomiting (5.2% each) were the most frequent grade 3/4 PLD-related AEs. No deaths attributed to drug-related AEs or unexpected AEs occurred. Five patients (6.5%) had a complete response and 19 patients (24.7%) achieved a partial response for an objective response rate of 31.2% with median response duration of 6.25 months. Sixteen patients (20.8%) had disease stabilization for a disease control rate of 51.9%. Median progression-free survival was 6.3 months and median overall survival was 16.4 months.ConclusionTrabectedin plus PLD confer clinically meaningful benefit to pre-treated patients with platinum-sensitive ROC, being comparable to those previously observed in selected populations from clinical trials and with a manageable safety profile.

No abstract

Background. In this prospective analysis, we aimed to characterize the treatment opinions on male breast cancer (MBC). Patients and methods. In this prospective cohort study we included patients treated between May2009 and June 2018 for MBC. Results. The median follow-up was 30 months (range 2-84 months) and the median age at diagnosis was 69 years (range 27-96 years). Radical mastectomy was performed in 354 (96.2%) cases. Most (n=194, 52.9%) patients underwent sentinel-node biopsy (SNB). However, the vast majority of patients with clinical and sonographic suspicious axillary lymph nodes (n=72, 81.8%) underwent ALND. Adjuvant radiation of chest wall post mastectomy or of the breast post breast conserving surgery was performed in 193 (51.9%) patients. Systemic therapy was administered to 155 (41.0%) patients, and was administered predominantly in the adjuvant setting. Most common was anthracycline-taxane-based therapy. Of patients with HER2 (n=43) overexpressing tumors, 29 (67.4%) received trastuzumab. Adjuvant endocrine therapy was administered to 92.3% of patients, predominantly tamoxifen. Important decision criteria for adjuvant radiation and chemotherapy were advanced stage of disease, lymph node metastases, undifferentiated tumors, lymph- and blood vessel invasion. During the follow up period 609 cycles of chemotherapy were administered (median 6 cycles per person). Haematological and non-haematological toxic effects were observed in 68 (16.4%) and 57 (53.3%) patients, respectively. Grade 3 and 4 haematological events were rare. The most common was neutropenia in 17 (15.8%) and febrile neutropenia in 10 (9.3%) cases. Nausea and vomiting were the most commonly observed grade 3 and 4 non-haematological adverse events observed in 7 (4.6%) cases. Endocrine therapy was discontinued in 53 (16.2%) patients and chemotherapy in 25 (16.1%) cases. Conclusions. In this large prospective study, we found that MBC is treated according to current guidelines and treatment seems to be not inferior in comparison with that treatment of FBC. Citation Format: Holm Eggemann, Cosima Brucker, Susen Schirrmeister, Uta Ringsdorf, Doris Augustin, Michael Schrauder, Marc Thill, Felix Flock, Susanne Kraudelt, Gabriele Gad, Anke Kleine-Tebbe, Mattea Reinisch, Serban- Dan Costa, Atanas Ignatov. Treatment strategies in male breast cancer: Results of a prospective multicenter study [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P4-17-06.

This non-interventional, prospective phase IV trial evaluated trabectedin in patients with soft tissue sarcoma (STS) in real-life clinical practice across Germany. The primary endpoints were progression-free survival (PFS) rates at 3 and 6 months, as defined by investigators. Overall, 128 patients from 19 German sites were evaluated for efficacy and 130 for safety. Median age was 58.5 years (range: 23–84) and leiomyosarcoma was the most frequent histotype (n = 45; 35.2%). Trabectedin was mostly used as second/third-line treatment (n = 91; 71.1%). Median PFS was 5.2 months (95% CI: 3.3–6.7), with 60.7% and 44.5% of patients free from progression at 3 and 6 months, respectively. Median overall survival was 15.2 months (95% CI: 9.6–21.4). One patient achieved a complete and 14 patients a partial response, conferring an objective response rate of 11.7%. Decreases in white blood cells (27.0% of patients), platelets (16.2%) and neutrophils (13.1%) and increased alanine aminotransferase (10.8%) were the most common trabectedin-related grade 3/4 adverse drug reactions. Two deaths due to pneumonia and sepsis were considered trabectedin-related. Trabectedin confers clinically meaningful activity in patients with multiple STS histotypes, comparable to that previously observed in clinical trials and other non-interventional studies, and with a manageable safety profile.