Search

Background Three-weekly BEP has been a standard of CT of advanced NSGCT for last two decades. We performed a phase II study to assess the efficacy and toxicity of two-weekly aBEP regimen in the first line treatment of NSGCT. Here we report final efficacy and safety results. Methods CT-naive NSGCT pts with intermediate or poor prognosis (IGCCCG) received aBEP as follows: cisplatin 20 mg/m2 days 1-5, etoposide 100 mg/m2 days 1-5, bleomycin 30 IU days 1,3,5 with G-CSF support 300 mcg days 6-10. Four cycles of aBEP were administered every 2 weeks. The primary endpoint was the progression free rate. Results From 2010 to 2014, 67 pts were treated. Intermediate and poor prognosis according IGCCCG had 35 (59%) and 32 (41%) of pts, respectively. In poor prognostic group mediastinal primary tumor had 11 (34%) pts, nonpulmonary visceral metastases - 16 (50%) pts. All pts were assessed for toxicity, which included (grade 3/4, per patient) neutropenia 72%, febrile neutropenia 26%, thrombocytopenia 18%, non-neutropenic infection 3%, anemia 31%. There were no toxic deaths. Dose reduction of cisplatin, etoposide and bleomycin were done on 16 (6.4%), 22 (8.9%) and 19 (7.7%) of 247 cycles, respectively. Median number of cycles was 4 (3-5). Two pts could not receive 4-th cycle due to toxicity. Median duration of treatment (from the first to the last doses of CT) was 7.4 (6.7-10.4) weeks. Totally 44 (72%) pts were able to start 4-th cycle of aBEP by day 50 ( Conclusions Two-weekly BEP regimen can be safely administered to NSGCT pts with intermediate and poor prognosis. Promising efficacy of aBEP warrants confirmation in ongoing randomized trial. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest.

Background MOGCT is rare tumors and represent 2% of all tumors of the ovary. Fertility preserving surgery is the standard of care for pts with MOGCT. Comprehensive surgical staging involves unilateral adnexectomy, omentectomy, peritoneal biopsies, washings and lymph node sampling. Visual inspection has been suggested as an alternative. Proposed surgical approach includes complete resection of the tumor-containing ovary with sparing of fallopian tube, inspection and palpation of contralateral ovary, omentum, lymph nodes, and peritoneum, biopsy of any suspicious lesions or lymph nodes, and collection of peritoneal washing or ascites. The objective of the study was to describe the clinico-pathologic features and treatment outcome of all patients diagnosed with MOGCT at the largest Russian Research Cancer Center. Methods A total of 149 pts treated for MOGCT in our center between 1987-2018 were included into this retrospective study. All data including clinical symptoms, demographics, stage, surgery, chemotherapy, survival and fertility function were analyzed and assessed in univariate and multivariate analysis. The median age was 22 years (range, 12-49 years). 109 (73.2%) of 149 underwent fertility-sparing surgery followed by chemotherapy (ChT). Histologically 29.5% (n = 44) of cases were pure dysgerminoma. All pts received BEP/EP regimens as a first line treatment. 14 (9.4%) pts had gonadal dysgenesis. Results With median follow-up of 86 mo. (range 1-337 mo.) 5-year OS was 92%. The 5-year disease free survival (DFS) was 87% (9.4% pts relapsed). The 5-year DFS in pts with dysgerminoma and non-dysgerminoma was 98% and 91% respectively (p = 0,2). The 5-year OS in pts with stage I was 100% and stages II-IV was 91%. Complete response reached in 97 (67.3%) of 144 assessed pts, marker-negative partial response registered in 34 (23.6%) pts. After first-line ChT completion 34/144 (23.6%) pts underwent surgical resection of residual masses. Conclusions The BEP regimen is a standard of care and provides high cure rate. Fertility-sparing surgery is standart volume of surgery even in advanced stages of disease. The BEP regimen does NOT adversely affect on fertility function of pts. Legal entity responsible for the study The authors. Funding Has not received any funding. All authors have declared no conflicts of interest.