e24107 Background: Despite many years of clinical research and development, nausea and vomiting remain challenging toxicities related to chemotherapy. The aim of our study was assessment of non-pharmacological, patient-related risk factors for chemotherapy-induced nausea and vomiting and development of unique predictive score in patients with gynaecological malignancies planned for chemotherapy. Methods: A research-based questionnaire of 27 risk factors was generated and provided to patients diagnosed with gynaecological malignancies prior to indicated chemotherapy. The data on nausea and vomiting from at least 3 cycles therapy was collected. Variable selection via stepwise and LASSO regression combined with patients history was used to identify a small set of questions with high predictive power. As risk prediction model, a Bayesian logistic regression was implemented with a cut-off chosen to yield a sensitivity of 80%. Area under the curve analysis (AUC) was conducted, and accuracy of prediction was calculated. Results: In total 191 patients were enrolled. The most frequent diagnosis and chemotherapy was ovarian cancer (69%) and carboplatinum/paclitaxel combination (57.7%), respectively. Six factors (emetogenic potential of the therapy, educational status, nausea and vomiting due to other medication, motion sickness, anxiety from therapy in general and anxiety from nausea due to therapy) were identified as most important predictive factors. All questions were answered by 132 (69.1%) patients. Among those 97 (68%) reported nausea or vomiting. The AUC of the predictive score consisting mentioned factors was 0.741, with a sensitivity of 80.4%, specificity of 51.4% and an overall accuracy of 72.7%. Conclusions: Patients related risk factors are missing in selection of the antiemetic prophylaxis in patients under chemotherapy. Presented predictive score showed very promising predictive power and is going to be validated in further phase of the trial. Clinical trial information: DRKS-ID: DRKS00015151.

Introduction/Background Nausea and vomiting are one of the most common and challenging side effects related to chemotherapy. The aim of the study was to develop a predictive score for chemotherapy-induced nausea and vomiting (CINV) in patients with gynaecological cancers planned for chemotherapy by identifying non-pharmacological, patient-related risk factors. Methodology A research-based questionnaire of 27 risk factors was designed and handed out to chemotherapy-naïve patients with gynaecological malignancies. Data on nausea and vomiting from at least 3 cycles of therapy was collected. Variable selection via stepwise and LASSO regression combined with patients' history was used to determine few questions with high predictive power. Bayesian logistic regression (risk prediction model) was implemented with a cut-off chosen to reach a sensitivity of 80%. Area under the curve analysis (AUC) was performed and the accuracy of prediction calculated. Results 191 patients were enrolled, of which 174 (91.1%) received at least one dose of chemotherapy (intention-to-treat population). Most patients suffered from ovarian cancer (68.0%) and received the carboplatinum/paclitaxel chemotherapy combination (57.5%). Leading predictive factors for CINV were educational status, nausea and vomiting due to other medication, motion sickness, anxiety from therapy in general, anxiety from nausea due to therapy, emetogenic potential of the therapy and distress level. 142 (81.6%) patients answered all questions concerning these factors. Among those, 107 (66.0%) were affected by nausea or vomiting. The AUC of the predictive score based on the above mentioned factors was 0.727 (95% CI [0.636, 0.818]), with a sensitivity of 80.4% [72.9%, 87.9%], a specificity of 48.6% [31.4%, 65.7%] and an overall accuracy of 72.5% [65.5%, 79.6%]. Conclusion To this day, a patient-related predictive model for the occurrence of CINV is missing, making the choice of the right antiemetic prophylaxis difficult. The score featured in our study showed very promising predictive power and is currently being validated.

Abstract Background: Ribociclib (RIB, a selective CDK4/6 inhibitor) plus an aromatase inhibitor (AI) or fulvestrant (FUL) is approved for the treatment of premenopausal and postmenopausal women with HR+/HER2- advanced breast cancer (aBC). Real-world evidence for the effectiveness, safety and tolerability of RIB + AI/FUL in routine clinical practice is needed to support the use of this combination. Methods: RIBANNA is a noninterventional study ongoing in Germany since October 2017. Premenopausal and postmenopausal patients (N=3020) treated with RIB + AI/FUL, or endocrine monotherapy (ET), or chemotherapy (CT) as first-line treatment for HR+/HER2- aBC in accordance with German guidelines were included. Data are being collected from clinical practice in all 3 cohorts. Further lines of treatment are noted to examine outcomes of sequential therapy. Results: For the first interim analysis, 461 patients were enrolled until October 9, 2018, while full analysis set comprised 282 patients (Table 1). The first-line mean daily dose of RIB was 382 mg including and 540 mg excluding dose interruptions, respectively. RIB was prescribed mainly in combination with letrozole (83%), anastrozole (8%), and exemestane (7%); ET included nonsteroidal AI (64%), selective estrogen receptor degrader (25%), selective estrogen receptor modulator (7%), and steroidal AI (5%); CT included taxane-based monotherapy (30%) or combination therapy (27%), other monotherapy (23%) or other combination therapy (13%), and anthracycline-based combination therapy (5%). Conclusion: RIBANNA study showed diverse population characteristics among patients who received RIB treatment in a real-world setting. Based on the baseline demographics data, RIB (CDK4/6 inhibitor) treatment was found to be very well adopted among premenopausal and postmenopausal patients with HR+/HER2- aBC. The second interim analysis is planned for October 2019. Updated baseline data of approximately 1200 to 1300 patients and information on safety and dose modification for first-line patients from all cohorts will be presented. Table 1. Baseline demographic characteristicsTotal (N = 282)RIB + AI (n = 216)Endocrine therapy (n = 26)Chemotherapy (n = 40)Mean age, years (SD)67 (11)67 (10)71 (12)62 (10)Mean time since initial diagnosis, years5.45.56.53.9T stage at initial diagnosis, n (%)T0+T161 (100)48 (79)6 (10)7 (11)T2-T4198 (100)149 (75)17 (9)32 (16)N stage at initial diagnosis, n (%)N0+N1186 (100)144 (77)16 (9)26 (14)N2+N364 (100)48 (75)5 (8)11 (17)M stage at initial diagnosis, n (%)M0156 (100)121 (78)14 (9)21 (13)M1101 (100)75 (74)9 (9)17 (17)Locally advanced, n (%)101 (100)73 (72)9 (9)19 (19)Metastatic, n (%)101 (100)75 (74)9 (9)17 (17)Metastatic location, n (%)CNS, liver, lungs119 (100)96 (81)1 (1)22 (18)Bone only84 (100)62 (74)17 (20)5 (6)Skin, lymph nodes, other52 (100)37 (71)6 (11)9 (17) Citation Format: Achim Wöckel, Pawel Basiora, Michael Bohlmann, Thomas Decker, Jörg Falbrede, Peter Fasching, Helmut Forstbauer, Tobias Hesse, Oliver Hoffmann, Christian Jackisch, Anna Kaczerowsky, Ralf Lorenz, Kerstin Lüdtke-Heckenkamp, Diana Lüftner, Frederik Marmé, Thomas Mueller, Christoph Mundhenke, Arnd Nusch, Volker Petersen, Gabriele Prange-Krex, Toralf Reimer, Thomas Resch, Christian Roos, Oliver Tomé, Anja Weishap. Real-world efficacy of ribociclib + aromatase inhibitor, or endocrine monotherapy, or chemotherapy as first-line treatment in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancer: Second interim analysis from the RIBANNA 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 P1-19-33.

e17080 Background: Presence of circulating tumor cells (CTCs) in peripheral blood is associated with impaired clinical outcome in a variety of cancers. So far, limited data are available on the significance of CTCs in gynaecological malignancies. Aims of the present study were to evaluate the dynamics of CTCs in patients with ovarian, fallopian tube and peritoneal cancer during chemotherapy and to assess the clinical relevance of these changes. Methods: 38 patients with ovarian (n=31), fallopian tube (n=4) and peritoneal (n=3) cancer were included into the study. All patients received chemotherapy in the first-line setting (n=19) or tumor recurrence (n=19). CTC analysis was performed prior to systemic treatment, after three and six cycles of chemotherapy and analysed using CellSearch system (Veridex). A tumor cell was defined as EpCAM+, cytokeratin+, CD45-, and positive for the nuclear stain DAPI. CTC positivity was defined as detection of at least one CTC per 7.5 ml blood. Results: 11 out of 38 (29%) patients were CTC positive at baseline. Positivity rate was 20% in patients with first-line setting and 37% in those with tumor recurrence. 1of the 4 patients with fallopian tube cancer presented with CTCs in contrast to 1 out of 3 patients with peritoneal cancer and 10 out of 31 ovarian cancer patients. Presence of CTCs was not correlated with other prognostic factors, such as the FIGO stage, nodal status, or grading. CTC positivity declined to 8% after three cycles of cytotoxic therapy and no patient was CTC positive after 6 cycles of chemotherapy. 12 patients died during follow-up. Patients with CTCs at baseline had significantly shorter overall survival compared with CTC negative patients (p = 0.002; mean OS 5.8 [95%-CI 2.7-8.9] vs. 15.2 [10.5-19.8] months, median OS 3.0 [1.4-4.6] vs. not reached). In the subgroup of patients with primary cancer, CTC positivity was significantly associated with overall survival in the univariate analysis (p = 0.008). Conclusions: Hematogenous dissemination of single tumor cells is a common phenomenon in ovarian, fallopian tube and peritoneal cancer. Patients with CTCs in the peripheral blood at time of diagnosis are more likely to die than those who are CTC-negative at baseline.