e17550 Background: Ovarian cancer (OC) is the the leading cause of cancer death in females. Most cases present at advanced stage. Standard treatment is cytoreductive surgery before or after paclitaxel and carboplatin chemotherapy (CT) followed by maintenance treatment. Weekly CT is at least as effective as three weekly CT in OC, and may overcome resistance in some patients. Hyperthermia has been used alone or in combination with radiotherapy and chemotherapy in the treatment of advanced cancer. Radiofrequency hyperthermia (Oncothermia-OT) is theoretically more effective and comfortable form of hyperthermia due to its selective effects on tumor cells. Since most advanced patients have disease limited to the abdominal cavity, OT can be applied with a single electrode to cover the whole abdomen. Immediately following CT, OT may result in aggregation of DNA repair ezymes secreted in response to CT in cancer cells. Methods: We used weekly CT with paclitaxel or nab-paclitaxel with carboplatin followed immediately by OT. (Oncotherm-EHY 3010) to the whole abdomen for one hour for eighteen weeks in 22 consecutive patients with advanced (III or IV) ovarian/primary peritoneal cancer between 2016 and 2021. 19 patients received bevacizumab every three weeks in addition to chemotherapy.All pts had ECOG PS 0-1. Maintenance treatment was bevacizumab (19 patients) or olaparib (3 patients) for one year. Patients were followed by periodic CT/MRI/PET-CT and CA-125 levels. Results: All patients completed eighteen weeks of planned treatment. No unexpected or grade III-IV toxicity was observed. Complete response was obtained in 21 patients and partial response in one patient. Median follow up is 30 months (range 8-73 months).18 patients are alive, with 12 patients in ongoing remission and 6 patients receiving palliative treatment. 4 patients have died of cancer. Conclusions: Although this is a single center retrospective observation, the combination of weekly paclitaxel/nab-paclitaxel and carboplatin CT in combination with immediate weekly OT appears tolerable and feasible. Despite all of the limitations of this observation, activity of CT and OT appears promising. These findings should be confirmed with prospective randomized trials.
Background: Ribociclib combined with endocrine therapy (ET) have demonstrated efficacy in patients with hormone receptor (HR) positive advanced breast cancer (ABC) who experienced progression during prior ET. However, there are scarce data chemo-endocrine refractory patients with ribociclib. We analyzed the efficiency and safety of ribociclib from the real world evidence in this heavily treated group of patients in Managed Access Programme (MAP). Methods: MAP launched in Turkey, between October 2017 and March 2018. We retrospectively analyzed survival outcomes and toxicities of 52 patients from this programme. Results: The median age of the total population was 54.5 years (28-76 years) and 71.2% (n=37) of the patients were postmenapousal. Median estrogen receptor and progesterone receptor positivity were 90% (15-100) and 25% (0-100), respectively. Median Ki67 was 25% (3-90%). 46.2% and 73.1% of the patients had adjuvant chemotherapy and ET, respectively. Denovo metastatic disease was detected 28.8% of the patients. Visceral disease (lung, liver, and others) was present in 21 patients (40.3%), and 16 (30.8%) had bone-only disease. Median treatment line of ABC before ribociclib was 4 (1-9). ET was performed 36.5% and 38.4% for the first and second line treatment of ABC, respectively. Most of the patients (71.5%) treated anthracycline and taxanes before ribociclib. Ribociclib combined with ET in the majority of the patients; aromatase inhibitors (51.9%), fulvestrant (26.9%) and tamoxifen (3.8%). However, 4 patients were receiving ribociclib monotherapy. As of May 21, 2019, 26.9% (n=14) of patients were still receiving treatment. Objective response rate was 38.4% (n=20) and additional 18 (34.6%) stable diseases were detected. Median progression free survival and overall survival were 5 months (3.9-6.1 months) and 15.2 months (13.7-16.8 months), respectively. While 48.1% of the patients treated with chemotherapy after ribociclib failure, only two patients treated with ET after ribociclib failure. Ribociclib was generally well tolerated all the study population, grade 2 emesis was developed only two patients. Grade 3/4 neutropenia was developed in 36.5% of the patients. There was no febrile neutropenia. Urosepsis (n=1) and grade 4 thrombocytopenia (n=1) were developed in seperate patients. A prolongation of QTcF from baseline occurred in two patients. Dose reductions occurred in 21.2% (n=11) of the patients. There was 3 deaths during treatment. Conclusions: Ribociclib is an effective agent with tolerable safety profile even in the heavily pretreated patients with HR positive ABC especially combined with ET. Citation Format: Umut Demirci, Erhan Gokmen, Yesim Eralp, Seyda Gunduz, Sema Sezgin Goksu, Taner Korkmaz, Osman Kostek, Serdar Turhal, Semra Paydas, Sevgi Topcu, Burcu Cakar, Bulent Karabulut, Ozgur Tanrıverdi, Burcak Karaca, Gulhan Ipek Deniz, Ozkan Alan, Fatma Paksoy Turkoz, Gul Basaran. Ribociclib for the treatment of hormone receptor-positive refractory advanced breast cancer: Managed access programme in Turkey [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 P5-11-19.
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