Tıp Fakültesi / Faculty of Medicine

Permanent URI for this collectionhttps://hdl.handle.net/11727/1403

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    Effect of Upfront Docetaxel in De Novo Metastatic Castration-Sensitive Prostate Cancer Patients with Gleason Grade Group 5
    (2023) Yildirim, Serkan; Yilmaz, Cengiz; 37926887
    Objective: To investigate whether adding docetaxel chemotherapy to androgen deprivation therapy is effective regarding progression-free and overall survival in patients with de novo metastatic castration- sensitive prostate cancer patients with Gleason Grade Group 5 (Gleason scores 9 and 10). Study Design: Observational study. Place and Duration of the Study: Department of Medical Oncology at Manisa Celal Bayar University, Izmir Ege University, Bitlis Tatvan Public Hospital, Izmir Bozyaka Education and Research Hospital, and Izmir Kent Hospital, from March 2015 to May 2020. Methodology: Patients with de novo metastatic castration-sensitive and histopathologically confirmed GGG 5 prostate cancer were evaluated retrospectively. The patients were divided into two groups. The first group included patients who were given androgen deprivation therapy alone ( ADT-only group), and the second group consisted of patients who were given ADT plus docetaxel (chemohormonal group). The two groups were compared in terms of overall survival and progression-free survival till cut-off limit. Results: A total of 194 patients with metastatic castration-sensitive and GGG 5 prostate cancer were analysed retrospectively. The chemohormonal group comprised of 72 patients, and the ADT-only group included 122 patients. Median progression-free survival was 15.7 months in the chemohormonal group and 14.8 months in the ADT-only group (p = 0.97). The median overall survival was 37.5 months in the chemohormonal group and 37.8 months in the ADT-only group (p = 0.93). Conclusion: The addition of docetaxel chemotherapy in patients with metastatic castration-sensitive and GGG 5 prostate cancer did not result in a statistically significant difference in terms of overall survival and progression-free survival. Docetaxel may be ineffective in this group of patients.
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    nextMONARCH Phase 2 randomized clinical trial: overall survival analysis of abemaciclib monotherapy or in combination with tamoxifen in patients with endocrine-refractory HR +, HER2-metastatic breast cancer
    (2022) Hamilton, Erika; Cortes, Javier; Ozyilkan, Ozgur; Chen, Shin-Cheh; Petrakova, Katarina; Manikhas, Aleksey; Jerusalem, Guy; Hegg, Roberto; Huober, Jens; Zhang, Wei; Chen, Yanyun; Martin, Miguel; 35829935
    Purpose Resistance to endocrine therapy poses a major clinical challenge for patients with hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). We present the preplanned 24-month final overall survival (OS) results, alongside updated progression-free survival (PFS), and objective response rate (ORR) results. Methods nextMONARCH is an open-label, controlled, randomized, Phase 2 study of abemaciclib alone or in combination with tamoxifen in women with endocrine-refractory HR + , HER2- MBC previously treated with chemotherapy. Patients were randomized 1:1:1 to: abemaciclib 150 mg and tamoxifen 20 mg (A + T), abemaciclib 150 mg (A-150), or abemaciclib 200 mg and prophylactic loperamide (A-200). OS was the main prespecified secondary endpoint. PFS, ORR, and safety at 24 months were compared to previously reported primary analysis results. Results Of the 234 patients enrolled, 12 were receiving study treatment at data cutoff (28Jun2019). Median follow-up was 27.2 months. Median OS was 24.2 months in the A + T arm, 20.8 months in A-150, and 17.0 months in A-200 (A + T versus A-200: HR 0.62; 95%CI [0.40, 0.97], P = 0.03 and A-150 versus A-200: HR 0.96; 95%CI [0.64, 1.44], P = 0.83). PFS and ORR results at 24 months were consistent with the primary analysis. The safety profile corresponded with previous reports. Conclusion The addition of tamoxifen to abemaciclib demonstrated greater OS benefit than monotherapy. This study confirmed the single-agent activity of abemaciclib in heavily pretreated women with endocrine-refractory HR + , HER2- MBC, as well as the previously reported primary PFS and ORR results, with no new safety signals observed.