Perez-Fidalgo, J.A. (José Alejandro)

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    GEICO1601-ROLANDO: a multicentric single arm Phase II clinical trial to evaluate the combination of olaparib and pegylated liposomal doxorubicin for platinum-resistant ovarian cancer
    (Future Science Ltd, 2019) Manso, L. (Luis); Calvo, E. (E.); Iglesias, M. (Maria); González-Martín, A. (Antonio); Bohn, U. (Uriel); Perez-Fidalgo, J.A. (José Alejandro); Garcia, Y. (Yolanda); Santaballa, A. (Ana); Guerra-Alia, E. (Eva)
    Response to polyadenosine diphosphate ribose polymerase (PARP) inhibitors in platinum-resistant ovarian cancer and in the absence of BRCA mutations is very low. Combining PARP inhibitors with other agents might overcome this lack of activity. Here we describe the rationale and design of GEICO1601-ROLANDO (resistant ovarian cancer treated with olaparib and pegylated liposomal doxorubin; NCT03161132). ROLANDO is a Phase II single-arm multicenter trial in which patients are treated with a combination of olaparib and pegylated liposomal doxorubicin (PLD) in platinum-resistant epithelial ovarian, primary peritoneal, or Fallopian tube cancer regardless of the BRCA mutation status. The primary end point is progression-free survival at 6 months. Other secondary end points are response rate, disease control rate, quality of life and overall survival. Lay abstract: PARP inhibitors as a single agent have shown very modest activity in platinum-resistant ovarian cancer in a BRCA nonselected population. The GEICO1601-ROLANDO trial is a protocol designed with the aim of assessing efficacy and safety of the combination of olaparib and pegylated liposomal doxorubin followed by olaparib maintenance in this setting.
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    Prospective Real-World Gynaecological Cancer Clinical Registry with Associated Biospecimens: A Collaborative Model to Promote Translational Research between GEICO and the Spanish Biobank Network
    (2022) Herrero, A.B. (Ana B.); Recalde, D. (Delia); Gallego-Martínez, A. (Alejandro); Esteban, C. (Carmen); Levin, A. M. (Ana M.); López-Guerrero, J.A. (José Antonio); Churruca, C. (Cristina); Gómez-Raposo, C. (César); Alarcón, J. (Jesús); Mendiola, M. (Marta); González-Martín, A. (Antonio); Marquina, G. (Gloria); Perez-Fidalgo, J.A. (José Alejandro); de Juan, A. (Ana); Torres, A. (Ana); Sánchez-Lorenzo, M. L. (María Luisa); Molina, E. (Elena); Gálvez-Montosa, F. (Fernando); Rubio, M. J. (María Jesús); Romero, I. (Ignacio); Guerra-Alia, E. (Eva)
    Patient registries linked to biorepositories constitute a valuable asset for clinical and translational research in oncology. The Spanish Group of Ovarian Cancer Research (GEICO), in collaboration with the Spanish Biobank Network (RNBB), has developed a multicentre, multistakeholder, prospective virtual clinical registry (VCR) associated with biobanks for the collection of real-world data and biological samples of gynaecological cancer patients. This collaborative project aims to promote research by providing broad access to high-quality clinical data and biospecimens for future research according to the needs of investigators and to increase diagnostic and therapeutic opportunities for gynaecological cancer patients in Spain. The VCR will include the participation of more than 60 Spanish hospitals entering relevant clinical information in harmonised electronic case report forms (eCRFs) in four different cohorts: ovarian, endometrial, cervical, and rare gynaecological cancers (gestational trophoblastic disease). Initial data for the cases included till December 2021 are presented. The model described herein establishes a real-world win-win collaboration between multicentre structures, promoted and supported by GEICO, that will contribute to the success of translational research in gynaecological cancer.