Iglesias, M. (Maria)

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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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    Laboratory Cross-Comparison and Ring Test Trial for Tumor BRCA Testing in a Multicenter Epithelial Ovarian Cancer Series: The BORNEO GEICO 60-0 Study
    (2022) Palacios, J. (José); Gallego-Martínez, A. (Alejandro); Márquez, A. (Antonia); Yubero, A. (Alfonso); Pérez-Segura, C. (Cristina); López-Guerrero, J.A. (José Antonio); Márquez, R. (Raúl); Alarcón, J. (Jesús); Mendiola, M. (Marta); Palacio, I. (Isabel); Alkorta-Aranburu, G. (Gorka); Cueva, J. (Juan); Matito, J. (Judit); Iglesias, M. (Maria); Moreno-Bueno, G. (Gema); Gaba, L. (Lydia); Antunez-Lopez, J. R. (José Ramón); Sánchez‑Heras, A.B. (Ana Beatriz); Sánchez-Lorenzo, M. L. (María Luisa); García-Casado, Z. (Zaida); Vivancos, A. (Ana); Oaknin, A. (Ana); Arcusa, A. (Angels); Romero, I. (Ignacio); Barretina-Ginesta, P. (Pilar); Guerra-Alia, E. (Eva)
    Germline and tumor BRCA testing constitutes a valuable tool for clinical decision-making in the management of epithelial ovarian cancer (EOC) patients. Tissue testing is able to identify both germline (g) and somatic (s) BRCA variants, but tissue preservation methods and the widespread implementation of NGS represent pre-analytical and analytical challenges that need to be managed. This study was carried out on a multicenter prospective GEICO cohort of EOC patients with known gBRCA status in order to determine the inter-laboratory reproducibility of tissue sBRCA testing. The study consisted of two independent experimental approaches, a bilateral comparison between two reference laboratories (RLs) testing 82 formalin-paraffin-embedded (FFPE) EOC samples each, and a Ring Test Trial (RTT) with five participating clinical laboratories (CLs) evaluating the performance of tissue BRCA testing in a total of nine samples. Importantly, labs employed their own locally adopted next-generation sequencing (NGS) analytical approach. BRCA mutation frequency in the RL sub-study cohort was 23.17%: 12 (63.1%) germline and 6 (31.6%) somatic. Concordance between the two RLs with respect to BRCA status was 84.2% (gBRCA 100%). The RTT study distributed a total of nine samples (three commercial synthetic human FFPE references, three FFPE, and three OC DNA) among five CLs. The median concordance detection rate among them was 64.7% (range: 35.3–70.6%). Analytical discrepancies were mainly due to the minimum variant allele frequency thresholds, bioinformatic pipeline filters, and downstream variant interpretation, some of them with consequences of clinical relevance. Our study demonstrates a wide range of concordance in the identification and interpretation of BRCA sequencing data, highlighting the relevance of establishing standard criteria for detecting, interpreting, and reporting BRCA variants.