Manso, L. (Luis)

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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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    Rucaparib in recurrent ovarian cancer: real-world experience from the rucaparib early access programme in Spain – A GEICO study
    (2022) Herrero, A.B. (Ana B.); Manso, L. (Luis); Calzas, J. (Julia); Reche, P. (Piedad); Yubero, A. (Alfonso); Barquín, A. (Aranzazu); Salvador, C. (Carmen); Márquez, R. (Raúl); Alarcón, J. (Jesús); Estévez, P. (Purificación); Constenla, M. (Manuel); Gutiérrez, M. (María); Fuentes, J.A. (José Antonio); González-Martín, A. (Antonio); Marquina, G. (Gloria); Gaba, L. (Lydia); Merino, M. (María); Pajares, B. (Bella); Sánchez-Lorenzo, M. L. (María Luisa); Madani, J. (Julia); Casado, V. (Victoria); Taus, A. (Álvaro); Dosil, A. (Alba); Santaballa, A. (Ana)
    Background: Rucaparib is a poly(ADP-ribose) polymerase inhibitor approved in Europe as maintenance therapy for recurrent platinum-sensitive (Pt-S) ovarian cancer (OC). The Rucaparib Access Programme (RAP) was designed to provide early access to rucaparib for the above-mentioned indication, as well as for patients with BRCA-mutated Pt-S or platinum-resistant (Pt-R) OC and no therapeutic alternatives. Methods: In this observational, retrospective study we analysed the efficacy and safety of rucaparib within the RAP in Spain. Hospitals associated with the Spanish Ovarian Cancer Research Group (GEICO) recruited patients with high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer treated with rucaparib 600 mg twice daily as maintenance or treatment (Pt-S/Pt-R) in the RAP. Baseline characteristics, efficacy, and safety data were collected. Results: Between July 2020 and February 2021, 51 patients treated in 22 hospitals in the RAP were included in the study. Eighteen patients with a median of 3 (range, 1–6) prior treatment lines received rucaparib as maintenance; median progression-free survival (PFS) for this group was 9.1 months (95% confidence interval [CI], 4.2–11.6 months). Among 33 patients (median 5 [range, 1–9] prior treatment lines) who received rucaparib as treatment, 7 and 26 patients had Pt-S and Pt-R disease, respectively. Median PFS was 10.6 months (95% CI, 2.5 months-not reached) in the Pt-S group and 2.2 months (95% CI, 1.1–3.2 months) in the Pt-R group. Grade ≥ 3 treatment-emergent adverse events were reported in 39% of all patients, the most common being anaemia (12% and 15% in the maintenance and treatment groups, respectively). At data cut-off, 5 patients remained on treatment. Conclusion Efficacy results in these heavily pre-treated patients were similar to those from previous trials. The safety profile of rucaparib in real life was predictable and manageable.
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    Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2(-) advanced breast cancer patients: Results from the compassionate use program in Spain (PALBOCOMP)
    (Elsevier, 2020) Manso, L. (Luis); Servitja, S. (Sónia); Llombart-Cussac, A. (Antonio); Bratos, R. (Raquel); Ruiz-Borrego, M. (Manuel); Gonzalez-Cao, M. (María); Echarri, M.J. (María J.); Gonzalez-Cortijo, L. (Lucía); Vega, E. (Estela); Gallegos, I. (Isabel); Hernando, B.A. (Blanca A.); Robles, C.E. (Carlos E.); Oliveira, M. (Mafalda); Galan, M. (María); Andres, R. (Raquel); Santisteban, M. (Marta); Alvarez-Busto, I. (Iñaki); Alés-Martínez, J.E. (José E.); Rodríguez, C.A. (C.A.); Echeverría, I. (Isabel); Moreno, F. (Fernando); Delgado-Mingorance, J. (Juan I.); Oltra, A. (Amparo); Blanch, S. (Salvador); Legeren, M. (Marta); Hernando, C. (Cristina); García-Garre, E. (Elisa); Aguirre, E. (Elena); Galve, E. (Elena); Ballesteros, A. (Ana); Reboredo, C. (Cristina); Lopez, R. (Rafael); Morales, S. (Serafín); Malón, D. (Diego); Cabrera, M.A. (Miguel A.)
    Background: This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavilypretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HRþ/ HER2- ) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017. Patients and methods: Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HRþ/HER2- mBC who had progressed on 4 treatments for advanced disease were eligible. Results: A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n ¼ 13) and 46.2% (n ¼ 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7e7.0) and the median overall survival was 19.0 months (95% CI 16.4e21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus 6 months; HR 1.93, 95% CI 1.37e2.73, p < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia. Conclusions: Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET.