Browsing by Subject "Real-world evidence"

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    Clinical Complete Response and Organ Preservation Strategies in Rectal Cancer: A Real-World Single-Center Experience Clinical Complete Response and Organ Preservation in Rectal Cancer
    (MDPI, 2026-02-27) Encarnación, J.A. ; Ibáñez, N. ; de la Fuente, I.; González, S. ; Sánchez, M.; Bautista, Y. ; Rodríguez, C.; Nadal, J.A. ; Abellán, I. ; Montoya, M.; Ono, A. ; Carbonell, G.; Frutos, L. ; Ortiz, E.; Manso, C. ; Ruiz Carreño, Paula; Marín Vera, Miguel; Quiles, B.; Abrisqueta Carrión, Jesús; Royo-Villanova Reparaz, Carlota; Alonso Romero, José Luis; Marín-Zafra, G.; Guirao, M.; Hernández, Q.; Medicina Interna; Facultades de la UMU::Facultad de Medicina
    Background: The management of rectal cancer has evolved toward response-adapted strategies, including organ preservation in selected patients achieving a clinical complete response (cCR) after neoadjuvant treatment. However, most available evidence derives from clinical trials, and data from real-world clinical practice remain limited. Methods: We conducted a retrospective observational cohort study including consecutive patients with rectal adenocarcinoma treated at a tertiary referral center between January 2021 and December 2025. Baseline clinical, tumor-related, and treatment characteristics were collected. Tumor response was assessed using clinical, endoscopic, and radiological criteria. The primary endpoint was the rate of clinical complete response and the implementation of watch-and-wait strategies. Secondary endpoints included recurrence patterns and exploratory oncologic outcomes according to baseline tumor characteristics. Results: A total of 229 patients were identified, of whom 148 were evaluable for treatment response. Clinical complete response was documented in 56 patients (37.8%), and a watch-and-wait strategy was implemented in 42 patients (28.4%). Higher cCR rates were observed in patients with stage I–II disease and in tumors measuring < 4 cm on baseline magnetic resonance imaging, with cCR rates exceeding 55% in this subgroup. Tumors ≥ 4 cm showed substantially lower response rates. Clinical complete responses were observed across both short-course radiotherapy plus chemotherapy and long-course chemoradiotherapy regimens in patients with small tumors and early-stage disease. Tumor distance from the anal verge was not consistently associated with response. With a median follow-up of 26 months in the watch-and-wait group, five recurrences were observed, including three local recurrences. Conclusions: In this real-world cohort, baseline tumor size and clinical stage were the main determinants of clinical complete response and eligibility for organ-preservation strategies in rectal cancer. Small tumors (<4 cm) showed high response rates regardless of neoadjuvant regimen. These findings support response-adapted, individualized treatment strategies and highlight the importance of tumor burden in selecting candidates for non-operative management in routine clinical practice.
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    Clinical subtypes in breast cancer patients with brain metastases from an ambispective registry of advanced breast cancer, GEICAM/2014-03 (RegistEM)
    (2026-02-20) López Tarruella, Sara ; Guerrero-Zotano, Ángel ; Antolín, Silvia ; Cruz, Josefina ; Martínez, Purificación ; Rodríguez, César A.; Falo, Catalina ; Rodríguez Lescure, Álvaro ; Adrover, Encarna ; Hernández, María ; Andrés, Raquel ; Chacón, José Ignacio ; Alonso Romero, José Luis; Miguel, Ana ; Gómez Raposo, César ; Margelí, Mireia ; González, Iria ; Guerra, José Antonio; Antón, Antonio ; Tibau, Ariadna ; Miralles, Juan José; Escudero, María José; Bezares, Susana ; Rojo, Federico ; Álvarez, Isabel ; Medicina Interna; Facultades de la UMU::Facultad de Medicina
    Background: Breast cancer frequently results in brain metastases (BCBM), leading to poor outcomes. Central nervous system (CNS) involvement entails significant challenges in advanced breast cancer (ABC) patients. Objectives: To characterize BCBM patients according to surrogate clinical BC subtypes and evaluate the interval between ABC and BCBM detection, both at ABC diagnosis (BCBM1 cohort) and for those who develop BCBM subsequently (BCBM2 cohort). Secondary objectives included analyzing the time-related outcomes by BC subtype. Design: RegistEM is an ongoing ambispective, observational study of ABC patients diagnosed since January/2016. Methods: We describe the characteristics of BCBM patients reported by January 22, 2024, categorized by BC subtype on the most recent tumor sample obtained before first-line therapy. Results: At the cutoff date, 346/1947 (18%) patients diagnosed with ABC between January/2016 and December/2019 developed BCBM, and 288/346 (83%) died. All patients were female, predominantly Caucasian (98%), with a median age of 55 years at ABC diagnosis. The distribution by subtype was 170/346 (49%) HR+/HER2−, 68/346 (20%) HR+/HER2+, 54/346 (16%) HR−/HER2+, and 51/346 (15%) HR−/HER2− (triple negative (TN)). One-fourth (85/346) were in the BCBM1 cohort, with 22/85 (26%) having BCBM as the only metastatic location; in this cohort, median time to BCBM was 38 months, with shorter intervals in HR−/HER2+ and TN subtypes (17 and 18 months, respectively). In the BCBM2 cohort (261/346), the median time to BCBM was 24 months, with the shortest interval in TN (13 months). Median survival from BCBM diagnosis was 26 months (95% confidence interval (CI), 20−35) in BCBM1 and 9 months (95% CI, 7−12) in BCBM2 (hazard ratio, 2.3; 95% CI, 1.7−3.0); TN subtype showed the poorest results (median of 6 months; 95% CI, 3−13). Conclusion: TN and HER2+ BC subtypes progressed faster to BCBM and had worse outcomes. Survival differed significantly between the two cohorts, BCBM1 and BCBM2. Continued research is essential to improve the treatment and prevention strategies.