C. Martín de Vidales

Hospital Universitario de La Princesa

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A. Zapatero

Hospital Universitario de La Princesa

F. Garcı́a‐Vicente

Hospital Universitario Ramón y Cajal

L. Cerezo

Hospital Universitario de La Princesa

Felipe A. Calvo

Clinica Universidad de Navarra

Francesc Casas

Hospital Clínic de Barcelona

A. Guerrero

Astellas Pharma (United States)

AÁ

A. Álvarez

Hospital General Universitario Gregorio Marañón

Xavier Maldonado

Vall d'Hebron Hospital Universitari

Carmen González San Segundo

Hospital General Universitario Gregorio Marañón

A. Boladeras

Institut Català d'Oncologia

Cooperative Institutions

Hospital Universitario de La Princesa

Hospital General Universitario Gregorio Marañón

Universidad Autónoma de Madrid

Hospital Universitario 12 De Octubre

Universidad Complutense de Madrid

Universitat Autònoma de Barcelona

Institut Català d'Oncologia

Hospital Universitario Ramón y Cajal

Instituto de Salud Carlos III

Complejo Hospitalario Universitario de Santiago

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Ten-Year Results of a Phase III Randomised Trial of High-Dose Radiotherapy and Risk-Adapted Androgen Deprivation in Localised Prostate Cancer

SSRN Electronic Journal (2021)

A. Zapatero A. Guerrero Xavier Maldonado A. Álvarez Carmen González‐San Segundo

Background: The optimal duration of androgen deprivation (AD) combined with high-dose radiotherapy (HDRT) in prostate cancer remains controversial. The DART trial was designed to determine whether long-term AD (LTAD) is superior to short-term AD (STAD) when combined with HDRT. In this report, we present the ten-year final results.Methods: The eligibility criteria included cT1c-T3aN0M0 adenocarcinoma of the prostate with intermediate and high-risk factors and PSA < 100 ng/ml. All patients received four months of neoadjuvant and concomitant AD (STAD) + HDRT (median radiation dose 78 Gy) before randomisation to adjuvant goserelin for two years (LTAD). Patients were stratified by risk group (intermediate risk [IR] versus high risk [HR]). Study endpoints included overall survival (OS), metastasis-free survival (MFS), disease-free survival (DFS), and biochemical disease-free survival (bDFS). OS rates were compared with Cox regression and cancer-specific death, MFS, and bDFS using competing-risk models. Follow-up is now complete, and this is the final report on the main endpoints. This trial is registered at ClinicalTrials.gov (NCT 02175212) and in the EU Clinical Trials Register (EudraCT 2005-000417-36).Results: A total of 355 patients were enrolled from Nov 7, 2005 to Dec 20, 2010. The 354 found to be eligible were randomly assigned to STAD (177) and LTAD (177). The median follow-up was 119 months (IQR 100·6-124·3). The ten-year bDFS for LTAD and STAD was 70·2% and 62·3%, respectively (hazard ratio [HR] 1·19, 95% CI 0·70-2·00). At ten years, OS was 78·4% for LTAD and 73·3% for STAD (HR 1·20, 95% CI 0·79-1·82), and MFS was 76·0% and 70·9% for LTAD and STAD, respectively (HR 1·12, 95% CI, 0·46-2·73). For high-risk patients treated with LTAD, the ten-year bDFS was 67·2% and 53·7% for STAD (HR 1·11, 95% CI 0·61-2·02). The ten-year OS was 78·5% and 67·0% for STAD (HR 1·74, 95% CI 0·99-3·06), and the ten-year MFS was 76·6% and 65·0% for LTAD and STAD, respectively (HR 1·12, 95% CI 0·41 to 3·07). Only 11 patients died from prostate cancer, all of them in the high-risk subgroup.Conclusion: After an extended ten-year follow-up, we were unable to confirm the statistically significant benefit of LTAD reported at five years. However, our results showed a consistent absolute benefit of 13% in bDFS, 11·6% in MFS, and 11·5% in OS in patients with high-risk prostate cancer. This finding is probably due to the competing risk of non–prostate cancer death in an aging population with a high life expectancy and to the lower number of events observed in both arms with respect to the initial expectations. Clinical Trial Registration Details: EudraCT, 2005-000417-36; NCT, 02175212.Funding Information: R. Funding was provided by a government grant (No. 04/2506) from the FIS (National Health Investigation Fund), a grant from the GICOR/SEOR (Grupo de Investigación en Oncología Radioterápica/Sociedad Española de Oncología Radioterápica), and AstraZeneca.Declaration of Interests: Dr Zapatero reports speaker honoraria from Astellas Pharma and Janssen, advisory board honoraria from Bayer, and research grants from AstraZeneca. Dr González-San Segundo reports speaker honoraria from Astellas Pharma and Janssen and advisory board honoraria from Bayer. Dr Maldonado reports speaker honoraria from Astellas Pharma, IPSEN, and Bayer and advisory board honoraria from Astellas Pharma and Bayer. Dr. Alvarez reports speaker honoraria from Astellas Pharma and Janssen and payment for medical research from Merck. Dr Casas reports speaker honoraria from Astellas Pharma, AstraZeneca, Bayer, GP Pharm, and Ipsen and advisory board honoraria from Janssen. Dr Boladeras reports speaker honoraria from Janssen, IPSEN, and Astellas Pharma and advisory board honoraria from Bayer. Dr Calvo, Dr Guerrero, Dr Vázquez de la Torre, Dr Pedro Olivé, Dr Cabeza, Dr Martin de Vidales, Dr Solé, Susana Vara, and Juan Luis Sanz declare that they have no conflicts of interest.Ethics Approval Statement: The study protocol and amendments were approved by the independent review board at each participating centre and conducted according to the provisions of the Declaration of Helsinki and the Good Clinical Practice Guidelines of the International Conference on Harmonisation. All patients provided their written informed consent before participating in the trial.

10.2139/ssrn.3984112

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Invasive bladder cancer: A singleinstitution experience with bladdersparing approach

International Journal of Cancer (2000)

A. Zapatero C. Martín de Vidales Alicia Marín L. Cerezo Ronald S. Arellano

Our objective was to assess the efficacy and safety of a selective bladder-preserving approach by transurethral resection and sequential chemoradiotherapy in patients with muscle-invasive bladder cancer. From 1989 through 1997, 40 patients with biopsy-confirmed bladder cancer, clinical stages T2–4NxM0, were treated with induction by aggressive transurethral resection (TUR) and three cycles of methotrexate, cisplatin, and vinblastine (MCV) chemotherapy. Tumor response was evaluated by cystoscopy and biopsy. In complete responders, the treatment was continued by radiotherapy (60 Gy to the bladder and 50 Gy to pelvic lymph nodes). Radical cystectomy was recommended to patients with residual tumor. Clinical complete response rate to TUR and MCV chemotherapy was 70%. The 4-year actuarial overall survival rate for the whole series was 80.5%. Among 36 patients who completed chemotherapy and radiotherapy, the 4-year actuarial survival was 84%, with 82.6% surviving with their bladders intact. Freedom from local failure in complete responders to TUR-chemotherapy was 84%. Multivariate analysis revealed that the extent of initial TUR and status after TUR-chemotherapy were independent prognostic factors associated with survival and disease-free survival. This study confirms that the combination of aggressive TUR and sequential chemoradiotherapy with bladder preservation is an alternative treatment option to primary cystectomy for selected patients with invasive bladder carcinoma. Int. J. Cancer (Radiat. Oncol. Invest.) 90, 287–294 (2000). © 2000 Wiley-Liss, Inc.

Chemoradiotherapy

10.1002/1097-0215(20001020)90:5<287::aid-ijc6>3.3.co;2-0

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Citations (4)

718 Preoperative versus postoperative radiation therapy for resectable rectal cancer

European Journal of Cancer (1995)

C. Martín de Vidales L. Cerezo A. Zapatero Pedro Domı́nguez B. Pinar

10.1016/0959-8049(95)95968-c

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Use of gold seeds in the treatment of prostate cancer IMRT.Implementing the NAL protocol for correction of motion of the prostate

F. Garcı́a‐Vicente V. Arroyo Fernández A. Autran Gomez A. Zapatero Inmaculada Fernández

Gold standard (test)

Source

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Prognostic value of HIF 1α, PAK-6 and PSMB4 expression in men treated with radiation and androgen deprivation for prostate cancer

Reports of Practical Oncology & Radiotherapy (2013)

A. Zapatero Manuel M. Morente Consuelo López C. Martín de Vidales Magdalena Adrados

Value (mathematics)

Expression (computer science)

10.1016/j.rpor.2013.03.853

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Best oral presentation: Long-term toxicity following high-dose radiotherapy and androgen deprivation for prostate cancer: Report of phase-III clinical trial DART 01/05

Reports of Practical Oncology & Radiotherapy (2013)

A. Álvarez A. Zapatero A. Guerrero Xavier Maldonado Carmen González San Segundo

Presentation (obstetrics)

10.1016/j.rpor.2013.03.804

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Predictors for Late Urinary Toxicity After High-Dose Radiation Therapy for Localized Prostate Cancer

International Journal of Radiation Oncology*Biology*Physics (2013)

F. Garcı́a‐Vicente A. Zapatero C. Martín de Vidales G. Rodríguez O. Leaman

10.1016/j.ijrobp.2013.06.960

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Citations (1)

Successful bone marrow transplantation in sensitized aplastic anemia patients using total lymphoid irradiation for conditioning: long-term follow-up

Hematological Oncology (1996)

A. Zapatero Alicia Marín Mario López C. Martín de Vidales L. Cerezo

Between June 1986 and November 1994, 22 previously transfused patients with severe aplastic anemia (SAA) were treated with high-dose cyclophosphamide (CY) (50 mg/kg over 4 consecutive days) and 7 Gy total lymphoid irradiation (TLI) in two fractions before allogeneic bone marrow transplantation (BMT) from HLA-identical sibling. Graft-versus-host-disease (GVHD) prophylaxis included the combination of methotrexate and cyclosporine A in all cases. Actuarial survival at 5 years is 73±9 per cent for the entire group and 86±13 per cent for the seven patients ⩽18 years. The incidence of graft failure was 0 per cent, and of acute GVHD and chronic GVHD was 31·5 per cent and 24 per cent respectively. Prolonged interval from diagnosis to BMT adversely influenced survival (P=0·03). No hypothyroidism or secondary malignancies have been documented in this series. Our findings indicate that survival with CY-TLI is comparable to that obtained using preparative regimens without radiation. The changing role of radiotherapy in pretransplant immunosuppression for SAA is discussed. © 1996 John Wiley & Sons, Ltd.

Aplastic anemia

Immunosuppression

10.1002/(sici)1099-1069(199612)14:4<165::aid-hon587>3.0.co;2-u

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Citations (10)

Stage I-III Hodgkin's Disease: Outcome and Pattern of Failure Following Treatment with Radiation Therapy and Chemotherapy in a Modern Era

Hematology (2002)

A. Zapatero Mario López L. Cerezo C. Martín de Vidales Alicia Marín

To analyse the long term outcome, pattern of failure and treatment related complications after radiation therapy (RT) with or without chemotherapy for stage I-III Hodgkin's disease (HD).Detailed records from 86 patients with stage I-III HD treated between 1989 and 1998, were retrospectively reviewed. Seventeen patients with favourable stage I-IIA were treated with RT alone, and the remaining 69 patients with combined modality treatment (CMT). Patients treated with RT received extended-field or subtotal nodal irradiation (STNI) to a total dose of 36-54 Gy, and patients with CMT, received involved-field irradiation to a lower doses, 26-40 Gy. The median follow-up time was 50 months (range 16-180).The 10-year overall survival (OS) for the whole group was 96% (SE 2%), 100% for stage I, 95% for stage II and 100% for stage III patients. Of potential prognostic factors analysed for statistical significance, only the response to chemotherapy (p=0.0393) was found to influence significantly OS rates. Twelve patients (13.9%) relapsed. Salvage treatment was effective in 10 of the 12 relapsed patients. The 10-year freedom from treatment failure (FFTF) was 79% (SE 6%). Although 8 (9.6%) of the 83 surviving patients developed late effects that could represent toxicity from the treatment, no patient died of late complications.RT alone for favourable early stage HD attains good survival rates with a modest treatment related morbidity. For patients with unfavourable stage II and stage III HD, CMT with limited RT provides a good to excellent prognosis.

10.1080/10245330290020117

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Citations (5)

1244 poster FIDUCIAL GOLD MARKERS IN INTENSITY-MODULATED RADIOTHERAPY FOR PROSTATE CANCER: APPLICATION OF THE NO ACTION LEVEL PROTOCOL TO CORRECT PROSTATE MOTION

Radiotherapy and Oncology (2011)

F. Garcı́a‐Vicente V. Fernández Bedoya A. Gómez Barrado A. Zapatero Inmaculada Fernández

Fiducial marker

10.1016/s0167-8140(11)71366-4

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