Carmen González‐San Segundo

Hospital General Universitario Gregorio Marañón

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Felipe A. Calvo

Clinica Universidad de Navarra

A. Zapatero

Hospital Universitario de La Princesa

AÁ

A. Álvarez

Hospital General Universitario Gregorio Marañón

Xavier Maldonado

Vall d'Hebron Hospital Universitari

A. Guerrero

Astellas Pharma (United States)

I. Henrı́quez

Hospital Universitari Sant Joan de Reus

ÁL

Álvaro Lassaletta

Hospital Infantil Universitario Niño Jesús

A. Gómez-Iturriaga

Hospital de Cruces

Marta Rodríguez‐Pertierra

Hospital General Universitario Gregorio Marañón

Mariano Provencio

Hospital Universitario Puerta de Hierro Majadahonda

Cooperative Institutions

Hospital General Universitario Gregorio Marañón

Hospital Infantil Universitario Niño Jesús

Universidad Complutense de Madrid

Hospital Universitario 12 De Octubre

University of California, Los Angeles

Hospital Universitario Puerta de Hierro Majadahonda

Menéndez Pelayo International University

Institut Català d'Oncologia

Hospital Universitario de La Princesa

Research Institute Hospital 12 de Octubre

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Biochemical Recurrence Surrogacy for Clinical Outcomes After Radiotherapy for Adenocarcinoma of the Prostate

Journal of Clinical Oncology (2023)

Soumyajit Roy Tahmineh Romero Jeff M. Michalski Felix Y. Feng Jason A. Efstathiou

The surrogacy of biochemical recurrence (BCR) for overall survival (OS) in localized prostate cancer remains controversial. Herein, we evaluate the surrogacy of BCR using different surrogacy analytic methods.Individual patient data from 11 trials evaluating radiotherapy dose escalation, androgen deprivation therapy (ADT) use, and ADT prolongation were obtained. Surrogate candidacy was assessed using the Prentice criteria (including landmark analyses) and the two-stage meta-analytic approach (estimating Kendall's tau and the R2). Biochemical recurrence-free survival (BCRFS, time from random assignment to BCR or any death) and time to BCR (TTBCR, time from random assignment to BCR or cancer-specific deaths censoring for noncancer-related deaths) were assessed.Overall, 10,741 patients were included. Dose escalation, addition of short-term ADT, and prolongation of ADT duration significantly improved BCR (hazard ratio [HR], 0.71 [95% CI, 0.63 to 0.79]; HR, 0.53 [95% CI, 0.48 to 0.59]; and HR, 0.54 [95% CI, 0.48 to 0.61], respectively). Adding short-term ADT (HR, 0.91 [95% CI, 0.84 to 0.99]) and prolonging ADT (HR, 0.86 [95% CI, 0.78 to 0.94]) significantly improved OS, whereas dose escalation did not (HR, 0.98 [95% CI, 0.87 to 1.11]). BCR at 48 months was associated with inferior OS in all three groups (HR, 2.46 [95% CI, 2.08 to 2.92]; HR, 1.51 [95% CI, 1.35 to 1.70]; and HR, 2.31 [95% CI, 2.04 to 2.61], respectively). However, after adjusting for BCR at 48 months, there was no significant treatment effect on OS (HR, 1.10 [95% CI, 0.96 to 1.27]; HR, 0.96 [95% CI, 0.87 to 1.06] and 1.00 [95% CI, 0.90 to 1.12], respectively). The patient-level correlation (Kendall's tau) for BCRFS and OS ranged between 0.59 and 0.69, and that for TTBCR and OS ranged between 0.23 and 0.41. The R2 values for trial-level correlation of the treatment effect on BCRFS and TTBCR with that on OS were 0.563 and 0.160, respectively.BCRFS and TTBCR are prognostic but failed to satisfy all surrogacy criteria. Strength of correlation was greater when noncancer-related deaths were considered events.

Biochemical recurrence

10.1200/jco.23.00617

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Citations (16)

Author response for "Long‐Term Follow‐Up of Patients with Nodular Lymphocyte Predominant Hodgkin Lymphoma: A Report from the Spanish Lymphoma Oncology Group"

B. Núñez García Marta Rodríguez‐Pertierra Silvia Sequero Laura Gálvez Alberto Ruano‐Raviña

10.1002/hon.2835/v2/response1

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Are all prostate cancer patients "fit" for salvage radiotherapy?

World Journal of Clinical Oncology (2019)

Carmen González‐San Segundo A. Gómez-Iturriaga Felipe Couñago

The indication for salvage radiotherapy (RT) (SRT) in patients with biochemically-recurrent prostate cancer after surgery is based on prostate-specific antigen (PSA) levels at the time of biochemical recurrence. Although there are clear criteria (pT3-pT4 disease and/or positive margins) for the use of adjuvant radiotherapy, no specific clinical or tumour-related criteria have yet been defined for SRT. In retrospective series, 5-year biochemical progression-free survival (PFS) ranges from 35%-85%, depending on the PSA level at the start of RT. Two phase 3 trials have compared SRT with and without androgen deprivation therapy (ADT), finding that combined treatment (SRT+ADT) improves both PFS and overall survival. Similar to adjuvant RT, the indication for ADT is based on tumour-related factors such as PSA levels, tumour stage, and surgical margins. The number of patients referred to radiation oncology departments for SRT continues to rise. In the present article, we define the clinical, therapeutic, and tumour-related factors that we believe should be evaluated before prescribing SRT. In addition, we propose a decision algorithm to determine whether the patient is fit for SRT. This algorithm will help to identify patients in whom radiotherapy is likely to improve survival without significantly worsening quality of life.

Salvage therapy

Adjuvant radiotherapy

Biochemical recurrence

10.5306/wjco.v11.i1.1

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Citations (3)

An Innovative Tool for Intraoperative Electron Beam Radiotherapy Simulation and Planning: Description and Initial Evaluation by Radiation Oncologists

International Journal of Radiation Oncology*Biology*Physics (2012)

Javier Pascau Juan Antonio Santos Miranda Felipe A. Calvo Ana Bouché Virgina Morillo

10.1016/j.ijrobp.2011.12.063

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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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Unusual pattern of recurrence and atypical visceral metastases in extremity soft tissue sarcoma: a case report

Precision Cancer Medicine (2021)

Paula Sedano Carmen González‐San Segundo Marta Rodríguez‐Pertierra Francisco Díaz-Gutiérrez Adriana Medrano

Abstract: Soft-tissue sarcomas (STS) are a rare group of tumors, commonly arising in the extremities. For extremity STS, the main treatment strategy is limb sparing surgery followed by neoadjuvant radiotherapy. Patterns of disease relapse after multimodal treatment have been analyzed in the past decades, being the lung the first recurrence site. Non-pulmonary metastases are uncommon and are associated with worse prognosis. Local recurrences are less frequent and usually develop after a longer period of time. Local control depends on tumor grade and size, surgical margins and adjuvant radiotherapy. Here, we describe the case of an extremity STS fibrosarcoma in a 30-year-old male that in the course of the disease developed multiple marginal recurrences followed by gastric, lung and soft-tissue metastases. All local recurrences where identified by the patient himself and confirmed by magnetic resonance imaging (MRI). Limb marginal recurrences were treated with a multidisciplinary approach consisting of radical surgery and radiotherapy. Metastatic lesions were initially resected and adjuvant chemotherapy was considered after the last distant failure. STS can have an unpredictable pattern of recurrence, therefore follow-up protocols should be tailored to individual risk. Multimodal management for primary site is the key to achieve higher local control rates, and it should also be considered as an approach for secondary sites in selected patients.

10.21037/pcm-20-49

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Metastatic hormone-sensitive prostate cancer: How should it be treated?

World Journal of Clinical Oncology (2021)

Fernando López‐Campos Carmen González‐San Segundo A. Conde Felipe Couñago

The primary aim of World Journal of Clinical Oncology (WJCO, World J Clin Oncol) is to provide scholars and readers from various fields of oncology with a platform to publish high-quality basic and clinical research articles and communicate their research findings online.WJCO mainly publishes articles reporting research results and findings obtained in the field of oncology and covering a wide range of topics including art of oncology, biology of neoplasia, breast cancer, cancer prevention and control, cancer-related complications, diagnosis in oncology, gastrointestinal cancer, genetic testing for cancer,

Hormone Therapy

10.5306/wjco.v12.i2.43

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Radiotherapy in Elderly Patients with Low-Risk Breast Cancer

Book Publisher International (a part of SCIENCEDOMAIN International) (2021)

Claudio Fuentes-Sánchez María Elena García-Morales Carmen González‐San Segundo

There have been few experiments on the treatment of elderly women with low-risk breast cancer. Although their clinical behaviour is similar to that of younger patients, there is a tendency to undertreat them, which may increase the risk of local relapses and reduce their survival. Even in low-risk patients, the rate of local recurrences after breast conserving surgery without adjuvant treatment (tamoxifen or radiotherapy) is high, approaching 20%, which is unacceptable. Despite the fact that tamoxifen and radiotherapy seem to have a similar impact in reducing local recurrence with similar overall survival, the combination of the two provides the best results with local relapses of less than 2%. Two studies that were designed specifically for elderly patients were published in recent years. Based on similar survival, these trials recommend omitting radiotherapy in patients with low-risk tumours treated with breast conserving surgery and tamoxifen, but with an increase in local relapses when radiotherapy is omitted, 10% at 10 years vs 2%. There is no evidence that tamoxifen treatment is less toxic in this group of patients who are typically poly-treated, and treatment compliance appears to be much lower than expected. This recommendation is highly contentious due to the reduction in the number of sessions in external radiotherapy with hypofractionation and the acceleration of partial breast irradiation, especially intraoperative radiotherapy with a single session. After breast conserving surgery, elderly patients may benefit from radiation therapy.

Breast-conserving surgery

10.9734/bpi/hmmr/v12/8638d

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Androgen Deprivation Therapy and Salvage Radiotherapy: Are We Missing Something?

European Urology (2019)

Carmen González‐San Segundo Felipe Couñago A. Gómez-Iturriaga

Salvage therapy

10.1016/j.eururo.2019.01.045

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Long‐term follow‐up of patients with nodular lymphocyte predominant Hodgkin lymphoma: A report from the Spanish Lymphoma Oncology Group

Hematological Oncology (2020)

Beatriz Núñez Marta Rodríguez‐Pertierra Silvia Sequero Laura Gálvez Alberto Ruano‐Raviña

Abstract Nodular lymphocytic predominance Hodgkin lymphoma (NLPHL) is a very uncommon subtype of Hodgkin lymphoma (HL), representing approximately 5% of all HL cases, with an incidence of 0.3/100,000 cases per year and with unique characteristics which distinguish it from classic Hodgkin lymphoma. Given its low frequency, there is a lack of prospective randomized studies to inform practice, the accumulated experience of academic groups being the main source of relevant information for the management of these patients. Eighty‐five patients recruited by the Spanish Lymphoma Group (GOTEL) from 12 different hospitals were retrospectively analyzed to describe their sociodemographic and clinical characteristics. The median follow‐up was 16 years, with a 10‐year overall survive of 92.9% and 81.2% at 20 years. Five patients developed a second malignancy. No transformation to a more aggressive lymphoma was detected. A total of 31% tumor relapses was found: 77% in a single location; most of them at a supra‐diaphragmatic level. Patients received different first‐line treatments, and progression was observed in 3/4 (75%) of the patients who did not receive any type of treatment, 6/23 (26%) who received both chemotherapy (CH) and radiotherapy (RT), 12/43 (27%) who received RT and 7/15 (47%) that received only CH treatment. The mean time to relapse was 3 years and 47% presented relapses beyond 5 years (higher probability in stage IV p < 0.001). This is one of the longest follow‐up series of NLPHL published, confirming its excellent prognosis, and that treatments may be adapted to reduce toxicity. Causes of death in these patients are varied, and the minority due to a primary malignancy relapses.

10.1002/hon.2835

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Citations (2)