A Phase II Trial of Stereotactic Body Radiation Therapy and Androgen Deprivation for Oligometastases in Prostate Cancer (SBRT-SG 05).

PURPOSE: SBRT-Spanish Group-05 (ClinicalTrials.gov.Identifier: NCT02192788) is a collaborative (SBRT-SG, Grupo de Investigación Clínica en Oncología Radioterápica, and Sociedad Española de Oncología Radioterápica) prospective multicenter phase II trial testing stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT) in patients with oligorecurrent prostate cancer. METHODS AND MATERIALS: Two cohorts of patients with prostate cancer in an oligorecurrent stage (hormone-sensitive in the principal cohort and castration-resistant in the exploratory cohort) were assigned to receive ADT and SBRT for at least 24 months from the time of the enrollment. Concomitant treatment with chemotherapy, abiraterone, or enzalutamide was not allowed. Oncologic outcomes were assessed in both cohorts. Toxicity was prospectively analyzed. RESULTS: From 2014 to 2019, 81 patients with a total of 126 lesions from 14 centers met the inclusion criteria, 14 of whom were castration-resistant. With a median follow-up of 40 months (12-58 months), 3-year local recurrence-free survival was 92.5% (95% CI, 79.9%-96.3%) and 85.7% (95% CI, 48.2%-95.6%) in the principal and exploratory cohorts, respectively. In the principal cohort, biochemical relapse-free survival and metastasis progression-free survival at 1, 2, and 3 years were 91% (95% CI, 81%-95.8%), 73.7% (95% CI, 61.1%-82.8%), 50.6% (95% CI, 36.2%-63.3%), and 92% (95% CI, 83%-97%), 81% (95% CI, 70%-89%), and 67% (95% CI, 53%-77%), respectively. In the exploratory cohort, metastasis progression-free survival at 1, 2, and 3 years was 64% (95% CI, 34%-83%), 43% (95% CI, 18%-66%), and 26% (95% CI, 7%-51%), respectively. None of the patients developed grade III or higher toxicity or symptoms related to local progression, and only 2 (2.4%) patients developed grade II toxicity. CONCLUSIONS: The combination of SBRT and ADT is safe and shows favorable clinical outcomes in patients with hormone-sensitive and castration-resistant prostate cancer. Validation studies are needed in patients with castration-resistant prostate cancer.

How to integrate stereotactic body radiation therapy and hypofractionation in the management of stage III lung cancer in the age of immunotherapy / Cómo integrar la radioterapia estereotáxica fraccionada y el hipofraccionamiento en el manejo del cáncer de pulmón localmente avanzado en la era de la inmunoterapia

The constant advances in the field of lung cancer immunotherapy have recently reached the treatment of locally advanced disease with the approval of durvalumab after concurrent chemoradiation. However, radiation therapy continues to be key for controlling the disease at this stage. Over the years, different strategies have been employed to try to optimize outcomes using radiotherapy, with cardiac and pulmonary toxicity as the main limitation on its success. The interest in the use of hypofractionation and stereotactic body radiation therapy for stage III non-small cell lung cancer has increased as knowledge regarding these kinds of treatments has been enhanced. Hypofractionation is a relatively frequent treatment, although the level of evidence that supports it is limited. For its part, stereotactic body radiation therapy has been particularly studied as a boost after chemoradiation, with encouraging results. In both cases, study of how to integrate these tools with chemotherapy and particularly with immunotherapy is essential, as they may have an immunomodulatory role

The constant advances in the field of lung cancer immunotherapy have recently reached the treatment of locally advanced disease with the approval of durvalumab after concurrent chemoradiation. However, radiation therapy continues to be key for controlling the disease at this stage. Over the years, different strategies have been employed to try to optimize outcomes using radiotherapy, with cardiac and pulmonary toxicity as the main limitation on its success. The interest in the use of hypofractionation and stereotactic body radiation therapy for stage III non-small cell lung cancer has increased as knowledge regarding these kinds of treatments has been enhanced. Hypofractionation is a relatively frequent treatment, although the level of evidence that supports it is limited. For its part, stereotactic body radiation therapy has been particularly studied as a boost after chemoradiation, with encouraging results. In both cases, study of how to integrate these tools with chemotherapy and particularly with immunotherapy is essential, as they may have an immunomodulatory role

Effect of mono/dual antiretroviral therapy on suppression of HCV and HIV during treatment of HCV infection in HIV/HCV-coinfected patients / Efecto de la terapia antirretroviral mono/dual sobre la supresión de VHC y VIH durante el tratamiento de la infección por VHC en pacientes co-infectados de VIH/VHC

OBJECTIVE: Data of hepatitis C treatment with direct-acting antivirals (DAAs) in HIV infected patients are limited to a few number of antiretroviral therapies (ART). The aim of this study was to assess the effectiveness and safety of non-conventional ART as monotherapy or dual therapy (MDT) when combined with DAA. METHODS: Retrospective review of HIV/HCV-coinfected patients treated with DAAs during one year in 3 centers. Sustained virologic response 12 weeks after therapy (SVR) and maintenance of HIV viral suppression were compared between patients receiving triple ART (TT) or MDT. RESULTS: Overall 485 patients were included (359 receiving TT and 126 MDT). HCV SVR was 93.4% (95%CI, 90.8% to 95.3%) in the intention-to-treat analysis without differences between groups: 92.8% on TT vs 95.2% on MDT (p = 0.3). HCV virological failure was associated with lower CD4 + cell count at baseline (for every 100-cell/μl increment: OR, 0.8; 95%CI, 0.7-0.9; p = 0.01) and with liver stiffness (for every 10-unit increment: OR, 1.5; 95%CI 1.2-1.8; p < 0.01). HIV-RNA during HCV treatment or 12 weeks after was detectable in 23 patients on TT (6.6%) and 9 (7.2%) patients on MDT (p = 0.8). The median (IQR) change in CD4 + cell count was not significantly different between the groups: 15 (-55 to 115) in TT vs -12 (-68 to 133) cells/μl in MDT (p = 0.8). CONCLUSION: DAAs obtain high rates of SVR among HIV/HCV-coinfected patients independently of whether TT or non-conventional ART is used. Suppression of HIV was maintained in both groups

OBJETIVO: Los datos sobre el tratamiento de la hepatitis C con antivirales de acción directa (AAD) en los pacientes infectados por VIH se limitan a un escaso número de terapias antirretrovirales (TARV). El objetivo de este estudio fue valorar la efectividad y seguridad de las TARV no convencionales, como monoterapia y terapia dual (MDT), al combinarse con AAD. MÉTODOS: Revisión retrospectiva de pacientes co-infectados por VIH/VHC, tratados con AAD durante un año en 3 centros. Se comparó la respuesta virológica sostenida (RVS) a las 12 semanas de la terapia, y el mantenimiento de la supresión viral del VIH, entre los pacientes que recibieron triple TARV o MDT. RESULTADOS: Se incluyó a un total de 485 pacientes (359 que recibieron triple TARV y 126 que recibieron MDT). La RVS de VHC fue del 93,4% (IC 95%: 90,8-95,3%) en el análisis por intención de tratar, sin diferencias entre grupos: 92,8% en el grupo triple TARV vs. 95,2% en el grupo MDT (p = 0,3). El fracaso virológico de VHC se asoció a un menor recuento basal de células CD4+ (para cada incremento de 100células/μl: OR: 0,8; IC 95%: 0,7-0,9; p = 0,01) y a la rigidez hepática (para cada incremento de 10 unidades: OR: 1,5; IC 95%: 1,2-1,8; p < 0,01). El ARN-VIH durante el tratamiento de VHC, o transcurridas 12 semanas, fue detectable en 23 pacientes en el grupo triple TARV (6,6%) y 9 (7,2%) pacientes en el grupo MDT (p = 0,8). El cambio medio (RIC) en el recuento de células CD4 + no fue significativamente diferente entre ambos grupos: 15 (de -55-115) en el grupo triple TARV vs. -12 (de -68-133) células/μl en el grupo MDT (p = 0,8). CONCLUSIÓN: Los AAD obtienen tasas altas de RVS entre los pacientes co-infectados de VIH/VHC, independientemente de si se utiliza triple TARV o TARV no convencional. La supresión de VIH se mantuvo en ambos grupos

Quality of life assessment by applying EORTC questionnaires to rectal cancer patients after surgery and neoadjuvant and adjuvant treatment

Background: Quality of Life (QoL) is a key element in rectal cancer (RC) patients. Aims: this study assesses QoL in a sample of RC patients in their treatment follow-up period, and compares surgery modalities. Patients and methods: eighty four locally advanced RC patients who had received surgery and neoadjuvant chemoradiotherapy were included in the study. Of these, 70 had adjuvant chemotherapy. All patients completed the EORTC QLQ-C30 and the QLQ-CR29 once at least one year after completion of their treatment. Low anterior resection (LAR) patients also completed a Functional Evaluation questionnaire. Results: QoL scores in the EORTC questionnaires for the sample as a whole were high in most dimensions, in line with the general population’s QoL values, although moderate limitations (> 30 points) were observed in urinary frequency, flatulence, impotence and sexual function. The scores for the Functional Evaluation were adequate (mean combined bowel function score of 18.2). LAR patients had a higher stool frequency than those with abdominoperineal resection (APR; p < 0.001). No differences in body image were found amongst LAR and APR patients. LAR patients with a lower anastomosis had higher faecal incontinence (p = 0.02), whereas those with a reservoir had better emotional functioning (p = 0.04) and higher faecal incontinence (p = 0.03). Conclusions: QoL scores and functional evaluation indicated patients had adapted to their disease and treatment. The few differences in QoL found between surgery modalities are in line with other recent studies and in contrast with earlier ones that suggested a lower QoL in APR patients (AU)

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