Induction avelumab followed by chemoimmunotherapy and maintenance versus chemotherapy alone as first-line therapy in cis-ineligible metastatic urothelial carcinoma (INDUCOMAIN): a randomized phase II study.

BACKGROUND: Platinum-based chemotherapy (ChT) has been the standard first-line treatment for metastatic urothelial carcinoma (mUC). The purpose of this study was to evaluate the use of induction avelumab followed by avelumab in combination with carboplatin-gemcitabine (carbo/gem) followed by avelumab maintenance. We tested the hypothesis that induction immunotherapy (IO) could enhance the response to ChT and prevent its detrimental effect on immune cells. MATERIALS AND METHODS: INDUCOMAIN is a multicenter, randomized, investigator-initiated, open-label phase II study evaluating the safety and efficacy of induction avelumab before carboplatin-gemcitabine-avelumab, followed by avelumab maintenance (arm A), compared to carbo/gem (arm B). Eligibility criteria included patients with mUC, no prior systemic therapy, and ineligibility for cisplatin by Galsky criteria. Patients were stratified by the presence/absence of visceral metastasis and Eastern Cooperative Oncology Group performance status 0-1 versus 2. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Eighty-five patients were included and randomized to arm A (n = 42) and arm B (n = 43), respectively. ORR was similar between treatment arms: 59.5% in arm A and 53.5% in arm B (P = 0.57). Fourteen patients (33%) in arm A early progressed/died before or at first response assessment, compared to three patients (7%) in arm B. Median OS was 11.1 months in arm A and 13.2 months in arm B [hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.57-1.46, P = 0.69]. Median PFS was 6.9 months in arm A versus 7.4 months in arm B (HR 0.99, 95% CI 0.61-1.60, P = 0.95). Treatment-related adverse events of grade 3-4 occurred in 70.7% of patients in arm A and in 72.1% in arm B. No predictive role of programmed death-ligand 1 expression was found. CONCLUSIONS: The hypothesis that induction avelumab could enhance the efficacy of subsequent ChT was not proven. Administering IO alone as induction before ChT is not an adequate strategy.

Progressive perioperative benefits of laparoscopy in combination with an ERAS (Enhanced Recovery After Surgery) protocol in radical cystectomy with ileal conduit. / Beneficios perioperatorios progresivos de la laparoscopia y su combinación con un programa Enhanced recovery after surgery (ERAS) en la cistectomía radical con derivación urinaria heterotópica.

INTRODUCTION: Although in the recent years, laparoscopy and Enhanced Recovery After Surgery (ERAS) protocols have improved postoperative recovery in radical cystectomy (RC), the clinical efficacy of their association remains unclear. Our objective is to analyze the possible benefits obtained from laparoscopic RC (LRC) and its subsequent combination with an ERAS (ERAS-LRC) protocol compared to open RC (ORC). MATERIAL AND METHODS: We analyzed 187 consecutive RCs with ileal conduit performed in our center, of which 139 met the inclusion criteria: 47 ORC, 39 LRC (both with conventional protocol) and 52 ERAS-LRCs. RESULTS: No significant differences were found regarding age, sex, BMI and ASA score between groups. ERAS-LRC obtained a shorter length of stay than LRC and ORC (median 8 [7-10]) vs. 13 [10-17] vs. 15 [13-19.5] days, respectively; P<.001). ERAS-LRC had a shorter stay in the ICU and less days of nasogastric tube (P<.001). Postoperative complications and readmission rates were similar among groups. Multivariate logistic regression showed that absence of complications, younger age and ERAS behaved as independent factors for shorter hospital stay, while ERAS was the only independent factor of lower readmission rate at 90 days. CONCLUSIONS: Although LRC presented perioperative benefits compared to ORC, the results were better after the implementation of an ERAS protocol. ERAS protocol had stronger impact on recovery than the surgical approach of the procedure.

Epidemiology of human papillomavirus-related oropharyngeal cancer in a classically low-burden region of southern Europe.

The incidence of human papillomavirus (HPV)-related oropharyngeal cancer is increasing in some regions. Nevertheless, the epidemiology of this disease has not been extensively investigated in southern Europe. We conducted a retrospective cohort study of patients diagnosed with primary oropharyngeal cancer from 1991 to 2016. Cancer tissues underwent histopathological evaluation, DNA quality control, HPV-DNA detection and p16INK4a immunohistochemistry. Data were collected from medical records. Factors associated with HPV positivity and time trends were evaluated with multivariable Bayesian models. The adjusted prevalence of HPV-related cases in 864 patients with a valid HPV-DNA result was 9.7%, with HPV-DNA/p16INK4a double positivity being considered. HPV-related oropharyngeal cancer was likely to occur in non-smokers and non-drinkers, to be located in the tonsil or diagnosed at advanced stages. Time-trend analysis showed an increasing risk of HPV-related oropharyngeal cancer in the most recent periods (5-year period increase of 30%). This increase was highest and with a clear increasing trend only in the most recent years (2012-2016). The prevalence of HPV-related oropharyngeal cancer started to sharply increase in the most recent years in our setting, as occurred two decades ago in areas where most oropharyngeal cancer cases are currently HPV-related. Our results provide a comprehensive assessment of the epidemiological landscape of HPV-related oropharyngeal cancer in a region of southern Europe.

Extravasation of oxaliplatin: an infrequent and irritant toxicity.

Oxaliplatin has been classified as an irritant drug. Less than 10 cases of oxaliplatin extravasation through a central venous access have been described to date. We present a case of extravasation through a central venous access, of the highest dose (165 mg) of oxaliplatin reported to date. We confirmed the irritant effect, and full recovery from toxicity was achieved. We describe the treatment administered and offer a review of literature.

Correction to: Curative radiation therapy for very elderly bladder cancer patients with localized disease.

In the original version of this article the figure captions of Figs. 1 and 2 were interchanged.

SEOM clinical guideline in nasopharynx cancer (2017).

Nasopharyngeal carcinoma (NPC) is distinct from other cancers of the head and neck in biology, epidemiology, histology, natural history, and response to treatment. Radiation therapy is an essential component of curative-intent of non-disseminated disease and the association of chemotherapy improves the rates of survival. In the case of metastatic disease stages, treatment requires platinum/gemcitabine-based chemotherapy and patients may achieve a long survival time.

Curative radiation therapy for very elderly bladder cancer patients with localized disease.

PURPOSE: To report the outcomes of a cohort of very elderly muscle-invasive bladder cancer (MIBC) patients treated with contemporary 3D-conformal radiation therapy (3D-CRT) with or without concurrent chemotherapy, after transurethral resection of bladder tumor (TURBT). METHODS: From February 2010 to January 2014, a total of 41 patients older than 75 years, with T2-3 N0-1 high-grade MIBC, a Karnofsky index (KI) of at least 90% and/or a Barthel scale score of at least 95, were treated with TURBT followed by radiotherapy (RT) with or without chemotherapy, and were prospectively followed-up. RESULTS: The mean age of patients was 82 years (range 76-88). Median follow-up was 47 months for surviving patients. Mean Charlson Comorbidity Index (CCI) score was 5 points. 28 patients (68.29%) were T2N0. All received 3D-CRT to a mean dose of 60 Gy (range 48.6-66 Gy), and chemotherapy was delivered to 34 patients (83%). Cause-specific survival (CSS) was 86 and 78.8% at 1 and 5 years, respectively. Patients achieving a complete response lived longer (48 vs 14 m, p = 0.036) than those with a progressive disease, who were more likely to die from cancer than from other causes (HR 3.865, IC95% 1.562-9.562). Dead patients had a longest treatment time (mean 56.78 vs 48.91 days, p = 0.019) than survivors. CONCLUSION: RT with contemporary 3D-CRT techniques after TURBT for MIBC in elderly patients is feasible and well-tolerated. Achieving a maximal response and shortening the total radiation treatment time may improve outcomes and quality of life.

SEOM clinical guideline in nasopharynx cancer (2017)

Nasopharyngeal carcinoma (NPC) is distinct from other cancers of the head and neck in biology, epidemiology, histology, natural history, and response to treatment. Radiation therapy is an essential component of curative-intent of non-disseminated disease and the association of chemotherapy improves the rates of survival. In the case of metastatic disease stages, treatment requires platinum/gemcitabine-based chemotherapy and patients may achieve a long survival time (AU)

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Beneficios perioperatorios progresivos de la laparoscopia y su combinación con un programa Enhanced recovery after surgery (ERAS) en la cistectomía radical con derivación urinaria heterotópica / Progressive perioperative benefits of laparoscopy in combination with an ERAS (Enhanced Recovery After Surgery) protocol in radical cystectomy with ileal conduit

Introducción: Aunque en los últimos años la laparoscopia y los protocolos de rehabilitación multimodal Enhanced recovery after surgery (ERAS) han demostrado mejorar la recuperación postoperatoria en la cistectomía radical (CR), la eficacia clínica de su asociación aún sigue en estudio. Nuestro objetivo es analizar los posibles beneficios obtenidos de la CR laparoscópica (CRL) y su posterior combinación con ERAS (ERAS-CRL) frente a la CR abierta (CRA).Material y métodosAnalizamos 187CR consecutivas con derivación urinaria heterotópica realizadas en nuestro centro, de las cuales 139 cumplieron los criterios de inclusión: 47CRA, 39CRL (ambas con protocolo convencional) y 52 ERAS-CRLResultadosNo se encontraron diferencias significativas en cuanto a edad, sexo, IMC y ASA entre los 3 grupos. ERAS-CRL obtuvo una estancia hospitalaria más corta que CRL y CRA (mediana 8 [7-10]) vs. 13 [10-17] vs. 15 [13-19,5] días, respectivamente; p<0,001). ERAS-CRL también tuvo una estancia más corta en la UCI y menos días de sonda nasogástrica (p<0,001). Las complicaciones postoperatorias y los reingresos fueron similares en los 3 grupos. La ausencia de complicaciones, una edad más joven y ERAS fueron factores independientes relacionados con una menor estancia hospitalaria, mientras que ERAS fue el único factor independiente asociado con un menor reingreso a los 90 días.ConclusionesAunque la CRL presentó beneficios perioperatorios respecto a la CRA, los resultados fueron mejores tras la implementación de un programa ERAS, siendo el impacto de este último más importante que la técnica quirúrgica utilizada. (AU)

Introduction: Although in the recent years, laparoscopy and Enhanced Recovery After Surgery (ERAS) protocols have improved postoperative recovery in radical cystectomy (RC), the clinical efficacy of their association remains unclear. Our objective is to analyze the possible benefits obtained from laparoscopic RC (LRC) and its subsequent combination with an ERAS (ERAS-LRC) protocol compared to open RC (ORC).Material and methodsWe analyzed 187 consecutive RCs with ileal conduit performed in our center, of which 139 met the inclusion criteria: 47 ORC, 39 LRC (both with conventional protocol) and 52 ERAS-LRCs.ResultsNo significant differences were found regarding age, sex, BMI and ASA score between groups. ERAS-LRC obtained a shorter length of stay than LRC and ORC (median 8 [7-10]) vs. 13 [10-17] vs. 15 [13-19.5] days, respectively; P<.001). ERAS-LRC had a shorter stay in the ICU and less days of nasogastric tube (P<.001). Postoperative complications and readmission rates were similar among groups. Multivariate logistic regression showed that absence of complications, younger age and ERAS behaved as independent factors for shorter hospital stay, while ERAS was the only independent factor of lower readmission rate at 90 days.ConclusionsAlthough LRC presented perioperative benefits compared to ORC, the results were better after the implementation of an ERAS protocol. ERAS protocol had stronger impact on recovery than the surgical approach of the procedure. (AU)

Curative radiation therapy for very elderly bladder cancer patients with localized disease

Purpose: To report the outcomes of a cohort of very elderly muscle-invasive bladder cancer (MIBC) patients treated with contemporary 3D-conformal radiation therapy (3D-CRT) with or without concurrent chemotherapy, after transurethral resection of bladder tumor (TURBT). Methods: From February 2010 to January 2014, a total of 41 patients older than 75 years, with T2-3 N0-1 high-grade MIBC, a Karnofsky index (KI) of at least 90% and/or a Barthel scale score of at least 95, were treated with TURBT followed by radiotherapy (RT) with or without chemotherapy, and were prospectively followed-up. Results: The mean age of patients was 82 years (range 76-88). Median follow-up was 47 months for surviving patients. Mean Charlson Comorbidity Index (CCI) score was 5 points. 28 patients (68.29%) were T2N0. All received 3D-CRT to a mean dose of 60 Gy (range 48.6-66 Gy), and chemotherapy was delivered to 34 patients (83%). Cause-specific survival (CSS) was 86 and 78.8% at 1 and 5 years, respectively. Patients achieving a complete response lived longer (48 vs 14 m, p = 0.036) than those with a progressive disease, who were more likely to die from cancer than from other causes (HR 3.865, IC95% 1.562-9.562). Dead patients had a longest treatment time (mean 56.78 vs 48.91 days, p = 0.019) than survivors. Conclusion: RT with contemporary 3D-CRT techniques after TURBT for MIBC in elderly patients is feasible and well-tolerated. Achieving a maximal response and shortening the total radiation treatment time may improve outcomes and quality of life

No disponible

Extravasation of oxaliplatin: an infrequent and irritant toxicity

Oxaliplatin has been classified as an irritant drug. Less than 10 cases of oxaliplatin extravasation through a central venous access have been described to date. We present a case of extravasation through a central venous access, of the highest dose (165 mg) of oxaliplatin reported to date. We confirmed the irritant effect, and full recovery from toxicity was achieved. We describe the treatment administered and offer a review of literature (AU)

No disponible