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Background: Abdominoperineal resection is the standard curative surgical technique for locally advanced adenocarcinoma of the lower rectum and squamous cell carcinoma of the anal canal after chemoradiotherapy. However, it requires a definitive abdominal colostomy that modifies the body appearance., Objective: The study aim was to evaluate the combination of abdominoperineal resection with perineal colostomy reconstruction and Malone antegrade continence enema., Design: This was a retrospective study., Settings: The study was conducted at the Toulouse Hospital Digestive Surgery Department., Patients: All of the patients with advanced adenocarcinoma or squamous cell carcinoma who underwent abdominoperineal resection with perineal colostomy reconstruction and Malone antegrade continence enema (n = 80) between December 1999 and December 2016 were included., Main Outcome Measures: The main outcome was the 5-year overall survival rate., Results: The 5-year overall survival was 74.89% (95% CI, 62.91%-83.50%), and the median recurrence-free survival was 107.6 months (95% CI, 65.1-198.1 mo). The median follow-up was 91.0 months (95% CI, 70.4-116.6 mo). R0 resection was obtained in 64 patients (80.0%). The median Cleveland Clinic Incontinence Score (to assess the functional outcomes) was 9.0 (interquartile range, 1.0-18.0), and it was lower in patients with advanced adenocarcinoma than with squamous cell carcinoma (7.0 (interquartile range, 2.0-18.0) vs 11.0 (interquartile range, 1.0-17.0); p = 0.01). Eleven patients (13.8%) reported perineal stains during the night, and 19 patients (23.8%) needed drugs to reduce colon motility. The rate of severe complications (Clavien-Dindo >II) was 11.7% (n = 9). Definitive colostomy was performed in 15 patients (18.8%)., Limitations: This retrospective study included a small number of patients from a single center. Moreover, the functional outcome was tested with self-report questionnaires (risk of response bias)., Conclusions: This study suggests that abdominoperineal resection associated with perineal reconstruction by perineal colostomy and Malone antegrade continence enema is safe and may improve patient quality of life. See Video Abstract at http://links.lww.com/DCR/B629., Resultados Oncolgicos Y Funcionales De La Reconstruccin Plviperineal Mediante Colostoma Perineal Y Procedimiento De Malone Despus De La Reseccin Abdominoperineal: ANTECEDENTES:La resección abdominoperineal es la técnica quirúrgica curativa estándar para el tratamiento del adenocarcinoma localmente avanzado del recto inferior y el carcinoma a células escamosas del canal anal, después de radio-quimioterapia. Sin embargo, requiere una colostomía abdominal definitiva que modifica la apariencia corporal.OBJETIVO:El propósito del presente estudio fue el evaluar la combinación de la resección abdominoperineal con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone.DISEÑO:Estudio retrospectivo.AJUSTES:Servicio de Cirugía Digestiva del Hospital de Toulouse, Francia.PACIENTES:Se incluyeron todos los pacientes con adenocarcinoma avanzado o carcinoma de células escamosas que se sometieron a resección abdominoperineal con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone (n = 80) entre diciembre de 1999 y diciembre de 2016.PRINCIPALES MEDIDAS DE RESULTADO:El principal resultado fue la tasa de sobrevida global a 5 años.RESULTADOS:La sobrevida global a 5 años fue de 74,89% (IC del 95%, 62,91 a 83,50) y la mediana de supervivencia libre de recurrencia fue de 107,6 meses (IC del 95%, 65,1 a 198,1). La mediana de seguimiento fue de 91,0 meses (IC del 95%, 70,4-116,6). La resección R0 se obtuvo en 64 pacientes (80,0%). La mediana de puntuación de la escala de incontinencia de la Cleveland Clinic (para evaluar los resultados funcionales) fue de 9,0 [1,0; 18,0], y fue menor en pacientes con adenocarcinoma avanzado que con carcinoma de células escamosas (7,0 [2,0; 18,0] versus 11,0 [1,0; 17,0]; p = 0,01). Once pacientes (13,8%) refirieron manchado perineal nocurno y 19 pacientes (23,8%) necesitaron fármacos para reducir la motilidad del colon. La tasa de complicaciones graves (Clavien-Dindo > II) fue del 11,7% (n = 9). Se realizó colostomía definitiva en 15 (18,8%) pacientes.LIMITACIONES:Este estudio retrospectivo incluyó un pequeño número de pacientes y de un solo centro. Además, el resultado funcional se probó con cuestionarios de autoinforme (riesgo de sesgo de respuesta).CONCLUSIONES:Este estudio sugiere que la resección abdominoperineal asociada con la confección de una colostomía perineal asociada a enemas de continencia anterógrada según Malone es segura y puede mejorar la calidad de vida de los pacientes. Consulte Video Resumen en http://links.lww.com/DCR/B629., (Copyright © The ASCRS 2021.)

Background: Concern for cardiovascular disease (particularly atrial fibrillation-AF) among women with breast cancer is becoming a major issue. We aimed at determining the incidence of cardiovascular disease events (AF, arterial and cardiac events, venous-thromboembolism-VTE) in patients diagnosed with breast cancer, and assessing potential risk factors., Methods: We reviewed medical records of all patients diagnosed with breast cancer from 2010 to 2011 in our cancer center. Baseline characteristics of patients and tumors were collected. The main outcome was the occurrence of cardiovascular disease events (AF, VTE, arterial and cardiac events) during the 5-years follow-up., Results: Among the 682 breast cancer patients, 22 (3.2%) patients had a history of atrial fibrillation. Thirty-four patients (5%) presented at least one cardiovascular disease event, leading to a cumulative incidence of 5.8% events at 5-years ([3.8-7.7] CI 95%), with most of them occurring in the first 2 years. AF cumulative incidence was 1.1% ([0.1-2.1] CI 95%). Factors associated with the occurrence of cardiovascular disease events (including AF) were an overexpression of HER-2 (HR 2.6 [1.21-5.56] p < 0.011), UICC-stage III tumors or more (HR 5.47 [2.78-10.76] p < 0.001) and pre-existing cardiovascular risk factors (HR 2.91 [1.36-6.23] p < 0.004)., Conclusion: The incidence of cardiovascular disease events was 5.8% ([3.8-7.7] CI 95%), with HER-2 over-expression, UICC-stage III tumors or more and pre-existing cardiovascular diseases being associated with them. These findings call for the development of preventive strategies in patients diagnosed with breast cancer.

Radiotherapy associated with cetuximab (Cet-RT) is an alternative treatment to platinum-based chemoradiotherapy in locally advanced head and neck carcinoma (LAHNC). Reviews suggest that the use of cetuximab is associated with poorer tolerance in patients unfit for chemotherapy than in pivotal trial. We retrospectively studied patients first treated by Cet-RT for LAHNC presenting contraindications to chemoradiotherapy. Objectives were treated population description, acute tolerance, progression-free survival (PFS), overall survival (OS), and 3-month clinical response. Eighty-eight patients were included. Treatment was completed without delay for 43 patients. Grade 3-4 acute toxicity was described in 44.3%: mucositis (n = 20), radiodermatitis (n = 25) folliculitis (n = 10), and anaphylaxis (n = 6). Fourteen patients died during treatment. Median PFS and OS were 6.3 and 18.7 months, respectively. We confirm that Cet-RT tolerance in unfit patients is poorer than that in trials. Survival data illustrate patients' frailty and suggest that balanced use of Cet-RT is required in this population.

Background and Purpose: Primary rectal squamous cell carcinoma (SCC) is an uncommon disease. Early reports stated that surgery is the most effective treatment. However, recent publications suggest conservative strategy with chemoradiation provides satisfactory results., Patients and Methods: We have retrospectively studied the medical charts of 23 patients treated for a rectal SCC in two teaching hospitals in France between 1992 and 2013. Twenty-one patients received an exclusive chemoradiotherapy (CRT) and two a pre-operative CRT followed by a planned surgery. Patients received pelvic irradiation with a dose ranging from 36-45 Gy followed by a boost of 15-23 Gy. Twenty-two patients received a concurrent chemotherapy., Results: After CRT, the rate of clinical complete response was 83%. With a median follow-up of 85 months, 5-year overall survival rate was 86%. Five patients presented with a relapse. The 5-year disease-free survival rate was 81%. The 5-year colostomy-free survival rate was 65%. Three patients (13%) presented with grade III-IV late rectal toxicity., Conclusions: Although retrospective, this is the largest cohort of patients treated with CRT for a rectal SCC. Exclusive CRT could result in high local control rate and prolonged survival in rectal SCC patients with a high rate of organ preservation., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Background: To determine efficacy and toxicity of radiation therapy combined with oxaliplatin, 5-fluorouracil, and folinic acid (FOLFOX) and cetuximab in patients with locally advanced oesophageal cancer., Patients and Methods: Patients with stage III oesophageal or gastro-oesophageal junction cancer were enrolled in a Simon's two-stage phase II study. Patients received FOLFOX and weekly cetuximab on week 1-10 with concurrent radiotherapy (50.4 Gy in 30 fractions) on week 5-10. Primary end-point was clinical overall response rate (ORR). An ORR rate of more than 50% was expected., Results: Among the 79 included patients, clinical ORR was 77% with 40% complete responses. Median overall survival and progression-free survival were 21.6 and 11.3 months, respectively. The most common grade III-IV toxicities observed during experimental chemoimmunotherapy followed by chemoradiation included neutropenia (28%), oesophagitis (12%), rash (11%), and allergy (9%). There was one treatment-related death due to oesophagitis with gastrointestinal bleeding., Conclusions: Cetuximab-FOLFOX regimen combined with radiotherapy demonstrated its efficacy and was well tolerated. Unfortunately, these results were not confirmed in two recent phase III studies., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Purpose/objectives: To assess feasibility and toxicity of Helical TomoTherapy for treating anal cancer patients., Methods: From 2007 to 2011, 64 patients were consecutively treated with TomoTherapy in three centres for locally advanced squamous-cell anal carcinoma (T2 > 4 cm or N positive). Prescribed doses were 45 Gy to the pelvis including inguinal nodes and 59.4 Gy to the primary site and involved nodes with fractions of 1.8 Gy, five days a week. A positional Megavoltage Computed Tomography was performed before each treatment session. All acute and late toxicities were graded according to Common Terminology Criteria for Adverse Events version 3.0. Survival analysis was performed using the Kaplan-Meier method., Results: Median follow-up was 22.9 months. Fifty-four women and 10 men were treated (median age: 62 years). Nineteen patients (29.7%) had T2, 16 patients (25.0%) T3, and 27 patients (42.2%) T4 tumours. Thirty-nine patients (60.9%) had nodal involvement. Median tumour size was 45 mm (range, 10-110 mm). Seven patients had a colostomy before treatment initiation. Fifty-seven patients received concomitant chemotherapy (5-FU/cisplatin or 5-FU/mitomycin-based therapy). Forty-seven patients (73.4 %) experienced a complete response, 13 a partial response or local recurrence, and 11 had salvage surgery; among these, six became complete responders, three experienced metastatic failure, and two local failure. At least four patients experienced metastatic recurrence (concomitant to a local failure for one patient). The two-year overall survival was 85.6% (95 %CI [71.1%-93.0%]), and the one-year disease-free survival, and colostomy-free survival were 68.7% (95 %CI [54.4%-79.4]), and 75.5% (95 %CI [60.7%-85.3%]) respectively. Overall survival, disease-free survival and colostomy free-survival were significantly better for women than men (p = 0.002, p = 0.004, and p = 0.002 respectively). Acute grade ≥3 toxicity included dermatologic (46.9% of patients), gastrointestinal (20.3%), and hematologic (17.2%) toxicity. Acute grade 4 hematologic toxicity occurred in one patient. No grade 5 event was observed., Conclusions: TomoTherapy for locally advanced anal cancer is feasible. In our three centres of expertise, this technique appeared to produce few acute gastrointestinal toxicities. However, high rates of dermatologic toxicity were observed. The therapeutic efficacy was within the range of expectations and similar to previous studies in accordance with the high rates of locally advanced tumours and nodal involvement.

Background: This phase I study evaluated the safety and efficacy of the oral mTOR inhibitor everolimus in combination with thoracic radiotherapy followed by consolidation chemotherapy in locally advanced or oligometastatic untreated non-small-cell lung cancer (NSCLC)., Patients and Methods: Everolimus dose was escalated in incremental steps [sequential cohorts of three patients until the occurrence of dose-limiting toxicity (DLT)] and administered orally weekly (weekly group: dose of 10, 20 or 50 mg) or daily (daily group: 2.5, 5 or 10 mg), 1 week before, and during radiotherapy until 3.5 weeks after the end of radiotherapy. Two cycles of chemotherapy (cisplatin-navelbine) were administrated 4.5 weeks after the end of radiotherapy., Results: Twenty-six patients were included in two centers, 56% had adenocarcinoma and 84% had stage III disease. In the weekly group (12 assessable patients), everolimus could be administered safely up to the maximum planned weekly dose of 50 mg; however, one patient experienced a DLT of interstitial pneumonitis at the weekly dose level of 20 mg. In the daily group (9 assessable patients): one DLT of interstitial pneumonitis with a fatal outcome was observed at the daily dose level of 2.5 mg; two other DLTs (one grade 3 esophagitis and one bilateral interstitial pneumonitis) were found at the daily dose level of 5 mg. Overall there were five patients with G3-4 interstitial pneumonitis related to treatment. Among 22 assessable patients for response, there were 9 (41%) partial response and 7 (32%) stable disease. At a median follow-up of 29 months, the 2-year overall survival and progression-free survival actuarial rates were 31% and 12%, respectively., Conclusion: In previously untreated and unselected NSCLC patients, the recommended phase II dose of everolimus in combination with thoracic radiotherapy is 50 mg/week. Pulmonary toxicity is of concern and should be carefully monitored to establish the potential role of mTOR inhibitor with concomitant radiotherapy., Eudract N: 2007-001698-27., (© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Purpose: To analyze the efficacy, toxicity, and pattern of relapse after adjuvant cisplatin-based chemotherapy followed by three-dimensional irradiation and concomitant LV5FU2 chemotherapy (high-dose leucovorin and 5-fluorouracil bolus plus continuous infusion) in the treatment of completely resected high-risk gastric cancer., Methods and Materials: This was a retrospective analysis of 52 patients with high-risk gastric cancer initially treated by total/partial gastrectomy and lymphadenectomy between January 2002 and June 2007. Median age was 54 years (range, 36-75 years). Postoperative treatment consisted of 5-fluorouracil and cisplatin chemotherapy. Adjuvant chemotherapy was followed by three-dimensional conformal radiotherapy in the tumor bed and regional lymph nodes at 4500 cGy/25 fractions in association with concomitant chemotherapy. Concomitant chemotherapy consisted of a 2-h infusion of leucovorin (200 mg/m²) followed by a bolus of 5-fluorouracil (400 mg/m²) and then a 44-h continuous infusion of 5-fluorouracil (2400-3600 mg/m²) given every 14 days, for three cycles (LV5FU2 protocol)., Results: Five-year overall and disease-free survival were 50% and 48%, respectively. Distant metastases and peritoneal spread were the most frequent sites of relapse (37% each). After multivariate analysis, only pathologic nodal status was significantly associated with disease-free and overall survival. Acute toxicities were essentially gastrointestinal and hematologic. One myocardial infarction and one pulmonary embolism were also reported. Eighteen patients had a radiotherapy program interruption because of acute toxicity. All patients but 2 have completed radiotherapy., Conclusion: Postoperative cisplatin-based chemotherapy followed by conformal radiotherapy in association with concurrent 5-fluorouracil seemed to be feasible and resulted in successful locoregional control., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Introduction: This study aimed to assess the impact of late treatment toxicity (especially radiotherapy toxicity), chemoradiotherapy treatment type (concurrent or sequential), depression and anxiety on overall, physical and emotional quality of life (QoL) in long-term breast cancer survivors. Method. We assessed 117 patients (mean follow-up since the end of treatment = 8.1 years) for late radiotherapy toxicity (LENT-SOMA scale), patient and doctor ratings of breast cosmetic outcomes, QoL (EORTC QLQ-C30), depression and anxiety (Hospital and Anxiety Depression scale)., Results: In univariate analyses, factors associated with significantly decreased QoL were: use of sequential treatment and decreased overall QoL (P = 0.002) and emotional QoL (P = 0.02) ; few radiotherapy late toxicity symptoms (pain and decreased physical QoL, P = 0.01 ; fibrosis and decreased emotional QoL, P = 0.04) ; probable depression or probable anxiety and decreased overall, physical and emotional QoL (P ≤ 0.005). In multivariate analyses, probable depression and probable anxiety were the most stronger predictors for decreased QoL in the overall, physical and emotional domains (P ≤ 0.02)., Conclusion: Improving screening for and treatment of depression and anxiety might improve QoL in long-term breast cancer survivors.