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PURPOSE: Sensory chemotherapy-induced peripheral neuropathy (CIPN) is well-recognized, but motor CIPN remains understudied. This secondary analysis focused on the long-term severity and impact of motor disorders, their relation to sensory CIPN, neuropathic pain, psychological distress, and health-related quality of life (HRQoL) after oxaliplatin-based chemotherapy in colorectal cancer (CRC) survivors. METHODS: Data from a multicenter, cross-sectional study were re-analyzed to explore motor CIPN among CRC survivors up to 5 years post-chemotherapy, with no longitudinal follow-up. Questionnaires assessed sensory and motor CIPN (QLQ-CIPN20), neuropathic pain (DN4), anxiety and depression (HADS), and HRQoL (QLQ-C30). RESULTS: Among 405 CRC survivors, 31.1% had sensory CIPN as previously described. When categorizing the 405 CRC survivors based on the years since their last oxaliplatin-based chemotherapy, the motor scores derived from the QLQ-CIPN20 showed no significant difference between years (p = 0.08). Motor CIPN scores correlated with female gender, higher oxaliplatin dose intensity, sensory CIPN, and neuropathic pain. Motor CIPN also linked to decreased HRQoL and increased psychological distress. CONCLUSION: The study underscores the detrimental impact of motor disorders on CRC survivors post-oxaliplatin-based chemotherapy. Oncologists should prioritize assessing and managing motor manifestations alongside sensory symptoms to enhance post-cancer quality of life. TRIAL REGISTRATION: NCT02970526 (2016-11-22). https://classic. CLINICALTRIALS: gov/ct2/show/NCT02970526?term=NCT02970526&draw=2&rank=1 .
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Antineoplásicos , Neoplasias Colorrectales , Oxaliplatino , Enfermedades del Sistema Nervioso Periférico , Calidad de Vida , Humanos , Oxaliplatino/efectos adversos , Masculino , Femenino , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Persona de Mediana Edad , Estudios Transversales , Anciano , Neoplasias Colorrectales/tratamiento farmacológico , Antineoplásicos/efectos adversos , Encuestas y Cuestionarios , Índice de Severidad de la Enfermedad , Trastornos Motores/inducido químicamente , Neuralgia/inducido químicamente , Adulto , Supervivientes de Cáncer/psicologíaRESUMEN
BACKGROUND: Defunctioning stoma (DS) can decrease the rate of symptomatic anastomotic leakage (AL). Since 2010, we have used tailored, highly selective DS management for low colorectal anastomosis (LCRA). METHODS: In total, 433 rectal cancer patients underwent the same standardized procedure. Non-stoma (NS) management was used in patients with no surgical difficulties as well as good colonic preparation and quality of anastomoses. In all other cases, DS was used. C-reactive protein was measured during postoperative follow-up. Imbalance in the initial population was adjusted using propensity-score matching according to sex, age, body mass index, tumor location, and American Society of Anesthesiologists score. Rate of AL within 30 days, 5-year overall survival, local relapse-free survival, and disease-free survival were recorded. RESULTS: Anastomosis was mostly ultra-low and was performed equally by laparoscopy or robotic surgery. The overall rate of AL was 13.4%, with no significant differences between groups (DS, 12.2%; NS, 14.6%; p = 0.575). Operative time, blood loss, and hospital stay were significantly lower for NS patients. The rate of secondary stoma was 11.4% overall. Pathological results were similar, with a 98% R0 resection rate. With a median follow-up of 5.5 years for the NS and DS groups, the overall survival was 84.9% and 73.4%, respectively (p = 0.064), disease-free survival was 67.0% and 55.8%, respectively (p = 0.095), and local relapse-free survival was 95.2% and 88.7%, respectively (p = 0.084). The long-term, stoma-free rate was 89.1% overall. CONCLUSIONS: Tailoring DS for LCRA seems safe and could provide potential benefits in postoperative morbidity with the same long-term oncological results in NS patients. Prospective, multicentric studies should validate this approach.
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Neoplasias del Recto , Recto , Anastomosis Quirúrgica/efectos adversos , Anastomosis Quirúrgica/métodos , Fuga Anastomótica/epidemiología , Fuga Anastomótica/etiología , Estudios de Seguimiento , Humanos , Estudios Prospectivos , Neoplasias del Recto/patología , Recto/patología , Recto/cirugía , Estudios RetrospectivosRESUMEN
AIM OF THE STUDY: To review and to analyse the feasibility of using no urinary catheter or a catheter for less than 24 h compared with longer post-operative catheter after colorectal surgery with infraperitoneal dissection. METHODS: We performed a systematic review and meta-analysis of studies comparing no urinary catheter or a catheter for less than 24 h (early removal, ER) and urinary catheter drainage for 2 days or longer (late removal, LR) after colorectal surgery with infraperitoneal dissection. Primary endpoint was acute urinary retention (AUR) requiring a re-catheterization. Secondary endpoints were urinary tract infection (UTI), overall morbidity and hospital length of stay. Meta-analysis met the PRISMA criteria, with a random model. RESULTS: Out of 3659 articles found, 82 comparative studies on catheter duration were selected, of which five were in colorectal surgery: three randomized trials, one retrospective and one prospective series. There were 396 ER and 410 LR patients. All had undergone surgery with infraperitoneal dissection. There was no significant difference regarding AUR (OR = 2.09 [95%CI 0.97-4.52]) but significantly less UTI (OR = 0.39 [95%CI 0.22-0.67]) for early urinary catheter removal. The number needed to harm was much higher for AUR than for UTI (23.3 vs. 8). CONCLUSION: This meta-analysis suggests that, in terms of benefit/risk ratio, in colorectal surgery with infraperitoneal anastomosis, early removal (< 24 h) of the urinary catheter would be beneficial (because of a more frequent UTI after LR than AUR after ER) and would reduce the occurrence of UTI if no AUR risk factors are present. However, these findings should be interpreted with caution because of the low quality of evidence.
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Cirugía Colorrectal , Infecciones Urinarias , Anastomosis Quirúrgica/efectos adversos , Catéteres de Permanencia , Remoción de Dispositivos , Humanos , Estudios Prospectivos , Estudios Retrospectivos , Factores de Tiempo , Cateterismo Urinario , Catéteres Urinarios/efectos adversos , Infecciones Urinarias/epidemiología , Infecciones Urinarias/etiología , Infecciones Urinarias/prevención & controlRESUMEN
PURPOSE: Bortezomib is a neurotoxic drug used in multiple myeloma and responsible for chemotherapy-induced peripheral neuropathy (CIPN). In a previous cross-sectional study, CIPN prevalence was about 26.9% in 67 patients. A second data analysis was performed to explore the relation between CIPN and auditory difficulties. METHODS: Based on 66 multiple myeloma patients from a single center, auditory difficulties were assessed with a self-questionnaire and compared to sensory CIPN (QLQ-CIPN20 questionnaire), patients' characteristics and anticancer treatments. RESULTS: The prevalence of auditory difficulties was about 42.4% (95% CI [30.6-55.2]) of the 66 patients analyzed and was higher in patients with CIPN than without (82.4% vs. 28.6%, p < 0.001). Auditory difficulties were not related to the characteristics of patients and treatments. The severity of auditory difficulties were correlated to CIPN severity (spearman's coefficient: 0.49, p = 0.009). Odds-ratio of auditory difficulties (multivariable analysis adjusted for sensory CIPN, recreation or professional noise exposure, gender, age, and treatments) was significantly associated with CIPN (18.7, 95% CI [3.0-117.1], p = 0.002). CONCLUSION: This relation between CIPN and auditory difficulties raises concerns about hearing safety in multiple myeloma patients treated by bortezomib. TRIAL REGISTRATION NUMBER: NCT03344328.
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Antineoplásicos , Mieloma Múltiple , Enfermedades del Sistema Nervioso Periférico , Antineoplásicos/efectos adversos , Bortezomib/efectos adversos , Estudios Transversales , Humanos , Mieloma Múltiple/inducido químicamente , Mieloma Múltiple/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/epidemiología , Calidad de VidaRESUMEN
PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is challenging for oncologists. Many publications mention the high incidence of CIPN and the lack of effective preventive/management strategies and robust diagnostic tools. This cross-sectional study was aimed at assessing the practice of French oncologists for CIPN prevention, diagnosis and management. METHODS: This web-based survey was sent to French oncologists by the regional cancer networks. Incidence and impact of CIPN were assessed using visual analogue scales (VAS) and diagnostic strategies were recorded. Also recorded were the drugs used to prevent or manage CIPN and their perceived efficacy and safety (VAS). RESULTS: Among the 210 oncologists included, the perceived incidence of CIPN was about 36.2 ± 22.1% of patients. About 99.5% of oncologists declared that they assess CIPN during medical follow-up. The use of drugs to prevent CIPN was reported by 9.6% of oncologists (group B vitamins (35.0%) and calcium and magnesium infusion (25.0%)). In the case of CIPN, the therapeutic adjustment of neurotoxic anticancer drugs is performed by 99.0% of oncologists (chemotherapy change (49.8%), dose reduction (30.9%) or interruption (19.3%)). The pharmacological management of CIPN was declared by 72.9% of oncologists. The main drugs used are pregabalin (75.8%), amitriptyline (32.7%) and gabapentin (25.5%). Duloxetine (ASCO recommendation) is used by only 11.8% of oncologists. CONCLUSION: Oncologists were clearly aware of CIPN risks, but its incidence tended to be underestimated and the ASCO recommendations for the management of CIPN were not followed. The prevention, diagnosis and management of CIPN remain problematic in clinical practice in France. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03854864.
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Antineoplásicos/efectos adversos , Síndromes de Neurotoxicidad/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Pautas de la Práctica en Medicina , Adulto , Amitriptilina/uso terapéutico , Calcio/uso terapéutico , Estudios Transversales , Clorhidrato de Duloxetina/uso terapéutico , Francia , Gabapentina/uso terapéutico , Humanos , Magnesio/uso terapéutico , Masculino , Persona de Mediana Edad , Oncólogos , Enfermedades del Sistema Nervioso Periférico/diagnóstico , Enfermedades del Sistema Nervioso Periférico/prevención & control , Pregabalina/uso terapéutico , Encuestas y Cuestionarios , Vitaminas/uso terapéuticoRESUMEN
Several low-impact laparoscopic strategies have been developed to improve the safety of pneumoperitoneum. We conducted a systematic review to establish the current evidence base for the use of the AIRSEAL® insufflation device for low-pressure pneumoperitoneum in laparoscopic surgery. We searched the literature using several electronic databases, for studies with comparative design published in the English language from January 2010 to April 2020. The population of interest included patients with any type of health condition who underwent laparoscopic surgery using the AIRSEAL® insufflation system or a standard CO2 insufflator. Ten studies (four randomized clinical trials/six non-randomized clinical trials), that enrolled 1394 participants in total who underwent urology, gynaecology or abdominal surgeries, were included. Total complication rates were similar between groups. Only three studies evaluated the impact of the insufflation system on post-operative pain, and showed inconsistent benefit of AIRSEAL® (significant decrease in pain in two studies, no difference in one). The same was observed in the two sole studies in which pain killers consumption was measured (significant decrease in morphine consumption 24 h after surgery in one study, no difference in the other). Operative duration was significantly shorter with AIRSEAL® in three studies. For both post-operative room and total length of stay, there was no difference between groups. No studies reported economic outcomes. Current literature supports the feasibility of the AIRSEAL® system during laparoscopic surgery but more studies are required to establish the added clinical benefit and to explore the preferences of physicians and patients.
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Insuflación , Laparoscopía , Dióxido de Carbono , Humanos , Dolor Postoperatorio/prevención & control , Neumoperitoneo ArtificialRESUMEN
BACKGROUND: Laparoscopic right colectomy (LRC) has become a gold standard. However, a major current concern is still whether anastomosis should be performed extracorporeally or entirely laparoscopically. This meta-analysis assesses and compares peri- and postoperative outcomes of intracorporeal anastomosis (IA) versus extracorporeal anastomosis (EA) in LRC. METHODS: The research used the PubMed, Embase and Cochrane databases for studies comparing IA with EA during LRC. Our main endpoint was parietal abscess. Secondary endpoints were 30-day morbidity, mortality, time to onset of gas and stools, length of stay, number of lymph nodes removed and postoperative incisional hernia rates. The MINORS criteria were used to evaluate the quality of the studies examined. RESULTS: Twenty-four articles comprising 3699 patients, published between 2004 and 2020, were included in this meta-analysis. After sensitivity analysis, IA was associated with a decrease in parietal abscesses (OR 0.526, IC 0.333-0.832, p = 0.006). CONCLUSION: This meta-analysis finds that IA allows a decrease in parietal abscesses and time to first gas and stools, surgical repair and length of stay, with similar overall complications.
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Hernia Incisional , Laparoscopía , Anastomosis Quirúrgica/efectos adversos , Colectomía , Humanos , Laparoscopía/efectos adversos , Complicaciones Posoperatorias/etiología , Periodo Posoperatorio , Resultado del TratamientoRESUMEN
INTRODUCTION: The COVID-19 pandemic is having a deep impact on our surgical practice and scientific publishing output. METHODS: The 100 best-ranked "surgery journals" were selected. The contents of the March, April, May, and June 2020 issues and ahead-of-print articles were screened. The retrieved articles on COVID-19 were separated into two categories: "opinion articles" and "scientific articles," i.e., randomized trials and original articles with structured methods and results. The number of COVID articles published in the TOP-10 journals was compared with that of COVID articles published elsewhere. RESULTS: There were 59 COVID original articles (8%). The great majority of articles were opinion articles (83.4%). Almost 40% of COVID articles were published in the TOP-10 journals. CONCLUSION: Original COVID articles (the core of our knowledge) are scant. Faced with a novel disease, neither the authors nor the editors should be criticized regarding this situation. The future step should be to publish high-quality papers in the setting of a major health crisis.
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Betacoronavirus , Bibliometría , Infecciones por Coronavirus , Exactitud de los Datos , Pandemias , Neumonía Viral , Actitud , COVID-19 , Humanos , SARS-CoV-2RESUMEN
BACKGROUND: Enhanced recovery programs (ERPs) are associated with a lower morbidity rate and a shorter length of stay. The present study's objective was to determine whether an ERP is feasible and effective for patients undergoing early cholecystectomy for grade I or II acute calculous cholecystitis. STUDY DESIGN: A 2-step multicenter study was performed. In the first step (the feasibility study), patients were consecutively included in a dedicated, prospective database from March 2019 until January 2020. The primary endpoint was the ERP's feasibility, evaluated in terms of the number and nature of the ERP components applied. During the second step, the ERP's effectiveness in acute calculous cholecystitis was evaluated in a case-control study. The ERP+ group comprised consecutive patients who were prospectively included from March 2019 to November 2020 and compared with a control (ERP-) group of patients extracted from the ABCAL randomized controlled trial treated between May 2010 and August 2012 and who had not participated in a dedicated ERP. RESULTS: During the feasibility study, 101 consecutive patients entered the ERP with 17 of the 20 ERP components applied. During the effectiveness study, 209 patients (ERP+ group) were compared with 414 patients (ERP- group). The median length of stay was significantly shorter in the ERP+ group (3.1 vs 5 days; p < 0.001). There were no intergroup differences in the severe morbidity rate, mortality rate, readmission rate, and reoperation rate. CONCLUSIONS: Implementation of an ERP after early cholecystectomy for acute calculous cholecystitis appeared to be feasible, effective, and safe for patients. The ERP significantly decreased the length of stay and did not increase the morbidity rate.
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Colecistectomía Laparoscópica , Colecistitis Aguda , Estudios de Casos y Controles , Colecistectomía , Colecistitis Aguda/cirugía , Estudios de Factibilidad , Humanos , Tiempo de Internación , Resultado del TratamientoRESUMEN
BACKGROUND: Donepezil, a cholinesterase inhibitor approved in Alzheimer's disease, has demonstrated analgesic and preventive effects in animal models of oxaliplatin-induced neuropathy. To improve the clinical interest of donepezil for the management and prevention of chemotherapy-induced peripheral neuropathy (CIPN), a broader validation is required in different animal models of CIPN. METHODS: using rat models of CIPN (bortezomib, paclitaxel, and vincristine), the analgesic and preventive efficacies of donepezil were evaluated on tactile, cold and heat hypersensitivities. The involvement of muscarinic M2 acetylcholine receptors (m2AChRs) in analgesic effects was investigated at the spinal level. The absence of interference of donepezil with the cytotoxic effect of chemotherapy has been controlled in cancer cell lines. RESULTS: the analgesic efficacy of donepezil was demonstrated for all CIPN models, mainly on tactile hypersensitivity (maximal efficacy at 60 min, p < 0.05 vs. vehicle group). This effect was suppressed by an intrathecal injection of methoctramine (m2AChR antagonist). Regarding preventive effects, donepezil limited tactile hypersensitivity induced by paclitaxel, but not for other CIPN models. Donepezil did not modify the viability of cancer cells or the efficacy of anticancer drugs. CONCLUSIONS: donepezil had a broad analgesic effect on animal models of CIPN and this effect involved spinal m2AChRs. This work validates the repositioning of donepezil in the management of CIPN.
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Antineoplásicos , Leucemia Mieloide Aguda , Enfermedades del Sistema Nervioso Periférico , Acetilcolina , Analgésicos/efectos adversos , Animales , Antineoplásicos/toxicidad , Inhibidores de la Colinesterasa/farmacología , Inhibidores de la Colinesterasa/uso terapéutico , Donepezilo , Modelos Animales , Paclitaxel/efectos adversos , Enfermedades del Sistema Nervioso Periférico/inducido químicamente , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Enfermedades del Sistema Nervioso Periférico/prevención & control , Ratas , Receptor Muscarínico M2 , Receptores MuscarínicosRESUMEN
INTRODUCTION: Peripheral neuropathic pain is a disabling condition for patients and a challenge for physicians. Although many drugs have been assessed in scientific studies, few have demonstrated clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raises the question of the benefit-risk ratio when used in patients experiencing peripheral neuropathies. AREAS COVERED: We conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat peripheral neuropathic pain. This second review was focused on opioids, cannabinoids, and other medications. The aim was to provide an overview of the treatment-emergent adverse events (TEAEs) (≥10%) and the serious adverse effects described in clinical trials. EXPERT OPINION: Opioids and cannabinoids had significantly more TEAEs than placebos. Locally administered analgesics, such as capsaicin, lidocaine, botulinum toxin A seemed to have the most acceptable safety with only local adverse effects. The results for NMDA antagonists were inconclusive since no safety report was available. Less than half of the studies included presented a good description of TEAEs that included a statistical comparison versus a placebo group. Major methodological improvements must be made to ameliorate the assessment of medication safety in future clinical trials.
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Analgésicos Opioides/efectos adversos , Cannabinoides/efectos adversos , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Analgésicos/administración & dosificación , Analgésicos/efectos adversos , Analgésicos Opioides/administración & dosificación , Cannabinoides/administración & dosificación , Método Doble Ciego , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de InvestigaciónRESUMEN
Bortezomib is a pivotal drug for the management of multiple myeloma. However, bortezomib is a neurotoxic anticancer drug responsible for chemotherapy-induced peripheral neuropathy (CIPN). CIPN is associated with psychological distress and a decrease of health-related quality of life (HRQoL), but little is known regarding bortezomib-related CIPN. This single center, cross-sectional study assessed the prevalence and severity of sensory/motor CIPN, neuropathic pain and ongoing pain medications, anxiety, depression, and HRQoL, in multiple myeloma patients after the end of bortezomib treatment. Paper questionnaires were sent to patients to record the scores of sensory and motor CIPNs (QLQ-CIPN20), neuropathic pain (visual analogue scale and DN4 interview), anxiety and depression (HADS), the scores of HRQoL (QLQ-C30 and QLQ-MY20) and ongoing pain medications. Oncological data were recorded using chemotherapy prescription software and patient medical records. The prevalence of sensory CIPN was 26.9% (95% CI 16.7; 39.1) among the 67 patients analyzed and for a mean time of 2.9 ± 2.8 years since the last bortezomib administration. The proportion of sensory CIPN was higher among patients treated by intravenous and subcutaneous routes than intravenous or subcutaneous routes (p = 0.003). QLQ-CIPN20 motor scores were higher for patients with a sensory CIPN than those without (p < 0.001) and were correlated with the duration of treatment and the cumulative dose of bortezomib (coefficient: 0.31 and 0.24, p = 0.01 and 0.0475, respectively), but not sensory scores. Neuropathic pain was screened in 44.4% of patients with sensory CIPN and 66.7% of them had ongoing pain medications, but none were treated with duloxetine (recommended drug). Multivariable analysis revealed that thalidomide treatment (odds-ratio: 6.7, 95% CI 1.3; 35.5, p = 0.03) and both routes of bortezomib administration (odds-ratio: 13.4, 95% CI 1.3; 139.1, p = 0.03) were associated with sensory CIPN. Sensory and motor CIPNs were associated with anxiety, depression, and deterioration of HRQoL. Sensory CIPN was identified in a quarter of patients after bortezomib treatment and associated with psychological distress that was far from being treated optimally. There is a need to improve the management of patients with CIPN, which may include better training of oncologists regarding its diagnosis and pharmacological treatment.
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BACKGROUND: Not all benign-appearance polyps are amenable to endoscopic removal and colectomy is required in some cases. This study aims to compare the early outcomes of cecal wedge resection with ileocecal valve sparring versus standard right colectomy in patients with endoscopically unresectable cecal polyps referred for surgery. METHODS: From Apr 2010 to Aug 2019, all consecutive patients who underwent cecal wedge resection or right colectomy in ten European centers for a presumed endoscopically benign polyp unsuitable for endoscopic resection were retrospectively analyzed. The primary endpoint was morbidity. Secondary endpoints were operative time and length of hospital stay. RESULTS: One hundred and ten patients were included: 25 patients underwent cecal wedge resection and 85 a right colectomy. There were 56 men (51%) and 90% of the procedures were performed laparoscopically. 29 lesions were located at the appendix orifice (26.4%). Mortality was nil. There were no significant differences between both procedures for morbidity rate (20% versus 24.7%) or reoperation (4% versus 4.7%). Cecal wedge was related to shorter operative time (63 min versus 150 min, P = .008) and shorter hospital stay (5 days versus 6 days, P = .049). Only 1 patient had a salvage right colectomy after cecal wedge for a pTis adenoma. CONCLUSIONS: For benign-appearance cecal polyps unsuitable for endoscopic ablation, cecal wedge resection is safe and should be considered as an attractive alternative to right colectomy.
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Colectomía , Pólipos del Colon , Válvula Ileocecal , Laparoscopía , Anciano , Anciano de 80 o más Años , Ciego/cirugía , Pólipos del Colon/cirugía , Colonoscopía , Femenino , Humanos , Válvula Ileocecal/cirugía , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
BACKGROUND: A surveillance program was performed in colorectal cancer (CRC) patients after surgery, to diagnose asymptomatic recurrence. AIMS: To assess whether 18-FDG positron emission tomography/CT (PET/CT) improved the detection of recurrence during a 3-year follow-up. METHODS: A multicentre, two-arm randomised prospective trial comparing different 36-month follow-up strategies. Complete colonoscopy was performed at baseline and after 3 years and clinical exams with imaging every 3 months. The conventional arm (A) received carcinoembryonic antigen, liver echography, and alternated between lung radiography and computed tomography (CT) scans. The experimental arm (B) received PET/CT. RESULTS: A total of 365 patients with colon (79.4%) or rectal cancer (20.6%), stages II (48.2%) or III (50.8%), were enroled in this study. At 36 months, intention-to-treat analysis revealed recurrence in 31 (17.2%) patients in arm A and 47 (25.4%) in arm B (pâ¯=â¯0.063). At 3 years, 7 of 31 relapses (22.5%) in arm A were surgically treated with curative intent, compared to 17 of 47 (36.2%) in arm B (pâ¯=â¯0.25). The rates of recurrence and new cancers were higher in arm B than arm A (pâ¯=â¯0.038). CONCLUSIONS: PET/CT follow-up every 6 months did not increase the rate of recurrence at 3 years or the rate of surgically treated recurrence compared with conventional follow-up.
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Antígeno Carcinoembrionario/sangre , Neoplasias Colorrectales/diagnóstico por imagen , Fluorodesoxiglucosa F18 , Recurrencia Local de Neoplasia/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones/métodos , Adulto , Anciano , Anciano de 80 o más Años , Neoplasias Colorrectales/sangre , Neoplasias Colorrectales/cirugía , Femenino , Estudios de Seguimiento , Francia , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/epidemiología , Estudios ProspectivosRESUMEN
BACKGROUND: In non-metastatic colorectal cancer (CRC), we evaluated prospectively the pertinence of longitudinal detection and quantification of circulating tumor DNA (ctDNA) as a prognostic marker of recurrence. METHOD: The presence of ctDNA was assessed from plasma collected before and after surgery for 184 patients classified as stage II or III and at each visit during 3-4 years of follow-up. The ctDNA analysis was performed by droplet-based digital polymerase chain reaction, targeting mutation and methylation markers, blindly from the clinical outcomes. Multivariate analyses were adjusted on age, gender, stage, and adjuvant chemotherapy. RESULTS: Before surgery, 27.5% of patients were positive for ctDNA detection. The rate of recurrence was 32.7% and 11.6% in patients with or without detectable ctDNA respectively (P = 0.001). Time to recurrence (TTR) was significantly shorter in patients with detectable ctDNA before (adjusted hazard ratio [HR] = 3.58, 95% confidence interval [CI] 1.71-7.47) or immediately after surgery (adjusted HR = 3.22, 95% CI 1.32-7.89). The TTR was significantly shorter in patients with detectable ctDNA during the early postoperative follow-up (1-6 months) (adjusted HR = 5, 95% CI 1.9-12.9). Beyond this period, ctDNA remained a prognostic marker with a median anticipated diagnosis of recurrence of 13.1 weeks (interquartile range 28 weeks) when compared to imaging follow-up. The rate of ctDNA+ might be underestimated knowing that consensus pre-analytical conditions were not described at initiation of the study. CONCLUSION: This prospective study confirms the relevance of ctDNA as a recurrence risk factor in stage II and III CRC before surgery and as a marker of minimal residual disease after surgery that may predict recurrence several months before imaging techniques.
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Biomarcadores de Tumor/sangre , ADN Tumoral Circulante/sangre , Neoplasias Colorrectales/sangre , Neoplasias Colorrectales/patología , Recurrencia Local de Neoplasia/sangre , Adulto , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/patología , Pronóstico , Estudios ProspectivosRESUMEN
Oxaliplatin, a pivotal drug in the management of colorectal cancer, causes chemotherapy-induced peripheral neuropathy (CIPN) in a third of cancer survivors. Based on a previous cross-sectional study assessing oxaliplatin-related sensory CIPN in colorectal cancer survivors, a secondary analysis was designed to explore the possibility that different clusters of patients may co-exist among a cohort of patients with oxaliplatin-related CIPN. Other objectives were to characterize these clusters considering CIPN severity, anxiety, depression, health-related quality of life (HRQOL), patients' characteristics and oxaliplatin treatments. Among the 96 patients analyzed, three clusters were identified (cluster 1: 52, cluster 2: 34, and cluster 3: 10 patients). Clusters were significantly different according to CIPN severity and the proportion of neuropathic pain (cluster 1: low, cluster 2: intermediate, and cluster 3: high). Anxiety, depressive disorders and HRQOL alteration were lower in cluster 1 in comparison to clusters 2 and 3, but not different between clusters 2 and 3. This study underlines that patients with CIPN are not a homogenous group, and that CIPN severity is associated with psychological distress and a decline of HRQOL. Further studies are needed to explore the relation between clusters and CIPN management.
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INTRODUCTION: Peripheral neuropathic pain is a highly disabling condition for patients and a challenge for neurologists and pain physicians. Although many drugs have been assessed in scientific studies, few have demonstrated a clear clinical efficacy against neuropathic pain. Moreover, the paucity of data regarding their safety raised the question on the benefit-risk ratio when used in patients experiencing peripheral neuropathies. AREAS COVERED: The authors conducted a review of double-blind, placebo-controlled, randomized clinical trials to assess the safety of medications used to treat neuropathic pain. This first review was focused on antidepressant and antiepileptic medications. The aim was to provide an overview of the treatment-emergent adverse events (≥10%) and the serious adverse effects described in clinical trials. EXPERT OPINION: Among antiepileptics and antidepressants, duloxetine appeared to have the most detailed safety for the treatment of peripheral neuropathic pain. Over all studies, the most commonly reported adverse effects were dizziness, drowsiness, nausea, and constipation. Only 20.0% of the included studies (N = 90) presented a good description of adverse effects that included a statistical comparison vers usa placebo group. Important methodological improvements must be made to improve the assessment of medication safety in future clinical trials.
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Anticonvulsivantes/efectos adversos , Antidepresivos/efectos adversos , Enfermedades del Sistema Nervioso Periférico/tratamiento farmacológico , Anticonvulsivantes/administración & dosificación , Antidepresivos/administración & dosificación , Clorhidrato de Duloxetina/administración & dosificación , Clorhidrato de Duloxetina/efectos adversos , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
(1) Background: Oxaliplatin is among the most neurotoxic anticancer drugs. Little data are available on the long-term prevalence and consequences of chemotherapy-induced peripheral neuropathy (CIPN), even though the third largest population of cancer survivors is made up of survivors of colorectal cancer. (2) Methods: A multicenter, cross-sectional study was conducted in 16 French centers to assess the prevalence of CIPN, as well as its consequences (neuropathic pain, anxiety, depression, and quality of life) in cancer survivors during the 5 years after the end of adjuvant oxaliplatin chemotherapy. (3) Results: Out of 406 patients, the prevalence of CIPN was 31.3% (95% confidence interval: 26.8-36.0). Little improvement in CIPN was found over the 5 years, and 36.5% of patients with CIPN also had neuropathic pain. CIPN was associated with anxiety, depression, and deterioration of quality of life. None of the patients with CIPN were treated with duloxetine (recommendation from American Society of Clinical Oncology), and only 3.2%, 1.6%, and 1.6% were treated with pregabalin, gabapentin, and amitriptyline, respectively. (4) Conclusions: Five years after the end of chemotherapy, a quarter of patients suffered from CIPN. The present study showed marked psychological distress and uncovered a failure in management in these patients.
RESUMEN
INTRODUCTION: Perioperative chemotherapy is the gold standard treatment of the resectable gastro-oesophageal adenocarcinoma. However, 70% of patients cannot receive the complete sequence because of a postoperative complication or a decrease in functional and nutritional reserves. Recently, a new concept appeared in digestive surgery: prehabilitation. This interventional process consists of patient preparation, between surgical consultation and surgery, and is based on 3 components: (1) physical management, (2) nutritional care and (3) psychological care. Prehabilitation should decrease postoperative complications and improve nutritional and physical status during the preoperative and postoperative periods. Therefore, it is becoming essential to evaluate the effect of prehabilitation, compared to conventional care, on the percentage of patients reaching the complete oncological treatment. METHODS AND ANALYSIS: The PREHAB trial aimed to evaluate the efficacy of prehabilitation compared to conventional care, in patients with gastro-oesophageal cancer with perioperative chemotherapy. This trial is a prospective, randomised, controlled, open-blind and interventional study in 4 centres. Patients (n=60 per group) will be randomly assigned for management with either prehabilitation or conventional care. The primary outcome is the percentage of patients reaching the complete oncological treatment decided in a multidisciplinary tumour board. The secondary outcomes are the postoperative morbidity, disease-free survival, overall survival, feasibility of the protocol, length of stay, variation of the functional reserve after the preoperative chemotherapy (defined by the VO2peak, ventilatory threshold and 6-min walk test), preoperative and postoperative nutritional status, preoperative anxiety, quality of life, 30-day and 90-day mortality and cumulative dose of cytotoxic treatment received. ETHICS AND DISSEMINATION: The study was approved by an independent medical ethics committee (IRB00008526, CPP Sud-Est VI, Clermont-Ferrand, France) and by the competent French authority (ANSM, Saint Denis, France) and registered on Clinicaltrial.gov. The results will be disseminated in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT02780921.