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Background: Perioperative chemotherapy has proven valuable in several tumors, but not in colon cancer (CC)., Objective: The aim of this study was to evaluate the efficacy and safety of perioperative chemotherapy in patients with locally advanced nonmetastatic CC., Methods: This is a French multicenter randomized phase II trial in patients with resectable high-risk T3, T4, and/or N2 CC on baseline computed tomography (CT) scan. Patients were randomized to receive either 6 months of adjuvant FOLFOX after colectomy (control) or perioperative FOLFOX for 4 cycles before surgery and 8 cycles after (FOLFOX peri-op). In RAS wild-type patients, a third arm testing perioperative FOLFOX-cetuximab was added. Tumor Regression Grade (TRG1) of Ryan et al was the primary endpoint. Secondary endpoints were toxicity, perioperative morbidity, and quality of surgery., Results: A total of 120 patients were enrolled. At interim analysis, the FOLFOX-cetuximab arm was stopped (lack of efficacy). The remaining 104 patients (control, n = 52; FOLFOX preop n = 52) represented our intention-to-treat population. In the FOLFOX perioperative group, 96% received the scheduled 4 cycles before surgery. R0 resection and complete mesocolic excision rate were 94% and 93%, respectively. Overall mortality and morbidity rates were similar in both groups. Perioperative FOLFOX chemotherapy did not improve major pathological response rate (TRG1 = 8%) but was associated with a significant pathological regression (TRG1-2 = 44% vs 8%, P < 0.001) and a trend to tumor downstaging as compared to the control group. CT scan criteria were associated with a 33% rate of overstaging in control group., Conclusions: Perioperative FOLFOX for locally advanced resectable CC is feasible with an acceptable tolerability but is not associated with an increased major pathological response rate as expected. However, perioperative FOLFOX induces pathological regression and downstaging. Better preoperative staging tools are needed to decrease the risk of overtreating patients.

Objective: To determine the efficacy of the thrombopoietin receptor agonist romiplostim for the prevention of temozolomide-induced thrombocytopenia in newly diagnosed glioblastoma., Methods: In the PLATUM phase II open-label, multicenter, single-arm trial, patients diagnosed with Common Terminology Criteria for Adverse Events grade 3 or 4 thrombocytopenia during chemoradiotherapy received weekly subcutaneous romiplostim injections. PLATUM aimed at demonstrating that the percentage of thrombocytopenic patients treated with romiplostim able to complete 6 cycles of maintenance temozolomide chemotherapy exceeded 10% ( p 0 = 0.10; p A = 0.35). Using type I error equal to 0.05% and 95% power, 31 patients had to be recruited. According to a Fleming 2-step design with a preplanned interim analysis after recruitment of 20 patients (step 1), the trial was terminated early for success., Results: Twenty patients were enrolled in step 1. Median age was 61 years (range 33-73). Twelve patients received 6 temozolomide cycles, corresponding to a success rate of 60% (95% confidence interval 36%-81%). Four patients discontinued temozolomide because they did not respond to romiplostim, 2 for progression, and 2 for adverse events unrelated to romiplostim., Conclusion: The thrombopoietin receptor agonist romiplostim improves exposure to chemotherapy in patients with glioblastoma experiencing temozolomide-induced thrombocytopenia., Clinicaltrialsgov Identifier: NCT02227576., Classification of Evidence: This study provides Class IV evidence that for patients with glioblastoma and thrombocytopenia, romiplostim is effective for the secondary prophylaxis of temozolomide-induced thrombocytopenia., (© 2019 American Academy of Neurology.)

Rectal cancer is a common and serious disease. The aim of the SUDCAN collaborative study was to compare the net survival from rectal cancer between six European Latin countries (Belgium, France, Italy, Portugal, Spain, and Switzerland) and provide trends in net survival and dynamics of excess mortality rates up to 5 years after diagnosis. The data were extracted from the EUROCARE-5 database. First, net survival was studied over the period 2000-2004 using the Pohar-Perme estimator. For trend analyses, the study-period was specific to each country. The results are reported from 1992 to 2004 in France, Italy, Spain, and Switzerland and from 2000 to 2004 in Belgium and Portugal. These analyses were carried out using a flexible excess rate modeling strategy. There were some differences between countries in age-standardized net survivals (2000-2004). The 5-year survival ranged from 55% (Portugal) to 62% (Belgium). There was an increase in age-standardized survival rates between 1992 and 2004 as observed at 1 and 5 years. This increase was observed in the 60 and 70-year age groups, but was less marked in the 80-year age group. This was related to a decrease in the excess mortality rates between 1992 and 2004, until ∼24 months after diagnosis in France and Switzerland, whereas it was continuous over the entire study period in Italy and Spain. Considerable improvements in survival from rectal cancer have been achieved. Further improvements are expected through better adherence to the guidelines and the implementation of mass screening.

The haemoglobin concentration measured by faecal immunochemical tests (FIT) may be decreased in cases of delayed sample return or high temperature. It is an issue of great importance. The aim of this study was to investigate the effects of sample return time and of season on the performance of an FIT (FOB-Gold) with a new buffer. The study included 20 371 participants involved in the French organized colorectal cancer (CRC) screening programme. The probability of a positive screening test, detection rates and positive predictive values for CRC and advanced adenoma were analysed according to sample return time and season of screening. A sample of positive FIT was stored for 7 days in an incubator at 20°C or 30°C. The positivity rate was 4.1% for a sample return time of up to 3 days, 4.1% for 4-5 days and 4.6% for 6-7 days (P=0.25). In multivariate analysis, there was no association between positivity rates, detection rates and positive predictive values for CRC and advanced adenoma and the sample return time or the season of screening. At a constant temperature of 20°C, there was a decrease in the haemoglobin concentration of 5.1% after 7 days. The decrease reached 20.5% at a temperature of 30°C. It was only 4.5% during the first 4 days of storage in the incubator. With the new buffer, delay in sample return or season did not affect the clinical outcome. When temperatures reach 30°C, the faecal sample must be returned promptly.

Purpose: To establish hand-held dynamometry (HHD) maximal isometric muscle torque (MIT) reference values for children and adolescents who are developing typically., Methods: The MIT of 10 upper and lower limb muscle groups was assessed in 351 Caucasian youth (4 years 2 months to 17 years) using a standardized HHD protocol, previously shown to be feasible, valid, and reliable., Results: The mean MIT and 95% confidence interval of the mean for all muscle groups, for each of the 14 age groups (1 year age span for each group), and for each sex, were reported in both absolute (Nm) and normalized (Nm/kg) values., Conclusion: These HHD reference values may be helpful in the identification of muscle strength impairments in several pediatric populations, especially when bilateral impairments are present.

Purpose: To determine, with respect to measurement of maximal isometric torque (MIT) using a specific hand-held dynamometer (HHD) protocol, (1) protocol feasibility over a wide age range, (2) intra- and interrater reliability, (3) standard error of measurement, and (4) concurrent validity., Methods: The MIT of selected upper and lower limb muscle groups was assessed (n = 74; age = 4-17.5 years) using a standardized, HHD protocol. Testing was repeated in 20 adolescents (n = 10 for each muscle group), who were also assessed with a Cybex dynamometer., Results: The protocol was feasible for all participants. Mean intra- and interrater reliability [intraclass correlation coefficient (ICC)] varied from 0.75 to 0.98, except for ankle dorsiflexor interrater reliability (mean ICC = 0.67). The standard error of measurement varied from 0.5 to 4.9 Nm and was highest for hip extensors. Mean concurrent validity (ICC) varied from 0.78 to 0.93, except for ankle plantar flexors (mean ICC = 0.48)., Conclusions: Our HHD protocol was feasible over a wide age range and most MIT values were valid and reliable.

Objectives: Time trends in the incidence of pancreatic cancer vary considerably between countries. The aim of this study was to provide time trends in incidence during a 25-year period in a well-defined French population., Methods: The cancer registry in Burgundy (France) was used to study time trends between 1981 and 2005 by sex, age, subsite, and histology. They were analyzed using an age-period cohort model., Results: Age-standardized incidence rates increased from 5.7 (1981-1985) to 7.9 per 100,000 (2001-2005) in men and from 2.6 to 4.6 in women. The mean percentage of variation by the 5-year period was +9.9% (P < 0.001, 95% confidence interval, 6.2%-13.6%) and +13.4% (P = 0.004, 95% confidence interval, 9.4%-17.5%), respectively. The increase in incidence was higher for cancers of the tail and corpus than for cancers of the head of pancreas and for malignant pancreatic endocrine tumors than for adenocarcinomas. The cumulative risk of developing a pancreatic cancer rose from 0.51% for men born in 1900 to 1.13% for those born in 1950. It was 0.34% and 0.55% for women, respectively., Conclusions: The incidence of pancreatic cancer has increased sharply in France both by period and by birth cohort. Etiological studies are required to explain the increase in the incidence.

Background: Neurofibromatosis type 1 is a genetic and ubiquitous disease, with an estimated incidence of one in 3000 live births. Neurofibromas, defined as various benign tumors, are hallmarks of the disease. Facial plexiform or diffuse neurofibromas usually occur unilaterally and can induce facial hemihypertrophy. Surgical treatment consists of partial removal, to prevent sacrificing nontumoral tissues, and is aimed at acceptable functional and cosmetic results, considering the hyperextensibility and lack of elasticity of patients' skin., Methods: The authors operated on 33 neurofibromatosis type 1 patients (15 men and 18 women) suffering from diffuse or plexiform benign facial neurofibromas with a facial aesthetic unit remodeling surgical technique with a resection pattern based on the substraction between aesthetic units of the affected hemiface and the symmetry of the nonaffected one. A tumescent infiltration preceded a monobloc translesional approach using bipolar coagulation scissors, with systematic ligation of venous confluents and a fibrin sealant spray. No preoperative angiography, arterial embolization of the tumor, or autologous transfusion was required., Results: The average number of procedures for each patient was 1.9. The mean length of stay was 3.65 days. The average tumor size was 11.13 cm. The average follow-up was 5.89 years. Only one patient received transfusion. One patient suffering from bilateral plexiform neurofibromas was beyond the limit of the technique (14 debulking procedures) and required a face transplantation., Conclusion: The facial aesthetic unit remodeling monobloc translesional resection technique on a preestablished pattern has been reproducible, offered increased predictability in functional and cosmetic results, and allowed us to operate on extensive hemifacial lesions with a lower transfusion risk.

Background: The management of severe postpregnancy musculoaponeurotic laxity remains a challenge for plastic and reconstructive surgeons. Several techniques have been proposed, but there is no consensus on the best treatment. The authors report the validity of their abdominoplasty method., Methods: From May of 1995 to May of 2006, a retrospective chart review was conducted on 52 women who underwent the authors' abdominoplasty technique. The average age was 39 years (range, 25 to 60 years). They had an average of 3.2 children (range, two to six). The average preoperative body mass index was 23.5 (range, 20 to 31.5). None of the patients included had preexisting medical conditions. The posterior rectus fascia was released and plicated at the midline. A resorbable mesh was used to reinforce the plication and to reduce the tension of the traction., Results: Follow-up ranged from 6 months to 11 years, with an average of 54 months. Complications included a bladder injury in one patient during posterior fascia release and epigastric bulging in one woman immediately after extubation. The local complications were seromas in two patients, skin flap necrosis in one smoking patient, and umbilical necrosis in one patient. Four patients required minor scar revision and liposuction under local anesthesia. There were no cases of systemic complications. No incidence of infection, dehiscence, or extrusion of the mesh was noted. All patients were completely satisfied., Conclusion: The release and plication of the posterior rectus sheath associated with the use of submuscular resorbable mesh is a long-lasting and reliable procedure in multiparous women with severe myoaponeurotic laxity.

The objective of this study was to analyse trends in the incidence of digestive cancers in France. Observed incidence and mortality data in the population covered by cancer registries were modelled using age-cohort models. An estimation of the incidence/mortality ratio was obtained from these models and was applied to the mortality rates predicted from an age-cohort model for the entire French population. Site-specific standardized-incidence rates by 1-year intervals and cumulative rate 0-74 years by birth cohort were estimated. On average, age-standardized incidence rates of large bowel cancers increased by 1.0% per year in men and 0.8% in women from 1980 to 2000. The estimated cumulative rate increased from 4.0% for men born in 1913 to 4.8% for those born in 1953. The corresponding values in women were 2.5 and 2.9%. The most striking increase in incidence was seen for primary liver cancer with an increase from 2000 incident cases in 1980 to nearly 6000 in 2000. The estimated cumulative rate was 0.5% for men born in 1913 and 2.9% for those born in 1953. The increase in incidence was lower for pancreas cancer. A decrease in the incidence of stomach cancer was observed for both sexes and of oesophageal cancer in men by slightly more than 2%. The study showed large changes in the cancer burden in France between 1980 and 2000.

Objective/background: Little is known about the epidemiology and the management of liver metastases from colorectal cancer at a population level. The aim of this population-based study was to report on the incidence, treatment, and prognosis of synchronous and metachronous liver metastases., Methods: Data were obtained from the population-based cancer registry of Burgundy (France)., Results: The proportion of patients with synchronous liver metastases was 14.5%. Age-standardized incidence rates were 7.6 per 100,000 in males, 3.7 per 100,000 in females. The 5-year cumulative metachronous liver metastasis rate was 14.5%. It was 3.7% for TNM stage I tumors, 13.3% for stage II, and 30.4% for stage III (P < 0.001). The risk of liver metastasis was also associated to gross features. Resection for cure was performed in 6.3% of synchronous liver metastases and 16.9% of metachronous liver metastases. Age, presence of another site of recurrence, and period of diagnosis were independent factors associated with the performance of a resection for cure. The 1- and 5-year survival rates were 34.8% and 3.3% for synchronous liver metastases. Their corresponding rates were, respectively, 37.6% and 6.1% for metachronous liver metastases., Conclusion: Liver metastases from colorectal cancer remain a substantial problem. More effective treatments and mass screening represent promising approaches to decrease this problem.

The aim of this study was to determine how the guidelines published after this conference have spread. Pretherapeutic evaluation and treatment were assessed for all colon cancers diagnosed in a well-defined French population in 2000. Patients were classified either as managed according to the recommendations, or as undermanaged or overmanaged. Outside the emergency context, pretherapeutic work-up was classified as in conformity with the consensus in 48.0% of the cases, as undervalued in 21.9% and as overvalued in 30.1%. The resection rate at 90% was not far from the optimum. Pathological data allowed us to classify nearly all cases according to the tumour node metastasis classification; however, the number of examined nodes was below the recommendations in 30.8% of cases. Chemotherapy was performed according to the recommendations in 71.4% of cases, 23.1% were undertreated and 5.5% were overtreated. The multivariate analysis indicates that patients aged 75 years or more were less likely to receive chemotherapy than was recommended (P<0.001). This study suggested that the main reasons for not following guideline recommendations were inertia due to previous practices, difficulty to perform a recommended behaviour and lack of familiarity.

Unlabelled: Ambulatory surgery can create significant anxiety. This prospective study measured whether music can influence anxiety and perioperative sedative requirements in outpatients undergoing surgery with spinal anesthesia. We also evaluated the correlation between two anxiety measures, the State-Trait Anxiety Inventory test (STAI) and the 0- to 10-cm visual analog scale (VAS 0-10), with 0 meaning complete relaxation and 10 the worst feeling of anxiety possible. Fifty unpremedicated patients were randomly assigned to listen to music of their choice via headset during the perioperative period (Group I) or to have no music (Group II). All participants used patient-controlled IV midazolam sedation and underwent repeated evaluations of their anxiety level with the STAI and the VAS 0-10. Midazolam requirements during surgery (Group I, 0.6 +/- 0.7 versus Group II, 1.3 +/- 1.1 mg; P < 0.05) and for the whole perioperative period (Group I, 1.2 +/- 1.3 versus Group II, 2.5 +/- 2.0 mg; P < 0.05) were smaller in patients listening to music. Anxiety levels, measured with STAI or VAS 0-10, were similar in both groups. The Spearman's coefficient values between STAI and VAS 0-10 ranged from 0.532 to 0.687. We conclude that patients listening to music require less midazolam to achieve a similar degree of relaxation as controls and that measures of anxiety obtained from the STAI and the VAS 0-10 are positively, but only moderately, correlated., Implications: It is possible to decrease sedative requirements during surgery under spinal anesthesia by allowing patients to listen to music to reduce their anxiety.