Benefits of using corneal topography to choose subjective refraction technique in keratoconus (RE-CON): a prospective comparative crossover clinical study.

PURPOSE: In prospective no-masking, comparative, crossover monocenter clinical trial, we aimed to evaluate whether the optimal subjective refraction technique varies with the keratoconus topography and to identify relevant topographic criteria. METHOD: This study included 72 keratoconus eyes with impaired visual acuity. Each eye tested three methods of refraction (Jackson cylinder, astigmatism dial, stenopeic slit), resulting in three eyeglass lenses. Patients were assigned to the group corresponding to the eyeglass lens offering the best visual acuity. Five topographical characteristics were collected via the Pentacam: mean keratometry (Km), maximum keratometry (Kmax), distance from corneal center to Kmax (dKmax), Belin/Ambrosio Display (BAD_D), and index of surface variance (ISV). RESULTS: Forty-six eyes were included in the dial group (64.8%), 23 eyes in the cylinder group (32.4%), and only 2 eyes in the slit group (2.8%); thus, we only compared dial and cylinder groups. The main analysis retrieved a significant probability to choose dial technic for BAD_D (p = 0.024); when BAD_D is > 9.71 (ROC threshold), the positive predictive value (PPV) = 89.5%, and for ISV, p = 0.012; when ISV is > 77, PPV = 89.1%. The sub-analysis of patients with different visual acuities between cylinder and dial confirmed these results with slightly different thresholds: the probability to choose dial technic was for BAD_D, p = 0.03; when BAD_D is > 7.55, PPV = 90%, and for ISV, p = 0.0084; when ISV is > 71, PPV = 88.5%. CONCLUSION: Refraction method is linked to topographic indices ISV and BAD_D. A BAD_D > 7.55 indicates the dial method. In addition to keratoconus screening and diagnosis, this study suggests a new application of the topographer to select a suitable refraction method for eyeglass prescription. TRIAL REGISTRATION: Study registered on the ClinicalTrials.gov database under n°: NCT04174209.

Continuous Wound Infiltration With Ropivacaine After Mastectomy: A Randomized Controlled Trial.

BACKGROUND: To evaluate the efficacy of continuous wound infiltration with ropivacaine to reduce acute postoperative pain in patients undergoing mastectomy for carcinoma of the breast. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was conducted. One hundred fifty patients were randomly assigned to receive continuous ropivacaine (0.2%) (group A, n = 74) or saline solution (0.9%) (group B, n = 76) at 10 mL/h for 48 h through a multilumen catheter placed during the surgical procedure. Postoperative morphine consumption and visual analog scale (VAS) pain scores were recorded. A quality of life score (Quality of life questionnaire Core 30) and a VAS score were obtained at 1, 3, and 6 mo after surgery. RESULTS: The difference in mean morphine consumption between the two groups was close to significance during the first 48 h postsurgery (P = 0.056; 10.8 ± 16.5 versus 4.8 ± 10.4 mg). At day 1, patients in the ropivacaine-infusion group had lower morphine consumption than the control group (P = 0.0026). The link between local ropivacaine infiltration and a decrease in mean postoperative VAS scores reached significance for the first 24 h postsurgery (P = 0.039). No significant difference was found between the two arms for VAS pain scores (P = 0.36) or for quality of life (overall QLQ-C30 score, P = 0.09) at 1, 3, or 6 mo. CONCLUSIONS: Continuous wound infiltration with ropivacaine is efficacious in reducing postoperative pain. Quality of life and chronic pain at 1, 3, and 6 mo were not improved by ropivacaine wound infiltration.

Improvement in adherence to Capecitabine and Lapatinib by way of a therapeutic education program.

PURPOSE: A patient non-adherence with oral anticancer agents is a well-recognized barrier to effective treatment. The aim of this prospective study was to evaluate the efficacy of a therapeutic education program among non-adherent patients treated with Capecitabine alone or associated with Lapatinib. METHODS: Sixty-five cancer patients were enrolled. Among them, 55 participated in the first observational phase of the study, measuring adherence using electronic MEMS pillboxes (medication event monitoring system). An adherence score was assessed in the form of a composite adherence score including intake dose and intake intervals. Ten non-adherent patients (adherence score < 80%) were included in the intervention phase of the study and were enrolled on a therapeutic education program. The efficacy of the program was evaluated on the basis of an improvement in adherence scores. We also studied factors influencing adherence. RESULTS: The average adherence score was 83.6 ± 15.7% in the overall population. Forty-one patients were adherent (adherence score > 80%) and 14 patients were non-adherent (adherence score < 80%). The therapeutic education program for non-adherent patients (n = 10) increased their adherence score by 17.8% and led 60% of these patients to become adherent. The number of toxicities during the first cycles was a predictive factor for non-adherence. CONCLUSION: This study showed an improvement in adherence to Capecitabine ± Lapatinib among non-adherent patients by way of a therapeutic education program.

Quality of life for older patients with cancer: a review of the evidence supporting melatonin use.

PURPOSE: The proportion of older populations living with cancer is on the increase. Maintaining or improving their quality of life (QoL) has become an important goal in the treatment of cancer and has become an endpoint in clinical trials. Melatonin regulates a wide variety of physiological functions and is involved in the initiation of sleep and the improvement of QoL. With age, the secretion of melatonin decreases and could lead to a deterioration in QoL. METHODS: Literature searches were conducted using the PubMed database. The search terms and derivatives of "metastatic cancer", "older patients", "quality of life" and "melatonin" were used. Titles and abstracts were screened to identify whether studies were relevant for full-text screening. RESULTS: There is major concern about the symptoms older cancer patients encounter during treatment because they can impact their QoL. Melatonin supplementation presents several benefits for older patients: improvement in survival, decrease in symptoms induced by cancer and cancer treatment, and also improvements in quality of life. CONCLUSION: It therefore seems appropriate to study the impact of melatonin supplementation during cytotoxic therapy on QoL among elderly patients with metastatic cancer. The use of melatonin as a therapeutic strategy seems particularly suitable for elderly patients, a population known to secrete significantly less melatonin. However, to date, no studies have been conducted in this population.

BRACAVENIR: an observational study of expectations and coping in young women with high hereditary risk of breast and ovarian cancer.

BACKGROUND: In families with high risk of hereditary breast/ovarian cancer (HBOC), women before age 30 do not yet undergo clinical screening, but they are exposed to contradictory information from diverse sources. They may be presented with surgical prevention options at a key moment of their identity construction, the start of a marital relationship and/or at the onset of procreation projects. We tested an original psychoeducational intervention to help these women better cope with these difficult issues. METHODS: Seven young female counselees (26.4 ± 2.9 years [23-30]) from the Oncogenetics Department at Jean Perrin Comprehensive Cancer Center were enrolled. A weekend group workshop composed of short conferences, group sharing and role playing activities was supervised by a psychotherapist. A longitudinal analysis of questionnaires over one year of follow-up was performed. The Herth Hope Inventory was evaluated, as well as self-esteem, anxiety, perceived control, coping, and quality of life. Participants' comments were collected by a genetic counselor throughout the workshop. RESULTS: All participants were BRCA mutation carriers and six had lived with a close relative affected by breast/ovarian cancer. Hope, self-esteem and quality of life increased during the year after the workshop (p = 0.0003). Coping by focus on the problem increased in the first 6 months (p = 0.011) and returned to baseline values at one year, while coping by focus on emotions decreased steadily (p = 0.021). Debriefing from the workshop highlighted the new medical opportunities proposed and the challenges these young women face, such as whether to have prophylactic surgery, and if so before or after having children, and how surgery might affect their relationship with their partner. CONCLUSION: A tailored two-day psychoeducational workshop may be sufficient to improve the way young women with BRCA mutations deal with the implications of HBOC risk. TRIAL REGISTRATION: BRACAVENIR was registered in ClinicalTrials.gov with no NCT02705924.

Analysis of tumour-infiltrating lymphocytes reveals two new biologically different subgroups of breast ductal carcinoma in situ.

BACKGROUND: Tumour-infiltrating lymphocytes (TILs) have been demonstrated to significantly influence prognosis and response to therapy of invasive breast cancer (IBC). Thus, it has been suggested that TIL density or/and immunophenotype could serve as biomarkers for selection of IBC patients for immunotherapy. However, much less is known about significance of TILs in breast ductal carcinoma in situ (DCIS). METHODS: We retrospectively investigated TIL density and immunophenotype in 96 pure DCIS and 35 microinvasive carcinomas (miCa). TIL density was assessed on H&E-stained breast biopsy sections as the percentage of tumour stromal area occupied by TILs, and classified into 4 grades: 0 (0%-9%), 1 (10-29%), 2 (30-49%) and 3 (50%-100%). TIL immunophenotype was assessed by immunohistochemistry for CD8, CD4, FoxP3, CD38 or CD20. RESULTS: Compared to pure DCIS, miCa contained significantly more cases with TIL density grade 3 (p = 0.028). Concordantly, CD8+, CD4+ and CD38+ cells were more numerous in miCa than in pure DCIS. In the pure DCIS subgroup with TIL density grades 2 and 3, all TIL subpopulations were more numerous than in the pure DCIS with TIL density grades 0 and 1, however the ratio between T-lymphocytes (CD8+ and CD4+) and B-lymphocytes (CD20+) was significantly lower (p = 0.029). On the other side, this ratio was significantly higher in miCa, in comparison with pure DCIS having TIL density grades 2 and 3 (p = 0.017). By cluster analysis of tumour cell pathobiological features we demonstrated similarity between miCa and the pure DCIS with TIL density grades 2 and 3. The only significant difference between those two categories was in the ratio of T- to B-TILs, higher in miCa. CONCLUSION: Results indicate that TIL density level can distinguish 2 biologically different DCIS subgroups, one of which (DCIS with ≥30% TILs, the TIL-rich DCIS) is like miCa. Similarity of TIL-rich pure DCIS and miCa as well as the role of B-lymphocytes in DCIS invasiveness are worth further investigating with regards to the potential development of immunotherapy-based prevention of DCIS progression.

Long-term improvement of breast cancer survivors' quality of life by a 2-week group physical and educational intervention: 5-year update of the 'PACThe' trial.

BACKGROUND: The advantages of adapted physical activity and nutritional education (APANE) on breast cancer prognosis and quality of life (QoL) are well known, but long-term results are lacking. METHODS: A randomised controlled trial testing a 2-week intervention in hydrothermal centres including APANE enrolled 251 patients post-chemotherapy. QoL and weight control were significantly improved at 12 months. A 5-year follow-up was performed to evaluate the persistence of improvements. RESULTS: QoL increase (SF36) was persistent: effect-size at 2, 3, 4 and 5 years equalled respectively 0.27 (-0.01; 0.56), 0.28 (-0.02; 0.58), 0.41 (0.02; 0.81) and 0.45 (0.11; 0.80). Weight control observed after intervention lasted 2 years: 2.7% decrease at 1 year (P=0.0085), 2.5% at 2 years (P=0.025); and respectively for waist -2.4% (-3.6; -1.1) (P=0.000014) and -1.3% (-2.5; -0.1) (P=0.0072). CONCLUSIONS: A 2-week intervention in hydrothermal centres performed shortly after chemotherapy can durably improve breast cancer patients' QoL and reduce weight.

A Retrospective Study on the Onset of Menopause after Chemotherapy: Analysis of Data Extracted from the Jean Perrin Comprehensive Cancer Center Database Concerning 345 Young Breast Cancer Patients Diagnosed between 1994 and 2012.

OBJECTIVE: Young breast cancer (BC) patients receiving chemotherapy are at risk of chemotherapy-induced menopause (CIM). We sought to define the incidence rate of premature menopause after chemotherapy and to retrospectively investigate factors related to the onset of menopause. METHODS: We identified BC patients who had received chemotherapy at the Cancer Center (Centre Jean-Perrin). We selected premenopausal women aged between 18 and 50 years at the moment of diagnosis who received chemotherapy between 1994 and 2012. RESULTS: Of the 345 selected patients, the median age was 42 years (interquartile range: 38-46). CIM was defined as amenorrhea for at least 2 years following the end of chemotherapy. A total of 260 premenopausal women versus 85 menopausal women were included. Among the 85 menopausal women, only 46 were in the CIM group (13.3%). This rate increased in the group of women aged >43 years at diagnosis and with early hot flushes. CONCLUSION: CIM occurred in 13.3% of BC patients after chemotherapy. Age >43 years and early hot flushes were significantly associated with the risk of CIM. We suggest that the definition of CIM should be standardized in the literature: "amenorrhea of at least 2 years" seems a good cutoff, although 2 patients recovered their menstrual cycles beyond this limit.

P-gp expression levels in the erythrocytes of brown trout: a new tool for aquatic sentinel biomarker development.

CONTEXT: P-glycoprotein (P-gp) is a ubiquitous membrane detoxification pump involved in cellular defence against xenobiotics. Blood is a hub for the trade and transport of physiological molecules and xenobiotics. Our recent studies have highlighted the expression of a 140-kDa P-gp in brown trout erythrocytes in primary cell culture and its dose-dependent response to Benzo[a]pyrene pollutant. OBJECTIVE: The purpose of this study was focused on using P-gp expression in brown trout erythrocytes as a biomarker for detecting the degree of river pollution. METHODS: abcb1 gene and P-gp expression level were analysed by reverse transcriptase-PCR and Western blot, in the erythrocytes of brown trouts. The latter were collected in upstream and downstream of four rivers in which 17 polycyclic aromatic hydrocarbons and 348 varieties of pesticides micro-residues were analysed by liquid chromatography and mass spectrometry. RESULTS: The abcb1 gene and the 140-kDa P-gp were not expressed in trout erythrocytes from uncontaminated river. In contrast, they are clearly expressed in contaminated rivers, in correlation with the river pollution degree and the nature of the pollutants. CONCLUSIONS: This biological tool may offer considerable advantages since it provides an effective response to the increasing need for an early biomarker.

Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer.

BACKGROUND: Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity. This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment. METHODS: Overall, 264 previously untreated stage II-III operable breast cancer patients were randomized to receive either standard treatment (arm A, n = 131), consisting of fluorouracil, epirubicin, and cyclophosphamide (FEC100: 500, 100, and 500 mg/m(2), respectively, for 3 cycles) followed by docetaxel (100 mg/m(2) for 3 cycles), or adapted treatment (arm B, n = 133), beginning with 2 cycles of FEC100 and switching to docetaxel if tumor size decreased by <30% after 2 cycles or <50% after 4 cycles of FEC100 (ultrasound assessments according to World Health Organization criteria). Otherwise, FEC100 was given for six cycles before surgery. Intent-to-treat analysis was performed. RESULTS: Similar results were observed for clinical response (objective response was 54% vs 56%, p = .18), breast conservation surgery (BCS; 67% vs 68%, p = .97), and pathological complete response rate (Chevallier classification: 14% vs 11%, p = .68; Statloff classification: 16% vs 13%, p = .82) between arms A and B. Similar toxicities were observed, even with unbalanced numbers of FEC100 and docetaxel courses. CONCLUSION: Adapted and standard treatments had similar results in terms of tumor response, BCS rate, and tolerability. Further survival outcome data are expected.

Prognostic factors in operable breast cancer treated with neoadjuvant chemotherapy: towards a quantification of residual disease.

OBJECTIVE: Neoadjuvant chemotherapy (NACT) allows for a more frequent use of breast-conservative surgery; it is also an in vivo model of individual tumor sensitivity which permits to determine new prognostic factors to personalize the therapeutic approach. METHODS: Between 2000 and 2012, 318 patients with primary invasive breast cancer were treated with a median of 6 cycles of NACT; they received either an anthracycline-based FEC 100 protocol (31.1%), or anthracyclines + taxanes (53.5%), with trastuzumab if indicated (15.4%). RESULTS: After a median follow-up of 44.2 months, the pathological complete response rate according to the classification of Chevallier et al. [Am J Clin Oncol 1993;16:223-228] was 19.3%, and overall (OS) and disease-free survival (DFS) at 10 years were 60.2 and 69.6%, respectively. Univariate analyses demonstrated that the Residual Disease in Breast and Nodes (RDBN) index was the most significant prognostic factor for OS (p = 0.0082) and DFS (p = 0.0022), and multivariate analyses mainly revealed that the residual tumor size, residual involved node number and post-chemotherapy Scarff-Bloom-Richardson (SBR) grading were the most significant prognostic factors. CONCLUSIONS: In a cohort of patients who were all homogeneously treated with some of the most common drugs for breast cancer, we demonstrate that NACT may provide additional prognostic factors and confirm the RDBN index. As this index allows for the prediction of survival with different breast cancer subtypes, we suggest that it should be calculated routinely to help clinicians to select patients who need adjuvant treatments.

Neurotoxicity as a prognostic factor in patients with metastatic breast cancer treated with ixabepilone as a first-line therapy.

OBJECTIVE: This study is a longitudinal follow-up of metastatic breast cancer patients treated with ixabepilone as first-line chemotherapy, with the aim to evaluate the association between a mechanism-based neurotoxicity and the efficacy of ixabepilone. PATIENTS AND METHODS: At the 2 main investigational sites of a phase II clinical trial, 50 patients previously treated with anthracycline received ixabepilone. A chart review was performed to evaluate overall survival (OS) and time to progression (TTP) and to describe the subsequent treatments. RESULTS: The severe neurotoxicity induced by ixabepilone (38%) is correlated with a higher overall response rate to ixabepilone (79 vs. 48%; p = 0.042), a longer TTP (11.4 vs. 6.8 months; p = 0.023) and a longer OS (36.6 vs. 19.9 months; p = 0.05). After ixabepilone discontinuation, patients received a median of 4 subsequent chemotherapy lines (range 1-12). Among the 31 patients who received taxanes, neither the neurotoxicity incidence under treatment with taxanes nor the response was affected by a previous occurrence under ixabepilone treatment. CONCLUSION: These findings suggest that neurotoxicity development under ixabepilone treatment is a predictor of treatment outcomes as well as a favorable prognostic factor. It highlights the risk-to-benefit ratio issue of ixabepilone. We noticed the possibility to treat patients with taxanes after ixabepilone without systematic recurrent neurotoxicity.

Everolimus in Metastatic Breast Cancer: Clinical Experience as a Late Treatment Line.

BACKGROUND: Everolimus (Afinitor®) plus exemestane are indicated for hormone receptor-positive, HER2/neu-negative metastatic breast cancer (MBC), in menopausal women without symptomatic visceral disease after recurrence or progression following aromatase inhibitors. But everolimus efficacy as late treatment has not been explored. METHODS: Sixty-three MBC patients progressing under hormonotherapy (HT; n = 30) or after chemotherapy (CT; n = 32) received everolimus plus HT (EHT) and were analyzed for safety, efficacy and overall survival (OS). This cohort was compared with our previous 530 MBC patients stratified by line (PMID 21852136). RESULTS: The median duration of EHT was 27.8 weeks at 5-10 mg/day until clinical progression or toxicity. Median OS was not reached (median follow-up 18 months). Twelve-month survival was 100, 79 and 49% for patients treated with 0 (n = 13), 1-2 (n = 18) and >3 CT (n = 32), respectively. Median time-to-treatment failure was 6.4 months. In 62 EHT patients randomly matched 1:7 with 421 previous patients for age and number of CT, OS improved compared with patients receiving a new CT (p = 0.062). In patients pretreated with <2 CT, EHT gave a better OS than in those with a new CT (p = 0.026). CONCLUSIONS: These results may support the use of EHT whatever the number of previous lines.

Brown adipose tissue activity in relation to weight gain during chemotherapy in breast cancer patients: a pilot study.

Weight gain has been reported in early stage breast cancer patients during chemotherapy, but the involved mechanisms remain unclear. A chemotherapy-induced decrease of brown adipose tissue (BAT) activity may partly contribute to weight gain in these patients. A positron emission tomography/computed tomography scan was performed at baseline and after 1 course of docetaxel + trastuzumab treatment in 26 breast cancer women. Variation of the maximal standardized uptake value of BAT in the cervical and supraclavicular regions between the 2 measures was assessed according to weight changes. Overall, (18)F-FDG uptakes in BAT decreased by 11.3% after 1 course of chemotherapy (p = 0.03). No correlation was found between the baseline values of (18)F-FDG uptake and body mass index or age of patients, but as expected (18)F-FDG uptake was dependent on season period. Among the patients, 35% gained weight, 25% lost weight, and 40% remained stable. Women who gained weight during chemotherapy experienced a significant decrease of (18)F-FDG uptake in BAT (p = 0.005). Decreased activity of BAT was associated with body weight gain during chemotherapy. These original data suggest for the first time that BAT modulation by chemotherapy would be a potential contributor to body weight gain through blunted thermogenesis in breast cancer patients.

Epidural versus continuous preperitoneal analgesia during fast-track open colorectal surgery: a randomized controlled trial.

BACKGROUND: Effective postoperative analgesia is essential for early rehabilitation after surgery. Continuous wound infiltration (CWI) of local anesthetics has been proposed as an alternative to epidural analgesia (EA) during colorectal surgery. This prospective, double-blind trial compared CWI and EA in patients undergoing elective open colorectal surgery. METHODS: Fifty consecutive patients were randomized to receive EA or CWI for 48 h. In both groups, patients were managed according to Enhanced Recovery After Surgery recommendations. The primary outcome was the dynamic pain score measured during mobilization 24 h after surgery (H24) using a 100-mm verbal numerical scale. Secondary outcomes were time to functional recovery, analgesic technique-related side effects, and length of hospital stay. RESULTS: Median postoperative dynamic pain score was lower in the EA than in the CWI group (10 [interquartile range: 1.6-20] vs. 37 [interquartile range: 30-49], P < 0.001) and remained lower until hospital discharge. The median times to return of gut function and tolerance of a normal, complete diet were shorter in the EA than in the CWI group (P < 0.01 each). Sleep quality was also better in the EA group, but there was no difference in urinary retention rate (P = 0.57). The median length of stay was lower in the EA than in the CWI group (4 [interquartile range: 3.4-5.3] days vs. 5.5 [interquartile range: 4.5-7] days; P = 0.006). CONCLUSION: Within an Enhanced Recovery After Surgery program, EA provided quicker functional recovery than CWI and reduced length of hospital stay after open colorectal surgery.

Oncogenetic pedigrees: Relation between design and ability to predict mutation.

We consider the risk of a disease caused by the presence within the genome of one deleterious mutation or two interacting mutations. For an individual, the probability of being mutated/doubly mutated can be estimated by knowing the phenotype of the other members in the family pedigree. We study the performance of this process as a function of the size, the shape of the family tree and the parameters of the model. We carry out simulations using the parameters pertaining to breast/ovarian cancer in BRCA-mutated families.

Noninvasive ventilation and alveolar recruitment maneuver improve respiratory function during and after intubation of morbidly obese patients: a randomized controlled study.

BACKGROUND: Morbid obesity predisposes patients to lung collapse and hypoxemia during induction of anesthesia. The aim of this prospective study was to determine whether noninvasive positive pressure ventilation (NPPV) improves arterial oxygenation and end-expiratory lung volume (EELV) compared with conventional preoxygenation, and whether NPPV followed by early recruitment maneuver (RM) after endotracheal intubation (ETI) further improves oxygenation and respiratory function compared with NPPV alone. METHODS: Sixty-six consecutive patients (body mass index, 46 ± 6 kg/m²) were randomized to receive 5 min of either conventional preoxygenation with spontaneous breathing of 100% O2 (CON), NPPV (pressure support and positive end-expiratory pressure), or NPPV followed by RM (NPPV+RM). Gas exchange was measured in awake patients, at the end of preoxygenation, immediately after ETI, and 5 min after the onset of mechanical ventilation. EELV was measured immediately after ETI and 5 min after mechanical ventilation. The primary endpoint was arterial oxygenation 5 min after the onset of mechanical ventilation. Results are presented as mean ± SD. RESULTS: At the end of preoxygenation, Pao2 was higher in the NPPV and NPPV+RM groups (382 ± 87 mmHg and 375 ± 82 mmHg, respectively; both P < 0.001) compared with the CON group (306 ± 51 mmHg) and remained higher after ETI (225 ± 104 mmHg and 221 ± 110 mmHg, in the NPPV and NPPV+RM groups, respectively; both P < 0.01 compared with the CON group [150 ± 50 mmHg]). After the onset of mechanical ventilation, Pao2 was 93 ± 25 mmHg in the CON group, 128 ± 54 mmHg in the NPPV group (P = 0.035 vs. CON group), and 234 ± 73 mmHg in the NPPV+RM group (P < 0.0001 vs. NPPV group). After ETI, EELV was higher in the NPPV group compared with the CON group (P < 0.001). Compared with NPPV alone, RM further improved gas exchange and EELV (all P < 0.05). A significant correlation was found between Pao2 obtained 5 min after mechanical ventilation and EELV (R = 0.41, P < 0.001). CONCLUSION: NPPV improves oxygenation and EELV in morbidly obese patients compared with conventional preoxygenation. NPPV combined with early RM is more effective than NPPV alone at improving respiratory function after ETI.

Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial.

BACKGROUND: Surgical management of left colonic cancer presenting as an acute obstruction remains controversial and still is associated with high mortality and morbidity rates. Recently, self-expandable metallic stents (SEMS) have been used as a bridge to surgery in an attempt to decompress the colon and then allow elective one-stage surgical resection without stoma placement. This study aimed to compare the outcomes of emergency surgery alone with emergency placement of colonic SEMS as a bridge to surgery in terms of efficiency and reduction of the stoma placement rate. METHODS: A multicenter prospective, randomized, controlled trial was conducted according to the consolidated standards of reporting trials (CONSORT) Statement criteria. Patients eligible for the study were randomized to either emergency surgery or emergency SEMS as a bridge to surgery. The primary outcome was the need for a stoma (temporary or permanent) for any reason. The secondary end points were mortality, morbidity, and length of hospital stay. RESULTS: Nine centers participated in the trial. Among the 70 patients eligible for the study, 60 were randomized and included for the final analysis, 30 patients in each group. Seven patients were randomized but did not fulfill the entry requirements, whereas three further eligible patients were not randomized for various reasons. Concerning the primary outcome, 17 patients in the surgery group sustained a stoma placement versus 13 patients in the SEMS group (p=0.30). No statistically significant difference was noted concerning the secondary outcomes. A total of 16 attempts at SEMS placement (53.3%) were technical failures. Two colonic perforations directly related to the stent placement procedure occurred among the 30 randomized patients and 1 perforation occurred among the nonrandomized patients, leading to premature closure of inclusions in the study before the expected number of 80 patients was reached. CONCLUSION: This randomized trial failed to demonstrate that emergency preoperative SEMS for patients presenting with acute left-sided malignant colonic obstruction could significantly decrease the need for stoma placement.

Long-term follow-up after laparoscopic management of endometrial cancer in the obese: a fifteen-year cohort study.

STUDY OBJECTIVE: To assess the surgical outcomes and long-term results of laparoscopic treatment of endometrial cancer in obese patients, and compare these results with those of nonobese women. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Two referral cancer centers. PATIENTS: Fifty-two obese and 155 nonobese women with clinical stage I endometrial cancer managed by laparoscopy from 1990-2005 in two referral centers. INTERVENTIONS: Demographic, surgical, perioperative and pathological characteristics of obese women and nonobese women with endometrial cancer treated by laparoscopy were analyzed and then compared. Recurrence-free and overall survival was calculated by use of Kaplan-Meier method. MEASUREMENTS AND MAIN RESULTS: Median BMI of the study population was 26.2 Kg/m(2). Median BMI among obese patients was 34.2 Kg/m(2). The conversion rate was independent from the BMI of the patient (3.8% vs 4.5%, p = .80). Neither mean operative time (187.5 vs 172 min, p = .11) neither hospital stay (5.2 vs 4.9 days, p = .44) were related with BMI. Lymphadenectomy was considered not feasible in 7 obese (17%) and 8 nonobese (7%) women (p = 0.09). Fewer lymph nodes were retrieved among obese women (8 versus 11, p <.0002). No differences were found between the groups in terms of perioperative complications. Median follow-up was 69 and 71 months for the obese and nonobese, respectively (p = .59). Overall and disease-free 5-year survival rates did not differ between obese and nonobese patients (90.3% and 87.5% versus 88.5% and 89.8%, respectively). CONCLUSION: Despite some limitations, the laparoscopic approach seems to be particularly useful for obese patients with endometrial cancer, with similar survival and recurrence rates and without any more complications compared to the nonobese population.

Multicenter randomized phase II study comparing docetaxel plus curcumin versus docetaxel plus placebo in first-line treatment of metastatic castration-resistant prostate cancer.

BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) patients have a poor prognosis, and curcumin is known to have antineoplastic properties. On the basis of previous phase I and phase II studies, we investigated whether the association of curcumin with docetaxel could improve prognosis among mCRPC patients. METHODS: A total of 50 mCRPC patients (included from June 2014 to July 2016) treated with docetaxel in association with oral curcumin (6 g/d for 7 days every 3 weeks) versus placebo were included in this double-blind, randomized, phase II study. The primary endpoint was to evaluate the time to progression. Among the secondary endpoints, compliance, overall survival, prostate-specific antigen (PSA) response, safety, curcumin absorption, and quality of life were investigated. An interim analysis was planned in the modified intention-to-treat population with data at 6 months (22 patients per arm). RESULTS: Despite good compliance and a verified absorption of curcumin, no difference was shown for our primary endpoint: progression-free survival (PFS) between the placebo and curcumin groups was, respectively, 5.3 months versus 3.7 months, p = 0.75. Similarly, no difference was observed for the secondary objectives: PSA response rate (p = 0.88), overall survival (p = 0.50), and quality of life (p = 0.49 and p = 0.47). CONCLUSION: Even though our previous studies and data in the literature seemed to support an association between curcumin and cancer therapies in order to improve patient outcome and prognosis, the results from this interim analysis clearly showed that adding curcumin to mCRPC patients' treatment strategies was not efficacious. The study was discontinued on the grounds of futility.