A national, prospective observational study of first recurrence after primary treatment for gynecological cancer in Norway.

INTRODUCTION: Gynecological cancer patients are routinely followed up for five years after primary treatment. However, the value of such follow up has been debated, as retrospective studies indicate that first recurrence is often symptomatic and occurs within two to three years of primary treatment. We prospectively investigated time to first recurrence, symptoms at recurrence, diagnostic procedures, and recurrence treatment in gynecological cancer patients after primary curative treatment. MATERIAL AND METHODS: Clinicians from 21 hospitals in Norway interviewed 680 patients with first recurrence of gynecological cancer (409 ovarian, 213 uterine, and 58 cervical cancer patients) between 2012 and 2016. A standardized questionnaire was used to collect information on self-reported and clinical variables. RESULTS: Within two years of primary treatment, 72% of ovarian, 64% of uterine, and 66% of cervical cancer patients were diagnosed with first recurrence, and 54, 67, and 72%, respectively, had symptomatic recurrence. Of symptomatic patients, 25-50% failed to make an appointment before their next scheduled follow-up visit. Computer tomography was the most common diagnostic procedure (89% of ovarian, 76% of uterine, and 62% of cervical cancer patients), and recurrence treatment in terms of chemotherapy was most frequently planned (86% of ovarian, 46% of uterine, and 62% of cervical cancer patients). CONCLUSIONS: A majority of patients experienced symptomatic recurrence, but many patients failed to make an appointment earlier than scheduled. Most first recurrences occurred within two years of primary treatment; the mean annual incidence rate for years 3-5 after primary treatment was <7%. New models for follow up of gynecological cancer patients could be considered.

Late-week surgical treatment of endometrial cancer is associated with worse long-term outcome: Results from a prospective, multicenter study.

Surgery is the cornerstone in primary endometrial cancer treatment, and with curative intent it constitutes total hysterectomy and bilateral salpingo-oopherectomy. In addition, lymphadenectomy is performed in selected patients dependent on a preoperative risk assessment. Recent reports from the surgical approach to esophageal cancer reveal worse outcome when esophagectomy is performed later in the week. On this basis, we set out to explore weekday of surgery in relation to long-term outcome in 1302 endometrial cancer patients prospectively included in the MoMaTEC multicenter study. Day of surgery was dichotomized as early-week (Monday-Tuesday) or late-week (Wednesday-Friday), and evaluated as a discrete variable. Adjusted for patient age, Body Mass Index (BMI), FIGO stage, and histology, surgery performed later in the week was associated with 50.9% increased risk of all-cause death (p = 0.029). Among high-stage patients (FIGO stage III and IV), 5-year disease-specific survival proportions were 53.0% for early-week operated vs. 40.2% for late-week operated (p = 0.005 for difference). In multivariate survival analysis of high-stage patients, late-week surgery correlated with an increased risk of disease-specific death by 88.7% and all-cause death by 76.4% (p<0.017). Evaluating only patients who underwent lymphadenectomy, the adverse prognostic effect of being operated late-week remained for both disease-specific and all-cause death (HR 2.151 and HR 1.912, p = 0.004). Whether surgery was performed early- or late-week was not influenced by patient age, BMI, preoperative histology risk classification, FIGO stage or postoperative histology (all p>0.05). In conclusion, endometrial cancer surgery conducted late-week is associated with worse long-term outcome. Our findings are most evident among patients with higher FIGO stages, and patients who underwent more extensive surgical procedure (lymphadenectomy). With support from other studies, our results suggest that high-risk patients may benefit from surgery earlier in the week.

Changes in Chromatin Structure in Curettage Specimens Identifies High-Risk Patients in Endometrial Cancer.

BACKGROUND: Most endometrial carcinoma patients are diagnosed at an early stage with a good prognosis. However, a relatively low fraction with lethal disease constitutes a substantial number of patients due to the high incidence rate. Preoperative identification of patients with high risk and low risk for poor outcome is necessary to tailor treatment. Nucleotyping refers to characterization of cell nuclei by image cytometry, including the assessment of chromatin structure by nuclear texture analysis. This method is a strong prognostic marker in many cancers but has not been evaluated in preoperative curettage specimens from endometrial carcinoma. METHODS: The prognostic impact of changes in chromatin structure quantified with Nucleotyping was evaluated in preoperative curettage specimens from 791 endometrial carcinoma patients prospectively included in the MoMaTEC multicenter trial. RESULTS: Nucleotyping was an independent prognostic marker of disease-specific survival in preoperative curettage specimens among patients with Federation Internationale des Gynaecologistes et Obstetristes (FIGO) stage I-II disease (HR=2.9; 95% CI, 1.2-6.5; P = 0.013) and significantly associated with age, FIGO stage, histologic type, histologic grade, myometrial infiltration, lymph node status, curettage histology type, and DNA ploidy. CONCLUSIONS: Nucleotyping in preoperative curettage specimens is an independent prognostic marker for disease-specific survival, with potential to supplement existing parameters for risk stratification to tailor treatment. IMPACT: This is the first study to evaluate the prognostic impact of Nucleotyping in curettage specimens from endometrial carcinoma and shows that this may be a clinically useful prognostic marker in endometrial cancer. External validation is warranted. Cancer Epidemiol Biomarkers Prev; 26(1); 61-67. ©2016 AACR.

Robotic camera holder as good as expert camera holder: a randomized crossover trial.

INTRODUCTION: This study aimed to compare the impact of robotic camera holder (RCH) and human camera holder (HCH) on product quality and procedure effectiveness of a simulated laparoscopic procedure. METHODS: This was a prospective randomized crossover trial including voluntary surgical residents. Block randomization generated RCH-HCH or HCH-RCH sequence allocation. The task was suturing a duodenal perforation on foam stomach with intracorporeally knot tying in a simulator. The camera was operated by the same robot and same expert. Product quality was measured by accuracy error, tissue damage, sliding knot, and leak. Procedure effectiveness was measured by operating time, nongoal directed actions, and dangerous actions. Kendall's coefficient tau_b was used for interrater reliability between 2 blinded assessors. RESULTS: Forty-four subjects performed their tasks as allocated. Product quality and procedure effectiveness were similar when first attempt of task was compared with the repeat task by same subject ignoring the type of camera holder. There was no evidence of significant unequal carryover effect when comparison was stratified by RCH-HCH or HCH-RCH sequences. There were no differences in product quality and procedure effectiveness when RCH was compared with HCH. Coefficient tau_b was > or = 0.80 for all but dangerous actions (0.72, P=0.08). CONCLUSIONS: RCH and HCH had similar impact on product quality and procedure effectiveness of simulated laparoscopic procedure.

The impact of sleep deprivation on product quality and procedure effectiveness in a laparoscopic physical simulator: a randomized controlled trial.

BACKGROUND: To compare the impact of sleep deprivation after 24-hour duty (post-call) with that of 8-hour work (post-work) on product quality (PQ) and procedure effectiveness (PE) in a laparoscopic physical simulator. METHODS: Voluntary surgeons and nurses were pretested with the Epworth Sleepiness Scale (ESS) and Minimally Invasive Surgical Trainer-Virtual Reality (MIST-VR). Surgical task was suturing perforated ulcer on a foam stomach in a physical simulator. PQ and PE were measured by accuracy error (AE), tissue damage (TD) leak rate (LR), goal- (GDA) non-goal-directed actions (NGDA), and operating time (OT), respectively. Construct validity was assessed comparing measures when surgeons and nurses performed the surgical task. Inter-rater reliability (IRR) was assessed by Kendall's tau b coefficient. An 80% power parallel block randomization design at alpha = .05 required 60 subjects. RESULTS: Thirty-two post-call surgeons and 32 post-work surgeons were well matched for age, gender, practice duration, and ESS and MIST-VR scores. The amount of time slept in the previous 24 hours was 1.5 versus 6.5 hours (P < .05). AE (1.0 mm vs. .5 mm), TD (2.18 mm vs. 2.18 mm), LR (56.2% vs. 65.6%), GDA (33.5 vs. 32.5), NGDA (.56 vs. .31), and OT (381.0 seconds vs. 364.5 seconds) were not significantly different when 32 surgeons in the post-call arm were compared with their 32 counterparts in the post-work arm, respectively. Construct validity was shown by significant improvement in 4 outcome measures (AE 1.0 mm vs. 2.0 mm, P = .00001; GDA 32.5 vs. 39.0, P = .07, NGDA .43 vs. .96, P = .045; and OT 377.5 vs. 557.0, P = .0005) when 64 surgeons performed the task as compared to 64 nurses. Tau b for IRR was 1.0 (P < .0001) for AE, TD, LR, and OT, .75 (P = .325) for GDA, and .77 (P = .305) for NGDA. CONCLUSIONS: Sleep deprivation had no impact on the studied outcome measures of a surgical task performed in a laparoscopic simulator.