Incidence of postoperative thrombotic events in ovarian cancer patients with a de-escalated prophylactic strategy: A retrospective cohort study.

OBJECTIVE: This study aimed to determine the incidence of thrombotic events in ovarian cancer patients following a de-escalated prophylactic strategy and to stratify risk groups. METHODS: We reviewed the records of patients who underwent debulking surgery for ovarian cancer at a single institution between January 2007 and May 2019. We identified clinically diagnosed and radiologically confirmed cases of thrombotic events-classified as pulmonary thromboembolism (PE), deep vein thrombosis (DVT), and other thrombotic events-within 6 months of debulking surgery. RESULTS: After excluding 13 patients diagnosed with thromboembolism at the baseline or during neoadjuvant chemotherapy, 799 were analyzed. Since the introduction of medical prophylaxis at our institution in 2009, 482 patients (60%) received medical prophylaxis with subcutaneous injection of low molecular weight heparin for 5 days with mechanical prophylaxis, whereas 317 (40%) received mechanical prophylaxis only. After debulking surgery, thrombotic events occurred in 28 patients (3.5%) including PE (n = 11), DVT (n = 10), and other thrombotic events (n = 7). Multivariable analysis identified age, body mass index (BMI), and operative duration as independent risk factors associated with thrombotic events. A thrombotic event was an independent prognostic factor for overall survival (HR 2.17, 95% CI 1.16-4.1). A cut-off analysis for pre-operative identifiable risk factors showed age < 57 years and BMI < 21 could help define low-risk groups. One patient from 172 low-risk patients (0.58%) experienced a thrombotic event. CONCLUSIONS: The thrombotic event incidence was low in our cohort. A de-escalated prophylaxis strategy may be considered in young (age < 57 years) and lean (BMI < 21) patients.

Efficacy and Cost-effectiveness of Surgical Biopsy for Histologic Diagnosis of Indeterminate Nodules Suspected for Early Stage Lung Cancer: Comparison with Percutaneous Needle Biopsy.

BACKGROUND: Indeterminate pulmonary nodules (IPN) suspected for early stage lung cancer mandate accurate diagnosis. Both percutaneous needle biopsy (PCNB) and surgical biopsy (SB) are valuable options. The present study aimed to compare the efficacy and cost-effectiveness between PCNB and SB for IPN suspected for early stage lung cancer. METHODS: During January-November 2018, patients who underwent operation for IPN suspected for early stage lung cancer (SB group, n = 245) or operation after PCNB (PCNB group, n = 113) were included. Patient-level cost data were extracted from medical bills from the institution. Propensity score matching was performed between the two groups from a retrospectively-collected database. RESULTS: Fifteen patients (11.5%) had complications after PCNB; thirteen (11.5%) were not confirmed to have lung cancer through PCNB but underwent operation for IPN. In SB group, 172 (70.2%) and 7 (2.9%) patients underwent wedge resection and segmentectomy for SB, respectively; 66 patients (26.9%) underwent direct lobectomy without SB. After propensity score matching, 58 paired samples were produced. Most patients in PCNB group were admitted twice (n = 55, 94.8%). The average hospital stay was longer in PCNB group (12.9 ± 5.3 vs. 7.3 ± 3.0, P < 0.001). Though the cost of the operation was comparable (USD 12,509 ± 2,909 vs. 12,669 ± 3,334; P = 0.782), the total cost was higher for PCNB group (USD 14,403 ± 3,085 vs. 12,669 ± 3,334; P = 0.006). The average subcategory cost, which increases proportional to hospital stay, was higher in PCNB group, whereas the cost of operation and surgical materials were comparable between the two groups. CONCLUSION: Lung cancer operation following SB for IPN was associated with lesser cost, shorter hospital stays, and lesser admission time than lung cancer operation after PCNB. The increased cost and longer hospital stay appear largely related to the admission for PCNB.

Early Assessment of Response to Neoadjuvant Chemotherapy with 18F-FDG-PET/CT in Patients with Advanced-Stage Ovarian Cancer.

PURPOSE: The aim of this study was to evaluate the ability of sequential 18F-fluorodeoxyglucose positron emission tomography/computed tomography (18F-FDG-PET/CT) after one cycle of neoadjuvant chemotherapy (NAC) to predict chemotherapy response before interval debulking surgery (IDS) in advanced-stage ovarian cancer patients. MATERIALS AND METHODS: Forty consecutive patients underwent 18F-FDG-PET/CT at baseline and after one cycle of NAC. Metabolic responses were assessed by quantitative decrease in the maximum standardized uptake value (SUVmax) with PET/CT. Decreases in SUVmax were compared with cancer antigen 125 (CA-125) level before IDS, response rate by Response Evaluation Criteria in Solid Tumors criteria before IDS, residual tumor at IDS, and I chemotherapy response score (CRS) at IDS. RESULTS: A 40% cut-off for the decrease in SUVmax provided the best performance to predict CRS 3 (compete or near-complete pathologic response), with sensitivity, specificity, and accuracy of 81.8%, 72.4%, and 72.4%, respectively. According to this 40% cut-off, there were 17 (42.5%) metabolic responders (≥ 40%) and 23 (57.5%) metabolic non-responders (< 40%). Metabolic responders had higher rate of CRS 3 (52.9% vs. 8.7%, p=0.003), CA-125 normalization (< 35 U/mL) before IDS (76.5% vs. 39.1%, p=0.019), and no residual tumor at IDS (70.6% vs. 31.8%, p=0.025) compared with metabolic non-responders. There were significant associations with progression-free survival (p=0.021) between metabolic responders and non-responders, but not overall survival (p=0.335). CONCLUSION: Early assessment with 18F-FDG-PET/CT after one cycle of NAC can be useful to predic response to chemotherapy before IDS in patients with advanced-stage ovarian cancer.

Development and validation of the smart management strategy for health assessment tool-short form (SAT-SF) in cancer survivors.

PURPOSE: The aim of this study was to develop and validate a short form (SF) of the Smart Management Strategy for Health Assessment Tool (SAT) for cancer patients. METHODS: Data for item reduction were derived from cancer patient data (n = 300) previously used to develop the original SAT. We used regression methods to select and score the new SAT-SF. To assess the instrument's reliability and validity, we recruited another 354 cancer patients from the same hospitals who were older than 18 years and accustomed to using the web. All results were compared with that of the long-form SAT (original SAT). RESULTS: The SAT-SF used is the shorter version, a 30-item (from the original 91-item) instrument, to measure cancer patient's health. The 30-item SAT-SF explained 97.7% of total variance of the full 91-item long-form SAT. All SAT-SF subscales demonstrated a high reliability with good internal consistency compared with the original SAT. The total short-form scores of the three SAT sets (SAT-Core, SAT-Preparation, SAT-Implementation) differentiated participant groups according to their stage of goal implementation and percentage of actions taken in the 10 Rules for Highly Effective Health Behavior. We found acceptable correlations between the three SAT-SF sets and the additional assessment tools compared with the original SAT. CONCLUSIONS: The 30-item SAT-SF had a satisfactory internal consistency and validity for cancer patients with minimal loss of information compared with the original SAT.

External validation of chemotherapy response score system for histopathological assessment of tumor regression after neoadjuvant chemotherapy in tubo-ovarian high-grade serous carcinoma.

OBJECTIVE: The chemotherapy response score (CRS) system based on histopathological examination has been recently proposed for tubo-ovarian high-grade serous carcinoma (HGSC) to assess response to neoadjuvant chemotherapy (NAC). This study was aimed at validating the CRS system in an external cohort of tubo-ovarian HGSC patients. METHODS: This study included 110 tubo-ovarian HGSC patients who underwent NAC followed by interval debulking surgery. The 3-tiered CRS of the omental and adnexal tissue sections was determined by 3 independent pathologists. Differences in patient outcomes according to CRS were analyzed. RESULTS: The CRS system was highly reproducible among the 3 pathologists. Fleiss' kappa value and Kendall's coefficient of concordance for the omental CRS were 0.656 and 0.669, respectively. The omental CRS significantly predicted progression-free survival (PFS). The median PFS of patients whose tumors exhibited the omental CRS 1-2 (15 months) was significantly shorter than that of patients with an omental CRS of 3 (19 months; p=0.016). In addition, after adjusting for age, stage, and debulking status, the omental CRS was an independent prognostic factor for PFS of tubo-ovarian HGSC patients who were treated with NAC (adjusted hazard ratio [HR]=1.74; 95% confidence interval [CI]=1.05-2.87). CONCLUSION: The CRS system for assessing NAC response was a reproducible prognostic tool in our cohort. The application of the CRS system after NAC can improve survival estimation in HGSC patients.

A novel algorithm for the treatment strategy for advanced epithelial ovarian cancer: consecutive imaging, frailty assessment, and diagnostic laparoscopy.

BACKGROUND: This study aimed to evaluate the perioperative outcomes and prognostic impact of the consecutive steps of imaging, frailty assessment, and diagnostic laparoscopy (DLS) in patients with advanced epithelial ovarian cancer (EOC). METHODS: Patients diagnosed with EOC during 2012-2015 were analyzed retrospectively. Surgical and survival outcomes were compared between three treatment groups: patients without high tumor dissemination (HTD) who underwent primary debulking surgery (PDS group); patients with HTD who underwent DLS (DLS group); and patients with HTD diagnosed by cytological confirmation of malignancy followed by neoadjuvant chemotherapy (NACT group). RESULTS: Of 181 patients, 85, 38, and 58 underwent PDS, DLS, and NACT, respectively. Among the 38 consecutive patients who initially underwent DLS, 6 were considered suitable for PDS; the remaining 32 were eligible for NACT followed by interval debulking surgery. The median operative times of debulking surgery in the PDS, DLS, and NACT groups were 365 min (interquartile range [IQR]: 216.5-476.5 min), 266.2 min (IQR: 160.3-193.5 min), and 339.0 min (IQR: 205-425 min; P = 0.042), respectively, with respective median estimated blood loss volumes of 962.2 mL (IQR: 300-1037.5 mL), 267.1 mL (IQR: 150-450 mL), and 861.7 mL (IQR: 150-1200 mL; P = 0.023). The DLS group had significantly reduced transfusion requirements and intensive care unit admission rates (P = 0.006). The Kaplan-Meier survival analysis indicated significantly poor PFS in the NACT group. However, there was no significant difference in OS among the three groups. CONCLUSIONS: The consecutive steps of imaging, frailty assessment, and DLS might facilitate rapid assessments of peritoneal disease extent and resectability; this novel algorithm might also be used to individualize treatment.

CT assessment-based direct surgical resection of part-solid nodules with solid component larger than 5 mm without preoperative biopsy: experience at a single tertiary hospital.

OBJECTIVES: To retrospectively evaluate the feasibility of CT assessment-based direct surgical resection of part-solid nodules (PSNs) with solid components > 5 mm without preoperative percutaneous transthoracic needle biopsies (PTNBs). METHODS: From January 2009-December 2014, 85 PSNs with solid components > 5 mm on CT were included. Preoperative PTNBs were performed for 41 PSNs (biopsy group) and CT assessment-based direct resections were performed for 44 PSNs (direct surgery group). Diagnostic accuracy and complication rates of the groups were compared. RESULTS: Pathological results of 83 PSNs excluding two indeterminate nodules included 76 adenocarcinomas (91.6%), two adenocarcinomas in situ (2.4%) and five benign lesions (6.0%). In the biopsy group, the overall sensitivity, specificity and accuracy for the diagnosis of adenocarcinoma were 78.9% (30/38), 100% (1/1) and 79.5% (31/39), respectively. Pneumothorax and haemoptysis occurred in 11 procedures (26.8%). In the direct surgery group, the respective values for the diagnosis of adenocarcinoma were 100% (38/38), 0% (0/6) and 86.4% (38/44), respectively. Seven pneumothoraces (15.9%); no haemoptysis occurred during localization procedures. There were no significant differences in diagnostic accuracy (P = 0.559) between the two groups. CONCLUSIONS: CT assessment-based direct resection can be reasonable for PSNs with solid part > 5 mm. KEY POINTS: • 91.6% of PSNs with solid component > 5 mm were adenocarcinomas. • PTNBs for PSNs with solid component > 5 mm had 79.5% accuracy. • CT-based resection for PSNs with solid component > 5 mm had 86.4% accuracy. • CT-based resection without biopsy can be a reasonable option in routine practice.

Perceived needs for the information communication technology (ICT)-based personalized health management program, and its association with information provision, health-related quality of life (HRQOL), and decisional conflict in cancer patients.

OBJECTIVE: The use of information communication technology (ICT)-based tailored health management program can have significant health impacts for cancer patients. Information provision, health-related quality of life (HRQOL), and decision conflicts were analyzed for their relationship with need for an ICT-based personalized health management program in Korean cancer survivors. METHODS: The health program needs of 625 cancer survivors from two Korean hospitals were analyzed in this cross-sectional study. Multivariate logistic regression was used to identify factors related to the need for an ICT-based tailored health management system. Association of the highest such need with medical information experience, HRQOL, and decision conflicts was determined. Furthermore, patient intentions and expectations for a web- or smartphone-based tailored health management program were investigated. RESULTS: Cancer survivors indicated high personalized health management program needs. Patients reporting the highest need included those with higher income (adjusted odds ratio [aOR], 1.70; 95% [confidence interval] CI, 1.10-2.63), those who had received enough information regarding helping themselves (aOR, 1.71; 95% CI, 1.09-2.66), and those who wished to receive more information (aOR, 1.59; 95% CI, 0.97-2.61). Participants with cognitive functioning problems (aOR, 2.87; 95%CI, 1.34-6.17) or appetite loss (aOR, 1.77; 95% CI, 1.07-2.93) indicated need for a tailored health care program. Patients who perceived greater support from the decision-making process also showed the highest need for an ICT-based program (aOR, 0.49; 95% CI, 0.30-0.82). CONCLUSIONS: We found that higher income, information provision experience, problematic HRQOL, and decisional conflicts are significantly associated with the need for an ICT-based tailored self-management program.

Treatment preferences of advanced ovarian cancer patients for adding bevacizumab to first-line therapy.

BACKGROUND: The GOG-218 and ICON-7 studies recently showed that adding bevacizumab to first-line therapy for patients with advanced ovarian cancer increased progression-free survival. However, the high cost and long treatment duration prevents the incorporation of bevacizumab in practice. The aim of this study was to explore and quantify patients' preferences for adding bevacizumab to first-line therapy. METHODS: A discrete choice experiment (DCE) and trade-off question were designed and distributed to 102 ovarian cancer patients. Participants were asked to choose between two hypothetical first-line therapies that differed in terms of effectiveness, safety, and the financial burden. A trade-off technique varying the cost of bevacizumab was used to quantify a willingness-to-pay threshold for selecting bevacizumab. RESULTS: All attributes of the DCE had a statistically significant impact on respondents' preferences and the financial burden was the most important attribute. The results of the trade-off question showed that more than half of patients would prefer to add bevacizumab to standard chemotherapy when the cost of the drug was reduced to 17% (1/6) of the baseline cost. CONCLUSION: Patients' preferences for bevacizumab in the adjuvant treatment of ovarian cancer depend primarily on drug costs. Our results suggest that the current cost of bevacizumab is sufficiently high that the majority of ovarian cancer patients are not willing to pay to accept a small increase in progression-free survival.

Patient-reported assessment of self-management strategies of health in cancer patients: development and validation of the Smart Management Strategy for Health Assessment Tool (SAT).

OBJECTIVE: The objective of this study was to evaluate the psychometric properties of the Smart Management Strategy for Health Assessment Tool (SAT), which we developed to enable cancer patients to assess their self-management (SM) strategies of health by themselves. PATIENTS AND METHODS: The development of the questionnaire included four phases: item generation, construction, pilot testing, and field testing. To assess the instrument's sensitivity and validity, we recruited 300 cancer patients from three Korean hospitals who were 18 or more years old and accustomed to using the Internet or email. Using the appropriate and priority criteria for pilot and field testing, we tightened the content and constructed the first version of the SAT. RESULTS: We developed the core strategies with 28 items, preparation strategies with 30 items, and implementation strategies with 33 items. Factor analysis of data from 300 patients resulted in core strategies with four factors, preparation strategies with five factors, and implementation strategies with six factors. All the SAT subscales demonstrated a high reliability with good internal consistency. The total scores of the three SAT sets differentiated participant groups well according to their stage of goal implementation and proportions of action of the 10 Rules for Highly Effective Health Behavior. Each factor of the three SAT sets correlated positively with the scores for additional assessment tool. CONCLUSION: The SAT is a three-set, 16-factor, 91-item tool that assesses the SM strategies of health that patients use to overcome a crisis. Patients can use the SAT to assess their SM strategies of health and obtain feedback from clinicians in the practice setting.

Cost-utility analysis for platinum-sensitive recurrent ovarian cancer therapy in South Korea: results of the polyethylene glycolated liposomal doxorubicin/carboplatin sequencing model.

OBJECTIVE: We performed a cost-utility analysis to assess the cost-effectiveness of a chemotherapy sequence including a combination of polyethylene glycolated liposomal doxorubicin (PLD)/carboplatin versus paclitaxel/carboplatin as a second-line treatment in women with platinum-sensitive ovarian cancer. METHODS: A Markov model was constructed with a 10-year time horizon. The treatment sequence consisted of first- to sixth-line chemotherapies and best supportive care (BSC) before death. Cycle length, a time interval for efficacy evaluation of chemotherapy, was 9 weeks. The model consisted of four health states: responsive, progressive, clinical remission, and death. At any given time, a patient may have remained on a current therapy or made a transition to the next therapy or death. Median time to progressions and overall survivals data were obtained through a systematic literature review and were pooled using a meta-analytical approach. If unavailable, this was elicited from an expert panel (eg, BSC). These outcomes were converted to transition probabilities using an appropriate formula. Direct costs included drug-acquisition costs for chemotherapies, premedication, adverse-event treatment and monitoring, efficacy evaluation, BSC, drug administration, and follow-up tests during remission. Indirect costs were transportation expenses. Utilities were also derived from the literature. Costs and utilities were discounted at an annual rate of 5% per cycle. RESULTS: PLD/carboplatin combination as the second line in the sequence is more effective and costly than paclitaxel/carboplatin combination, showing an additional US$21,658 per quality-adjusted life years. This result was robust in a deterministic sensitivity analysis except when median time to progression of second-line therapies and administration cost of PLD/carboplatin per administration cycle were varied. The probability of cost-effectiveness for PLD/carboplatin combination was 49.4% at a willingness to pay $20,000. CONCLUSION: A PLD/carboplatin combination is an economically valuable option as second-line chemotherapy for the treatment of platinum-sensitive ovarian cancer in South Korea.

Comparisons of surgical outcomes, complications, and costs between laparotomy and laparoscopy in early-stage ovarian cancer.

OBJECTIVES: The purpose of this study was to compare the surgical outcomes, complications, and costs between laparoscopic staging and laparotomic staging for early-stage ovarian cancer. METHODS: We evaluated 113 patients who underwent laparoscopy (n = 26) or laparotomy (n = 87) for staging. We retrospectively analyzed patients' demographics and operative variables, including operative time, estimated blood loss, lymph node count, hospital stay, complications, postoperative pain, and return to normal activity. In addition, costs for laparoscopy and laparotomy groups were also compared. RESULTS: The mean operation time was longer in laparoscopy group compared to laparotomy group (227.6 minutes vs 184.6 minutes, P = 0.016). The laparoscopy group had less intraoperative blood loss, less transfusion requirement, shorter postoperative hospital stay, earlier general diet intake, shorter time to adjuvant chemotherapy, and lower postoperative pain score after 6, 24, and 48 hours compared with the laparotomy group. The mean number of lymph node retrievals was comparable between the groups. The incidence of operative complications was lower in the laparoscopy group (7.7%) relative to the laparotomy group (23.0%). The total average cost for staging completed via laparotomy was $1237 and that via laparoscopy was $1998, with significant difference. CONCLUSIONS: Complete surgical staging by laparoscopy was achieved in all cases with comparable operative time and less operative complications compared with laparotomy for selected patients with early-stage ovarian cancer. However, the operation costs for laparoscopy were significantly higher than the operation costs for laparotomic staging surgery.

Role of robot-assisted surgery in cervical cancer.

BACKGROUND: The development of robotic technology has facilitated the application of minimally invasive techniques for complex operations in gynecologic oncology. OBJECTIVES: The objective of the study was to assess and summarize the current literature on the role of robot-assisted surgery in cervical cancer in terms of its utility and outcome. METHODS: Literature review concerning the use of robot-assisted technology in the management of cervical cancer, including radical hysterectomy, trachelectomy, parametrectomy, pelvic and aortic lymphadenectomy, and pelvic exenteration, was performed. RESULTS: To date, 12 articles addressing radical hysterectomy, 5 articles of radical trachelectomy, and 6 articles of surgical procedure in advanced or recurrent cervical cancer, all performed robotically, are published in the literature. The advantages of the robotic system include 3-dimensional vision, tremor reduction, motion downscaling, improved ergonomics, and greater dexterity with instrument articulation. Because of these benefits, the robotic technology seems to facilitate the surgical approach for technically challenging operations performed to treat primary, early or advanced, and recurrent cervical cancer as evidenced by the current literature. CONCLUSIONS: Surgical management of cervical cancer may be one of the gynecologic oncology surgeries that can take full advantage of robotic assistance in a minimally invasive manner. Continued research and clinical trials are needed to further elucidate the equivalence or superiority of robot-assisted surgery to conventional methods in terms of oncological outcome and patient's quality of life.

Costs for 5-year lung cancer survivors in a tertiary care hospital in South Korea.

INTRODUCTION: As the population of patients with lung cancer increases, the expenditure on lung cancer treatment will become a huge economic burden in many countries. To support public health services for the treatment of lung cancer, the calculation of lung cancer-specific costs is important. METHODS: This study included newly diagnosed 76 lung cancer patients who had survived for at least 5 years after the diagnosis in a tertiary care hospital in South Korea. Direct medical costs were calculated from health care claims obtained from Seoul National University Hospital, which included out-of-pocket expenditures. Direct non-medical and indirect costs were calculated from national statistics. RESULTS: Mean direct medical costs, direct non-medical costs, and indirect costs amounted to $21,321, $6444 and $4943 respectively, based on an exchange rate of Korean Won 1200=US $1. The average cost for treatment of one lung cancer patient for all 5 years was $32,708. This constituted 44.7% of the per capita income during the same 5-year period. CONCLUSION: The economic burden of lung cancer treatment is significant in Korea.