Survey of Opioid Risk Tool Among Cancer Patients Receiving Opioid Analgesics.

BACKGROUND: The risk of opioid-related aberrant behavior (OAB) in Korean cancer patients has not been previously evaluated. The purpose of this study is to investigate the Opioid Risk Tool (ORT) in Korean cancer patients receiving opioid treatment. METHODS: Data were obtained from a multicenter, cross-sectional, nationwide observational study regarding breakthrough cancer pain. The study was conducted in 33 South Korean institutions from March 2016 to December 2017. Patients were eligible if they had cancer-related pain within the past 7 days, which was treated with strong opioids in the previous 7 days. RESULTS: We analyzed ORT results of 946 patients. Only one patient in each sex (0.2%) was classified as high risk for OAB. Moderate risk was observed in 18 males (3.3%) and in three females (0.7%). Scores above 0 were primarily derived from positive responses for personal or familial history of alcohol abuse (in men), or depression (in women). In patients with an ORT score of 1 or higher (n = 132, 14%), the score primarily represented positive responses for personal history of depression (in females), personal or family history of alcohol abuse (in males), or 16-45 years age range. These patients had more severe worst and average pain intensity (proportion of numeric rating scale ≥ 4: 20.5% vs. 11.4%, P < 0.001) and used rescue analgesics more frequently than patients with ORT scores of 0. The proportion of moderate- or high-risk patients according to ORT was lower in patients receiving low doses of long-acting opioids than in those receiving high doses (2.0% vs. 6.6%, P = 0.031). Moderate or high risk was more frequent when ORT was completed in an isolated room than in an open, busy place (2.7% vs. 0.6%, P = 0.089). CONCLUSIONS: The score of ORT was very low in cancer patients receiving strong opioids for analgesia. Higher pain intensity may associate with positive response to one or more ORT item.

"The surprise questions" using variable time frames in hospitalized patients with advanced cancer.

OBJECTIVE: Several studies supported the usefulness of "the surprise question" in terms of 1-year mortality of patients. "The surprise question" requires a "Yes" or "No" answer to the question "Would I be surprised if this patient died in [specific time frame]." However, the 1-year time frame is often too long for advanced cancer patients seen by palliative care personnel. "The surprise question" with shorter time frames is needed for decision making. We examined the accuracy of "the surprise question" for 7-day, 21-day, and 42-day survival in hospitalized patients admitted to palliative care units (PCUs). METHOD: This was a prospective multicenter cohort study of 130 adult patients with advanced cancer admitted to 7 hospital-based PCUs in South Korea. The accuracy of "the surprise question" was compared with that of the temporal question for clinician's prediction of survival. RESULTS: We analyzed 130 inpatients who died in PCUs during the study period. The median survival was 21.0 days. The sensitivity, specificity, and overall accuracy for the 7-day "the surprise question" were 46.7, 88.7, and 83.9%, respectively. The sensitivity, specificity, and overall accuracy for the 7-day temporal question were 6.7, 98.3, and 87.7%, respectively. The c-indices of the 7-day "the surprise question" and 7-day temporal question were 0.662 (95% CI: 0.539-0.785) and 0.521 (95% CI: 0.464-0.579), respectively. The c-indices of the 42-day "the surprise question" and 42-day temporal question were 0.554 (95% CI: 0.509-0.599) and 0.616 (95% CI: 0.569-0.663), respectively. SIGNIFICANCE OF RESULTS: Surprisingly, "the surprise questions" and temporal questions had similar accuracies. The high specificities for the 7-day "the surprise question" and 7- and 21-day temporal question suggest they may be useful to rule in death if positive.

Is spirituality related to survival in advanced cancer inpatients in Korea?

OBJECTIVE: Spirituality is what gives people meaning and purpose in life, and it has been recognized as a critical factor in patients' well-being, particularly at the ends of their lives. Studies have demonstrated relationships between spirituality and patient-reported outcomes such as quality of life and mental health. Although a number of studies have suggested that spiritual belief can be associated with mortality, the results are inconsistent. We aimed to determine whether spirituality was related to survival in advanced cancer inpatients in Korea. METHOD: For this multicenter study, we recruited adult advanced cancer inpatients who had been admitted to seven palliative care units with estimated survival of <3 months. We measured spirituality at admission using the Korean version of the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-sp), which comprises two subscales: meaning/peace and faith. We calculated a Kaplan-Meier curve for spirituality, dichotomized at the predefined cutoffs and medians for the total scale and each of the two subscales, and performed univariate regression with a Cox proportional hazard model.ResultWe enrolled a total of 204 adults (mean age: 64.5 ± 13.0; 48.5% female) in the study. The most common primary cancer diagnoses were lung (21.6%), colorectal (18.6%), and liver/biliary tract (13.0%). Median survival was 19.5 days (95% confidence interval [CI95%]: 23.5, 30.6). Total FACIT-sp score was not related to survival time (hazard ratio [HR] = 0.981, CI95% = 0.957, 1.007), and neither were the scores for its two subscales, meaning/peace (HR = 0.969, CI95% = 0.932, 1.008) and faith (HR = 0.981, CI95% = 0.938, 1.026).Significance of resultsSpirituality was not related to survival in advanced cancer inpatients in Korea. Plausible mechanisms merit further investigation.

End-of-life care decisions using a Korean advance directive among cancer patient-caregiver dyads.

OBJECTIVE: The Korean advance directive (K-AD) comprises a value statement, treatment directives, preferences for cardiopulmonary resuscitation (CPR), artificial ventilation, tube feeding, and hospice care, as well as a proxy appointment. The K-AD can facilitate a patient's decision making with respect to end-of-life (EoL) care. The present study aimed to examine the extent to which patient-caregiver dyads would use the K-AD and agree on EoL care decisions. METHODS: Using a descriptive study design, 81 cancer patients were invited to participate. The final sample consisted of 44 patient-caregiver dyads who completed survey questionnaires, including the K-AD. One patient did not complete all parts of the questionnaire, and 36 (44.4%) declined to participate. Content analysis was conducted to examine the K-AD value statements. Cohen's kappa coefficient was calculated to determine the degree of patient-caregiver dyadic agreement on K-AD treatment directives (Sudore & Fried, 2010). RESULTS: Our patient participants had the following cancer diagnoses: colorectal 29.5%, breast 29.5%, and liver/biliary tract cancers, 15.9%. Half of the sample had advanced-stage disease. Spouses (70.5%) or adult children (20.4%) were the primary caregivers, with perceived bonding rated as fair (31.8%) or good (65.9%). Rejection of the K-AD was mainly due to the difficulty involved in deciding on EoL care (50%). Comfort while dying was the most common theme expressed by patients (73.8%) and caregivers (66.7%). In terms of treatment directives, dyads advocated for hospice care (66.7%) and reduced support for aggressive treatments of CPR or artificial ventilation. The use of CPR (κ = 0.43, p = 0.004) and artificial ventilation (κ = 0.28, p = 0.046) showed significantly mild to moderate concordance among the dyads. Some 16 of the 21 dyads identified their spouses as a proxy, with others designating their adult children. SIGNIFICANCE OF RESULTS: The degree of patient-caregiver concordance on the K-AD seemed applicable, and achieved mild to moderate concordance. Our findings are exploratory but suggest the need for EoL discussions where patient-caregiver dyads are encouraged to participate in EoL care decision making.

Safety, efficacy, and patient-perceived satisfaction of peripherally inserted central catheters in terminally ill cancer patients: a prospective multicenter observational study.

PURPOSE: The purpose of this study was to investigate the safety, efficacy, and subjective satisfaction of peripherally inserted central catheters (PICCs) in terminally ill cancer patients. METHODS: All PICCs were inserted by an interventional radiologist with radiological guidance. We monitored the occurrence of PICC-related complication and evaluated the patient-perceived satisfaction for PICC using semi-structured questionnaire. RESULTS: A total of 36 terminally ill cancer patients underwent PICC. Three patients had 2 PICC insertions; hence, finally 39 episodes during 829 PICC days were analyzed. All procedures were completed without any procedure-related complication. The median catheter life span was 19.0 days (95 % CI, 14.1-23.9). Thirty-four cases maintained the PICC until the intended time, while the other 5 cases (12.8 %; 6.1/1000 PICC days) were premature PICC removals. Totally 10 complications (25.6 %; 12.3/1000 PICC days) were reported including premature removals (n = 5), trivial bleedings (n = 3), and thrombophlebitis (n = 2). Patients reported that the procedure was not distressing (42 %), a little distressing (36 %), or distressing (21 %). Of 30 patients who had preserved cognitive function at fifth day, most patients (n = 25, 83 %) reported more comfort although the other 5 patients reported no change (n = 3) or less comfort (n = 2). CONCLUSIONS: PICCs were safely inserted and showed favorable maintenance rate with acceptable complications. Additionally, most of the patients felt that parenteral access became much comfortable after PICC insertion. When considering the characteristics of terminally ill cancer patients, poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access.

A Phase II Study About Efficacy and Safety of the Continuous IntraVenous Infusion of Ketamine as Adjuvant to Opioids in Terminally Ill Cancer Patients With Refractory Cancer Pain (CIVIK Trial).

BACKGROUND: Ketamine has been used to control refractory cancer pain as an adjuvant to opioids. We conducted a prospective phase II study to investigate the efficacy and safety of 5-day continuous intravenous infusion (CIVI) of Ketamine in terminally ill cancer patients with refractory cancer pain. METHODS: Hospitalized terminally ill cancer patients with refractory cancer pain were enrolled. Refractory cancer pain was indicated by requirements for 4 or more rescue opioids or pain intensity using numerical rating scale > personalized pain goal (PPG) despite of intravenous morphine equivalent daily dose (IV MEDD) ≥ 120 mg/day. The CIVI of ketamine was increased from .05 mg/kg/hour to .5 mg/kg/hour by .05 every 8 hours if pain intensity exceeded PPG or if number of rescue opioids ≥2 during prior 8 hours was required. The primary end-point was overall pain response rate, which indicates complete response (both rescue opioid ≤3/day and pain intensity ≤ PPG) plus partial response (rescue opioid ≤3/day), without unacceptable toxicities. RESULTS: Among 21 eligible patients enrolled between September 2019 and January 2023, 20 were analyzed. Most pain mechanisms were mixed type (n = 15, 75%), with neuropathic component (n = 17, 85%). The baseline background opioids were IV MEDD 186 mg/24hour (range, 124-592), number of rescue opioids was 6 (IQR, 5-9), and median PPG was 4 (IQR, 3-4). The overall pain response rate was 50% (n = 10) including 40% (n = 8) for complete pain response and 10% (n = 2) for partial pain response. CONCLUSION: This study showed efficacy of gradually increasing CIVI of ketamine for terminally ill cancer patients with refractory cancer pain. CIVI of ketamine could be a useful tool in these patients considering the limited treatment options. (NCT03362073, Initial Release: November 15, 2017).

Effectiveness of Adding Docetaxel to Androgen Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer in Korean Real-World Practice.

PURPOSE: Evidence in favor of adding docetaxel in treatment of metastatic hormone-sensitive prostate cancer (mHSPC) has led to docetaxel in conjunction with androgen deprivation therapy (ADT) as standard therapy. The aim of this study was to examine the effectiveness of docetaxel with ADT for Korean patients with mHSPC in real-world practice. MATERIALS AND METHODS: A retrospective cohort study was performed at six Korean hospitals for patients with mHSPC treated with docetaxel plus ADT. Patients were treated every 3 weeks for up to six cycles with 75 mg/m² of docetaxel. The primary endpoint was time to castration resistant prostate cancer (CRPC). RESULTS: This study included 46 eligible patients from June 2016 to February 2021. Median age was 68.5 years (range, 52-84) and all patients present with de novo M1 with high-volume disease. The median prostate-specific antigen (PSA) level at ADT initiation was 205.4 (7.7-1933) ng/mL, and time from ADT to docetaxel was 2.4 months (0-5.3). All six planned cycles of docetaxel were delivered in 36 patients (78%), 7 patients (15%) discontinued treatment due to adverse events, and 3 patients (7%) discontinued due to progression. At the time of the analysis, CRPC had developed in 34 patients (74%), and the median time to CRPC was 18.0 (95% confidence interval, 14.1-21.9) months. PSA <0.2 ng/mL was achieved in 11 patients (24%) after 6 months of ADT and in 10 patients (22%) after 12 months. At last follow-up, 35 patients (76%) were alive; the median overall survival was not reached. CONCLUSION: The effect of docetaxel combined with ADT for Korean patients with mHSPC is comparable with prior results in Western studies.

Phase II study of neoadjuvant chemotherapy with four cycles of dose-dense MVAC followed by radical cystectomy in Korean patients with muscle-invasive or locally advanced urothelial carcinoma of bladder.

PURPOSE: While previous retrospective or phase II studies in Western populations showed that dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) as neoadjuvant chemotherapy (NAC) was beneficial, no studies have been reported in Asian populations. This prospective phase II study aimed to evaluate efficacy and safety of ddMVAC in Korean patients with muscle-invasive bladder cancer (MIBC) or locally advanced urothelial cancer (UC). MATERIALS AND METHODS: Patients with MIBC (cT2-4aN0M0) or locally advanced UC (cTanyN1-3M0) eligible for radical cystectomy (RC) were enrolled prospectively. The participants were treated with four cycles of ddMVAC with pegfilgrastim every 2 weeks. The primary endpoint was pathologic response rate (≤ypT1N0). Secondary endpoints were pathologic complete response (pCR, ypT0N0), relapse-free survival (RFS), overall survival (OS), and safety. RESULTS: Among 24 patients enrolled between December 2019 and August 2021, 23 were evaluable (52%, cT2-4aN0; 48%, cTanyN1-3). Eighteen patients (78%) completed four cycles of ddMVAC, while remaining five patients experienced early discontinuation. Dose modification (91%) and dose delay (70%) occurred, and the dose intensity of ddMVAC was 79%. Nineteen patients underwent RC and four patients declined. Of 19 patients who underwent RC, eight patients (42%) achieved ≤ypT1N0. With a median follow-up of 22.8 months, the median RFS was 13.5 months (95% CI, not yet evaluable) and the median OS was 28.9 months (95% confidence interval, 19.9-37.9). CONCLUSION: Our study showed substantial efficacy and safety of ddMVAC, even in patients with locally advanced UC. The ddMVAC still should be a promising option as NAC in Asian patients with UC.

Comparison of prophylactic effects for chemotherapy induced neutropenia between same-day versus next-day administration of pegteograstim (Neurapeg®) in patients treated with chemotherapy regimen composed of day 1 intensive myleosuppressive agent: A randomized phase III clinical trial.

BACKGROUND AND PURPOSE: Administration of pegylated granulocyte-colony-stimulating factor (peg-GCSF) 24 to 72 hours after chemotherapy is usually recommended. Next-day administration (after 24 hours) resulted in fewer duration of grade (Gr) 4 chemotherapy-induced neutropenia (CIN) and decreased severity of CIN than same-day (within 4 hours). However, patients sometimes receive same-day Peg-GCSF for the sake of convenience. In addition, a few prior studies showed that the same-day method is comparable or superior to the next-day method in preventing CIN, especially in chemotherapy regimens that include day 1 myelosuppressive agents. Thus, we aim to verify the hypothesis that same-day administration of pegteograstim, a new formulation of peg-GCSF, is non-inferior to next-day administration in terms of Gr4 CIN duration. METHODS: This study is a randomized, multicenter, open-label, investigator-initiated phase 3 study. Patients with adjuvant/neoadjuvant or first-line palliative chemotherapy comprising intensively myelosuppressive agents on day 1 (mFOLFIRINOX, ECb, EP, FOLFIRI, and FOLFOX) are enrolled. The patients are assigned to the same-day arm or the next-day arm in a 1:1 ratio. The randomizations are stratified according to number of patient CIN risk factors (1 vs ≥2), chemotherapy setting (perioperative vs palliative), and interval (2-week vs 3-week). In the same-day arm, pegteograstim 6 mg is subcutaneously injected within 4 hours after completion of chemotherapy. In the next-day arm, pegetograstim is injected at 24 to 36 hours post-chemotherapy. A complete blood count test is performed daily from day 5 to 9 during the cycle 1. The primary endpoint is duration of Gr4 CIN (cycle 1), and secondary endpoints include incidence of Gr 3 to 4 CIN (cycle 1), severity of CIN (cycle 1), time to recovery absolute neutrophil count 1000/µL (cycle 1), incidence of febrile neutropenia, incidence of CIN-related dose delay, and dose intensity. In order to verify non-inferiority of 0.6 days, we estimated a significance level of 5%, power of 80%, and drop-out rate of 15%. This results in the need for a total of 160 patients, 80 in each group.

Comparative efficacy of sunitinib versus sorafenib as first-line treatment for patients with metastatic renal cell carcinoma.

BACKGROUND: This study investigated the efficacy and toxicity of sorafenib and sunitinib as primary treatment for patients with metastatic renal cell carcinoma (mRCC). METHODS: We identified 49 and 220 patients treated with sorafenib and sunitinib, respectively, as first-line therapy in the Asan Medical Centre from April 2005 to March 2011. RESULTS: Disease control rates of 71 and 74% were achieved with sorafenib and sunitinib, respectively (p = 0.687). After a median follow-up of 27.6 months, progression-free survival (PFS) and overall survival (OS) were not significantly different between the sorafenib and the sunitinib group (PFS 8.6 vs. 9.9 months, respectively, p = 0.948, and OS 25.7 vs. 22.6 months, p = 0.774). Patients treated with sorafenib required dose reduction due to toxicities less frequently than those treated with sunitinib (37 vs. 54%, p = 0.034). Haematological toxicity of grade 3 or 4 was more common in the sunitinib group than in the sorafenib group (45 vs. 4%, p < 0.001). Multivariate analysis showed old age, Heng's risk group, and bone and liver metastases, but not the type of vascular endothelial growth factor tyrosine kinase inhibitor, were independent prognostic factors affecting OS. CONCLUSION: The results of this study indicate that sorafenib has comparable efficacy to sunitinib in the treatment of mRCC patients and fewer and less severe toxicities, but the number of patients included in the study was small.

Prognostic model in patients with metastatic urothelial carcinoma receiving immune checkpoint inhibitors after platinum failure.

Immune checkpoint inhibitors (ICIs) have become a standard treatment for metastatic urothelial carcinoma (mUC) after platinum-based chemotherapy. However, the prognostic factors for patients with mUC receiving ICIs are not well established. We retrospectively collected clinical and laboratory data and reviewed the survival outcomes of patients with mUC who were treated with ICIs after platinum-based chemotherapy. We used univariate and multivariable Cox proportional hazard models to identify independent prognostic factors, and the concordance index (C-index) to evaluate the performance of the new prognostic model. In addition, bootstrap analysis was employed for internal validation of the prognostic model. A total of 224 patients were included in the study. With a median follow-up of 10.5 months (interquartile range, 5.1-17.4 months), median overall survival (OS) was 13.6 months (95% confidence interval [CI], 9.7-17.3 months). In multivariable analysis, independent prognostic factors predicting adverse OS were the presence of liver metastasis (LM), hypoalbuminemia, and neutrophil-lymphocyte ratio (NLR) >5. When patients were categorized into 3 risk groups, median OS was not reached (NR) (95% CI, 17.3-NR), 9.5 months (6.8-NR), and 2.9 months (2.3-4.4) for patients with a score of 0, 1, and 2+, respectively. The C-index for the new model was 0.763 (95% CI, 0.739-0.787). A novel prognostic model, including LM, hypoalbuminemia, and NLR, was developed and validated to estimate OS in patients with platinum-refractory disease on second- or subsequent-line ICI therapy. Further investigations, including prospective validation, are needed.

Genotypic and Phenotypic Characteristics of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome in Korean Patients.

BACKGROUND: Hereditary leiomyomatosis and renal cell cancer (HLRCC) is an autosomal dominant cancer predisposition syndrome. HLRCC is characterized by the development of cutaneous leiomyomas, early-onset uterine leiomyomas, and HLRCC-associated renal cell cancer (RCC) and caused by germline fumarate hydratase (FH) deficiency. We investigated the genotypic and phenotypic characteristics of Korean patients with HLRCC. METHODS: We performed direct sequencing analysis of FH in 13 patients with suspected HLRCC and their family members. A chromosomal microarray test was performed in female patients with negative sequencing results but highly suspected HLRCC. In addition, we analyzed the clinical characteristics and evaluated the genotype-phenotype correlations in Korean patients with HLRCC. RESULTS: We identified six different pathogenic or likely pathogenic FH variants in six of the 13 patients (46.2%). The variants included two nonsense variants, two splicing variants, one frameshift variant, and one missense variant. Of the six variants, two (33.3%) were novel (c.132+1G>C, and c.243dup). RCC and early-onset uterine leiomyoma were frequently observed in families with HLRCC, while cutaneous leiomyoma was less common. No significant genotype-phenotype correlation was observed. CONCLUSIONS: We describe the genotypic and phenotypic spectrum in a small series of Korean patients with HLRCC. Our data reveal the unique characteristics of Korean patients with HLRCC and suggest a need for establishing an optimal diagnostic approach for them.

Safety, Efficacy, and Patient Satisfaction with Initial Peripherally Inserted Central Catheters Compared with Usual Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study.

PURPOSE: The purpose of this study was to investigate whether routine insertion of peripherally inserted central catheter (PICC) at admission to a hospice-palliative care (HPC) unit is acceptable in terms of safety and efficacy and whether it results in superior patient satisfaction compared to usual intravenous (IV) access. MATERIALS AND METHODS: Terminally ill cancer patients were randomly assigned to two arms: routine PICC access and usual IV access arm. The primary endpoint was IV maintenance success rate, defined as the rate of functional IV maintenance until the intended time (discharge, transfer, or death). RESULTS: A total of 66 terminally ill cancer patients were enrolled and randomized to study arms. Among them, 57 patients (routine PICC, 29; usual IV, 28) were analyzed. In the routine PICC arm, mean time to PICC was 0.84 days (range, 0 to 3 days), 27 patients maintained PICC with function until the intended time. In the usual IV arm, 11 patients maintained peripheral IV access until the intended time, and 15 patients underwent PICC insertion. The IV maintenance success rate in the routine PICC arm (27/29, 93.1%) was similar to that in the usual IV arm (26/28, 92.8%, p=0.958). Patient satisfaction at day 5 was better in the routine PICC arm (97%, 'a little comfort' or 'much comfort') compared with the usual IV arm (21%) (p <0.001). CONCLUSION: Routine PICC insertion in terminally ill cancer patients was comparable in safety and efficacy and resulted in superior satisfaction compared with usual IV access. Thus, routine PICC insertion could be considered at admission to the HPC unit.

Safety and feasibility of 3-month interval access and flushing for maintenance of totally implantable central venous port system in colorectal cancer patients after completion of curative intended treatments.

ABSTRACT: Patients with colorectal cancer (CRC) treated with curative intent surgery undergo continuous fluorouracil (5-FU) infusion-based chemotherapy using totally implantable central venous port system (TICVPS) in cases with high risk of recurrence. Approximately 30% of patients relapse after therapy completion, especially within 2 years. Hence, many patients with high risk CRC keep the TICVPS for 6 to 24 months after treatment with regular intervals of TICVPS flushing. However, little is known about the proper interval duration of the port. The aim of this study is to investigate whether a 3 months extended interval is safe and if port maintenance is feasible.A retrospective cohort was compiled of patients with CRC who underwent curative intent surgery and perioperative chemotherapy using TICVPS between 2010 and 2017. The primary end point was TICVPS maintenance rate, including maintenance of TICVPS for at least 6 months, planned TICVPS removal after 6 months, and regaining the use of TICVPS at the time of recurrence.A total of 214 patients with CRC underwent curative intent treatments during the study period. Among them, 60 patients were excluded, including 6 patients for early recurrence within 3 months and 54 patients with violation of flushing interval. Finally, 154 patients were analyzed. Mean flushing interval was 98.4 days (95% confidence interval [CI], 96.2-100.6; range, 60-120). In December 2018, 35 patients kept the TICVPS, 92 patients had planned removal, 25 patients reused the TICVPS, and 2 patients had to unexpectedly remove the TICVPS due to site infection and pain. Thus, the functional TICVPS maintenance rate was 98.8% (152/154). Thirty-eight patients relapsed, and 30 patients were treated with intravenous chemotherapy. Among them, 25 patients (83.3%) reused the maintained TICVPS without a reinsertion procedures.Our study demonstrated that 3-month interval access and flushing is safe and feasible for maintaining TICVPS during surveillance of patients with CRC. An extended interval up to 3 months can be considered because it is compatible with CRC surveillance visit schedules.

Verification of performance of a direct fluorescent assay for cell-free DNA quantification, stability according to pre-analytical storage conditions, and the effect of freeze-thawing.

A simple fluorescence-based cell-free DNA (CFD) assay has been previously developed that can directly measure nucleic acids without prior DNA extraction and amplification. However, studies on fluorescence-based CFD are lacking. In particular, there is no known information regarding the stability with regard to pre-analytical storage conditions in relation to time and temperature, or on the influence of freeze-thawing. Plasma was directly assayed to measure CFD using PicoGreen™ reagent. Standard linearity and accuracy were confirmed using salmon sperm DNA. Whole blood was left at room temperature (RT) and at 4˚C, and then plasma was separated. The CFD was also measured using thawed plasma after 1 week of freezing. As a correlation with a sperm DNA concentration, CFD demonstrated linearity over a wide range of concentrations, with a 0.998 correlation coefficient. The CFD level showed a change of up to 2.5 µg/ml according to pre-analytical storage time, and the changes were not consistent over time. The CFD values at RT after 1 h were similar to the baseline values, and the relative standard deviation was lowest under this condition. The CFD values between 4˚C and RT were similar over all time periods assessed. After freeze-thawing, the change in CFD value was reduced compared to that before freezing. The present study showed that CFD measurements using plasma processed within 1 h were optimal. Additionally, the effects of substantial changes according to storage conditions were reduced after freeze-thawing, and thus studies using stored samples is viable and relevant.

Development of a One-item Screening Question to Assess Spiritual Well-Being for Advanced Cancer Inpatients in Korea.

CONTEXT: Spiritual well-being (SWB) is significant for patients with life-limiting illnesses. Thus, shortened versions of questions would be helpful in approaching SWB. OBJECTIVES: Our goal was to develop a one-item screening question to assess the SWB of advanced cancer inpatients. METHODS: This was a cross-sectional, multicenter study involving adult advanced cancer inpatients from seven palliative care units in South Korea. The candidate one-item questions were three questions scored using numeric rating scales from 0 to 10: feeling at peace (Are you at peace?), self-rated spirituality (Do you think of yourself as a spiritual person?), and self-rated religiosity (Do you think of yourself as a religious person?). The Functional Assessment of Chronic Illness Therapy-Spirituality 12 (FACIT-Sp-12) comprised of two subscales Meaning/Peace and Faith was used to assess SWB. Pearson's correlation test was conducted to determine the relationship between the three questions, the total FACIT-Sp-12 score, and its subscales. RESULTS: A total of 202 patients were enrolled. A strong correlation was observed between self-rated spirituality (r = 0.732 and 0.790; P < 0.001 and < 0.001 respectively) and religiosity (r = 0.708 and 0.758; P < 0.001 and < 0.001 respectively) with the total FACIT-Sp-12 scores and faith subscale scores. Feeling at peace showed a moderate correlation with the total of FACIT-Sp-12 scores (r = 0.505, P < 0.01). All three questions had a moderate correlation with the meaning/peace subscale. CONCLUSION: Self-rated spirituality and religiosity showed better convergence validity than feeling at peace. Therefore, we recommend self-rated spirituality or religiosity as a one-item question for screening SWB in inpatients with advanced cancer.

2020 Korean guidelines for the management of metastatic prostate cancer.

In 2017, Korean Society of Medical Oncology (KSMO) published the Korean management guideline of metastatic prostate cancer. This paper is the 2nd edition of the Korean management guideline of metastatic prostate cancer. We updated recent many changes of management in metastatic prostate cancer in this 2nd edition guideline. The present guideline consists of the three categories: management of metastatic hormone sensitive prostate cancer; management of metastatic castration resistant prostate cancer; and clinical consideration for treating patients with metastatic prostate cancer. In category 1 and 2, levels of evidence (LEs) have been mentioned according to the general principles of evidence-based medicine. And grades of recommendation (GR) was taken into account the quality of evidence, the balance between desirable and undesirable effects, the values and preferences, and the use of resources and GR were divided into strong recommendations (SR) and weak recommendations (WR). A total of 16 key questions are selected. And we proposed recommendations and described key evidence for each recommendation. The treatment landscape of metastatic prostate cancer is changing very rapid and many trials are ongoing. To verify the results of the future trials is necessary and should be applied to the treatment for metastatic prostate cancer patients in the clinical practice. Especially, many prostate cancer patients are old age, have multiple underlying medical comorbidities, clinicians should be aware of the significance of medical management as well as clinical efficacy of systemic treatment.

Effect of education on preference of parenteral nutrition for patients in palliative care unit: quantitative and qualitative study with an anthropological approach.

BACKGROUND: Patients and their family have resistance in withholding parenteral nutrition (PN) when patient become unable to intake food in the end-of-life. We aimed to investigate whether the preference for PN is changed after receiving an individual education about the risk and benefit of PN. Additionally, we focused on the preferences of patients and their family and why they prefer it about the nutritional support in the end of life. METHODS: This is prospective study. Patients are eligible if they cannot tolerate oral intake and enteral feeding and have Palliative Performance Scale (PPS) ≤50% due to progressive cancer. After informed consent, investigators educated patients and family for an hour using the handouts. Then, patients decided if they will receive PN. Quality of life (QOL) was checked by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C15-PAL) weekly during 3 weeks. Symptoms related to fluid overloading or dehydration was surveyed weekly also. A social anthropologist participated as an observer or interviewer during whole process of this study. RESULTS: After education, 12 patients (80%) chose to keep receiving PN and 3 patients (20%) changed their decision from PN to minimal hydration among the 15 patients. More calories were administered to patients who chosen PN (median 1,042.2 vs. 324.3 Kcal/day, P<0.001) for initial 7 days. Overall survival, scores of QLQ-C15-PAL, and symptoms were not different with or without PN. According to the anthropologist, medical staffs regard PN as complex medical treatments, while patients and family recognize it as meal rather than medicine. CONCLUSIONS: Most patients and family prefer to receive PN despite its potential harm and marginal benefit. An in-depth discussion about prognosis and aim of care must be preceded before a decision whether to receive PN can be made.

Clinical Characteristics of Clear Cell Ovarian Cancer: A Retrospective Multicenter Experience of 308 Patients in South Korea.

PURPOSE: The purpose of this study was to evaluate clinical characteristics and treatment pattern of ovarian clear cell carcinoma (OCCC) in Korea and the role of adjuvant chemotherapy in early stage. MATERIALS AND METHODS: Medical records of 308 cases of from 21 institutions were reviewed and data including age, performance status, endometriosis, thromboembolism, stage, cancer antigen 125, treatment, recurrence, and death were collected. RESULTS: Regarding stage of OCCC, it was stage I in 194 (63.6%), stage II in 34 (11.1%), stage III in 66 (21.6%), and stage IV in 11 (3.6%) patients. All patients underwent surgery. Optimal surgery (residual disease ≤ 1 cm) was achieved in 89.3%. Majority of patients (80.5%) received postoperative chemotherapy. The most common regimen was taxane-platinum combination (96%). Median relapse-free survival (RFS) was 138.5 months for stage I, 33.4 for stage II, 19.3 for stage III, and 9.7 for stage IV. Median overall survival (OS) were not reached, 112.4, 48.7, and 18.3 months for stage I, II, III, and IV, respectively. Early-stage (stage I), endometriosis, and optimal debulking were identified as favorable prognostic factors for RFS. Early-stage and optimal debulking were also favorable prognostic factors for OS. Majority of patients with early-stage received adjuvant chemotherapy. However, additional survival benefit was not found in terms of recurrence. CONCLUSION: Majority of patients had early-stage and received postoperative chemotherapy regardless of stage. Early-stage and optimal debulking were identified as favorable prognostic factors. In stage IA or IB, adding adjuvant chemotherapy did not show difference in survival. Further study focusing on OCCC is required.

Random Allocated Study of Wrapping Oblate for Prevention of Everolimus-associated Stomatitis in Patients With Metastatic Renal Cell Carcinoma.

BACKGROUND: The study aim was to evaluate the efficacy of wrapping oblate for prevention of everolimus-associated stomatitis in metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS: Patients with mRCC prescribed everolimus after failure of vascular endothelial growth factor-tyrosine kinase inhibitor were enrolled. Patients were consecutively assigned to take everolimus covered with or without oblate. The primary end-points were the incidence of and time to grade 2 or more stomatitis. Additionally, we assessed whether grade 2 or more stomatitis that occurred in the non-oblate group could be prevented with crossover application of oblate. RESULTS: This study included 79 patients [oblate group: 42(53%); non-oblate group: 37(47%)]. Thirty (38%) patients developed grade 2 or more stomatitis [incidence: oblate group, 31% (13/42); non-oblate group, 46% (17/37), p=0.245; median time to grade 2 or more stomatitis: oblate group, not reached; non-oblate group, 6.0 months, p=0.251]. Among 10 patients who developed grade 2 or more stomatitis in the non-oblate group and received oblate-covered everolimus, nine (90%) showed complete recovery or improved to grade 1, which persisted until discontinuation of everolimus. CONCLUSION: Oblate-covered everolimus improved the incidence of and time to grade 2 or more stomatitis, although it was not statistically significantly different compared to the non-oblate group. Oblate wrapping prevented recurrence of grade 2 or more stomatitis in patients who took uncovered everolimus and developed significant stomatitis.