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The Hand, Foot and Mouth Disease (HFMD) is a highly contagious viral illness generally manifests as a mild disease in young children and immunocompromised adults. It has however emerged as a significant public health threat in recent years as outbreaks have been occurring regularly, especially in the Asia–Pacific. The disease can result from infections by a wide variety of human enteroviruses, particularly, Enterovirus A71 (EV-A71) has garnered more attention due to its association with severe disease in infected patients. Despite the potential to result severe neurological complications or even fatality, there is currently no effective antiviral for treatment of EV-A71 infections and the only vaccines available are restricted to distribution in China. In this study, we report the in vitro and in vivo evaluation of two candidate antiviral compounds active against EV-A71, a viral capsid inhibitor (G197) and a novel host-targeting phosphatidylinositol 4-kinase III beta inhibitor (N373) which, especially when used in combination, can significantly improve the survival and pathology of infected mice.

AimsHeterotopic ossification (HO) is a potentially devastating complication of the surgical treatment of a proximal humeral fracture. The literature on the rate and risk factors for the development of HO under these circumstances is lacking. The aim of this study was to determine the incidence and risk factors for the development of HO in these patients.MethodsA retrospective analysis of 170 patients who underwent operative treatment for a proximal humeral fracture between 2005 and 2016, in a single institution, was undertaken. The mean follow-up was 18.2 months (1.5 to 140). The presence of HO was identified on follow-up radiographs.ResultsThe incidence of HO was 15% (n = 26). Our multivariate model revealed that male sex (odds ratio (OR) 3.57, 95% confidence interval (CI) 1.30 to 9.80 compared to female) and dislocation as the initial injury (OR 5.01, 95% CI 1.31 to 19.22) were significantly associated with the formation of HO (p < 0.05) while no significant associations were seen for the age of the patient, the characteristics of the injury, or the type of operative treatment.ConclusionThis retrospective radiological study is the first to investigate the association between the method of surgical treatment for a proximal humeral fracture and the formation of HO postoperatively. We found that male sex and dislocation as the initial injury were risk factors for HO formation, whereas the method of surgical treatment, the age of the patient, and the pattern of the fracture were not predictive of HO formation. While additional studies are needed, these findings can help to identify those at an increased risk for HO formation under these circumstances. Cite this article: Bone Joint J 2020;102-B(4):539–544.

Background Serum amylase testing is not recommended for the workup of acute pancreatitis; yet it is commonly ordered in acute care settings. Methods This was a student-led quality improvement initiative with application of a pre-post study design at two urban hospitals: Mount Sinai Hospital, a 1,134-bed academic hospital, and Mount Sinai Queens, a 235-bed community hospital. The multifaceted intervention combined a targeted educational and awareness campaign with the decoupling of amylase from electronic order sets (at the academic hospital only), as well as a nonintrusive electronic medical record (EMR) advisory statement (at both hospitals). Monthly amylase orders were tracked for all emergency department visits and hospital admissions between January 2016 and May 2018 for both hospitals Results There was a significant and sustained decrease in amylase ordering at both the academic hospital (from 3,214 orders per month to 2,348 orders per month; p = 0.011) and the community hospital (from 100 orders per month to 23 orders per month; p = 0.001). Specifically, the nonintrusive EMR order advisory statement was independently associated with a significant reduction in serum amylase ordering. There was an estimated net annual cost reduction of $44,999. Conclusions This student-led initiative was successful in reducing unnecessary amylase ordering across two diverse institutions through a combination of education, publicity, and EMR changes.

BACKGROUND Achieving a pathologic complete response (pCR) with neoadjuvant chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) has been associated with improved overall survival (OS). This study was aimed at evaluating the impact of pathologic downstaging (pDS; ie, a pT stage at least 1 stage lower than the pre-NAC cT stage) on the OS of patients with MIBC treated with NAC. METHODS The Retrospective International Study of Cancers of the Urothelial Tract (RISC) and the National Cancer Database (NCDB) were queried for cT2-4N0M0 patients treated with NAC. A multivariable Cox model including either pDS or pCR was generated. A nested model was built to evaluate the added value of pDS (excluding patients achieving a pCR) to a model including pCR alone. C indices were computed to assess discrimination. NCDB was used for validation. The treatment effect of NAC versus cystectomy alone in achieving pDS was estimated through an inverse probability-weighted regression adjustment. RESULTS Overall, 189 and 2010 patients from the RISC and NCDB cohorts, respectively, were included; pDS and pCR were achieved by 33% and 35% and by 20% and 15% in RISC and NCDB, respectively. In both data sets, pDS and pCR were associated with better OS and C indices. Adding pDS excluding pCR to the model with pCR fit the data better (likelihood ratio, P = .019 for RISC and P

INTRODUCTION Simplifying the learning of cardiopulmonary resuscitation (CPR) is advocated to improve skill acquisition and retention. A simplified CPR training programme focusing on continuous chest compression, with a simple landmark tracing technique, was introduced to laypeople. The study aimed to examine the effectiveness of the simplified CPR training in improving lay rescuers' CPR performance as compared to standard CPR. METHODS A total of 85 laypeople (aged 21-60 years) were recruited and randomly assigned to undertake either a two-hour simplified or standard CPR training session. They were tested two months after the training on a simulated cardiac arrest scenario. Participants' performance on the sequence of CPR steps was observed and evaluated using a validated CPR algorithm checklist. The quality of chest compression and ventilation was assessed from the recording manikins. RESULTS The simplified CPR group performed significantly better on the CPR algorithm when compared to the standard CPR group (p < 0.01). No significant difference was found between the groups in time taken to initiate CPR. However, a significantly higher number of compressions and proportion of adequate compressions was demonstrated by the simplified group than the standard group (p < 0.01). Hands-off time was significantly shorter in the simplified CPR group than in the standard CPR group (p < 0.001). CONCLUSION Simplifying the learning of CPR by focusing on continuous chest compressions, with simple hand placement for chest compression, could lead to better acquisition and retention of CPR algorithms, and better quality of chest compressions than standard CPR.

In Singapore, care of patients is often seen as part of the duty of the family unit with care decisions and treatment costs determined by the eldest son. Rising costs and increasing care needs, however, have led to the diversification of care roles. Understanding how these roles are determined is critical to decision-making, better patient care and effective communication with the family. This study seeks to explore the factors behind the selection of the main caregiver, who provides the majority of physical care to the patient, and the decision-maker, who is tasked with deciding on treatment plans. Twenty-one oncologic patients and caregivers attending an ambulatory treatment unit at a tertiary oncology centre viewed a video vignette and were asked about the suitability of the three children who suggest different options to care of their mother following her diagnosis of metastatic terminal cancer. Participants were also asked what factors they considered when selecting a surrogate. Contrary to traditional reliance upon gender roles to determine care roles and duties, nearly 60% of caregivers and 40% of patients prioritised the availability, willingness and capability of family members, and their financial and personal situations in determining their choice of caregiver and surrogate decision-maker. The shift away from gender-determined roles stems from the evolving nature of Confucian beliefs that are influenced by practical and sociocultural considerations. These findings remind healthcare professionals that gender stereotypes have begun to fade and that they should continually review familial and cultural beliefs in care determinations at the end of life.

Background As immune checkpoint inhibitor (ICI) therapies (PD(L)1 and CTLA-4 inhibitors) are increasingly used for treating malignancy, immune-related adverse events (irAEs) are being encountered by clinicians more frequently. Obesity is a pro-inflammatory metabolic state that has been associated with a higher risk of developing autoimmune disease, but its role in irAEs in patients treated with ICIs is not well characterized. Hypothesis We hypothesized that patients on ICI therapy who were overweight or obese would be more likely to have a grade 2 or greater irAE compared to normal or underweight patients. Methods We retrospectively collected clinical data for 398 cancer patients with baseline body mass index (BMI) data who received ICIs between January 2011 and April 2017 at our institution. Patients were categorized as having lower BMI (low or normal weight

Background Human Papillomavirus oropharyngeal carcinoma (HPVOPC) has better progression free (PFS) and overall survival (OS) than non-HPVOPC. Standard-dose chemoradiotherapy (sdCRT) results in significant acute toxicity and late morbidity. We hypothesized that after induction chemotherapy (IC), reduced dose chemoradiation (rdCRT) would result in equivalent PFS and OS compared to sdCRT plus IC in HPVOPC and would reduce toxicity. Methods Patients with p16+, previously untreated, locally advanced HPVOPC and ≤20 pack years smoking history received 3 cycles of IC with docetaxel, cisplatin and fluorouracil (TPF). Clinical responders who were HPV positive by type-specific PCR were randomized 1:2 to sdCRT (7000 cGy) or rdCRT (5600 cGy) with weekly carboplatin. The endpoints of the study were 3 year PFS and OS. Results 23 patients were enrolled, 22 were evaluable for TPF toxicity and 20 were randomized, 8 to sdCRT and 12 to rdCRT. Sixteen (80%) were HPV 16+ and 4 (20%) were other high risk (HR) variants. Fourteen (70%) had high risk features: T4, N2c, or N3. Median follow up was 56 months (range 42–70). Three-year PFS/OS for sdCRT and rdCRT are 87.5% vs 83.3% (log-rank test p = 0.85), respectively. All 3 failures are locoregional within 4 months of completion of CRT; 2 were in HR variants (50%). Conclusions rdCRT after IC resulted in similar PFS/OS compared sdCRT. These data support Phase 3 clinical trials of radiation dose reduction after IC as a treatment strategy in HPVOPC. Molecular HPV with variant testing and smoking history are necessary for de-escalation trials.

Purpose Clinical trials are critical to informing cancer care but often are hampered by slow accrual and lack of generalizability because of poor geographic accessibility. We tested the feasibility of replacing onsite study visits with telemedicine visits in a prospective clinical trial. Methods Castration-naïve patients with prostate cancer and a rising serum prostate-specific antigen after definitive local therapy were eligible. Patients were required to have a single onsite visit for enrollment. Study treatment consisted of oral metformin 850 mg daily for 1 month followed by 850 mg twice daily for 5 months. Telehealth video visits (televisits) were conducted monthly by using a Health Insurance Portability and Accountability Act–compliant smartphone application. The primary objective was to determine the feasibility of telemedicine-enabled study visits. Secondary objectives were defining safety, anticancer activity, quality of life, and patient satisfaction. Results Fifteen patients with a median age of 68 years (range, 57 to 83 years) and median one-way driving time to the study center of 71 minutes (range, 12 to 147 minutes) were enrolled. The patients completed 84 eligible televisits (completion rate, 100%; 95% CI, 0.80 to 1). Diarrhea was the most common adverse event but was limited to grade 1 in severity; a single patient experienced grade ≥ 3 adverse events. Seven patients (46.7%; 95% CI, 24.8% to 69.9%) had a ≤ 20% increase in prostate-specific antigen relative to baseline. Patients agreed or strongly agreed that they would participate in a telemedicine-enabled clinical trial in the future. Conclusion To our knowledge, this interventional oncology clinical trial is the first to be conducted through telemedicine. Telemedicine-enabled trials are feasible and may overcome geographic barriers to trial participation. Metformin was generally well tolerated but associated with modest anticancer activity.

Background Although radical cystectomy (RC) is a standard treatment for muscle-invasive bladder cancer (MIBC), for many patients the risks versus benefits of RC may favor other approaches. We sought to define the landscape of early postcystectomy mortality in the United States and identify patients at high risk using pretreatment variables. Methods We identified patients with MIBC (cT2-T4aN0M0) who underwent RC without perioperative chemotherapy within the National Cancer Database (2003–2012). Using multistate multivariable modeling, we calculated time spent in three health states: hospitalized, discharged, and death more than 90 days postcystectomy. Cross-validation was performed by geographic region. Time spent in each state was weighted by utility to determine 90-day quality-adjusted life days (QALDs). Results Among 7922 patients, 90-day mortality was 7.6% (8.0% for lower and 6.7% for higher volume hospitals). Increasing age, clinical T stage, Charlson Comorbidity Index, and lower volume were associated with higher 90-day mortality and were included in the model. Cross-validation revealed appropriate performance (C-statistics of 0.53–0.74; calibration slopes of 0.50–1.67). The model predicted 25% of patients had a 90-day mortality risk higher than 10%, and observed 90-day mortality in this group was 14.0% (95% CI = 12.5% to 15.6%). Mean quality-adjusted life days (QALDs) was 63 (range = 44–68). Conclusions RC is associated with relatively high early mortality risk. Pretreatment variables may identify patients at particularly high risk, which may inform clinical trial design, facilitate shared decision making, and enhance quality improvement initiatives.

Background: Healthcare providers often struggle to balance the sometimes competing considerations of maximizing quality of life (QoL) and quantity of life with disease-modifying treatment (DMT). These decisions require in-depth dialog between all parties in order to understand the concerns and perspectives of the patient and caregiver in this period. Objectives: The objectives of this study were to explore Singaporean patients’ and caregivers’ attitudes towards QoL and DMT, and to examine the reasons behind their beliefs. Methods: Participants were given a video vignette of a family discussing how best to care for their mother who is recently diagnosed with cancer and were interviewed regarding their thoughts on QoL and DMT for a 70-year-old patient with stage IV metastatic cancer. Subjects/Setting: A total of 21 patients and caregivers were recruited from a tertiary oncology centre. Results: Both patients and caregivers show little support for pursuing QoL, despite the likely compromise to the patients’ QoL. These participants believed that not pursuing DMT was tantamount to giving up and accepting death. Whilst patients did accept that in some circumstances a QoL approach would be acceptable, caregivers remained adamant upon a DMT approach. The perspectives of caregivers reflected the influence of the Confucian-inspired practice of filial piety. Conclusion: Local sociocultural beliefs and values continue to play a significant consideration in end-of-life decision-making. However, compliance with these beliefs have evolved, with greater consideration given to clinical and QoL factors.

Objective:Advanced care plans (ACPs) are designed to convey the wishes of patients with regards to their care in the event of incapacity. There are a number of prerequisites for creation of an effective ACP. First, the patient must be aware of their condition, their prognosis, the likely trajectory of the illness, and the potential treatment options available to them. Second, patient input into ACP must be free of any coercive factors. Third, the patient must be able to remain involved in adapting their ACP as their condition evolves. Continued use of familial determination and collusion within the local healthcare system, however, has raised concerns that the basic requirements for effective ACP cannot be met.Method:To assess the credibility of these concerns, we employed a video vignette approach depicting a family of three adult children discussing whether or not to reveal a cancer diagnosis to their mother. Semistructured interviews with 72 oncology patients and 60 of their caregivers were conducted afterwards to explore the views of the participants on the different positions taken by the children.Results:Collusion, family-centric decision making, adulteration of information provided to patients, and circumnavigation of patient involvement appear to be context-dependent. Patients and families alike believe that patients should be told of their conditions. However, the incidence of collusion and familial determination increases with determinations of a poor prognosis, a poor anticipated response to chemotherapy, and a poor premorbid health status. Financial considerations with respect to care determinations remain secondary considerations.Significance of results:Our data suggest that ACPs can be effectively constructed in family-centric societies so long as healthcare professionals continue to update and educate families on the patient's situation. Collusion and familial intervention in the decision-making process are part of efforts to protect the patient from distress and are neither solely dependent on cultural nor an “all-or-nothing” phenomenon. The response of families are context-dependent and patient-specific, weighing the patient's right to know and prepare and the potential distress it is likely to cause. In most cases, the news is broken gently over time to allow the patient to digest the information and for the family to assess how well they cope with the news. Furthermore, the actions of families are dependent upon their understanding of the situation, highlighting the need for continued engagement with healthcare professionals.

In family-centric societies, maintenance of hope amongst ill family members is a pivotal duty of the family. Meeting this duty often takes the form of continuing treatment even when such options may be futile. This makes efforts to maximize quality-of-life options challenging. We explore Singaporean perceptions surrounding quality-of-life advocates who advice quality-of-life measures over potentially life-prolonging treatment in terminal illness using a novel video vignette based semi-structured interviews. Findings suggest that quality-oflife advocates are viewed as failing in their filial obligations and perceived as ‘selfish’, ‘money-minded’ and ‘immoral’. These findings highlight the need to educate patients and caregivers about quality-of-life approaches.

Purpose Achieving a pathologic complete response (pCR) with neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (MIBC) is associated with a favorable prognosis. Patients with pathologic residual disease (pRD) generally have poor outcomes. However, prognosis after radical cystectomy (RC) improves with ongoing survivorship. Our objective was to determine whether the difference in prognosis of patients with pCR and pRD changes over time. Materials and Methods We queried the National Cancer Database for patients who received NAC and RC for localized MIBC (cT2-T4aN0M0) between 1998 and 2012. pCR was defined as ≤Tis disease. Kaplan-Meier analysis was used to estimate conditional survival to 5 years given survival to 1, 2, 3, and 4 years post-RC. Cox proportional hazard modeling was used to estimate the effect of pRD vs. pCR on overall survival. Results The cohort comprised 1,553 patients (pCR: 314 and pRD: 1,239). With median follow-up 2.65 years (range 0.01–9.97), median survival was 2.5 years (95% confidence interval 2.2–2.9) and not reached for pRD and pCR, respectively. All patients had improved conditional survival with each additional year of survivorship. Patients with pCR had improved overall survival relative to those with pRD. The effect of pRD vs. pCR on conditional survival did not differ over time (P = 0.7). Conclusions MIBC patients with pCR after NAC have improved conditional survival relative to those with pRD post-RC. This survival advantage does not significantly change over time. These findings may inform patient counseling, surveillance intensity, and novel adjuvant approaches for patients with pRD.

491 Background: Achieving a pathologic complete response (pCR) with neoadjuvat chemotherapy (NAC) in patients with muscle-invasive bladder cancer (MIBC) has been correlated with improved survival. Such findings have served as justification for using pCR as an intermediate endpoint for clinical trials and perpetuated the notion that NAC only benefits patients achieving a pCR. The impact of downstaging (pDS) on outcomes of patients with MIBC treated with NAC has been underexplored. Methods: The National Cancer Database (NCDB) was queried to identify patients with MIBC (cT2-4N0M) treated with platinum-based NAC. A multivariable Cox model including either pDS or pCR and adjusted for potential confounders was generated and c-indices were computed to evaluate whether the inclusion of pDS or pCR was more informative in predicting overall survival (OS). Results: Overall 2,010 patients from NCDB met inclusion criteria. The median follow-up for survivors was 36 months with a 5-year OS of 47% (95% CI 44, 50%). Overall, 694 (43.5%) patients achieved pDS; 139, 201, 291, 49 and 14 downstaged of 1, 2, 3, 4 and 5 categories, respectively. The 5-year OS rate for patients who achieved pDS was 70%. A pCR was achieved by 306 (15%) of the patients, the 5-year OS rate in this group was 84%. In the NCDB, pDS and pCR emerged as predictors of OS: HR:0.36 (95% CI: 0.30,0.44, p

In pre-literate societies, oral tradition is anchored in the landscape, linking it with its inhabitants. The first part of this paper details the documentation of a legend of the Abui community of Alor, Eastern Indonesia. It describes the relationship of the legend with landscape and its functions in the community. We recorded the first version of the legend of the Giant Snake Mon Mot in the community of Tifolafeng in 2003. We combined linguistic, anthropological, geographic, and historical methods with fine arts resulting in a multi-faceted documentation for diverse audience. We have created a range materials from illustrated books, games, to a film documentary, made the raw data available. In the second part of the paper, we lay out our strategy for integration of mechanics of telling and listening, and the mnemotechnic structure of oral tradition with the digital humanities. We also address the need of systematic research into the response of the community, which our approach allows.

460 Background: Although RC is the standard treatment for MIBC, it is associated with non-negligible morbidity and mortality. Given the advanced age and prevalence of comorbidities in MIBC patients, many are suboptimal RC candidates. We sought to develop a prediction rule for determining high surgical risk using routinely available pre-surgical variables. Methods: We identified N=8,634 patients with MIBC (cT2-T4aN0M0) who underwent RC, without perioperative chemotherapy, within the National Cancer Database (2003-2012). Using multi-state modeling, we calculated time spent in 3 health states: hospitalized, discharged and death over 90 days post-RC. Predictors were selected in a stepwise manner. Cross validation was performed leaving one of 6 geographic regions out to assess model performance. Time spent in each state was weighted by utility (0=death, 1=full health) to determine 90d quality-adjusted survival (QAS) as a composite of morbidity and mortality. Results: Median age: 69y (IQR 62-78), mean length of stay: 10±12d, and 90d mortality: 654/8,634 (7.6%). Increasing age, cT stage, Charlson comorbidity index (CCI) and lower hospital RC volume were associated with greater 90d mortality (Table). C-statistics of 0.57-0.73 and calibration slopes of 0.54-1.37 (1=perfect) were sufficient across the regions. Our model predicted 25% of patients had a 90d mortality >10%; observed 90d mortality in this group was 14.0% (95% CI 12.5-15.5). Mean QAS was 63d (range 43-68). Conclusions: We developed a multi-state model to identify high post-RC risk that may ultimately help to identify patients for ‘prehabilitation’ strategies and/or inform standard definitions of ‘cystectomy ineligibility’ for clinical trials. [Table: see text]

520 Background: Achieving a pathologic complete response (pCR) with NAC for MIBC is associated with a favorable prognosis. Patients with pathologic residual disease (pRD) generally have poor outcomes. However, prognosis after radical cystectomy (RC) improves with ongoing survivorship. Whether the difference in prognosis of patients with pCR and pRD is sustained over time has not been explored. Methods: We queried the National Cancer Database for patients who received NAC and RC for clinically localized MIBC (cT2-T4aN0M0) between 2002-2010. We identified patients with pCR (15 RC/year: 61% vs. 49%). Patients with pCR had improved CS relative to those with pRD with survivorship up to 3 years, but the benefit associated with pCR becomes attenuated from 4 years post-RC (Table). Conclusions: MIBC patients with pRD after NAC have worse CS up to years 3 post-RC, but this difference diminishes after 4 years. These findings may inform patient counseling, surveillance intensity, and novel adjuvant approaches for patients with pRD, and are subject to confirmation with a forthcoming multivariable analysis. Probability of surviving to X years (95% CI). [Table: see text]

Background Compression-only cardiopulmonary resuscitation (CPR) has been advocated as a preferable approach for bystanders in an out-of-hospital cardiac arrest (OHCA) event as it has been associated with an increased chance of survival. The elimination of mouth-to-mouth ventilation also addresses some of the barriers to performing CPR. The aim of this study is to undertake a literature review investigating the effectiveness of compression-only CPR in improving rescuers’ CPR performance when compared with standard CPR. Methods A literature search was conducted in the following databases: Cumulative Index to Nursing and Allied Health Literature, Science Direct, Scopus and PubMed from January 2003 to January 2014, to include research studies that compared compression-only CPR with standard CPR on participants above the age of 21, and reported quality of CPR performance as the primary outcome. Findings Of the 3004 articles retrieved, 16 met the inclusion criteria. The reviewed studies revealed that compression-only CPR requires a shorter time to initiate CPR and delivers a higher number of total compressions. The depth of compressions in compression-only CPR performed may be shallower than that of standard CPR due to greater rescuer fatigue. It therefore remains inconclusive if compression-only CPR can deliver a higher number of adequate compressions over extended periods of time. It is also unclear if simplified CPR can improve skill retention level in the long run. Conclusions More studies are needed to determine whether compression-only CPR can indeed help improve rescuers’ CPR performance. Future research efforts, together with resuscitation policy and practice implications, are needed to further improve rescuers’ CPR performance with the ultimate goal to enhance OHCA survival rates.

6069 Background: Locally advanced Human Papillomavirus (HPV) + oropharyngeal carcinoma (OPC) has a significantly better response, locoregional control and survival compared to non HPVOPC. Standard-dose chemoradiotherapy (sdCRT) results in significant side effects, leading to acute and life-threatening late morbidity. We studied whether reduced dose chemoradiation (rdCRT) after induction chemotherapy (IC) resulted in equivalent progression-free survival (PFS) compared to sdCRT + IC with decreased late morbidity. Methods: Patients with locally advanced OPC and < 20 pack years (py) smoking history were tested for p16 and then HPV by type-specific PCR. After 3 cycles of docetaxel, cisplatin and fluorouracil (TPF) IC all HPV+/p16+ subjects underwent clinical and radiographic evaluation. Clinical responders were randomized to either sdCRT (70Gy) or rdCRT (56Gy) with weekly carboplatin (AUC 1.5) at a 1:2 ratio. The primary endpoint was 2 year PFS; the secondary endpoint was 2 year overall survival (OS). Toxicity, late morbidity and swallowing were monitored. Results: 23 patients were enrolled and 20 randomized, 8 to sdCRT and 12 to rdCRT; 2 were HPV- and 1 refused further therapy after IC and were not randomized. Median age was 56.5 yrs (range 36-78); 30% were African-American, 10% were Hispanic, 5% were female; 16 were HPV 16+ and 4 were other high risk (HR) variants; 60% never smoked, 25% were < 10 py, and 15% were 10-20 py; 70% had high risk features: T4, N2c, or N3. Clinical response to TPF was 100%; 70% had a clinical complete response. As of February 1, patients have been followed for a median of 37.5 months (range 21.7 – 49.5). 2 year PFS/OS for sdCRT and rdCRT are 87.5% vs 83.3% (log-rank test p = 0.85), respectively. All 3 failures were local or regional and 2 of 3 occurred in non HPV16 HR variants. Conclusions: HPV+ OPC patients who received rdCRT after TPF IC had similar PFS/OS compared to those receiving sdCRT. These results uphold the potential clinical benefit of radiation dose reduction as a treatment option with comparable survival to the standard radiation dose. A Phase III trial comparing IC plus rdCRT to sdCRT alone or with IC is warranted in this population. Non-HPV16 HR variants may have a worse outcome. Clinical trial information: NCT01706939.

To evaluate the accuracy of platelet counts from various hematology analyzers using a reference immunologic method.We tested 403 samples with platelet counts less than 50 × 10(9)/L with the Advia (Siemens, Tarrytown, NY), Sysmex (Mundelein, IL), and Abbott (Santa Clara, CA) analyzers.All methods showed a positive bias, especially at less than 20 × 10(9)/L and less than 10 × 10(9)/L. Undertransfusion risk ranged from 9.1% to 43.3 % in the groups below 20 × 10(9)/L and below 10 × 10(9)/L, respectively. For patients with optical counts more than 10 × 10(9)/L and CD61 less than 10 × 10(9)/L, 64.5% were transfused within 24 hours of the reported count, while 35.5% were transfused in more than 24 hours, after a subsequent optical platelet count of 10 × 10(9)/L or less was reported.Although optical and impedance methods were shown to be falsely increased in severely thrombocytopenic samples, further studies are needed to determine if more accurate methods would be clinically useful.

To determine a relationship between sexual functioning and health state among survivors of stage I endometrial cancer, and to examine whether adjuvant intravaginal radiotherapy (IVRT) affects these measures compared to hysterectomy alone. Two hundred five survivors (>1 year from surgery) completed questionnaires containing the EuroQol (EQ5D) and the Female Sexual Function Index (FSFI). A total of 136 (66.3 %) underwent surgery alone, and 69 (33.7 %) received IVRT. Pearson correlation was used to correlate FSFI and EQ5D–Health State scores. Multivariable regression was performed to measure the impact of IVRT on sexual functioning and health state. A majority of patients (80 %) met criteria for sexual dysfunction by FSFI

Background: Sexual dysfunction is reported after chemotherapy and endocrine therapies. However, the prevalence and severity of sexual dysfunction in premenopausal women undergoing therapy for both local and metastatic disease is not well defined. This study was performed in order to understand the impact of contemporary breast cancer treatment on the prevalence and severity of sexual health in premenopausal women. Methods: We developed a survey that includes a previously validated questionnaire, the Female Sexual Function Index (FSFI), as well as an established measure of health-related quality of life (the EuroQol EQ-5D), and disease-specific items to characterize sexual dysfunction and its causes based on literature review and expert consultations. Anonymous administration of the surveys was conducted in outpatient clinic waiting areas of the Breast Cancer Center at Memorial Sloan-Kettering Cancer Center (MSKCC), under an IRB waiver of consent. Results: 372 consecutively approached premenopausal women with breast cancer of any stage, undergoing treatment were each queried once. The mean age was 47. 87% reported current or past hormonal treatment, and 86% reported current or past chemotherapy (76% adjuvant; 24% for metastatic disease). Sexual dysfunction attributed to breast cancer or its treatment, defined as an FSFI score =5/10). In a multivariate analysis, metastatic disease, development of amenorrhea from cancer treatment, antidepressant use and poorer overall health were each significantly associated with worse FSFI scores. Lower FSFI scores were also significantly associated with worse health-related quality of life. Conclusion: Sexual dysfunction is prevalent in premenopausal women treated for breast cancer and should be discussed with patients as a potential adverse effect of therapy. Assessment of sexual symptoms throughout treatment and beyond may facilitate the use of potential interventions such as lubricants, dilators, treatment modification and counseling. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD04-03.

Background: Sexual dysfunction is reported after chemotherapy and endocrine therapies, and causes a substantial burden on women with breast cancer. However, the prevalence and severity of sexual dysfunction in women undergoing therapy for both local and metastatic disease is not well defined. Improved understanding of sexual dysfunction may facilitate enhanced treatment and interventions in patients with breast cancer undergoing active treatment, and in survivors of this disease.Methods: We developed a survey that includes a previously validated questionnaire, the female sexual function index (FSFI), as well as an established measure of health-related quality of life (the EuroQol EQ-5D), and disease-specific items to characterize sexual dysfunction and its causes based on literature review and expert consultations. Anonymous administration of the surveys was conducted in outpatient clinic waiting areas of the Breast Cancer Center at Memorial Sloan-Kettering Cancer Center (MSKCC) and two community centers, under an IRB waiver of consent.Results: During November 2008 through May 2009, 509 women undergoing treatment for breast cancer of all stages were each queried once. The mean age was 51 (range 26-91). 87% reported current or past hormonal treatment, and 82% reported current or past chemotherapy (76% adjuvant; 24% for metastatic disease). Sexual dysfunction attributed to breast cancer or its treatment, defined as an FSFI score =5/10). Patients attributed their sexual dysfunction to chemotherapy in 318/373 (85%) of cases; to hormonal therapy in 221/298 (74%) of cases; and to surgery in 331/442 (66%) of cases. Other reported contributors to sexual dysfunction include a new diagnosis of breast cancer by 81% of respondents, anxiety by 82% of respondents, and change in relationship with a partner by 55% of respondents.Conclusion: Sexual dysfunction is prevalent in women treated for breast cancer and should be discussed with patients as a potential adverse effect of therapy. Assessment of sexual symptoms throughout treatment and beyond may facilitate the use of potential interventions such as lubricants, dilators, treatment modification, topical estrogens, and counseling. Future work includes a longitudinal prospective trial to further characterize the etiologies of these symptoms and a randomized controlled trial to evaluate interventions for sexual dysfunction. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 1056.