Specialized Cancer Centers Research Articles

Escherichia coli blood stream infection in cancer patients: a multicentre, multidisciplinary collaborative audit to identify risk factors in order to target preventative strategies for improvement of patient care and outcomes

Background Escherichia coli is a common cause of blood stream infections (BSI) in the UK. Published figures for E. coli BSI show higher rates in specialist cancer centres than in other hospitals, but the aetiology in oncology patients is not fully understood. Methods Five UK cancer centres coll aborated to review how E. coli affects oncology patients. A key part of this work has been an audit of all cases of E.coli BSI in patients in 2019 that met UK HCAI surveillance definitions. A multidisciplinary team of clinicians, nurses and pharmacists designed the audit to include >60 variables which may affect cancer patients. Results The risk factors for E. coli BSI among these cancer patients showed marked differences from those seen in the general UK population. The affected population was younger; there was higher rate of hospital-onset infections ; and, taking into account a number of healthcare interactions, the potential for healthcare associated infections was much higher. There was also a higher associated 30-day mortality and high rates of antimicrobial resistance in BSI isolates. Common univariate risk factors associated with BSI included use of SACT, neutropaenia, presence of acute kidney injury, presence of an invasive device, antimicrobial therapy, use of PPIs and a lack of independent hydration. By contrast, haematopoietic stem cell transplantation, mucositis and recent surgery were less common associations. Conclusion This audit demonstrates differences between risk factors seen in cancer patients with E.coli BSI and may explain why rates are higher in cancer centres.

I-Move, a personalised exercise intervention for patients with advanced melanoma receiving immunotherapy: a randomised feasibility trial protocol

IntroductionThere is increasing evidence demonstrating the benefits of exercise in counteracting cancer treatment-related fatigue. Immunotherapy is an established treatment for advanced melanoma, and is associated with fatigue in a third...

The impact of mismatch repair status to the preoperative staging of local colon cancer: Implications for clinical management.

16 Background: Computed tomography (CT) scan is standard in preoperative local staging of colon cancer. Tumours with a deficient mismatch repair (dMMR) system are characterised by unique clinical and pathophysiologic aspects that may impact on the accuracy of the preoperative CT staging. Methods: Data from the Danish Colorectal Cancer Group national clinical database addressing a cohort of patients operated for stage I-III colon cancer in 2010-15 was analysed. The analyses of MMR status had been conducted consecutively through means of immunohistochemistry. All CT scans were blindly assessed by a certified radiologist. Results: Data from 590 patients, operated at a specialised cancer centre were available for analyses. A dMMR phenotype was detected in 135 (22.9%) of the patients. The overall correlation of the clinical and pathological T-category was significant for both groups. There was inferior correlation between cN and pN (p > 0.05) in pMMR cancers with a higher degree of over-staging assessed by CT-scan, compared to a significant correlation between cN and pN stage in pMMR cancers (p < 0.01). Of the 91 dMMR tumours judged node-positive by the preoperative CT scan, 59 (64.8%) showed no sign of metastatic involvement at the postoperative assessment. Conclusions: The accuracy of preoperative CT lymph node staging in colon cancer seems to differ depending on MMR status and may impact the clinical management including the neoadjuvant setting.

Cryotherapy in addition to chemotherapy for palliation of inoperable esophageal cancer: A multicenter prospective study.

342 Background: Palliation of dysphagia (Dys) in patients with inoperable esophageal cancer (EC) can be challenging. The major goal of palliation therapy is to improve patient’s quality of life (QoL) and Dys and allow adequate caloric intake. The most commonly used palliative modalities for Dys are radiation therapy (RT) and esophageal stenting. However, RT is limited by total dose and adverse events (AE) in patients receiving systemic therapy (ST), and stenting suffers from a high rate of AE including reflux and chest pain. A relatively new modality of liquid nitrogen endoscopic spray cryotherapy (cryo) has been reported in retrospective studies to improve Dys in patients receiving systemic therapy. We prospectively evaluated Dys and QoL of patients with inoperable EC undergoing cryo in addition to ST for palliation. Methods: A prospective multicenter study of 24 adult inoperable EC patients undergoing cryo and ST for palliation at 4 specialized cancer centers from Sep 2017 to Aug 2019. QoL was assessed using a modified EORTC QLQ-OES18 questionnaire (score 18 to 72, with higher scores indicating worse QoL). Dys was measured using a 4-point Likert scale: 0, no Dys; 1, Dys to solids; 2, Dys to semi-solids; 3, Dys to liquids; 4, Dys to saliva. Paired t-test was used to evaluate change in QoL and Dys between pre- and post-cryo. Results: There were 19 males and 5 females (17 stage IV, 5 stage III, and 2 stage II at diagnosis). Among 24 patients, a total of 71 cryo were performed, with a mean of 2.9 treatments per patient. After a median follow-up of 2 months, the mean EORTC score improved significantly from 35.4 at baseline to 25.5 at last follow-up ( p < 0.001). Similarly, the Dys score improved significantly from 2.0 at baseline to 0.87 at last follow-up ( p < 0.001). Grade 3 or higher AE were seen in only one patient (4%) who had GI bleeding 2 weeks after cryo and was diagnosed with bleeding from severe reflux esophagitis related to gastric outlet obstruction. Conclusions: The analysis of this multicenter prospective study shows that cryo in addition to ST for palliation of EC is well tolerated with significant improvement in Dys and QoL.

Health problems among breast cancer survivors after completing conventional treatments: A cross‐sectional study

This cross-sectional design study aimed to explore health problems among breast cancer survivors after completing conventional treatments. Purposive sampling was adopted to recruit 160 breast cancer survivors from a regional tertiary care hospital and hospital with a specialist cancer center in southern Thailand. STROBE checklist of items for cross-sectional studies is applied to report the study. Five most frequent, severe, and distressing symptoms faced in the first 3 years after cancer treatment were reported as numbness to the affected side, difficulty sleeping, fatigue, pain, and skin changes. Almost half of the participants reported symptoms indicating a definite diagnosis of anxiety, and nearly 70% of them rated themselves as borderline depressed or depressed. Approximately 50% of participants reported no change in their relationships with significant people, and about 60% of them reported a high-level fear of recurrence. Symptom frequency, severity, and distress were positively associated with anxiety, depression, and menopausal symptoms, while relationship changes were negatively associated with menopausal symptoms, anxiety, and depression. Support and information for these women are required after active treatment has ceased to deal with ongoing symptoms.

End-of-life care among patients with schizophrenia and cancer: a population-based cohort study from the French national hospital database

Patients with schizophrenia represent a vulnerable, underserved, and undertreated population who have been neglected in health disparities work. Understanding of end-of-life care in patients with schizophrenia and cancer is poor. We aimed to establish whether end-of-life care delivered to patients with schizophrenia and cancer differed from that delivered to patients with cancer who do not have diagnosed mental illness. We did a population-based cohort study of all patients older than 15 years who had a diagnosis of advanced cancer and who died in hospital in France between Jan 1, 2013, and Dec 31, 2016. We divided this population into cases (ie, patients with schizophrenia) and controls (ie, patients without a diagnosis of mental illness) and compared access to palliative care and indicators of high-intensity end-of-life care between groups. In addition to unmatched analyses, we also did matched analyses (matched in terms of age at death, sex, and site of primary cancer) between patients with schizophrenia and matched controls (1:4). Multivariable generalised linear models were done with adjustment for social deprivation, year of death, time from cancer diagnosis to death, metastases, comorbidity, and hospital type (ie, specialist cancer centre vs non-specialist centre). The main analysis included 2481 patients with schizophrenia and 222 477 controls. The matched analyses included 2477 patients with schizophrenia and 9896 controls. Patients with schizophrenia were more likely to receive palliative care in the last 31 days of life (adjusted odds ratio 1·61 [95% CI 1·45-1·80]; p<0·0001) and less likely to receive high-intensity end-of-life care-such as chemotherapy and surgery-than were matched controls without a diagnosis of mental illness. Patients with schizophrenia were also more likely to die younger, had a shorter duration between cancer diagnosis and death, and were more likely to have thoracic cancers and comorbidities than were controls. Our findings suggest the existence of disparities in health and health care between patients with schizophrenia and patients without a diagnosis of mental illness. These findings underscore the need for better understanding of health inequalities so that effective interventions can be developed for this vulnerable population. Assistance Publique des Hôpitaux de Marseille and Aix-Marseille University.

Prolonged time to treatment initiation in advanced pancreatic cancer patients has no major effect on treatment outcome: a retrospective cohort study controlled for lead time bias and waiting time paradox.

A prolonged time to treatment initiation (TTI) correlates with an adverse prognosis in different cancer types including resectable pancreatic cancer (PC). Only limited evidence on the correlation between TTI and prognosis in advanced PC exists. Consecutive PC patients (n = 368) who were diagnosed or treated at our high-volume comprehensive cancer center were included in a prospectively maintained database. We retrospectively analyzed time from first imaging showing advanced PC to initiation of palliative first-line chemotherapy. Lead time bias and waiting time paradox were addressed by landmark analysis and correlation of tumor burden with TTI. Two hundred and ninety-seven patients met the pre-specified in- and exclusion criteria of our study. Median TTI was 29days (range: 1-124days). Most common reasons for prolonged TTI (> 21days) were referral from an external treatment center (39%) and a second biopsy (31%). A TTI above the median-, 75th or 90th percentile (43 or 60days, respectively) had no impact on overall survival. Furthermore, no correlation between levels of carbohydrate antigen 19-9 (CA 19-9) at time of treatment initiation and TTI was observed. While a timely work-up of advanced PC patients remains important, delays in treatment initiation due to repeated biopsies, inclusion in a clinical study or transfer to a specialized cancer center appear to be justified in light of the absence of a strong adverse effect of prolonged TTI on prognosis in advanced PC patients.

Outcomes of Patients with Early Onset Colorectal Cancer Treated in a UK Specialist Cancer Center.

The incidence of early onset colorectal cancer (EOCRC) is rapidly increasing, but there remains paucity of outcome data for young CRC patients. We reviewed the characteristics and outcomes of 241 adults, age <50, who were diagnosed with EOCRC between January 2009 and December 2014. Median age was 42, 56% were male, and 7% had hereditary etiology. Seventy percent had left-sided primaries. At diagnosis, 11%, 50%, and 39% had stage II, III, and IV CRC. Of the patients with stage II and III CRC who underwent curative surgery, 60% and 88% had adjuvant chemotherapy, with 5-year relapse free survival of 82% and 74% respectively. Of the 123 patients with metastatic (m) EOCRC, 93%, 63%, 33%, and 12% had 1st, 2nd, 3rd, and 4th line systemic anticancer therapy (SACT) respectively. For first line SACT, 99% had doublet chemotherapy, with bevacizumab or an anti-EGFR antibody in 57%. Median overall survival (mOS) of mEOCRC patients was 20.1 months (95% C.I: 15.9–23.2). Younger age and signet cells were associated with shorter mOS, whereas more lines of SACT and curative metastasectomy with longer mOS. Metastatic EOCRC patients had poorer outcomes than expected, despite optimal multimodality treatment. This suggests an aggressive disease biology that warrants further research and therapy development.

Health-care delivery and cancer care systems: Economics and a market perspective of the cancer care spectrum

The purpose of this study is to evaluate and classify the economic market structure of cancer care in the United States, across the spectrum of cancer care. The author reviewed current published reports regarding demand, growth and costs of cancer care and oncological health service. The market structure for several product lines in the oncological services industry were compared against currently established economic models. A structural approach, based on economic theory, was used to evaluate the various market structures involved in the continuum of cancer care products. An overview of healthcare markets is described. In general, at a national level, cancer care follows a monopolistic competition market, where each centre competes with cancer centres, hospitals, outpatient facilities and heath organisations that meet the cancer care needs. Specialised cancer centres also fall into a unique category for research and survivorship programmes, forming a natural monopoly. Healthcare organisations that provide all forms of cancer care services need to be able to adapt to meet the need of each market position.

The Stage of Colorectal Cancer in Surgical Patients in Greece

Aim-Background: The aim of this study was to examine the symptomatology and the staging status of patients with colorectal cancer (CRC) at the time of diagnosis, and the type of surgical treatment. Methods: The hospital records were studied retrospectively of 249 patients with CRC who had undergone a surgical procedure with curative intent in a 7-year period, in the 4th Surgical Department, G. Papanicolaou Hospital Thessaloniki and the 1st Surgical Department, 401 Army General Hospital Athens,. The patients were divided into two groups, according to the location of their tumor (colon and rectum), and the results were compared with cancer databases of developed countries. Results: Abdominal pain was the most common presenting symptom (29.1% of cases) for right-sided CRC, and a change in bowel habits for left-sided CRC. In this series, 27.7% of the patients were admitted as surgical emergencies, while only 4.8% of the malignancies had been detected by screening. The surgical procedure varied, depending on the location and the stage of the tumor. According to histopathological examination of the resected specimens, 5 patients (2%) were diagnosed at stage 0,45 (18.1%) at stage I, 83 (33.3%) at stage II, 95 (38.2%) at stage III, and 21 (8.4%) at stage IV CRC. Conclusions: The demographic and clinical characteristics of the patients in this series were in agreement with the current bibliographical evidence. Further interpretation of the results highlights the need for increased participation in screening programs, the creation of specialized cancer centers of excellence and the establishment of a national cancer database, in order to improve the early diagnosis and treatment of CRC.

Reliability of preoperative breast biopsies showing ductal carcinoma in situ and implications for non-operative treatment: a cohort study

PurposeThe future of non-operative management of DCIS relies on distinguishing lesions requiring treatment from those needing only active surveillance. More accurate preoperative staging and grading of DCIS would be helpful. We identified determinants of upstaging preoperative breast biopsies showing ductal carcinoma in situ (DCIS) to invasive breast cancer (IBC), or of upgrading them to higher-grade DCIS, following examination of the surgically excised specimen.MethodsWe studied all women with DCIS at preoperative biopsy in a large specialist cancer centre during 2000–2014. Information from clinical records, mammography, and pathology specimens from both preoperative biopsy and excised specimen were abstracted. Women suspected of having IBC during biopsy were excluded.ResultsAmong 606 preoperative biopsies showing DCIS, 15.0% (95% confidence interval 12.3–18.1) were upstaged to IBC and a further 14.6% (11.3–18.4) upgraded to higher-grade DCIS. The risk of upstaging increased with presence of a palpable lump (21.1% vs 13.0%, pdifference = 0.04), while the risk of upgrading increased with presence of necrosis on biopsy (33.0% vs 9.5%, pdifference < 0.001) and with use of 14G core-needle rather than 9G vacuum-assisted biopsy (22.8% vs 7.0%, pdifference < 0.001). Larger mammographic size increased the risk of both upgrading (pheterogeneity = 0.01) and upstaging (pheterogeneity = 0.004).ConclusionsThe risk of upstaging of DCIS in preoperative biopsies is lower than previously estimated and justifies conducting randomized clinical trials testing the safety of active surveillance for lower grade DCIS. Selection of women with low grade DCIS for such trials, or for active surveillance, may be improved by consideration of the additional factors identified in this study.

Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease-driven strategy in patients with chronic lymphocytic leukaemia (ICLL07 FILO): a single-arm, multicentre, phase 2 trial

In patients with chronic lymphocytic leukaemia, achievement of a complete response with minimal residual disease of less than 0·01% (ie, <1 chronic lymphocytic leukaemia cell per 10 000 leukocytes) in bone marrow has been associated with improved progression-free survival. We aimed to explore the activity of induction therapy for 9 months with obinutuzumab and ibrutinib, followed up with a minimal residual disease-driven therapeutic strategy for 6 additional months, in previously untreated patients. We did a single-arm, phase 2 trial in 27 university hospitals, general hospitals, and specialist cancer centres in France. Eligible patients were at least 18 years old and previously untreated, and had immunophenotypically confirmed B-cell chronic lymphocytic leukaemia; an Eastern Cooperative Oncology Group (ECOG) performance status score of less than 2; a Binet stage C according to IWCLL 2008 criteria or Binet stage A and B with active disease; no 17p deletion or absence of p53 mutation; and were considered medically fit. In the first part of the study (induction phase), all participants received eight intravenous infusions of obinutuzumab 1000 mg over six 4-weekly cycles and oral ibrutinib 420 mg once per day for 9 months. In part 2, after assessment on day 1 of month 9, patients with a complete response and bone marrow minimal residual disease of less than 0·01% received only oral ibrutinib 420 mg once per day for 6 additional months. Patients with a partial response, or with a complete response and bone marrow minimal residual disease of 0·01% or more, received 6 months of four 4-weekly cycles of intravenous fludarabine, cyclophosphamide, and obinutuzumab 1000 mg, alongside continuing ibrutinib 420 mg once per day. The primary endpoint was the proportion of patients achieving a complete response with bone marrow minimal residual disease less than 0·01% on day 1 of month 16 assessed by intention to treat (ITT). This trial is registered with ClinicalTrials.gov (number NCT02666898) and is still open for follow-up. Between Oct 27, 2015, and May 16, 2017, 135 patients were enrolled. After induction treatment (day 1 of month 9), 130 patients were evaluable, of which ten (8%) achieved a complete response with bone marrow minimal residual disease of less than 0·01% and were assigned to ibrutinib, and 120 (92%) were assigned to ibrutinib plus fludarabine, cyclophosphamide, and obinutuzumab. After minimal residual disease-guided treatment (day 1 of month 16), 84 (62%, 90% CI 55-69) of 135 patients (ITT population) achieved a complete response with bone marrow minimal residual disease of less than 0·01%. The most common haematological adverse event was thrombocytopenia (in 45 [34%] of 133 patients at grade 1-2 in months 1-9 and in 43 [33%] of 130 patients at grade 1-2 in months 9-15). The most common non-haematological adverse events were infusion-related reactions (in 83 [62%] patients at grade 1-2 in months 1-9) and gastrointestinal disorders (in 62 [48%] patients at grades 1 and 2 in months 9-15). 49 serious adverse events occurred, most frequently infections (ten), cardiac events (eight), and haematological events (eight). No treatment-related deaths occurred. Obinutuzumab and ibrutinib induction therapy followed by a minimal residual disease driven strategy is safe and active in patients with previously untreated chronic lymphocytic leukaemia. With longer follow-up, including assessing the evolution of minimal residual disease, if response is maintained, this strategy could be an option in the first-line setting in patients with chronic lymphocytic leukaemia, although randomised evidence is needed. Roche, Janssen.

Unmet needs in patients with high risk uveal melanoma undergoing liver surveillance

Uveal melanoma (UM) is a rare form of cancer diagnosed in about 500 people a year in the UK. In most patients at time of diagnosis the disease is limited to the eye, but about 30% die of distant metastasis before five years and about 45% at 15 years post diagnosis. Although the survival benefits of liver screening are not proven, national guidance recommends liver surveillance for patients with high-risk disease every six months in the first five years after diagnosis, then annually for the rest of the person’s life.This article describes the findings of an audit of the unmet needs of patients undergoing regular liver surveillance following diagnosis of UM. The audit was conducted retrospectively over 12 months using the Macmillan National Cancer Survivorship Initiative holistic needs assessment checklist. The findings provide a snapshot of the issues faced by patients who survive a rare cancer and who are undergoing regular follow-up at a specialist cancer centre.

Survival analysis of gastric cancer in a Hispanic population: 15-years of experience at a specialized cancer center

Survival analysis of gastric cancer in a Hispanic population: 15-years of experience at a specialized cancer center

Comparison of Hospitals Affiliated With PPS-Exempt Cancer Centers, Other Hospitals Affiliated With NCI-Designated Cancer Centers, and Other Hospitals That Provide Cancer Care

Congress has exempted 11 specialized cancer centers in the United States from the Prospective Payment System (PPS). These centers are also exempt from reporting many of the process-of-care and outcome measures to the Centers for Medicare & Medicaid Services that are required for hospitals in the PPS. It is not known how hospitals affiliated with PPS-exempt cancer centers differ from other hospitals affiliated with National Cancer Institute cancer centers (NCI-CCs) or other US hospitals that provide cancer care. To examine differences between hospitals affiliated with PPS-exempt cancer centers, other hospitals affiliated with NCI-CCs, and other hospitals that provide cancer care on metrics that could be used in public reporting. This retrospective cohort study compared hospital characteristics and cancer-related services using data from the American Hospital Association Annual Survey and US News Best Hospitals rankings. With a 100% sample of Medicare beneficiaries who underwent 1 of 9 cancer operations (brain tumor resection, colorectal resection, cystectomy, esophagectomy, gastrectomy, liver resection, lung resection, pancreatic resection, prostatectomy) from January 1, 2011, to May 31, 2015, we used hierarchical logistic regression methods to compare differences in 18 postoperative outcomes. Data analysis was conducted from February 2018 to August 2018. This study evaluated hospital characteristics, including cancer-specific services, patient comorbidity burden, and cancer surgery postoperative outcomes, from PPS-exempt cancer centers, NCI-affiliated cancer centers, and other US hospitals that provide cancer care. Hospitals affiliated with PPS-exempt cancer centers (n = 15) and NCI-CCs (n = 54) were similar in hospital characteristics, basic cancer-related services, and patient comorbidity burden. Compared with NCI-CCs, PPS-exempt cancer centers had significantly higher US News reputation scores (mean [SD], 17.5 [24.0] vs 2.6 [4.8]; P < .001) but no differences in oncology patient volume, patient safety ratings, comorbidity burden, nurse staffing, US News total cancer scores, or US News survival scores. Hospitals affiliated with PPS-exempt cancer centers and NCI-CCs had similar adjusted postoperative outcomes for 15 of 18 measures, including mortality, readmission, and surgical site infections. Compared with hospitals affiliated with PPS-exempt cancer centers, patients treated at NCI-CCs were more likely to have postoperative sepsis (3.1% vs 1.7%; P = .002), acute renal failure (6.2% vs 3.9%; P = .01), and urinary tract infection (6.4% vs 4.0%; P = .002). Compared with the other hospitals that provide cancer care (n = 3578), PPS-exempt cancer center status was associated with improved outcomes for 7 of 18 measures, including mortality, sepsis, acute renal failure, pulmonary failure, and failure to rescue. Hospitals affiliated with PPS-exempt cancer centers and NCI-CCs had generally similar hospital characteristics, patient comorbidity burden, and cancer surgery outcomes. These findings raise questions about why some cancer centers are designated as PPS-exempt and why most hospitals are not required to publicly report cancer-specific quality metrics.

The prevalence of patient-reported dysphagia and oral complications in cancer patients.

Research investigating swallowing problems (dysphagia) and complications within the oral cavity in non-head and neck cancer patients is limited. The purpose of this study was to determine the prevalence of patient-reported dysphagia and oral complications in all cancer patients and to examine the relationships between cancer types, oral complications and dysphagia. A cross-sectional study was conducted at a specialist cancer centre in Australia. Data on patient-reported dysphagia and oral complications were collected using the Vanderbilt Head and Neck Symptom Survey (version 2.0) which was completed by participants in one of three settings: inpatients, ambulatory patients receiving chemotherapy, or ambulatory patients receiving radiotherapy. Data were collected on 239 patients, receiving treatment for 14 cancer types. The proportion of patients who reported dysphagic symptoms were as follows: any dysphagia (54%); dysphagia for liquids (20%); and dysphagia for solids (46%). Significantly more head and neck patients and significantly fewer breast patients reported dysphagia, but there were no differences between other tumour types. Oral symptoms across all cancer types were reported at the following rates: taste changes (62%); xerostomia (56%); voice changes (37%); smell changes (35%); thick mucous (33%); difficulty with teeth/dentures (25%); mouth/throat pain (20%); and trismus (19%). This is the first time comprehensive data on dysphagia and oral complications across all cancer patients have been collected. We have identified that dysphagic symptoms and oral complications-which have implications for quality of life and function-are common in all cancer patients, not just those with head and neck cancer.

Experience and challenges of setting up a new lung cancer chemotherapy clinic in resource limited setting in Nepal.

e18104 Background: Nepal is a developing country with a Gross Domestic Product per capita of 2400 US dollars. There are only two specialized cancer centers in whole of Nepal. They are at best, understaffed, overburdened and limited by logistics. Cancer diagnosis is easily accepted as a death sentence in the society and treatment rarely done due to the lack of universal coverage or health insurance. The nearest Cancer hospital is 400km away. In this background, in an academic institute serving as the referral center for Eastern Nepal, lung cancer chemotherapy clinic has started in last one year duration. Methods: A prospective Observational Study was done from May 2017 to May 2018 by the newly set up Lung Cancer treatment unit in an academic medical institute in Eastern Nepal. Readiness to undergo biopsy after suspicion of lung cancer as well as readiness for chemotherapy was looked at along with Clinico-radiologic characteristics, demographics, presumptive stage of disease and treatment outcome were recorded. Results: 53 patients were suspected of lung cancer based on imaging. Of these 14 did not agree for biopsy. Of the 39 who underwent biopsy, lung cancer was the diagnosis in 31 cases. In 4 cases the lung biopsy was not definitive for a diagnosis. Histology samples were obtained by USG guided Trans-thoracic needle biopsy in 25 cases and by bronchoscopic biopsy in 14 cases. The predominant histology was Adenocarcinoma (42%, 13/31) followed by Squamous Cell Carcinoma (29%, 9/31). There were 3 cases of Small Cell Carcinoma. Of the cases diagnosed as lung cancer, 45% (14/31) refused treatment. Immunohistochemistry and/or molecular testing for EGFR and ALK are not available routinely in our country. Only 3 patients opted for molecular testing abroad and of these 3, 2 were EGFR positive. Conclusions: Due to perception of poor prognosis, cancer diagnosis is taken as a death sentence and only 50% patients opt for treatment. Treatment is limited by lack of adequately trained surgeons, availability of radiotherapy facilities, lack of Molecular testing and especially by the high cost of treatment. There is an urgent need to train manpower, increase awareness and subsidize the treatment of lung cancer in some form in our country.

Tucidinostat plus exemestane for postmenopausal patients with advanced, hormone receptor-positive breast cancer (ACE): a randomised, double-blind, placebo-controlled, phase 3 trial

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. In an exploratory study, the combination of tucidinostat with exemestane showed preliminary signs of encouraging anti-tumour activity in patients with advanced hormone receptor-positive breast cancer. To build on these findings, we aimed to assess the efficacy and safety of this combination in a randomised trial in a larger population of postmenopausal patients with advanced, hormone receptor-positive breast cancer. We did the randomised, double-blind, placebo-controlled, phase 3 ACE trial at 22 specialist cancer centres in China. Eligible patients were postmenopausal women (aged ≥60 years or aged <60 years if their serum follicle-stimulating hormone and oestradiol concentrations were within postmenopausal ranges) with hormone receptor-positive, HER2-negative breast cancer, whose disease had relapsed or progressed after at least one endocrine therapy (either in advanced or metastatic or adjuvant setting), and who had at least one measurable lesion, adequate organ function, Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate haematological and biochemical parameters. Endocrine therapy did not have to be the most recent therapy before randomisation, but recurrence or progression after the most recent therapy was a prerequisite. Patients were randomly assigned (2:1) by a dynamic randomisation scheme via an interactive web-response system to receive 30 mg oral tucidinostat or placebo twice weekly. All patients in both groups also received 25 mg oral exemestane daily. Randomisation was stratified according to the presence of visceral metastases (yes vs no). Patients, investigators, study site staff, and the sponsor were masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival. Efficacy analyses were done in the full analysis set population, comprising all patients who received at least one dose of any study treatment, and safety analyses were done in all patients who received at least one dose of any study treatment and for whom at least one safety case report form was available. This study is registered with ClinicalTrials.gov, number NCT02482753. The study has reached the required number of events for final analysis of the primary endpoint. The trial is no longer enrolling patients, but follow-up for investigation of overall survival is ongoing. Between July 20, 2015, and June 26, 2017, 365 patients were enrolled and randomly assigned, 244 to the tucidinostat group and 121 to the placebo group. The median duration of follow-up was 13·9 months (IQR 9·8-17·5). Investigator-assessed median progression-free survival was 7·4 months (95% CI 5·5-9·2) in the tucidinostat group and 3·8 months (3·7-5·5) in the placebo group (HR 0·75 [95% CI 0·58-0·98]; p=0·033). The most common grade 3 or 4 adverse events in either group were neutropenia (124 [51%] of 244 patients in the tucidinostat group vs three [2%] of 121 patients in the placebo group), thrombocytopenia (67 [27%] vs three [2%]), and leucopenia (46 [19%] vs three [2%]). Serious adverse events of any cause occurred in 51 (21%) of 244 patients in the tucidinostat group and seven (6%) of 121 patients in the placebo group. No treatment-related deaths were reported. Tucidinostat plus exemestane improved progression-free survival compared with placebo plus exemestane in patients with advanced, hormone receptor-positive, HER2-negative breast cancer that progressed after previous endocrine therapy. Grade 3-4 haematological adverse events were more common in the tucidinostat plus exemestane group than in the placebo plus exemestane group. Tucidinostat plus exemestane could represent a new treatment option for these patients. Chipscreen Biosciences.

2019 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: A proposal to optimize care for patients with valvular heart disease: A Joint Report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons.

This statement was commissioned as a Multisociety Expert Consensus Systems of Care Document by the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Society for Cardiovascular Angiography and Interventions (SCAI), and

Prechemotherapy Levels of Plasma Dehydroepiandrosterone and Its Sulfated Form as Predictors of Cancer-Related Cognitive Impairment in Patients with Breast Cancer Receiving Chemotherapy.

Study ObjectiveDehydroepiandrosterone (DHEA) and its sulfated form (DHEAS)—jointly referred to as DHEA(S)—are neurosteroids known to regulate brain development and function that have been found to be positively correlated with cognitive function. It is unknown whether prechemotherapy plasma DHEA(S) levels are associated with the onset of cancer‐related cognitive impairment (CRCI). The objective of this study was to evaluate whether an association exists between prechemotherapy plasma DHEA(S) levels and onset of CRCI in patients with breast cancer receiving chemotherapy.DesignMulticenter, prospective cohort study.SettingTwo specialized cancer centers in Singapore.PatientsEighty‐one patients with early‐stage breast cancer (stages I–III) who had no prior exposure to chemotherapy and/or radiotherapy and were scheduled to receive anthracycline‐based or taxane‐based chemotherapy treatment with curative intent.Measurements and Main ResultsPatients completed assessments for self‐perceived and objective cognitive function at three time points: prechemotherapy (T1), during chemotherapy (T2), and after chemotherapy (T3). Plasma samples were collected prior to chemotherapy, and DHEA(S) levels were quantified by using ultra–high‐performance liquid chromatography–tandem mass spectrometry. Multivariable logistic regression was used to adjust for clinically important factors and to evaluate the association between prechemotherapy plasma DHEA(S) levels and CRCI. Mean ± SD age was 48.9 ± 9.3 years, with 27.8% of patients experiencing clinically significant cognitive impairment based on global Functional Assessment of Cancer Therapy–Cognitive Function scores. The mean ± SD prechemotherapy plasma DHEAS and DHEA levels were 1.61 ± 0.91 μmol/L and 19.21 ± 13.13 nmol/L, respectively. Prechemotherapy DHEAS levels were found to be associated with impairment in the self‐perceived cognitive domains of verbal fluency (adjusted odds ratio [OR] 0.27, 95% confidence interval [CI] 0.08–0.96) and mental acuity (adjusted OR 0.25, 95% CI 0.08–0.74). Conversely, DHEA levels were not associated with impairment in any cognitive subdomains.ConclusionOur findings suggest that patients with higher prechemotherapy DHEAS levels had lower odds of developing self‐perceived cognitive impairment. Future studies are required to further investigate the effect of DHEA(S) on specific cognitive domains and to validate our findings in independent cohorts.