Large Comprehensive Cancer Center Research Articles

Preoperative Anxiety in Patients Undergoing Outpatient Cancer Surgery

Objective:Our primary research aim was to determine the prevalence of preoperative anxiety in patients undergoing outpatient cancer surgery. Our secondary aim was to examine the association between preoperative anxiety and negative intraoperative and postoperative outcomes in patients undergoing outpatient cancer surgery, including increased anesthesia requirements, postoperative nausea and vomiting (PONV), extended overnight stay, total length of stay (LOS), transfer to hospital, surgical complications, and postoperative visits to urgent care centers (UCC).Methods:We conducted a retrospective cohort study to investigate the prevalence of preoperative anxiety and its association with postoperative outcomes in patients undergoing outpatient cancer surgery. Our retrospective cohort included 10,048 outpatient procedures performed on 8683 patients at a large comprehensive cancer center between January 1, 2016, and April 30, 2018.Results:The analysis included 8665 patients undergoing procedures at an outpatient facility over 16 months; 16.7% had preoperative anxiety. In patients with preoperative anxiety, higher rates of adverse outcomes were seen, including PONV (adjusted difference 1.8%, 95% confidence interval [CI] 0.12%, 3.4%, P = 0.029), unplanned overnight admission (adjusted difference 1.1%, 95% CI 0.07%, 2.0%, P = 0.021), and urgent care visits within 30 days (adjusted difference 1.5%, 95% CI 0.44%, 2.6%, P = 0.002).Conclusions:Even assuming a causal relationship between preoperative anxiety and postoperative outcomes, preventing one instance of PONV would require treating at least 30 patients for anxiety, and preventing longer-term outcomes such as urgent care visits or readmissions within 30 days would require treating even larger numbers of patients. Future studies should attempt to elucidate the causal pathway between preoperative anxiety and postoperative adverse events in outpatients undergoing outpatient cancer surgery.

Healthcare Workers Knowledge and Perceptions of Coming to Work Sick At a Large Comprehensive Cancer Center

BACKGROUND Hospital staff who come to work sick can transmit infections to patients. Such events are particularly important among immunocompromised patients who are at increased risk for morbidity and mortality from many of these pathogens. Despite dedicated education to counter presentism at our large cancer center, hospital staff still come to work sick. Therefore, we set out to understand perceptions, knowledge of institutional policies and reasons for working while sick. METHODS Clinical and non-clinical staff at our cancer center complete an annual online infection prevention training module. We attached an optional anonymous survey with eight questions, five of which targeted staff experiences and knowledge around presentism at module completion. Our questionnaire was modified from a published survey (Szymczak JAMA Pediatrics 2015), and addressed staff awareness, and experience with local institutional sick policies. RESULTS A total of 2751 staff completed the required training module in 2016 and 2017, of whom 33% (899/2751) completed the optional anonymous survey. Nearly all survey respondents understood that coming to work sick was “dangerous for patients” (890/898 [99%]), however, 29% (258/899) indicated that they still came to work sick. The most common reasons for working sick were that they “didn't want to let their colleagues down” (50% of respondents), they “only had allergies” (38%), and that “leadership was not supportive” (21%). Only 10% (91/891) of respondents said that they “never” saw colleagues come to work sick. CONCLUSIONS Comprehensive education at our center assured that the vast majority of staff understand the importance of sick policies. However, despite being among high-risk patients at a cancer center, staff still come to work sick and perceive that presentism remained high among their colleagues. Our data suggest that to prevent presentism, efforts targeting staffing support systems, professional behavior and enhanced sick policies may be more impactful than those focusing solely on patient safety.

Patterns of Fertility Preservation and Pregnancy Outcome After Breast Cancer at a Large Comprehensive Cancer Center.

Background: In the last decades, long-term outcomes of breast cancer (BC) patients have improved, raising new survivorship issues, including fertility preservation and safety of pregnancy after BC. This study assesses evolution in patterns of fertility discussion/preservation over time and reports pregnancy outcomes in a cohort of young BC patients.Methods: A retrospective cohort of 590 BC patients aged ≤40 diagnosed between 2000 and 2016 at a large cancer center was identified. Fertility counseling and preservation patterns for patients receiving chemotherapy were analyzed and compared for two cohorts: 2004–2006 and 2014–2016 (total n = 161). Outcomes were reported for patients with documented pregnancy after BC.Results: Significantly, more patients diagnosed in 2014–2016 had evidence of discussion on fertility issues and/or application of fertility preservation techniques versus patients diagnosed in 2004–2006 (82.9% vs. 66.0%, p = 0.017). In particular, there was a significant difference in rate of documented fertility issues discussion (67.6% vs. 34.0%, p < 0.001). Age >35 and parity were associated with lower rates of fertility discussion/preservation. However, rates significantly improved over time (77.6% in 2014–2016 vs. 58.1% in 2004–2006 for patients aged >35, p = 0.046; 80.7% in 2014–2016 vs. 57.6% in 2004–2006 for patients with children at diagnosis, p = 0.018). Twenty-six patients with pregnancy after BC were identified; eight delivered at the age of >40. No complications for women or newborns were reported. Only two patients experienced BC relapse.Conclusions: In this small retrospective cohort, no safety concerns were identified for pregnancy after BC. The importance attributed by clinicians to address fertility issues has increased over time.

Residents' attitudes and beliefs towards palliative care in a community teaching hospital.

89 Background: Early integrated palliative care improves the quality of life in patients with cancer. Wong et al. (2016) recently demonstrated that residents and fellows in a university hospital-based large comprehensive cancer center believed palliative care services to be beneficial for patient care. However, there are substantial differences between the clinical learning environments of a university and community teaching hospital. We aim to assess residents' attitudes and beliefs towards palliative care in the oncologic population in a community teaching hospital. Methods: We surveyed all residents (n = 90) in Mercy Catholic Medical Center's internal medicine, transitional year, and general surgery residencies about their knowledge, training, attitudes and beliefs regarding palliative care using a survey modified from Wong et al. (2015). Mercy Catholic Medical Center is a conglomeration of two community teaching hospitals in greater Philadelphia. The factors associated with awareness were analyzed using chi square or fisher exact test and logistic regression. Results: A total of 57 (63%) residents participated. The differences between the knowledge of residents from other specialties were not statistically significant. The awareness was reported more among residents who are American medical graduates (p = 0.03). The majority of the residents believed palliative care was beneficial to patients and families (98%), reduce health care costs (91%), decrease overall symptom burden (86%) and symptomatic management in newly diagnosed cancer (81%). Residents who reported having palliative care training during residency had significantly higher awareness (OR = 2.99, p = 0.04). Conclusions: Our study shows that the attitude and belief of residents at community teaching hospital is similar to the trainees at university teaching hospital. The implementation of palliative care rotation for all residents from clinical specialties can be effective in improving trainee’s attitude and belief regarding increased and early referral to palliative care.

Developing a Model of Distributed, Decentralized Digitally Connected Cancer Control Program

Background and context: Traditional method of managing cancer through establishing large comprehensive cancer centers are ineffective in developing country setting that has poorly developed primary health care facilities. These larger cancer centers become victims of their success and attract increasing number of patients from distant places, overstretching the resources and increasing out-of-pocket expenses for the patients. Increasing the number of cancer centers also is not effective as each unit by itself will not have the critical mass of expertise to offer comprehensive cancer care. In addition, for sustainability and improved resource utilization, the cancer care needs to be integrated with the existing health care system. The state with a population ∼ 33.3 million has 19 cancer treatment facilities distributed throughout the coastal districts. The cancer incidence rate of the state is 128 per 100,000, which is the fourth highest in the country. Aim: To develop a model for distributed, decentralized digitally connected cancer control program for the state of Kerala, India. Strategy/Tactics: A model for distributed, decentralized digitally connected cancer care that offers resource stratified cancer care and integrate with the existing health care. Program/Policy process: The distributed cancer care network for the state that will be digitally connected using a recently introduced e-health program to interconnect the cancer care as well as to integrate with the existing healthcare network. The cancer centers will be stratified in 4 levels. Level 1 would be 3 apex cancer centers with most advanced infrastructure and serves as quaternary centers and coordinate cancer care in 3 zones. The Level 2 cancer centers established at medical colleges and cancer centers in major private medical hospitals offer comprehensive cancer care in a geographic area and serve as tertiary cancer referral centers. Level 3 centers are located in the district and Taluk hospitals that offers primary cancer care for common cancers including palliative daycare chemotherapy. Level 4 units are established as part of the national health mission in primary and family health centers which provide the important task of cancer surveillance and improving cancer literacy for the public with peoples participation. Outcomes: The expected outcomes are downstaging of cancer, developing a resource-stratified referral pathway that minimize treatment delay, provide cancer care within 90 minutes of travel and lowering out-of-pocket expenses. What was learned: Planning of the program involved participation of major stakeholders of cancer and health care of the state as well as NGO.

Seasonal clustering of sinopulmonary mucormycosis in patients with hematologic malignancies at a large comprehensive cancer center

BackgroundInvasive Mucorales infections (IMI) lead to significant morbidity and mortality in immunocompromised hosts. The role of season and climatic conditions in case clustering of IMI remain poorly understood.MethodsFollowing detection of a cluster of sinopulmonary IMIs in patients with hematologic malignancies, we reviewed center-based medical records of all patients with IMIs and other invasive fungal infections (IFIs) between January of 2012 and August of 2015 to assess for case clustering in relation to seasonality.ResultsA cluster of 7 patients were identified with sinopulmonary IMIs (Rhizopus microsporus/azygosporus, 6; Rhizomucor pusillus, 1) during a 3 month period between June and August of 2014. All patients died or were discharged to hospice. The cluster was managed with institution of standardized posaconazole prophylaxis to high-risk patients and patient use of N-95 masks when outside of protected areas on the inpatient service. Review of an earlier study period identified 11 patients with IMIs of varying species over the preceding 29 months without evidence of clustering. There were 9 total IMIs in the later study period (12 month post-initial cluster) with 5 additional cases in the summer months, again suggesting seasonal clustering. Extensive environmental sampling did not reveal a source of mold. Using local climatological data abstracted from National Centers for Environmental Information the clusters appeared to be associated with high temperatures and low precipitation.ConclusionsSinopulmonary Mucorales clusters at our center had a seasonal variation which appeared to be related to temperature and precipitation. Given the significant mortality associated with IMIs, local climatic conditions may need to be considered when considering center specific fungal prevention and prophylaxis strategies for high-risk patients.

Resisting RECIST-Uniformity Versus Clinical Validity.

The Response Evaluation Criteria in Solid Tumors (RECIST) International Working Group developed criteria for tumor response and progression to standardize radiological assessment in patients receiving chemotherapy in phase 2 trials. However, it is unclear whether the defined percentage change in tumor size and volume reflects true clinical benefit for the patient. The RECIST criteria were designed to improve objectivity in trials, but not to replace clinical decision making. The aim of this study was to understand clinicians' opinions about RECIST in current oncology practice. Using Web-based questionnaires, we investigated attitudes to the use of RECIST at a large comprehensive cancer center and in an international group of gynecologic cancer specialists through the Gynecologic Cancer InterGroup. The results reported here relate to the survey focusing on gynecologic cancer. Sixty medical professionals from 13 countries responded to the survey. The majority of respondents worked at a tertiary or specialist cancer center (51; 86%). Overall, 66% of respondents felt RECIST increased trial objectivity and was a good measure of response. The majority of respondents (81%) reported that they infrequently challenged RECIST evaluation. Overall, 60% felt more than 10% of patients came off trial for clinical rather than radiological progression. In the context of a new small lesion, only 35% felt that should always be considered disease progression. The importance of both clinician and radiologist input was highlighted with nontarget progression. Nontarget progression and target progression were recognized as equally important for clinical decision making (72%). RECIST is a key criterion for endpoint assessment in clinical trials with its value recognized by clinicians. However, this survey also highlights the practical limitations of RECIST. Disconnect can be seen between the radiological result and the clinical picture-learning from these patients is critical. Continued efforts to improve metrics assessing patient benefit in trials remains a priority.

Interdisciplinary implementation of tacrolimus intravenous standard concentration in hematopoietic stem cell transplantation recipients.

Purpose Reduction in waste of intravenous (IV) tacrolimus, an immunosuppressant used to prevent graft-versus-host disease in allogeneic hematopoietic stem cell transplantation recipients, was evaluated after standardizing the concentration. Methods A single-center, retrospective cohort study at a large academic comprehensive cancer center was performed comparing patient-specific intravenous tacrolimus doses (tacrolimus doses in 50, 100, or 250 mL of normal saline based on manufacturer's recommended concentration) to tacrolimus intravenous standard concentration (tacrolimus 1 mg in 250 mL of normal saline) continuous intravenous infusion titrated to prescribed dose. The cohort study was performed on two hematopoietic stem cell transplantation nursing units consisting of a prepilot phase during which time patient-specific intravenous tacrolimus doses were compounded and administered, followed by the pilot phase during which patients received tacrolimus intravenous standard concentration. The primary endpoint was reduction in tacrolimus intravenous bags wasted. Secondary endpoints were drug cost savings, decreased intravenous infusion line supplies, decrease in time needed to execute dose changes, reduction in infusion pump alerts, and number of patient safety events. Results Compared to the prepilot phase, there was a 64% reduction in tacrolimus intravenous bags wasted during the pilot phase ( p = 0.029), resulting in a mean monthly total cost savings of $224.31 for pilot units. Intravenous pump line use was reduced by 18% ( p = 0.067), yielding a monthly total cost savings of $84.02 for pilot units. The median time needed to execute dose changes and intravenous pump overrides was significantly reduced ( p < 0.0001, p < 0.0001, respectively). Conclusion This interdisciplinary quality improvement initiative led to increased efficiency, reduction in waste, and decreased intravenous pump alerts utilizing tacrolimus intravenous standard concentration.

Failure to Treat: Audit of an Institutional Cancer Registry Database at a Large Comprehensive Cancer Center Reveals Factors Affecting the Treatment of Pancreatic Cancer.

National Cancer Database analysis showed 70% of patients with stage I pancreatic adenocarcinoma (PDA) did not have surgery. We sought to analyze adherence to expected treatment (ET) by stage for PDA and identify factors that led to no treatment (NT) or unexpected treatment (UT) in a recent cohort. Using our Institutional Cancer Registry (ICR), we identified patients with PDA from 2004 to 2013. ET was defined as surgery±chemotherapy±radiation for stages I and II, chemotherapy±radiation for stage III, and chemotherapy for stage IV, while UT was defined as no surgery for stages I and II, surgery for stage III, or±surgery±XRT for stage IV. Overall, 2340 patients were identified (stages I and II=51%, stage III=11%, stage IV=38%; ET=58%, UT=18%, NT=24%). A total of 1183 patients had resectable PDA (stages I and II; ET=57%, UT=27%, NT=16%), with ET demonstrating the best overall survival, but UT showing better survival than NT (p<0.0001). In addition, 261 patients had unresectable PDA (stage III; ET=69%, UT=12%, NT=18%), and survival was best in UT, but ET had a survival advantage over NT (p<0.0001). Finally, 896 patients had metastatic PDA (stage IV; ET=55%; UT=9%; NT=36%), with the NT group showing worse survival than the ET and UT groups (p<0.0001). Unlike previous reports, most patients with early-stage disease had ET. ET and UT were associated with better survival than NT in all stages, and surgical cohorts have improved survival regardless of stage. Younger age, male sex, white race, and less comorbidity were predictors of receiving treatment.

Genomic-directed therapy of gastrointestinal cancers by comprehensive genomic profile (CGP): Clinical and genomic characteristics at the John Theurer Cancer Center (JTCC).

803 Background: The routine use of comprehensive genomic profiling (CGP) has led to better genomic characterization, more personalized treatments and higher enrollment in clinical trials for many solid cancers. The aim of this study was to evaluate the clinical and genomic prolife of patients (pts) with gastrointestinal cancers (GIC) with the use of a CGP assay and their potential therapeutic benefit at a large comprehensive cancer center. Methods: We retrospectively analyzed 83 consecutive pts with GIC that had CGP at the JTCC between 01/2014-09/2016. Demographics, CGP results, and clinical characteristics were studied. Clinically relevant genomic alterations (CRGAs) were identified using the FoundationOne assay (Foundation Medicine, Cambridge, MA), and were defined as alterations linked to approved therapies and those under evaluation in genotype-driven clinical trials. Results: 83 pts with GIC were analyzed. 46.9% males and 53.0% females. The median age at diagnosis was 58.5 years. 73 (88%) patients were stage III/IV at diagnosis. Tumors consisted of colorectal (36%), gastric (24%), pancreatic (12%) and cholangiocarcinoma (6%). All the pts were found to have at least one genomic alteration (GA). CRGAs were identified in 63 (76%) of cases, with an average of 2 per pt. The most frequently identified GAs were TP53 43 (29.9%), APC 24 (16.7%), KRAS 31 (21.5%), ARID1A 12 (8.3%), PIK3CA 11 (7.6%), and SMAD4 11 (7.6%). Of the 63 pts with CRGAs, 23 (36%) received one of the therapies suggested by the NGS assay, and 9 (14%) were enrolled in a clinical trial. Conclusions: The use of CGP assay identified a high frequency of CRGAs in GIC pts. The assay provided information for genomic-directed therapy in 36% of the patients. The routine use of CGP in GIC may lead to pts receive more personalized treatments. The potential benefit of selected targeted therapies in individual cases suggests that larger studies of treatment guided by routine CGP in gastrointestinal malignancies are warranted.

Emergency Department Management of Patients With Febrile Neutropenia: Guideline Concordant or Overly Aggressive?

The Infectious Diseases Society of America and the American Society of Clinical Oncology recommend risk stratification of patients with febrile neutropenia (FN) and discharge with oral antibiotics for low-risk patients. We studied guideline concordance and clinical outcomes of FN management in our emergency department (ED). Our urban, tertiary care teaching hospital provides all emergency and inpatient services to a large comprehensive cancer center. We performed a structured chart review of all FN patients seen in our ED from January 2010 to December 2014. Using electronic medical records, we identified all visits by patients with fever and an absolute neutrophil countof <1000 cells/mm3 and then included only patients without a clear source of infection. Following national guidelines, we classified patients as low or high risk and assessed guideline concordance in disposition and parenteral versus oral antibiotic therapy by risk category as our main outcome measure. Of 173 qualifying visits, we classified 44 (25%) as low risk and 129 (75%) as high risk. Management was guideline concordant in 121 (70%, 95% confidence interval [CI]= 63% to 77%). Management was guideline discordant in 43 (98%, 95% CI= 88% to 100%) of low-risk patients versus 9 (7%, 95% CI= 3% to 13%) of high-risk patients (relative risk [RR]= 14, 95% CI= 7.5 to 26). Of 52 guideline-discordant cases, 36 (83%, 95% CI= 72% to 93%) involved low-risk cases with treatment that was more aggressive than recommended. Guideline concordance was low among low-risk patients, with management tending to be more aggressive than recommended. Unless data emerge that undermine the guidelines, we believe that many of these hospitalizations and parenteral antibiotic regimens can be avoided, decreasing the risks associated with hospitalization, while improving antibiotic stewardship and patient comfort.

Viral associated diarrhea in immunocompromised and cancer patients at a large comprehensive cancer center: a 10-year retrospective study

Background: Viral associated diarrhea (VAD) due to Norovirus (NV), Rotavirus (RV) and Adenovirus (AV) is common in immunocompromised and cancer patients. We sought to determine if the clinical characteristics, morbidity and seasonality of infection differed according to the type of enteric virus identified.Methods: Cases of NV, RV and AV were identified in stool specimens submitted to the clinical microbiology laboratory between November 2005 and February 2015. Clinical characteristics of patients, potential risk factors and outcomes were compared.Results: A total of 97 VAD cases were identified: NV (n = 49), RV (n = 34) and AV (n = 14). The majority of cases were in patients with leukemia and lymphoma. NV (59%), RV (74%) and AV (78%) were identified in hematopoietic stem cell transplant (HSCT) recipients; and in patients with graft versus host disease (GVHD): NV (34%), RV (46%) and AV (57%). Nine cases of NV were genotyped; all were due to genotype II. Nine of 49 (18%) cases of NV, 7 of 34 (20%) cases of RV and 2 of 14 (14%) cases of AV were considered to be health care acquired (HCA). In multivariate analysis, immunosuppression (OR 2.8 95% CI 1.26-6.60, p = .01) and neutropenia (OR 4.8 95% CI 1.27-18.5, p = .01) were identified as risk factors for NV diarrhea compared to RV and AV.Conclusions: In our study, agents responsible for VAD occurred year round but predominated in the winter time; caused prolonged illness and were frequently health care associated. Presentations were atypical in many cases without upper gastrointestinal symptoms such as nausea and vomiting.

E-Mail Communication Practices and Preferences Among Patients and Providers in a Large Comprehensive Cancer Center.

Little is known about how electronic mail (e-mail) is currently used in oncology practice to facilitate patient care. The objective of our study was to understand the current e-mail practices and preferences of patients and physicians in a large comprehensive cancer center. Separate cross-sectional surveys were administered to patients and physicians (staff physicians and clinical fellows) at the Princess Margaret Cancer Centre. Logistic regression was used to identify factors associated with current e-mail use. Record review was performed to assess the impact of e-mail communication on care. The survey was completed by 833 patients. E-mail contact with a member of the health care team was reported by 41% of respondents. The team members contacted included administrative assistants (52%), nurses (45%), specialist physicians (36%), and family physicians (18%). Patient factors associated with a higher likelihood of e-mail contact with the health care team included younger age, higher education, higher income, enrollment in a clinical trial, and receipt of multiple treatments. Eighty percent of physicians (n = 63 of 79) reported previous contact with a patient via e-mail. Physician factors associated with a greater likelihood of e-mail contact with patients included older age, more senior clinical position, and higher patient volume. Nine hundred sixty-two patient records were reviewed, with e-mail correspondence documented in only 9% of cases. E-mail is commonly used for patient care but is poorly documented. The use of e-mail in this setting can be developed with appropriate guidance; however, there may be concerns about widening the gap between certain groups of patients.

Email communication practices and preferences among patients and providers in a large comprehensive cancer center.

6519 Background: Little is known about how email is currently used in healthcare to facilitate patient care. The objective of our study was to understand current practices and preferences of patien...

Place of Death among Hospitalized Patients with Cancer at the End of Life.

The majority of hospital deaths in the United States occur after ICU admission. The characteristics associated with the place of death within the hospital are not known for patients with cancer. The study objective was to identify patient characteristics associated with place of death among hospitalized patients with cancer who were at the end of life. A retrospective cohort study design was implemented. Subjects were consecutive patients hospitalized between 2003 and 2007 at a large comprehensive cancer center in the United States. Multinomial logistic regression analysis was used to identify patient characteristics associated with place of death (ICU, hospital following ICU, hospital without ICU) among hospital decedents. Among 105,157 hospital discharges, 3860 (3.7%) died in the hospital: 42% in the ICU, 14% in the hospital following an ICU stay, and 44% in the hospital without ICU services. Individuals with the following characteristics had an increased risk of dying in the ICU: nonlocal residence, newly diagnosed hematologic or nonmetastatic solid tumor malignancies, elective admission, surgical or pediatric services. A palliative care consultation on admission was associated with dying in the hospital without ICU services. Understanding existing patterns of care at the end of life will help guide decisions about resource allocation and palliative care programs. Patients who seek care at dedicated cancer centers may elect more aggressive care; thus the generalizability of this study is limited. Although dying in a hospital may be unavoidable for patients who have uncontrolled symptoms that cannot be managed at home, palliative care consultations with patients and their families in advance regarding end-of-life preferences may prevent unwanted admission to the ICU.

Low Yield From Hepatitis C Virus (HCV) Lookback At a Large Cancer Center

While chronic hepatitis due to HCV is a major health problem in the USA, blood transfusions pose a low risk of transmission. The federally mandated lookback process is initiated when a blood donor, previously negative or untested for HCV, now has a positive test. The process serves to identify any possible transmission during the “window period.” While there have been publications on lookback series from single institutions and countries, to date there has not been data presented solely from a cancer center. Moffitt Cancer Center (MCC), a large NCI-designated comprehensive cancer center, has had 291 HCV lookback investigations. Although the average age at time of transfusion was 51, this failed to include a number of patients on whom an electronic medical record was not created. Most of the transfusion recipients had advanced age or were ill from their cancer and had died prior to the investigation, accounting for 234 (80.4%) of the cases. Five of the cases were blood components that had expired and were never transfused. Six cases identified blood components that were never received and were actually transfused at other facilities. One case had no documentation of the recipient of the fresh frozen plasma unit. Eight cases were from patients who were alive but not tested either due to patient decision or inability to get in contact with them. Out of the 37 patients that were subsequently tested, 35 (94.5%) of them tested negative for HCV by either anti-HCV enzyme immunoassays (EIA) or nucleic acid amplification tests (NAT), or both. Only 2 patients (or 0.7% of all cases investigated) tested HCV seropositive (EIA and RIBA confirmed). Both transfusion recipients were elderly women who were asymptomatic for chronic hepatitis and who posed no current or past risk for transmission via their blood or body fluids. In our case series, 80.4% of recipients were deceased at the time of the investigation. The seroprevalence rate in our case series, among the 37 recipients tested for HCV and transfused between 1988 and 2012, was 5.4%. In the USA, HCV prevalence continues to be low with current estimates &lt;1.5%. The CDC has recently expanded the recommendations for HCV testing to any persons born between 1945 and 1965, recipients of blood transfusions before July 1992, and patients with abnormal liver enzymes. Since the initiation of blood donor HCV EIA testing in 1990 and NAT testing in 1999, the risk of transfusion-transmitted HCV infection has plummeted. Given the improved public awareness of HCV, improved blood donor testing, and the low yield of the lookback process to both the recipient and society, discontinuation of the HCV lookback requirement should be considered. This case series also highlights that most transfusion recipients are either older or ill. As with HCV, several recent publications document the infrequency of transmitting human immunodeficiency virus (HIV) through modern transfusions; In England and Wales from October 1995 to December 2008, only 1 HIV positive recipient was identified with the lookback procedure. In conclusion, our large cancer center had almost 300 HCV lookback notifications and most transfusion recipients had advanced cancer and died prior to case investigation. The series found 94.5% of recipients tested had no evidence of HCV transmission. Consideration should be given to focusing HCV detection efforts on the general public and to eliminating the HCV lookback requirement in transfusion recipients. Disclosures: No relevant conflicts of interest to declare.

Implementation of chemotherapy treatment plans (CTP) in a large comprehensive cancer center (CCC): The key roles of infrastructure and data sharing.

20 Background: ASCO recommends that prior to initiating chemotherapy, a synoptic CTP should be created. At a large CCC, there was no tool to consistently or clearly communicate chemotherapy plans within the electronic health record (EHR). Methods: In 2011, a structured tool was created in the EHR to document patient diagnosis, tumor characteristics, planned regimen, side effects, performance status, and other elements when starting a new chemotherapy. Completion of a CTP generates a synoptic note in the EHR, pre-populates a chemotherapy consent form and computerized chemotherapy ordering template, helping to integrate CTPs into normal workflow and removing steps for possible errors. Completed CTPs can be accessed by care team members and sent to external referring providers. Implementation strategy included education on the importance of and how to complete CTPs and sending monthly compliance reports to disease centers (DC) and regional sites (RS). Compliance was defined as number completed CTPs / number new chemotherapy starts. Results: The CTP tool was introduced in a staggered rollout in mid-2011 (compliance reporting began in 2012). Six DC and 3 RS presently complete and use CTPs. 3,569 CTPs were completed since 2012. The table shows compliance by quarter, demonstrating significant variation among DC and RS. We attribute increased compliance to introduction of formal feedback reports that allow for identification of high-volume providers not completing CTPs, triggering individual interventions, especially targeted re-education. We also suspect shared reporting led to competition among providers, further improving performance. No incentives were provided for CTP completion. Conclusions: By creating a tool within the existing workflow and providing formal feedback, CTPs have been implemented as a communication tool at a CCC. [Table: see text]

Preemptive tumor profiling for biomarker-stratified early clinical drug development in metastatic breast cancer patients

Biomarker-stratified cancer pharmacotherapy was pioneered in the care of breast cancer patients. The utility of agents modulating hormone receptors, synthesis of steroid hormones, or HER2-targeting agents has been greatly enhanced by the detection of predictive biomarkers in diagnostic tumor samples. Based on deeper understanding of breast cancer biology multiple drug candidates have been developed to modulate additional molecular targets which may associate with specific biomarker profiles. Accordingly, exploratory biomarkers are increasingly incorporated in early clinical trials, thus demanding a new process of patient selection. Here, we describe the implementation of preemptive, multiplexed biomarker profiling linked to standard diagnostic algorithms for metastatic breast cancer patients treated at the West German Cancer Center. Profiling for experimental biomarkers was prospectively offered to patients with metastatic breast cancer who met generic clinical trial inclusion criteria. Formalin-fixed, paraffin-embedded tumor samples were retrieved and studied for potentially “actionable” biomarkers related to active clinical trials by immunohistochemistry, amplicon sequencing, and in situ hybridization. The clinical course of those “profiled” patients was closely monitored to offer trial participation whenever applicable. Here, we report results from the first 131 patients enrolled in this program. PIK3CA mutations (23 %) and amplifications (2 %), loss of PTEN expression (13 %), and FGFR1 amplifications (8 %) were detected next to established biomarkers such as estrogen (67 %) and progesterone receptor expression (52 %), and HER2 overexpression or amplification (23 %). So far 16 “profiled” patients (12 %) have been enrolled in biomarker-stratified early clinical trials. Preemptive profiling of investigational biomarkers can be integrated into the diagnostic algorithm of a large Comprehensive Cancer Center. Extensive administrative efforts are required to successfully enroll “profiled” patients with metastatic breast cancer in early clinical trials stratified by exploratory biomarkers.

Routine screening for suicidal intention in patients with cancer

Suicide rates are elevated in individuals with cancer, although suicidal intention is not typically assessed in cancer centers. We evaluated in a large comprehensive cancer center the utility of an electronic Distress Assessment and Response Tool (DART), in which suicidal intention is assessed with a single item. Patients attending cancer clinics completed DART as part of routine care. DART includes measures of physical symptoms, depression, anxiety, social difficulties, and practical concerns. Medical variables were obtained from the Princess Margaret Cancer Registry, the data warehouse of cancer patient statistics. A Generalized Estimating Equation (GEE) model was used to assess factors associated with suicidal intention. Between September 2009 and March 2012, 4822/5461 patients (88.3%) who completed DART consented to the use of their data for research. Amongst the latter, 280 (5.9%) of the 4775 patients who answered the question reported suicidal ideation, which was related to physical and psychological distress, and social difficulties (ps < 0.0001). Amongst those with ideation who responded to the intention question, 20/186 (10.8%) reported suicidal intention. Of respondents with more severe suicidal ideation, 12/49 (24.5%) reported suicidal intention. Using a GEE model, suicidal intention in those with ideation was significantly associated with male sex, difficulty making treatment decisions, and with everyday living concerns. Suicidal ideation is reported on an electronic distress screening tool (DART) by almost 6% of cancer patients, of whom almost 11% report suicidal intention and 33% decline to indicate intention. DART demonstrated utility in identifying patients who may be at highest risk of completed suicide and who require urgent clinical assessment.

Feasibility of preemptive biomarker profiling for personalised early clinical drug development at a Comprehensive Cancer Center

PurposeMultiple investigational drugs are currently explored in cancer patient populations defined by specific biomarkers. This demands a new process of patient selection for clinical trials. Patients and methodsStarting January 1, 2012, preemptive biomarker profiling was offered at the West German Cancer Center to all patients with advanced non-small-cell lung (NSCLC) or colorectal cancer (CRC), who met generic study inclusion criteria. Tumour specimens were subjected to prespecified profiling algorithms to detect ‘actionable biomarkers’ by amplicon sequencing, in situ hybridisation and immunohistochemistry. The clinical course was closely monitored to offer trial participation whenever applicable. ResultsWithin 12 months, 267 patients (188 NSCLC, 79 CRC) were profiled. Estimated additional cost for biomarker profiling was 219615.51 EUR excluding histopathology workup and administration. The most prevalent biomarkers in pulmonary adenocarcinoma were KRAS mutations (29%), loss of PTEN expression (18%), EGFR mutations (9%), HER2 amplification (5%) and BRAF mutations (3%), while the prevalence of ALK translocations and PIK3CA mutations was extremely low. In pulmonary squamous cell carcinoma FGFR1 amplifications were found in 15%, PTEN expression was lost in 20% and DDR2 was mutated in a single case. KRAS mutations (41%) predominated in CRC, followed by loss of PTEN expression (16%), PIK3CA (5%) and BRAF (5%) mutations. So far 13 patients (5%) have entered biomarker-stratified clinical trials. Therapeutic decisions for approved drugs were guided in another 45 patients (17%). ConclusionPreemptive biomarker profiling can be implemented into the diagnostic algorithm of a large Comprehensive Cancer Center. Substantial investments in diagnostics and administration are required.