Ambulatory Chemotherapy Research Articles

Risk Score For Venous Thromboembolism (VTE) In Ambulatory Patients: Impact Of Cancer Type and Risk Score On VTE Incidence, Early Mortality and Progression-Free Survival

BackgroundWhile ambulatory patients receiving cancer chemotherapy are at increased risk for venous thromboembolism (VTE), current guidelines do not recommend routine thromboprophylaxis with a few notable exceptions (Lyman, Khorana et al, J Clin Oncol 2013). A previously validated VTE risk score for cancer outpatients stratifies patients into low (0), intermediate (1-2), or high (>=3) risk categories (Khorana, Kuderer et al, Blood 2008). Understanding cancer types at greatest risk for VTE as well as early mortality and progression based on the risk score provides key clinical understanding. MethodsA prospective cohort study was conducted of consenting solid tumor and lymphoma patients initiating a new chemotherapy regimen at 115 randomly selected US oncology practices between 2002 – 2006 by the ANC Study Group. VTE incidence, progression-free survival (PFS), and all-cause mortality over the first 120 days (early mortality) of ambulatory chemotherapy were estimated based on the method of Kaplan and Meier. ResultsAmong 4,458 patients initiating a new chemotherapy regimen, 93 (2.1%) developed a symptomatic VTE within 120 days of chemotherapy. The risk of VTE across cancer types increased from 0.6%, to 1.8% to 6.6% in low-, intermediate- and high-risk categories, respectively. The risk of VTE among low risk patients was 1% or less across all cancer types. However, the risk of VTE was highest among intermediate- and high-risk categories in patients with breast, colorectal, and lung cancer, reaching 16% for high risk breast cancer patients. Early all-cause mortality occurred in 136 patients (3.1%) and also increased with increasing risk score from 0.8% to 3.4% to 6.4% in low-, intermediate- and high-risk categories, respectively. The risk of early mortality was 2.1% or less in low risk patients across all cancer types. However, the risk of early mortality was highest among high-risk category patients, reaching 23% and 14% in colorectal cancer patients and pancreatic or gastric cancer patients, respectively. PFS decreased from 92% to 82% to 72% across the three risk categories, with lowest rates of PFS among colorectal (52%) and lung cancer (52%) patients. ConclusionsVTE incidence and all-cause mortality increase and PFS correspondingly decreases with increasing VTE risk score across major solid tumors. Interestingly, while breast cancer is not considered a high risk tumor for VTE, breast cancer patients with a risk score of >=3 had the highest VTE incidence compared to other major solid tumor types. Among patients with a risk score of >=3, gastrointestinal cancer patients had the greatest risk of early mortality and correspondingly, the lowest PFS compared to other major solid tumors. These findings also suggest that both the mortality risk as well as the VTE risk are only partially influenced by tumor type.Funding: 1KM1-CA156687-01 (NK), ASCO Young Investigator Award (NK), NHLBI-1R01HL095109 (all), ANC Study Group (GL), and K23 CA120587 (AK). Disclosures:No relevant conflicts of interest to declare.

Optimizing patient scheduling for ambulatory chemotherapy.

199 Background: The Odette Cancer Centre (OCC) manages more than 24,000 chemotherapy visits annually. The delivery process is complex and patients have significant wait times for treatment. The OCC was faced with improving this process with no data infrastructure to support continuous quality improvement. Methods: An electronic scheduling manager, Chemotherapy Appointment Reservation Manager (CHARM) was built in house to improve scheduling logic and optimize bed and chair utilization. The chemotherapy unit has recently undergone renovations to change the staff-to-patient ratio and chair distribution. At baseline, a nurse is assigned to 4 chairs in a “pod” without adjustment for patient and chemotherapy intensity variation. An interprofessional team participated in a Kaizen event to create a Value Stream Map of the scheduling process. Scheduling logic considerations were identified to better match nursing and chair resources to patient appointment times. An analysis was performed to evaluate the distribution of patients throughout the chemotherapy unit by time of day, and day of week to identify opportunities to align the schedule with nursing and pharmacy resources. Results: The mean number of patients seen per day was 85 with a range of 65 to 105. 80% of patients are scheduled before 11:30 (the unit operations 08:30 to 18:00). The mean number of patients assigned to a pod was 8 with a range of 3 to 15. Unit performance on days of >95 patients was observed to be poorest. Load levelling techniques were established to reduce the range of patients booked per day throughout the week. New considerations for scheduling are: maximum 12 patients per nurse per pod per day, maximum 3 new patients per nurse per pod per day, maximum 10 clinical trials per day, and maximum 50% of patients scheduled before 11:30 per day. Conclusions: Matching the patient schedule to the nursing and pharmacy resources of the unit is critical to efficient and safe chemotherapy delivery. A Plan-Do-Study-Act is scheduled for September 2013 to implement the scheduling changes and evaluate the impact of the new logic on unit operations. Further work to improve the delivery process and pharmacy medication processing is ongoing.

Using RFID technology to drive quality improvement.

70 Background: The Odette Cancer Centre (OCC) is the sixth largest cancer institution in North America and manages over 24,000 chemotherapy patient visits/year. We initiated an automated system whereby patients can “actively” self-check-in using Radio Frequency Identification (RFID) cards to the chemotherapy unit as part of a quality improvement initiative. Methods: Four self check-in kiosks were implemented into the OCC and all patients received a unique identifiable RFID card. Patients “self-arrived” to the OCC upon entry as well as before the nursing assessment. The technology created an electronic data infrastructure to capture patient experience data for ambulatory chemotherapy. In addition, visual management boards have been implemented that display the patients’ unique identifiers and communicates their process status. This tool also acts as a call-in system wherein the screen flashes and prompts the patient to proceed to the service area. Data was extracted electronically from various information systems, consolidated in excel linking information by the patients hospital file number. Results were analyzed. Results: The mean number of patients treated per day is 85 with a range of 65 to 105 (n=853). Median wait time from arrival to chair placement was 1:52 minutes ranging 0:02 to 6:12. There were 43% of patients that had medication ready within 30 minutes of their appointment time. There was an observed reduction in interruptions to the assessment nurses related to patient status updates (data to be presented). Patient satisfaction was high despite the modest improvement in efficiency. Conclusions: A comprehensive business analysis is being performed on the operations of the OCC with the implementation of this technology. The visual management boards enhance communication to patients while increasing privacy and patient confidentiality. The boards allow for patient mobility in the waiting room and eases anxiety associated with being “lost in the queue”. Next steps for the OCC are to create a data cube linked with other systems to further enrich the data. This technology enabled data analysis, evaluated the impact of change, set baseline targets for performance and built continuous quality improvement.

Chemotherapy safety initiative.

226 Background: The 2006 Institute of Medicine report "Preventing Medication Errors," stated that “medication errors harm at least 1.5 million patients every year…” Chemotherapy (CT) has a narrow therapeutic index and safety margin which can and does lead to fatal errors. University Hospitals Seidman Cancer Center (UHSCC), an National Cancer Institute (NCI) designated Comprehensive Cancer Center, dispensed 10,500 CT doses in 2012 and has taken an active approach to enhance CT safety. Methods: In the last quarter of 2012, a nurse coordinator (NC) for chemotherapy orders and a Chemotherapy Safety Governance Committee (CSGC) was conceptualized. The NC’s role would be to incorporate CT safety best practices into order set development. The charter for the CSGC includes 1) to establish cancer CT standards and operating procedures across the adult and pediatric oncology population; 2) to develop and oversee cancer CT order set infrastructure applicable to our hybrid electronic/paper current state; and 3) to lead performance improvement initiatives related to CT safety. Leading organizations involved in oncology practice and medication safety standard-setting (ASCO, Oncology Nursing Society, Institute For Safe Medication Practices, National Comprehensive Cancer Network, Journal of Cancer Research) were reviewed for recommendations for standards for CT order sets. Results: Thirty standards for a CT order template were identified by the NC. A comprehensive gap analysis was completed to compare the current inpatient and ambulatory CT order sets to these standards. Results of the gap analysis were brought to the CSGC, a multi-disciplinary group of cancer and quality clinicians and leaders over 6 meetings. Consensus was achieved on the application of these standards to CT order sets. Our new orders will adopt 100% of all identified standards for CT orders. Conclusions: The gap analysis led to the development of a CT order set template that maximizes safety by applying best-practice standards. This template is designed to be applicable to electronic and paper-based order sets and with minor variation, appropriate to all disease-based order sets. This template is currently being utilized to revise 330 electronic and 398 paper CT order sets at UHSCC. [Table: see text]

Patients receiving ambulatory care: a problematic autonomy situation

This article addresses the issue of the autonomy of patients who are not treated in standard situations of hospitalisation in institutions, but who receive ambulatory care. Academic and institutional discourses both suggest that the development of out-of-hospital care delivery models promotes patient autonomy. Through a qualitative study based on semi-structured interviews of cancer patients treated using ambulatory chemotherapy in a French hospital we show that some of the constraints usually encountered by patients receiving care in institutions are also observed in patients receiving ambulatory care. They experience a form of cognitive isolation regarding access to information about their health, and their social life appears to be institutionalised.

Ambulatory consolidation chemotherapy for acute myeloid leukemia with antibacterial prophylaxis is associated with frequent bacteremia and the emergence of fluoroquinolone resistant E. Coli

BackgroundAmbulatory consolidation chemotherapy for acute myeloid leukemia (AML) is frequently associated with bloodstream infections but the spectrum of bacterial pathogens in this setting has not been well-described.MethodsWe evaluated the emergence of bacteremias and their respective antibiotic susceptibility patterns in AML patients receiving ambulatory-based consolidation therapy. Following achievement of complete remission, 207 patients received the first cycle (C1), and 195 the second cycle (C2), of consolidation on an ambulatory basis. Antimicrobial prophylaxis consisted of ciprofloxacin, amoxicillin and fluconazole.ResultsThere were significantly more positive blood cultures for E. coli in C2 as compared to C1 (10 vs. 1, p=0.0045); all E. coli strains for which susceptibility testing was performed demonstrated resistance to ciprofloxacin. In patients under age 60 there was a significantly higher rate of Streptococccus spp. bacteremia in C2 vs. C1; despite amoxicillin prophylaxis all Streptococcus isolates in C2 were sensitive to penicillin. Patients with Staphylococcus bacteremia in C1 had significantly higher rates of Staphylococcus bacteremia in C2 (p=0.009, OR=8.6).ConclusionsFor AML patients undergoing outpatient-based intensive consolidation chemotherapy with antibiotic prophylaxis, the second cycle is associated with higher rates of ciprofloxacin resistant E. coli, penicillin-sensitive Streptococcus bacteremias and recurrent Staphylococcus infections.

Intravenous chemotherapy preparation errors: Patient safety risks identified in a pan-Canadian exploratory study

This exploratory study was launched following a critical chemotherapy medication incident to thoroughly and proactively examine the current processes for ordering, preparing, labeling, verifying, administering, and documenting ambulatory intravenous chemotherapy in Canada, and to identify factors that may contribute to preventable adverse drug events. Field observations in six Canadian cancer centers to identify end-to-end processes in clinic, pharmacy, and treatment areas; analysis of processes to identify risks. Three types of previously locally unrecognized potential chemotherapy preparation errors in Canadian oncology pharmacies were uncovered, all of which are undetectable if they occur. Although the frequency of these errors is unknown, their impact is potentially catastrophic. Dispensing errors in high-risk intravenous preparation have been studied in the past, but it is unlikely that these studies have detected these errors because of the inherent limitations of the detection methods used. Research on preparation errors using more sensitive methods is therefore urgently needed to establish the extent to which pharmacy preparation practices may be error-prone, and to allow reliable evaluation of the impact of mitigation strategies. Widespread practice changes in Canadian oncology pharmacies are necessary, and are currently underway.

Outcome and predictors of mortality in patients requiring invasive mechanical ventilation due to acute respiratory failure while undergoing ambulatory chemotherapy for solid cancers

Acute respiratory failure that requires invasive mechanical ventilation is a leading cause of death in critically ill cancer patients. The aim of this study was to evaluate the outcome and prognostic factors of patients requiring invasive mechanical ventilator for acute respiratory failure, within 1 month of ambulatory chemotherapy for solid cancer. A retrospective observational study of patients who underwent ambulatory chemotherapy at Samsung Medical Center, between January of 2007 and April of 2009, was employed for this study. A total of 51 patients met the inclusion criteria and were included in the study. The median age was 65 years (25-87) and the majority of the patients were male (n = 38, 74.5%). There were 42 patients (82.3%) with lung cancer. The most common cause of acute respiratory failure was pneumonia (n = 24, 47.1%), followed by acute respiratory failure due to extra-pulmonary infection, drug-induced pneumonitis, alveolar hemorrhage, and cancer progression. The intensive care unit (ICU) mortality was 68.6% and the most common cause of death in the ICU was uncorrected cause of acute respiratory failure. Before adjustment for others factors, prechemotherapy Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) (P = 0.03), Sequential Organ Failure Assessment score (P = 0.01), and anemia (P = 0.04) were significantly associated with ICU mortality. However, when adjusted for age, sex, and Acute Physiologic and Chronic Health Evaluation II score, only poor ECOG PS (≥2) was significantly associated with ICU mortality [OR 6.36 (95% CI (1.02-39.5))]. The outcome of patients with acute respiratory failure needing invasive mechanical ventilation during ambulatory chemotherapy for solid cancer is poor. Prechemotherapy performance status is an independent predictor of mortality.

Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents

To evaluate the effectiveness of a closed system drug-transfer device, EquaShield®, at reducing surface contamination with antineoplastic agents throughout an ambulatory cancer chemotherapy infusion center. Surfaces throughout the cancer center were sampled three times. The first samples were obtained in June 2010 without prior cleaning to measure baseline levels of contamination of the current technique (Chemo Dispensing Pin, B. Braun Medical Inc.). The second samples were obtained in August 2010 after the implementation of the closed system drug-transfer device and cleaning to evaluate if the contamination was removed. The third samples were obtained in August 2011. Wipe samples were taken from five positions in the pharmacy and from five positions in the infusion suite. Wipe samples were also collected from two positions in office areas. Samples were analyzed for cyclophosphamide and 5-fluorouracil. The results from the first two sets of samples showed contamination with cyclophosphamide on about half of the positions at all locations during both collection periods. However, levels of contamination were very low and mostly just above the detection limit of the analytical method. The highest level of contamination was found on the door and handle in the pharmacy. Contamination with 5-fluorouracil was only observed on the dispensing counter in the pharmacy during the second collection period. The results from the third and final collection period showed no contamination with cyclophosphamide or 5-fluorouracil in the pharmacy, the infusion suite or in offices of the cancer center. Implementation of the closed system drug-transfer device for preparing and administering chemotherapy eliminated surface contamination with cytotoxic agents at the ambulatory cancer chemotherapy infusion center.

Use of performance data to drive process change and improve patient wait time for chemotherapy treatment.

223 Background: The Odette Cancer Centre (OCC) manages more than 24,000 chemotherapy visits annually. The delivery process is complex and patients have significant wait times for treatment. The OCC was faced with improving this process with no data infrastructure to support continuous quality improvement. Methods: An electronic scheduling manager, Chemotherapy Appointment Reservation Manager (CHARM) was designed that includes workflow communication between pharmacy and nursing. A multidisciplinary team created a value stream map of the process. Rate limiting steps and key milestones in the delivery process were identified. CHARM timestamps stages in the chemotherapy process, from nurse approval to pharmacy verification, medication processing and medications received on the chemotherapy unit. Extracted data was used to create a weekly report to monitor key performance indicators (KPIs). Results: An analysis of six months of data led to the establishment of KPIs and targets. Our baseline targets were established as pharmacy turnaround time (AR) < 1 hour, pharmacy verification (HP)< 13 minutes, medication processing (PR) <45 minutes and chemotherapy ready (CR) +/- 30 minutes of the patient appointment time. Since April 2012, KPIs have been reported. Over a four month period (81 clinic days and 5,920 appointments) the median AR time was 1:02 (hh:min), HP was 00:12 and PR was 00:43. The KPI targets were met AR 46%, HP 52% and PR 51% and CR 29% of the time. The data infrastructure now drives the quality improvement initiatives. An early strategy implemented queuing theory, to process orders by appointment rather than approval time, resulting in no change in median AR time, but a decrease of seven minutes AR range. Conclusions: Quality improvement is hinged on measurement and evaluation. The OCC has successfully implemented a continuous quality improvement data infrastructure that monitors quality of ambulatory chemotherapy delivery. These data describe pharmacy and nursing processes. Further work to improve the delivery process and data infrastrucutre is ongoing.

Late Diagnosed Cervical Spine TBC Spondylitis: Case Report

SUMMARY Cervical tuberculosis is a rare disease with a high complication rate. Tuberculosis of the cervical spine is reported in about 6-9% of all cases of spinal tuberculosis. Early diagnosis and treatment of spinal tuberculosis is essential in order to prevent neural deficit. Management strategies for spinal tuberculosis range from ambulatory chemotherapy to radical surgical debridement with fusion. The paper presents a case of an 18-year-old patient with TBC spondylitis C3- C5. Eleven months passed from the onset of the disease until surgery and final diagnosis. When hospitalized, the patient suffered from the overall weakness, a 15- kg weight loss, dysphagia, neck pain, neck rigidity, febrility, cervical radiculopathy and paresthesia of both upper extremities. MR image showed a complete destruction of C3, abscess perforation in the anterior epidural space with the spinal cord compression and abscess extension to prevertebral space from C2 to C5. After the radical surgical debridement of C3-C5 and anterior decompression, a tricorticate autologous bone graft obtained from the iliac crest was placed and a plate fixation was done. Tuberculostatics were included for 12 months after surgery. Complete recovery occurred six months after surgery. Anterior decompression with autologous iliac bone graft led to a good clinical and radiological outcome in patients with cervical spine tuberculosis.

The use of technology to improve the delivery process of ambulatory chemotherapy at the Odette Cancer Centre (OCC).

290 Background: The OCC manages over 24,000 chemotherapy patient visits/year. Over time the number of patients, complexity of treatment and staffing requirements increase. Barriers to efficient delivery of chemotherapy include: same day (as clinic visit) treatment, missing MD orders, manual appointment scheduling and poor communication between chemo nurses and pharmacists during drug preparation. These issues were addressed by (1) non-same day chemotherapy, (2) MD orders expected day prior to treatment, (3) development of two web-based tools for chemotherapy scheduling and communication. Methods: Two independent process reviews were undertaken confirming system inefficiencies. The move to non-same day chemotherapy was implemented. An electronic Chemotherapy Appointment Reservation Manager (CHARM) was developed and linked to the computerized physician order entry (CPOE) system, and reminders were sent to MDs with outstanding orders 72, 48, and 24 hours pre-chemotherapy. The tool was developed to facilitate staff communication during chemotherapy preparation. Data relating to each process improvement was collected pre- and post-implementation. Results: Over 300 of the more than 400 chemotherapy regimens were reviewed for nurse assessment, medication preparation, and in-chair infusion times, with the results used to build the algorithms for CHARM. With the move to non-same day chemotherapy over 80% of patients are treated on a non-clinic day compared with 40% pre-implementation. With CHARM the average number of patients booked/day went from 68 to 100, a 47% increase. Currently, 90% of physician orders are entered by 2pm the day before treatment. Use of the communication tool resulted in an 89% reduction in phone calls between the nurses and pharmacy. 36% of patients started treatment +/- 30 min of scheduled time in both time peroids. Conclusions: OCC introduced several innovative approaches to improving the safe delivery of chemotherapy to cancer patients. Patient volumes have increased while communication around care delivery has improved. The approach allows ongoing research and development to improve workflow and communication.

O1-008 - Self-Assessment System of Febrile Neutropenia (FN) by Patients Receiving Ambulatory Chemotherapy for Solid Tumor

ABSTRACT Background Febrile neutropenia is one of the oncology emergencies, which usually should be timely assessed and treated at the hospital. In some areas of Japan, however, medical resources are limited in especially nights and holidays. In Hyogo Cancer Center department of medical oncology, majority of patients have breast and gynecologic (GYN) malignant disease, those who are relatively young and without COPD. These patients may be managed by a self-assessment system of FN, although the feasibility is still unknown. Methods Self-assessment system consists of three steps, such as prescription of Ciprofloxacin 1200 mg b.i.d., educating patients by the team (doctors, pharmacists, and nurses) with written material, and evaluation at the hospital if febrile episode (FE) continues for longer than 48 h. FE is defined as body temperature higher than 38°C. Frequency of FE, admission to the hospital, ICU stay, and 30 days mortality rate were assessed retrospectively. Results From August 2006 to October 2011, 476 patients were treated in ambulatory chemotherapy center under self-assessment system. The median age was 58 years (range 17–82), 87% of them were under 60 years old. The literacy rate was 100%. All had solid tumors, 75% of them had breast (n = 157) or GYN (ovary and primary peritoneal cancer; n = 155, cervix; n = 40, corpus; n = 4) malignancy. Platinum-based regimens (n = 184) and anthracycline based regimens (n = 131) were dominant. FE occurred in 159 patients (33.4%). Forty-three patients (9%) were admitted to the hospital. Two patients were admitted to ICU. The thirty-day mortality rate was 0 %. The median MASCC score of admitted patients was 21 (range 14–21). About half (47%) had high risk score (≤20). Conclusions In areas with limited resources, self-assessment of FN can be an alternative option, although that should be applied to young and literate patients educated by skilled medical team.

Cost Effectiveness of Integrated Medicine in Patients With Cancer Receiving Anticancer Chemotherapy

Ambulatory chemotherapy is patient friendly but may result in toxicity-induced unscheduled hospitalizations (TIUHs). This emerging issue may increase health care costs. We studied the cost effectiveness of a hospital-home monitoring program based on systematic iterative telephone calls after chemotherapy. We retrospectively evaluated the rates of chemotherapy-induced unscheduled hospitalizations in patients who were treated in August 2008. Patients were contacted by telephone 1 day before chemotherapy and on the second and eighth days after undergoing chemotherapy. Costs associated with TIUHs were calculated and compared with those of a cohort concomitantly treated using the standard follow-up procedure. A total of 259 patients entered the hospital-home monitoring program. They were compared with 86 patients who had similar characteristics but underwent the standard treatment and follow-up procedure. Inclusion in the hospital-home monitoring program resulted in patients experiencing TIUHs approximately half as frequently as patients in the other group (2.4% v 4.9%; P < .01). Patients in the program experienced TIUHs for a median length of stay of 4 days, representing a nonsignificant reduction in duration of hospitalization (P not significant). Consequently, through a two-fold reduction in TIUH annual incidence, this program represents a reduction in unscheduled hospitalizations per year of 383 days, decreasing hospital costs by €201.468 ($292,468) per year. The hospital-home monitoring program is a cost-effective strategy for offering ambulatory chemotherapy treatment to patients with cancer. This program has become our standard procedure for ambulatory chemotherapy in patients with cancer.

Determining resource intensity weights in ambulatory chemotherapy related to nursing workload

Ontario cancer programs aim to deliver high-quality nursing care and treatment that is safe for patients and staff. The reality of health care is that financial constraints, inherent in the delivery of care, require that funding mechanisms count not only the cost of drugs, but factors such as pharmacy and nursing human resource costs. While some organizations have developed patient classification systems to measure nursing intensity and workload, these systems apply primarily to inpatient populations, and are fraught with numerous challenges, such as the need for nurses to document to justify the workload required for care. The purpose of this paper is to outline the methodology and engagement of nurses to develop regimen-based resource intensity weights that can be applied to ambulatory chemotherapy suites. The methodology included determination of workload related to nursing time to prepare, teach, counsel and assess patients, as well as time to gather supplies, access lines, monitor, manage adverse reactions, manage symptoms and document care. Resource intensity weights provide better measures of the complexity of care required by cancer patients in ambulatory settings.

Self-assessment system of febrile neutropenia (FN) by patients receiving ambulatory chemotherapy for solid tumor.

e19548 Background: Febrile neutropenia is one of the oncology emergencies, which usually should be timely assessed and treated at the hospital. In some areas of Japan, however, medical resources are limited in especially nights and holidays. In Hyogo Cancer Center department of medical oncology, majority of pts have breast and gynecologic (GYN) malignant disease, those who are relatively young and without COPD. These pts may be managed by a self -assessment system of FN, although the feasibility is still unknown. Methods: Self assessment system consists of three steps, such as, prescription of Ciprofloxacin 1200mg b.i.d., educating pts by the team (doctors, pharmacists, and nurses) with written material, and evaluation at the hospital if febrile episode (FE) continues for longer than 48 hours. FE is defined as body temperature higher than 38 °C. Frequency of FE, admission to the hospital, ICU stay, and 30 days mortality rate were assessed retrospectively. Results: From Aug. 2006 to Oct. 2011, 476 pts were treated in ambulatory chemotherapy center under self-assessment system. Median age was 58 years old (range; 17 - 82), 87 % of them were under 60 years old. Literacy rate was 100 %. All had solid tumors, 75 % of them had breast (n= 157) or GYN (ovary and primary peritoneal cancer; n = 155, cervix; n = 40, corpus; n = 4) malignancy. Platinum based regimens (n = 184) and anthracycline based regimens (n = 131) were dominant. FE occurred in 159 pts (33.4%). Forty three pts (9%) were admitted to the hospital. Two pts were admitted to ICU. 30 days mortality rate was 0 %. The median MASCC score of admitted pts was 21 (range; 14 - 21). About half (47 %) had high risk score (&lt; 20). Conclusions: In areas with limited resources, self assessment of FN can be an alternative option, although that should be applied to young and literate pts educated by skilled medical team.

Outcome research: Ambulatory intraperitoneal chemotherapy in stage IIIC ovarian cancer.

e15507 Background: Intraperitoneal chemotherapy in stage III ovarian cancer is indicated following the results of the GOG 172 study but the ambulatory application of the scheme in 24 hours continuous infusion is not feasible. Following expert recommendations (Walker, ASCO 2009 Educational Book), we evaluated the feasibility of administrating a modified GOG 172 regime in an ambulatory form. Methods: Between September 2009 and October 2010, ten patients diagnosed with stage IIIC ovarian cancer and optimal cytoreduction received the following treatment in ambulatory form: IV paclitaxel (135mg/m2/3hrs Day 1), followed by IP cisplatin (60-75mg/m2 Day 2), plus IP paclitaxel (60mg/m2 Day 8). Cycles were administered every 21 days, up to a maximum of six cycles. The tolerance for this treatment was evaluated according to the CTC for Adverse Event 3.0. Results: Population Characteristics: Mean age (47 years; range 26-64). PS (0: 4 pt; 1: 6 pt). Pathology (Papillary: 7 Pts; Mucinous, Endometroid and Poorly Differentiated: 1 pt each). N-positives: 4 pt; N-negatives: 6 pt. Intestinal resection: 1pt. In all cases, treatment was applied according to the specified parameters. Total number of cycles administered: 37 (mean cycles per pt 3 range 2-6). The average time of treatment application was 3 hours per day (9 hours total). Toxicity (G3-4): Leukopenia (2 pts). Toxicity (G1-2): Alopecia (10 pts), Anemia (9 pts), Myalgia (8 pts), Neurologic (7 pts), Fatigue (6 pts), Nausea and vomiting (6pt), Renal (2 pts), Allergy (1 pt), Pain at Catheter site (1 pt). With an average follow up time of 16 months (Range: 9-26), none of the patients have died. Three patients have progressed after the Intraperitoneal chemotherapy, while seven are alive without evidence of disease after the treatment. Conclusions: 1) The modified GOG 172 scheme can be safely applied in an ambulatory form. 2) The time required for applying the treatment is similar to that of other frequently used treatments (BEP, paclitaxel – trastuzumab, R-CHOP, b-FOL). 3) Patient tolerance was very good. 4) With an average follow-up of 16 months, all 10 patients are alive and 7 of them remain free of disease.

Validation of the 34-item Supportive Care Needs Survey and 8-item Breast module French versions (SCNS-SF34-Fr and SCNS-BR8-Fr) in breast cancer patients

This study aimed to assess the psychometric robustness of the French version of the Supportive Care Needs Survey and breast cancer (BC) module (SCNS-SF34-Fr and SCNS-BR8-Fr). Breast cancer patients were recruited in two hospitals (in Paris, France and Lausanne, Switzerland) either in ambulatory chemotherapy or radiotherapy, or surgery services. They were invited to complete the SCNS-SF34-Fr and SCNS-BR8-Fr as well as quality of life and patient satisfaction questionnaires. Three hundred and eighty-four (73% response rate) BC patients returned completed questionnaires. A five-factor model was confirmed for the SCNS-SF34-Fr with adequate goodness-of-fit indexes, although some items evidenced content redundancy, and a one-factor was identified for the SCNS-BR8-Fr. Internal consistency and test-retest estimates were satisfactory for most scales. The SCNS-SF34-Fr and SCNS-BR8-Fr scales demonstrated conceptual differences with the quality of life and satisfaction with care scales, highlighting the specific relevance of this assessment. Different levels of needs could be differentiated between groups of BC patients in terms of age and level of education (P < 0.001). The SCNS-SF34-Fr and SCNS-BR8-Fr present adequate psychometric properties despite some redundant items. These questionnaires allow for the crucial endeavour to design appropriate care services according to BC patients' characteristics.

A case of zoledronate-induced tubulointerstitial nephritis with Fanconi syndrome

A 54-year-old female underwent mastectomy in 1992 for breast cancer, but later developed liver metastasis in 2004, which was treated with docetaxel for a short period, and then discontinued due to nausea. Bone metastasis diagnosed in 2005 was treated with the combination of trastuzumab and zoledronate (4 mg/month) as well as radiotherapy. Progressive hypokalemia and renal dysfunction were observed since 2006 and the patient was admitted to our department in 2009 for further management of hypokalemia (serum potassium 2.2 mEq/L) and renal dysfunction (serum creatinine: 2.0 mg/dL). Accelerated potassium excretion and metabolic acidosis of the normal anion gap were observed and the patient was diagnosed with hypokalemia associated with renal tubular acidosis. Moreover, development of glucosuria, hypophosphatemia, hyperphosphaturia, hyponatremia, hypouricemia, and high β2-microglobulin/NAG, together with histopathological findings compatible with renal tubular injury/interstitial nephritis on renal biopsy, allowed the diagnosis of Fanconi syndrome. Because the syndrome was considered to be induced by zoledronate based on the onset and clinical course, we stopped zoledronate. However, she continued the ambulatory chemotherapy with trastuzumab. This resulted in immediate and sustained improvement in renal function. To our knowledge, this is the first report of zoledronate-induced interstitial nephritis-Fanconi syndrome and indicates the close monitoring of renal function to avoid potential nephrotoxicity of zoledronate.

Optimizing the Design of Preprinted Orders for Ambulatory Chemotherapy: Combining Oncology, Human Factors, and Graphic Design

To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.