Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial.

OBJECTIVE: To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. DESIGN: Pragmatic, cluster randomised trial. SETTING: 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. PARTICIPANTS: All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. INTERVENTIONS: Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. MAIN OUTCOME MEASURES: The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. RESULTS: Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. CONCLUSIONS: Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. TRIAL REGISTRATION: ClinicalTrials.gov NCT02485678.

Associations between body mass index and the surgical phenotype and location of endometriotic lesions.

RESEARCH QUESTION: Is there a relationship between body mass index (BMI) and endometriotic lesions, specifically surgical phenotype and lesion location? DESIGN: An observational retrospective cohort study at the Royal Women's Hospital, Melbourne, Australia, including 471 histologically confirmed endometriosis patients. Statistical analyses included multivariate logistic regression and multivariate modelling, correcting for multiple testing. Outcomes were the presence or absence of surgically classified lesion phenotypes, as per revised American Society for Reproductive Medicine criteria including superficial or deep, peritoneal or ovarian, and adhesions (Study I); and lesions at specific anatomical locations (including pelvic side wall, uterosacral ligament, pouch of Douglas, ovarian, uterovesical fold, bladder, and pararectal endometriosis) (Study II). RESULTS: In Study I, patients with higher BMI were more likely to have superficial peritoneal lesions (odds ratio [OR] 1.070, 95% confidence interval [CI] 1.004-1.144; P = 0.044), and less likely to have deep ovarian lesions (OR 0.928, 95% CI 0.864-0.993; P = 0.034). In Study II, patients with higher BMI were less likely to have uterovesical fold lesions (OR 0.927, 95% CI 0.867-0.985; P = 0.021) or anterior compartment lesions (OR 0.940, 95% CI 0.888-0.989; P = 0.023). After correcting for multiple testing, the relationship between BMI and lesion phenotypes did not persist (P > 0.01). CONCLUSIONS: This analysis does not conclusively support an influence of BMI on endometriotic lesion phenotype based on surgical classification or location. Further investigation of the physiological disturbances underlying BMI and the promotion of endometriotic lesion phenotypes and their location is warranted, but any effect is likely to be small.

Elusive quality: the challenges and ethical dilemmas faced by international non-governmental organisations in sourcing quality assured medical products.

Although medical products that are of sound quality are fundamental to the delivery of healthcare, so too is their availability, affordability, accessibility and acceptability. However, achieving all of these aims consistently and simultaneously may be unfeasible due to a host of barriers-no matter the country. If uncertainty, constraints and conflicting priorities also threaten their delivery, not only does the situation becomes yet more challenging, the morally just course of action becomes yet more opaque. While global health organisations, supply chains and projects are heterogenous, international non-governmental organisations (iNGOs) responding to humanitarian crises or delivering development assistance in low-income and middle-income countries are undoubtedly prone to this issue. In a novel framing of the problem of substandard and falsified medicines, this article explores some ethical dilemmas that, directly or indirectly, could result in the quality of medical products in iNGO health projects to be compromised. Drawing on a broad literature base and years of experience as a senior humanitarian pharmacist, the author reflects on the barriers, culture and system that contributes to the existence and persistence of substandard and falsified medical products in global assistance projects. The paper offers an in-depth examination of pressures that may arise in four key areas (capacity, supply chain, bureaucracy and quality assurance) and postulates on the myriad ways in which this may alter the attitudes, behaviours and decision-making of iNGOs in a manner that disincentivises the prioritisation of medical product quality. This paper does not seek to excoriate the aid sector, but rather to lend a new perspective: that such predicaments are overlooked, real-world ethical dilemmas in urgent need of greater openness, research, debate and guidance, for the benefit of moral decision-making and patient care.

Increasing Referrals of Patients With Gastrointestinal Cancer to a Cancer Rehabilitation Program: A Quality Improvement Initiative.

BACKGROUND: People with cancer are at risk for initial, late, and long-term effects of cancer and its treatments. Cancer rehabilitation (CR) focuses on prevention/treatment of these sequelae and optimization of physical, social, and vocational functioning. Our center has a multidisciplinary impairment-driven outpatient CR program, but referrals of patients with GI cancer were low. AIMS: We aimed (for 2019, relative to 2018) (1) to increase CR referrals of patients with GI cancer by 50% and (2) to increase the proportion of referrals coming from oncologists. Balancing measures included inappropriate referrals and cancellations. METHODS: A rapid cycle improvement approach was used to optimize GI referrals to the CR program. Barriers to CR referral were identified through a literature review and informal interviews of GI clinicians. Barriers included (a) knowledge of CR program existence, (b) awareness of the referral process, (c) time, and (d) lack of CR program exposure. The team used Plan-Do-Study-Act (PDSA) cycles every 2 months from January to December 2019 to address barriers. A p-chart was used to analyze the results. RESULTS: PDSA cycles included CR program advertisement, a presentation to GI staff, nurse-led patient identification, patient-facing posters, and clinician thank-you emails. The p-chart showed a 100% relative increase in referral numbers and an improvement in the percentage of patients referred by oncologists from 51% to 75%. There was no significant change in inappropriate referrals or cancellations. CONCLUSION: Through PDSA cycles, we improved the total number of patients with GI cancer and percentage referred by an oncologist to a CR program. Future work will assess sustainability.

How Do We Align Health Services Research and Quality Improvement?

Quality improvement (QI) initiatives and health services research (HSR) are commonly used to target health care quality. These disciplines are increasingly important because of the movement toward value-based health care as alternative payment and care delivery models drive institutions and investigators to focus on reducing unnecessary health care use and improving care coordination. QI efforts frequently target medical error and/or efficiency of care through the Plan-Do-Study-Act methodology. Within the QI framework, strategies for data display (e.g., Pareto charts, run charts, histograms, scatter plots) are leveraged to identify opportunities for intervention and improvement. HSR is a multidisciplinary field of study that seeks to identify the most effective way to organize, deliver, and finance health care to maximize the quality and value of care at both the individual and population levels. HSR uses a diverse set of quantitative and qualitative methodologies, such as case-control studies, cohort studies, randomized control trials, and semistructured interview/focus group evaluations. This manuscript provides examples of methodologic approaches for QI and HSR, discusses potential challenges associated with concurrent quality efforts, and identifies strategies to successfully leverage the strengths of each discipline in care delivery.

Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol.

BACKGROUND: Population-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials. Chemotherapy-related toxicities are often predictable and, consequently, acute care visits may be preventable with adequate treatment planning and support between visits to the cancer centre. We will evaluate the impact of proactive telephone-based toxicity management on emergency department visits and hospitalizations in women with early stage breast cancer receiving chemotherapy. METHODS: In this pragmatic covariate constraint-based cluster randomized trial, 20 centres in Ontario, Canada are randomly allocated to either proactive telephone toxicity management (intervention) or routine care (control). The primary outcome is the cluster-level mean number of ED + H visits per patient evaluated using Ontario administrative healthcare data. Participants are all patients with early stage (I-III) breast cancer commencing adjuvant or neo-adjuvant chemotherapy at participating institutions during the intervention period. At least 25 patients at each centre participate in a patient reported outcomes sub-study involving the collection of standardized questionnaires to measure: severity of treatment toxicities, self-care, self-efficacy, quality of life, and coordination of care. Patients participating in the patient reported outcomes (PRO) sub-study are asked to provide written consent to link their PRO data to administrative data. Unit costs will be applied to each per person resource utilized, and a total cost per population and patient will be generated. An incremental cost-effectiveness analysis will be undertaken to compare the incremental costs and outcomes between the intervention and control groups from the health system perspective. DISCUSSION: This study evaluates the effectiveness of a proactive toxicity management intervention in a routine care setting. The use of administrative healthcare data to evaluate the primary outcome enables an evaluation in a real world setting and at a much larger scale than previous studies. TRIAL REGISTRATION: Clinicaltrials.gov , NCT02485678. Registered 30 June 2015.

User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients.

BACKGROUND: Cancer patients receiving chemotherapy have high symptom needs that can negatively impact quality of life and result in high rates of unplanned acute care visits. Remote monitoring tools may improve symptom management in this patient population. OBJECTIVE: This study aimed to design a prototype tool to facilitate remote management of chemotherapy-related toxicities. METHODS: User needs were assessed using a participatory, user-centered design methodology that included field observation, interviews, and focus groups, and then analyzed using affinity diagramming. Participants included oncology patients, caregivers, and health care providers (HCPs) including medical oncologists, oncology nurses, primary care physicians, and pharmacists in Ontario, Canada. Overarching themes informed development of a Web-based prototype, which was further refined over 2 rounds of usability testing with end users. RESULTS: Overarching themes were derived from needs assessments, which included 14 patients, 1 caregiver, and 12 HCPs. Themes common to both patients and HCPs included gaps and barriers in current systems, need for decision aids, improved communication and options in care delivery, secure access to credible and timely information, and integration into existing systems. In addition, patients identified missed opportunities, care not meeting their needs, feeling overwhelmed and anxious, and wanting to be more empowered. HCPs identified accountability for patient management as an issue. These themes informed development of a Web-based prototype (bridges), which included toxicity tracking, self-management advice, and HCP communication functionalities. Usability testing with 11 patients and 11 HCPs was generally positive; however, identified challenges included tool integration into existing workflows, need for standardized toxicity self-management advice, issues of privacy and consent, and patient-tailored information. CONCLUSIONS: Web-based tools integrating just-in-time self-management advice and HCP support into routine care may address gaps in systems for managing chemotherapy-related toxicities. Attention to the integration of new electronic tools into self-care by patients and practice was a strong theme for both patients and HCP participants and is a key issue that needs to be addressed for wide-scale adoption.

Can Chemotherapy-Related Acute Care Visits Be Accurately Identified in Administrative Data?

PURPOSE: There is increasing interest in using administrative data to examine treatment-related complications that lead to emergency department (ED) visits or hospitalizations (H). The purpose of this study was to evaluate the reliability of billing codes for identifying chemotherapy-related acute care visits (CRVs) among women with early-stage breast cancer. MATERIALS AND METHODS: The cohort was identified by using deterministically linked health databases and consisted of women who were diagnosed with early-stage breast cancer who started adjuvant chemotherapy between 2007 and 2009 in Ontario, Canada. A random sample of 496 patient cases was chosen as the validation cohort. Sensitivity (SN) and specificity (SP) were calculated for three scenarios: chemotherapy-related ED visit, chemotherapy-related H, and febrile neutropenia (FN)-related visit. For FN-related visits, three definitions were considered: general, moderate, and strict. RESULTS: The administrative cohort consisted of 8,359 patients, 43.4% of whom had at least one ED or H, including 1,496 women who had multiple visits that resulted in 6,293 unique visits. Of these, 73.1% were considered CRVs. The algorithm performed well in identifying CRVs that included H either from ED (SN, 90%; SP, 100%) or directly from home (SN, 91%; SP, 93%), but less well for ED visits that did not result in H (SN, 65%; SP, 80%). Depending on which FN algorithm was used, 4.8% to 24% of visits were considered related. The moderate FN algorithm provided the best tradeoff between SN (69% to 97%) and SP (83% to 98%). CONCLUSION: Administrative data can be valuable in evaluating chemotherapy-related serious events. Algorithm validation in other cohorts is needed.

Setting Quality Improvement Priorities for Women Receiving Systemic Therapy for Early-Stage Breast Cancer by Using Population-Level Administrative Data.

Purpose Routine evaluation of quality measures (QMs) can drive improvement in cancer systems by highlighting gaps in care. Targeting quality improvement at QMs that demonstrate substantial variation has the potential to make the largest impact at the population level. We developed an approach that uses both variation in performance and number of patients affected by the QM to set priorities for improving the quality of systemic therapy for women with early-stage breast cancer (EBC). Patients and Methods Patients with EBC diagnosed from 2006 to 2010 in Ontario, Canada, were identified in the Ontario Cancer Registry and linked deterministically to multiple health care databases. Individual QMs within a panel of 15 QMs previously developed to assess the quality of systemic therapy across four domains (access, treatment delivery, toxicity, and safety) were ranked on interinstitutional variation in performance (using interquartile range) and the number of patients who were affected; then the two rankings were averaged for a summative priority ranking. Results We identified 28,427 patients with EBC who were treated at 84 institutions. The use of computerized physician electronic order entry for chemotherapy, emergency room visits or hospitalizations during chemotherapy, and timely receipt of chemotherapy were identified as the QMs that had the largest potential to improve quality of care at a system level within this cohort. Conclusion A simple ranking system based on interinstitutional variation in performance and patient volume can be used to identify high-priority areas for quality improvement from a population perspective. This approach is generalizable to other health care systems that use QMs to drive improvement.

Establishing achievable benchmarks for quality improvement in systemic therapy for early-stage breast cancer.

BACKGROUND: Setting realistic targets for performance is a consistent challenge in quality improvement. In the current study, the authors used administrative data to define achievable targets for a panel of 15 previously developed quality indicators (QIs) focusing on systemic therapy in patients with early-stage breast cancer. METHODS: Deterministically linked administrative databases were used to identify patients with TNM stage I to stage III breast cancer who were diagnosed between 2006 and 2010 in Ontario, Canada. For each individual indicator, data-driven empirical benchmarks were calculated using the pared-mean benchmark approach. Variation in institution-level performance for each indicator was examined through the construction of funnel plots. RESULTS: A total of 28,303 patients with early-stage breast cancer were identified, 43% of whom received adjuvant chemotherapy. For the 9 QIs for which receiving the service or outcome was desirable (ie, consultation with a medical oncologist), the benchmark varied from 40.9% to 100%. For the 6 indicators for which not receiving the service or outcome was desirable (ie, incidence of febrile neutropenia), the benchmark varied from 0% to 49.0%. There was substantial variation noted with regard to the number of institutions meeting the target and the amount of interinstitution variation between the QIs. Top performing institutions varied by indicator, with no individual institution meeting the benchmark for all indicators. For the majority of indicators, institution size was not found to be correlated with performance. CONCLUSIONS: Data-derived benchmarking can be used to facilitate quality improvement by identifying areas of both good as well as suboptimal performance while defining an achievable target for which to strive. Cancer 2017;123:3772-3780. © 2017 American Cancer Society.

Assessment of Fever Advisory Cards (FACs) as an Initiative to Improve Febrile Neutropenia Management in a Regional Cancer Center Emergency Department.

PURPOSE: We aimed to improve the time to antibiotics (TTA) for patients treated with chemotherapy who present to the emergency department (ED) with febrile neutropenia (FN) by using standardized fever advisory cards (FACs). METHODS: Patients treated with chemotherapy who visited the ED at the Peel Regional Cancer Center in Ontario, Canada, with suspected FN were identified, before (April 2012 to March 2013) and after (October 2013 to March 2014) FAC implementation. The primary outcome of interest was TTA. Additional process measures included Canadian Triage and Acuity Scale score, time to physician assessment, and FAC compliance. Outcomes were analyzed with descriptive statistics and control charts to determine whether the change in primary measures were within statistical control over time. RESULTS: Between the pre-FAC cohort (n = 239) and post-FAC cohort (n = 69), TTA did not change significantly post-FACs (195 v 244 min, P = .09), with monthly averages demonstrating normal variation by statistical process control methodology. The introduction of FACs increased the percentage of patients with correctly assigned Canadian Triage and Acuity Scale scores (87% v 100%) but did not affect time to physician assessment. Compliance with FACs among patients was not ideal, with only 62.5% using them as intended. CONCLUSION: The distribution of FACs was associated with an improved incidence of correct FN triaging but did not demonstrate a meaningful improvement in the quality of FN management. This may be explained by FAC use among patients not being ideal. Next steps in the continued effort toward high-quality FN care include redesign of FACs, reinforcement of provider and patient education, and ED outreach.

Improving documentation of oral chemotherapy at a community cancer center.

PURPOSE: Safe administration of oral chemotherapy is a complex process that represents a potential threat to patient safety. Clear documentation of the plan of care for patients receiving oral chemotherapy can improve patient safety by ensuring complete health information is available to the health care team. METHODS: We undertook a rapid-cycle improvement project to improve documentation of oral chemotherapy by increasing the number of components of an oral chemotherapy care plan (as outlined by American Society of Clinical Oncology and Oncology Nursing Society) documented in the medical record before starting a new oral chemotherapy drug. Three improvement cycles were implemented, including: introduction of a standardized nursing flow sheet, use of computerized physician order entry for oral chemotherapy prescribing, and a review of computerized physician order entry to ensure all oral chemotherapy regimens were included. RESULTS: Our intervention resulted in a meaningful and sustained improvement in the number of components of oral chemotherapy care plans documented in the medical record, from a mean of 67% (eight of 12 components) to a mean of 92% (11 of 12). CONCLUSION: We are hopeful that this improvement project will enhance patient safety by improving communication within the health care team regarding the details of the chemotherapy care plan.

Population-based assessment of emergency room visits and hospitalizations among women receiving adjuvant chemotherapy for early breast cancer.

PURPOSE: Adjuvant chemotherapy is considered standard care for patients with lymph node (LN) -positive and high-risk LN-negative early breast cancer (EBC). Although chemotherapy-associated toxicities are documented in clinical trials, the impact of toxicities on emergency room (ER) visits and hospitalizations (ER + Hs) at a population level with contemporary chemotherapy is unknown. We undertook a population-based study of ER + Hs in patients with EBC receiving adjuvant chemotherapy compared with noncancer controls (NCCs). METHODS: All patients diagnosed with EBC between January 2007 and December 2009 in Ontario, Canada, were identified from the Ontario Cancer Registry. Patient records were linked deterministically to provincial health care databases to provide comprehensive medical follow-up. All patients received ≥ one cycle of adjuvant chemotherapy. Patient cases of EBC (n = 8,359) were matched to NCCs (n = 8,359) on age, comorbidity, and geographic location. ER + Hs within 30 days of chemotherapy were identified. If the primary reason for the visit was a common chemotherapy toxicity, the visit was considered chemotherapy associated. All-cause and chemotherapy-associated visits were compared between patient cases and controls. Logistic regression models were used to identify covariates associated with ER + Hs. RESULTS: The proportion of patients with at least one ER + H was significantly higher in patients with EBC undergoing chemotherapy compared with NCCs (43.4% v 9.4%; P < .001). Patients with EBC were also more likely to have multiple ER + Hs (17.9% v 2.4%; P < .001). On multivariable analysis, comorbidity, receiving a regimen containing docetaxel, and certain geographic regions were associated with increased odds of ER + Hs. CONCLUSION: ER + Hs are common among patients with EBC receiving chemotherapy and significantly higher than among controls. This represents a potential opportunity for quality improvement.

Platinum-based chemotherapy in triple-negative advanced breast cancer.

The purpose of this study was to evaluate the efficacy of platinum-based chemotherapy (PBC) versus conventional non-PBC regimens in a metastatic triple-negative breast cancer (TNBC) setting. We reviewed the electronic patient records of patients with confirmed metastatic TNBC at four major cancer centres in Canada. All patients were allocated into two groups based on type of chemotherapy received (PBC vs. non-PBC) and line of treatment (first-, second-, or third-line). The primary objective of this study was to evaluate the efficacy of PBC in metastatic TNBC in terms of median duration of overall survival (OS) from diagnosis of distant metastatic disease and compare it with the efficacy of conventional non-platinum-based chemotherapy in metastatic TNBC after controlling for known prognostic factors. A total of 153 metastatic TNBC patients were identified, 58 treated with PBC and 95 with non-PBC. The median time in first-line PBC versus non-PBC was not different between the two groups (2 vs. 2 months, p = 0.9), the median time on treatment in second and third-line therapy was longer for the PBC group compared to the conventional treated group (4 vs. 1 months, p = 0.004; 4 vs. 0.5 months, p = 0.004, respectively). Patients who received PBC had a longer OS compared to those managed conventionally (14.5 vs. 10 months, p = 0.041). This study evaluates the survival outcomes in a homogenous group of TNBC metastatic patients treated with or without PBC. Our results confirmed our hypothesis of a better OS among PBC-treated TNBC patients compared to conventionally managed TNBC patients. Currently ongoing Phase III trials assessing the benefit of PBC versus other chemotherapeutic regimens in advanced TNBC will help define the role of these agents for the management of this breast cancer subtype.

The contents and readability of informed consent forms for oncology clinical trials.

OBJECTIVES: To compare the quality of informed consent forms (ICF) for different trial phases, funding sources, oncology subspecialties, disease settings, and intervention modalities. METHODS: ICF for prospectively conducted clinical trials were examined for their descriptions of benefits and risks, study alternatives, voluntary participation, and confidentiality. Readability was assessed with Flesch Reading Ease (FRE) score and Flesch-Kincaid Reading Grade Level. RESULTS: Among 262 evaluable trials, ICF contained an average of 3982 words, 379 sentences, and 10.5 pages. The mean FRE score and Reading Grade Level were 61.2 and 7.4, respectively. All ICF explicitly stated that the intervention was investigational. Only 2 (1%) promised direct personal benefits, 16 (6%) suggested the chance of cure or prolonged survival, and 89 (34%) indicated a potential for tumor response. Conversely, 239 (91%) mentioned the risk of serious harms, 217 (83%) admitted that some side effects could be unknown or unpredictable, and 126 (48%) reported hospitalization or death as a possibility. Alternatives to participation, right to withdraw from study, and data confidentiality were addressed in 242 (92%), 254 (97%), and 260 (99%) ICF, respectively. Hematology, industry-funded, metastatic, and systemic therapy trials were most likely to highlight major risks (P < 0.05). Readability was better in phase I trials and in studies, which were performed by medical oncologists, sponsored by governmental agencies, conducted in the metastatic setting, and involved systemic therapy (P < 0.05). CONCLUSIONS: ICF had acceptable readability and provided a realistic overview of the benefits and risks of clinical trials, but the potential for hospitalization or fatality was underreported.

Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design.

BACKGROUND: Clinical experience suggests that many women with triple-negative metastatic breast cancer (MBC) relapse quickly. This has implications for clinical practice and trial design. We evaluated the duration of first-, second-, and third-line chemotherapy as a surrogate for duration of treatment response. PATIENTS AND METHODS: We performed a retrospective multicenter chart review of patients with triple-negative MBC receiving palliative chemotherapy. Primary outcome was duration of palliative chemotherapy, and secondary outcome was to identify prognostic variables. RESULTS: A total of 111 patients were analyzed. Median age at diagnosis was 51 years (range, 26-82 years). Fourteen percent of patients presented with MBC. Twenty-seven percent received neoadjuvant chemotherapy, and 48% received adjuvant chemotherapy. Median distant disease-free interval (DDFI) was 18 months (range, 0-172 months). At presentation of MBC, 68% had visceral and 71% had multiple sites of disease. Median survival with MBC was 13.3 months (range, 0.8-99.8 months). Median duration of first-line palliative therapy was 11.9 weeks (range, 0-73.1 weeks). Eighty-seven patients (78%) went on to receive second-line therapy with a median duration of 9 weeks (range, 0-120.9 weeks), and 55 (49%) received third-line therapy with a median duration of 4 weeks (range, 0-59 weeks). Multivariate analysis revealed that age < 50 years, ALP > 120 U/L, history of previous chemotherapy, DDFI < 12 months, and visceral presentation were all independently associated with a poor prognosis. CONCLUSION: Despite the poorer overall prognosis of patients with triple-negative disease, there remains considerable heterogeneity in individual outcomes. Many women with recurrent triple-negative disease will progress quickly on first-, second-, and third-line palliative treatment. Future clinical trials in this population must take into account their shorter time to progression when determining optimal trial design.