Large Community Oncology Practice Research Articles

Expanding access to genetic evaluations in a large community oncology practice through a collaborative service delivery model.

123 Background: Identifying individuals with inherited cancer susceptibility is critical to cancer treatment and prevention in patients and families. While the identification and management of inherited susceptibility to cancer is the standard of care, genetic testing rates are low; 1.2 million women with breast and/or ovarian cancer who qualify have yet to undergo genetic testing (Childers et al 2017). The Genetic Risk Evaluation and Testing Program (GREAT) formed to improve access to genetic evaluations and testing in Texas Oncology, a large, state-wide community oncology practice. Methods: The GREAT program is a collaborative service delivery model, utilizing 4 certified genetic counselors (CGC) to lead advanced practice providers and physicians in offering pre and post-test evaluations to oncology patients in their own community. Training involves 8-12 weeks of didactic lectures, precepting, and ongoing education and support. GREAT-trained providers then offer comprehensive genetic evaluations and testing to established oncology patients as well as at-risk individuals from the surrounding community. Results: The GREAT program has trained 72 providers at 52 cancer centers. Rates of genetic evaluations increased each year from 2012 to 2018. Overall findings: 19,129 unique patients received an evaluation; 17,305 genetic tests were completed; 2,597 pathogenic/likely pathogenic variants (P/VLP) have been identified. Conclusions: Despite guidelines recommending genetic evaluations for hereditary cancer syndromes, most patients are not receiving this service. A hybrid service delivery model utilizing regional CGCs to train providers in community oncology offices can significantly increase access to genetic services. The model described is an effective and expansive mechanism for the delivery of high-quality cancer genetics care. The GREAT program plans to hire additional CGCs to train more providers across Texas Oncology with the goal of expanding access. [Table: see text]

Understanding the challenges for oncologists in predicting the end-of-life phase of care in cancer patients with advanced solid tumor diagnoses.

281 Background: Early advanced care planning and palliative care improves outcomes during the end-of-life phase of care (EOL) for metastatic cancer patients. Identifying patients who are likely to transition to EOL is a necessary step to prioritize limited palliative care resources and is integral to success in value-based payment models. We analyzed whether physician documentation of prognosis in a clinical pathways system (CPS) could reliably predict when patients are nearing EOL for a large community oncology practice of more than 70 medical oncologists. Methods: Tennessee Oncology (TO) requires physicians to use CPS for all Medicare patients. CPS prompts physicians to answer the “prognostic question” “would you be surprised if this patient died in the next year?” for all OCM patients with advanced solid tumors at the beginning of treatment or at the time of a change in treatment plan. Prognostic question responses were compared to actual dates of death documented in the practice management system. Results: A total of 5,266 distinct patients were expected to trigger an OCM episode during 2017. The CPS prompted a response to the prognostic question for 1,228 (23%) of these OCM patients. There were 665 (54%) positive prognoses (expect patient to live more than 1 year) and 563 (46%) negative prognoses (expect patient to die within 1 year). Physicians documented accurate prognoses in 712 (58%) of cases. For patients with positive prognosis 557 (84%) were accurate. For patients with negative prognosis 155 (21.8%) were accurate. Conclusions: We found that for patients with terminal cancer, it is difficult for physicians to accurately predict prognosis. These findings support the importance of ASCO guidelines pertaining to patient access to palliative care during the entirety of cancer treatment for all patients with metastatic cancer. [Table: see text]

Effect of a Collaboration Between a Health Plan, Oncology Practice, and Comprehensive Genomic Profiling Company from the Payer Perspective.

Comprehensive genomic profiling (CGP) is a next-generation sequencing-based methodology that detects 4 classes of genomic alterations, as well as gene signature biomarkers such as microsatellite instability and tumor mutational burden. In the context of precision oncology, CGP can help to direct treatment to genomically matched therapies. To describe the results of a 3-year observational analysis of patients undergoing testing with CGP assays (either FoundationOne or FoundationOne Heme) at a community oncology practice after a regional health plan implemented a medical policy that enabled coverage of CGP. A retrospective analysis of medical records was completed at the oncology practice from November 2013 to January 2017; this date range was chosen to coincide with the regional health plan's medical policy implementation of CGP. The medical policy provided coverage of CGP for patients with advanced solid and hematologic cancers. A medical record review assessed all previous and current molecular test results, matched therapy or clinical trial enrollment, and clinical outcomes (clinical benefit or disease progression). The potential cost diversion, from payer to study sponsor, for patients who enrolled in clinical trials was explored. There were 96 patients in the community oncology practice who received CGP over the 3-year period, 86 of whom had clinically relevant genomic alterations. Of the 86, 15 patients were treated with genomically matched therapy, and 6 patients enrolled in clinical trials based on CGP results. In a subset of 32 patients who previously underwent conventional testing, most (84%) had clinically relevant genomic alterations detected by CGP that conventional testing did not identify, and a portion of these patients subsequently received treatment based on the CGP results. In the separate cost diversion analysis of 20 patients who enrolled in phase 1 clinical trials, an estimated $25,000 per-patient cost-benefit may have been accrued to the payer. This observational analysis characterized the use of CGP in a large community oncology practice among a group of patients insured by a regional health plan. Clinical trial enrollment was facilitated by CGP use in the community setting and may have contributed to cost diversion from the payer to study sponsors. No separate study-related funding was provided by or to Priority Health, Foundation Medicine, and Cancer and Hematology Centers of West Michigan. Data analysis by Reitsma was conducted as part of an internship funded by Priority Health. Reitsma and Fox are employed by Priority Health. Anhorn, Vanden Borre, Cavanaugh, Chudnovsky, and Erlich are employed by Foundation Medicine.

Lessons learned from the investigation of a sustained increase in paclitaxel hypersensitivity reactions (P-HSR) at a large community oncology practice: A mystery not fully solved.

233 Background: Trillium Health Partners (THP) is a large community oncology practice that has a culture of quality and safety. An investigation was triggered by a perceived increase in the rate of P-HSR during a weekly quality huddle in the chemotherapy suite. At the time THP had no formal hypersensitivity reaction tracking process. A retrospective review of P-HSR over the preceding 18 months identified an increase in reaction rates from a baseline of 1% to 4.5% that started 3 months prior to the raised concern. Methods: A systematic quality review was undertaken to identify triggers for the change and to identify steps to decrease P-HSR to baseline. There was no identified change in premedication, administration or compounding practice and no association with drug or lot number was identified. The increase in P-HSR was coincident with a change in the intravenous (IV) pumps and tubing system across the hospital. The change in IV pumps introduced several potential triggers including: a change in the options for priming the IV tubing which introduced a potential for variable concentrations of drug reaching the patient at the outset of the infusion, an interaction between drug and IV tubing, and a doubling of the IV tubing length which could result in incomplete delivery of the premedication. Results: Sequential practice changes were introduced to address each potential driver including i) a slow infusion protocol for first 2 cycles, ii) alternative tubing sets, iii) practice alert regarding potential for under-delivery of premedication. Over time P-HSR trended down towards the historic baseline, no single intervention had a sustained impact, although the practice alert regarding the administration of premedication seemed to induce the most change. A step wise withdrawal of interventions that were felt to be non impactful is underway. Conclusions: Although no clear cause for the increase in P-HSR was identified the systematic quality review resulted in improved standardization of nursing practice for chemotherapy delivery and the methodical approach also lead to the establishment of a more comprehensive hypersensitivity reporting system at THP.

The challenges of implementing the CMS oncology care model (OCM) in a large multi-center community oncology practice.

115 Background: Our oncology practice has participated in the OCM program since July 2016. The purpose was to build improvement in quality care delivery and create methodology to reduce costs. We peered our work with ten cancer centers from ten states along the east coast. Methods: For all performance periods, we focused on building our strengths via five teams: Access, Care Mgmt., Post-acute transition, Finance, and Reporting. A registry was created in Epic. Data was collated and categorized as “OCM Eligible” and “OCM patients.” The Care Team worked with IT to create beneficiary identifications, discrete chart elements, financial estimations, and reports. Results: From Oct. to Dec. 2017 (latest quarter review), 589 patients were attributable. Our black and Hispanic population was +72.9% and +413.3% v. OCM (+76.6% and +381.2% v. all). We were categorized as high risk in the hierarchal condition category: +14% v. OCM, +17.7% v. all at the 25th percentile; +21.6% and +32.6% at the 50th percentile, +14.2% and +17.5 % at the 75th percentile respectively. Our dually enrolled, Medicare / Medicaid was 29% (+113% v. OCM). ED visit utilization was +2.6% (not leading to admits or observations (Obs). IP admits were utilized at a rate of 27.3 per 100 beneficiaries v. 25.8 for OCM (+5.9%) and 26.1 for all (+4.9%). Those that resulted from ED visits only were 15.8 v. 16.2 (-2.5%). Those resulted from Obs were 0.8 v. 0.3 OCM (+142.4%). Unplanned readmits within 30 days were 6.4 (per 100) v. 5.7 OCM (+13.9%). Imaging utilization was -35.2% v. OCM and -38.5% v. all. Hospice use was 3.7% v. a 5% median OCM rate. Home health was +26% v. OCM and +15.8% v. all. Risk-adjusted four Qtr. avg. expenditures were +14.5% per beneficiary v. OCM (Jan. – Dec. 2017); however, mortality rates were -10.9% v. OCM. Conclusions: Our practice data led us to identify and prioritize PI initiatives, helped us engage providers, and educate stakeholders. While certain costs were lower, drug utilization remains high. The ED and IP admits from Obs have been a challenge, even with phone triage assistance developed previously as participants of the ASCO Quality Training Program. Our PI plan is to develop oncology expanded care clinics to reduce ED and Obs utilization.

Medically integrated pharmacy: A team-based approach to improve oral oncolytic therapy for cancer patients.

140 Background: The use of oral oncolytic therapies in the treatment of cancer is rising dramatically. Cost barriers to obtaining drugs and side effects of therapies lead 1 to poor adherence to oral regimens resulting in detrimental outcomes. External specialty pharmacies have attempted to assist patients but this often leads to further fragmentation of care. We report on the performance of a medically integrated pharmacy within a large community oncology practice to achieve better patient outcomes. Methods: The Texas Oncology medically integrated pharmacy (MIP)consists of oncologists, oncology nurses, advanced practice providers, and specially trained pharmacy staff utilizing real-time access to the patient’s electronic medical and pharmacy records when oral therapy is prescribed. The team processes prior authorizations and patient assistance requests, ensures drug delivery, provides education, monitoring, and follow up of side effects for oral therapies. The care team is available to provide early intervention and side effect management. Treatment initiations, dose adjustments, and treatment discontinuations are communicated seamlessly in real time. Results: Texas Oncology MIPs process over 14,500 prescriptions annually with a 99% prior authorization approval rate. Service is timely with a representative sample of 4 practices showing 64% of prescriptions filled within 24 hours of prescribing and 72% filled within 72 hours. Prior authorization and patient assistance were the leading causes of delays. The patient assistance team processes over 3,200 requests annually with over $121 million copay assistance obtained. Adherence to therapy within Texas Oncology is over 92% for the 7 most commonly prescribed oral oncolytic drugs. Patient satisfaction surveys reveal 96% satisfaction with the medically integrated pharmacy. Conclusions: The MIP is a fully aligned team based approach for the delivery of oral oncolytics. A medically integrated pharmacy provides timely access, copay assistance, monitoring and management of side effects resulting in increased adherence to therapy and an overall improvement in quality and satisfaction.

An Assessment of the Quality Oncology Practice Initiative: Lessons Learned From a Detailed Assessment of a Well-Established Profession-Based Performance Measurement Program.

National performance measurement programs used to improve quality and/or accountability are prevalent. Professional society-based programs largely assess practice or provider performance. We tested the limitations of the Quality Oncology Practice Initiative (QOPI), a well-established program. We investigated the potential limitations of the QOPI limited sampling strategy and end-of-life (EOL) metrics through a retrospective review of all decedents meeting the QOPI eligibility criteria at a large three-site community oncology practice. Relative precision for each EOL metric was measured and simulated scenarios modeled via log-normal distributions were compared. A total of 246 deaths were identified; only 14% of decedents were included in the QOPI limited sample. Important differences in relative precision between samples were evident. Chemotherapy administered at the EOL was 2.8 times greater among the full cohort compared to the sample. The limited sampling strategy demonstrated the lack of precision explained by sampling variability confounded in smaller sample sizes. Our analyses demonstrated that practices reporting the same metric may stem from very different underlying distributions, which limits the ability to understand complex practice patterns and improve care. These findings may be of significance to other performance measurement programs that utilize similar testing strategies.

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice.

To describe the prevalence, severity, and risk factors of chemotherapy-induced peripheral neuropathy (CIPN) and its impact on function and quality of life (QOL) among women treated for breast cancer in a large U.S. Community Oncology practice. Women previously treated with taxane-based chemotherapy for early-stage breast cancer completed the EORTC QLQ-C30, QLQ-BR23, and QLQ-CIPN20. Subscales are scored 0-100; higher scores indicate greater symptom severity. Pre-specified hypotheses were tested. 126 women with mean age 56.7years (SD 11.8) were stage I-II (79.4%) or stage III (20.6%) at the time of the survey; 65.1% were White and 27.8% were Black or African American. The mean time since last taxane chemotherapy cycle was 144.9weeks (SD 112.9). 73.0% reported having CIPN. QLQ-CIPN20 mean scores for the sensory, motor, and autonomic subscales were 18.9 (SD 23.1), 18.6 (SD 18.7), and 17.1 (SD 21.8), respectively. CIPN symptom severity was negatively correlated with global health status/QOL and physical and role functioning (range of r=-0.46 to -0.72). It was not associated with age, body mass index, diabetes, or cumulative taxane dosage, but was greater for Black or African American women (e.g., sensory, p<0.002). CIPN sensory impairment was marginally greater for patients treated with paclitaxel compared to docetaxel (p<0.064). CIPN was prevalent in this community oncology practice and significantly impacts function and QOL. These data highlight the importance of developing methods to mitigate CIPN, and for screening for CIPN particularly among Black or African American women.

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice

The prevalence and pattern of chemotherapy-induced peripheral neuropathy among women with breast cancer receiving care in a large community oncology practice

Improvements in communication and engagement of advance care planning in adults with metastatic cancer through a targeted team approach.

14 Background: Advance care planning (ACP) continues to be a vital part of comprehensive, person-centered cancer care. A large community oncology practice performed a targeted approach to improve patient engagement of ACP. A process improvement project with three goals was set: increasing ACP referrals, ACP counseling visits and completed Values Assessment (VA) instrument. A leadership team consisting of practice director, physician, nurse manager, and nurse practitioner was developed with ownership of roles and responsibilities. Methods: The ACP leadership team outlined workflows to be tested, followed by evaluating outcomes of each goal over 107 days. Barriers and challenges were identified; ACP education was taught to staff. NP and RNs introduced ACP to patients during ChemoTeaching. Eligible patients were identified weekly by infusion RNs on C1D1, and patients were given the VA. Desk RNs would speak with patients on C1D2 to review symptoms and VA responses. RNs would offer ACP visits to patients. Referrals were made for patients to have one-on-one counseling with NP. Staff was educated about EMR documentation by RN manager. Weekly team phone meetings were held to discuss project status. Results: During the first 53 days of the project, 20 patients were identified at C1D1, 5 VA were completed and 15 ACP visits occurred. After evaluation, weekly communication with clinical staff increased to daily huddles. Daily communication allowed for RNs to identify C1D1 patients and communicate to the full team. During the second 54 days, 94 patients were identified at C1D1, 46 VA were completed, and 27 ACP visits occurred. A 5-fold increase occurred in patient identification; a 9-fold increase in VA completion occurred, and approximately 2-fold increase occurred in ACP counseling. Conclusions: By developing a focused and concerted process on ACP, the cancer center was able to show that patient engagement in the ACP process markedly improved. A navigation process for identifying patients who would benefit from ACP counseling was vital in increasing in the counseling visits. Continual quality improvement by refining processes in the ACP program will benefit patients.

The prevalence and pattern of chemotherapy-induced peripheral neuropathy (CIPN) among women with breast cancer receiving care in a large community oncology practice.

80 Background: CIPN is a common side effect of taxane-based chemotherapy agents. This study examined the prevalence, severity, and risk factors of CIPN and its impact on quality of life (QOL) among women treated for breast cancer in a large U.S. community oncology practice. Methods: In this cross-sectional survey study, women previously treated with taxane-based chemotherapy for early stage breast cancer completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), breast cancer module (QLQ-BR23) and CIPN module (QLQ-CIPN20). Each subscale is scored 0-100 where higher scores indicate better function or greater symptom severity. Clinical data were abstracted from the medical record. Bivariate analyses were conducted to test pre- specified hypotheses. Results: 126 women with mean age 56.7 years (SD = 11.8) were stage I-II (79.4%) or stage III (20.6%) at the time of the survey; 65.1% were White and 27.8% were Black or African American. 73.0% of women reported they had CIPN. The mean time since last taxane chemotherapy cycle was 144.9 weeks (SD = 112.9). The mean (SD) score of QLQ-C30 global health status/QOL was 77.0 (20.3) and physical function was 85.7 (17.1). QLQ-CIPN20 mean scores for the sensory, motor, and autonomic subscales were 18.9 (23.1), 18.6 (18.7), and 17.1 (21.8), respectively. Presence of CIPN was associated with patient referral and visitation to a neurologist or pain specialist (p &lt; 0.05). CIPN symptom severity was negatively correlated with global health status/QOL and physical and role functioning (range of r= -0.46 to -0.72). Further, it was not associated with age, body mass index, diabetes, or cumulative taxane dosage, but was greater for Black or African American patients versus White patients (e.g., sensory: 28.6 vs 14.5, p &lt; 0.002). CIPN sensory impairment was marginally greater for patients treated with paclitaxel compared to docetaxel (23.3 vs 15.6, p &lt; 0.06). Conclusions: CIPN was prevalent in this community oncology practice and significantly impacts function and QOL. These data highlight the importance of developing methods to mitigate CIPN.

The prevalence and pattern of chemotherapy induced peripheral neuropathy (CIPN) among women with breast cancer receiving care in a large community oncology practice.

The prevalence and pattern of chemotherapy induced peripheral neuropathy (CIPN) among women with breast cancer receiving care in a large community oncology practice.

Impact of a nurse practitioner-staffed, symptom-management clinic on emergency department utilization in a large community oncology cancer institute.

58 Background: Emergency department (ED) utilization among oncology patients is a source of patient distress as well as a financial burden to the health care system. Effective outpatient symptom management can potentially reduce ED utilization. In this analysis, we review ED utilization prior to and post the institution of a nurse practitioner staffed symptom management clinic in a large community oncology practice. Methods: In April 2014 a symptom management clinic staffed by a nurse practitioner five days a week was established at our outpatient cancer institute to increase patient access to acute symptom management. ED utilization 6 months prior to and post starting this clinic was measured. Only patients who received chemotherapy within 30 days of an ED visit were included in this analysis. Results: Between October 2013 and September 2014, a total of 420 visits to the ED were documented. A total of 196 visits occurred in the 6 months prior to establishing the clinic. There was an increase in visits to 224 after instituting the clinic. The median number of monthly visits was 34.5 (range 24-38) prior to the clinic and increased to 38 (range 30-43) after establishing the clinic. Conclusions: In our practice, a nurse practitioner led symptom management clinic did not reduce ED utilization in patients receiving chemotherapy. Based on published studies, other factors may need to be incorporated into our cancer institute to effectively reduce ED utilization. These include standardizing symptom assessment and management, patient and caregiver education on how to effectively manage symptoms at home, and improved coordination with supportive services.

Five-year retrospective review of end-of-life care quality metrics in a large, multidisciplinary community oncology practice.

108 Background: It is increasingly recognized that earlier integration of palliative care for patients with advanced cancers positively impacts both cost and quality of oncology care. Compass Oncology (CO) is a multidisciplinary community oncology practice and a member of The US Oncology Network; 39 medical, gynecologic, and radiation oncologists and 18 advance practice providers serve patients at 6 sites in Oregon and Washington. In 2008, CO prioritized practice improvement in end of life care, identifying metrics for ongoing assessment. Between 2009 and 2014, quality improvement (QI) projects focused on communication skills; whole-staff palliative care education; integration of social workers; initiation of embedded palliative care at 2 sites; and development of a more standardized approach to Advance Care Planning (ACP). Methods: Systematic retrospective record review of patient deaths from January 2009 to December 2013, targeting analysis of hospice utilization, chemotherapy use at end of life, and ACP. Results: Among patients with a CO visit within 6 months of a documented date of death (n= 783 in 2009; n= 909 in 2013), both hospice utilization and ACP participation improved significantly. Percent of patients with evidence for Advance Directive (AD), POLST or code status documented in the electronic medical record (EMR) improved from 36% in 2009 to 50 % in 2013 (p&lt;0.001). Percent of patients enrolled in hospice at the time of death improved from 56% in 2009 to 63% in 2013 (p= 0.003). No statistically significant change was noted in % patients receiving chemotherapy in the last 14 days of life. Conclusions: Focused implementation of end of life care QI strategies in a large multidisciplinary community oncology practice appears to result in both improved hospice utilization and ACP. Chemotherapy usage in the last 14 days of life remains a meaningful target for intervention. Future QI efforts will focus on ongoing, scalable improvement in these metrics. [Table: see text]

Limitations of QOPI end-of-life (EOL) data use for purposes of accountability: Comparison of sample versus full cohort analysis.

87 Background: Quality Oncology Practice Initiative (QOPI) retrospectively collects process measures at the practice level. Sample size is determined by number of full-time equivalent physicians. Although intended as an improvement program, there is growing pressure to use QOPI for accountability. Methods: We investigated QOPI sampling strategy for EOL measures in a large three-site community oncology practice for all patients meeting QOPI sampling criteria. Analysis period was July 1 to December 31, 2012. We included all patients submitted for the QOPI EOL module and compared the QOPI sample to the full but non-QOPI cohort using Fisher’s exact test. To assess relative precision, we calculated rates and 95% confidence intervals (CI) for the sampled vs. full cohorts (inclusive of QOPI cohort). Results: 246 deaths were analyzed, with 34 (13.8%) from the QOPI sample. No statistically significant differences were found between sampled and full non-QOPI cohorts. However, sampling was associated with wide CIs compared to precision using the full cohort (Table); e.g. #38 yields a CI width of 24.2% QOPI vs. 4.9% full. Similarly, #47 shows CI width of 27.7% vs. 9.0%. Low statistical significance yet wide CIs indicate comparison data are representative but with variability in precision. Conclusions: Although no statistically significant differences were identified, comparing QOPI sampling strategy to full cohort yielded presence of marked differences in precision. We suggest caution in use of current QOPI EOL sampling strategy if used for purposes other than improvement. [Table: see text]

A non-interventional study of biosimilar granulocyte colony-stimulating factor as prophylaxis for chemotherapy-induced neutropenia in a community oncology centre

Prophylaxis with granulocyte colony-stimulating factor (G-CSF) reduces the severity of chemotherapy-induced neutropenia. Biosimilar G-CSF is now approved for use, based on comparable efficacy, safety and quality with the originator product. We conducted a retrospective review of patients' charts following the switch from originator G-CSF (Neupogen(®)) to biosimilar G-CSF (Zarzio(®)/Filgrastim Hexal(®)) in a large community oncology practice. A total of 77 consecutive patients with cancer who received biosimilar G-CSF were reviewed, as were 25 patients who received originator G-CSF at the same centre. The median age of patients in the biosimilar G-CSF cohort was 67 years (range 20-83). In this cohort 48% had chemotherapy with a febrile neutropenia risk of >20%. Biosimilar G-CSF was given as primary prophylaxis in 52% and as secondary prophylaxis in 48% of patients. Age and febrile neutropenia in medical history or in previous chemotherapy were factors that triggered the use of G-CSF in patients with a febrile neutropenia risk of <20%. One patient developed febrile neutropenia. Neutropenia led to chemotherapy dose reductions in five patients (6.5%) and discontinuation in two patients (2.5%). No unexpected safety findings were observed. Patient characteristics were generally similar in the originator G-CSF cohort. Only 24% of patients had a febrile neutropenia risk >20% and 36% received primary prophylactic G-CSF. One patient developed febrile neutropenia. Neutropenia led to chemotherapy dose reductions in two patients (8%) and discontinuation in two patients (8%). Biosimilar G-CSF was effective and prevented dose reductions/discontinuation in the majority of patients. Biosimilar G-CSF was considered clinically comparable to its reference product.

Prognostic significance of circulating tumor cell (CTC) levels at various times during first- and second-line chemotherapy for metastatic breast cancer (MBC).

e21077 Background: CTCs have prognostic capability in the treatment of MBC based on a dichotomous level of ≥5/7.5 ml blood (Hi) vs. &lt;5/7.5 ml blood (Lo) at baseline and first follow-up. The value of CTCs beyond baseline is not well established, and the implication of values that are reduced but remain high has not been explored. Methods: Chart review of patients (pts) on 1st or 2nd line treatment of MBC, with CTC determinations between 2/2008 and 9/2011, were retrospectively identified at a large community oncology practice. Pts with ≥2 CTCs or 1 CTC ≥5 were eligible. Demographics, treatment regimens and progression-free survival (PFS) were assessed. The Veridex Cell Search system was utilized for all CTC determinations. Qualifying baseline CTCs were those drawn -14 days to +30 days from start of treatment. Results: 221 eligible pts were identified, 71 with baseline CTCs in 1st line, and 84 in 2nd line. Median age was 59.5 (range 26-90), 40.7% were African-American, 17.6% HER2+, and 63%/49% ER/PR+. The median time to baseline CTC was 5 days in the 1st line and 1 day in the 2nd line. 1st line PFS was 8.0 vs. 5.8 mo among baseline Hi vs. Lo groups (p = 0.085). 2nd line PFS was 3.7 vs. 4.0 mo for Hi and Lo groups, respectively, (ns). Follow-up CTCs were obtained at clinical convenience. A 90 day landmark was used for analysis of PFS by four baseline/follow-up CTC pattern groups. 1st line PFS showed medians ranging from 6.0 mo (Hi/Hi) to 10.2 mo (Lo/Lo). In 1st line pts with Hi baseline CTCs (n=24), median PFS was 6.0 vs. 7.0 mo for Hi vs. Lo at follow-up (p = .64). Grouping pts with Hi baseline CTCs by reductions in absolute CTC count at follow-up (&lt;33% vs. ≥33%) showed median PFS 3.5 mo for &lt;33% reduction, 8.8 mo for ≥33% reduction (p = .0179). Sensitivity analyses with other cutoffs in reduction from 20-80% showed similar results. Conclusions: In the community setting, baseline and subsequent CTCs obtained at various times after baseline yield clinically useful prognostic information. Pts with positive baseline CTC levels experiencing a reduction of ≥33% exhibit significantly longer PFS, indicating that a simple high/low approach to the test can be modified to yield more prognostic value.

P5-20-07: Estimation of Febrile Neutropenia in Women Receiving Docetaxel Plus Cyclophosphamide as Adjuvant Therapy for Early Stage Breast Cancer: A Retrospective Analysis.

Abstract Background: US Oncology Trial 9735 (Jones S, et al. JCO. 2006;24:5381–5387) established the docetaxel plus cyclophosphamide (TC) regimen as an effective adjuvant therapy for early stage breast cancer (ESBC). This trial did not specifically evaluate the incidence of febrile neutropenia (FN) as a study endpoint, but rates of 4%-8% were reported. Prophylactic granulocyte colony-stimulating factor (G-CSF) support was not allowed; reactive G-CSF support overall was not reported. Subsequent reports in the community setting have indicated FN rates of 25%-50% without G-CSF support and 0%-6.3% with G-CSF support (Table 1). To better determine the incidence of FN among ESBC patients treated with TC, we performed a retrospective clinical data review from the electronic medical record (EMR) database of Georgia Cancer Specialists, a large community oncology practice. Methods: EMR data were captured between January 2006 and March 2010. Eligibility included women ≥ 18 years old with ESBC (stage I-IIIA) who completed ≥ 1 cycle of TC. The study time period was from the first dose of chemotherapy (CTX) to 6 weeks after the last dose of CTX, death, or loss to follow-up. The primary endpoint was the incidence of FN. Other endpoints included the incidence of severe (grade 3/4) neutropenia, neutropenia-related hospitalizations, G-CSF use, relative dose intensity (RDI), and dose delays and reductions. Results: Data from 662 patients were included in the analysis. Median age was 55 (range: 25–81) years. 40% of patients were white. The median number of CTX cycles received was 4 (range: 1–6). Most patients (91%) received G-CSF support; 73% as primary prophylaxis. See Table 2 for additional results. Conclusions: This is the largest retrospective, community-based study to evaluate the incidence of FN in ESBC patients treated with TC. The observed FN rate of 5% (with 91% of patients receiving G-CSF) is consistent with other published reports using TC (Table 1). Our results suggest that TC is a taxane regimen with clinically significant myelosuppression (similar to other commonly used regimens in ESBC, such as TAC [NCCN Guidelines v2.2011]) and that the use of G-CSF support should always be considered. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-20-07.

The Patient Care Monitor-Neutropenia Index: Development, Reliability, and Validity of a Measure for Chemotherapy-Induced Neutropenia

To provide an initial evaluation of the psychometric properties of the Patient Care Monitor 1.0 Revised-Neutropenia Index (PCM-N), a symptom-based assessment tool designed to measure health-related quality-of-life (HRQOL) changes associated with chemotherapy-induced neutropenia. Known-groups methodology and self-report instrument validation. A large community oncology practice in Memphis, TN. 424 patients with cancer in four samples. All patients in the first three samples were assessed at baseline of chemotherapy administration and at a point analogous to midcycle. The fourth sample underwent a cross-sectional evaluation of the ability of the PCM-N to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia. PCM-N score, grade of neutropenia, and febrile status. Internal consistency reliability and factor analysis supported the single additive scale structure of the 13 items of the PCM-N. The PCM-N demonstrated good known-groups validity and was able to distinguish patients with grades 3-4 neutropenia from those with grades 0-2. The tool also was able to distinguish patients with febrile neutropenia, severe afebrile neutropenia, and no neutropenia. Receiver operating characteristic analyses provided a psychometrically based threshold score. The PCM-N is a reliable and valid instrument sensitive to changes in HRQOL associated with moderate-to-severe chemotherapy-induced neutropenia. Nurses can use the PCM-N as a rapid and cost-effective tool for monitoring symptoms of neutropenia in patients with cancer.

The Relation of Trouble Sleeping, Depressed Mood, Pain, and Fatigue in Patients with Cancer

To evaluate the relation among several symptoms that occur commonly in cancer patients: trouble sleeping, fatigue/sleepiness, depressed mood, and pain in a large cohort of cancer patients undergoing treatment in a community oncology practice. Demographic, clinical, and patient reported outcomes data from 11,445 cancer patients undergoing treatment in a large community oncology practice were analyzed using structural equation modeling. The data were split so that a model was constructed using half of the patients; this model was then cross-validated on the remaining patients. Fatigue was best represented as a latent variable, and significant direct effects were found for trouble sleeping, depressed mood, and pain. Also, there were significant indirect effects of these variables on fatigue. The effect of depressed mood on fatigue and pain was mediated by trouble sleeping, and the effect of trouble sleeping on fatigue was mediated by pain. These results predict that interventions aimed at treatment of trouble sleeping, depressed mood, and pain will improve fatigue in patients with cancer. Further, these data predict that treatment of trouble sleeping will improve pain management in this population.