Impact of Genomic Assay Testing and Clinical Factors on Chemotherapy Use After Implementation of Standardized Testing Criteria.

BACKGROUND: For clinically appropriate early-stage breast cancer patients, reflex criteria for Oncotype DX ordering ("the intervention") were implemented at our comprehensive cancer center, which reduced time-to-adjuvant chemotherapy initiation. Our objective was to evaluate Oncotype DX ordering practices and chemotherapy use before and after implementation of the intervention. MATERIALS AND METHODS: We examined medical records for 498 patients who had definitive breast cancer surgery at our center. The post-intervention cohort consisted of 232 consecutive patients who had Oncotype DX testing after reflex criteria implementation. This group was compared to a retrospective cohort of 266 patients who were diagnosed and treated prior to reflex criteria implementation, including patients who did and did not have Oncotype DX ordered. Factors associated with Oncotype DX ordering pre- and post-intervention were examined. We used multivariate logistic regression to evaluate factors associated with chemotherapy receipt among patients with Oncotype DX testing. RESULTS: The distribution of Oncotype DX scores, the proportion of those having Oncotype DX testing (28.9% vs. 34.1%) and those receiving chemotherapy (14.3% vs. 19.4%), did not significantly change between pre- and post-intervention groups. Age ≤65 years, stage II, grade 2, 1-3+ nodes, and tumor size >2 cm were associated with higher odds of Oncotype DX testing. Among patients having Oncotype DX testing, node status and Oncotype DX scores were significantly associated with chemotherapy receipt. CONCLUSION: Our criteria for reflex Oncotype DX ordering appropriately targeted patients for whom Oncotype DX would typically be ordered by providers. No significant change in the rate of Oncotype DX ordering or chemotherapy use was observed after reflex testing implementation. IMPLICATIONS FOR PRACTICE: This study demonstrates that implementing multidisciplinary consensus reflex criteria for Oncotype DX ordering maintains a stable Oncotype DX ordering rate and chemotherapy rate, mirroring what was observed in a specific clinical practice, while decreasing treatment delays due to additional testing. These reflex criteria appropriately capture patients who would likely have had Oncotype DX ordered by their providers and for whom the test results are predicted to influence management. This intervention serves as a potential model for other large integrated, multidisciplinary oncology centers to institute processes targeting patient populations most likely to benefit from genomic assay testing, while mitigating treatment delays.

Surgeon Variability and Factors Predicting for Reoperation Following Breast-Conserving Surgery.

BACKGROUND: Reoperation after breast-conserving surgery (BCS) is common and has been partially associated with the lack of consensus on margin definition. We sought to investigate factors associated with reoperations and variation in reoperation rates across breast surgeons at our cancer center. METHODS: Retrospective analyses of patients with clinical stage I-II breast cancer who underwent BCS between January and December 2014 were conducted prior to the recommendation of 'no ink on tumor' margin. Patient demographics and tumor and surgical data were extracted from medical records. A multivariate regression model was used to identify factors associated with reoperation. RESULTS: Overall, 490 patients with stage I (n  = 408) and stage II (n  = 89) breast cancer underwent BCS; seven patients had bilateral breast cancer and underwent bilateral BCS procedures. Median invasive tumor size was 1.1 cm, reoperation rate was 22.9% (n  = 114) and varied among surgeons (range 15-40%), and, in 100 (88%) patients, the second procedure was re-excision, followed by unilateral mastectomy (n  = 7, 6%) and bilateral mastectomy (n  = 7, 6%). Intraoperative margin techniques (global cavity or targeted shaves) were utilized in 50.1% of cases, while no specific margin technique was utilized in 49.9% of cases. Median total specimen size was 65.8 cm3 (range 24.5-156.0). In the adjusted model, patients with multifocal disease were more likely to undergo reoperation [odds ratio (OR) 5.78, 95% confidence interval (CI) 2.17-15.42]. In addition, two surgeons were found to have significantly higher reoperation rates (OR 6.41, 95% CI 1.94-21.22; OR 3.41, 95% CI 1.07-10.85). CONCLUSIONS: Examination of BCS demonstrated variability in reoperation rates and margin practices among our breast surgeons. Future trials should look at surgeon-specific factors that may predict for reoperations.

Implementation of Surgeon-Initiated Gene Expression Profile Testing (Onco type DX) Among Patients With Early-Stage Breast Cancer to Reduce Delays in Chemotherapy Initiation.

PURPOSE: Delays to adjuvant chemotherapy initiation in breast cancer may adversely affect clinical outcomes and patient satisfaction. We previously identified an association between genomic testing (Onco type DX) and delayed chemotherapy initiation. We sought to reduce the interval between surgery and adjuvant chemotherapy initiation by developing standardized criteria and workflows for Onco type DX testing. METHODS: Criteria for surgeon-initiated reflex Onco type DX testing, workflows for communication between surgeons and medical oncologists, and a streamlined process for receiving and processing Onco type DX requests in pathology were established by multidisciplinary consensus. Criteria for surgeon-initiated testing included patients ≤ 65 years old with T1cN0 (grade 2 or 3), T2N0 (grade 1 or 2), or T1/T2N1 (grade 1 or 2) breast cancer on final surgical pathology. Medical oncologists could elect to initiate Onco type testing for cases falling outside the criteria. We then examined 720 consecutive patients with breast cancer who underwent Onco type DX testing postoperatively between January 1, 2014 and November 28, 2016 and measured intervals between date of surgery, Onco type DX order date, result received date, and chemotherapy initiation date (if applicable) before and after intervention implementation. RESULTS: The introduction of standardized criteria and workflows reduced time between surgery and Onco type DX ordering, and time from surgery to receipt of result, by 7.3 days ( P < .001) and 6.3 days ( P < .001), respectively. The mean number of days between surgery and initiation of chemotherapy was also reduced by 6.4 days ( P = .004). CONCLUSION: Developing consensus on Onco type DX testing criteria and implementing streamlined workflows has led to clinically significant reductions in wait times to chemotherapy decision making and initiation.

Factors Associated With Delays in Chemotherapy Initiation Among Patients With Breast Cancer at a Comprehensive Cancer Center.

BACKGROUND: National guidelines endorse time-dependent quality metrics for breast cancer care. We examined factors associated with delays in chemotherapy initiation at an NCI-Designated Comprehensive Cancer Center. PATIENTS AND METHODS: We identified 523 patients who received postoperative adjuvant chemotherapy between January 2011 and December 2013 at our center. We defined 28 days from last definitive surgery (LDS) to chemotherapy as the target time frame, and an unacceptable delay in chemotherapy initiation (UCD) as greater than 42 days from LDS. Multivariate regression models were used to identify factors associated with UCD and the impact of Oncotype DX testing in patients with hormone receptor (HR)-positive breast cancer. RESULTS: Median days between LDS and chemotherapy initiation was 34 (interquartile range, 15), with 30% of patients starting within 28 days of LDS and 26.9% having UCD. Tumor characteristics such as subtype and stage affected UCD; patients with HR-positive or HER2-positive tumors were more likely to be delayed compared with those with triple-negative breast cancer. Patients with stage I disease, those undergoing mastectomy with or without immediate reconstruction, and those whose pathology sign-out was greater than 10 days postoperatively were more likely to be delayed. A higher proportion of UCD was found in HR-positive patients (31%) for whom Oncotype DX testing was ordered compared with those in whom it was not ordered (20%). CONCLUSIONS: This study provides insight into subpopulations that may be at risk to experience delays in chemotherapy initiation, directing interventions to improve the timeliness of care.

Variation in the use of granulocyte-colony stimulating factor for dose dense paclitaxel: A single institution retrospective study.

INTRODUCTION: The necessity of using granulocyte-colony stimulating factor (G-CSF) during dose-dense (DD) paclitaxel (T) after doxorubicin and cyclophosphamide (AC) is unclear. METHODS: This was a retrospective cohort study including patients with stage I-III breast cancer treated at Dana-Farber Cancer Institute with adjuvant DD-ACT between January 2011 and December 2013. Descriptive analyses evaluating patterns of G-CSF utilization during T were performed. RESULTS: Overall, 156 patients were treated with DD-ACT by 26 providers. The majority of patients (135, 87%) received at least one dose of G-CSF during T (group 1), 17% of these patients received it in only one cycle and 48% received it in all four cycles. Reasons for omitting G-CSF included high baseline absolute neutrophil count and pain. Twenty-one (13%) patients did not receive any G-CSF during T (group 2). Respectively, 94% and 90% of patients completed the treatment in groups 1 and 2. There were no cases of treatment cessation due to neutropenia. Six percent of patients in group 1 had at least one treatment delay. There were no treatment delays reported in group 2. Variation in the use of G-CSF by provider and by patient was found, with 11 providers choosing not to use G-CSF in at least one patient. CONCLUSIONS: We identified substantial variation in the use of G-CSF within the practice. However, omission of G-CSF was not associated with treatment delays or adverse events. Prospective studies are warranted to formally test whether routine G-CSF is necessary during dose-dense T therapy.

Measuring Chemotherapy Appointment Duration and Variation Using Real-Time Location Systems.

INTRODUCTION: Clinical schedules drive resource utilization, cost, and patient wait time. Accurate appointment duration allocation ensures appropriate staffing ratios to daily caseloads and maximizes scarce resources. Dana-Farber Cancer Institute (DFCI) infusion appointment duration is adjusted by regimen using a consensus method of experts including pharmacists, nurses, and administrators. Using real-time location system (RTLS), we examined the accuracy of observed appointment duration compared with the scheduled duration. METHODS: Appointment duration was calculated using RTLS at DFCI between August 1, 2013, and September 30, 2013. Duration was defined as the total time a patient occupied an infusion chair. The top 10 administered infusion regimens were investigated (n = 805). RESULTS: Median observed appointment durations were statistically different than the scheduled durations. Appointment durations were shorter than scheduled 98% (C), 95% (I), and 75% (F) of the time and longer than scheduled 77% (A) and 76% (G) of the time. Fifty-six percent of the longer than scheduled (A) appointments were at least 30 minute longer. CONCLUSION: RTLS provides reliable and unbiased data to improve schedule accuracy. Replacing consensus with system-based data may improve clinic flow, relieve staff stress, and increase patient satisfaction. Further investigation is warranted to elucidate factors that impact variation in appointment duration.

Implementation of a Breast/Reconstruction Surgery Coordinator to Reduce Preoperative Delays for Patients Undergoing Mastectomy With Immediate Reconstruction.

PURPOSE: Mastectomy with immediate reconstruction (MIR) requires coordination between breast and reconstructive surgical teams, leading to increased preoperative delays that may adversely impact patient outcomes and satisfaction. Our cancer center established a target of 28 days from initial consultation with the breast surgeon to MIR. We sought to determine if a centralized breast/reconstructive surgical coordinator (BRC) could reduce care delays. METHODS: A 60-day pilot to evaluate the impact of a BRC on timeliness of care was initiated at our cancer center. All reconstructive surgery candidates were referred to the BRC, who had access to surgical clinic and operating room schedules. The BRC worked with both surgical services to identify the earliest surgery dates and facilitated operative bookings. The median time to MIR and the proportion of MIR cases that met the time-to-treatment goal was determined. These results were compared with a baseline cohort of patients undergoing MIR during the same time period (January to March) in 2013 and 2014. RESULTS: A total of 99 patients were referred to the BRC (62% cancer, 21% neoadjuvant, 17% prophylactic) during the pilot period. Focusing exclusively on patients with a cancer diagnosis, an 18.5% increase in the percentage of cases meeting the target (P = .04) and a 7-day reduction to MIR (P = .02) were observed. CONCLUSION: A significant reduction in time to MIR was achieved through the implementation of the BRC. Further research is warranted to validate these findings and assess the impact the BRC has on operational efficiency and workflows.

Does "Two is Better Than One" Apply to Surgeons? Comparing Single-Surgeon Versus Co-surgeon Bilateral Mastectomies.

BACKGROUND: Bilateral mastectomies (BM) are traditionally performed by single surgeons (SS); a co-surgeon (CS) technique, where each surgeon concurrently performs a unilateral mastectomy, offers an alternative approach. We examined differences in general surgery time (GST), overall surgery time (OST), and patient complications for BM performed by CS and SS. METHODS: Patients undergoing BM with tissue expander reconstruction (BMTR) between January 2010 and May 2014 at our center were identified through operative case logs. GST (incision to end of BM procedure), reconstruction duration (RST) (plastic surgery start to end of reconstruction) and OST (OST = GST + RST) was calculated. Patient age, presence/stage of cancer, breast weight, axillary procedure performed, and 30-day postoperative complications were extracted from medical records. Differences in GST and OST between CS and SS cases were assessed with a t test. A multivariate linear regression was fit to identify factors associated with GST. RESULTS: A total of 116 BMTR cases were performed [CS, n = 67 (57.8 %); SS, n = 49 (42.2 %)]. Demographic characteristics did not differ between groups. GST and OST were significantly shorter for CS cases, 75.8 versus 116.8 min, p < .0001, and 255.2 versus 278.3 min, p = .005, respectively. Presence of a CS significantly reduces BMTR time (ß = -38.82, p < .0001). Breast weight (ß = 0.0093, p = .03) and axillary dissection (ß = 28.69, p = .0003) also impacted GST. CONCLUSIONS: The CS approach to BMTR reduced both GST and OST; however, the degree of time savings (35.1 and 8.3 %, respectively) was less than hypothesized. A larger study is warranted to better characterize time, cost, and outcomes of the CS-approach for BM.

Variation in Additional Breast Imaging Orders and Impact on Surgical Wait Times at a Comprehensive Cancer Center.

BACKGROUND: In the multidisciplinary care model, breast imagers frequently provide second-opinion reviews of imaging studies performed at outside institutions. However, the need for additional imaging and timeliness of obtaining these studies has yet to be established. We sought to evaluate the frequency of additional imaging orders by breast surgeons and to evaluate the impact of this supplementary imaging on timeliness of surgery. METHODS: We identified 2489 consecutive women with breast cancer who underwent first definitive surgery (FDS) at our comprehensive cancer center between 2011 and 2013. The number of breast-specific imaging studies performed for each patient between initial consultation and FDS was obtained. χ (2) tests were used to quantify the proportion of patients undergoing additional imaging by surgeon. Interval time between initial consultation and additional imaging and/or biopsy was calculated. The delay of additional imaging on time to FDS was assessed by t test. RESULTS: Of 2489 patients, 615 (24.7 %) had at least one additional breast-specific imaging study performed between initial consultation and FDS, with 222 patients undergoing additional biopsies (8.9 %). The proportion of patients receiving imaging tests by breast surgeon ranged from 15 to 39 % (p < 0.0001). Patients receiving additional imaging had statistically longer wait times to FDS for BCT (21.4-28.5 days, p < 0.0001). CONCLUSIONS: Substantial variability exists in the utilization of additional breast-specific imaging and in the timeliness of obtaining these tests among breast surgeons. Further research is warranted to assess the sources and impact of this variation on patient care, cost, and outcomes.

The Influence of Radiology Image Consultation in the Surgical Management of Breast Cancer Patients.

BACKGROUND: Patients referred to comprehensive cancer centers arrive with clinical data requiring review. Radiology consultation for second opinions often generates additional imaging requests; however, the impact of this service on breast cancer management remains unclear. We sought to identify the incidence of additional imaging requests and the effect additional imaging has on patients' ultimate surgical management. METHODS: Between November 2013 and March 2014, 153 consecutive patients with breast cancer received second opinion imaging reviews and definitive surgery at our cancer center. We identified the number of additional imaging requests, the number of fulfilled requests, the modality of additional imaging completed, the number of biopsies performed, and the number of patients whose management was altered due to additional imaging results. RESULTS: Of 153 patients, the mean age was 55 years; 98.9% were female; 23.5% (36) had in situ carcinoma (35 DCIS/1 LCIS), and 76.5% (117) had invasive carcinoma. Additional imaging was suggested for 47.7% (73/153) of patients. After multidisciplinary consultation, 65.8% (48/73) of patients underwent additional imaging. Imaging review resulted in biopsy in 43.7% (21/48) of patients and ultimately altered preliminary treatment plans in 37.5% (18/48) of patients (Fig. 1). Changes in management included: conversion to mastectomy or breast conservation, neoadjuvant therapy, additional wire placement, and need for contralateral breast surgery. Fig. 1 Impact of second-opinion imaging reviews on the management of breast cancer patients CONCLUSIONS: Our analysis of second opinion imaging consultation demonstrates the significant value that this service has on breast cancer management. Overall, 11.7% (18/153) of patients who underwent breast surgery had management changes as a consequence of radiologic imaging review.

Understanding process-of-care delays in surgical treatment of breast cancer at a comprehensive cancer center.

Few studies have examined care processes within providers' and institutions' control that expedite or delay care. The authors investigated the timeliness of breast cancer care at a comprehensive cancer center, focusing on factors influencing the time from initial consultation to first definitive surgery (FDS). The care of 1,461 women with breast cancer who underwent surgery at Dana-Farber/Brigham and Women's Cancer Center from 2011 to 2013 was studied. The interval between consultation and FDS was calculated to identify variation in timeliness of care based on procedure, provider, and patients' sociodemographic characteristics. Targets of 14 days for lumpectomy and mastectomy and 28 days from mastectomy with immediate reconstruction were set and used to define delay. Mean days between consultation and FDS was 21.6 (range 1-175, sd 15.8) for lumpectomy, 36.7 (5-230, 29.1) for mastectomy, and 37.5 (7-111, 16) for mastectomy with reconstruction. Patients under 40 were less likely to be delayed (OR = 0.56, 95 % CI = 0.33-0.94, p = 0.03). Patients undergoing mastectomy alone (OR = 2.64, 95 % CI = 1.80-3.89, p < 0.0001) and mastectomy with immediate reconstruction (OR = 1.34 95 % CI = 1.00-1.79, p = 0.05) were more likely to be delayed when compared to lumpectomy. Substantial variation in surgical timeliness was identified. This study provides insight into targets for improvement including better coordination with plastic surgery and streamlining pre-operative testing. Cancer centers may consider investing in efforts to measure and improve the timeliness of cancer care.

Measuring opportunities to improve timeliness of breast cancer care at Dana-Farber/Brigham and Women's Cancer Center.

The authors sought to measure the timeliness of care for patients with breast cancer at Dana-Farber/Brigham and Women's Cancer Center throughout the treatment continuum, and to identify sources of variation that may serve as targets for improving care delivery. This report describes the methods that were developed to measure and analyze baseline performance.