bluuebunny/crossref_metadata_2025 huggingface dataset:
National survey of breast cancer screening in rural America.
Authors: Peppercorn Jeffrey M. , Houck Kevin , Wogu Adane Fekadu , Villagra Victor , Lyman Gary H. , Wheeler Stephanie B.
Published: February 2017

13

Background: Screening mammography leads to early detection of breast cancer and improved survival. We conducted a survey of predominantly rural U.S. women who receive health insurance through the National Rural Electric Cooperative Association (NRECA) to evaluate the prevalence of annual and biennial screening and to identify potential disparities and barriers to breast cancer screening. Methods: We conducted a national cross-sectional survey of women between ages 40 and 65 who are insured by the NRECA regarding their utilization of mammography screening and barriers to screening. A study specific survey was mailed to 2,000 randomly selected eligible women without prior diagnosis of breast cancer. We assessed demographics and receipt of mammography within past 12 months (all women) and number of screening mammograms within the past 4 years (among women age 44 and older) to identify consistent annual screening and biennial screening patterns. Results: 1,204 women responded to the survey (response rate 60.2%). 74% live in rural areas, 18% suburban, 8% urban. 73% report less than 4 years college education and 19% have family incomes < $50,000/year. Overall, 72% reported screening mammography within 12 months, 59% reported consistent annual screening and 84% reported at least biennial screening. Rural women were less likely to undergo consistent annual (56% vs. 66%, p = 0.003) or biennial screening (82% vs. 89%, p = 0.01) compared to women in non-rural areas. Women under 50 were less likely to report screening within 12 months (67% vs. 77%, p = 0.0002), consistent annual (49% vs. 63%, p < 0.0001) or biennial screening (79% vs. 86%, p = 0.002). Significantly more rural women cited cost and distance as barriers, while busy schedule, fear of diagnosis, and fear of discomfort were important barriers among all demographic groups. Fear of the test was a greater barrier among younger vs. older women (p < 0.02). In univariate analysis; household income did not correlate with screening, and education was only a factor among younger women. Conclusions: A substantial percentage of rural U.S. women fail to undergo screening mammography. Potentially modifiable barriers include out of pocket expenses, convenience of screening, and fear of diagnosis and the test itself.
BRCA-1 promotor methylation as predictor of benefit from adjuvant CMF in triple-negative breast cancer not responsive to taxane-based neoadjuvant chemotherapy.
Authors: Bartsch Rupert , Födermayr Mathilde , Sebesta Miriam , Rudas Margaretha , Berghoff Anna Sophie , Promberger Regina , Preusser Matthias , Dubsky Peter Christian , Fitzal Florian , Gnant Michael , Weltermann Ansgar , Zielinski Christoph , Steger Guenther G. , Zach Otto
Published: February 2017

148

Background: Triple-negative breast cancer (TNBC) patients (pts) without pathological complete response (pCR) to neoadjuvant chemotherapy (NAC) have an unfavourable prognosis. ABCSG trials 14 and 24 defined 6 cycles of epirubicin/docetaxel (+/- capecitabine) as active NAC regimen; pts without pCR commonly received another 4-8 cycles of adjuvant CMF. Different studies suggested that breast tumours harbouring BRCA-1 germline mutations were resistant to taxane-based therapy while sensitivity to DNA-damaging agents was retained. BRCA-1 mutations are rare in sporadic BC; BRCA-1 promotor methylation (PM), however, is frequently observed. We hypothesized that pts with TNBC harbouring BRCA1 PM would benefit from adjuvant CMF salvage therapy. Methods: For this analysis, we included all pts with TNBC refractory to taxane-based NAC who received adjuvant CMF. DNA was extracted from formalin-fixed paraffin-embedded tissue samples, purified and bisulfite-converted. The TaqMan assay was used in order to perform a quantitative methylation-specific PCR. Actin-b was used as reference gene to normalise the amount of provided DNA; bisulfite-converted, artificially methylated DNA was used as positive control. Results: Twenty-four pts, median age 47 years, were available for this analysis. In 9/24 pts (37.5%), BRCA-1 PM was detected. At a median follow-up of 27.5 months, 1/9 pts (11.1%) with BRCA-1 PM had a disease-free survival (DFS) event, as compared to 10/15 (66.6%) in the non-methylated group (p = 0.013; Fisher’s exact test). Kaplan Meier estimation of DFS in the non-methylated group was 24 months (95% CI 14.06-33.94) and was not reached in the methylated group (n.s.). Conclusions: In TNBC refractory to taxane-based NAC, adjuvant CMF is of limited efficacy. In tumours harbouring BRCA-1 PM, however, a significant decrease of DFS events was observed. Therefore, tumours harbouring defects in genetic repair mechanism might be exceptionally sensitive to drugs causing DNA-damage. Further clinical investigation of this concept is warranted.
A phase I pharmacokinetics trial comparing PF-05280014 (a potential biosimilar) and trastuzumab in healthy volunteers (REFLECTIONS B327-01).
Authors: Yin Donghua , Barker Kerry B. , Li Ruifeng , Meng Xu , Reich Steven D. , Ricart Alejandro D. , Rudin Dan , Taylor Carrie T. , Zacharchuk Charles M. , Hansson Arne G.
Published: February 2017

171

Background: PF-05280014, a proposed biosimilar to trastuzumab, has an identical amino acid sequence and similar physicochemical and in vitro functional properties to trastuzumab. This study was designed to demonstrate PK similarity of PF-05280014 to trastuzumab from the US (trastuzumab-US) and EU (trastuzumab-EU), and between the licensed drugs. Safety and immunogenicity were also evaluated. Methods: In this double-blind trial (NCT01603264), 105 healthy male volunteers, 18-55 years old were randomized 1:1:1 to receive a single 6 mg/kg IV dose of PF-05280014, trastuzumab-US or trastuzumab-EU. All subjects provided informed consent. PK, safety and immunogenicity assessments were conducted for 70 days. PK similarity for a given test-to-reference comparison was considered to be demonstrated if the 90% CI of the test-to-reference ratio of the AUC from time 0 to the last time point (AUCT) and maximum concentration (Cmax) were within 80% – 125%. Results: The baseline demographics for the 101 subjects evaluable for PK were similar among 3 treatment arms. The 3 study drugs exhibited similar characteristics of target-mediated disposition and similar PK parameters (Table). The 90% CI for the ratios of Cmax, AUCT, and AUC0-∞were within 80% – 125% for the comparisons of PF-05280014 to trastuzumab-EU or trastuzumab-US, and trastuzumab-EU to trastuzumab-US. Adverse events (AE) were similar for the 3 arms with treatment-related AEs reported by 71.4%, 68.6%, and 65.7% subjects in the PF-05280014, trastuzumab-EU and trastuzumab-US, respectively. No serious AEs were reported. Only 4 subjects had treatment interruptions; 2 discontinued. Only 1 subject (trastuzumab-EU) developed anti-drug antibodies after dosing. Conclusions: This study demonstrates PK similarity of PF-05280014 to both trastuzumab-US and trastuzumab-EU and of trastuzumab-EU to trastuzumab-US. The 3 study drugs also showed similar safety profiles. Clinical trial information: NCT01603264. [Table: see text]
Calculation of an immunoscore based on extensive flow cytometry analysis of PBMCs from metastatic breast cancer patients treated with docetaxel alone or in combination with vaccine.
Authors: Grenga Italia , Donahue Renee Nicole , Kim Peter Sungwhan , Dempsey Brendan , Gulley James L. , Heery Christopher Ryan , Madan Ravi Amrit , Schlom Jeffrey , Farsaci Benedetto
Published: February 2017

31

Background: Therapeutic vaccine is emerging as a potentially efficacious and safe treatment for cancer patients. However, markers are not available to identify patients more likely to benefit from this treatment. Aim of this retrospective study was to analyze before treatment immune subsets that correlated with clinical outcome in metastatic breast cancer patients treated with docetaxel alone or in combination with vaccine. Methods: We applied multi-color flow cytometry analysis of PBMCs harvested prior to treatment from patients (n=43) enrolled in a small randomized phase II study of docetaxel alone (n=20) or in combination with PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) encoding for the tumor-associated antigens CEA and MUC-1, along with a TRIad of COstimulatory Molecules (B7-1, ICAM-1, and LFA-3; called TRICOM) (n=23). Frequency of more than 200 immune sub-populations before treatment was measured by flow cytometry. Each of the resulting subsets was ranked in tertiles. For immune subsets that correlated directly with PFS, 2 points were assigned if the frequency fell in the highest tertile, 1 point if in the middle, and 0 if in the lowest tertile. For subsets that correlated inversely with PFS, the points were assigned in the opposite order. An immunoscore was calculated based on the sum of points assigned to each subset. Log-Rank analysis, with the cutoff based on the median of the immunoscores, was performed to evaluate differences in PFS between patients with a low and high immunoscore. Results: In vaccine plus docetaxel arm, 10 immune subsets from PBMCs before treatment correlated with PFS and were used for the calculation of the immunoscore. Patients with an immunoscore above the median showed a statistically significant longer PFS compared to those with lower score in vaccine plus docetaxel arm (p<0.001, HR=0.1466, 95% CI= 0.0478-0.4375) but not in docetaxel alone arm (p=0.097, HR=0.418, 95% CI=0.147-1.172). Conclusions: Calculation of an immunoscore from PBMCs before treatment based on flow cytometry screening of immune subsets may identify patients that will most likely benefit from vaccine combination immunotherapy.
Quantitative analysis of breast parenchymal background enhancement (BPE) on magnetic resonance (MR) imaging: Association with mammographic breast density and aggressiveness of the primary cancer in postmenopausal women.
Authors: Ahn Hye Shin , Kim Sun Mi , Jang Mijung , Yun Bo La
Published: February 2017

38

Background: To evaluate semiautomated quantitative analysis of the BPE in postmenopausal women who were diagnosed breast cancer and to correlate it with mammographic breast density and aggressiveness of the primary cancer. Methods: Informed patient consent was waived after institutional review board approved this study. Four hundred eighty two breast cancer patients performed breast MRI in our institution during 16 months, and 84 postmenopausal women of them were included in this study (median age, 67.2 years; range, 60-76 years). Ordinary values of BPE and breast density were described by an experienced breast radiologist using the BIRADS lexicon. The BPE was calculated with semiautomated quantitative method for quantitative analysis: BPE coefficient (BEC = SI1-SI0 / S0 × 100), where SI is signal intensity, SI1 is the SI enhancement measured in the largest dimension of the sagittal plane at the first postcontrast image, and S0 is the SI before contrast injection. On surgical pathology, pathologic subtype, nuclear and histologic grade, estrogen receptor (ER), progesterone receptor (PR), HER2≠neu, venous and lymphatic invasion, lymph node metastasis was evaluated. And then, the mean BEC of the patients who diagnosed local or systemic recurrence on follow-up was calculated and compared with that of the patients without recurrence. The statistical analysis was performed using Kruskal-Wallis test and Mann-Whitney U test. Results: The mean BEC of the postmenopausal women was 3.96 ± 6.71 in right breast and 3.41 ± 8.09 in left breast. There was no significant difference in the BEC between mammographic breast density groups (P > 0.05). There was no significant correlation between BPE and aggressiveness of the primary breast cancer. However, the mean BEC was higher in the recurrent patient group (n = 6, mean=16.23 ± 19.88) compared with the patients without recurrence (n = 78, mean=2.44 ± 5.62). Conclusions: No association was found between BPE and aggressiveness of the primary breast cancer, BPE and breast density. However, the mean BEC was higher in the patients who diagnosed local or systemic recurrence.
Perceived stress to predict for acute radiation-induced skin toxicity: The mind-body connection.
Authors: Eaton Bree Ruppert , Liu Tian , Yang Xiaofeng , Mister Donna , Zhao Yize , Miller Andrew H. , Long Qi , Torres Mylin Ann
Published: February 2017

62

Background: Previous studies have reported that breast cancer patients with high stress levels at diagnosis develop more frequent and severe side effects of chemotherapy treatment. However, the relationship between stress and radiotherapy (RT) related treatment toxicity has not been evaluated. We investigated whether baseline stress is associated with worse acute skin toxicity in women undergoing breast RT. Methods: Between March 2010 and April 2013, 80 post-lumpectomy breast cancer patients were enrolled on a prospective study prior to undergoing definitive whole breast RT (50 Gy plus a 10 Gy boost). Prior to RT (baseline), at week 6 of RT (T2), and 6 weeks post RT (T3), subjects completed the Perceived Stress Scale (PSS) and underwent objective ultrasound measurements of epidermal thickness over the lumpectomy cavity and in all four quadrants of the treated breast. A skin thickness ratio (STRA) was generated by normalizing for measurements taken of the untreated breast. RT-induced skin toxicity was assessed by measuring the change in STRA from baseline to T2 and T3. Results: Mean STRA increased by 23% (SD 27%) and 33% (SD 25%) from baseline to T2 and T3, respectively. Univariate analysis revealed PSS score at baseline (p=.04), body mass index (p=.03), maximum RT dose (Dmax) (p=.02) and whole breast volume (p<.001) were significantly associated with increased changes in STRA during RT. Depression, fatigue, race, chemotherapy, patient age, and tumor stage were not associated with changes in STRA. On multivariate analysis, PSS (p=.05), breast volume (p=.004), and Caucasian race (p=.04) were associated with greater acute changes in STRA from baseline to T2. Breast volume (p=.01), but not PSS, predicted for greater changes in STRA 6 weeks after RT was completed. Conclusions: In women with breast cancer, a high level of perceived stress prior to RT is associated with more severe acute skin toxicity during RT but not after RT is completed. Strategies to reduce stress prior to RT may improve tolerance of treatment.
Early clinical results of intraoperative radiation therapy (IORT) during breast conservation using an electronic brachytherapy (EBX) technique.
Authors: Arterbery V. Elayne , Johnson Pamela
Published: February 2017

83

Background: Intraoperative radiation therapy (IORT) as an alternative to whole breast irradiation (WBI) has been described for patients with early-stage breast cancer. The randomized phase III TARGiT trial demonstrated similar recurrence rates to WBI and a lower overall toxicity profile. IORT-related effects and early postoperative outcome were assessed. We report our clinical experience using a 50 Kv EBX HDR radiotherapy delivery system using a balloon technique. We assessed institutional postoperative complications, clinical outcome and histological findings in patients undergoing IORT for breast cancer on a physician sponsored study. Methods: 22 patients (median age 71 years, negative LN and tumor less than 3 cm) underwent lumpectomy, sentinel lymph node (SLN) biopsy, and concurrent IORT from December 2010 to January 2013. 18 were treated on the study and 4 refused enrollment and elected to be treated off protocol. Patients received IORT (20 Gy) during breast conserving surgery using an EBX technique. WBI was added according to clinical guidelines. Cosmetic results and quality of life were evaluated. Results: Postoperative complications and toxicity was rare without grade 3/4 toxicities. The most frequent postoperative side effects were palpable seroma (8.3%). Erythema grade 1-2 of the breast was found in (13%); whereas in some (3.4%), mastitis. In 80% of the cases patient had IFDCA, the remainder DCIS and tumor size ranged between 0.7 and 2.6 cm (median = 1.0cm). At median 1 year follow-up, no patient suffered a local recurrence. Cosmetic outcome was perceived excellent in most patients and 100% would recommend the procedure. One patient required WBI due to close margins at re-excision. No patient had positive SLN on final path. Conclusions: IORT using electronic brachytherapy as part of breast conservation is safe. The potential advantages of IORT are minimal time needed for cellular repopulation between surgery and radiation treatment, cosmetic outcome and significant logistical advantages and reduced cost. Careful surgical assessment minimizes the need for WBI. Longer follow-up will determine clinical results for cosmetic outcome and local control.
Accelerated partial-breast irradiation using strut-based brachytherapy in ductal carcinoma in situ patients: A report on 321 patients with median 25-month follow-up.
Authors: Einck John Paul , Finkelstein Steven E. , Han Ben , Hong Robert , Komarnicky Lydia T. , Kuske Robert R. , Mahalingam Sudha B. , Mantz Constantine , Morcovescu Serban , Nigh Stephen S. , Perry Kerri L. , Pollock Jondavid , Reiff Jay E. , Scanderbeg Daniel , Strasser Jon F. , Yashar Catheryn M. ,   SAVI Collaborative Research Group
Published: February 2017

92

Background: Limited data are available on the treatment of ductal carcinoma in situ (DCIS) with accelerated partial breast irradiation (APBI). The American Society for Radiation Oncology (ASTRO) consensus guidelines on APBI classify patients with DCIS as “cautionary”. We present the largest series of DCIS patients reported to date treated with APBI using strut-based brachytherapy. Methods: The SAVI Collaborative Research Group (SCRG) database was used to identify APBI patients with DCIS at 15 institutions treated with strut-based brachytherapy. All patients had a histologic diagnosis of DCIS and received monotherapy APBI (34 Gy in 10 fractions). Data on patient age and margin status, implant dosimetry, device size, disease status and toxicity in this population were analyzed. Results: From 2007-2011, 321 patients (322 breasts) with DCIS received APBI using strut-based brachytherapy. Patient ages ranged from 40-88 with a median age of 62. 51 patients were under 50 years of age. Detailed dosimetry data were reported on 245 patients. Long-term follow up was available on 221 breasts (median F/U = 25 months). Sixty patients have been followed for >3 years. Skin spacing was a challenge in a significant number of patients including 52 with skin spacing ≤ 5mm and 20 with skin spacing ≤ 3mm. Median maximum skin dose in those patient groups were 87% and 84% of prescription dose (PD), respectively. Overall reported dosimetry (n=245) was excellent: median percent of target volume receiving 90% PD was 96.9%, median maximum skin dose was 83.2%, V150% and V200% (volume at 150% and 200% PD) were 25.2 cc and 12.7 cc respectively. The ipsilateral recurrence rate was 2.2% (1.1% TR/MM). Late toxicity (grade ≥ 2) was low: hyperpigmentation = 0.0%, telangiectasias =1.4%, seroma = 3.2%, and fat necrosis in 1.8%. Conclusions: APBI using strut-based brachytherapy appears to be an effective treatment for patients with DCIS with acceptably low ipsilateral breast recurrence rates and low rates of late toxicity. 52 patients in our series had skin spacing 5 mm or less. APBI using brachytherapy may not have been possible for these women with other single-entry devices.
Second-look axillary ultrasound after breast MRI for enhanced preoperative nodal staging in newly diagnosed breast cancer patients.
Authors: Hieken Tina J. , Jones Katie N. , Boughey Judy Caroline , Shah Sejal , Glazebrook Katrina N.
Published: February 2017

98

Background: Concomitant with widespread adoption of axillary ultrasound (AUS) with ultrasound-guided needle biopsy (USNB) of suspicious lymph nodes (LN) for preoperative nodal staging of breast cancer patients, utilization of breast MRI, which includes axillary imaging, has increased. Little is known about the added value of MRI imaging of the axilla in this context. We undertook this study to assess the role of breast MRI in preoperative axillary nodal staging. Methods: We studied 988 consecutive invasive breast cancers in patients undergoing primary operation including axillary surgery, without neoadjuvant therapy, from 2010-2011. Results: 505 patients (51%) underwent MRI of which 168 (33%) demonstrated suspicious findings in the axilla. Abnormal axillary MRI findings included cortical thickening, edema, enhancement, hilar effacement, and/or altered shape and size. 114 patients had findings concordant with AUS. 54 patients had suspicious LNs on MRI either without a preceding AUS (33 cases) or after an initially negative AUS (21 cases). Second look AUS was performed in 29 of these cases and was abnormal in 3 (10%) in whom USNB confirmed metastatic adenopathy. Of the 54 cases with MRI-detected suspicious LNs 20 (37%) were node positive at operation with a pN stage of N0 (63%), N0i+ (5%), N1mic (4%), N1 (20%), N2 (6%), N3 (2%); extranodal extension was seen in 7 of 20 node-positive patients (35%). Conclusions: Second look AUS, when performed secondary to suspicious axillary MRI findings, identified LN metastasis preoperatively in 10% of patients. When MRI is done to evaluate the breast in newly diagnosed breast cancer patients, axillary findings can enhance the accuracy of preoperative nodal staging. We recommend second look AUS when MRI demonstrates suspicious axillary LN findings. [Table: see text]
Real-time extraction of breast cancer treatment process and outcome measures from an EPIC electronic health record (EHR).
Authors: Kuznetsov Julie Lawrence , Bailey Kathryn , Bombach Pacharintra K. , Carmichael Stacey , Chen Xuemei , Herberg Maja Lichstein , Owen Terri , Wilson Jorge , Blayney Douglas W.
Published: February 2017

1

Background: In 2011, Stanford Cancer Institute (SCI) clinical leadership began process improvements to enhance patient satisfaction and quality of care. To measure impacts, unnecessary care variation, and outcomes, we recently developed an informatics infrastructure utilizing data from our EHR (epic modules: BEACON, Cadence, OpTime). We report successful initial efforts including real-time cohort identification (comparing with “gold standard” registry data), and improvements in time to treatment. Methods: A cohort of 1,692 patients was defined by 3 criteria: newly evaluated at SCI, AND received treatment [surgery, chemotherapy (chemo), or radiation (XRT)] at SCI, AND had a breast cancer related ICD-9 code. We analyzed data by fiscal year (FY), starting September, 2010 to FY13 year-to-date. “Time to treatment (Rx)” was measured as the interval between first EHR time stamp for SCI patient contact and Rx date. We used discrete data from the BEACON staging module to create sub-cohorts by stage, and used BEACON protocols to identify chemo regimens. Our cohorts were compared with SCI tumor registry data, and presented in a dynamic Qlikview dashboard. Results: 98% of the EHR-defined cohort matched a similarly defined tumor registry cohort. We detected the effect of process improvements (including scheduling a visit on first contact, coordinating among surgical specialties, outside records available pre-visit, etc.), which resulted in an accelerated time to Rx (Table). Discrete BEACON stage is available for 7% of these 1692 patients. The methodology is scalable and has been successfully replicated in GI and thoracic cohorts. Conclusions: Our work demonstrates utility of EHR data to track process improvements. Uniform use of the BEACON staging module will facilitate variation analysis across cancer types and stages, and allow us to explore variation within modalities (chemo, surgery, XRT). We will analyze associated costs and intermediate clinical outcomes (e.g., unplanned emergency visits and hospitalizations) to inform care pathway choice. [Table: see text]
Do pharmaceutical claims accurately reflect oncology prescribing practice? Evidence from an Australian HER2+ early breast cancer cohort (HER2EBC).
Authors: Harris Carole A. , Ward Robyn L. , Daniels Benjamin , Pearson Sallie
Published: February 2017

100

Background: Pharmaceutical claims are used increasingly to investigate the real-world use and impact of prescribed medicines. Claims databases are established for payment purposes, lack clinical data and only capture prescriptions for which insurers pay a contribution. We compare Pharmaceutical Benefits Scheme (PBS) dispensing claims of HER2EBC patients, with prescriptions written in oncology clinics to determine the accuracy of dispensing data to identify treatment protocols and estimate treatment cycles and durations of therapy. Methods: Our cohort comprised 110 female HER2EBC patients commencing treatment at 4 Sydney cancer centres between 2008 and 2011. Patients consented to medical chart audit and linkage to PBS claims. We constructed protocols from prescribing and dispensing records independently, based on the timing of trastuzumab and cytotoxic treatments; estimated the median number of treatment cycles and duration of therapy by protocol; and compared prescription and dispensing data. Results: Patients’ median age was 53 years (range 21.1-86.2). Based on prescribing data, 67 patients received anthracycline-containing protocols, 43 received taxane only protocols. ACTH and TCH accounted for 90% of all protocols. 75 patients (68.2%) were assigned the same protocols based on prescribing and claims data; 26 did not match as cyclophosphamide falls below the patient copayment for general PBS beneficiaries and is not captured in the claims data. Compared with prescription data, number of treatment cycles was underestimated in dispensing data (ACTH: median 30 vs 44; TCH 26 vs 29); trastuzumab-based treatment is administered weekly in ACTH but only dispensed 3-weekly. Durations of therapy differed by ≤5% in dispensing versus prescription data (ACTH 422 days vs 466; TCH 368 vs 367). Conclusions: PBS dispensing data is reliable for establishing treatment protocols in concessional beneficiaries and duration of therapy in all patients. Claims data underestimates treatment cycles as administration occurs more frequently than dispensing. These limitations must be considered when undertaking population-based studies using claims data in HER2EBC.
HER2-positive early breast cancer (HER2EBC): An Australian pattern of care study.
Authors: Harris Carole A. , Pearson Sallie , Daniels Benjamin , Srasuebkul Preeyaporn , Ward Robyn L.
Published: February 2017

101

Background: Clinical trials have demonstrated the benefits of trastuzumab in treating HER2EBC. However, in routine care it is unclear which patients are recommended treatment, what chemotherapy partners are used and whether patients receive all of their intended treatments. In this study we describe the real world treatment patterns in HER2EBC patients. Methods: We undertook a clinical audit of patients diagnosed with HER2EBC (stage I-III) at four Sydney-based cancer centres between 2008 and 2011. We identified patients from pathology records and extracted information on patient and cancer characteristics, treatments planned and received from medical notes and medication charts. Results: 203 patients formed the study cohort; median age 55 years (range: 21-91), all but one patient was female. 77 patients had stage I disease, 84 stage II, and 42 stage III. 176 patients (86.7%) were recommended trastuzumab-based treatment and 168 patients initiated therapy. 96 were treated with anthracycline-based chemotherapy and 70 with taxane-based chemotherapy. 76.7% completed the planned number of taxane-based treatments compared with than the 60% receiving anthracycline-based therapies; toxicity being the main reason for not completing treatment. Younger patients (OR 0.89, 95%CI 0.84-0.93, p<0.001) and those with grade 3 tumours compared to grade 1 and 2 combined (OR 3.99, 95%CI 1.31-12.08, p0.014) were more likely to be recommended trastuzumab-based treatment. Younger patients (OR 0.85, 95%CI 0.81-0.90, p <0.001) with a high HER2 gene copy number (OR 4.10, 95%CI 1.06-15.81, p 0.041) multifocal disease (OR 3.53, 95%CI 1.06- 15.82 p 0.023) and stage II and III disease (OR 0.73, 95%CI 0.25-0.90 p 0.011) were more likely to be recommended anthracycline over taxane-based therapy. Conclusions: Trastuzumab-based therapy is standard of care for patients with HER2EBC regardless of patient or cancer characteristics. Whilst chemotherapy partners are determined by patient and cancer characteristics, treatment limiting toxicities also need to be considered in order to maximise patient benefit.
The use of PET scans in the management of non-small cell lung cancer patients relative to evidence-based indications across Canada.
Authors: Bryant Heather E. , Rahal Rami
Published: February 2017

104

Background: PET scans are playing an increasingly important role in the management of cancer patients, particularly those diagnosed with non-small cell lung cancer (NSCLC). At the same time, the high capital and operating costs of the technology in the publicly funded Canadian health care system presents a strong case for monitoring use of PET scans relative to evidence based indications. This study by the Canadian Partnership Against Cancer reports on the use of PET scans in the management on NSCLC across Canada. Methods: PET scan utilization data from all hospitals providing the service in six Canadian provinces was linked to provincial cancer registry data, which allowed for the identification of demographic, diagnostic/prognostic, and treatment information on each NSCLC patient receiving a PET scan. The indication for each scan was then inferred from the timing of the scan relative to the dates of diagnosis, neoadjuvant therapy, surgery, curative chemo-radiation, or palliative treatment, as relevant for each patient’s care pathway. This way, the scan indications were identified as one of the following: staging, treatment planning, assessing treatment response during active treatment, and assessing metastases following end of curative treatment or palliative treatment. Results: The study results were not yet available at the time of submission of this abstract. Preliminary results and analyses will be available by the November 1, 2013, conference date. The results will include the following indicators for the 2009-2011 timeframe: percentage of NSCLC cases receiving a PET scan by stage; percentage NSCLC PET scans that are performed for each of the identified indications (diagnosis/staging, treatment planning, treatment response, follow up) by stage at diagnosis; variations by province, age group, and sex. Conclusions: This work will identify patterns in the use of PET scans for NSCLC patients across Canada and assess the extent to which this use is consistent with currently supported evidence based indications. The results will help inform more evidence-based use of the diagnostic technology across Canada and will form a baseline for future monitoring as the evidence evolves.
An interoperable HL7 document standard to improve the quality of cancer care across multiple locations.
Authors: Warner Jeremy , Hughes Kevin S. , Krauss John C. , Maddux Suzanne , Yu Peter Paul , Ambinder Edward P.
Published: February 2017

12

Background: Cancer care is by nature interdisciplinary and increasingly depends on seamless electronic transmission of clinical data. Health information exchange and semantic understanding are critical for improved outcomes, personalized medicine, comparative effectiveness research, and cost control. While there is a growing focus on this, sharing patient information remains difficult due to a lack of standardization and general incompatibility between electronic health record products. There is a need for well-designed, oncology-specific interoperability standards. Thus ASCO is developing standards to improve the quality and insight of cancer care. Methods: ASCO volunteers formed a Standards Work Group (Standards WG) in 2012, and ASCO engaged an independent consulting firm to perform the technical work. The Standards WG first developed an interoperable standard with broad application that would also be a foundation for future standards work. They adapted ASCO’s Breast Cancer Adjuvant Treatment Plan and Summary (Breast TPS), which was originally developed as a paper-based form. This adaptation required extensive work involving input from medical and surgical oncologists, ASCO staff, and the consultants. This preparatory work was vital to define and disambiguate clinical concepts. Some value sets in the original Breast TPS were replaced with National Cancer Institute value sets. Multiple oncology and standards stakeholders reviewed the draft to ensure accurate representation of the data and harmonization with related standards. Results: The standard was developed using the Health Level Seven International (HL7) Clinical Document Architecture, a widely used XML-based markup standard with national and international recognition. The draft Breast Cancer Adjuvant Treatment Plan and Summary Standard was successfully balloted through HL7 in May 2013 and will subsequently be published for trial use in late 2013. Conclusions: The Breast Cancer Adjuvant Treatment Plan and Summary Standard will improve quality by allowing providers to efficiently transmit clinical data with semantic meaning to health professionals, patients, quality improvement initiatives, and registries.
Opportunities for improved end-of-life (EOL) care for adult patients with advanced cancer: Results of a longitudinal assessment of care provided by Quality Oncology Practice Initiative (QOPI) participants.
Authors: Dougherty David W. , Kadlubek Pamela , Pham Trang , Earle Craig , Malin Jennifer , Breathwaite Larry , Jacobson Joseph O.
Published: February 2017

132

Background: End of life care of patients with advanced cancer has received recent attention because of evidence of widespread variation in utilization of aggressive therapies and interventions and possible suboptimal use of palliative care and hospice services. QOPI, the ASCO sponsored quality assessment program, has been available to all United States physician members since January 2006 and has assessed EOL care since its inception. The current analysis explores whether the increased national focus on EOL and increased availability of palliative care and hospice services has resulted in improvements in EOL care as reported by QOPI participants. Methods: Data was aggregated across all EOL care quality measures for 9 sequential semi-annual QOPI collection periods from 2008 through 2012. Trends were analyzed among rates of eligible patients related to hospice enrollment and timing of enrollment, palliative care referrals, discussions about hospice and palliative care, and chemotherapy administration at the end of life. The Cochran-Armitage trend test was performed to determine the significance of trends and differences in measure performance over time. Results: From Fall 2008 to Fall 2012, the rate of hospice enrollment for appropriate patients improved by 7.4% [51.8% to 59.2%; p<0.0001] and the rate of hospice enrollment or palliative care referral improved by 5.6% [63.3% to 68.9%; p<0.0001]. Modest improvements were seen in the rates of hospice enrollment more than 3 and 7 days before death [2.8%, 2.6%], discussion of hospice or palliative care with patients not referred for these services within the last 2 months of life [2.7% increase; 19% to 21.7%], and chemotherapy administration within the last 2 weeks of life [2.4% improvement from 13.7% to 11.3%]. Conclusions: Despite modest increases in the rate of hospice enrollment and palliative care referrals over time, EOL care for adult patients with cancer associated with QOPI practices remains suboptimal. Opportunities exist to increase more meaningful participation in hospice and palliative care and to reduce exposure to chemotherapy near death.
Standardizing chemotherapy education for quality improvement.
Authors: Dalby Carole Kathleen , Nesbitt Marylou , Kennerley Kathleen , Lacoursiere Lisa , Frechette Carol , Flaherty Stephen , Catalano Paul J. , Fuller Frances , Thiele Jodi , Gilchrist Heather , Kostka Judith , Buswell Lori A.
Published: February 2017

136

Background: Variation of chemotherapy teaching at three affiliated regional oncology centers was associated with a low patient satisfaction PS; Press Ganey Survey for Adult Oncology score of 83.7% in understanding what to expect during chemotherapy treatment and 72.9% in how to manage chemotherapy side effects. Nursing staff collaborated to standardize content to improve PS and quality of care. Methods: Chemotherapy teaching tools varied across practice locations. From September-January 2012, three plan-do-study-act cycles were implemented. 1) A standardized teaching checklist, 2) electronic patient calendars, 3) 3 weeks later a patient education assessment survey (EAS). The teaching checklist detailed: 1) relevant chemotherapy information; 2) calendars listing (clinic appointments, symptoms requiring MD/NP notification, how to contact providers); and 3) ES assessed patient’s level of comprehension. Results: We used logistic regression for each PS score, estimating the time-trend of scores for each period and compared the time trend slopes pre versus post using a two-sided test for interaction. For each item, the Table displays the slope estimate (log odds-ratio per month) for each relevant intervention period, the associated 95% confidence intervals and the interaction test p-value. Negative slope indicates decreasing score trend with time while positive slope indicates increasing trend. The interaction test for each PS measure showed statistically significantly different slopes when comparing pre versus post periods for each PS item. Post intervention, scores for what to expect during chemotherapy rose 83.7% to 92.1%. Explanation of how to manage chemotherapy side effects rose 72.9% to 91.9%. Staff reported high satisfaction, highlighting its benefit to patients. Conclusions: Standardizing chemotherapy teaching improves PS as evidenced by statistically significant improvement in scores. Future endeavors will involve sharing chemotherapy teaching tools throughout the institution to improve PS scores for chemotherapy education. [Table: see text]
Screening for hepatitis B virus prior to chemotherapy: A quality improvement project.
Authors: Hicks Lisa K. , Leung Patricia , Cape Jennifer
Published: February 2017

158

Background: Hepatitis B virus (HBV) reactivation is a well-recognized and serious complication of chemotherapy which can be prevented with prophylactic antiviral therapy. St. Michael’s Hospital (SMH) is an academic hospital in Toronto, Canada, serving an inner city population. The prevalence of chronic HBV in populations such as ours is estimated to be > 8%, compared to 2% of all Canadians. In this context, surveillance for HBV prior to chemotherapy is very important. Aim: To increase the HBV screening rate among patients starting IV chemotherapy at SMH to greater than 90% by December 2013. Methods: Repeated plan-do-study-act (PDSA) cycles targeting HBV screening in our chemotherapy unit were initiated in January 2013 and are on-going. Appropriate HBV screening was defined as at least one HBsAg test up to 3 months prior to, or 3 weeks after starting chemotherapy. Interventions included education sessions, posters, standardized HBV lab order sets, and pharmacist review of lab data prior to first chemotherapy with reminders to physicians when HBV testing was absent. Pre and post-intervention HBV screening rates were compared using process control charting. Results: Between January 1, 2012, and June 15, 2013, 407 unique patients started IV chemotherapy at SMH. Prior to our interventions a stable HBV screening rate of approximately 30% was observed. Sequential process improvements were introduced in January and April 2013. Process control charting demonstrated the presence of special cause variation subsequent to our interventions with a significant improvement in the HBV testing rate (post-intervention rate of 70%). The HBV testing rate began to improve in January 2013 and met criteria for special cause variation by February 2013. Conclusions: It is possible to dramatically increase the rate of HBV testing prior to chemotherapy through relatively simple, low tech process improvements. Further improvements are necessary to reach our goal of a 90% HBV screening rate prior to IV chemotherapy. Additional planned interventions include individualized physician report cards on HBV screening rates using achievable benchmark criteria and an education campaign directed at empowering patients to ask about HBV testing.
Perceived versus measured functional vaginal capacity in cancer patients with sexual function concerns.
Authors: Kennedy Vanessa Amy , Lindau Stacy Tessler , Yamada Seiko Diane , Wroblewski Kristen , Abramsohn Emily , Makelarski Jennifer
Published: February 2017

170

Background: Actual and perceived loss of vaginal capacity can be a source of distress among female cancer survivors. The objective of this study was to assess perceived (PC) versus measured (MC) functional vaginal capacity in patients presenting with sexual function concerns. Methods: This was a cross-sectional registry-based study of women seen at the Program in Integrative Sexual Medicine for Women and Girls with Cancer (PRISM) Clinic. During the visit, patients were presented with graduated vaginal dilators and asked to select the largest dilator they perceived could be inserted without pain (PC) and the dilator representing their desired functional capacity (DC) (for patients with a male partner, this was the size closest to the partner’s erect penis). Two models of dilators were offered. Dilators were numbered 1-24 in order of increasing volume. If the patient could accommodate the dilator chosen as PC without pain, she was examined with dilators of gradually increasing size until the patient reported discomfort. The largest dilator tolerated without pain was MC. Differences between PC and MC, and between DC and MC were calculated. The association between penetrative sexual activity in the prior 4 weeks and accuracy of PC was assessed using the Mann-Whitney U test. Results: Mean patient age was 46 years (range 21-80, N=69). Most patients had breast (43%) or a gynecologic cancer (16%); 29% had benign disease. Nearly half reported two or more sexual concerns; painful intercourse (81%), vaginal complaints (21%), and loss of libido (19%) were most common. Median PC was 50cm3 (IQR 35-65cm3), median MC was 81cm3 (IQR 60-90cm3), and median DC was 90cm3 (IQR 81-132cm3). PC equaled MC in 22%. PC was less than MC in 75% and less than DC in 81% of patients. Of patients with PC less than DC, 41% had MC equal to or larger than DC. PC was closer to MC in patients reporting penetrative sexual activity in the prior 4 weeks (p=0.02). Conclusions: In this single-site study, many cancer survivors seeking care for sexual concerns underestimate their functional vaginal capacity. Further study is needed to determine whether correcting patient perception of capacity lessens distress and improves function.
Increasing on-treatment visit compliance for radiation therapy cancer patients.
Authors: Bar-Ad Voichita , Wilson Kathleen W. , Munro Susan , Harrison Amy , Eldredge Harriet , Siglin Joshua , Doyle Laura , Lowther Anne , Clancy Daniel , Hurwitz Mark
Published: February 2017

175

Background: Weekly on-treatment-visits (OTVs) represent standard care in radiation oncology and have significant impact on the quality of patient care. Ensuring that OTVs are completed might decrease the severity of acute treatment-related side effects by facilitating timely treatment of symptoms. This study evaluates factors contributing to missed OTVs and formulates a plan to mitigate this problem. Methods: A multidisciplinary team of radiation oncology staff members reviewed clinical work flow data to determine the number of patients missing their weekly OTVs. These numbers generated benchmarks for the QIP. The team used 30 patient questionnaires and 291 electronic medical records to identify the causative factors for missing the OTVs. After analyzing these results the team generated an action plan for multiple interventions and future audit protocols. Results: On average, 5% of patients miss their weekly OTVs during radiotherapy course. The identified reasons which affected patient compliance with OTVs include: patient inconvenience waiting for the MD, parking concerns, difficulty navigating the clinic to find the exam room, failure of therapist to send the patient for OTVs, changes in MD’s schedule, lack of patient awareness about expected treatment related side effects and importance of immediate treatment of their symptoms. We developed a multidisciplinary plan to minimize patients missing OTVs which includes electronic medical record alerts, communication cues, physical triggers and improved patient education. Additionally, electronic data collection has been implemented for OTV performance metrics and auditing. Conclusions: Patients missing their weekly OTVs during radiotherapy course might be at risk for more severe treatment-related side effects. The details of this multidisciplinary QIP implementation and its impact on quality of care will be presented at the meeting.
Kaiser Permanente HealthConnect Oncology Beacon module.
Authors: Ichiuji Mary Mitsuko , Schottinger Joanne E. , Campen David , Fredriks Dean
Published: February 2017

238

Background: Ordering and administration of chemotherapy was performed on paper in Kaiser Permanente until 2008. Chemotherapy is complex because treatments can be given over more than one day and over multiple cycles. Side effects may occur which require additional medications. Within the KP system, oncologists used more than 1,400 chemotherapy protocols. Each patient's regimen was physician dictated and standardization was rare. Reliable chemotherapy adminstration data did not exist for clinical quality, utilization and outcomes evaluation. The KP HealthConnect Oncology Beacon Module was created to standardize chemotherapy, enhance safety, and simplify ordering and administration of complex medications. This project required collaboration among oncologists, nurses, pharmacists and information technologists throughout the organization. This process assures that the right patient gets the right drug at the right dose at the right time. Methods: In 2005, a collaborative group of oncologists, nurses, pharmacists and IT from across KP began to develop chemotherapy protocols which included orders for medications, fluids, rates and routes of administration and nursing instructions. They worked with deployment teams to communicate change, assess workflows, develop and deliver training.The guiding principles for protocol development were: Evidence Based Effectiveness, Safety, Efficiency and Cost. Results: Decreased number of Chemotherapy Protocols through evidence review and consensus from 1,400 to 433 standardized templates. 84% or higher adherence to evidence-based templates. Reduced adverse events per 1,000 chemotherapy related medications by 9% at the San Jose Medical Center (pilot site). Increases capability to manage pharmacy and biotechnology resources and respond quickly to new knowledge about treatments or drug efficacy ( incorporated use of Gcsf to Docetaxol-Cyclophosphamide when excessive febrile neutropenia was found). Provides database for treatment outcomes research that is likely to generate important findings. Conclusions: The KP Health Connect Oncology Beacon Module exemplifies what KP is uniquely able to deliver: integration, standardization and use of technology to offer the highest quality care for our members.