bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality of cancer family history and referral for genetic counseling and testing among oncology practices: A pilot test of quality measures as part of the ASCO Quality Oncology Practice Initiative (QOPI).
Authors: Wood Marie , Kadlubek Pamela , Lu Karen H. , Wollins Dana , Weitzel Jeffrey N. , Neuss Michael N. , Hughes Kevin S. 
Published: February 2017

CRA1505 Background: The cancer family history (CFH) is an important tool for identification of individuals for genetic counseling/testing (GC/GT). Prior studies demonstrate a low rate of family history documentation and low referral rates for genetic counseling and genetic testing. Methods: In 2011ASCO began pilot testing new measures in QOPI to evaluate the practice of family history taking and referral for genetic counseling/testing in patients with either breast cancer (BC) or colorectal cancer (CRC). The measures assessed the presence or absence of CFH in 1st/2nd degree relatives, age at cancer diagnosis, referral for GC/GT and outcomes of referral. Results: Between September and October 2011 272 practices pilot tested these measures and reported on 10,466 patients (BC 6569, CRC 3897). 77.4% of all charts reviewed documented presence or absence of CFH in 1st degree relatives (BC 81.2% (CI 80-82%), CRC 77.4% (CI 76-79%), p= <0.001) and 61.5% of charts documented presence or absence of CFH in 2nd degree relatives (BC 68.9% (CI 68-70%), CRC 57.3% (CI 56-59%) p=<0.001). Age at diagnosis was documented for all relatives with cancer in 30.7% of charts (BC 45.2% (CI 44-47%), CRC 35.4% (CI 34-37%) p=<0.001). Patients were referred for GC/GT in 22.1% of all charts reviewed (BC 29.1% (CI 28-30%), CRC 19.6% (CI, 18-21%) p=<0.001). Of patients with hereditary risk (defined by selected risk guidelines) 52.2% of BC and 26.4% CRC were referred for GC/GT. When genetic testing was performed by the practice consent was documented 77.7% of the time and discussion of results was documented 78.8% of the time. Conclusions: Appropriate referral for GC/GT requires a complete and accurate CFH. In this pilot testing of QOPI measures we identified a higher quality of CFH information than expected though with room for improvement. Significant differences were seen between BC and CRC charts with greater accuracy of CFH and higher referral rates among BC patients. To obtain improvement in the identification and management of patients at high risk, significant improvements are needed. Education is part of the answer.
Patient preference between pazopanib (Paz) and sunitinib (Sun): Results of a randomized double-blind, placebo-controlled, cross-over study in patients with metastatic renal cell carcinoma (mRCC)—PISCES study, NCT 01064310.
Authors: Escudier Bernard J. , Porta Camillo , Bono Petri , De Giorgi Ugo , Parikh Omi , Hawkins Robert E. , Sevin Emmanuel , Negrier Sylvie , Khan Sadya , McCann Lauren , Mehmud Faisal , Cella David 
Published: February 2017

CRA4502 Background: Increasingly pt reported outcomes are being added to traditional efficacy outcomes to understand the clinical relevance of toxicity differences between therapies. This study investigated if tolerability differences were significant enough to lead a patient to prefer continuing their treatment with Paz or Sun. Methods: Pts with mRCC were randomized 1:1 to receive as first line treatment blinded 800mg Paz for 10 weeks followed by a 2-week washout and then 50mg Sun for 10 weeks (4/2 weeks schedule) or vice versa. Pts were stratified based on ECOG performance status (0 vs 1) and number of metastatic sites (0/1 vs 2+). The primary endpoint, patient preference assessed at 22 weeks, was compared using Prescott’s test (α=0.10). At least 102 of 160 planned pts were required to complete the preference questionnaire to provide 80% power to detect a preference for one drug over another of 50% vs 30% with 20% expressing no preference. Other endpoints included physician preference, safety, QoL, pharmacokinetics and biomarkers. Results: Of 168 randomized pts, 126 completed the preference questionnaire. In the protocol-driven primary analysis (n=114), Paz was preferred by 70% of pts, Sun by 22% and 8% had no preference. After adjusting for a modest sequence effect, the difference in preference was 49% [90% CI 37.0 – 61.5% p <0.001] in favor of Paz. All pre-planned sensitivity analyses conducted were statistically significant in favor of Paz, including one which imputed Sun for all unavailable pt preference data. The most common reasons for Paz preference were better QoL and less fatigue. 60% of physicians preferred Paz vs 21% for Sun vs 19% no preference. Adverse events (AE) were in line with known profiles for both drugs. Pts on Paz had fewer dose reductions (13% vs 20%) and interruptions (6% vs 12%) vs Sun, mostly due to AE. There was less fatigue on Paz as assessed by FACIT-Fatigue; treatment difference of 2.49, p=0.002. Investigator assessed response (RECIST 1.1) was 22% with Paz vs 24% with Sun, p=0.87. Conclusions: This innovative trial design clearly demonstrates the better tolerability of Paz compared to Sun.
Patterns of decision making about cancer clinical trial participation among the online cancer treatment community: A collaboration between SWOG and NexCura.
Authors: Unger Joseph M , Hershman Dawn L. , Burg Kenda , Moinpour Carol , Albain Kathy S. , Petersen Judith A. , Crowley John 
Published: February 2017

CRA6009 Background: Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of SES on decision-making about CT participation. Methods: We assessed patterns of CT treatment decision-making according to important SES and demographic factors (age, sex, race, income, education) in a large sample of patients surveyed via a web-based treatment decision tool (NexCura, The Woodlands, TX). Eligible patients had a new diagnosis of breast, lung, colorectal, or prostate cancer, and were >18. Logistic regression (conditioning on type of cancer) was used. Reasons for non-participation in CTs were assessed using pre-specified items about treatment, family, cost, and logistics. All data were self-reported. Results: 5,499 patients were surveyed from 2007-2011. 40% discussed CTs with their physician; this differed by age (42% <65 v. 29% >65), income (42% >$50k/yr v. 36% <$50k/yr), and education (42% >college degree (CD) v. 37% <CD). 45% of discussions led to offers of CT participation, and 51% of offers led to CT participation. The overall CT participation rate was 9%, differing by age, income, and education (see table below). In a multivariate model including all SES and demographic factors (plus covariates comorbidity status and “distance to clinic”, a surrogate for convenience), income remained a predictor of CT participation (OR 0.73, 95% CI, 0.57-0.94, p=.01). Even in patients >65, who are nearly universally covered by Medicare, lower income predicted reduced CT participation (age by income interaction test, p>.05). Cost concerns were much more evident among lower income patients (p=.0001). Conclusions: Lower income patients were less likely to participate in CTs, even when considering age group.A better understanding of why income is a barrier may help identify ways to make CTs better available to all patients, and would increase the generalizability of CT study results across all levels of SES. [Table: see text]
Axitinib versus sorafenib as second‑line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study.
Authors: Qin Shukui , Bi Feng , Cheng Ying , Guo Jun , Ren Xiu Bao , Huang Yiran , Wang Jinwan , Ben Yong , Kim Sinil , Tang Jie , Ye Dingwei 
Published: February 2017

LBA4537 Notice of Retraction: "Axitinib versus sorafenib as second-line therapy in Asian patients with metastatic renal cell carcinoma (mRCC): Results from a registrational study." Abstract LBA4537, published in the 2012 Annual Meeting Proceedings Part II, a supplement to the Journal of Clinical Oncology, has been retracted by Shukui Qin, MD, on behalf of all authors of the abstract. The adjudication portion of the Independent Review Committee (IRC) tumor assessments were incomplete for some of the ongoing patients in the study reported in the abstract and the adjudication could not be completed in time for presentation at the 2012 ASCO Annual Meeting. Background: An earlier phase III trial in 723 patients with previously treated mRCC demonstrated significantly longer progression-free survival (PFS) for axitinib, a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors, compared with sorafenib. We conducted a multicenter, randomized, open-label trial to estimate PFS for axitinib and sorafenib in 204 Asian patients with previously treated mRCC. Methods: Patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1 and measurable, clear-cell, mRCC that had progressed after 1 prior first-line systemic regimen (sunitinib or cytokines) were randomly assigned (2:1) to 28-day cycles of axitinib 5 mg twice daily (BID) or sorafenib 400 mg BID. Axitinib dose reductions and stepwise dose titrations to 7 mg BID and then 10 mg BID, as tolerated, were allowed; sorafenib dose reductions to 400 mg daily or every other day were also allowed. Primary endpoint was PFS per independent review committee. Results: Patients were stratified by ECOG PS and prior first-line systemic therapy: 135 received axitinib and 69 received sorafenib.Baseline patient characteristics included median age 56 years, 70% male, 99% Asian, and 63% ECOG PS 0. Prior therapy included sunitinib (45%) or cytokines (53%). Median PFS was 6.4 months (95% confidence interval: 4.6, 8.3) with axitinib and 4.8 months (2.8, 6.5) with sorafenib. Objective response rates were 23.7% with axitinib and 10.1% with sorafenib. All-grade adverse events in ≥15% of patients (axitinib, sorafenib) included hypertension (50%, 36%), weight decreased (37%, 33%), diarrhea (34%, 30%), hand-foot syndrome (32%, 57%), decreased appetite (30%, 20%), hypothyroidism (28%, 23%), fatigue (27%, 23%), proteinuria (21%, 20%), dysphonia (19%, 9%), cough (16%, 16%), rash (15%, 28%), pyrexia (7%, 16%), alopecia (3%, 22%). Conclusions: Asian patients receiving axitinib as second-line therapy for mRCC had a similar PFS and objective response rate as in a previous global phase III trial, with an acceptable safety profile.
Randomized phase III study of erlotinib versus observation in patients with no evidence of disease progression after first-line platin-based chemotherapy for ovarian carcinoma: A GCIG and EORTC-GCG study.
Authors: Vergote Ignace B. , Joly Florence , Katsaros Dionyssios , Coens Corneel , Reinthaller Alexander , Hall Marcia , Steer Christopher B. , Colombo Nicoletta , Lesoin Anne , Casado Antonio , Petru Edgar , Green John , Buck Martin , Ray-Coquard Isabelle Laure , Ferrero Annamaria , Favier Laure , Reed Nicholas , Curve Herve , Jimeno Antonio , Pujade-Lauraine Eric 
Published: February 2017

LBA5000 Background: The epidermal growth factor receptor (EGFR) has been found to be overexpressed in 55-98% of advanced epithelial ovarian cancer. This trial evaluated the efficacy of maintenance erlotinib, an EGFR tyrosine kinase inhibitor, after first-line chemotherapy. Methods: Eligible patients (pts) had high-risk FIGO stage I or stage II-IV epithelial ovarian, peritoneal or fallopian tube cancer and were not selected for EGFR expression. All patients underwent first line therapy (6-9 cycles of 3-weekly platinum-based chemotherapy (CT)) and showed no signs of progression at the end of CT. Patients were randomised to maintenance erlotinib 150 mg daily for 2 years or observation. Primary endpoint was progression-free survival (PFS) by RECIST in combination with GCIG CA125 criteria. The final design provided 80% power to detect a PFS hazard ratio (HR) of 0.80 with 2-sided log-rank test at 5% after 632 events in 830 patients. Stratifications factors were stage, institution, age, response to and type of first-line CT. Immunohistochemistry (IHC) and FISH for EGFR, and EGFR mutation analyses were performed in 330 patients. The study was registered as NCT00263822 and EudraCT number 2004-004333-34. Results: Between Oct 2005 and Feb 2008, 835 pts were randomised by 125 institutions from 10 countries. The most important baseline characteristics, PFS and OS are summarized in the table. Median follow-up was 51 months. 25% of the patients stopped erlotinib due to side effects (of these 67% due to rash). The predictive value of IHC and FISH for EGFR, and EGFR mutations are being evaluated and will be presented at the meeting. Conclusions: In the overall study populationmaintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival. [Table: see text]
Evaluation of lapatinib as a component of neoadjuvant therapy for HER2+ operable breast cancer: NSABP protocol B-41.
Authors: Robidoux Andre , Tang Gong , Rastogi Priya , Geyer Charles E. , Azar Catherine A. , Atkins James Norman , Fehrenbacher Louis , Bear Harry Douglas , Baez-Diaz Luis , Kuebler J. Phillip , Margolese Richard G. , Farrar William Blair , Brufsky Adam , Shibata Henry R. , Bandos Hanna , Paik Soonmyung , Costantino Joseph P. , Swain Sandra M. , Mamounas Eleftherios P. , Wolmark Norman 
Published: February 2017

LBA506 Background: The purposes of this trial are to determine the effect of substituting lapatinib (L) for trastuzumab (T) in combination with weekly paclitaxel (WP) following AC as well as adding L to T with WP following AC on pathologic complete response (pCR) rates. Methods: Women with HER2-positive operable breast cancer received standard AC q3wks x 4 cycles followed by WP (80 mg/m2) on days 1, 8, and 15 q28 days x 4 cycles. Concurrently with WP, patients received either T (4 mg/kg load, then 2 mg/kg) weekly until surgery, L (1250 mg) daily until surgery, or weekly T plus L (750 mg) daily until surgery. Following surgery, patients received trastuzumab to complete 52 wks of HER2-targeted therapy. The primary endpoint is pCR breast. For each of the two primary comparisons, the Fisher’s exact test was used to test the equality of pCR rates. A Hochberg-type step-up procedure was applied to address multiple testings and to control the family-wise error rate at 0.05. Results: 51% were clinically node positive and 63% had HR+ tumors. pCR assessments were available from 519 of 529 patients. pCR percentage was 52.5% for AC→WP+T, 53.2% (p=0.9) for AC→WP+L, and 62% (p=0.075) for AC→WP+TL. pCR percentages in the HR+ subset were 46.7%, 48% (p=0.85), and 55.6% (p=0.18), respectively, and were 65.5%, 60.6% (p=0.57), and 73% (p=0.37) in the HR- cohort. The corresponding pCR breast and nodes percentages were 49.1%, 47.4% (p=0.74), and 60.4% (p=0.04). Grade 3/4 toxicities include diarrhea in 2%, 20%, 27% (p<0.001), and symptomatic Gr 3/4 left ventricular systolic dysfunction in 4%, 4%, and 2% (p=0.49). Conclusions: Substitution of lapatinib for trastuzumab in combination with the chemotherapy program employed in this study resulted in similar high percentages of pCR in both HR+ and HR- cohorts. Combined HER2-targeted therapy produced a numerically higher pCR percentage than single agent HER2-directed therapy, but the difference was not statistically significant. Central review of HER2 and ER is being conducted to determine if subsets benefiting from the combined HER2-targeted therapy can be identified. Funding: GlaxoSmithKline.
Response and long-term outcomes after neoadjuvant chemotherapy: Pooled dataset of patients stratified by molecular subtyping by MammaPrint and BluePrint.
Authors: Gluck Stefan , De Snoo Femke , Peeters Justine , Somlo George , Stork-Sloots Lisette , van 't Veer Laura J. 
Published: February 2017

10 Background: Classification of breast cancers into molecular subtypes may be important for the proper selection of therapy for patients with early breast cancer. Previous analyses had shown that breast cancer subtypes have distinct clinical outcome (Sorlie, PNAS, 2001; Esserman, BCRT, 2011). Herein, we analyze using MammaPrint together with an 80-gene molecular subtyping profile (BluePrint) the response to neo-adjuvant chemotherapy and long term outcomes. Methods: This study was carried out on data from 144 patients from the I-SPY I trial; 232 patients from biomarker discovery program at MD Anderson (133 and 99 respectively; Hess, 2006, JCO; Iwamoto, 2011, BCRT); and 68 patients from City of Hope (Somlo, ASCO, 2010). All patients were treated in the neo-adjuvant setting with standard chemotherapy. MammaPrint and BluePrint were determined on 44K Agilent arrays run at Agendia or available through the I-SPY 1 data portal, or from Affymetrix U133A arrays. MammaPrint and BluePrint resulted in 4 distinct molecular groups: Luminal A (MammaPrint Low-risk/Luminal-type), Luminal B (MammaPrint High-risk/Luminal-type), Basal-type and HER2-type. Results: The overall pCR of this patient cohort was 22% but differed substantially among the subgroups. pCR was observed in 5% of the Luminal-A samples and 10% of Luminal-B, in 39% of the HER2-type samples and in 33% of the Basal-type samples. Patients with Basal-type tumors had a 5-year DFS of 71%; HER2-type had a 5-year DFS of 67% (n=71); 69% in HER2-type subgroup not treated with HER2-targeted therapy (n=45); Luminal-B type had a 5-year DFS of 77% and Luminal-A type showed 5-year DFS of 95%. Conclusions: We observed marked differences in response and DFS to neo-adjuvant treatment in groups stratified by MammaPrint and BluePrint. These findings confirm differences in chemotherapy response among molecular subgroups and indicate that the BluePrint and MP profile used for this analysis helps to further establish a clinical correlation between molecular subtyping and treatment outcomes.
Triple-negative breast cancer (TNBC) and residual disease (non-pCR): Does size matter?
Authors: Kern Peter , Badiian Mahyar , Minckwitz Gunter , Kimmig Rainer , Liedtke Cornelia , Rezai Mahdi 
Published: February 2017

106 Background: TNBC is associated with distinctly worse survival rates than non-TNBC unless a pCR is achieved (Liedtke C et al. J Clin Oncol. 2008;26:1275-1281) or almost achieved (Symmans WF. J Clin Oncol. 2007;25:4414-4422). Recent pooled analyses pointed out that pCR defined as "no invasive and no in situ residuals in breast and lymph nodes" can best discriminate between patients with favorable and unfavorable outcomes (Minckwitz von G. J Clin Oncol. 16 April 2012). However, no differentiation has been made with regard to the prognosis within the category of "gross disease" (non-pCR, > 5 mm) after primary systemic therapy (PST). Methods: In this retrospective case series study, we analyzed 506 non-pCR patients out of a cohort of 16,196 patients with neoadjuvant or adjuvant chemotherapy from breast units of the West German Breast Center (WBC) at 24 months after surgery. Results: Overall survival (OS) differed significantly between the non-pCR groups ypT1 a (88%) and ypT1b,c (both 77%) likewise the disease-free survival (DFS) was 79% versus 63% (p< 0.05) at 24 months after surgery. Beyond ypT1-stage, we found that ypT1+2 and ypT3+4 set up two significantly distinct groups in OS and DFS, with OS rates of 79% for ypT1+2 and 60% respectively 68% for ypT3 and ypT4. DFS rates were alike differing with 68 % and 62 % for ypT 1 and ypT2 from both ypT3 and ypT4 (20% and 28%). Distant disease free survival (DDFS) was markedly superior in ypT1a (93%) and ypT1b (88%) versus ypT1c (77%). Stage-dependent DDFS was 82% for ypT1 respectively 81% for ypT2 and thus significantly different from stages ypT3 and ypT4 (43% and 52%) (p< 0.05). Conclusions: Risk stratification currently is made dichotomously: pCR and non-pCR. However it does not differentiate within the group of non-pCR. This case cohort trial investigates the prognosis of non-pCR according to the actual size of the residual disease. Overall survival at 24 months after surgery has to be differentiated between the groups ypT1a and ypTb,c and moreover between ypT1+2 and ypT3+4. This is to our knowledge the largest case cohort study analyzing the effect of gross residual disease on prognosis of patients with TNBC demonstrating: size does matter.
Treatment patterns by lines of therapy in metastatic breast cancer: Evidence from a large insured population in the United States.
Authors: Ray Saurabh , Bonthapally Vijayveer , McMorrow Donna , Bonafede Machaon , Landsman-Blumberg Pamela 
Published: February 2017

116 Background: Metastatic breast cancer (mBC) guidelines contain multiple lines of treatment (LOTs) and regimen options, however little data on treatment patterns is available from real world clinical practice. This study describes patterns of chemo and biologic therapy use by LOT observed within a large U.S. insured population. Methods: Adult women with newly diagnosed mBC and starting anti-neoplastic treatment were identified in the 2005-2009 MarketScan Database which contains medical, pharmacy claims of > 40 million enrollees insured with >100 health plans across the United States. The index date was the first prescription fill or administration of anti-neoplastic treatment following metastatic diagnosis. A 90-day gap in treatment or initiation of a new regimen defined the end of a LOT. Patient demographics and clinical characteristics were measured at index. Descriptive analyses included the distribution of patients, use of chemo and biologic therapies and their therapy duration, across the first 4 LOTs observed. Results: Of 7,767 patients identified (mean (SD) age=58.2 (11.9) years), ≥50% received a subsequent LOT across the 4 LOTs (2nd LOT n=4,077, 3rd LOT n=2,033, 4th LOT n=1,059). Bone (44%) was the major metastatic site at diagnosis. The days on therapy (mean, SD, median) varied across LOTs: (162.7, 176.9, 108.0) in 1st, (147.5, 146.7, 99.0) in 2nd, (139.9, 131.1, 99.0) in 3rd, and (130.9, 123.4, 94.0) in 4th LOT. The most common backbone chemotherapies were: paclitaxel (26%), capecitabine (22%), docetaxel (22%) in 1st; paclitaxel (28%), capecitabine (18%), gemcitabine (16%) in 2nd; paclitaxel (22%), gemcitabine (19%), capecitabine (16%) in 3rd, and gemcitabine (19%), paclitaxel (18%), capecitabine (16%) in 4th LOT. Trastuzumab was the most frequently used biologic across all 4 lines (20%, 19%, 19%, 19% in 1st to 4th LOT respectively) followed by bevacizumab (20%, 19%, 19%, 19% in 1st to 4th LOT respectively). Lapatinib was used in 3rd (6%) and 4thLOTs (8%) only. Conclusions: Frequency and duration of chemo and biologic therapy use varied by LOT. The most frequently used agents across the 4 LOTs were paclitaxel (chemo backbones) and trastuzumab (biologics). Number of patients halved with each subsequent LOT.