bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P6-06-46: Treatment decisions and five year outcomes of the oncotype Dx test: An independent assessment
Authors: Bhargava R , Brufsky AM , Lembersky BC , Jankovic R , Puhalla SL , Oesterreich S , Lee A , Dabbs DJ 
Published: August 2014

Abstract
INTRODUCTION: Oncotype DX (ODx) was validated to provide prognostic information in ER+ lymph node negative tumors. The work of Paik et al. (JCO 2006 23:3737) has provided evidence of predictive power of ODx for chemotherapy, but there is contrary literature in this regard (Ionnadis JP Oncologist 2007, 12: 301-11; NICE Guideline March 2013 http://guidance.nice.org.uk/DT4). The specific aims of our institutional study are to determine (1) how ODx influenced treatment decisions and (2) the outcomes of patients who had ODx.
METHODS: Tumor registry follow-up information was supplied for 580 patients who had ODx and follow-up (mean/median 60/63 months).
RESULTS: (Table 1) Distribution of RS was 40% intermediate (232/580), 15% high RS (87/580) and 45% (261/580) low RS. Hormonal therapy was recommended to 96% (558 of 580), but refused by 3% (16 of 580) and for 1% data was unavailable. In the high RS group, chemo was recommended to 90% (79 of 87), of which 6 (8%) refused. In the intermediate RS group, chemo was recommended to 49% of the patients of which 20 (18% of recommended) refused. In the low RS group, chemo was recommended to 12% of the patients of which 8 (26% of recommended) refused. Most chemotherapy treatment decisions made at our institution were based on oncotype DX. High RS group recurrence was 9% (7 of 87) of which 2 patients died. Of these 7 patients, 3 did not receive chemotherapy (2 were recommended but refused). The recurrence rate in the intermediate RS group was 6.5% (14 of 232) of which 3 patients died. Of these 14 patients, 8 did not receive chemotherapy based on clinician's judgment. The recurrence rate in the low RS group was 1% (3 of 261) and there were no deaths due to breast cancer. Of these 3 cases, one received chemotherapy.
Oncotype DX Type of Recurrence vs Recurrence ScoresType RecurrenceHigh RSIntermediate RSLow RSTotalLocoregional49114(Scores)(35,38,47,63)(19,20,20,23,24,26,26,27,29)(16) Distant2529(Scores)(31,61)(19,19,22,29,30)(2,11) Local or Distant1 1Total714324
Conclusion: (1) The oncotype DX recurrence score is prognostic when low risk and high risk categories are considered. (2)The large number (40%) of intermediate RS appears to be a prognostic limitation of the test. (3) Of patients that recurred, (50%) received chemotherapy and were somewhat equally distributed between the high RS and the intermediate RS categories. Further follow-up of this cohort should address concerns of clinical utility of the Oncotype Dx test, especially for the intermediate RS category.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-46.
Abstract P6-06-57: Progesterone receptor status and Ki-67 index may predict early relapse in luminal B/HER2 negative breast cancer patients
Authors: Zong Y , Zhu L , Wu J , Chen X , Huang O , Fei X , He J , Chen W , Li Y , Shen K 
Published: August 2014

Abstract
Purpose
Few studies has documented early relapse in luminalB/HER2-negative breast cancer. We examined prognostic factors for early relapse among these patients to improve treatment decision-making.
Patients and Methods
A total 398 patients with luminalB/HER2-negative breast cancer were included. Kaplan-Meier curves were applied to estimate disease-free survival (DFS) and Cox regression to identify prognostic factors.
Results
Absence of progesterone receptor (PR) expression was associated with higher tumor grade (p&lt; .001) and Ki-67 index (p = .010). PR-absent patients received more chemotherapy than the PR-present group (p = .009). After a median follow-up of 2 years, 17 patients (4.3%) had early relapses and 6 patients (1.5%) had died. The 2-year disease-free survival (DFS) was 97.2% in the PR-present and 88.6% in the PR-absent groups (Log-rank p = .004). Also, patients with a high Ki-67 index (defined as &gt;30%) had a reduced DFS when compared with low Ki-67 index group (≤30%) (97.6% vs 91.3%, respectively, Log-rank p = .025). In multivariate analysis, PR absence was significantly associated with a reduced DFS (HR = 4.031, 95% CI 1.293-12.574, p = .016).
Conclusion
PR absence was a prognostic factor for early relapse in luminal B/HER2-negative breast cancer, while a high Ki-67 index suggested a higher risk of early relapse.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-06-57.
Abstract P6-07-09: What should be done after PHARE and HERA? Using value of information analysis as a guide
Authors: Conter HJ 
Published: August 2014

Abstract
Background:
Adjuvant trastuzumab therapy totaling 12 months (AT-12) is the current standard of care in the treatment of early-stage, HER-2/neu amplified breast cancer. Two studies, PHARE and HERA, examined whether the duration of adjuvant trastuzumab should be decreased safely to 6 months (AT-6) or increased to 2 years (AT-24), respectively. Could the implementation of value of information (VOI) analysis inform future clinical trial priority setting in this sphere?
Methods:
A Markov health-state transition model was employed to compare 3 adjuvant therapy options: AT-12, AT-6, and AT-24. Patients transitioned through 3 health states, disease free, metastatic recurrence, and death, over 3-month time intervals. The simulation was run using a lifetime time horizon. Transition probabilities of the health states in the AT-12 cohort were estimated from the National Surgical Adjuvant Breast and Bowel Project B-31 and North Central Cancer Treatment Group N9831 trials. Based on the efficacy assumptions that provided the foundation for HERA, the AT-24 probabilities were imputed. AT-6 transition probabilities were assumed to equal AT-12 probabilities. Health outcomes were measured in quality adjusted life years (QALY) and costs in 2012 United States dollars. Health outcomes and costs were discounted to the present value by 5% annually, compounded quarterly.
Result:
In the reference case, AT-24 had an incremental cost-effectiveness ratio of $57,784/QALY. Probabilistic sensitivity analysis revealed that AT-24 was likely to be 0.3%, 11%, 58%, and 93% cost effective at a threshold willingness-to-pay (WTP) of $20,000, $40,000, $60,000, and $80,000/QALY, respectively. At a WTP threshold of 65,000, the expected VOI payoff from conducting the HERA trial was computed as $204,692 per patient treated per year. Conversely, AT-6 would be expected to cost $100,592 less than AT-12 over a patient's life, corresponding to an expected $249,564 per patient per year payoff for the PHARE trial.
Since neither PHARE nor HERA were able to achieve their primary objectives, a new trial testing the duration of trastuzumab could be considered. Employing the same model, AT for 9 months would be expected to save $50,596 per patient compared to AT-12. The VOI of such a trial is estimated to be $224,504 per patient treated per year.
Conclusion:
Despite the results of PHARE and HERA, VOI analysis suggests that a non-inferiority trial examining 9 months of AT compared to AT-12 should be considered. The actual value of such a trial may be even greater if new HER-2 targeted therapies may be added to AT in the future. However, determining the total net benefit to society of performing such research requires information on its associated budgetary outlays. Cooperative groups should make the their individual trial expenses public to facilitate improved collective decision-making on future trials.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-07-09.
Abstract P6-08-01: Analysis of patient-reported outcomes following nipple-sparing mastectomy and implant reconstruction
Authors: Pharmer LA , Koslow SB , Martins D , Theodore R , Christos PJ , Talmor M , Simmons RM , Tousimis E , Swistel AJ 
Published: August 2014

Abstract
Background: Nipple-sparing mastectomy (NSM) is gaining popularity among women undergoing prophylactic and therapeutic mastectomy. Using the BREAST-Q, a validated condition-specific patient-reported outcome instrument which measures postsurgical patient satisfaction and health-related quality of life (HR-QoL), we sought to determine whether satisfaction and HR-QoL differ between patients undergoing NSM and skin-sparing mastectomy (SSM) with immediate implant reconstruction.
Methods: From 2005 to 2012, a total of 572 patients underwent mastectomy; of these 261 patients (46%) had NSM. All mastectomy patients were mailed the BREAST-Q reconstruction questionnaire consisting of 3 scales (scored 0-100): Satisfaction with Breasts, Satisfaction with Outcome, and Psychosocial Well-Being. Excluded from this analysis were males, autologous tissue reconstruction, and conversion from NSM to SSM. Comparisons were made between NSM and SSM groups using univariable analysis and multivariable linear regression models (MVA).
Results: The BREAST-Q completion rate was 27% with a median time from surgery to survey of 36 months (range 4 to 86). Women undergoing NSM, compared to SSM, were younger (mean 46 v 50 years; p = 0.01), more likely to be married (80% v 52%; p = 0.001), have bilateral mastectomies (79% v 59%; p = 0.01), and had less time between surgery and BREAST-Q completion (median 25 v 49 months; p&lt;0.001). 19 NSM patients (25%) and 7 SSM patients (13%) underwent prophylactic mastectomy (p = 0.07). There were no differences regarding tumor characteristics or treatment. Patients undergoing NSM, compared to SSM, had a higher unadjusted mean score for Satisfaction with Breasts (71 v 60; p&lt;0.001), Satisfaction with Outcome (80 v 69; p = 0.003), and Psychosocial Well-Being (84 v 74; p = 0.006). On MVA analysis, NSM (compared to SSM) was associated with greater Satisfaction with Breasts (adjusted mean difference: +13, 95% Confidence Interval[CI]: 6-21, p = 0.001), Satisfaction with Outcome (adjusted mean difference: +17, 95% CI: 7-27, p = 0.001), and Psychosocial Well-Being (adjusted mean difference: +12, 95% CI: 3-22, p = 0.013), after controlling for age at mastectomy, marital status, laterality, cancer vs. non-cancer diagnosis, post-mastectomy radiation treatment, and time from mastectomy to BREAST-Q completion. Not being married (adjusted mean difference: +8, 95% CI: 2-15, p = 0.014) and having a bilateral mastectomy (adjusted mean difference: +8, 95% CI: 1-14, p = 0.029) were also significant predictors of increased Satisfaction with Breasts.
Conclusion: These findings suggest that, in the setting of implant reconstruction, NSM is associated with higher patient satisfaction with their breasts, overall outcome, and improved emotional/social well being.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-08-01.
Abstract P6-08-09: A national survey on oncology clinicians’ recommendations and knowledge of contraception for women with cancer
Authors: Giordano SB , York SL , Gosiengfiao Y , Smith K , Kiley J 
Published: August 2014

Abstract
PURPOSE
Women with cancer have specific reproductive health needs and often look to their oncology clinicians for recommendations and guidance. This study's purpose was to determine contraceptive knowledge and recommendations of oncology clinicians.
METHODS
An online survey was emailed to U.S.-based medical and pediatric oncologists and oncologic advanced practice clinicians caring for women age 13-45 years. The primary outcome was regular recommendation to start or continue contraception during cancer treatment. Knowledge of pertinent information on contraception was calculated based on percent correct answers to questions on contraceptive failure rates and safety.
RESULTS
18.5% of subjects responded to questionnaires (612 initiated surveys of 3334 requests). Pediatric clinicians constituted the majority of the 577 participants meeting inclusion criteria (pediatric oncologists: 48.7%; pediatric advanced practice clinicians: 38.1%). Most clinicians (81.8%) recommend contraception. The mean contraceptive knowledge score was 47.5% (SD: ±17.6%), with 27.2% answering ≥60% questions correctly.
Recommending contraception was associated with rating contraception as important (aOR 3.49, 95% CI: 1.46, 8.38); comfort with contraceptive counseling (aOR 1.77, 95% CI: 1.04, 3.00); regular referral to a gynecologist/women's health care provider (aOR 2.92, 95% CI: 1.44, 5.94); and frequency of patients discussing contraception (aOR 4.21, 95% CI: 1.55, 11.43). Advanced practice nurses/physician assistants were less likely to correctly answer ≥60% of contraceptive knowledge questions (aOR 0.44, 95% CI: 0.27, 0.71).
CONCLUSION
Oncology clinicians recommend young women with cancer use contraception but lack essential knowledge to provide adequate counseling.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-08-09.
Abstract P6-08-11: Count us, know us, join us global survey: Comparing the feelings and needs of advanced breast cancer patients in the United States with patients in Latin America, Europe, and Asia
Authors: Miller H , Percassi D 
Published: August 2014

Abstract
Background: Advanced breast cancer (stage III and stage IV/metastatic) (ABC) is the most serious form of breast cancer, with nearly 250,000 people across the globe living with the disease. Because ABC often metastasizes to the brain, bone, or liver, it has important health implications, requires life-long treatment, and is usually fatal. Support needs for this patient group are unique, yet rarely met. Hoping to identify new approaches to meeting the needs of this community, a global survey was commissioned by Novartis Oncology in partnership with the global advocacy community. Method: Harris Interactive conducted an online survey between October 2012 and March 2013. It was completed by 1,273 female metastatic breast cancer patients ages 21+ from 12 countries (United States [US], Canada, Mexico, Brazil, Argentina, United Kingdom, Germany, Russia, India, Lebanon, Taiwan, and Hong Kong). Total sample data are not weighted and are representative only of the individuals surveyed. A global post-weight was applied to ensure that all countries received an equal weight in the global and regional data. Results: Patients in the US (70%) are more likely than patients in most other countries surveyed to feel isolated from the non-metastatic community (40% globally). In addition, US patients (73%) are significantly more likely than their counterparts in most other countries to often feel that no one understands what they are going through (63% globally). Patients in the US (53%) are also more likely than those in most other countries to say that support from friends and family has diminished since their initial advanced diagnosis (41% globally), and employed US patients (34%) are more likely than those in many other countries to believe their colleagues look at them differently as a result of their metastatic breast cancer (17% globally). Women in the US were most likely to be actively seeking information (97%) compared with patients in other countries (77% globally). Although more US women patients are active information seekers, they are most likely to be unsatisfied with the information that is currently available compared to patients in the other countries (31%; 51% globally). Conclusions: Despite the significant amount of attention paid to breast cancer in the US and the resources available, many US women with metastatic breast cancer feel more alone and isolated than do their counterparts in most other countries surveyed. These US women are also significantly more likely than their counterparts in other countries to often feel as though no one understands what they are going through. More needs to be done to help women in the US feel supported emotionally throughout their entire ABC journey.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-08-11.
Abstract P6-09-08: Withania somnifera extract inhibits invasion and metastasis of MDA-MB-231 cells by inhibiting CCL2 and CD44 high/CD24low stem cells
Authors: Khazal KF , Simon L , Odemuyiwa S , Hill D , Grubbs C 
Published: August 2014

Abstract
Standard approaches to the treatment of cancer, including surgery, chemotherapy, and radiation, when used alone or in combination, have had limited efficacy in curing the disease. These treatments frequently produce debilitating side effects, such as nausea, vomiting, loss of hair, and suppression of immunity. Due to these side effects, interest in other cancer treatments, including herbal extracts, has increased. Traditional herbal extracts are considered to be safe and economically feasible as alternative medicines to treat cancer. An alcoholic extract of the roots of Withania somnifera (WS), a traditional herbal remedy, has immunostimulatory, radiosensitizing, and anticancer effects. Knowledge of the medicinal properties of this plant motivated us to investigate its efficacy as an antitumor agent against breast cancer
MDA-MB-231 human breast cancer cells were used as a model. Tests included an MTT assay for cell viability, an assay for testing of migration of cancer cells, PCR analysis for cytokines, evaluation of gene expression, an immunohistopathological assay for expression of cytokines in isolated tissues, and xenografts in nude mice to evaluate inhibition of tumor growth.
In cell cultures, WS showed antiproliferative and anti-invasive effects against MDA-MB-231 breast cancer cells; it also inhibited the metastasis of xenografted MDA-MB-231 cells to the lungs of treated mice. These findings were substantiated in vitro by use of a microarray technique. WS caused down-regulation of cytokines CCL2, CXCL1, CXCL2, CXCL3, IL-1b, and TGF-β3. CCL2 is the cytokine considered to be most responsible for the metastasis of breast cancer cells. The inhibition of CCL2 by WS was confirmed in sections of xenografted treated tumors and in cell culture by use of immunohistochemical and flow cytometry techniques, respectively. WS caused 50% inhibition of CD44-bearing breast cancer stem cells, the predominant stem cells of the MDA-MB-231 breast cancer cell line. This finding will be further pursued by sorting CD44high/CD24low stem cells by use of flow cytometry.
In summary, WS caused inhibition of proliferation and invasion of breast cancer cells in culture and growth of xenografted cancer cells in mice. These effects may be associated with inhibition of cytokines such as CCL2 and CD 44high/CD 24low s.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-09-08.
Abstract P6-10-01: Evaluation of post-progression survival (PPS) in advanced breast cancer (ABC) according to treatment line: Correlation with PFS and OS in an unselected population
Authors: Ciccarese M , Forcignanò R , Petrucelli L , Fabi A , Chiuri VE , Cairo G , Lupo L , Gambino A , Saracino V , Ronzino G , Licchetta A , Giannarelli D 
Published: August 2014

Abstract
Background: MBC remains an incurable disease with a median survival of 2-3 years despite the use of new drugs. The validation of PPS as surrogate endpoint and its correlation to PFS and OS is matter of debate.
Methods: From 2006-2012 we analyzed retrospectively consecutive 192 pts treated for MBC outside of clinical trials, 103 with at least 3 lines CT, in order to evaluate post-progression survival (PPS) according to treatment line and its relation to PFS and OS. Moreover we evaluated the gain of benefit after CT3 and predictive factors of response to multiple lines of therapy.
Results: Median age at M+ diagnosis was 59 years (30-89), median site of disease was 2 (1-6), 67% visceral, HER-2 + pts 32%, median number of anti-Her-2 treatment was 2 (0-6); median number of treatment was 3 (1-8). Median OS for all pts was 45.6 (95% CI: 36.5-54.7). Median OS for CT &gt; = 3 vs CT &lt; 3 was respectively 52.5 (95% CI: 43.3-61.7) and 32.3 (95% CI: 23.6-41.2) P = 0.007. Multivariate Cox analysis showed that OS is related with ER/Pgr status (positive versus negative p&lt;0.0001) number of lines (&gt;3 vs ≤3) p = 0.001 and number of metastatic sites (&gt;2 vs ≤2) p&lt;0.0001. We evaluated the relation between PFS and OS and between PPS and OS until the 6th line of therapy with a linear regression model.
Median PFS (95% c.i.)Median PPS (95% c.i.)Median OS from M+ diagnosisCorrelation OS-PPSCorrelation OS-PFS1st line11.0 (9.5-12.5)29.9 (18.2-41.6)Not reachedP&lt;0.0001 OS-PPS1P&lt;0.0001 OS-PFS12nd line7.0 (5.8-8.2)20.9 (11.7-30.0)29.1 (17.5-40.7)P&lt;0.0001 OS-PPS2P&lt;0.0001 OS-PFS23rd line5.6 (4.5-6.7)19.5 (14.9-24.1)41.9 (15.5-68.2)P&lt;0.0001 OS-PPS3P&lt;0.0001 OS-PFS34th line5.7 (4.0-7.4)15.3 (13.4-17.2)50.4 (27.4-73.4)P&lt;0.0001 OS-PPS4P&lt;0.0001 OS-PFS45th line3.9 (3.1-4.7)11.2 (7.8-14.5)65.9 (20.8-112.2)P = 0.004 OS-PPS5P&lt;0.0001 OS-PFS56th line3.3 (2.6-4.0)8.2 (2.2-14.2)56.8 (48.7-64.9)P = 0.36 OS- PPS6P = 0.002 OS-PFS6
Conclusion: These results supported the use of chemotherapy after CT3. PFS and PPS are related to OS until the 6th line of treatment. The utility of PPS as surrogate endpoint of OS is a valid hypothesis that could be evaluated in prospective trials of MBC.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-10-01.
Abstract P6-10-05: First-line chemotherapy versus first-line endocrine therapy in hormone receptor positive HER2 negative patients with metastatic breast cancer in China: Results of the study of breast cancer group of the Chinese Society of Clinical Oncology (CSCO)
Authors: Wang T , Yang TT , Yang LJ , Song HY , Ouyang CQ , Wang JX , Hu CX , Zhang JG , Xu HB , Feng FJ , Tong SZ , Jiang FZ 
Published: August 2014

Abstract
Background: The primary objective for metastatic breast cancer is to prolong the patients survival. So the appropriate choice of the first-line therapy strategy is very important. For the HR-positive metastatic breast cancer, we haven't strong data to head-to-head compare the chemotherapy with endocrine therapy as the first-line treatment.
Methods: Two hundreds patients with HR-positive metastatic breast cancer were enrolled at 47 cancer centers in China from 2009 to 2012. Investigators decided to give chemotherapy or endocrine therapy according to their clinical judgements. Chemotherapy and endocrine therapy regimens followed the NCCN guildline. All the patiens haven't take any treatment after relapse or metastasis. All the patients were estrogen- receptor positive and/or progesterone-receptor positive,HER2 negative. Chemotherapy or endocrine therapy was continued in the progressive disease(PD) or unacceptable toxicity. Primary endpoint was progression-free survival(PFS), second endpoints were time to failure(TTF), response rate.
Results: According to the investigator judgements, one hundred patient took chemotherapy(CT arm), another one hundreds patients took endocrine therapy(ET arm). Pt characteristics were balanced between the two arms: median age 49y/50y, median disease-free survival(DFS) 40m/30m, visceral/non-visceral metastatic 52%/40%. There was more patients with ≥2 metastatic sites in CT arm than ET arm (50% vs 32%). Following up to Dec 2012, reasons for early treatment discontinuation were : PD 25 pts, toxicity 38 pts in CT arm, PD 82 pts, toxicity 2 pts in ET ram. The median PFS was 52 weeks(95% CI 23.2-80.8 weeks) and 48 weeks(95% CI 38.9-57.0 weeks) for CT arm and ET arm(P = 0.589),respectively. The median TTF was 20 weeks and 48 weeks for CT arm and ET arm,respectively(P = 0.025). Response rate was 63% and 22% for CT arm and ET arm,respectively(P&lt;0.001). But clinical benefit rate(CR+PR+SD≥6months) was 67% and 69% for CT arm and ET arm,respectively(P = 0.333). Subgroup analysis showed TTF were 48 weeks in ET arm and 15 weeks in CT arm(p = 0.038) for patients who had more than 2 years DFS. TTF results also indicated significant difference in single metastatic site pts and non-visceral metastatic pts between two arms. ET arm was superior to CT arm.
Conclusions: Our results indicate first-line chemotherapy has higher response rate than first-line endocrine therapy for HR-positive meatstatic breast cancer, but chemotherapy has shorter maintaining therapy time. First-line endocrine therapy was more suitable than first-line chemotherapy for pts with DFS≥2y, single metastatic site and non-visceral metastatic.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P6-10-05.