bluuebunny/crossref_metadata_2025_split huggingface dataset:
Low-dose metronomic cyclophosphamide/methotrexate (LDCM) and aspirin for patients who fail to achieve pathologic complete response (pCR) after neoadjuvant treatment for stage II-III breast cancer.
Authors: Burdette-Radoux Susan , Holmes Chris E. , Khan Farrah B. , Dittus Kim , Wilson Karen M. , Wood Marie E. 
Published: March 2020

e12000 Background: Patients (pts) who fail to achieve pCR after neoadjuvant chemotherapy have a 20% risk of recurrence at two years. Data for effective postsurgical chemotherapy in this population is lacking. LDCM is an all-oral chemotherapy regimen with anti-angiogenic activity and acceptable toxicity in metastatic breast cancer. Aspirin is associated with a lower risk of breast cancer recurrence in retrospective studies and has anti-angiogenic activity. Here we combine LDCM and aspirin for high risk pts with poor response to neoadjuvant chemotherapy. Methods: Pts with stage II-III HER-2 negative breast cancer who had residual invasive cancer after neoadjuvant chemotherapy were eligible. Pts completed surgery and radiotherapy prior to enrolment and began study treatment within 180 days of surgery. Pts received four 28-day cycles of LDCM (cyclophosphamide 50 mg po daily, and methotrexate 2.5 mg po twice daily on days 1 and 2 each week ). Aspirin 325 mg daily was added on cycles 3 and 4. Pts were evaluated for the primary endpoint of toxicity and safety every 28 days. Secondary endpoint was 2 year relapse free survival. Results: 10 of 13 planned pts were evaluable for toxicity as of Jan 24, 2013. Pathologic stage ranged from T2N0 to T3N3. 70% of tumors were chemoresistant (stable or upstaged at time of surgery). 60% of pts had hormone receptor positive tumors and received concurrent hormonal therapy. Median age was 59 years (range 38-76). All pts completed 4 cycles of study treatment without dose reduction. There were no grade 3 or 4 related toxicities. Worst hematologic toxicity was grade 2 leukopenia. Worst nonhematologic toxicity was grade 2 fatigue; all other related toxicities were grade 1. 9 pts were evaluable for recurrence and none had recurred at a median followup of 13 months (range 7-23). Conclusions: This antiangiogenic regimen is well tolerated in patients at high risk for recurrence after neoadjuvant chemotherapy, resulting in no recurrences at 13 months followup, and suggesting it may be a candidate for future trials in this setting. Subsequent analyses will include longer term followup and biomarkers for angiogenesis. Clinical trial information: NCT01612247.
Feasibility study of cationic liposome-encapsulated paclitaxel in combination with paclitaxel followed by FEC as induction therapy in HER2-negative breast cancer.
Authors: Ignatiadis Michail , Lemort Marc , Wilke Celine , Vanderbeeken Marie-Catherine , D'hondt Veronique , Gombos Andrea , De Azambuja Evandro , Lebrun Fabienne , Dal Lago Lissandra , Maetens Marion , Ameye Lieveke , Veys Isabelle , Michiels Stefan , Paesmans Marianne , Larsimont Denis , Sotiriou Christos , Nogaret Jean-Marie , Piccart-Gebhart Martine J. , Awada Ahmad 
Published: March 2020

e12008 Background: Cationic liposome-encapsulated paclitaxel , a tumor endothelial targeting agent (composition of paclitaxel combined with neutral and cationic lipids) has shown activity in metastatic triple-negative breast cancer (BC) in combination with paclitaxel (Awada et al. ESMO2010). No data exist in the non-metastatic setting. Methods: HER2-negative BC candidates for neoadjuvant chemotherapy were scheduled to receive 12 cycles of weeklycationic liposome-encapsulated paclitaxel 22mg/m2 plus paclitaxel 70mg/m2 followed by 3 cycles of FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) every 3 weeks followed by surgery. Primary endpoint was percent (%) reduction in Magnetic Resonance Imaging (MRI) estimated tumor volume at the end of cationic liposome-encapsulated paclitaxel plus paclitaxel administration as compared to baseline. Safety, pathological complete response (pCR) defined as no residual tumor in breast and axillary nodes at surgery and correlation between % reduction in MRI estimated tumor volume and pCR were also evaluated. Results: Six patients with estrogen receptor (ER)-negative/HER2-negative and 9 with ER-positive/HER2-negative BC were included. Nine patients completed treatment as per protocol. Despite premedication and slow infusion rates, grade 3 hypersensitivity reactions to cationic liposome-encapsulated paclitaxel were observed during the 1st, 2nd, 3rd and 6th weekly infusion in 4 patients, respectively and required permanent discontinuation of the cationic liposome-encapsulated paclitaxel . Two patients stopped cationic liposome-encapsulated paclitaxel plus paclitaxel after 8 and 9 weeks due to clinical disease progression, two patients had grade 3 increase in transaminases and 1 patient grade 4 neutropenia. PCR was observed in 5 of the 6 ER-/HER2- and in none of the 8 ER+/HER2- BC patients. The median % reduction in MRI estimated tumor volume at the end of cationic liposome-encapsulated paclitaxel plus paclitaxel treatment was 90% (95% Confidence Interval: 69-99%), (p<0.001, sign test) for the 14 patients that underwent surgery; 99% (CI:87-100%) for patients with pCR and 84% (CI:50-95%) for patients with no pCR. Conclusions: The cationic liposome-encapsulated paclitaxel and paclitaxel combination showed promising preliminary activity as preoperative treatment, especially in ER-/HER2- patients. Further studies are warranted with need of premedication optimization. Clinical trial information: NCT01537536.
An examination of medical and economic outcomes of U.S. veteran breast cancer patients.
Authors: Wang Li , Fritschel Elyse , Li Lu , Huang Ahong , Baser Onur 
Published: March 2020

e12010 Background: While a breast cancer diagnosis is common in many medical settings, it is still uncommon in the U.S. Department of Veterans Affairs (VA) population, namely due to the minority of female veterans and infrequent diagnosis among men (Neumayer L, Schifftner TL, Henderson WG, et al. Breast cancer surgery in Veterans Affairs and selected university medical centers: results of the patient safety in surgery study. J Am Coll Surg. 2007; 204(6): 1235-41.). Currently, few studies describe the outcomes of breast cancer patients in the VA population. Methods: Using the Veterans Health Administration (VHA) datasets, a retrospective, observational study of patients diagnosed with breast cancer during the study period from October 1, 2005 to September 30, 2010 was conducted. Mortality, health care resource use, and costs were assessed for the 12-month follow-up period. Patients' clinical characteristics were assessed descriptively, and mortality rates were calculated using the Kaplan-Meier method. Results: In patients identified with breast cancer (n=11,719), the total follow-up mortality rate reached 17.04% (n=1,993). Mortality by age stratum totaled 26.07% for patients 65 years and over (n=1,192), 10.64% for those age 40 to 64 years (n=711), and 20.22% (n=90) for patients under 39 years. Nearly one-fifth of all breast cancer patients had follow-up inpatient visits (19.00%), which translated into an average inpatient cost of $22,220 annually per patient. While a similar percentage of patients had follow-up emergency room (ER) visits (18.79%), the average ER cost per patient totaled $140.53 annually. Conclusions: Mortality rate is the lowest for U.S. veteran breast cancer patients between ages 40 and 64 and more than doubles for those over age 65. The mortality rate of patients under age 39 years also exceeded the rate of the 40-64 age group, leading to more years of potential life lost. Additionally, inpatient utilization contributes to a high average annual cost incurred by U.S. veteran breast cancer patients. This information may further aid physicians and researchers as the number of female veterans increases.
Type of surgery for early breast cancer and predictive factors an institutional review: A regression model.
Authors: Muzaffar Mahvish , Mohamed Iman , Gaba Colette , Khuder Sadik 
Published: March 2020

e12016 Background: Breast conserving surgery (BCS) is the preferred surgical management for most early-stage breast cancer, given the equivalent survival after BCS plus radiation and mastectomy (M). Clinical reports of an increasing trend in mastectomy from some institutional reviews have been published. The aim of this study was to assess correlation of type of surgery with different factors in our cancer registry database. Methods: We retrospectively reviewed the cancer registry data at UTMC for early breast cancer stage I/II from 2006-2010. Patient demographics, tumor characteristics, institution of surgery, academic versus private surgeon were identified and compared. We used univariate analysis to select factors for entry into a multivariate analysis. Multinomial logistic regression analysis was performed to predict the type of surgery (cancer side mastectomy (CSM) versus BCS, bilateral mastectomy (BM) versus BCS based on the above variables. A p-value of < 0.05 was significant and comparisons were two tailed. Results: We identified 506 eligible patients with stage I/II breast cancer. 306(60.5%) had undergone breast conservative surgery (BCS), 91 (18%) patients had cancer side mastectomy (CSM) and 109 (21.5%) patients had bilateral mastectomy (BM). 298 (59%) patients were stage I and 208 (41%) had stage II, 218 (42%) had undergone surgery at academic center versus 298 (58%) at nonacademic institution. Predictors o CSM were stage II (p =0.0193), high-grade tumor (p=0.015), surgeon from academic institution (p=0.64), age (p=0.61). Predictors of BM were surgeon from academic institution (p=0.060), age (p=0.07). Conclusions: This study confirms some known factors like stage, surgeon expertise, as influencing factors in type of local surgery, while at the same time did not show impact of race and other tumor characteristics. Further research of these factors need to confirm the influence on decision making prospectively.
Efficacy and safety of first-line bevacizumab combined with paclitaxel in 220 patients with metastatic breast cancer: The Hungarian AVAREG observational study.
Authors: Dank Magdolna , Budi Laszlo , Landherr Laszlo , Piko Bela , Mangel Laszlo , Erfán Jozsef , Cseh Jozsef , Ruzsa Agnes , Nagy Andras 
Published: March 2020

e12022^ Background: First-line bevacizumab (Bev) combined with paclitaxel (Pac) significantly improves progression-free survival (PFS) and response rate vs. Pac alone in HER2-negative metastatic breast cancer (mBC), as shown in the E2100 study. The efficacy and safety of first-line Bev-Pac treatment was investigated in a non-interventional study in routine oncology practice in Hungary. Methods: Patients (pts) who had received no prior chemotherapy for mBC received Bev–Pac combination therapy according to the EU label. The primary endpoint was PFS. Efficacy and safety were documented until progression, death, or Bev discontinuation, whichever occurred first. Subgroup analyses of efficacy were conducted in pts with triple-negative mBC (TNBC). Results: Efficacy and safety data were available from 220 treated pts. Baseline characteristics were: median age 56 years (range 30–79; 13% ≥65 years; 4% ≥70 years); 18%/23% stage III/IV disease at first diagnosis; 36% disease-free interval ≤2 years; 46%/44%/30% bone/lung/liver metastases; 75%/21%/3% ECOG status 0/1/2; 45% ER positive; 48% TNBC. The Bev schedule was 10 mg/kg q2w (median 14 q2w Bev cycles) in 51% of pts and 15 mg/kg q3w (median 10 q3w Bev cycles) in 49%. The median duration of follow-up was 12.2 months (range: 0.9–36.5). Median PFS was 9.3 months (95% CI 7.8–10.8) in the total population (events in 63%), 8.3 months (95% CI 7.8–8.8) in the TNBC subgroup, and 13.3 months (95% CI 10.9–15.6) in the non-TNBC subgroup (log-rank p=0.001 between the TNBC and non-TNBC subgroups). Median time to treatment failure was 7.0 months (95% CI 6.1–8.0). The 1-year survival rate was 68%. Median OS was not reached. Adverse events (AEs) occurred in 36% of pts, and were classified as serious in 8% (20 events). The most common AEs (any grade) were hypertension, neuropathy, proteinuria, and anemia. There were three deaths, from pulmonary embolism, venous thromboembolism, and cardiomyopathy, on Bev therapy. No new safety signals were seen. Conclusions: These data in the real-life setting reconfirm that first-line Bev–Pac therapy is an effective and well-tolerated treatment option for mBC pts, with notable activity in pts with TNBC. Clinical trial information: NCT01777932.
Pneumocystis pneumonia incidence in metastatic solid tumor and lymphoma patients from an administrative health care claims database.
Authors: McCusker Margaret Elizabeth , Huang Jian , Walls Robert 
Published: March 2020

e12500 Background: Pneumoncystis jiroveci pneumonia (PJP) causes severe, often life-threatening illness in immunocompromised patients, including patients with cancer. PJP incidence estimates have been reported for several different cancer types based on case series from single institutions. In order to obtain incidence estimates from a larger pool of patients, we studied PJP claims among patients with metastatic solid tumors (MSTs) or lymphomas in a large administrative healthcare claims database. Methods: Adults diagnosed with MSTs or lymphomas between January 1999-September 2011 were identified in the MarketScan commercial, Medicare supplemental and Medicaid databases based on ICD-9 diagnosis codes. First PJP after cancer diagnosis was defined by PJP ICD-9 code (136.3) associated with an inpatient hospital stay of at least 1 day. Patients with a PJP claim before their cancer diagnosis were excluded. PJP incidence proportions and rates (with 95% CIs) were calculated by age group, sex, HIV status, and tumor type. Results: There were 158 PJP cases (0.04%) among 392,369 HIV-negative MST patients, an incidence rate of 3.0/10,000 pt-yrs (95% CI 2.6-3.5). Incidence rates by metastatic cancer type were 6.8/10,000 pt-yrs for lung, 5.4/10,000 pt-yrs for pancreas, 4.1/10,000 pt-yrs for prostate, 3.0/10,000 pt-yrs for breast, and 0.9/10,000 pt-yrs each for colorectal and ovary. There were 337 PJP cases (0.21%) among 162,799 HIV-negative lymphoma patients, an incidence rate of 9.4/10,000 pt-yrs (95% CI 8.5-10.5). Incidence was higher among males compared to females in both MST and lymphoma patients. PJP incidence rates in HIV-positive patients were approximately 14 times higher than in HIV-negative patients. Conclusions: PJP is a rare occurrence among patients with MSTs or lymphomas. In this analysis of a large administrative healthcare claims database, PJP incidence was higher among lymphoma patients compared to MST patients. Incidence estimates were lower than reports from institutional case series, but patterns of occurrence were consistent in terms of higher incidence in patients with lymphomas or HIV. Differences in incidence by tumor type were also observed among MST patients.
Retrospective analysis of breast cancer patients in an Asian-majority community clinic.
Authors: Hu Adriana , Keung Yi-Kong , Lau Ryan A , Keung Lap-Woon , Hu Eddie 
Published: March 2020

e12502 Background: Incidence of breast cancer in Asian countries is about one third to one half of that of the US. Asian immigrants have a higher risk of developing breast cancer in the US presumably by adopting more westernized lifestyles. We conduct a retrospective analysis of breast cancer patients (pts) in an Asian-majority community in Southern California. Methods: Unselected consecutive female breast cancer pts were studied. Clinical data were review and statistical analysis was conducted by SPSS 16.0. Results: 501 pts, 334 Asians (incl. Chinese 84%) and 167 non-Asians (incl. Caucasian 47% and Hispanic 45%) were studied. Conclusions: This study raised several intriguing findings: 1. Asian pts are significantly younger and have lower BMI than non-Asians. 2. Asian pts are more likely to undergo mastectomy than breast conserving surgery. 3. Asian pts tend to have denser breasts which may potentially limit the sensitivity of mammogram. Since the ratio of DCIS to invasive cancer is comparable between Asian and non-Asian pts in this study, mammogram is probably effective in detecting early cancer in Asians. 4. Significantly fewer Asian pts are diagnosed by screening mammogram. It is probably due to lower utilization of mammogram in the Asian population. 5. BRCA1/2 mutation is not significantly different between Asians and non-Asians. Due to inherent limitations of retrospective study, these findings need to be confirmed in a larger prospective study. [Table: see text]
Results of the MARS study on the management of antiangiogenics’ renovascular safety in breast cancer.
Authors: Gligorov Joseph , Janus Nicolas , Daniel Catherine , Beuzeboc Philippe , Ray-Coquard Isabelle , Rey Jean-Baptiste , Jouannaud Christelle , Spano Jean-Philippe , Thery Jean Christophe , Morere Jean F. , Goldwasser Francois , Mir Olivier , Scotte Florian , Oudard Stephane , Azizi Michel , Dorent Richard , Deray Gilbert , Launay-Vacher Vincent 
Published: March 2020

e12504 Background: Anti-VEGF drugs (AVD) are widely used in cancer patients (pts). Hypertension (HTN) and proteinuria (Pu) are class-side-effects of AVD, related to the inhibition of the VEGF pathway. The MARS study has been conducted to assess the renovascular tolerance of these drugs in the clinical setting. Methods: This multicentric, prospective, observational study evaluated the renovascular safety of AVD in pts naive from any AVD, conducted in 7 centres in France, from 2009 to 2012, with a follow-up (f/u) of 1 year. Data collected included: gender, age, serum creatinine (SCr), diabetes, HTN, hematuria (Hu) and dipstick Pu, at baseline and at each visit. Results: 1,124 pts were included; 402 breast cancer (BC) pts received bevacizumab. Median age at inclusion was 55 years. Visceral, bone and cerebral metastasis frequencies were 74.7, 5.1 and 2.5%, respectively. HTN prevalences: 12.4%. Baseline renal assessment retrieved: Pu 23.9%, Hu 16.2%, mean aMDRD 96.4 ml/min/1.73m2 and 14 pts with aMDRD<60. The incidence of de novo Pu and HTN during f/u was 61.7 and 16.8% (Table). 69.7 % of pts with Pu at inclusion improved or remained stable. Among pts with de novo Pu, 75.7% afterwards improved/normalized. No grade 4 Pu has been reported. Renal function remained stable with a mean aMDRD of 96.2 at the end of f/u. 7.4% had grade 2-3 SCr increase (no grade 3-4). No thrombotic micro-angiopathy (TMA) was reported. Conclusions: These results on the renovascular safety of bevacizumab in BC patients showed that 1) TMA is rare, 2) Grade 3 Pu developed in 4.6% of pts, with no grade 4, 3) less than 17% developed HTN, and 4) aMDRD was stable. Furthermore, in case of a renovascular effect, investigators followed the recommendations from the French Society of Nephrology (Halimi JM. Nephrol Ther 2008) and no treatment withdrawal for unmanageable renovascular toxicity occurred. [Table: see text]
Familial breast cancer in Spain: A retrospective study of family history and clinical/pathologic characteristics from the GEICAM “El Álamo III” project.
Authors: Marquez-Rodas Ivan , Pollán Marina , Lluch Ana , Ramon y Cajal Teresa , Guerrero-Zotano Angel , Servitja Sonia , Martin Miguel , Blanco Ignacio , Martinez del Prado Purificacion , Gonzalez-Santiago Santiago , Santaballa Ana , Llort Gemma , Andres Raquel , Ortega Granados Ana Laura , Jara-Sanchez Carlos , Juan Fita Maria Jose , Caballero Rosalia , Escudero Maria Jose , Carrasco Eva Maria , Lopez-Tarruella Sara ,   Spanish Breast Cancer Research Group (GEICAM)
Published: March 2020

e12513 Background: Family history (FH) of breast cancer (BC), ovarian cancer (OC), and individual features (IF), like early age of onset, bilateral BC, coexistence of BC and OC, and triple negative BC (TNBC) younger than 50 years, are suspicion criteria of hereditary BC. Although it is assumed in the literature that 15-30% of BC cases can be familial BC (FBC), only 5-10% of BC are hereditary, explained by a germline mutation in BRCA1 or 2. Moreover, there is no international consensus to define FBC (e.g. number of relatives affected, age of onset), in contrast with, e.g. Lynch syndrome and Amsterdam/Bethesda criteria, in order to offer genetic counseling. In Spain, there are not population-based studies analyzing the real percentage of BC with familial and/or individual high risk features. Methods: A retrospective study based on 10,641 Spanish BC patients diagnosed from 1998-2001, collected in the “El Álamo III project”, was conducted. Specific data regarding FBC were analyzed: IF (age of onset, bilateral breast cancer, ovarian cancer and TNBC; and FH features (first and second degree relatives with BC and /or OC). Results: The Table summarizes the results. Conclusions: 21% of BC patients in Spain diagnosed from 1998 to 2001 have at least one relative with BC and/or OC. In addition, 2.8 % of patients with no FH of BC/OC fulfill high risk criteria. However, several study characteristics, such as 18% patients with no FH recorded, and lack of data regarding age of affected relatives, limit the interpretation of these results, being necessary to improve the family data collection in further “El Álamo” project studies. [Table: see text]
SMRP in screening of mesothelioma in asbestos-exposed workers: A study of 1,704 subjects.
Authors: Mencoboni Manlio , Cioe Alex , Michelazzi Luigi , Bruzzone Andrea , DelCorso Lisette , Simonassi Claudio , Mortara Virginia , Filiberti Rosangela , Marroni Paola , Spigno Fabio 
Published: March 2020

e12518 Background: The soluble mesothelin-related peptide (SMRP) is a marker in the diagnosis for mesothelioma. The role of SMRP as a potential screening tool in subjects with a past asbestos exposure is being debated. Objective: to evaluate SMRP and incidence of malignant mesothelioma in an asbestos exposed cohort. Methods: 1,704 subjects (Median Age 62) occupationally exposed to asbestos were enrolled in the study. A questionnaire on individual characteristics, disease history, and occupational or non-occupational exposure to asbestos was administered. All subjectsunderwent clinical examination and collection of serum sample for SMRP measurement that were repeated after 1 and 2 years. The samples were stored at -80 °C until assayed. Results: Median baseline SMRP was 0.45 nmol/l (range 0.1-4.45). SMRP was higher than 1.5 nmol/l (defined as cut-off) in 40 participants. 9 subjects had recognized lung cancer at the time of screening (median baseline SMRP 0.65 nmo/l, range 0.1-1.7) and 109 had recognized tumors at other sites (median 0.52 nmol/l, range 0.1-3.0). Overall, median follow-up of all subjects was 31.5 months During follow-up, recurrent or metastatic tumors were observed in 23 out of 118 tumors. Sixty-one subjects developed a new tumor. An epithelioid pleural mesothelioma occurred in two subjects, 13 and 17 months after the last SMRP evaluation, respectively. Baseline SMRP was 0.52 nmol/l and 0.17 nmol/l, respectively. In subjects with tumor, SMRP increased of 20-50% in 13 subjects (15%), two of them with abnormal SMRP (1 bladder and 1 prostate cancer). An increase greater than 50% was found in 19 subjects (22%). SMRP was higher than the threshold value in 3 tumors (1 lung, 1 colon and 1 prostate, diagnosed 2 months from last SMRP measure). Overall, mesothelin was above the cut-off in 58 subjects without any evidence of neoplastic disease. Conclusions: we cannot confirm the predictive role of SMRP for mesothelioma because we found two cases with low mesothelin levels 13 and 17 months before the diagnosis. The low number of mesotheliomas could be due to the low median age of our population. It will be intriguing to follow up in the future the subjects that showed an increase of SMRP.