bluuebunny/crossref_metadata_2025 huggingface dataset:
Prospective study comparing hospital costs and DRG reimbursement of inpatient treatment of febrile neutropenia during adjuvant anthracycline-based CTX for primary breast cancer
Authors: Jacobs V. R. , Mayer S. C. , Paessens B. , Anker G. , Schwarz-Boeger U. , Paepke S. , Harbeck N. , Bernard R. , Kiechle M. , Ihbe-Heffinger A.
Published: August 2020

e11570

Background: Febrile neutropenia (FN) is an undesired effect of myelosuppressive chemotherapy (CTX). To date limited data on costs of FN management is available. We compared costs and reimbursement of FN in a study of BC patients during adjuvant anthracycline (AC)-based CTX. Methods: Prospective, observational, longitudinal study in primary BC patients, enrolled 1–12/2006 consecutively before start of CTX in a German university clinic. FN was defined as fever >38ºC + ANC <1x109/L. Clinical and resource use data + DRG reimbursement were analyzed from medical charts. Costs for inpatient therapy of FN were compared to DRG reimbursement and results are presented from provider's perspective. Results: Of all patients approached (n=61), n=54 signed informed consent (88.5%), n=2 withdraw (3.3%) and n=2 were excluded from evaluation because of non-AC-based CTX. Patients were on avg. 57.4 (32–74) years and otherwise healthy ECOG 1 (n=50; 100%). Tumor classification was T1 n=25, T2 n=19, ≥T3 n=5 and pTx n=1. Chemo regimen was either AC-based n=29 (58.0%) or AC+taxane-based n=21 (42.0%). 12 episodes of FN occurred (24.0%) in 11 patients, one patient had 2 episodes; n=11 were treated as inpatients, n=1 as outpatient. Hospital stay for inpatients was on avg. 5.4 days (4–8), 0.7 days below average according to G-DRG catalog. Mean cost per FN episode requiring hospital treatment was 1.827 €, SD ±795 € (95%CI: 1293, 2361). Basic hospital costs were 83%, drug treatment 9% and diagnostics 8% of total direct costs. DRG reimbursement for inpatient FN was 2.145 € per episode, thus cost covering for the provider. Avg. reimbursement rate/day was 417 € (253–665 €). Inadequately DRG coding (n=4) resulted in a loss of 1.069 €/case (-42.2%). Conclusions: Costs for FN treatment vary among patients and DRG reimbursement does not necessarily reflect providers’ costs. Main cost drivers are hospitalization, length of stay, diagnostics and antibiotics. Surprisingly, inpatient treatment of FN under current therapy regimen is cost covering if adequately coded. This prospective evaluation and calculation of provider's costs and reimbursement helps understanding the allocation of resources for rational and cost-covering therapy.

[Table: see text]
Sentinel lymphadenectomy for the staging of clinical axillary node-negative breast cancer before neoadjuvant chemotherapy
Authors: Jean Pierre M. , Extra J. , Jacquemier J. , Buttarelli M. , Lambaudie E. , Bannier M. , Brenot Rossi I. , Houvenaeghel G.
Published: August 2020

e11575

Background: Several authors reported sentinel lymph node biopsy after neoadjuvant chemotherapy. Nevertheless, the ideal time of sentinel lymph node biopsy is still a matter of debate. Methods: We evaluated the feasibility and the accuracy of sentinel lymph node biopsy before neoadjuvant chemotherapy using a combined procedure (blue dye and radio-labelled detection) in a homogeneous cohort study with clinically axillary node-negative breast cancer. Study candidates were patients referred to the Institut Paoli-Calmettes Cancer Center (Marseille, France) for the treatment of invasive breast cancer. Patients were included in the study if they had tumor more than 3 cm in diameter without palpable axillary lymph node for which a neoadjuvant chemotherapy was indicated in order to enhance the likelihood of breast conservation. An axillary lymph node dissection was performed after completion of neoadjuvant chemotherapy. Results: From September 2005 to September 2007, thirty-one women with T2 or T3 invasive breast cancer without palpable axillary lymph node underwent sentinel lymph node biopsy before neoadjuvant chemotherapy and an axillary lymph node dissection after neoadjuvant chemotherapy. Among the 20 women who had metastatic sentinel lymph node biopsy (65%), 4 (20%) had additional metastatic node on axillary lymph node dissection. By contrast, all the 11 women who had no metastatic sentinel lymph node biopsy had no involved nodes in the axillary lymph node dissection. The sentinel lymph node biopsy identification rate before neoadjuvant chemotherapy was 100% with any false negative. Conclusions: Sentinel lymph node biopsy before neoadjuvant chemotherapy is a feasible and an accurate diagnostic tool to predict the pre-therapeutic axilla status. These findings suggest that axillary lymph node dissection may be avoided in patients with a negative sentinel lymph node biopsy performed before neoadjuvant chemotherapy.

No significant financial relationships to disclose.
Cardiac safety of docetaxel/cyclophosphamide/trastuzumab (DCH) as adjuvant therapy for HER-2 (+) early stage breast cancer
Authors: Mato A. , Cappa M. , Fox K. , Policarpo G. , Cohen J. , Wall H. , Rossi S. , Mintzer D.
Published: August 2020

e11577

Background: The addition of trastuzumab to adjuvant chemotherapy is standard for Her2(+) breast cancer. In our practice, adjuvant docetaxel/cyclophosphamide (DC) + 1 yr of trastuzumab is offered to pts with low-risk Her2(+) disease. Although the HERA trial allowed the use of a variety of chemotherapy regimens to combine with trastuzumab, it predates the acceptance of DC as an adjuvant care-standard and therefore the safety profile of DCH has not been reported. Methods: We conducted a two-center, retrospective cohort study including all pts treated with adjuvant DCH between 12/06 and 3/08 to assess its safety profile. Using the CTCAE criteria, records were screened for toxicity from DCH initiation to the present. The primary outcome was cardiac toxicity defined as clinical CHF or a confirmed significant LVEF decline (≥ 16% decrease in EF from baseline or EF < 50% + ≥ 10% decrease from baseline). Results: 27 pts, mean age 54, were identified with a median follow-up of 23.4 months (range 12.2- 42.0 months). The mean tumor size was 1.4 cm (0.5–4.3 cm) with 84% hormone receptor(+), 96% node(-) and 100% Her2(+) by FISH or IHC. 52% of pts received DCH concurrently and 48% received trastuzumab following DC. Baseline mean EF was 65% (53–86%). EF assessments were performed every 3 months/pt. 7.4% and 11.1% of pts had a prior history of anthracycline exposure or cardiac disease respectively. 11.1% of pts experienced a significant LVEF decline occurring on ≥ 2 sequential EF measurements. The trastuzumab discontinuation rate was 3.7% (1 pt). No pt developed clinical CHF. 88% of pts have now completed trastuzumab therapy. 33% of pts received pegfilgrastim with chemotherapy. 25% of pts experienced grade III-IV neutropenia. Grade III-IV anemia and thrombocytopenia were not observed. Trastuzumab-related infusion reactions were observed in 1 pt and did not warrant drug discontinuation. At this time all pts are alive and no patient has experienced disease recurrence. Conclusions: The DCH regimen, given in sequence or concomitantly, appears to be a safe and effective adjuvant treatment for women with Her2(+) disease. Along with docetaxel/carboplatin/trastuzumab, DCH represents another acceptable non-anthracycline containing regimen for low-risk, Her2(+) pts.

No significant financial relationships to disclose.
Long-term results of breast-conservation therapy for Japanese women classified according to intrinsic subtype
Authors: Shiraishi K. , Nakagawa K. , Yamashita H. , Terahara A. , Ohtomo K. , Yamaguchi T.
Published: August 2020

e11578

Background: Microarray analysis has identified breast cancer subtypes with distinct gene expression profiles according to the estrogen receptor (ER) and the human epidermal growth factor 2 (HER2) expression. The luminal subtypes (ER-positive) appear to be associated with the better prognosis, whereas the basal and HER2 subgroups tend to have worse recurrence rates. The impact of intrinsic subtype for Japanese women with early-stage invasive breast cancer on prognosis is unknown. The purpose of this study is to address whether breast cancer subtype is associated with recurrence among Japanese women who receive breast-conservation therapy (BCT). Methods: The study cohort included 770 consecutive women with invasive breast cancer who received BCT at University of Tokyo Hospital from 1994 through 2007. Among them, 285 women had complete information on the ER and HER2 status of their primary tumors. The number of patients according to luminal A (ER+HER2- ), luminal B (ER+ HER2+), basal (ER-HER2-) and HER2 (ER-HER2+) subtype was 162, 66, 40 and 17, respectively. All patients received external-beam radiation therapy to the whole breast. The most common doses were 50 Gy in 25 fractions to the whole breast plus a tumor-bed boost to 60 Gy. Results: Median follow-up time was 55 months (range, 6 to 144 months). No significant difference was observed between 5-year disease control and four major subtypes. The 5-year relapse free survival rate of HER2-positive and -negative patients was 77% vs. 95%, which was of statistically significance (p = 0.001). Multivariate analysis showed that T stage, N stage, HER2 status and lymphatic vessel invasion correlated significantly with shorter relapse free survival. Multivariate analysis showed that only N stage was associated with decreased overall survival (p = 0.017). Conclusions: Overall, the 5-year relapse free survival rate after BCT was high, and no significant difference was found in four major subtypes as approximated using ER and HER2 status in Japanese women who receive BCT. Only HER2 status was a statistically significant risk factor after BCT. Although further follow-up is needed, BCT may still be optimal option in Japanese women with early-stage invasive breast cancer to whichever intrinsic subtype their tumors belong.

No significant financial relationships to disclose.
Phase II study of neoadjuvant treatment with docetaxel, capecitabine, and trastuzumab in HER-2-positive locally advanced or inflammatory breast cancer: TXH trial
Authors: Perez Manga G. , Khosravi-Shahi P. , Izarzugaza Peron Y. , Soria Lovelle A. , Gonzalez del Val R. , Palomero Plaza M. , Riesco Martinez M. , Jerez Gilarranz Y. , Adeva Alfonso J. , Alonso A.
Published: August 2020

e11581

Background: Preoperative chemotherapy(CT) with trastuzumab(H)improves pathologic complete responses(pCR) in patients(ps)with Her-2+locally advanced breast cancer(LABC). Methods: This is an unicenter phaseII trial of a new neoadjuvant CT with H(without anthracyclines)in Her-2+LABC.Primary end-point was pCR.Secondary endpoints were:clinical response rate(CRR);breast conservative surgery rate(BCSR);pathologic tumoral size(pTS);disease-free survival(DFS);overall survival(OS)and toxicity profile.Ps with histologically confirmed Her-2+LABC, PS ≤2, LVEF >50%,and adequate bone marrow, renal and hepatic function were eligible.Treatment:docetaxel(T)36 mg/m2IV d1,8 and 22;capecitabine(X)750 mg/m2/12h PO d1- 14;and H 4mg/kgIV 1ºd,followed by weekly 2mg/kg in a 4-week course repeated for up to 4cycles,followed by surgery.Ps received a maximum of 6 cycles,according to investigator criteria.Radiotherapy(RT)and hormonetherapy(Ht) were allowed after surgery.Expression of markers was determined by immunohistochemistry(IHC)before CT. Results: The trial was closed due to poor accrual on March 2008.N=16ps:median age=47years(30–68); premenopausal=69%; ductal carcinoma=94%; left side=37,5%; clinical(c)stage:IIA=6.2%,IIB=43.8%;IIIA=31.2%;IIIB=18.8%;c node+=50%; median c tumoral size= 5cm(2- 10);grade:G2=53%and G3=47%;ER+ =75%;PgR+=62.5%;RP+/RE+ =62.5%;EGFR negative =87.5%;p53+=37.5;median KI67=22.5%(2- 79%);Her2+ by IHC+++ =87.5%and IHC++/FISH+ =12.5%;RT= 50%;median dose=50Gy;Ht=75%;and all ps received adjuvant H. 1º End Point: Three ps(18.8%) had pCR in breast and nodes;4ps(25%)had pCR in primary site,and among ps with c node+ 37.5%(3ps)had pCR in nodes. 2º End-Points: 1)CRR=81.2%(complete response=25%;partial=56.2%;no response=18.8%);2)BCSR=6.2%;3)Median pTS=2cm(0–5cm);4)Safety:TXH is very well tolerated:dose delays=14%;dose reductions=7%;no p had a decreased LVEF after neoadjuvant CT.Three ps had decreased LVEF during adjuvant H(median=43%).5)Only 2 events had occurred.Survival data will be reported in the meeting. Conclusions: Neoadjuvant TXH is a new active regimen in Her- 2+LABC with a manageable toxicity profile.

No significant financial relationships to disclose.
External quality assurance of breast cancer pathologic reporting in Kenya
Authors: Trinkaus M. E. , Sayed S. , Gakinya S. , Hanna W. , Moloo Z. , Rahim Y.
Published: August 2020

e11586

Background: Eighty percent of women diagnosed with breast cancer (BC) in East Africa present with advanced disease; current literature suggests a preponderance of triple negative/basal like breast cancer in this subset of African women. These studies are limited by their retrospective nature, small numbers, and unclear quality of pathologic specimen reporting. The objective of this study is to provide external quality assurance (EQA), quality control, and validation of hormone receptor and Her2 status of breast cancer specimens from Kenya. Methods: 108 retrospectively identified BC tumour blocks from the Aga Khan University Hospital (Nairobi, Kenya) during 2006–2008 will undergo repeat pathologic assessment for estrogen receptor (ER), progesterone receptor (PR), and Her2 status at Sunnybrook Health Sciences Center (Toronto, Canada).Currently at the Aga Khan University Pathology Lab, ER,PR and Her2 testing is performed manually once every two weeks using Heat Induced Antigen Retrieval and Dako reagents including the ENVISION detection system. Parallel controls of known tissue reactivity are also run; however there is currently no formal EQA. Results: Results will be used to identify areas of improvement in specimen handling and pathology reporting. Conclusions: Standardized and accurate pathologic assessment of BC specimens in East Africa is essential for establishing centres of excellence in Kenya and the wider East African region for hormone receptor and Her2 neu analysis. Results would contribute to understanding the prevalence of triple negative disease in East Africa, lead to improved treatment recommendations and patient outcomes, and serve as a foundation for prospective studies in East Africa.

No significant financial relationships to disclose.
Phase II study of AC (doxorubicin and cyclophosphamide) followed by weekly paclitaxel as neoadjuvant chemotherapy in operable patients with primary breast cancer
Authors: Iwase S. , Yamamoto D. , Kitamura K. , Odagiri H. , Teramoto S. , Ohtani S. , Doi T. , Kinebuchi K. , Kuroda Y. , Nagumo Y.
Published: August 2020

e11587

Background: The objective of this multi center Phase II clinical study prove the benefit of neoadjuvant combination therapy using anthracycline based AC therapy (doxorubicin and cyclophosphamide), which is useful as a standard therapy, followed by weekly PTX(paclitaxel) in patients with early stage breast cancer. Methods: Forty-seven patients with operable breast cancer were enrolled to the study. Patients received four cycles of AC followed by weekly PTX. The primary endpoint was disease free survival (DFS) stratified by the absence of presence of Quasi-pCR (QpCR: absence of invasive tumor or only focal residual tumor cells). Secondary endpoints were predictors for QpCR, clinical response, breast conservation rate, and safety. The planned sample size was 25. Results: Of 43 assessable patients, 25.6% achieved QpCR. With 28.6 months median follow-up, DFS was estimated at 72% for all patients. 3 year DFS for patients with QpCR was 80% vs. 72% without QpCR. HER2 status and response to AC were independent predictors of QpCR. The overall clinical response was 79%; 58% of patients achieved breast conservation. Nausea was the most common adverse event, observed in 62.8% and 33.3% of patients during AC and PTX respectively. The second common adverse event was peripheral neuritis, observed in 9.3% and 57.1% of patients during AC and PTX respectively. Conclusions: Despite the small sample size, these data shows that AC followed PTX is a highly active neoadjuvant therapy for women with early stage breast cancer.

No significant financial relationships to disclose.
Effect of primary polychemotherapy after sentinel lymph node biopsy on the necessity for lymphadenectomy in stage II breast cancer patients
Authors: Bohn U. , Pavcovich M. , Jimenez P. , Hernandez M. , Lloret M. , Cazorla M. , Reyes I. , Baratta T. , Bustos C.
Published: August 2020

e11589

Background: Sentinel lymph node (SLN) biopsy is the standard procedure for assessing axillary status in stage I-II breast cancer patients. Realizing this procedure before the administration of primary polichemotherapy would reduce the number of unnecesary lymphadenectomy in patients with negative sentinel lymph node. Methods: From January 2006 to May 2008, twenty-one patients with breast cancer on stage II-IIIA were included in the study. The median age was of 49 years (range 22–74y). The median palpable tumour size was of 3.5cm (range 1.8–6.0) and by ultrasonography 2.0cm (range 1.8–5.0cm.). Stage II:19 and Stage III:2 (cT:6.0cm.). Breast biopsy was performed in all cases with: IDC:20. G1:9 (42,8%), G:2:11(52%) and G3:1(4,76%). ER+:18 (85,7%), PR+:13 (61,9%), HER2 (+):6 (28,5) and triple negative:3 (14,2%).The scheme of treatment was: 4Epi: 90mg/M2 and Cyclophosphamide 600mg/M2 day 1/3w/4cycles, followed by paclitaxel (P) 100mg/M2 day 1/wekly/8. Trastuzumab was given during one year 4/2mg/Kg and started with (P). Tumorectomy and limphadenectomy was planned, followed by radiotherapy ± Hormonotherapy ± trastuzumab. Results: The 21 patients were evaluable for the analysis. The median sentinel lymph nodes resected was of 2 (range 2–6). The SLN biopsy was positive in 12 (57,1%) cases and negative in 9 (42,8%). Followed the primary chemotherapy, tumorectomy and axillary lymphadenectomy (AL) were performed in all 21 cases. The 12 positive SLN showed in the AL 9/12 (75%) pN0 and the 9 negative SLN showed in the AL 0/9 (0%) pN1. There were 4/20 (20%) completely pathological tumour response and 4/20 (20%) cases with only isolated malignant cells. The treatment was well tolerated with not a case of grade 3–4 toxicity. Conclusions: The primary chemotherapy given after the biopsy of sentinel lymph node was very effective showing in the lymphadenectomy a high percentage of pathologic negative lymph nodes (9/12) and an overall tumour response of 40% (8/20) with 4/20 (20%) completely pathological response and 4/20 (20%) cases with only isolated malignant cells.

No significant financial relationships to disclose.
Epirubicin and cyclophosphamide (EC) followed by weekly paclitaxel with/without trastuzumab as primary systemic therapy in locally advanced breast cancer: Phase II study
Authors: Hirano A. , Shimizu T. , Kamimura M. , Goto N. , Watanabe O. , Kinoshita J. , Domoto K. , Aiba M. , Ogawa K. , Miura D.
Published: August 2020

e11590

Background: Primary systemic therapy (PST) has become a standard therapy for locally advanced breast cancer (LABC). The aim of this study was to evaluate the activity and toxicity of EC (epirubicin/cyclophosphamide) followed by weekly paclitaxel with/without trastuzumab as PST in LABC. Methods: Primary endpoint was pathologic complete response (pCR) rate in the breast and axilla, and secondary endpoints were breast conserving rate and toxicities. Patients with histologically diagnosed invasive breast cancer by core needle biopsy of the T2–4 (>3 cm) or N1–3 were included in this study. Eligible patients were age >20 years, had a performance status of 0 to 1, and had adequate organ functions. It was determined that the expected rate of pCR in the trial was 25%, and the sample size was calculated using the Simon method, with a type I error of 5% and a study power of 80%. The target enrollment was estimated to be 40 evaluable patients. Treatment: Patients received epirubicin (100 mg/m2) and cyclophosphamide (600mg/m2 ) every 3 weeks for four cycles followed by paclitaxel (80 mg/m2 ) every week for 12 cycles. Trastuzumab (2mg/kg) was added to paclitaxel in HER2-positive patients. Results: Forty-three patients were enrolled into this study and 3 patients withdrew. pCR were observed in 8 patients and pCR rate was 20.0% (95% confidence interval, 7.6- 32.4). Twenty-four patients (60.0%) underwent breast conserving surgery. In particular, patients with HER2 positive tumor had significantly higher rate of pCR than the others (62.5% vs. 8.6%; p=0.0014). Grade 4 neutropenia was recorded in 27.5% of the patients, and febrile neutropenia occurred in 4 patients (10.0%). No heart failure was seen. Conclusions: EC followed by weekly paclitaxel with/without trastuzumab was an active and well-tolerated treatment for LABC.

No significant financial relationships to disclose.
Image-guided near-infrared fluorescent sentinel lymph node mapping in human breast cancer
Authors: Troyan S. , Gibbs-Strauss S. , Gioux S. , Oketokoun R. , Azar F. , Khamene A. , Kianzad V. , Rosenberg M. , Clough B. L. , Frangioni J. V.
Published: August 2020

e11591

Background: Breast cancer surgery is presently performed without real-time image-guidance. We have developed a novel optical imaging system for image-guided surgery that uses invisible near-infrared (NIR) fluorescent light to highlight structures on the surgical field with high sensitivity, specificity, and contrast. We have also performed the first human clinical trial of the imaging system in women undergoing SLN mapping for breast cancer. Methods: We used a portable imaging system with an articulating arm that has 6 degrees of freedom, high power LED light source, custom optics, custom software, and sterile drape. The imaging system provided simultaneous and real-time imaging of color video and NIR fluorescence at up to 15 frames per second. N = 6 women with biopsy- confirmed breast cancer undergoing SLN mapping gave informed consent. All subjects received conventional mapping with Tc-99m sulfur colloid using a handheld gamma probe as well as NIR fluorescence-guided SLN mapping using a mixture of indocyanine green (ICG) diluted to a final concentration of 10 μM in human serum albumin (ICG:HSA). Results: The imaging system was easy to position in the operating room, with the articulating arm providing 50” horizontal reach and 70” vertical reach. Working distance to the patient was 18”. NIR fluorescence excitation was 20 mW/cm2 at 760 nm. NIR-depleted white light was 40,000 lux. A total of 1.6 ml of ICG:HSA was injected intra-tumorally and peri-tumorally and the site massaged for 5 min. 8 of 9 SLNs identified by Tc- 99m sulfur colloid were also identified by NIR fluorescence. However, NIR fluorescence identified an SLN, confirmed to have cancer in it, that was not identified by Tc-99m sulfur colloid. These differences were consistent with asynchrony in the injection techniques. Unlike the gamma-ray probe, NIR fluorescence provided high-resolution, large area optical imaging of the surgical field, and helped guide surgical resection. Conclusions: In this 6-patient pilot study, a novel NIR fluorescence optical imaging system was used for the first time, and provided real-time image-guided surgery for SLN mapping of breast cancer.

No significant financial relationships to disclose.
First data from the the Patient's Anastrozole Compliance to Therapy Programme evaluating the influence of a standardized information service on compliance in postmenopausal women with early breast cancer
Authors: Jackisch C. , Harbeck N. , Blettner M. , Hadji P. , Lück H. , Schmidt D. C. , Haidinger R. , Gutendorf B. , Kreienberg R.
Published: August 2020

e11592

Background: Retrospective pharmacy data suggest that within the first year of therapy patients’ pick-up rate of aromatase inhibitor (AI) packs prescribed for early breast cancer (EBC) drops below 70%. Little is known about compliance to AI and patient motivation outside of clinical trials and the effect of compliance on patient outcome. Methods: The Patient´s Anastrozole Compliance to Therapy (PACT) programme, a two arm, randomized parallel group trial with 60 months follow-up, randomized postmenopausal women with HR+ EBC receiving anastrozole as adjuvant treatment and who consented to participate, to routine clinical care alone or additional standardized information consisting of 9 mailings of brochures and letters over the first 12 months following initiation of therapy. Primary endpoint is compliance rate in the standard versus intervention arm after 12 months, secondary endpoints include safety, reasons for non-compliance, influence of baseline characteristics, and of compliance on clinical outcome parameters. Compliance was evaluated by patient self reporting via standardized questionnaires, cross-checks of prescription data from hospital records and physician recall. QoL and patients’ satisfaction are assessed with standard questionnaires. Results: From Jul 2006 to Nov 2008, 4,924 patients were enrolled. Demographic data and baseline characteristics including median age, disease parameters, BMI, QoL at study start, co-morbidities and concomitant medication will be presented Conclusions: As of today, PACT is the largest prospective investigation on compliance to AI. It will provide valuable insights into the reasons for non-compliance to adjuvant AI therapy and demonstrate if a simple intervention such as standardized written information throughout the first treatment year may improve compliance and patient outcome.

[Table: see text]
One-day surgery in breast cancer: Monoinstitutional results (experience during 2. 5 years)
Authors: Giovanardi F. , Scaltriti L. , Gibertoni F. , Cagossi K. , Cavanna L. , Artioli F. , Giovanardi G.
Published: August 2020

e11596

Background: We want determine the effect of early discharge from hospital after surgery for breast cancer on physical and psychological illness. Moreover the study aimed to evaluate the management of post operative symptoms and post operative care. Methods: From January 2006 to July 2008, all breast cancer patients undergoing conservative breast cancer surgery or total mastectomy were offered surgery as an outpatient at One- Day Surgery Unit. Results: Three hundred seventy five patients underwent outpatient surgery for a total of four hundred four surgical procedures. The age of 375 patients varied from 14 years old to 94 years old, mean age was 55; in 79 of 404 (19.5%) surgical procedures patient remained in the hospital, for one night, after a surgical procedure regarding total axillary resection. Patients characteristics and post-operative complications were recorded for all 375 patients and 404 surgical procedures. All complications were treated by medical or nursing care. Complications included axillary seroma in nine patients (2.2 %), abscess in three patients (0.9%), pain in two patient (0.5%), hematoma formation in five patients (1.2%) for a total of 17 complications (4.2%). In our series, no hospital readmission was recorded during the first night and the first week and no death occurred. Conclusions: One day surgery for breast cancer patients is a totally safe and feasible procedure. We haven’t an increased rates of physical or psychological illness from early discharge after surgery for breast cancer. This policy can be recommended for patients with support at home.

No significant financial relationships to disclose.
Complications of local/regional treatment of breast cancer and quality of life
Authors: Ozcinar B. , Ozmen V. , Guler S. A. , Gulluoglu B. M. , Kocaman N. , Ozkan M. , Muslumanoglu M. E. , Igci A. , Kecer M. , Dagoglu T.
Published: August 2020

e11597

The aim of this prospective clinical study was to evaluate early and late complications of different surgical procedures, and compare conservative surgical treatments (breast conserving surgery, sentinel lymph node biopsy) to more radical ones (mastectomy, axillary lymph node dissection), and find factors that were related to these complications. 218 early stage breast cancer patients (stage I and II) were enrolled in this study. Physical complications (restrictions in shoulder motions, shoulder functional capacity, pain, lymphedema and sensory loss), psychological complications and the factors related to these complications were studied in patients after breast cancer surgery and/or radiotherapy at first week, at 9th-12th months and at mean follow up time of 34 months. Lymphedema rates after surgery were 14.7 %, 24.8% and 17.0% at first week, 9th-12th months, and long term respectively. In early postoperative period, pain and functional capacity of the effected shoulder were worse than preoperatively measured values and all axis of motion of shoulder joint were effected significantly. On the other hand, at 9th-12th months, only internal flexion was still affected. At the long term period, all axis of motion of shoulder joint, pain and functional capacity were in normal range as before treatment. The factors related to lymphedema were axillary lymph node dissection (p=0.002), radiation therapy to axillae (p<0.001). The patients who had both axillary lymph node dissection and axillary radiotherapy had more lymphedema than the patients who only had axillary lymph node dissection or sentinel lymph node biopsy (p=0.004). The factors related to postoperative depression at early period were cigarette smoking (p=0.008), axillary lymph node dissection (p=0.045) and arm lymphedema (p=0.005). At long term period they were axillary lymph node dissection (p=0.021), mastectomy (p=0.036), drain usage (p=0.028) and sensory loss (p=0.027). The patients who had sentinel lymph node biopsy, axillary dissection without axillary radiotherapy had better quality of life. The patients with cigarette smoking, axillary lymph node dissection, mastectomy, drain, lymphedema and sensory loss had increased incidence of depression than others, these results were statistically significant.

No significant financial relationships to disclose.
Clinical Features of 57 Patients with Lipoid Congenital Adrenal Hyperplasia: Criteria for Nonclassic Form Revisited
Authors: Ishii Tomohiro , Tajima Toshihiro , Kashimada Kenichi , Mukai Tokuo , Tanahashi Yusuke , Katsumata Noriyuki , Kanno Junko , Hamajima Takashi , Miyako Kenichi , Ida Shinobu , Hasegawa Tomonobu
Published: August 2020

Context

Lipoid congenital adrenal hyperplasia (LCAH) is caused by mutations in STAR. Classic (CLCAH) and nonclassic (NCLCAH) forms were reported as total and partial deficiencies, respectively, of adrenal and gonadal steroid hormones. The rarity of LCAH has precluded large-scale epidemiological and clinical investigations.

Objective

To determine the epidemiological and clinical characteristics of 2 forms of LCAH.

Design

A multicenter cross-sectional cohort study in Japan on December 1, 2017.

Participants

Fifty-seven patients with LCAH (median age, 23.7 years; range, 0.0–47.5 years).

Main Outcome Measures

Patient demographics, STAR genotype, Quigley grade, endocrinological and imaging data, treatment, and prognosis.

Results

Fifty-three and 4 patients fulfilled definite and probable diagnostic criteria for LCAH, respectively. When NCLCAH was defined as either Quigley grade 1 in XY karyotype, no episode of salt losing or requirement of fludrocortisone, or onset of primary adrenal insufficiency (PAI) at 1 year or older, patients were divided into groups of 43 patients with CLCAH (75.4%), 11 with NCLCAH (19.3%), and 3 with unclassified LCAH (5.3%). All of the patients with CLCAH and 7/11 NCLCAH (63.6%) were treated with fludrocortisone. CLCAH was diagnosed at a significantly younger age than NCLCAH (median, 0.0 vs 4.0 years). STAR-Arg272Cys or -Met225Thr was identified only in NCLCAH (8/11, 72.7%).

Conclusions

We demonstrated the relative proportions and clinical and molecular characteristics of NCLCAH and CLCAH in Japan. These criteria for NCLCAH correspond to all previously published cases and our cases whose masculinization of the external genitalia, ability of mineralocorticoid production, and onset of PAI were described.
Copeptin Kinetics and Its Relationship to Osmolality During Rehydration for Diabetic Ketoacidosis in Children
Authors: Burckhardt Marie-Anne , Gotta Verena , Beglinger Svetlana , Renggli Luzia , Bachmann Sara , Hess Melanie , Rentsch Katharina , Pfister Marc , Koch Gilbert , Davis Elizabeth A , Zumsteg Urs , Jones Timothy W , Szinnai Gabor
Published: August 2020

Context

Copeptin is a surrogate marker for arginine vasopressin (AVP) release in response to hyperosmolal stimuli such as diabetic ketoacidosis (DKA).

Objective

The objective of this work is to characterize kinetics of copeptin and osmolality, and their dynamic relationship during rehydration and insulin therapy in children with type 1 diabetes (T1D) and DKA.

Design and Setting

A prospective, observational, multicenter study was conducted.

Patients and Intervention

Children with T1D admitted for DKA underwent serial serum copeptin and osmolality measurements from start of rehydration at 14 time points during 72 hours.

Main Outcome Measures

Measurements included temporal course of copeptin and osmolality (kinetics), relationship between both (dynamics), and association between-subject variability (BSV) (coefficient of variation, CV%).

Results

Twenty-eight children (20 newly diagnosed T1D) aged 1 to 16 years were included. Copeptin decreased from 95 pmol/L (95% CI, 55-136 pmol/L) (CV%, 158%) to 9.7 pmol/L (95% CI, 8.1-11.4 pmol/L) (CV%, 31%) with a 50% recovery time (t1/2) of 7.1 hours (range, 5.1-11.5 hours) (114%). Serum osmolality decreased from 321 mOsm/kg (range, 315-327 mOsm/kg) (4%) to 294 mOsm/kg (range, 292-296 mOsm/kg) (1%) with a t1/2 of 4.3 hours (range, 3.0-5.6 hours) (64%). Copeptin levels doubled with each osmolality increase by 15 mOsm/kg (range, 10-21 mOsm/kg) (59%), from 9.8 pmol/L (range, 7.3-12.3 pmol/L) (48%) to 280 mOsm/kg. Copeptin kinetics differed between newly diagnosed and known T1D patients (P = .001), and less between mild vs moderate-severe DKA (P = .04).

Conclusions

First, this study characterized for the first time copeptin kinetics and dynamics in the high hyperosmolar range in children with DKA. Second, it revealed significant differences in copeptin kinetics between newly diagnosed and known T1D patients that may be explained by changes at the osmoreceptor and renal AVP receptor level due to longstanding osmotic diuresis and DKA.
Spontaneous Spread of Limb Complex Regional Pain Syndrome to the Ipsilateral Face With Ultimate Corneal Abrasion: A Case Report
Authors: Cook Arianna , Ghanavatian Shirin , Jowza Maryam
Published: August 2020

Complex regional pain syndrome (CRPS) has the potential to spread from the initial site to distant areas of the body. However, there is a paucity of data reporting the patterns and underlying cause of the spread. This case describes spontaneous, ipsilateral spread of CRPS from the right lower extremity to the orbit, leading to corneal abrasion.
“Still There”: (Dis)engaging with Dickens's Minor Characters
Authors: Starkowski Kristen H.
Published: August 2020

More can be done in minor character studies to account for the strong sense of being that emerges at the edges of the nineteenth-century novel. By pairing traditional readings of the minor character in narrative theory with sociologist Erving Goffman's writings on disengagement, this article offers a different perspective on the competition for narrative attention as we know it. For example, when disengagement is taken into account, Alex Woloch's losers in the competition for narrative attention become winners in the formulation of a fulfilling social life. Dickens's minor characters take part in central spaces while not being contained by them. Their distance from main scenes and settings, captured in passing by a gaze that has no interest in registering these elsewheres in any level of depth, has the effect of making minor characters appear strange, memorable, or other, even though their worlds are quite rich. But Dickens's minor characters define the ingenuity of counterintuition, pointing toward a suppressed energy that belies the flatness of a minor character. Drawn with care, these characters build alternative, codependent ways of surviving on the edges of the characterological field.
Anti-individualism in the Victorian Family Chronicle
Authors: Mcaleavey Maia
Published: August 2020

The bildungsroman privileges singularity: the unique and, often, the only child. This essay turns away from familiar literary narratives of a protagonist's personal development in order to examine the narrative possibilities of a genre that instead maintains focus on a group of siblings: the Victorian family chronicle. Family chronicles understand their large families as systems; they celebrate the replaceability of relationships rather than the irreplaceability of individuals. By insisting that a flourishing group can function in the absence of any particular person, they achieve fulfillment not in individualist plots but in group activities and brimful houses. The most influential Victorian family chronicler was Charlotte Mary Yonge. Yonge's episodic form was taken up by Anthony Trollope, Margaret Oliphant, Louisa May Alcott, and Margaret Sidney. These writers’ chronicles are non-protagonistic, nearly plotless, and potentially endless. They have been dismissed as minor works; nonetheless the anti-individualism of the large family chronicle offers an innovative approach to the nineteenth-century novel's tense negotiation between individual needs and group membership. Glimpses of chronicle narration can be seen operating within and against the competitive character systems that dominate canonical Victorian novels. A twentieth-century variant, Gilbreth and Carey's Cheaper by the Dozen, proves that the mutualistic form is also capable of hardening the boundaries around a family unit in order to compete in a capitalist marketplace. Nonetheless, the family chronicles developed by Yonge model a social economy in which both narrative and economic resources are not concentrated on a single striver but are distributed across a system.
Jewett in the Systems Epoch
Authors: Mehlman Gabriel
Published: August 2020

This article focuses on Sarah Orne Jewett's The Country of the Pointed Firs, the most famous example of the realist genre of local color. Published in 1898, the novel was written during the very moment of the generic collapse of local color. That collapse occurs within the literary system, in which any work of literature is enfolded—the functionally differentiated system that comprises writers, readers, genres, styles, the critical apparatus, and the publishing apparatus. As Firs stages the death of a small Maine community, it models its own death as a generic instance within the literary system. Firs both encodes and observes the gradual denaturing and collapse of its own classical-realist premises, which cannot abide the drawing into equivalence of character, interiority, and interpersonal communication with the inhuman formalism of systems. In the wake of the collapse of its classical-realist premises, the novel offers a final, speculative vision of a realism for the systems epoch.
Writing (for) Workers: Alternative Workers’ Magazines in Francoist Spain and in State Socialist Poland in the 1960s and 1970s
Authors: Delius Anna
Published: August 2020

This article explores how repression and everyday conflicts at the workplace were connected with labor rights and trade unionism in two authoritarian regimes. It focuses on worker and labor activists’ media in Francoist Spain and in state socialist Poland during the years 1965–68 and 1977–79, respectively. Spanish and Polish workers both lacked the right to join and form independent trade unions, the right to free assembly and association, and the right to strike. At the same time, they faced comparable problems in their everyday working lives, including low salaries, excessive overtime, incompetent management, and deficits in safety and hygiene standards. In this context, (illegal) magazines for workers emerged. They provided new arenas for exchanging experiences, advertised strike actions all across the country, called for united action, and explained national legislation and global labor norms. Based on an analysis of Spanish and Polish workers’ publications, this contribution investigates how labor activists in these states addressed day-to-day problems and the constant violations of internationally binding labor norms.
Supine versus prone position in percutaneous nephrolithotomy: a systematic review and meta-analysis
Authors: Birowo Ponco , Tendi William , Widyahening Indah S. , Rasyid Nur , Atmoko Widi
Published: August 2020

Background: The decision for using supine or prone position in percutaneous nephrolithotomy (PCNL) is still debatable. The aim of this study is to compare the efficacy and safety profile of the supine and prone position when performing PCNL.

Methods: A systematic electronic search was performed using the database from MEDLINE, Cochrane library and Google Scholar from January 2009 to November 2019. The outcomes assessed were stone free rate, major complication rate, length of hospital stay and mean operation time.

Results: A total of 11 articles were included in qualitative and quantitative analysis. The efficacy of PCNL in supine position as determined by stone free rate is significantly lower than in prone position (OR: 0.74; 95% CI: 0.66 – 0.83; p<0.00001), However, major complication rate is also lower in the supine group compared with the prone group (OR: 0.70; 95% CI: 0.51 – 0.96; p=0.03). There is no statistically significant difference in the length of hospital stay and mean operation time between both groups.

Conclusion: Prone position leads to a higher stone free rate, but also a higher rate of major complication. Thus, the decision of using which position during PCNL should be based on the surgeon’s experience and clinical aspects of the patients.
maxRatio improves the detection of samples with abnormal amplification profiles on QIAgen’s artus HIV-1 qPCR assay
Authors: Marongiu Luigi , Shain Eric B. , Martinelli Marianna , Pagliari Matteo , Allgayer Heike
Published: August 2020

Background: Accurate viral load (VL) determination is paramount to determine the efficacy of anti-HIV-1 therapy. The conventional method used, fit-point (FP), assumes an equal efficiency in the polymerase chain reaction (PCR) among samples that might not hold for low-input templates. An alternative approach, maxRatio, was introduced to compensate for inhibition in PCR.

Methods: Herein, we assessed whether maxRatio could improve VL quantification using 2,544 QIAgen artus HI virus-1 RT-PCR reactions. The assay’s standard dilutions were used to build external standard curves with either FP or maxRatio that re-calculated the VLs.

Results: FP and maxRatio were highly comparable (Pearson’s ρ=0.994, Cohen’s  κ=0.885), and the combination of the two methods identified samples (n=41) with aberrant amplification profiles.

Conclusions: The combination of maxRatio and FP could improve the predictive value of the assay.
Grandchild’s IQ is associated with grandparental environments prior to the birth of the parents
Authors: Golding Jean , van den Berg Gerard , Northstone Kate , Suderman Matthew , Ellis Genette , Iles-Caven Yasmin , Gregory Steve , Pembrey Marcus
Published: August 2020

Background:In spite of convincing animal experiments demonstrating the potential for environmental exposures in one generation to have demonstrable effects generations later, there have been few relevant human studies. Those that have been undertaken have demonstrated associations, for example, between exposures such as nutrition and cigarette smoking in the grandparental generation and outcomes in grandchildren. We hypothesised that such transgenerational associations might be associated with the IQ of the grandchild, and that it would be likely that there would be differences in results between the sexes of the grandparents, parents and children.

Methods:We used three-generational data from the Avon Longitudinal Study of Parents and Children (ALSPAC).  We incorporated environmental factors concerning grandparents (F0) and focussed on three exposures that we hypothesised may have independent transgenerational associations with the IQ of the grandchildren (F2): (i) UK Gross Domestic Product (GDP) at grandparental birth year; (ii) whether the grandfather smoked; and (iii) whether the grandmother smoked in the relevant pregnancy. Potential confounders were ages of grandparents when the relevant parent was born, ethnic background, education level and social class of each grandparent.

Results:After adjustment, all three target exposures had specific associations with measures of IQ in the grandchild. Paternal grandfather smoking was associated with reduced total IQ at 15 years; maternal grandfather smoking with reduced performance IQ at 8 years and reduced total IQ at 15.  Paternal grandmother smoking in pregnancy was associated with reduced performance IQ at 8, especially in grandsons. GDP at grandparents’ birth produced independent associations of reduced IQ with higher GDP; this was particularly true of paternal grandmothers.

Conclusions:These results are complex and need to be tested in other datasets. They highlight the need to consider possible transgenerational associations in studying developmental variation in populations.
Uczeni i ich losy… – Mirosław Skarżyński jako badacz dziejów polskiej lingwistyki
Authors: Czelakowska Anna
Published: August 2020

Scholars and Their Fates… – Mirosław Skarżyński as a Researcher of the History of Polish Linguistics

The paper presents Mirosław Skarżyński’s studies in the field of the history of Polish linguistics, and their consecutive phases: history of ideas (concepts, grammatical descriptions); history of people – researchers who once laid the foundations of scientific linguistics; and history of institutions. The emerging picture reveals that the research procedure adopted by Skarżyński was analogous to the method of historical sciences which demand that facts of the past should be described based on direct source information. In this perspective, the description of Polish linguistics must have been preceded by a considerable number of detailed studies, and publication of sources. Skarżyński put particular emphasis on the edition of memoirs and correspondence from the past. He saw in them not merely a complementary fond of information in research on the history of ideas and institutions, but primarily a road to understanding the personalities and fates of past scholars, as well as the conditions in which Polish scientific linguistics was born.
Krakowskie listy Jana Baudouina de Courtenay do Jana Karłowicza z 1894 r.
Authors: Rak Maciej
Published: August 2020

Cracow Letters of Jan Baudouin de Courtenay to Jan Karłowicz from 1894

The presented correspondence includes nine letters and nine postcards from 1894, sent by Jan Baudouin de Courtenay to Jan Karłowicz. Among other things, it shows the scientific and extra-scientific relations in Cracow in the last decade of the 19th century – although, owing to the person of the addressee, it also refers to Warsaw. The main scientific topics are 1) comments on the etymology of lexemes studied by J. Karłowicz for a dictionary of foreign words which were used in Polish and had a less clear origin; 2) matters related to changes in Polish orthography; and 3) comments on the edition of the so-called Warsaw dictionary.