bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pathologic complete response (pCR) in HER2 positive breast cancer to sequential FEC 100-docetaxel (D) plus trastuzumab (T) neoadjuvant chemotherapy (NCT)
Authors: Chollet P. J. , Dubray P. , Durando X. , Abrial C. , Nayl B. , Mouret-Reynier M. , Pomel C. , Bellière A. , Lemery S. , Penault-Llorca F. 
Published: August 2020

e11560 Background: Trastuzumab plus chemotherapy has become the standard of care for Her-2-positive breast cancer. Recent trials have shown higher pCR rates in Her2-positive tumors with trastuzumab-driven combinations (Buzdar, JCO 2005; Coudert, Ann Oncol, 2006). The purpose of this study was to review efficacity of sequential FEC followed by D+T. Methods: 21 patients (pts) with Her2-positive breast cancer (defined as either immunohistochemical 3+ or fluorescence in situ hybridization-positive) from June 2006 to September 2008 with breast cancer received 3 cycles (c) of FEC 100 ( epirubicin 100 mg/m2 + 5-fluorouracil and cyclophosphamide 500mg/m2) followed by 3 c of D (100mg/m2) every 3 weeks +T 2mg/kg weekly or 6mg/kg every 3 weeks (9 weeks of T). pCR was defined according to Chevallier's (Am J Clin Oncol, 1993) as level 1 and 2 and to Sataloff's classification (J Am Coll Surg, 1995) as grade A. A clinical, mammography and ultrasound breast evaluation was performed at baseline, after 3 or 4 c and before surgery. Cardiac evaluation (ejection fraction) was performed at baseline, after 3 c of FEC, before surgery and every 3 months after. Results: Median age was 52.1 years [27–71]. Median diameter of the tumors was 45 mm [10–160]. All pts had a ductal carcinoma. 5 pts had inflammatory breast cancer. 1 pts were grade I SBR, 13 grade II SBR, 6 grade III SBR and 1 unspecified. 5 tumors were HR+, 15 HR- and 1 unspecified. After FEC 100 x3, a clinical partial response (PR) was obtained in 4 pts (19%). After completion of NCT,clinical objective response rate was 95.2%: 13 pts had a complete response and 7 pts a partial response. 13 pts (62%) underwent breast-conserving surgery. 10 pts (47.6%) achieved pCR using Chevallier's classification (1 HR+ and 9 HR-) and 12 pts (57.1%) using Sataloff's classification (2 HR+ and 10 HR-). At the time of the analysis for cardiac evaluation, 8 pts continued to receive adjuvant T. 1 pt was lost for follow-up. 5 pts (25%) had an asymptomatic drop of ejection fraction greater than 10%. Conclusions: This regimen with only 9 weeks preoperative trastuzumab resulted in a high rate of pCR in Her2-positive tumors, without clinical cardiac events until now. No significant financial relationships to disclose.
Bone density changes during adjuvant aromatase inhibitor treatment in breast cancer patients: Single center experience
Authors: Almatari M. , Moe M. , Ali P. , Willshaw P. 
Published: August 2020

e11565 Background: Adjuvant aromatase inhibitors (AI) therapy in breast cancer accelerates bone loss resulting in increased incidence of fracture. We evaluated the effect of AI on bone density changes among breast cancer patients. Method: A total of 85 patients who had adjuvant AI for more than 24 months and 3 Dual energy X-ray Absorptiometry (DXA) scans were included in this study. Annual bone density change was calculated and correlated with various risk and prognostic factors. Results: Adjuvant AI was given in up-front (50), sequential (15) and extended adjuvant (17) therapy settings, with a median duration of 31 months. Intervals between scans varied from 6 - 33 months (median = 13 months), 63 patients had baseline DXA scans undertaken within 6 months from start of AI. Bisphosphonate was prescribed to 35 patients during AI therapy according to local practice. Changes in bone density according to WHO classification is shown in the table. Annual bone density change in the spine at 2nd scan was (-9.2% to +11%, mean = -0.89±4.11), after 3rd scan, (-11.7% to +10.7%, mean = 0.021±3.84). In the group of patients who had adjuvant chemotherapy (59 patients), significant bone loss was seen in the patients who did not have bisphosphonate (n=39), (-0.011 in BMD, Mean=0.88±0.02) compared to those who had bisphosphonate (n=20), (0.036 in BMD, Mean=0.93±0.02). In the patients who did not have chemotherapy (n=26), no bone loss was seen whether bisphosphonate was used or not. No clinical bone fracture was reported among patients who had osteoporosis at baseline. Conclusions: The patients who had chemotherapy are more likely to lose bone density and close monitoring is required for bisphosphonate therapy. Bone loss is more significant in the lumbar spine compared to the hip. Following intervention with bisphosphonate, the rate of bone loss was reduced, and as a result only 2.3% of patients developed osteoporosis during AI treatment. AI can be safely given from the bone health point of view with the appropriate use of bisphosphonate. [Table: see text] No significant financial relationships to disclose.
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.