bluuebunny/crossref_metadata_2025_split huggingface dataset:
Treatment of invasive lobular carcinoma with breast conserving therapy
Authors: Tulusan A. H. , Bühner M. , Popovich M. 
Published: March 2020

11046 Background: Invasive lobular carcinoma (ILC) is the second most common histological type of breast carcinoma .There is still a persisting concern regarding the use of breast-conserving therapy(BCT) in patients with ILC.Difficulty to identify the exact size , location of ILC and multifocality and/or multicentricity are the reasons to suggest that patients with ILC might be poor candidates for BCT. The aim of our current study was to evaluate the possibilty of risk adapted BCT for patients with ILC with or without breast irradiation. Methods: 277 patients with ILC pure or mixed type between 1994 and 2006 were accrued for pospective risk adapted therapy. Contraindications for BCT are multicentricity , inability to obtain negative margins or poor cosmesis. Palpation, mammograpy,ultrasound were routinely done and preoperative MRI in cases with no sharp tumor image. Breast conserving surgery was standardised by performing a radial segmental resection. Inking margins,histological semiserial step sections and specimen radiography was done. Sharp dileneated ILC with a free margins of >/= 1cm and no lymphvesel invasion(LVI) were treated by BCT without breast irradiation(Rx). Patients with ER + were treated with endocrine therapy.Mean follow-up time was 74 months. Results: Of the 277 ILC cases , 55(19,8%) were treated by mastectomy and five patients palliatively because of distant metastases. 217 ILC (79%) were treated with BCT (T1:108/48%;T2:45(21%);T3:67/31% ; NO:135/62%; ER+: 295/94%). 6 patients(2,8%) had local recurrence(LR). 161 ILC (T1 38%; T2 22%; T3 39%; N0 55%) were treated with BCT with Rx. Patients mean age was 57 years. 6(3,7%) of the patients had local recurrence (4 LR only, 2 LR and distant metastases). 56 ILC (T1 69%; T2 15% T3 22% ; NO 81%) were treated with BCT without Rx. Mean age 66 years. There were no LR , 2 patients had distant metastases. Conclusions: Using strict selecting criteria with a standardized breast conserving surgical procedure, thorough histological examination and using all breast imaging possibilities risk adapted BCT for ILC are not more likely to fail than BCT of other types of breast cancer. These results support the use of BCT for ILC patients. No significant financial relationships to disclose.
Biweekly nonpegylated liposomal doxorubicin (M) and docetaxel (T) as neoadjuvant treatment in patients with stage II-III breast cancer
Authors: Alvarez I. , Modolell A. , Mayordomo J. I. , Janariz J. , Centelles M. , García J. M. , Puerto P. , Diego C. , Madroñal C. , Burillo-R Andres M. A. 
Published: March 2020

11049 Background: We have previously reported (ASCO 2006) the efficacy and toxicity of 4 courses of M (75mg/m2) and T (75mg/m2) with G-CSF support in a 21 day schedule as neoadjuvant treatment in patients with resectable breast cancer. Aim: To evaluate the clinical and pathological response rate (RR) and toxicity of biweekly M and T given prior to surgery in patients with breast cancer. Methods: Patients with histological confirmation of breast cancer (stage II-III and inflammatory), age >18 years, left ventricular ejection fraction > 45% and adequate bone marrow, renal and hepatic function were included in the study. Prior systemic therapy, radiotherapy or surgery for breast cancer were not allowed. The treatment was: M (60 mg/m2) and T (60mg/m2) each in 1 hour infusion, with subcutaneous G-CSF (5 mcg/kg) support on days 4–9. Courses were repeated every 14 days. Patients received 6 courses prior to surgery. Results: To date 45 patients have been enrolled; 20 who have completed therapy and underwent surgery (except for patients with progression) were included in this interim analysis. Median age: 48 years (38–63), ECOG PS 0: 90%, ECOG PS1: 10%, postmenopausal: 35%. Histology was infiltrating ductal carcinoma in 80%. Patients received a total of 110 courses (median 6, range 2–6). Efficacy: Of 19 evaluable patients, 4 achieved a clinical complete response (cCR) (21%), 12 partial response (cPR) (63%), 1 stable disease (cSD) (5%) and 2 progressive disease (cPD) (10%), resulting in a clinical response rate (cRR) of 84%. Surgery was performed in 17 (85%) patients, 4 (23%) of them had pathological complete response (pCR), 12 (70%) partial response (pPR), 1 (6%) stable disease (pSD), resulting in a pathological RR of 93%. Median time to progression and overall survival have not been reached. Toxicity: Hematological grade III/IV toxicities per patient were neutropenia (10%), febrile neutropenia (10%) and thrombocytopenia (5%). Non-hematological grade III/IV toxicities per patient were mucositis (10%), nausea/vomiting (10%) and epigastralgia (10%) Conclusions: Six courses of T and M every 14 days with G- CSF support as induction treatment in stage II and III breast cancer are active and well tolerated. No significant financial relationships to disclose.
Screening for clonal hematopoiesis as a predictive marker for development of t-AML following adjuvant therapy for breast cancer (S0012)
Authors: Slovak M. L. , Bedell V. , Lew D. , Albain K. S. , Ellis G. K. , Livingston R. , Martino S. , Perez E. , Sher D. , Stock W. 
Published: March 2020

11051 Background: A serious complication associated with breast cancer treatment is the increased risk for development of therapy-related acute myeloid leukemia (t-AML). To evaluate and possibly identify patients (pts) at high risk for development of t-AML, the Southwest Oncology Group asked whether dose-intensive adjuvant regimens for high risk breast cancer pts induced genetic damage to hematopoietic stem cells (HSC), defined by the emergence of clonal hematopoiesis, an early marker of HSC damage. Methods: 274 pts consented to the clonal hematopoiesis study objective of S0012, a randomized clinical trial of standard doxorubicin and cyclophosphamide followed by weekly paclitaxel (arm 1, 129 pts) vs. weekly doxorubicin and daily oral cyclophosphamide plus G-CSF followed by weekly paclitaxel (arm 2, 145 pts) as neoadjuvant therapy for inflammatory and locally advanced breast cancer. Two different clonality assays were used: the HUMARA (HUMan Androgen Receptor) Assay to estimate the incidence of early genetic damage by clonal proliferation and microsatellite instability (MSI) testing at 5 loci (Bat 26, Bat 40, APC, Mfd, D2S123), common ‘hotspots‘ in t-AML, to screen for loss of heterozygosity or defective DNA mismatch repair mechanisms. Blood samples were evaluated prior to treatment and at 6 and 12 mos post-surgery for emergence of clonal hematopoiesis. Results: Of the 274 pts enrolled, follow-up clonal hematopoiesis samples were available for 195 pts; 96 pts on arm 1 and 99 pts on arm 2. Both HUMARA and MSI results were negative for clonal hematopoiesis in 96% of samples analyzed. In 14 cases, the HUMARA assay suggested that a clonal population was present, but MSI analysis was negative. No cases were HUMARA+/MSI+. With a median follow-up of 19.6 mos, only one pt has developed t-AML 3 yr 5 mos post randomization. Her clonal hematopoiesis test samples at 6 and 12 mos following treatment were negative. Conclusions: Clonal hematopoiesis assays performed within the first year following neoadjuvant therapy and surgery on S0012 failed to identify an emerging clonal HSC population. Longer clinical follow-up will be necessary to define the positive predictive value of detecting clonal hematopoiesis in the 14 HUMARA+/MSI- cases as a harbinger of t-AML. No significant financial relationships to disclose.
Costs and benefits of dose-dense chemotherapy scheduling in Hong Kong Chinese patients with primary breast cancer
Authors: Tsang J. , Yau T. , Chan A. T. , Liang R. H. , Yeo W. , Epstein R. J. 
Published: March 2020

11054 Background: Routine prophylactic administration of recombinant granulocyte colony-stimulating factor (G-CSF, filgrastim) has enabled more frequent scheduling of adjuvant cytotoxic drugs in primary breast cancer. Dose-dense chemotherapy of this kind has become popular in recent years, but few studies have compared the costs and benefits of this treatment approach. Methods: We conducted a retrospective comparison of 150 Hong Kong Chinese primary breast cancer patients treated with either conventional 3-weekly chemotherapy or G-CSF-supported 2-weekly (dose-dense) chemotherapy using similar cytotoxic regimens (four cycles of doxorubicin and cyclophosphamide, followed by four cycles of taxane) between April 2004 and May 2006 in two teaching hospitals. Assessments of treatment tolerance, toxicity, scheduling, and expense were applied to both patient cohorts. Results: Compared to conventionally treated patients (n = 117), dose-dense patients (n = 33) benefited from 52.3% fewer chemotherapy delays (21.2% vs. 44.4%; p = 0.02), 79.3% fewer hospital admissions for febrile neutropenia (3.0% vs. 14.5%; p = 0.07), and 54.8% enhancement of cytotoxic dose intensity (p < 0.001). Dose-dense patients also developed less nausea (p < 0.001) and stomatitis (p = 0.01) but more frequent bone pain (p < 0.001). After subtracting costs saved by fewer hospital admissions, dose-dense patients incurred higher total expenses approximating US$500 per cycle. Conclusion: Routine G-CSF administration to Hong Kong Chinese patients with primary breast cancer is associated with major improvements in cytotoxic drug delivery, which could plausibly translate into greater therapeutic efficacy in some patients. In addition, dose- dense treatment is shorter, safer, and more reliably scheduled, and is associated with unexpected improvements in nausea and stomatitis. The extent to which these gains justify the rise in net costs needs to be further defined in prospective randomized studies, both in different adjuvant patient subsets and in differently resourced socioeconomic contexts. No significant financial relationships to disclose.
Recurrence and morbidity in patients undergoing sentinel lymph node biopsy in Japanese breast cancer patients
Authors: Fujiwara I. , Nakajima H. , Mizuta N. , Sakaguchi K. , Hachimine Y. 
Published: March 2020

11062 Background: Aim of this study was to determine the axillary lymph nodes recurrence rate in breast cancer patients with tumor less than 5 cm (T2), who did not have axillary node dissection with negative sentinel lymph node (SLN). Methods: SLN biopsies were performed in 403 consecutive patients with breast cancer up to 5 cm and clinically negative axillary node from May, 2000, to December, 2005. SLN were identified using the combined method with sulfan blue dye and technetium 99m-labelled stannous phytate. SLN were examined with H&E staining. In patinets with negative SLN, additional axillary nodes dissection were avoided. Results: The SLN identification rate was 99.8% (402 out of 403). Three-hundred forty-one (341) patients (84.8%) who were found to have no metastatic disease, were observed and followed without further axillary dissection. At a mean follow-up of 35.7 months (range, 12–79 months), five of these patients (1.5%) developed an axillary recurrence. SLN biopsy was not associated with morbidity such as arm lymph edema. Conclusion: With intermediate-term follow-up, the axillary recurrence rate was low and there was none of morbidity. We conclude that SLN biopsy is a promising alternative to axillary lymph node dissection in patients with breast cancer up to 5 cm in Japanese women. No significant financial relationships to disclose.
Aromatase inhibitor-induced joint symptom in patients with breast cancer
Authors: Yamamoto Y. , Kawasoe T. , Ibusuki M. , Kai K. , Tomita S. , Iwase H. 
Published: March 2020

11070 Background: Aromatase inhibitor (AI) are superior to tamoxifen (TAM) for postmenopausal women with estrogen receptor (ER)-positive breast cancer. Toxic profiles are different between AI and TAM. The frequency of bone fracture and joint symptom are high in AI compared with TAM. However, there is little report concerning a detailed joint symptom. Methods: From January 2002 to March 2006, 120 postmenopausal women with ER-positive breast cancer were treated with anastrozole 1mg or exemestane 25mg daily at our hospital. We studied retrospectively the incidence, onset, type, sites, grade, and change of joint symptom. We also investigated the incidence of discontinuation due to joint symptoms and correlation between patient’s characteristics and joint symptoms. Results: Median follow-up time is 590 days and median age is 63 years old. Forty-seven (39.1%) of 120 patients complained of joint symptom. Median onset time of the symptom was 90 days of starting AI. All cases with the symptom complained of joint stiffness and 33 (70.2%) of 47 patients with the symptom have joint pain. In decreasing order, the most commonly affected sites were hand, knee, wrist, ankle, shoulder and elbow. The joint symptom was mostly grade 1/2, and most symptom ware resolved with exercise. Most common feature is morning digital stiffness like initial symptom of rheumatoid arthritis. Some patients experienced severe joint symptom. Subsequently, 15 (12.5%) patients had to discontinue AI because of the severe symptom. Discontinuation of AI led to improvement of symptoms, and patients received TAM in stead of AI also led to resolution of symptoms. AI-induced joint symptom was significantly correlated with young age, prior chemotherapy and switching from TAM to AI. Conclusions: Most AI-induced joint symptom is modest, and this symptom can lead to resolution with exercise. However, some patients lead to discontinue AI because of AI-induced severe joint symptom. We should inform patients treated with AI about AI- induced joint symptom and observe patient’s symptom in detail because severe joint symptom can prevent maintenance of quality of life and compliance. No significant financial relationships to disclose.
In vivo response-adapted dose-dense (dd) doxorubicin and cyclophosphamide (AC) –> weekly carboplatin and albumin-bound paclitaxel (nab-TC)/trastuzumab (H)/bevacizumab (B) in large and inflammatory breast cancer (BC): A phase II study
Authors: Bernstein J. A. , Mehta R. 
Published: March 2020

11078 Background: We showed high pathologic complete remission (pCR) rate with dd AC weekly (wkly) cremophor(c)-TCH in HER2+ BC in contrast to dd AC c-TC in HER2- BC (SABCS 2005). We substituted nab-T for c-T, and added B in HER2- BC to exploit the known synergy between the two in preclinical models. Methods: Pts received in vivo response-adapted 2–4 cycles of AC with G/GM-CSF followed by wkly 9–12 nab-T at 100 mg/m2 and C (AUC of 2), 3 wks on, 1 wk off. HER2+ patients (pts) received concurrent 12–16 wkly H (4mg/kg induction, 2mg/kg maintenance) and HER2- pts received 6–8 bi-wkly B (10 mg/kg). 37 of the proposed 43 pts with stage II-IV BC have been enrolled. Median age is 53 (range 32–76). Results: Median ejection fraction by echocardiogram was 67% (55–78) at baseline, 65% (55–80) after 2 cycles of dd AC and 66% (55–68) following nab-TCH. Additionally, no clinical cardiac dysfunction demonstrated. Adverse event with dd AC included neutropenic fever in 2 pts. 8 of 88 dd AC cycles administered were delayed by =1 wk. Of the 37 pts evaluated, 30 were switched to nab-TCH/TCB after 2 cycles of AC for less than 50% tumor reduction and 7 completed 4 cycles. Adverse event with nab- TCH/TCB included grade III arthralgia in 2 pts and TIA in 1 pt. pCR was documented in 5 of 8 HER2+ after nab-TCH, and 3 of 10 HER2- tumors after nab-TCB. Across the spectrum of stage II-IV, inflammatory and lobular carcinoma, tumors were reduced to ≤ 5 mm in first 7 of 8 (87.5%) HER2+ and 8 of 10 (80%) HER2- BC. Progression free survival at a median follow-up of 6 months (range 2–15 month) remains 100%. Conclusion: Induction chemotherapy with dd AC followed by wkly targeted chemotherapy is well tolerated. Additionally, limiting the exposure of AC to 2 cycles in resistant BC may reduce the known cumulative cardiac toxicity and yet allow the targeting of different clones in a heterogeneous BC population. [Table: see text]
Combination chemotherapy with gencitabine and cisplatin in anthracycline and taxane pretreated metastatic breast cancer
Authors: Peria F. M. , Zola F. E. , Tiezzi D. G. , Carrara H. H. , Philbert P. M. , Marana H. R. , Andrade J. M. 
Published: March 2020

1108 Background: Metastatic breast cancer (MBC) anthracycline (A) and taxane (T) resistant has a complicated management.Combination chemotherapy, even in 2nd line, may have advantages over single agent therapy. Gencitabine (G) - cisplatin (C) combinations have been used as synergistic salvage therapy in MBC and it’s another option for patients with important symptoms and aggressive visceral disseminated disease. Methods: This trial analyses the safety and efficacy of G-C in A-T pretreated MBC. Eligibility criteria include: confirmatory pathological analyses; measurable disease; adequate performance status, organ and hematological functions. It was not allowed patients with exclusive bone metastasis. They received IV G 750mg/m2 and C 30mg/m2, both d1 and d8 every three weeks for 6 cycles up to a maximum of 9 cycles. Response evaluation was performed every third cycle and in the end of treatment. Results: From February 2005 through December 2006, 31 patients have been evaluated for response and toxicity from G-C combination. For 20/31 patients this treatment was 2nd line palliative chemotherapy. 26/31 received at least 3 or more cycles (medium 4 cycles) and no one treatment was discontinued due to toxicity. The most frequent site of metastasis was lung (20/31), followed by hepatic in 13 patients, bone in 11, skin in 10, lymph nodes in 7, brain metastasis in 3 and pericardium in only one. Each patient had at least lung or hepatic metastasis and medium of 2 different metastatic sites. According to RECIST criteria, partial response were observed in 8/31, stable disease in 17/31 (55%) and progressive disease in 6 patients. 90% of cycles were given at full dose and at the right time. Hematological toxicity was modest with grade 2–3 (NCI-CTC) leucopenia in 58/140 cycles, grade 1–2 anemia in 40/140, grade 1–2 thrombocytopenia in 27/140 and was none febrile neutropenia. Non hematological toxicity: grade 2 fatigue in 4 patients and grade 2 nausea in 6/31. Following 22 months, global survival was at mean 4.8 months. Conclusions: Combination chemotherapy with gencitabine 750mg/m2 and cisplatin 30mg/m2 both d1 and d8 is feasible and effective in A-T pretreated MBC and demonstrated good tolerance with low intensity of collateral effects. No significant financial relationships to disclose.
Phase II study of primary chemotherapy with paclitaxel plus gemcitabine in patients with stage II and III breast cancer
Authors: Lee K. S. , Kwon Y. , Kang H. S. , Kim E. A. , Kim S. W. , Lee E. S. , Shin K. H. , Ro J. 
Published: March 2020

11080 Background: Adding taxane in the preoperative therapy increases both clinical and pathologic responses in pts with early breast cancer (BC). Clinical outcomes were superior by adding gemcitabine (G) to paclitaxel (P) compared with P alone in metastatic BC. This study evaluated clinical and pathological response rates and adverse events by primary chemotherapy with P and G in stage II and III BC. Methods: Patients (pts) with histologically confirmed stage II and III BC with positve axillary nodes by PET or positive FNA under sono guidance, age = 18 years, adequate organ functions and good PS were eligible. No prior hormonal or chemo-therapy, radiation, or surgery was allowed. Pts received P 80 mg/m2 and G 1,200 mg/m2, intravenously, d1/d8 every 3 weeks x 4. Postoperatively, doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, intravenously, d1 every 3 weeks x 4 were given followed by radiation therapy. Assessment for clinical response was majorly done by ultrasound. Results: All planned 44 pts were enrolled between September 2005 and April 2006. The median age was 43 years (range, 30–72 years), the median primary tumor size was 5.5 cm (range, 2.1 to 12.4 cm) with 27%, stage II and 73%, stage III BC. Thirty three tumors (75%) were multiple and 25 %, single. Thirty tumors (68 %) were ER or PR positive and 32 %, HER2 IHC 3+. The median relative dose intensities were 0.97 for both P and G . Clinical responses were 1-CR (2%), 34-PR (77%), 7-SD (16%) and 1-PD (2%). One pt did not return after 1st cycle (2%). 43 pts underwent surgery with 28 (64%) breast conserving surgery. Eight pts achieved pathologic CR in primary tumors (18%), 11 in axillary nodes (25%), and 5 in combined tumor and axillary nodes (11%). Grade III/IV toxicities were neutropenia (57%), leucopenia (14 %), febrile neutropenia (2%), and headache (2%). Conclusions: Preoperative P and G combination therapy given on d1/d8 every 3 weeks for 4 cycles is well tolerable and effective for stage II and III breast cancer. Supported in part by NCC Grant No. 06102240 and SHIN POONG PHARM CO., LTD. which provided paclitaxel and gemcitabine. No significant financial relationships to disclose.
Primary systemic chemotherapy for operable breast cancer with docetaxel followed by cyclophosphamide, epirubicin, and fluorauracil (DOC-CEF)
Authors: Kikawa Y. , Masai Y. , Hashimoto T. , Nakamoto Y. , Nishikawa H. , Takahara S. , Suwa H. , Tachibana T. 
Published: March 2020

11085 Background: Primary systemic chemotherapy (PSC) for breast cancer has been considered to be useful controlling the micrometastasis and shown to increase the breast conserving surgery rate, result in similar survival rate as usual post-operative adjuvant chemotherapy. Recently, doxorubicin based regimen followed by taxan regimen in neoadjuvant chemotherapy has shown a high response rate and sequential administration is supposed to be important. However, taxan regimens sequentially followed by doxorubicin are not so common. The purpose of this study is to evaluate the efficacy of primary systemic chemotherapy with docetaxel followed by cyclophosphamide, epirubicin and fluoraouracil (DOC-CEF) in breast cancer. Methods: Since 2003, 80 women histologically proven as the primary breast cancer, measurable lesion >= 2cm or inflammatory breast cancer, age 20–75, PS 0–1 were enrolled. The patients received 4 cycles of DOC (75mg/m2) every 3 weeks followed by CEF (500mg/m2, 75mg/m2, 500mg/m2) every 3 weeks as the primary systemic chemotherapy. After administrations, clinical responses and tumor vascularities were recorded by ultrasonography and pathological responses were examined after surgery for all patients. Results: 57 out of 80 patients (T2: 45, T3 6, T4 6) were analyzed at this time. Clinical response rate recorded by ultrasonography and pathological response rate were 82.4% (47/57) and 91.2% (52/57) respectively. Pathological CR rate was 26.3% (15/57). 8 pCR cases showed ER/PR-negative tumors of which 3 cases showed ER/PR-negative/Her2-negative (triple negative pattern). Breast conservative surgery was underwent in 51 patients (89.5%). Among the response group, the tumor vascularities were almost remarkably decreased in the early phase (mostly until 2–3 cycles) of the chemotherapy. Grade 4 neutropenia was observed in 16% (9/57) and 4% (2/57) had febrile neutropenia. Conclusion: This regimen is well tolerated and has good feasibility because most patients have experienced the early reduction of tumor by high response rate of docetaxel. No significant financial relationships to disclose.