bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pathological response to neoadjuvant chemotherapy for inflammatory breast cancer (IBC). Critical evaluation of Chevallier’s and Sataloff’s classifications
Authors: Baranzelli M. , Cabaret V. , Vanlemmens L. , Desauw C. , Giard S. , Chauvet M. , Belkacemi Y. , Mailliez A. , Deschildre L. , Bonneterre J. 
Published: March 2020

10666 Background: The aim of this study was to compare the two most frequently used pathological classifications to assess the response to chemotherapy (CT) in IBC. Methods: The pathological characteristics of 85 inflammatory breast cancers were reviewed. 52 patients (pts) had a post-CT mastectomy , 49 a tumor biopsy before CT and 16 both. Tumor types, grade, hormonal and Her status were evaluated before and after CT, when available. Results: Among 49 pts with initial biopsy, 1 had a high grade intraductular carcinoma and 48 an invasive carcinoma (42 ductular, 5 lobular, 1 mucinous). 27 (56%) invasive tumors were grade 3 and 21 (44%) grade 2, none was grade 1. Median value of mitotic index (Ki 67) was 23%. Hormone receptors (HR) were evaluable for 46 pts; 28 (61%) were negative. 13 (29%) out of 45 evaluable pts were Her2 3+. The pathological response was evaluated according to the Chevallier et Sataloff classifications in the 52 pts with post CT- mastectomy. According to Chevallier there were no grade 1(no microscopic invasive or in situ carcinoma) or 2 (microscopic in situ carcinoma without invasive carcinoma or axillary lymph node metastases), 44 (85%) were grade 3 (invasive carcinoma with fibrosis or sclerosis) and 8 grade 4 (no modification of initial tumor). There was no pathological complete response. According to Sataloff there were 4 grade TA (complete or nearly complete response), 15 (29%) TB (therapeutic response over 50%), 23 (44%) TC (therapeutic response above 50%), 10 TD (no evident therapeutic effect). There were 4 pathological complete responses out of 52 ( 8%). 16 pts had initial biopsy and post chemotherapy mastectomy. According to the OMS clinical classification there were 5 CR, 37 PR, 10 ST. Among the 4 pathological CR according to Sataloff (TA), 2 were CR and 2 PR. Conclusions: In our experience, there was a very poor correlation between the two pathological classifications and between pathological and clinical classifications. A clinical residual tumor can be due to fibrosis only. The classification used for the determination of the pathological response should always be given in clinical studies. No significant financial relationships to disclose.
In situ evaluation of residual breast tumor and tumor grade using medical hyperspectral imaging (MHSI)
Authors: Freeman J. E. , Yang S. , Panasyuk S. V. , Lew R. A. , Ngo D. , Faller D. V. , Rogers A. E. 
Published: March 2020

10677 Background: MHSI is a camera-based technique providing spectral data regarding tissue chemistry for each pixel in an image. Over 30% of women suffer local recurrence after resection. Intraoperative assessment of residual tumor & tumor grade would optimize care. Methods: We studied 42 S-D rats w/ breast tumors induced by gavage of DMBA & 15 controls. Tumors were exposed & resected, intentionally leaving ∼1mm residual tumor pieces. Gross examination, histo-pathology & MHSI (total 335) were performed for tumors, tumor beds after partial and total resection & control sites. A visible light MHSI system (HyperMed,Waltham, MA) w/ 40μm resolution & algorithms based on spectral features of the surgical field were developed and implemented for this study. Gross observation at surgery represents truth, as small tumor pieces were left intentionally by the surgeon and recorded. Samples from tumor beds were collected and histopathologically analyzed. When seen, gross tumor was removed from tumor bed by the pathologist. Results: MHSI performed well at identifying tumor. The kappa statistic(κ) for gross vs MHSI (84%) is significantly higher than κ for gross vs histopathology (76%) where for the κ the estimated asymptotic standard error is 3%. MHSI associates more strongly with gross than histopathology does. 81 tissue samples were separated into histologic grade: 0 = normal, 1 = benign tumor, 2 = intraductal Ca, 3 = papillary & cribiform Ca, 4 = papillary & cribiform Ca with invasion &/or comedo Ca. The imaging team (blinded) assigned tumor grade to each MHSI image. Statistical analysis defined 3 histologic groups: 9 normal (grade 0) tissue, 18 benign & intraductal tumors (grades 1–2), 54 advanced tumors (papillary, cribiform with invasion/comedo Ca, grades 3–4). Both histopathology & MHSI identified all 9 normal samples. Of 18 samples in group 2 (benign/intraductal by histopathology), 17 were qualified as benign/intraductal by MHSI (94% sens) & 1 as advanced. Of 54 samples with adv tumors by histopathology, MHSI identified 48 (89% sens) as advanced & 6 as intraductal. Conclusions: MHSI may provide convenient intraoperative, near real-time images with useful data about residual tumor & tumor grade. Human trials are planned. [Table: see text]
Pilot study of capecitabine combined with celecoxib (CapCel) for the treatment of far advanced metastatic breast cancer (MBC) patients (pts)
Authors: Fabi A. , Milella M. , Malaguti P. , Papaldo P. , Ferretti G. , Carlini P. , Gelibter A. , Felici A. , Sperduti I. , Cognetti F. 
Published: March 2020

10680 Background: COX-2 is overexpressed during cancer progression in several solid tumors, including breast cancer, and constitutes an attractive therapeutic target. Selective COX-2 inhibitors, such as Celecoxib, have been successfully combined with fluoropyrimidine-based regimens, resulting in a lower-than-expected hematologic, GI, and skin toxicity rate. Methods: MBC pts who had progressed after at least one chemotherapy regimen for metastatic disease were eligible for the study. Capecitabine was administered at the starting dose of 1500–2000 mg/m2 daily for 14 days q3 wks. Celecoxib was administered at 200 mg b.i.d., continuously, starting on day 1. Dose escalation to Capecitabine 2000 or 2500 mg/m2 was allowed in the absence of toxicity > G1. Results: To date, 22 pts (median age: 55 yrs, range 35–81; ECOG PS 0: 21 pts) have been accrued; all pts had MBC and the majority had received adjuvant chemotherapy and hormonal treatment in the adjuvant and/or metastatic setting; all pts had been exposed to anthracyclines and/or taxanes. CapCel was administered as 2nd-, 3rd-, or ≥ 4th-line chemotherapy in 3, 10, and 9 pts, respectively. Capecitabine starting dose was 1500 mg/m2 in 9 pts and 2000 mg/m2 in 13 pts. Median number of cycles administered was 5 (range: 1–15). Toxicity was negligible: 1 pt experienced G3 neutropenia, 2 pts G3 skin/nail toxicity, and 1 pt G3 liver toxicity; all other toxicities were of grade ≤2. No Celecoxib-related GI or cardiovascular toxicities were observed. Capecitabine dose was escalated from 1500 to 2000 mg/m2 in 3/9 pts and from 2000 to 2500 mg/m2 in 2/13 pts, respectively, and reduced from 2000 to 1500 mg/m2 in 4/13 pts. Twenty pts are currently evaluable for response: 2 pts had PR (duration 48 and 49 wks, respectively), 15 pts had SD (median duration: 20 wks, range 12–44), and 3 pts progressed on therapy, for an overall clinical benefit rate of 40%. Median survival has not been reached. Conclusions: Overall, these preliminary results indicate that CapCel is extremely well-tolerated and has significant anti-tumor activity in a population of far advanced MBC pts. The study will continue to reach the projected accrual of 45 pts. No significant financial relationships to disclose.
Weekly paclitaxel in Japanese women with metastatic or advanced breast cancer
Authors: Rai Y. , Tajima T. , Tamura K. , Morishita Y. , Taki T. , Hisamatsu K. , Ito Y. , Seriu T. 
Published: March 2020

10702 Background: Weekly administration of paclitaxel (WP) has been reported to be at least as well-tolerated and effective as conventional tri-weekly treatment (TP). The present study was to evaluate the efficacy and safety of weekly paclitaxel treatment for japanese women with metastatic or advanced breast cancer. Methods: Eligibility criteria included < 75 years of age, histologically-proven advanced or recurrent breast cancer, and performance status (PS) of 0 to 2. Patients were scheduled to receive at least one course of paclitaxel 100 mg/m2/week for 6 consecutive weeks followed by 1 week off. The present WP results were compared with the previous TP data generated by the same trial group in Japan. In the TP group, paclitaxel 210 mg/m2 was given every 3 weeks up to 3 cycles or more until tumor progression or severe toxicity was observed. Results: From December 2002 to July 2005, 69 patients were enrolled into the study of WP and 68 were eligible for evaluation. All were previously treated, and 51 of 69 patients (73.9%) had received anthracyclines prior to this study. The median age was 55 years (range 27–74), and 66 patients (95.7%) had PS of 0–1. Sixty nine patients have been analyzed for efficacy and toxicity by the evaluation committee. The median dose intensity was 81.25 mg/m2 per week. In total, 270 courses of WP were administered (median 3 courses; range 1–13). Three patients entered into complete remission (CR) and 28 achieved partial response (PR) by the WHO response criteria with a response rate (RR) of 44.9%, which is similar to RR in the historical TP group (RR of 33.9% in 62 Patients). Median duration of response was 238 days (range 91–631). Time to progression was 193 days. It is of note that grade 3–4 neutropenia was observed less frequently in WP as compared with TP (37.7 vs. 93.3%). Other major toxicities including peripheral neuropathy (PNP) appear to be similar between the two regimens through all toxicity grades of PNP (WP and TP group; 89.9% and 93.3%, respectively). Conclusion: WP appears to have similar or better efficacy with better toxicity profile as TP in patients with metastatic or advanced breast cancer. No significant financial relationships to disclose.
First-line treatment of metastatic breast cancer with weekly abraxane (nab-paclitaxel: a 130 nm albumin-bound paclitaxel particle): A preliminary analysis of the phase II international oncology network ION-04–012 study
Authors: Mirtsching B. , Chidiac T. , Cosgriff T. 
Published: March 2020

10707 Background: Abraxane (paclitaxel protein-bound particles) by intravenous weekly administration schedule has been demonstrated to be active and well tolerated in patients with metastatic breast cancer (MBC) refractory to prior taxane therapy. The purpose of this Phase II, open-label, non-randomized study is to evaluate the efficacy and safety of Abraxane administered weekly to patients with locally-advanced unresectable breast cancer (LABC) or MBC as first-line treatment. Methods: Patients ≥ 18 years with histologically confirmed LABC or MBC received Abraxane (125 mg/m2) by 30 minute IV infusion on days 1, 8, and 15 for the first 3 weeks of each 4-week cycle. HER2-positive patients received concurrent Herceptin given weekly throughout therapy, 4 mg/kg on week 1, and 2 mg/kg on subsequent weeks. Results: From March 11, 2005 to January 4, 2006, 28 patients were enrolled and 27 received study medication (included in this preliminary analysis). Patient accrual continues. Patient characteristics included: gender (M/F) 0/27, median age 60.5 years (range 36–83), ECOG performance status (0–1) 13/14, and HER2 status (±/missing) 6/18/3. A total of 285 cycles have been administered (median 3 [range 1–8]) with a median dose of 125 mg/m2 (range 0–130 mg/m2) and 6 dose modifications have occurred due to toxicity. Eighteen patients are still on study. CTC hematologic toxicities were grade 3 leukopenia (3.7% of patients) and grade 3 neutropenia (7.4%). Grade 3 nonhematologic toxicities were gastritis (3.7%), peripheral sensory neuropathy (7.4%), arthralgia (3.7%), and bone pain (3.7%). No grade 4 nonhematologic toxicities occurred. Conclusions: Preliminary data show that Abraxane given weekly at 125 mg/m2 (with or without Herceptin) for first-line treatment of MBC is well tolerated. Patient accrual continues in this study. Updated analysis of this study will be provided at the meeting. No significant financial relationships to disclose.
Phase II study of capecitabine (X) as single agent in elderly patients (p) with metastatic breast cancer (MBC): Final results
Authors: Zamora P. , Álvarez de Mon M. , Calvo L. , Jara C. , Virizuela J. A. , Yubero A. , Chacón J. , Mira J. , González Barón M. 
Published: March 2020

10709 Background: X is a selectively tumour-activated fluoropyrimidine active in solid tumours. Twice-daily oral administration of X enables chronic dosing that mimics a continuous infusion of 5-FU. In p with pretreated advanced BC, X is effective as monotherapy and also in combination with other agents. Some studies have shown that safety data of X in general population also apply to elderly p. The objective of this study is to evaluate the toxicity profile and response rate of X in elderly p with MBC. Methods: P histologically confirmed of breast adenocarcinoma, metastatic disease, age ≥70 years, ECOG PS <2, measurable disease and adequate bone marrow, renal and hepatic functions were included. Prior X, CNS metastases or radiotherapy within 4 weeks of treatment start was not allowed. P received X monotherapy 1250 mg/m2 b.i.d. (X 950 mg/m2 in p with creatinine clearance 30–50 ml/min), days 1–14 every 3 weeks for a maximum of 9 cycles. P can be previously treated with chemotherapy, hormonotherapy or radiotherapy for the metastatic disease. Clinical response was evaluated every 3 cycles (RECIST). Results: Twenty three p were enrolled with histology confirmed adenocarcinoma, median age was 77 years old (68–88) and ECOG PS 0/1 in 33%/67% of p. Surgery was performed in all p. Adjuvant chemotherapy and hormonotherapy was administered in 65% and 74% of p, respectively. Prior chemotherapy for MBC was administered in 13.0% of p. Median number of metastatic lesions was 3 (90% with ≥2 sites), in bone (57%), lung (43%), liver (43%) and lymph nodes (38%) mainly. A total of 117 cycles (median 4, range 1–9) were administered. Median RDI was 86% and 100% for X 1250 mg/m2 and X 950 mg/m2, respectively. All p were evaluable for toxicity. Grade III/IV toxicity per patient were hand-foot syndrome (13%), asthenia (13%), mucositis (9%), diarrhoea (9%), neutropenia (4%), thrombocytopenia (4%), nausea (4%) and vomiting (4%). Efficacy analysis: over 16 evaluable p, 2 achieved PR, 7 SD and 7 PD, resulting in an ORR of 13% (95% CI: 0–29). Median TTP was 7.5 months (95% CI: 4.5–10.5), median OS was 13.3 months (95% CI: 9.6–16.9) and one year survival 55.5% (95% CI: 33.7–77.2). Conclusions: Twice daily oral X seems to be an effective and well tolerated treatment in pretreated elderly MBC p. No significant financial relationships to disclose.
Phase II trial of nanoparticle albumin-bound paclitaxel (ABX) + capecitabine (XEL) in first line treatment of metastatic breast cancer (MBC)
Authors: Mintzer D. , Schwartzberg L. S. , Cobb P. , Henry D. , Epperson A. , Fortner B. V. 
Published: March 2020

10731 Background: ABX and XEL both have substantial single agent activity in MBC. Taxane and anti-metabolic doublets improve response rate and TTP compared to singlet therapy. ABX given weekly has excellent safety and efficacy profile with maintenance of dose intensity. We designed this study to test the safety and efficacy of ABX + XEL given in a novel combination schedule. Methods: This phase II, multicenter open label study utilized ABX 125 mg/m2 IV on day 1, 8 and with no premeds and Xeloda 825 mg/m2 PO days 1–14 every three weeks. Entry criteria include measurable MBC by RECIST, no prior chemo for metastatic disease, > 6 months since adjuvant fluoropyrimidine and paclitaxel. A total of 50 patients (pts) are scheduled to be enrolled. Primary endpoint is objective response rate. Results: To date, 14 patients have entered on study. Safety analysis prespecified by the protocol is completed in the 1st six patients. No unique, unexpected or grade 4 toxicities have occurred. Two patients have grade 3 hand-foot syndrome, one had grade 3 neutropenia and one had grade 3 fatigue. Enrollment is continuing without change in dose/schedule. Response data is available in the first two cycles of therapy in 8 patients. At this point, two pts have achieved PR, four have stable disease and two have progressive disease. Conclusions: The combination of weekly ABX plus daily XEL orally at clinically effective doses is safe and shows preliminary evidence of efficacy. Complete enrollment of this trial is expected by May 2006 and updated results will be presented. [Table: see text]
Early results of a phase I clinical trial of capecitabine in combination with CPT-11 for metastatic breast cancer (MBC) pre-treated with anthracycline and taxane
Authors: Kashiwaba M. , Inaba T. , Hayakawa Y. , Takiyama I. , Wakabayashi G. 
Published: March 2020

10750 Background: Capecitabine (C) is administrated with other drugs to improve response rate of single agent and to extend time to progression for MBC expecting up-regulation of thymidine phosphorylase activity. Conversely, administration of CPT-11 (TOP) against MBC is less common while superiority of combination therapy C and TOP is established in metastatic setting of colorectal cancer. Therefore a phase I clinical trial was conducted to determine the recommended dose (RD) of TOP administrated with fixed dose of C (1,657 mg/m2/day) against MBC pre-treated with antracycline and taxane. Methods: Five dose level of CPT-11 (80, 90, 100,110 and 120 mg/m2) on Day 1 and 15 and C (1,657 mg/m2/day) on Day 1–21 were given every 28 days. A standard “3+3” design is used and dose limiting toxicity is defined in cycle 1. Results: To date, five patients were enrolled from October 2005 to January 2006 and 8 cycles were administrated without grade 3–4 toxicities as followed: 3 pts in Level I (TOP: 80 mg/m2), 2 pts in Level II (TOP: 90mg/m2). 5 pts have archived a response: PR in 1, SD in 2. Conclusions: Combination therapy C and TOP against MBC pre-treated antracycline and taxane is well-tolerated. Enrollment will continue until the RD is identified for further phase II clinical trial. No significant financial relationships to disclose.
The analyses of disease free survival and overall survival in premenopausal and postmenopausal axillary node negative breast cancer patients
Authors: Bajic N. D. , Scepanovic D. D. 
Published: March 2020

10757 Background: The aim of this study was to analyse in which order known traditional prognostic factors predict disease free survival (DFS) and overall survival (OS) in breast cancer patients (pts) who are patohystologicaly axillary node negative. Methods: From 1998 till 2004, 258 patients were treated of axillary node negative breast cancer. We analysed 3 and 5 years (yrs) DFS and 3 and 5 yrs OS for all patients as well as for premenopausal (96 pts, 37%) and postmenopausal (162 pts, 63%). The mean follow-up time for DFS was 60 months (mo) (min 30, max 136 mo) and for OS was 66 mo (min 36, max 140 mo). As prognostic factors for DFS and OS, age, tumour size, HG as well as adjuvant treatment (locoregional and systemic) were analysed accordingly. Fifty two patients (20%) were HG1 while 190 pts (74%), were HG2 & 3; 30 pts (11%) had tumour up to 1cm and 157 pts (61%) had tumours up to 3cm and 71 pts (28%) above 3cm. Radical mastectomy was performed in 92 pts (36%) while conservative surgery were performed in 166 pts (64%). Systemic therapy was applied in 224 pts (87% of which 57% were treated with hormonotherapy). Results: 3 yrs DFS for 258 treated pts were 87% - there was no statistically significant difference among pre- and postmenopausal pts; 5 yrs DFS were 73% with no statistically significant difference among pre- and postmenopausal group of pts (p > 0.05). 3 yrs overall survival were 94% and 5 yrs 80% with no statistically significant difference among pre- and postmenopausal pts (p > 0.05). There were statistically different DFS and OS among those pts treated with adjuvant radiotherapy as well as for those with adjuvant systemic therapy in both group of pts (p < 0.001). Also as independent prognostic factor for DFS and OS were HG (Cox regression model). Conclusions: Although, HG and adjuvant therapy are the most important prognostic factors for DFS and OS in premenopausal and postmenopausal patients, we found that there is no statistically significant difference between the groups respectively. However, life-expectancy for premenopausal patients is longer. Therefore further adjuvant therapy research is needed to achieve better DFS and OS in this group of pts. No significant financial relationships to disclose.
Clinical and pathological characteristics of basal -like breast carcinomas
Authors: Gago F. , Ciocca D. R. , Mendiondo B. , Orozco J. , Tello O. 
Published: March 2020

10768 Clinical and pathological characteristics of basal -like breast carcinomas. Background: Genetic studies have revealed different subtypes of breast carcinomas with particular molecular characteristics. Basal-like breast carcinomas are characterized by negative hormonal receptors and negative HER-2 receptor. We have compared basal-like breast carcinomas with a randomized control population selected from our data base of breast cancer. Methods: From 2127 breast invasive carcinomas, 716 were evaluated with immunohistochemical methods, considering the expression of estrogen receptors, progesterone receptor, HER-2 and p53 protein, between 1989 and 2005. According to the molecular classification the results were: 1) Luminal 398 (55.6%), 2) HER- 2 positive: 193 (26.9%) and 3) Basal-like 124 (17.5%). We retrospectively analyzed the age at diagnosis, menopausal status, tumor size, histological grade, histopathology, lymph node status, stage and the evolution of the breast cancer. The average follow-up was 66.2 months. The control group consisted of 170 patients. The statistical analysis was performed with chi-square test, Fisher’s test and the non parametric test of the Mac Nemar’s signs. Results: The median age at diagnosis was 52 years old. This is lower than the average age of the Tumor Register of Mendoza, that is 60 years (p: < 0.01). The basal-like carcinomas predominated in premenopausal women (p = 0.07), and had a higher proportion of high tumor grade (p ≤ 0.0001) and expression of p53 protein (p=0.01). There were not significant statistical differences concerning the tumor size, the lymph node status, histopathology, and the stage at presentation. The 5-year disease-free survival (DFS) of basal-like breast carcinomas was 71.7% and the 5-year overall survival (OS) was 83.3%. Whereas the DFS for the control group was 77.3% and the OS was 87.3%. Conclusions: The basal-like breast carcinomas are characterized by having a younger age at presentation, predominating in premenopausal women, and presenting a high tumor grade with overexpression of p53 protein. No significant financial relationships to disclose.