bluuebunny/crossref_metadata_2025_split huggingface dataset:
Concurrent chemoradiotherapy (CRT) following neoadjuvant chemotherapy (NACT) in locally advanced breast cancer (LABC)
Authors: Alvarado-Miranda A. , Morales-Barrera R. , Arrieta O. , Zinser-Sierra J. , Gamboa-Vignole A. , Maafs-Molina E. , Ramirez-Ugalde T. , Lara-Medina F. 
Published: March 2020

11063 Background: Despite broad advances in the treatment of LABC, 30 to 40% of patients responding to NACT develop locoregional relapse. We performed a retrospective analysis of the experience obtained so far in patients with LABC who were treated with CRT after NACT in terms of pathologic complete response (pCR), relapse-free survival (RFS) and overall survival (OS) at our institution. Methods: One hundred and twelve patients with LABC (Stage IIB-IIIB) were treated between January 2000 and December 2003 with NACT with 5FU 500mg/m2, doxorubicin 50 mg/m2 and cyclophosphamide 500mg/m2 (FAC) or doxorubicin 50 mg/m2 and cyclophosphamide 500mg/m2 (AC) administered i.v. in four 21-day cycles. CRT with 60 Gy whole-breast irradiation and concurrent weekly mitomycin 5mg, 5FU 500mg and dexamethasone 16 mg or cisplatin 30 mg, gemcitabine 100 mg and dexamethasone 16 mg. Subsequently they underwent surgery and 6 to 8 weeks later received 2 additional courses of FAC, AC or paclitaxel 90mg weekly for 12 weeks and in estrogen receptor (ER) positive patients hormone therapy. Results: Median tumor size 5 cm; stages IIB, IIIA and IIIB were 21.4%, 42.9% and 35.7% respectively. pCR was 42% (CI 95% 33.2 - 50.5) in breast and 29.5% (CI 95% 21.4 - 37.5) in breast and axillary lymph nodes. Multivariate analysis showed the main determinant of pCR was negative ER (P 0.016). Median RFS has not been reached. The 5 year RFS is 76.9% (CI 95% 68.2 - 84.7). No relationship between pCR and RFS was found. Multivariate analysis showed the main determinant of RFS was the clinical stage (p=0.03). Only one patient had local recurrence. The 5 year OS is 84.2% (CI 95% 75 - 93.2). Toxicity during CRT: grade 1–2 neutropenia 32.2%, grade 1–2 anemia 5.2%, grade 3 radioepithelitis 22.4% Conclusions: This modality has good locoregional control for locally advanced breast cancer with an acceptable toxicity profile. Futher investigation of concurrent chemoradiotherapy should be explored in LABC. No significant financial relationships to disclose.
The role of MRI in therapy management in triple-negative (TN) breast cancer
Authors: Lex B. , Russu V. , Popovich M. , Gilster T. , Pfaffenberger K. , Volkholz H. , Tulusan A. 
Published: March 2020

11079 Background: Triple-negative breast cancer (estrogen receptor-negative, progesterone receptor-negative, and HER2-negative) is a high-risk breast cancer that lacks the benefit of specific therapy which targets these proteins. TN is associated with decreased survival. Data for defining the optimal systemic therapy in patients with TN are still missing. Reported clinical and pathological response rates in TN due to different chemotherapy schedules are rare and data are inconsistent. Our study group showed that MRI is an effective method to monitor the tumour-response in PST (Russu V et al. Proc Am Soc Clin Oncol 2004, abstract 9704). The aim of this study was to clarify the accuracy of MRI in monitoring the tumor-response to PST in TN. Methods: 43 female patients (range of age: 29a-67a) with TN (cT2 â€“ cT4) were examined with dynamic contrast enhanced MRI after PST. 34 patients were examined with MRI before and after PST. 12 patients were treated with sequential anthracyclin and taxan based chemotherapy and 31 with only anthracyclin based chemotherapy. 22 patients were premenopausal. 34 patients had ductal-invasive carcinomas, 9 lobular-invasive The measure of tumour-response to PST was graded in partial response (PR: > 50% of tumour reduction mm2), no change (NC: < 50%) and complete response (CR: no evidence of residual tumour-cells). Results: Comparing tumour-size measured by MRI before and after PST 22 patients had PR and 7 CR. NC had 5. The histological tumour-size after PST strongly correlated with the size measured by MRI r = 0,931(pâ€ 0,001). Conclusions: MRI seems to be a useful method in monitoring the tumour-response to PST in TN. Further studies could find out if MRI is a suitable tool to detect chemotherapy-resistance very early in TN. No significant financial relationships to disclose.
Urokinase-type plasminogen activator (uPA) and its inhibitor PAI-1 for improved management in node-negative (N0) breast cancer: Experiences from the ongoing multicenter trial NNBC 3-Europe
Authors: Persing M. M. , Paepke D. , Schmidt M. , Veyret C. , Augustin D. , Guerts A. , Martin P. M. , von Minckwitz G. , Thomssen C. , Harbeck N. 
Published: March 2020

11081 Risk-assessment in N0 breast cancer is still controversial. In line with St. Gallen, only few patients (pts) are considered at such low risk of relapse, that adjuvant chemotherapy could be avoided. Various groups have started clinical trials aimed at improved risk-assessment by gene or protein analysis of the primary tumor. We launched the NNBC 3-Europe trial asking the following questions: Is the identification of low- risk pts by the invasion markers uPA and PAI-1 more effective than by St. Gallen criteria? Is adjuvant chemotherapy using an anthracycline- taxane sequence superior to standard FEC in N0 high-risk pts? The centres of the NNBC 3 trial had to choose their mode of risk- assessment (either St. Gallen criteria or uPA/PAI-1) prior to recruitment. High-risk pts receive chemotherapy randomly assigned to FEC-100*3 followed by Docetaxel-100*3 (FEC-Doc), or FEC-100*6. No adjuvant chemotherapy is given to low-risk pts. Pts with hormone receptor positive tumors receive standard endocrine therapy. To date, 1206 pts in 57 centres have been registered. Using fresh frozen tumor tissue, uPA and PAI-1 are tested in nine laboratories; inter-laboratory quality assurance is performed. In 141 of 1188 evaluable pts, St Gallen criteria were used. In the biological risk-assessment group, 150 of 1047 tumors (14.3%) were well differentiated, thus regarded as low-risk. Using both, tumor grade and uPA/PAI-1, 35.3% of the pts were considered low-risk, whereas the remaining 64.7% high-risk pts received adjuvant chemotherapy (FEC-Doc, n=334, or FEC, n=343). Multicenter prospective risk assessment based on testing of fresh frozen (or paraffin- embedded) tumor tissue is sophisticated. All trials with similar approach (MINDACT, TAILORx) had a long preparation phase including thorough assay validation. The ongoing NNBC-3 trial demonstrates that inclusion of pts based on testing of fresh frozen material is feasible in a routine setting. Risk-group distribution is as expected. The study is planned to recruit 5,700 pts and it is performed in cooperation with the EORTC Patho-Biology Group, the German AGO Breast Group, and the German Breast Group (GBG). Unrestricted grants by Sanofi-Aventis and Pfizer. [Table: see text]
Evaluation of clinicopathological features from core needle biopsy and CT imaging as predictors of response to primary systemic therapy for operable breast cancer
Authors: Shien T. , Akashi-Tanaka S. , Shimizu C. , Hojo T. , Seki K. , Kohno T. , Ando M. , Katsumata N. , Fujiwara Y. , Kinoshita T. 
Published: March 2020

11086 Background: Primary systemic therapy (PST) is standard therapy for patients with locally advanced breast cancer and increasingly used for early-stage operable disease. Clinical and pathologic responses are important prognostic parameters and clinicopathological markers to predict response to PST are needed to individualize treatment. Methods: From 1998 to 2005, 403 primary breast cancer patients were underwent curative surgical treatment after PST (Anthlacycline and/or Taxane) at NCCH. We retrospectively evaluated the clinicopathological features (age, histological type, histological grade, ER, PgR and HER-2) and classification of tumors using CT (localized tumor type and diffused tumor type) at before PST and analyzed the correlation with clinical response and pathological complete response (pCR). The log-rank statistic was used for univariate comparisons and multivariate analysis performed using Cox hazard model. Results: Overall response and pCR rate were 87% and 18%. Breast conserving surgery was performed 37% patients. Histological grade 3 (p<0.0001), ER negative (p<0.0001), PgR negative (p<0.0001), solid-tubular type (p=0.0006), age (>50) (p=0.008) and localized tumor type (p=0.02) correlated with pCR. In multivariate analysis, Histological grade 3 (p=0.01) and localized tumor type (p=0.036) were independent predictors for pCR. ER positive, histological grade 2 or 1, invasive lobular carcinoma and diffuse tumor type associated with low chemosensitivity and low breast conserving surgery rate. Conclusions: Clinical and pathological response significantly associated with ER status and histological grade. Furthermore the classification of tumor type using CT was effective to predict of response to PST. No significant financial relationships to disclose.
Phase II study of neoadjuvant docetaxel (T), doxorubicin (A) and capecitabine (X) in locally advanced or inflammatory breast cancer (LABC)
Authors: Perez-Manga G. , Mendez M. , Palomero M. I. , Quiben R. , Belon J. 
Published: March 2020

11092 Background: Studies suggest that chemotherapy + surgery + radiotherapy gives a high survival rate in patients with LABC. Primary objective was to evaluate response rate. Secondary endpoints were time to progression and toxicity profile of neoadjuvant T, A and X in LABC. Methods: Eligibility: histologically confirmed LABC, ECOG PS =2, age =75 years, LVEF >50%, and adequate bone marrow, renal and hepatic function. Prior systemic therapy, surgery or radiotherapy for breast cancer was not allowed. Patients with invasive bilateral breast cancer were not included. Treatment: T (30 mg/m2) iv day 1, 8 and 15, A (50 mg/m2) iv day 1 and X (1500 mg/m2 o.d.) days 1–14, in a 4-week course repeated for up to 4 cycles followed by surgery. According to investigator criteria patients received a maximum of 6 cycles. Radiotherapy and hormone therapy were allowed after surgery. Expression of markers was determined by immunohistochemistry before chemotherapy. Results: 43 patients were included in this analysis, median age 48 years (25–73). ECOG PS was 0 in 37% of patients and 1 in 63%. Hormonal receptor status was ER+ 44%, PR+ 34% and C-erb2+ 59%. In total, 157 cycles (median 4, range 2–4) were given. Median relative dose intensity was 86% for T, 92% for A and 88% for X. Of 43 patients evaluable for efficacy, 13 achieved CR, 24 PR and 1 PD resulting in an ORR of 97% (CI 95%: 92–100). Surgery was performed in 40 patients: 4 (10%) achieved pathologic CR and one additional patient had non-invasive carcinoma. Grade III/IV toxicity per patient was neutropenia (74%), leukopenia (56%), febrile neutropenia (9%), mucositis (12%), diarrhea (12%), nausea/vomiting (5%), dysgeusia (2%) and asthenia (2%). Median follow-up time was 19.5 months. Conclusions: Neoadjuvant T, A and X every 28 days for 4 cycles is an active regimen in LABC with a manageable toxicity profile before surgery. No significant financial relationships to disclose.
Phase I study of preoperative chemoradiation therapy in unresectable locally advanced breast cancer (LABC)
Authors: Conzen S. , Hahn O. , Vanderpuye V. , Fleming G. , Olopade F. , Haraf D. , Jaskowiak N. , Heimann R. 
Published: March 2020

11097 Introduction: Therapy of unresectable LABC is challenging due to the need to resect local disease and prevent distant metastases. We conducted a phase I trial to determine the maximum tolerated dose of preoperative vinorelbine (VIN) combined with paclitaxel (P) and radiation (XRT). Methods: Eligible patients (pts) had unresectable LABC, ECOG performance 0–2 and adequate organ function. Prior chemotherapy and metastatic disease were permitted. All pts received weekly bolus P 80 mg/m2 and concurrent XRT at 2.0 Gy daily for 5 days in a week-on/week-off (WO/WO) schedule for 12 weeks. A planned 59 -70 Gy were delivered to the breast, chest wall and supraclavicular regions. In dose level 2, VIN 15 mg/m2 /week was added. Results: Twenty-six pts were enrolled from July 1999-July 2005 with a median age of 51 years (range 24–69); 9 pts had stage IV disease, 17 pts had stage IIIB disease, and 13 pts had received prior chemotherapy. VIN was not tolerated due to grade (G) 4 neutropenia despite GCSF; however single-agent P and concurrent XRT was well-tolerated. Thus, 7 pts in the final cohort received P/XRT without GCSF. This regimen was well-tolerated; toxicities seen included: G3 in-field skin desquamation 4/7; G4 lymphopenia 7/7, G3 infection 1/7; G3 wound dehiscence 1/7. After therapy, 20/26 pts underwent mastectomy: 6 pts had a pathologic complete response (no invasive disease), 12 had a pathologic partial response (scattered microscopic disease), and 2 pts had no response. Overall pathologic response rate was 90% for pts undergoing mastectomy; only 3 of the 20 resectable pts are alive without relapse a mean of 19.5 months after mastectomy. Conclusions: Neoadjuvant P 80 mg/m2 with full dose XRT in a WO/WO schedule is tolerable and effective allowing 20/26 unresectable pts to undergo successful mastectomy. Pts do not require routine GCSF support. Although most pts eventually relapse distantly, this regimen does render some pts not responding to initial doxorubicin-based therapy resectable. [Table: see text] No significant financial relationships to disclose.
Concomitant chemoradiotherapy in adjuvant treatment of breast cancer: A retrospective study of 296 cases
Authors: Errihani H. 
Published: March 2020

11099 Background: Concomitant chemo-radio-therapy in adjuvant treatment of breast cancer is an attractive method which is under ongoing research program. We are trying by this retrospective study to document and support the feasibility of concomitant methods at the Oncology Institute in Rabat. Methods: Two hundred ninety six patients having breast cancer were investigated in a retrospective study. All patients were either treated by radical chirurgy (86.5%) or conservative treatment (13.5%). The study compares two adjuvant treatments associating concomitant chemotherapy and radiotherapy. In the first treatment (first brace) the patients were treated by chemotherapy and radiotherapy in concomitant way using anthracycline [(doxorubicine 60mg and cyclophosphamide 600mg/m2 (AC60), 5-fluorouracile 500mg/m2, doxorubicine 50mg/m2, and cyclophosphamide 500mg/m2 (FAC50), 5- fluorouracile 500mg/m2, epirubicine 75mg/m2, and cyclophosphamide 500mg/m2 FEC75)] (N=123). In the second treatment (second brace) the chemotherapy was CMF type (cyclophosphamide 500mg/m2, methotrexate 60mg/m2 and 5-fluorouracil 500mg/m2) (N=173). Chemotherapy was administered in six cycles, one each 3 weeks. Radiotherapy delivered a radiation dose of 50 Gy on the breast (or on the external layer) Results: With an average time of 37 months after the end of the treatment, only one patient was recidivist of the breast cancer disease as a loco regional breast cancer when the treatment was based on anthracycline. So in 3 years the rate of recidivism of the disease was 0.6%. All the other recidivists were metastasic. The survival rate without disease, after 3 years, in the anthracycline brace was 87% compared to 86.5% in the CMF brace (p> 0,5). The global survival probability after 3 years was 93% in the anthracycline brace and was 90.84% in the CMF treatment. Conclusions: From the three year retrospective investigation we showed a similarity of the two cancer treatment results with higher haematological toxicity in the concomitant treatment based on anthracycline. Waiting for the results of ongoing research we recommend the use of adjuvant treatments in sequential mode by using the chemotherapy prior to radiotherapy. No significant financial relationships to disclose.
Randomized controlled comparative clinical pharmacokinetic study of nab-paclitaxel and solvent-based paclitaxel in Chinese patients (pts) with metastatic breast cancer (MBC)
Authors: Li S. , Guan Z. , Yao Z. , Teng X. , Liao H. , Deng L. , Pan Y. , Yao Q. X. , Hawkins M. J. 
Published: March 2020

11505 Background: nab-paclitaxel is a novel solvent-free, 130-nM albumin-bound (nab™) formulation of paclitaxel. In previous studies, nab-paclitaxel demonstrated higher volume of distribution and clearance than that of paclitaxel formulated with Cremophor (Cr-PAC) in Caucasian patients (Sparreboom, Clin Cancer Res 2005;11:4136) and had greater response rate and favorable safety profile in pts with MBC (Gradishar et al., JCO, 2005;23:7794) . The aim of this study was to evaluate nab-paclitaxel blood pharmacokinetics (PK) and compare it with that of Cr-PAC in Chinese MBC patients.Methods: In this randomized controlled, open-label study, patients were assigned to either nab-paclitaxel 260 mg/m2 intravenously (iv) over 30 minutes q3w or Cr-PAC 175 mg/m2 iv over 3 hours q3w. At cycle 1, 12 patients in each treatment group participated in the PK study and then continued treatment until PD or unacceptable toxicity. Plasma samples from pts were analyzed for PK parameters. The primary clinical endpoints were ORR and toxicity (Guan et al; submitted, ASCO, 2007). Results: 24 female pts (median age 44.5 years) participated. No statistically significant between group differences were noted in age, height, weight, or baseline liver function. Paclitaxel blood PK parameters in 2 treatment groups are summarized in the Table. ORR: nab-paclitaxel, 75%; Cr-PAC, 25% (P = 0.018). The maximum grade (G) of neutropenia and neuropathy in the nab-paclitaxel and Cr-PAC groups were G3 and G2, respectively, with no significant between-group difference. Conclusion: nab-Paclitaxel had a greater distribution volume, clearance, and smaller dose adjusted AUC0-inf compared with that of Cr-PAC. There was no significant difference in T1/2 in the 2 groups. PK results in Chinese pts are identical to data reported in Caucasian pts. The lower CL and Vz for Cr-PAC are probably related to sequestration of paclitaxel in the blood by Cremophor. * dose adjusted AUC0-inf [Table: see text] [Table: see text]
Trastuzumab and paclitaxel or vinorelbine for HER2+ metastatic breast cancer: A retrospective study and analysis of economic cost
Authors: Scola A. , Koussis H. , Jirillo A. , Ghiotto C. , Lonardi S. , Bortolami A. , Monfardini S. 
Published: March 2020

11517 Background: We analyses a mono institutional series of patients treated with metastatic breast cancer (MBC). Methods: From 2000 to 2006 forty consecutive patients affected by MBC were evaluated. The average age was 50 years (range: 30–79). All patients had HER2+ tumors (IHC 3+ or FISH+) and LVEF > 50%. Metastatic sites were: liver 18, lymph nodes 10, bone 9, skin 7, lung 5 pts. In 11 cases the sites of metastases were multiple (1–3). All patients were treated with Trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly thereafter with weekly Paclitaxel 80 mg/m2 or weekly Vinorelbine 25 mg/m2; specifically, Paclitaxel was used in 26 patients and Vinorelbine in 14 patients. The endpoints were time to progression (TTP), duration of response, toxicity (including cardiologic) and overall survival. Results: A total of 1271 courses of weekly Trastuzumab were administered (average 28 courses per patient: range 8–72). There were 22 complete and partial responses (CR+PR=55%). In the association of Trastuzumab and Paclitaxel were seen :11 CR, 6 PR, 3 SD and 6 PD, (RR 65.3%). In the combination of Trastuzumab and Vinorelbine: 2 CR, 3 PR, 4 SD and 5 PD (RR 35.7%) . The most responsive sites were: liver 15 CR+PR (37.5%), lung 11 CR+PR (27.5%), lymph nodes 8 CR+PR (20%), and skin 6 CR+PR (15%). TTP was 7 months (2–27 months) and response duration 6.7 months (2–26 months). Overall survival at 5 years was estimated at 26.4 months. Toxicity rates were: hematological grade 4 in 2 pts, grade 3 in 3 pts, neurological grade 3 in 19 pts. No important cardiologic toxicity was observed: LVEF was reduced to 40% in 4 pts. Seven patients developed brain metastasis during therapy. The patients in PD continued Trastuzumab with other chemotherapy, no responses were observed. The median cost of treatment with Trastuzumab for patient was 16.147 € (range 3.987–39.959 €. Conclusions: Treatment with Trastuzumab plus chemotherapy has been shown to be effective and well-tolerated providing a good quality of life. The economic impact is important and is to define. The cost/benefit in this cohort of the patients is ongoing. No significant financial relationships to disclose.
Radiographic evaluation of recurrent glioblastoma multiforme (GBM) in patients treated with bevacizumab and irinotecan
Authors: Andre J. , Spearman K. , Lu S. , Hwang S. , Dorsett L. , Raval S. 
Published: March 2020

12512 Background: Recurrent GBM carries a poor prognosis after first-line therapies have been exhausted, even in the setting of gross total resection. Bevacizumab and Irinotecan have shown promising results in patients with recurrent GBM (Stark-Vance, et al. Neuro- Oncol, 2005). We sought to retrospectively document the short-term effects of this chemotherapeutic regimen on recurrent GBM, as evidenced by comparative MRI brain scans obtained prior to, and one-month following initiation of treatment. Methods: We collected brain MRI data from August 2005 to December 2006, in which post-contrast spin-echo T1-weighted images demonstrated measurable enhancement and/or GBM tumor mass. Having failed temozolomide and radiation therapy, 14 consecutive patients’ MRI scans were available for review at this institution by a neuro-radiologist, in which both pre- and post-treatment hard and/or soft copy MR images were available for direct measurement. Each was treated with Bevacizumab 5 mg/kg IV and Irinotecan 125 mg/m2 IV infusion every 2 weeks until disease progression, or development of unacceptable toxicity. We measured pre- and post-treatment recurrent GBM bulk tumor in anteroposterior, transverse, and cranio-caudad dimensions, and calculated volumetric data, assuming an ellipsoid tumor configuration. Results: Pre-treatment MRI scans were performed 2 weeks prior to initiation of therapy (Mean: 13 days; Median: 10 days). Post-treatment scans were performed at approximately one month following initial treatment (Mean: 30 days; Median: 28 days). All patients witnessed significant decrease in tumor bulk volume ranging from 15.3 to 89.8%, having received an average of two cycles of chemotherapy. We observed a mean decrease in tumor volume of 46.6% (SD = 22.6%; SEM = 6.0%; 95% CI = 33.6 - 60.0 % decrease). Conclusions: We report 46.6% mean reduction in recurrent GBM tumor bulk at an average of 1-month post-treatment in patients treated with an average of two cycles of Bevacizumab and Irinotecan therapy. These promising initial results necessitate further long-term prospective evaluation of this chemotherapy. No significant financial relationships to disclose.