bluuebunny/crossref_metadata_2025_split huggingface dataset:
Gemcitabine in metastatic breast cancer
Authors: Bensalem A. , Bouzid K. 
Published: March 2020

10735 Background: Gemcitabine (GEM) has shown efficacy in metastatic breast cancer (MBC). We conducted studies with GEM-based regimens to assess the efficacy and toxicity of GEM combined with other drugs in MBC. GEM was combined with docetaxel (DXL) in pre-treated MBC with an anthracycline-based regimen and GEM was combined with doxorubicin (DXR) in chemonaive patients (pts) with MBC. The studies’ objectives were to show clinically relevant hematologic toxicity and response rates among pts treated with GEM-DXL either in combination in pre-treated pts with anthracycline regimen or GEM-DXR in chemonaive pts with MBC to assess the efficacy of GEM in MBC either in neoadjuvant or first-line treatment. Methods: For GEM-DXL: 42 pts were enrolled; GEM: 1250 mg /m2 D1 & D8, DXL: 75 mg /m2 D1, every 21 days with classical premedication for DXL. For GEM-DXR: 51 pts were enrolled; GEM: 1250 mg /m2 D1 & D 8, DXR: 25 mg/m2 D1 & D8, every 21 days. Results: See table below. In the GEM-DXR group, surgery was performed in 30 pts, and 13 (43.2%) had histologically complete response. The median TTP in this group was 13.3 months (range, 2–53). Conclusions: GEM in MBC is very efficient and produced an interesting objective response and clinical benefit. This activity is consistent in either chemonaive pts or in pts with relapsing breast cancer. [Table: see text] No significant financial relationships to disclose.
Is the prophylactic use of colony stimulating factor and oral ciprofloxacin effective to prevent neutropenia in patients having docetaxel, doxorubicin, and cyclophosphamide for breast cancer as an adjuvant chemotherapy in Korea?
Authors: Suh Y. , Chun C. , Oh S. , Jung S. 
Published: March 2020

10736 Background: Recently, the combination chemotherapy including docetaxel (75 mg/m2), doxorubicin (adriamycin) (50 mg/m2), andcyclophosphamide (500 mg/m2) has been reported to be effective as an adjuvant treatment for the early breast cancer patients. Though a few studies have been published to show preventive effect of the routine use of G-CSF and oral antibiotics on the severe neutropenia. We prosepctively tried to compare the possible role of this prophylactic measure on the prevention of high-grade neutropenia in breast cancer patients having this regimen in Korea. Methods: We prospectively compared prophylactic user group (100 patients) with non-use group (100 patients). Stage II breast cancer patients were enrolled for this study. We used three-day prescription of G-CSF (150 ug/day) and oral ciprofloxacin (500 mg/day) five days after the completion of each cycle for the user-group. Results: The percentage of febrile neutropenia was strikingly decreased in the user group (p < .01). Number of patients showing grade II, III neutropenia didn’t show statistical difference between groups. Averge days required to recover from the neutropenia was 2.7days in two groups. The nadir of neutropenia was between 7–10 days after each cycle regardless of the prophylaxis. The duration of neutropenia seems to be dependent on the presence of the fever over 38’C after the chemotherapy. Once the fever developed, the neutropenia was becoming severer and more protracted. Conclusions: We think this combination chemotherapy effective to be used as an adjuvant treatment for the early breast cancer patients. But more care should be provided to prevent severe neutropenia after each cycle. Routine use of this prophylaxis failed to show significant differences in the rate of occurence of the severe neutropenia. But, we think that the prophylaxis seems to e effective to prevent febrile neutropenia. So, we suggest the routine prophylactic use of G-CSF and oral ciprofloxacin should be considered to be used in breast patients having docetaxel, adriamycin, and cyclophosphamide. No significant financial relationships to disclose.
Monocentric retrospective analysis of locally advanced and inflammatory breast cancer (IBC) patients (pts) having received a neoadjuvant chemotherapy with docetaxel (D) and anthracyclines
Authors: Audhuy B. , Meyer C. , Nierges D. , Barats J. C. , Straub P. 
Published: March 2020

10743 Background: Anthracycline-based neoadjuvant therapy is a standard treatment, but use of D in the preoperative setting increases clinical and pathological response, as monotherapy or as part of combination chemotherapy for preoperative setting. Our purpose was to assess the efficacy in pts who were treated with D and anthracyclines (doxorubicine A or epirubicine E) in neoadjuvant setting. Methods: Pts with histologically proven, unilateral breast cancer, T2-T4, N0-N2, M0 tumors received every 3 weeks an association of D and A or E, according to different schedules. This retrospective analysis was designed to evaluate the clinical and pathological response rate of this association. Results: Between October 1999 and December 2003 45 pts (44 women and 1 man) were treated with associations: 39 D and E or A, 3 D, A and vinorelbine, 1 D, A and capecitabine (X), 1 D, A and trastuzumab (H), 1 D, X and H; median age 47 [27–71] years; median number of cycles of chemotherapy: 4 [3–6]; median tumour diameter: 50 mm [20–150] with 6 IBC; median radiological size: mammography 32 mm [11–90], echography 32.5 mm [8–90]; tumour stage: 15 T2N0 (33%), 12 T2N1 (27%), 7 T3N0 (15%), 2 T3N1 (4%), 1 T3N2 (2%), 1 T4bN1 (2%), 1 T4cN2 (2%), 3 T4dN0 (7%), 2 T4dN2 (4%), 1 T4N0 (2%); tumour grade: 22 grade II (49%), 22 grade III (49%), 1 unknown; tumour histology : 31 ductal carcinoma (69%), 13 lobular carcinoma (29%), 1 mucineous carcinoma (2%); hormonal status: 29 positive (64%), 16 negative (36%). Among these pts, 13 had nodal curage concomitant with diagnosis biopsy. All pts were evaluable for clinical response: ORR was 91% (18 complete response CR 40%, 23 partial response PR 51%. Histological response was available in 32 pts: Chevallier classification pCR grade 1–2: 5 (11%), Sataloff TA /NA-NB 5 (16%). On 32 pts with postchemotherapy nodal curage, 16 had negative nodal disease. On these 16 pts, 8 were N0 at diagnosis, 5 N1 and 3 N2. Conclusions: Association of D and anthracyclines in breast carcinoma exhibits a high pathological response rate. No significant financial relationships to disclose.
Nanoparticle albumin-bound (Nab) paclitaxel (P) in combination with bevacizumab (B) with and without gemcitabine (G): Early experience at the Braman Family Breast Cancer Institute
Authors: Lobo C. F. , Lopes G. , Silva O. , Gluck S. 
Published: March 2020

10748 Background: Nab-P improves outcomes when compared against single agent cremophor-based P, as does the addition of bevacizumab or gemcitabine to the same agent. There are no available data regarding combinations of Nab-P with B and/or G. Ongoing investigational efforts are evaluating various doublets with these agents, but, to the best of our knowledge, not all 3 of them in the same regimen. All drugs are currently FDA-approved in the treatment of breast cancer. Methods: Review of single-institution experience, evaluating safety and preliminary evidence of activity with the use of Nab-P and B with and without G in heavily pretreated her2neu negative metastatic breast cancer patients. Assessment of response was undertaken by the investigators independently of treating physician. RECIST criteria were used. Three patients received Nab-P and B at the following doses: Nab-P 100 mg/m2, B 10 mg/kg every 2 weeks, and 2 patients received all 3 drugs as follows: Nab-P 100 mg/m2, G 1,000 mg/m2, B 10 mg/kg every 2 weeks. Results: Five women have been evaluated. Median age was 51 (range 34–69). Two patients had hormone-receptor positive disease and 3 had ER/PR/Her2neu-negative cancer. Prior number of regimens was 3 (range 2–7). Four patients had been treated with a taxane. One received both paclitaxel and docetaxel, and 3 docetaxel only. A median of 5 cycles have been administered (range 3–9). First-cycle grade 3/4 toxicity was seen in only one patient who had a baseline grade 2 thrombocytopenia that progressed to grade 3. The thrombocytopenia resolved without requiring transfusion and without any hemorrhagic complication. Another patient developed grade 2 peripheral neuropathy. Two patients are not yet assessable for response. At time of first evaluation 1 patient had progressive disease (Nab-P, B; 7 prior lines of treatment), one had stable disease (Nab-P, B, G; 3 prior lines of therapy, including docetaxel), and 1 had a partial response (Nab-P, B, G; 2 prior therapies, including docetaxel). Conclusions: These very preliminary data suggest that Nab-P in combination with B with and without G is a safe regimen and formal Phase I/II trials are being developed to confirm its clinical activity. [Table: see text]
Randomized open label phase II study of pegilated liposomal doxorubicine (PLD) four or six-week scheduled in metastatic breast cancer (MBC) patients (p)
Authors: Ruiz M. , Bayo J. L. , Moreno Nogueira J. A. , Dorta J. , Casas A. M. , Morales M. 
Published: March 2020

10751 Background: PLD has the advantage of delivering the active anthracycline directly to the tumour site, provide comparable efficacy to conventional doxorubicin with a more favourable toxicity profile and significantly less cardiotoxicity. The most frequent dosing schedule is 50 mg/m2 every 4 weeks. Recent studies have shown that PLD 60 mg/m2 every 6 weeks is an active and well tolerated treatment, and could be more convenient for the p. The primary objective was to evaluate response rate in six- and four-week schedule (arms A and B). Secondary objective was toxicity profile. Methods: P histologically confirmed of MBC, age 18–75 years old, ECOG PS ≤ 2, at least one measurable lesion and adequate bone marrow, renal, hepatic and cardiac function, were eligible. Prior chemotherapy with anthracyclines for MBC or adjuvant anthracycline-based regimen in the previous 12 months was not allowed. P were randomly assigned to receive PLD 60 mg/m2 i.v. in 1 hour every 6 weeks (arm A) or PLD 50 mg/m2 i.v. in 1 hour every 4 weeks (arm B). Results: Ten p have been included in the interim analysis over 11 enrolled, with median age of 50 years, ECOG PS 0–1 70% and stage IV 50%. Median time from diagnosis of metastatic disease was 9.2 months. Histology: 80% of p had ductal carcinoma, 10% lobular and 10% undifferentiated. Main tumour locations were lung (60%), liver (60%) and bone (40%). Two p had positive hormonal receptor status in arm A and 4 in arm B. Previous treatment included chemotherapy (80%), hormonotherapy (80%) and radiotherapy (40%). Up to date, a total of 15/17 cycles (median 3/3, range 1–6/1–5) were administered. Absolute dose intensity was 2.2 mg/day in arm A and 3.0 mg/day in arm B. Two p were not evaluated and over 8 evaluable p for efficacy (4 A and 4 B), 2 achieved partial response in arm A and 1 in arm B. Median time to progression was 168 days in arm A and 104 in arm B. The only grade III/IV toxicity was mucositis and stomatitis in 4 p. The most common grade I/II toxicities were palmar-plantar erythrodysesthesia (5p), anorexia (4p) and alopecia (4p). Conclusions: PLD at 50 mg/m2 every 4 weeks and 60 mg/m2 every 6 weeks are effective and well tolerated regimens in MBC p. The most relevant adverse events were mucositis and palmar-plantar erythrodysesthesia. No significant financial relationships to disclose.
Infiltrating ductal carcinoma of male breast: A retrospective study
Authors: Puri T. , Malik M. , Gunabushanam G. , Sharma D. N. , Julka P. K. , Rath G. K. 
Published: March 2020

10753 Background: A single-institution retrospective review of the clinical presentation, treatment and outcome of male breast infiltrating ductal carcinoma (IDC). Methods: Case records of 25 male patients with a histological diagnosis of infiltrating ductal carcinoma (IDC) of breast who were treated in a single institution between 1997 to 2004 were retrospectively reviewed. Results: Patients presented at a mean age of 56 years (range, 34 to 80 years). The presenting complaint was a painless lump in the breast in all the cases. The right breast was involved in 13 cases (52%). There were no cases of bilateral breast cancer. The distribution of patients by stage at presentation are: stage IIA (24%), IIB (20%), IIIA (8%), IIIB (40%), and IV (8%). None of the patients presented with stage I disease. One patient had lung metastases at presentation. Rest of the 24 patients (96%) underwent surgery (modified radical mastectomy, 22 patients; simple mastectomy, 2 patients). Fifteen patients (60%) received adjuvant local radiotherapy. All patients received adjuvant chemotherapy: As per departmental protocol, those presenting before 2000 were treated using a regimen of Cyclophosphamide, Adriamycin and 5-Fluorouracil. After 2000, Ebirubicin was substituted for Adriamycin. Three patients were further administered Docetaxel, the indication being disease progression after first line adjuvant chemotherapy. Estrogen & Progesterone receptor positivity was 64% and 60% respectively. Hormonal therapy (Tamoxifen 14 patients, Anastrozole 2 patients) was administered in these patients. The length of follow-up from time of presentation ranged from 4 to 100 months (mean, 28 months; median, 13 months). At the time of analysis, of the 25 patients, 18 patients (72%) remain disease free, whereas 7 patients (28%) developed progressive disease. Median survival was not reached at the present time. Conclusions: Breast cancer, specifically IDC tends to present at a later stage in males, due to a lack of screening for the disease. In the present series, as a result of the advanced stage of initial presentation, all patients received adjuvant chemotherapy. There is a need to improve awareness among males, of the possibility of a painless breast lump being the first symptom of an underlying malignancy. No significant financial relationships to disclose.
Pattern of breast diseases in Kuwait Cancer Control Center, Kuwait
Authors: Alawadi S. A. , Delvadiya M. D. 
Published: March 2020

10754 Background: The aim of this case series study is to evaluate the outline and pattern of female breast cancers in Kuwait. Methods: Our study consisted of data from 300 cases of female breast cancer seen in our outpatient department. Data on profile of their disease at presentation and known risk factors was retrieved. The analysis indented to examine the pattern of the disease and risk factor profile of the patients. Results: Out of 300 patients, 52% were Kuwaiti citizens, 24% were Arabs from other countries, 23% were of Asian origin and 1% was of other nationality. Their median age ± SD (Standard Deviation) was 50 ± 9.7 years. Most patients were younger than 55 years (77.4%) and were predominantly premenopausals (63%). Only 18% had stage I disease at presentation, whilst 54 %, 24 %, and 4% had stage II, III and IV disease, respectively. Among patients with known axillary nodal status (298 patients) 44.3% were node-negative whilst 39.6% and 16.8% had N1 and N2 disease, respectively. History of benign breast disease was positive in 9% and only 1% had breast biopsy done before the biopsy which diagnosed cancer. In 20.7% there was family history of breast cancer. Among them 11.7% had first degree relative with breast cancer, 3.3%, 7.3% and 1% patients had either mother, sister or both with history of breast cancer. Whilst 12% patients had second degree relatives with breast cancer, 3% patients out of them had both first and second degree relatives with breast cancer. History of alcohol ingestion was rare, only 0.7% patients were taking alcohol. 9.7% patients were nulliparous, while 10.7% patients had their first child after the age of 30 years. Breast feeding was common, 80 % patients breast fed their children and 43.3 % did that for more than 6 months. Age at menarche was 12 years or less in 34 % patients and age at menopause was more than 55 years in only 6.3% patients. Oral contraceptives were used by 38.7% patients, 12%, 9.3% and 17.3% patients used them for 2 or less, 2 to 5 or more than 5 years, respectively. Only 3% patients took hormone replacement therapy, 7 of them took that fore more than 2 years. Only 6 % patients gave history of smoking and only half of them were currently smoking. Conclusions: This data analysis suggested that pattern of breast cancer in Kuwait is similar to other countries in this region. No significant financial relationships to disclose.
MIX —The first results of the ongoing prospective multicentre phase II study
Authors: Lux M. 
Published: March 2020

10756 Background: The treatment of patiens with metastatic breast cancer (MBC) previously treated with anthracycline represents a significant challenge. Several studies have shown that oral capecitabine is an effective and well-tolerated agent. Mitomycin C has notable therapeutic activity and presents additive effects. Primary endpoints of this ongoing prospective, multi-centre, phase II study are to evaluate the safety and efficacy of the combination. TTP and QoL are secondary endpoints. Methods: Patients receive six cycles of mitomycin C 8 mg/m2, d1, and capecitabine 2,000 mg/m2, d1–14, q21d. 46 patients are planned for treatment, 17 patients are already enrolled. Evaluation (RECIST) has to be done after the fourth and sixth cycle. Safety is evaluated in all patients. Data for 16 patients were analysed, one patient has not be monitored up to date. Results: All patients have been pre-treated with anthracyclines and 62.5% with taxanes. 68.8% had multiple sites of metastases. 6.3% received just 1 cycle, 6.3% 2, 12.5% 3, 31.3% 4 and 43.8% 6 cycles. 11.3% of the cycles received dose reduction and 12.7% interval prolongation. Following grade 3- and 4-toxicities (NCI CTC) were observed in the 71 cycles: dyspnea [3 × grade 3 and 2 × grade 4; all occurred in patients with pulmonal metastases or pleural effusions], nausea (1 × grade 3), thrombopenia (2 × grade 3), fatigue (1 × grade 3), mucositis (1 × grade 3) and hand-foot-syndrome (4 × grade 3). Best response rates were: 18.8% progressive disease, 37.5% stable disease, 31.3% partial remission and 12.5% complete remission. Conclusions: The treatment with mitomycin C and capecitabine presents a favourable safety profile, which is well tolerated and active in this setting. The safety commission recommends the continuation after revision of the preliminary data. No significant financial relationships to disclose.
Epirubicin and docetaxel is an effective neoadjuvant therapy for breast cancer: Result of a phase II study
Authors: Bova A. , Jennifer H. , Venkatappa S. , Ozer H. , Tfayli A. 
Published: March 2020

10759 Background: Anthracyclines and Taxanes represent the 2 most active classes of chemotherapeutic drugs against breast cancer. This study assesses the efficacy of Epirubicin and Docetaxel as neoadjuvant therapy for women with breast cancer. Methods: This is a single institution, single arm, phase II study of Epirubicin given at 75 mg/m2 and Docetaxel at 75 mg/m2 every three weeks for 4 cycles prior to surgical excision in women with large breast cancers. Pegfilgrastim was routinely administered as primary prophylaxis against febrile neutropenia. Results: Of 18 patients enrolled on the study, 12 (66.7%) had a clinical response and 13 (72.2%) had a pathologic response, with a pathologic complete response of 5.6%. Premenopausal women and patients with estrogen receptor positive tumors had a higher response rate. One patient died due to sepsis and febrile neutropenia. Conclusions: Combination chemotherapy with Epirubicin and Docetaxel is highly active against breast cancer. With close monitoring for toxicity, this combination can be safely administered with mild side effects. [Table: see text]
The role of bisphosphonates and bone health issues in Japanese Breast Cancer patients: Efficacy of alendronate with aromatase inhibitors
Authors: Yamada K. , Kohno N. , Endoh K. , Kimura D. , Ueno F. , Ogata A. , Ohta D. , Kaise H. , Kato H. 
Published: March 2020

10777 Background: Adjuvant hormonal therapy for postmenopausal breast cancer is now one of the most significant therapies in the world. From the results of the ATAC trial and the ITA trial, standard hormonal therapy for postmenopausal breast cancer has changed from tamoxifen to aromatase inhibitor. However concerning the rate of bone-relating complications including bone fracture, osteoporosis, a decrease in bone mineral density (BMD), aromatase inhibitor is reported higher than tamoxifen. According to the 2003 ASCO guidelines on the role of bisphosphonates in women with breast cancer, most women with newly diagnosed breast cancer are at risk of osteoporosis due to either their age or their breast cancer treatment. The Panel recommended an algorithm for patient management to maintain bone health. The purpose of the study is to investigate the efficacy of bisphosphonate for prevention from osteoporosis by aromatase inhibitor in Japanese women with breast cancer. Methods: From 2002 to 2004, we experienced 92 cases of postmenopausal Japanese women who underwent breast cancer operations and take aromatase inhibitor after operations in Tokyo Medical University hospital. We selected two medicines. One is Anastrozole (ArimidexR) as an aromatase inhibitor, and the other is Alendronate (BonalonR) as a bisphosphonate medicine.We investigated the change of BMD, calcium, bone absorption marker like NTX, I-CTP. Results: The value of NTX which patients take Alendronate with Anastrozole decreased about 40% than which patients take Anastrozole alone. Also the rate of bone-relating complications is lower.The mean value of BMD, % YAM, T-score, Z-score is 0.86, 81.0, −1.52, 1.47, respectively. Conclusions: The results suggest the efficacy of bisphosphonate for prevention from bone-relating complications osteoporosis by aromatase inhibitor in Japanese women with breast cancer. No significant financial relationships to disclose.