bluuebunny/crossref_metadata_2025_split huggingface dataset:
Adjuvant CAF versus AC followed by paclitaxel for operable breast cancer with 4 or more involved axillary lymph nodes: Retrospective analysis
Authors: Ahn J. , Kim S. , Son B. , Ahn S. , Kim W. 
Published: March 2020

10610 Background: Recently, adjuvant AC followed by paclitaxel has improved disease-free survival (DFS) or overall survival (OS) of node-positive breast cancer. Although adjuvant TAC, as compared with FAC, significantly improves DFS and OS rate in node-positive breast cancer, AC→T has not been yet compared with FAC. Since 2001, we discussed the options of adjuvant CAF versus AC→T with patients who had 4 or more positive axillary nodes. We evaluated the efficacies of adjuvant CAF and AC→T, retrospectively. Methods: Between September 2001 and July 2004, a total of 1,394 patients underwent surgery and received adjuvant chemotherapy. Among them, 253 (18.1%) patients had 4 or more than axillary nodes and received either six cycles of CAF (n = 116) or 4 cycles of AC→T) (n = 137). The medical records and pathologic data of these patients were reviewed, retrospectively. Results: Median age of all patients was 46 years (range, 22∼76 years). The two groups were well balanced in terms of demographic and tumor characteristics. With a median follow-up period of 24 months (range, 6∼90 months), 49 (19.4%) patients had disease recurrence including 27 (23.3%) in CAF group and 22 (16.1%) in AC→T group (p = 0.155). The 3 year-DFS rate was 68.3% in CAF group and 71.1% in AC→T group (p = 0.9366), and the estimated 3-year OS rate was 90.3% and 92.3%, respectively (p = 0.8237). There was no significant difference in 3-year DFS rate according to hormone-receptor status. Febrile neutropenia occurred in 11 (9.6%) patients in CAF group and 7 (5.1%) patients in AC→T group (p = 0.222). Conclusion: Our data suggest that there is no significant difference in DFS or OS rates between six cycles of CAF and 4 cycles of AC followed by 4 cycles of paclitaxel as adjuvant chemotherapy in patients with 4 or more than involved axillary nodes. However, long-term follow-up period and prospective studies are needed to define better regimen. No significant financial relationships to disclose.
Oral adjuvant treatment choices and local recurrence risk in early stage breast cancer
Authors: Russo S. A. , Akbari M. , Grann V. R. , Jacobson J. S. , Chen C. 
Published: March 2020

10625 Background: Among women (W) with early-stage breast cancer (BC) treated with lumpectomy and radiation therapy (RT), those who also receive oral adjuvant therapy (OAT) have a lower risk of local recurrence (LR). The purpose of this study was to evaluate the associations of age (A), race/ethnicity (RE), education (E), socioeconomic status (SS), LR rate, and knowledge about potential side effects (SE) with W’s willingness to receive OAT. Methods: Between 6/05 and 9/05, we asked W with (+) and without (−) BC to participate in an IRB-approved survey. The survey questionnaire presented W with clinical vignettes including information about RT ± 5 years of OAT and the LR and SE associated with treatment options. It then asked W to choose between the treatment options and to rate them, using a time trade-off method, given LR and SE. Results: The distribution of the 161 respondents (55 (+)BC and 106 (−)BC) by A, RE, E, SS is shown in the table below. A and RE were associated with a W’s choice of combined modality treatment (CMT) consisting of RT and OAT, to decrease the risk of LR (p < 0.009 and p < 0.056). Stratified analysis showed an association between CMT and E (p < 0.006) in W (+)BC; A (p < 0.04) and SS (p < 0.04) were associated with CMT choice when SE were described. In W (−) BC, RE (p < 0.02) and SS (p < 0.04) were associated with CMT choice when SE were described. Compared to W who had used oral contraceptive agents (OCA), women who did not use OCA were 45% less likely to trade time to decrease their risk of LR by taking OAT when told about similar SE between OCA and OAT (OR = 0.55, 95% CI 0.28, 1.09), but this association was not statistically significant. Conclusions: W of various A, RE, E and SS who were given information about treatment choices with LR rates chose therapies that gave them the best chance of disease-free survival. For W (+) BC history, level of E significantly influenced the choice to proceed with CMT. A, RE and SS influenced CMT choice when SE were described. W who had used OCA in the past may have been less concerned than others about potential side effects of OAT. [Table: see text] No significant financial relationships to disclose.
Factors influencing the switch from Tamoxifen (TAM) to Aromatase Inhibitors (AIs) as adjuvant therapy in early breast cancer (EBC) patients (pts). Results from the NORA study
Authors: Pronzato P. , Cazzaniga M. E. , Mustacchi G. , De Matteis A. , Di Costanzo F. , Verusio C. , Marzano N. , Rulli E. , Floriani I. 
Published: March 2020

10633 Background: Results from recent trials indicate that AIs as adjuvant treatment, either as up-front therapy or sequencing after TAM, can improve the clinical outcome of EBC pts. It is therefore important to assess the prevalence of the AI use in adjuvant setting and the reasons associated to the choice of this treatment. PATIENTS AND Methods: The NORA trial is an observational study, aimed at investigating adjuvant treatment modalities, that consecutively enrolled 3515 EBC pts, according to the following criteria: 10 pts each year starting from 2000 (retrospective cohort) and 20 pts starting from the beginning of 2003 or the date of ethical approval, if subsequent (prospective cohort). Using data from NORA, we focused on the subgroup of pts who switched from TAM to AIs in order to determine which factors are more likely to be associated with the probability of switching. Multivariate analysis was conducted using the Cox’s regression model. Results: Out of 2075 pts who started TAM, 329 (15.9%) switched to AIs. They had a median age of 63.1 yrs, 147 (45.9%) were N+, 190 (57.8%) received chemotherapy, 179 (54.6%) were T1, 248 (77.5%) were ER+/PgR+. Switch from TAM to AIs was influenced by N+ status, previous chemotherapy and age, whereas no effect was observed for T size or HR status. Previous chemotherapy increases the probability of switching by 27% (95% CI -4% to +70%, p = 0.10), each age decade increase by 35% (95% CI +21% to +52%, p < 0.0001), N+ status by 16% (95% CI +1% to 34%, p = 0.03). Conclusion: As expected, high risk N+ pts have higher probabilities to be switched in comparison to other groups, probably due to the encouraging results of AIs trials. In previously treated or older age pts, TAM side effects could have determined the switch. No significant financial relationships to disclose.
Analysis of skeletal morbidity in breast cancer (BC) patients treated with zoledronic acid (Zol) or placebo: Time to first pathologic fracture
Authors: Sauter N. , Minami H. , Kohno N. , Aogi K. , Takashima S. 
Published: March 2020

10639 Background: We have previously reported that Zol significantly delayed time to first skeletal-related event (SRE) compared with placebo in BC patients with bone metastases in a multicenter randomized trial conducted in Japan. Patients with bone metastases from BC suffer from a range of skeletal complications, including pathologic fractures that can dramatically decrease mobility and adversely affect patient autonomy and quality of life. Methods: 228 women with bone metastases were randomized to 4 mg Zol (n = 114) or placebo (n = 114) every 4 weeks for 1 year. Time to first skeletal event was estimated using the Kaplan-Meier method for all individual types of event. Median time to individual skeletal events was not reached in either treatment group; therefore, data are presented as the incidence at 1 year, and the log-rank P value is from the Kaplan-Meier estimate of time to first event. Results: Median time to first SRE (including hypercalcemia) was not reached in the Zol group versus 360 days in the placebo group (P = .002). Time to first pathologic fracture (P = .022), spinal cord compression (P = .022), need for radiation therapy to palliate bone pain (P = .054), and hypercalcemia (P = .040) were all reduced in the Zol group compared with the placebo group. The incidence of each of these events at 1 year is shown in the table . Cox regression analysis (adjusting for stratification factors) also showed that treatment with Zol significantly reduced the risk of pathologic fractures by 39% compared with placebo (hazard ratio = 0.61; P = .041). Conclusions: This prospective analysis of time to first skeletal event demonstrates that treatment of BC patients with Zol significantly delays the onset and reduces the risk of skeletal complications, including pathologic fractures, which may help preserve independence and quality of life. [Table: see text] [Table: see text]
Phase II study of weekly nanoparticle paclitaxel (ABI-007), carboplatin and trastuzumab as first-line therapy of HER2-positive metastatic breast cancer
Authors: Seidman A. D. , Danso M. , Bach A. , Smith M. , Liu M. , Dickler M. , Robson M. , Moynahan M. E. , Lake D. , Hudis C. A. 
Published: March 2020

10650 Background: The combination of carboplatin (C), paclitaxel (P) and trastuzumab (T) is active in HER2+ metastatic breast cancer (MBC) (Robert N et al. Proc ASCO 2003), and safer with weekly administration of all 3 agents (Perez E et al. Proc ASCO 2004). The superiority of nanoparticle paclitaxel (Abraxane, AB) over Cremophor-based paclitaxel (Gradishar W et al. JCO 2005), and the efficacy and safety of weekly AB in MBC (Blum J et al. Proc ASCO 2005) motivated us to conduct this study. Materials/Methods: To date 10 of 50 planned patients (pts) with measurable, HER2+ MBC have entered. After we established the safety of AB at 75 mg/m2 on days 1, 8, and 15 every 28 days (n = 4 pts), all subsequent pts received AB at 100 mg/m2. C was dosed at AUC = 2 on the same schedule, and T was weekly at 2 mg/kg without interruption, after a 4 mg/kg load. Initially, no prophylactic anti-allergy medication was given. Treatment is until disease progression (PD) or prohibitive toxicity. Pts without PD at 6 months may opt to continue T alone. Median age: 42 yrs (29–66), ECOG PS 0/1 (70/30%); 6 pts had prior adjuvant chemotherapy; 1 with anthracycline (A) and 4 with A + taxane (> 1 yr prior). Results: 68 cycles have been delivered to date (median: 8, range 1–9). Dose reductions of AB and C have been necessary in 4 pts (to 80 mg/m2 and AUC of 1.5 weekly), with delays in 4 pts. 3 pts had hypersensitivity reactions (HSR) to C and continued protocol therapy without C (n = 2) or with C and the addition of anti-HSR premeds (n = 1). Grade ¾ toxicities include neutropenia (44/11%) with 1 episode of febrile neutropenia. Grade ¾ anemia or thrombocytopenia has not occurred. Grade ¾ non-hematologic toxicity has been rare: 1 instance of grade 3 neuropathy (2 pts with grade 2). 7 partial responses have been observed in the first 9 evaluable pts (78%, 95% CI 44–93%), in liver, lung, bone and soft tissue sites, including 4 pts with prior adjuvant taxane. The median time to PD is not reached at 9.9+ months (7.3–9.9+). Accrual continues as the trial expands to additional study sites. Conclusions: The weekly administration of AB, C, and T demonstrates promising preliminary efficacy as 1st-line treatment for HER2+ MBC. With the exception of HSRs due to weekly C, a very favorable toxicity profile is observed. [Table: see text]
Internet use is associated with utilization of genetic counseling for BRCA 1/2 mutations in women with a family history of breast or ovarian cancer
Authors: Armstrong K. , Gray S. , Domchek S. 
Published: March 2020

10654 Background: Women obtain breast cancer risk information from a variety of sources including mass media, the internet and personal and professional sources. Little is know about how internet use for health information influences choices about breast cancer risk evaluation and decision making. Methods: Case control study of 408 women with a family history of breast or ovarian cancer, of whom 217 underwent genetic counseling for BRCA 1/2 testing (cases) and 191 women who did not (controls). Participants received primary care within a large health system in greater Philadelphia, PA. Results: Women with a family history of breast or ovarian cancer who reported frequent use of the internet for health information (>1–2 times a month) were significantly more likely to undergo genetic counseling for BRCA 1/2 testing than women that rarely used the internet to obtain health information (<2 times a year) (odds ratio 2.6; 95% CI 1.7–4.0). This association persisted after adjustment for age, race, education and Gail risk (adjusted odds ratio 2.1; 95% CI 1.05–4.2) Conclusions: Frequent use of the internet for health care information is associated with higher use of genetic counseling for BRCA 1/2 mutations in women with a family history of breast or ovarian cancer. The association can not be explained by differences in education, cancer risk, age or race. A possible hypothesis for this association is that internet use exposes women to more information about genetic testing, BRCA testing opportunities and the experiences of other women who have utilized BRCA counseling services. No significant financial relationships to disclose.
Correlation of dynamic infrared imaging with radiologic and pathologic response for patients treated with primary systemic therapy for locally advanced breast cancer
Authors: Fanning S. R. , Short S. , Coleman K. , Andresen S. , Budd G. T. , Moore H. , Rim A. , Crowe J. , Weng D. E. 
Published: March 2020

10696 Background: Assessment of response to therapy for locally advanced breast cancer includes serial assessments of physical exam, radiologic imaging, or repeated biopsies. Expense, subjective assessment, and patient risk make these methods impractical. Dynamic infrared imaging (DIRI) utilizes a quantum well infrared photon (QWIP) sensor with software to analyze the emission patterns over time. DIRI can detect biological temperature gradients with sensitivity of 0.009ºC. Tumor-induced local tissue nitric oxide production can increase local capillary blood flow. Anti-tumor therapies have been shown to result in decreased peri-tumoral capillary blood flow. These changes in temperature, detected by serial DIRI imaging, may provide a low cost, non-invasive, easily reproducible objective tool for real-time clinical assessment. Methods: In this prospective pilot study, we are evaluating patients with locally advanced breast cancer using serial DIRI. Primary endpoints include: sensitivity, specificity, PPV, and NPV of DIRI in comparison to pathologic response, concordance of DIRI to physical exam, and concordance of DIRI to standard radiographic evaluation at initial diagnosis and prior to surgery. DIRI results are reported as quantification of changes in the 0.2Hz modulation of temperature over the breast during the course of treatment and measurement of area of average temperature in a region of interest compared between breasts. One hundred patients will be enrolled in this trial. Results: Sixteen patients have been enrolled. Six have proceeded to surgery. All but one patient exhibited evidence of tumor response by physical exam. These findings correlated with response when comparing initial to pre-surgical MRI. In all responding patients, DIRI results revealed a decrease in the number of regions over the breast in which the 0.2Hz frequency dominated. Similarly, DIRI evaluation according to area of average temperature in the region of interest compared between breasts was concordant in patients with response to therapy. Conclusions: Assessment of response by physical exam, MRI, and DIRI were consistent. Preliminary data reveals that serial DIRI imaging can be an effective adjunctive tool. No significant financial relationships to disclose.
Randomized phase II trial of two different schedules of carboplatin (C) and paclitaxel (P) + trastuzumab (T) as first line treatment for metastatic breast cancer (MBC)
Authors: Tauer K. , Schwartzberg L. S. , Epperson A. , Fortner B. V. 
Published: March 2020

10697 Background: Platinum compounds given with taxanes have emerged as an active combination for the treatment of MBC. However, optimal scheduling of these drugs is unknown. While evidence suggests weekly P may be superior to Q 3 wks, conflicting data exists for weekly vs. Q 3–4 wk C. Methods: Eligible patients (pts) had no prior chemotherapy for Stage IV disease and no prior exposure to platinum agents. Pts were stratified by HER2 status and randomized to receive either C, AUC 2, day 1,8,15 (C1 arm) + P 80 mg/m2 day 1,8,15 or C, AUC 6 day 1 (C4 arm) + P 80 mg/m2 day 1, 8, 15 in a 28 day cycle. HER2+ pts received T weekly at 2mg/kg after a loading dose of 4 mg/kg. The primary endpoint, overall response rate (ORR), was evaluated after every 2 cycles of therapy. Results: To date, 35 patients have been enrolled (19 HER2+). 31 are evaluable for toxicity and 22 for response. The median age is 52 (range 25–76), 17 had prior adjuvant therapy, median number of sites of disease was 2. Partial responses were noted in 4/10 in C4 arm and 7/12 in C1 arm for an ORR of 50%. The ORR for Her2+ pts to CP+T was 64%. 8/16 (50%) pts on the C4 arm and 2/15 (13.3%) pts on the C1 arm had grade 3/4 toxicity, predominantly hematological. Dose reductions occurred in 3 pts on C4 arm and 3 pts on C1 arm. Conclusions: Carboplatin and paclitaxel (± trastuzumab) is an active regimen when C is given in either weekly or Q 4 wk schedules. Hematologic toxicity is significantly less when C and P are both given weekly, and thus should become the preferred schedule in MBC. No significant financial relationships to disclose.
Experience with breast cancer in a single oncology clinic in Nairobi
Authors: Othieno-Abinya N. A. , Abwao H. O. , Bird P. , Baraza R. , Byakika B. , Kodwavwalla Y. 
Published: March 2020

10714 Background: Combinations of anthracyclines and cyclophosphamide ± 5-FU are widely used in treatment of breast cancer (BC) in the adjuvant setting. Addition of taxanes is beneficial. For Her2-positive tumours addition of herceptin may improve relapse-free survival in the adjuvant setting, and prolongs survival in metastatic setting. We routinely use doxorubicin and cyclophosphamide (AC) x 6 courses for standard risk disease and give the same x 4 followed by docetaxel ± herceptin x 4 for those with ≥ 10 positive axillary nodes. We also use AC as first line for endocrine nonresponsive metastatic BC. Methods: A total of 173 BC patients seen in our clinic between January 1997 and May 2005, 83 were given chemotherapy both in the adjuvant and metastatic settings. Results: Of 83 patients, 81 were female and 2 males, age range 24–71, median 45 years. Seventy-eight cases were ductal carcinoma, not otherwise stated, 1 colloid, 1 anaplastic, 1 adenosarcomatoid, 2 medullary. Fifty-six were post resection and 27 metastatic. Thirty eight sites of metastasis or spread were evaluable. These were skeletal 10 (26.3%), liver 7 (18.4%), chest wall 6 (15.9%), lungs and pleura 9 (23.7%), brain 4 (10.5%) and supraclavicular nodes 2 (5.3%). Her2 expression by immunohistochemistry in 20 cases was - 3+ in 7 (35%), 2+ in 3 (15%) and ≤ 1+ in 10 (50%). Out of 40 cases, 15 (37.5%) were endocrine responsive, 17 (42.5%) nonresponsive and 8 (20%) indeterminate. Twenty seven patients treated before January 2004 were recorded dead after survival ranging between 8 and 96 months, median 36 months. Only 3 patients with resected BC were recorded dead as opposed to 24 with MBC at diagnosis. Two of the deaths in the adjuvant setting were in patients with ≥ 10 nodes positive and both had the brain as the only site of metastasis. There was no significant correlation between nodal status and follow-up duration (P = 0.43), hormone receptor status and survival (P = 0.20), and Her2-expression and survival (P = 0.23). Conclusions: This material shows a low frequency of ER positivity and higher mortality particularly from brain metastasis than most Western series. It does however show a similarity to recent reports of breast cancer in African-American women. No significant financial relationships to disclose.
High efficacy and low toxicity of the combination of vinorelbine and capecitabine as second line treatment in metastatic breast cancer previously treated with taxanes and/or anthracyclines
Authors: Orphanos G. , Alexopoulos A. , Ioannidis G. , Kandylis C. , Ardavanis A. , Stavrakakis J. , Rigatos G. 
Published: March 2020

10719 Background: Capecitabine and Vinorelbine have shown considerable activity given as single agent or in combination with other drugs. The aim of this single institution ph.II study is to evaluate the response to the combination of Capecitabine and Vinorelbine given as second line treatment in patients with metastatic breast cancer previously treated with taxanes and/or anthracyclines. Methods: The regimen consists of Capecitabine 2000 mg/m2 D1-D14 and Vinorelbine 20 mg/m2 D1,D8 q 3 weeks for six cycles. Evaluation of response was accomplished with CT scan after the third and sixth cycle. Patients with disease progression after cycle 3 are taken off protocol. Patients with gr 2/3 granulocytopenia are given G-CSF for all subsequent cycles and there is a 20% dose reduction in both drugs for patients with gr 4 granulocytopenia. Results: 30 pts have been enrolled so far; according to statistical planning the total number of accrued pts should reach 63. Median age 55 yrs (30–76), median ECOG PS 1 (0–2), pre/postmenopausal 6/24. Number of metastatic sites: 1 in 6 pts, 2 in 15 pts, 3 in 6 pts and 4 in 3 pts. A total of 146 cycles was administered. Overall response rate 50% with CR in 2 (6.7%) pts, PR in 13 (43.3%) pts. Stable disease was observed in 4 (13.3%) pts, 8 (26.6%) pts had progressive disease and 3 (10%) were non evaluable. Toxicity: anemia gr 2 in 2 (6.7%) pts and gr 3 in 1 (3.3%) ptn, thrombocytopenia gr2 in 2 (6.7%) pts, granulocytopenia gr 2/3 in 17 (56.7%) pts and gr4 in 1 (3.3%) ptn. Gr 1/2 nausea or vomiting was observed in 5 (16.6%) pts and gr 3/4 in 2 (6.7%) pts. Vinorelbine induced phlebitis in 3 (10%) pts, gr1/2 diarrhea in 3 (10%) and fungal infection of the nail beds in 2 (6.7%) pts. Conclusions: Preleminary results suggest that the Capecitabine and Vinorelbine combination is an active and safe regimen for second line metastatic breast cancer treatment. The study remains open to achieve the planned patient accrual. No significant financial relationships to disclose.