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1.
Ajay Dhakal Christina M. Matthews Ellis Glenn Levine Kilian Elizabeth Salerno Fan Zhang Kazuaki Takabe Amy P. Early Stephen B. Edge Tracy O&#x;Connor Thaer Khoury Jessica S. Young Mateusz Opyrchal 《Clinical breast cancer》2018,18(6):e1401-e1405
Purpose
Outcome data on hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) nonamplified (HER2?) metastatic breast cancer (MBC) treated with palbociclib after treatment with everolimus are lacking. The PALOMA-3 trial, showing benefit of palbociclib plus fulvestrant compared to fulvestrant alone in HR+HER2? MBC after progression while receiving endocrine therapy excluded women previously treated with everolimus. The objective of this study was to examine outcomes of HR+HER2? MBC with prior exposure to everolimus while receiving palbociclib-based therapy.Patients and Methods
A retrospective, single-institute review was conducted of HR+HER2? MBC from January 2014 to November 2016 in patients treated with palbociclib after prior treatment with everolimus. Progression-free survival (PFS) was defined as the time from initiation of palbociclib to the date of progression as determined by the treating physician based on radiologic, biochemical, and/or clinical criteria. Response rates were determined on the basis of available radiologic data. Objective response rate (ORR) was defined as the rate of any complete or partial responses; clinical benefit rate (CBR) was the rate of complete response, partial response, or stable disease for at least 24 weeks.Results
Twenty-three patients with a mean (range) age of 68 (42-81) years were identified. Kaplan-Meier estimate showed median PFS of 2.9 months (95% confidence interval, 2.1-4.2); ORR was 0 of 23 and CBR was 4 (17.4%) of 23. In the PALOMA-3 trial, median PFS, ORR, and CBR of palbociclib cohort were 9.5 months (95% confidence interval, 9.2-11.0), 19%, and 67%, respectively.Conclusion
There is a limited clinical activity of palbociclib combinations after progression with everolimus combination therapy. Further studies are necessary to confirm these findings. 相似文献2.
Jacques Raphael Alex Kiss Sharon Nofech-Mozes Maureen Trudeau 《Clinical breast cancer》2018,18(6):e1381-e1387
Purpose
To compare tumor response rates and survival outcomes between single and double hormone receptor (HR)-positive breast cancer (BC) patients treated with neoadjuvant chemotherapy.Patients and Methods
A retrospective review was conducted using the Sunnybrook Biomatrix database to identify eligible patients. A multivariable logistic regression analysis was performed to assess the association between HR status (single/double HR+) and pathologic complete response (pCR) rates. A Kaplan-Meier method was used to estimate recurrence-free survival (RFS), and a log-rank test was used to compare RFS between 3 subgroups: single or double HR+ and HR? patients.Results
Three hundred four BC patients were included in the analysis with a median follow-up of 43.3 months (Q1-Q3, 28.7-61.1). Forty-seven percent (47/101), 31% (11/36), and 14% (23/167) of patients with HR?, single HR+, and double HR+ disease experienced pCR, respectively. Patients’ characteristics differed between single and double HR+ disease (age, human epidermal growth factor receptor 2, and nodal status). Only in univariate analysis were patients with single HR+ disease more likely than patients with double HR+ disease to experience a pCR (odds ratio = 2.6; 95% confidence interval, 1.14-6.01; P = .02). However, this association did not remain significant in multivariable logistic regression analysis (odds ratio = 1.82; 95% confidence interval, 0.72-4.56; P = .2). No difference in survival (RFS) was seen in the 3 subgroups: HR?, and single and double HR+ patients.Conclusion
Patients with single versus double HR+ BC have different tumor characteristics. Their outcome may differ in terms of pCR and survival. Prospective studies are needed to validate this conclusion, which may have treatment implications. 相似文献3.
Eunhae Um Ji-Won Kang SaeByul Lee Hee Jeong Kim Tae in Yoon Guiyun Sohn Il Yong Chung Jisun Kim Jong Won Lee Byung Ho Son Sei Hyun Ahn Beom Seok Ko 《Clinical breast cancer》2018,18(5):e1087-e1091
Background
Neoadjuvant systemic therapy (NST) is performed to increase the rate of breast-conserving surgery in advanced breast cancer patients. Although magnetic resonance imaging (MRI) is accurate in predicting residual cancer, if calcification remains, the issue of whether to perform the surgery on the basis of the residual tumor prediction range in mammography (MMG) or MRI has not yet been elucidated. This study aimed to estimate the accuracy of predicting residual tumor after NST for residual microcalcification on mammographic and enhancing lesion on MRI.Patients and Methods
This was a single-center, retrospective study. We included breast cancer patients who underwent NST, had microcalcifications in the post-NST MMG, and underwent surgery from January 2, 2013 to December 30, 2014 at Asan Medical Center. Patients with post-NST MMG as well as MRI were included. Final pathologic tumor size with histopathology and biomarker status were obtained postoperatively.Results
In total, 151 patients were included in this study. Overall, MRI correlated better than MMG in predicting the tumor size (intraclass correlation coefficient [ICC], 0.769 vs. 0.651). For hormone receptor (HR)-positive (HR+)/HER2? subtype, MMG had higher correlation than MRI (ICC = 0.747 vs. 0.575). In HR? subtype, MRI had a strong correlation with pathology (HR?/HER2+ or triple negative (TN), ICC = 0.939 vs. 0.750), whereas MMG tended to overestimate the tumor size (HR?/HER2+ or TN, ICC = 0.543 vs. 0.479).Conclusion
Post-NST residual microcalcifications on MMG have a lower correlation with residual tumor size than MRI. Other than HR+/HER2? subtype, the extent of calcifications on preoperative evaluation might not be accurate in evaluating the residual extent of the tumor after NST. 相似文献4.
Naoki Hayashi Yuko Takahashi Naoko Matsuda Hiroko Tsunoda Atsushi Yoshida Koyu Suzuki Seigo Nakamura Hideko Yamauchi 《Clinical breast cancer》2018,18(2):e219-e229
Background
Although the prognostic value of pathologic complete response (pCR) after neoadjuvant chemotherapy (NAC) depends on the intrinsic subtype of breast cancer, it is not clear whether chemosensitivity itself, shown by a decreasing tumor burden after NAC, contributes to improved prognosis in primary breast cancer patients, especially in patients with non-pCR. The aim of this study was to assess the prognostic effect of changes in tumor stage or nodal status after NAC in each primary breast cancer subtype.Patients and Methods
We assessed 719 consecutive patients with primary breast cancer who underwent surgical resection after NAC between 2001 and 2010. The patients were divided into 5 subtypes according to their hormone receptor (HR) status, HER2 status, and nuclear grade (NG; 1/2 = low, and 3 = high).Results
In patients with HR-positive (HR+)/HER2?/NG-low tumors, regardless of change in tumor size, the loss of node positivity after NAC significantly improved disease-free survival (DFS). In patients with HR+/HER2?/NG-high tumors, achievement of tumor downstaging as well as the loss of node positivity improved their DFS. In patients with HR?/HER2? tumors, tumor downstaging and the loss of node positivity significantly improved DFS, despite a non-pCR. In contrast, in patients with HER2+ tumors, changes in tumor stage or nodal status were not associated with prognosis unless pCR was achieved.Conclusion
Our results revealed that changes in tumor stage and nodal status after NAC might be prognostic markers in patients with HR+/HER2?/NG-high tumors or HR?/HER2? tumors, even if there are residual tumors in the breast. 相似文献5.
Sunil W. Dutta Daniel M. Trifiletti Surbhi Grover Kara D. Romano Einsley-Marie Janowski Shayna L. Showalter 《Clinical breast cancer》2018,18(2):121-127
Background
There is an established relationship between hormone receptor (HR; estrogen and/or progesterone receptors) status, HER2 status, and locoregional recurrence. The purpose of this study was to analyze how HR and HER2 receptor status have influenced the surgical management trends among patients with early stage breast cancer.Patients and Methods
The National Cancer Database was queried for patients with cT1 to cT3, cN0, and cM0 breast carcinoma from 2004 to 2012. Patients were grouped on the basis of receptor status and surgical management (mastectomy or breast-conserving surgery [BCS]). Multivariable analyses were performed to investigate factors associated with increased odds of receiving mastectomy over BCS. Among a subgroup of patients who underwent ipsilateral mastectomy, analyses were performed to determine any association between contralateral prophylactic mastectomy (CPM) and receptor status.Results
We found 280,241 patients who met inclusion criteria for analyzing mastectomy or BCS surgical decision. Patients with HER2-positive (HER2+) tumors (HR+/HER+ and HR?/HER2+) were the most likely to undergo mastectomy (odds ratio [OR], 1.212 and 1.499 respectively, compared with HR+/HER2? patients, each P < .001). HR status alone did not affect ipsilateral surgical management as patients with HR+/HER2? and HR?/HER2? tumors demonstrated similar mastectomy rates (P = .391). Among the 108,018 who underwent mastectomy, 20% underwent CPM. After adjustment, patients with HR+/HER2+, HR?/HER2+, and HR?/HER2? were all more likely to undergo CPM (OR 1.356, 1.608, and 1.358, respectively compared with HR+/HER2? patients, each P < .001).Conclusion
This analysis indicates that patients with early stage breast cancer are more likely to undergo a mastectomy and CPM if they have HER2+ tumors. 相似文献6.
Barbara Fowble Abhishek Keshav Jairam Frederick Wang Anne Peled Michael Alvarado Cheryl Ewing Laura Esserman Catherine Park Ann Lazar 《Clinical breast cancer》2018,18(1):e107-e113
Introduction
Downstaging with neoadjuvant chemotherapy (NAC) might obscure indications for postmastectomy radiation (PMRT). The degree of downstaging that results in local-regional recurrence (LRR) rates low enough to omit PMRT remains controversial. We examined the rate of LRR in women who received NAC who underwent mastectomy without PMRT.Patients and Methods
Between 2004 and 2013, 81 women with stage I to IIIA breast cancer had NAC and mastectomy; 48 patients (59%) were clinical N0 and 33 patients (41%) were clinical N1; median age was 45 years; 33 patients (41%) had hormone receptor-positive (HR+)HER2?, 21 patients (26%) HR+HER2+, 19 patients (23%) HR? HER2?, and 7 patients (9%) HR?HER2+ disease. We explored how LRR rates varied with age, BRCA status, Grade, receptor status, clinical N status, pathologic response, lymphovascular invasion, and mastectomy margins. Median follow-up was 4.9 years.Results
After NAC, 35 patients (43%) had a pathologic complete response (pCR), 33 patients (41%) were ypN0, and 13 patients (16%) were ypN1-3+. There were 8 LRRs (6 chest wall, 1 axillary, 1 supraclavicular node). The 5-year cumulative incidence of LRR was 8% for all patients, 3% for pCR, 16% for ypN0, 10% for ypN1-3+, 6% for HR+HER2?, 25% for HR+HER2+, 0% for HR?HER2?, and 0% for HR?HER2+. LRR was 31% in the ypN0 and 33% in the ypN1-3+ HR+HER2+ women, and 12% in the ypN0 and 0% in the ypN1 to ypN3+ HR+HER2? patients.Conclusion
This study is unique. All HER2+ patients received trastuzumab and LRR was analyzed according to treatment response, clinicopathologic factors, and receptor status. pCR patients including young women and clinical stage IIIA had low LRR rates. However, ypN0 and ypN1-3+ HR+HER2+ patients had higher rates of LRR compared with other receptor subgroups and on the basis of limited data should be considered for PMRT. 相似文献7.
Thehang Luu Kyu-pyo Kim Suzette Blanchard Bean Anyang Arti Hurria Lixin Yang Jan H. Beumer George Somlo Yun Yen 《Breast cancer research and treatment》2018,167(2):469-478
Purpose
To translate promising preclinical data on the combination of vorinostat and ixabepilone for metastatic breast cancer (MBC) into clinical trials.Methods
We conducted a randomized two-arm Phase IB clinical trial of ascending doses of vorinostat and ixabepilone in prior -treated MBC patients. To determine the maximum tolerated dose (MTD), 37 patients were randomized to schedule A: every-3-week ixabepilone + vorinostat (days 1–14), or schedule B: weekly ixabepilone + vorinostat (days 1–7; 15–21) Pharmacokinetics were assessed. Nineteen additional patients were randomized to schedule A or B and objective response rate (ORR), clinical benefit rate (CBR), toxicity, progression-free survival (PFS), and overall survival (OS) were assessed.Results
The schedule A MTD was vorinostat 300 mg daily (days 1–14), ixabepilone 32 mg/m2 (day 2); 21-day cycle 27% dose-limiting toxicities (DLTs). The schedule B MTD was vorinostat 300 mg daily (days 1–7; 15–21), ixabepilone 16 mg/m2 (days 2, 9, 16); 28-day cycle; no DLTs. Vorinostat and ixabepilone clearances were 194 L/h and 21.3 L/h/m2, respectively. Grade 3 peripheral sensory neuropathy was reported in 8% (A) and 21% (B) of patients. The ORR and CBR were 22 and 22% (A); 30 and 35% (B). Median PFS was 3.9 (A) and 3.7 (B) months. OS was 14.8 (A) and 17.1 (B) months.Conclusions
We established the MTD of vorinostat and ixabepilone. This drug combination offers a novel therapy for previously treated MBC patients. The potential for lower toxicity and comparable efficacy compared to current therapies warrants further study.8.
Introduction
Patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2?) breast cancer have a constant risk of relapse over time. Nearly one-half of the recurrences occur more than 5 years after diagnosis, described as late recurrence, but little is known about late recurrence.Patients and Methods
We reviewed the clinical data of 1941 patients with HR+/HER2? breast cancer who had operations in the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, during 2003 to 2009, and found 390 relapsed cases. Among them, 281 patients were early recurrence, and 109 were late recurrence.Results
In the late recurrence group, patients with ≤ 3 lymph node metastases, double HR+ (estrogen receptor-positive/progesterone receptor-positive) were more common (72.48% vs. 55.52%; P = .005; 82.57% vs. 71.89%; P = .029, respectively) when compared with the early recurrence group. The lung seemed to be a preferential site of late recurrence. Although visceral disease and multi-organ metastases were more frequent in the late recurrence group, survival after recurrence was significantly longer than that in the early recurrence group (52 vs. 40 months; hazard ratio, 1.508; 95% confidence interval, 1.142-1.992; P = .003). Moreover, progression-free survival of first-line treatment was an independent prognostic factor of survival after recurrence in the late recurrence group.Conclusion
Late recurrence differed from early recurrence in many ways in HR+/HER2? breast cancer, and its prognosis was much better. The lung may be a preferential site of late recurrence. More attention should be paid to late recurrence itself. 相似文献9.
Daria Gaut Myung Shin Sim Yuguang Yue Brian R. Wolf Phillip A. Abarca James M. Carroll Jonathan W. Goldman Edward B. Garon 《Clinical lung cancer》2018,19(1):e19-e28
Background
The secondary T790M mutation accounts for more than 50% of acquired tyrosine kinase inhibitor (TKI) resistance in patients with EGFR-mutated non–small-cell lung cancer (NSCLC). Recent reports suggest this resistance mutation may be more common among patients with longer progression-free survival (PFS) on first-line TKI therapy, but much is still unknown.Materials and Methods
Our group collected medical records from patients who underwent a biopsy for T790M mutation testing while screening for clinical trials involving the drug rociletinib (CO-1686), a T790M mutation–specific TKI. Medical records were retrospectively analyzed for demographic data, PFS, and best response to previous therapies.Results
Our patient cohort included 69 T790M+ patients and 28 T790M? patients. Patients who later developed a T790M mutation had a longer PFS on first-line TKI therapy (12.0 vs. 9.0 months, P = .021), but overall response rate (ORR) was the same (75.0% vs. 81.0%, P = .76). There was no difference in PFS on TKI rechallenge (4.0 vs. 3.0 months, P = .94), although there was a trend toward higher ORR in T790M+ patients (22.2% vs. 0%, P = .12). T790M+ patients had a longer PFS on initial chemotherapy treatment (5.0 vs. 4.0 months, P = .025) and a trend toward higher ORR (40.0% vs. 21.4%, P = .31).Conclusion
Our study confirms that tumors expressing T790M have a more indolent progression of disease compared with their T790M? counterparts when treated with both first-line TKI and cytotoxic chemotherapy. 相似文献10.
David R. Spigel Alexander Luft Henrik Depenbrock Rodryg Ramlau Mazen Khalil Joo-Hang Kim Carlos Mayo Grace Yi Chao Coleman Obasaju Ronald Natale 《Clinical lung cancer》2017,18(5):480-488
Background
The combination of necitumumab with gemcitabine-cisplatin significantly improved overall survival (OS) in patients with stage IV squamous non–small-cell lung cancer (NSCLC), in the phase III SQUamous NSCLC treatment with the Inhibitor of EGF REceptor (SQUIRE) trial. Paclitaxel-carboplatin was selected as an alternative standard of care in the current phase II study.Patients and Methods
Patients were randomized (stratified according to Eastern Cooperative Oncology Group performance status and sex) 2:1 to ≤ six 3-week cycles (Q3W) of paclitaxel and carboplatin with or without necitumumab. Chemotherapy was paclitaxel 200 mg/m2 on day 1 Q3W and carboplatin area under the curve 6 on day 1 Q3W. Necitumumab 800 mg, on days 1 and 8, was continued until disease progression or intolerable toxicity occurred. The primary end point was objective response rate (ORR) on the basis of Response Evaluation Criteria In Solid Tumors version 1.1.Results
One hundred sixty-seven patients were randomized to the necitumumab-containing arm (n = 110) or the chemotherapy-only arm (n = 57). The combination of necitumumab with chemotherapy resulted in an ORR of 48.9% versus 40.0%. Median progression-free survival and OS were 5.4 versus 5.6 months (hazard ratio [HR], 1.0) and 13.2 versus 11.2 months (HR, 0.83; P = .379) in each treatment arm, respectively. Disease control rate was 87.2% versus 84.0%. Grade ≥ 3 adverse events typically associated with epidermal growth factor receptor (EGFR) monoclonal antibodies showing a > 2% increase were hypomagnesemia (5.7% vs. 0) and rash (2.8% vs. 0). Any Grade thromboembolic events occurred in < 4% of patients in either arm.Conclusion
The results of our study support previously reported results that the combination of necitumumab with chemotherapy improves survival in patients with advanced squamous NSCLC and shows a safety profile consistent with that of EGFR monoclonal antibodies. 相似文献11.
Emmanouil Saloustros Michail Nikolaou Konstantinos Kalbakis Aris Polyzos Charalampos Christofillakis Nikolaos Kentepozidis Nikolaos Pistamaltzian Charalampos Kourousis Lampros Vamvakas Vasilios Georgoulias Dimitris Mavroudis 《Clinical breast cancer》2018,18(1):88-94
Background
Triple-negative breast cancer (TNBC) lacks a standard targeted therapeutic strategy and is treated with conventional cytotoxic agents. Because of the sensitivity of TNBC to platinum compounds and the synergistic effect of bevacizumab with paclitaxel we investigated the efficacy and toxicity of weekly paclitaxel and carboplatin in combination with bevacizumab as first-line treatment in metastatic TNBC.Patients and Methods
This phase II study followed the Simon’s 2-stage optimal design. Paclitaxel (90 mg/m2) and carboplatin (2 area under the curve) were administered on days 1, 8, and 15 every 4 weeks, preceded by bevacizumab 10 mg/kg on days 1 and 15. The primary end point was the objective response rate (ORR). The null hypothesis that the ORR is ≤ 40% could be rejected if the number of objective responses was ≥ 23 among 46 evaluable patients.Results
A total of 46 patients were enrolled. Seven (15.2%) complete and 23 (50%) partial responses were observed for an ORR of 65.2% (95% confidence interval, 52.9%-80.4%). The median progression-free survival was 10.3 months, the median overall survival 25.7 months, and the median duration of response 18.2 months. Neutropenia Grade III and IV was experienced by 13 (28.3%) and 6 (13.04%) patients, respectively. One patient developed an uneventful Grade IV thrombocytopenia. There was 1 toxic death due to febrile neutropenia. Other Grade III toxicities included anemia (n = 2), neurotoxicity (n = 2), thrombocytopenia (n = 1), and diarrhea (n = 1). No serious bevacizumab-related toxicities were observed.Conclusion
The study achieved its primary end point by showing clinical activity for weekly paclitaxel with carboplatin and bevacizumab combination. This regimen merits further evaluation in this setting. 相似文献12.
Etsushi Akimoto Takayuki Kadoya Keiko Kajitani Akiko Emi Hideo Shigematsu Masahiro Ohara Norio Masumoto Morihito Okada 《Clinical breast cancer》2018,18(1):45-52
Background
Breast cancer can be assessed preoperatively and postoperatively using 18F-fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT). We prospectively analyzed the maximum baseline standardized uptake value (SUVmax) derived from FDG PET/CT to predict the outcomes after neoadjuvant chemotherapy (NAC) for breast cancer.Patients and Methods
We assessed 130 consecutive female patients with primary breast cancer (mean age, 53.9 years) using PET/CT before and after NAC. The SUVmax before (pre-SUVmax) and after (post-SUVmax) NAC and the SUVmax reduction rates (ΔSUVmax) after NAC with sequential anthracyclines and a taxane were assessed to predict the pathologic complete response (pCR) and prognosis.Results
Of the 130 patients, 30 (23.1%) achieved a pCR. The pCR rate of the patients with human epidermal growth factor receptor 2-positive (HER2+) and triple-negative (TN) breast cancer was 52.8% and 40.0%, respectively. In contrast, only 1.4% of those with estrogen receptor-positive and HER2? cancer achieved a pCR. The post-SUVmax correlated closely with the pCR (area under the curve, 0.700) but not with the pre-SUVmax and ΔSUVmax (area under the curve, 0.414 and 0.589, respectively) in patients with HER2+ and TN breast cancer. The post-SUVmax was associated with the pCR (P = .019), and multivariate analysis selected post-SUVmax as a significant prognostic factor (P = .014). The post-SUVmax correlated significantly with recurrence-free survival and recurrence (P = .026, log-rank test).Conclusion
The SUVmax determined after NAC using FDG PET/CT can predict for the pCR and the prognosis of patients with operable HER2+ and TN breast cancer. In the future, additional chemotherapy will be applied according to the post-SUVmax after standard NAC to achieve a pCR or omit surgery. 相似文献13.
Patrick G. Morris Selene Rota Karen Cadoo Stephen Zamora Sujata Patil Gabriella D&#x;Andrea Theresa Gilewski Jacqueline Bromberg Chau Dang Maura Dickler Shanu Modi Andrew D. Seidman Nancy Sklarin Larry Norton Clifford A. Hudis Monica N. Fornier 《Clinical breast cancer》2018,18(5):387-394
Background
Overexpression and activation of tyrosine kinase Src has been linked to breast carcinogenesis and bone metastases. We showed the feasibility of combining the SRC inhibitor dasatinib with weekly paclitaxel in patients with metastatic breast cancer (MBC) and herein report the subsequent phase II trial.Patients and Methods
Patients had received ≤ 2 chemotherapy regimens for measurable, HER2-negative MBC. Patients received paclitaxel and dasatinib (120 mg daily) and were assessed according to Response Evaluation Criteria in Solid Tumors for overall response rate (ORR), the primary end point. Secondary end points included progression-free survival (PFS) and overall survival (OS). A 30% ORR (n = 55) was deemed worthy of further investigation. Exploratory biomarkers included N-telopeptide (NTX) and plasma vascular epidermal growth factor (VEGF) receptor 2 as predictors of clinical benefit.Results
From March 2010 to March 2014, 40 patients, including 2 men enrolled. The study was stopped early because of slow accrual. Overall, 32 patients (80%) had estrogen receptor-positive tumors and 23 (58%) had previously received taxanes. Of the 35 assessable patients, 1 (3%) had complete response and 7 (20%) partial response, resulting in an ORR of 23%. The median PFS and OS was 5.2 (95% confidence interval [CI], 2.9-9.9) and 20.6 (95% CI, 12.9-25.2) months, respectively. As expected, fatigue (75%), neuropathy (65%), and diarrhea (50%) were common side effects, but were generally low-grade. Median baseline NTX was similar in patients who had clinical benefit (8.2 nmol BCE) and no clinical benefit (10.9 nmol BCE). Similarly, median baseline VEGF levels were similar between the 2 groups; 93.0 pg/mL versus 83.0 pg/mL.Conclusion
This phase II study of dasatinib and paclitaxel was stopped early because of slow accrual but showed some clinical activity. Further study is not planned. 相似文献14.
Fatma Abd-Elshahed Abd-Elhay Khaled Mosaad Elhusseiny Mohamed Gomaa Kamel Soon Khai Low To Kim Sang Ghaleb Muhammad Mehyar Le Huu Nhat Minh Mohammad Rashidul Hashan Nguyen Tien Huy 《Clinical breast cancer》2018,18(6):e1293-e1310
Background
Male breast cancer (MBC) is usually diagnosed at late stages and therefore has a worse prognosis than female breast cancer (FBC). MBC is also more likely to have lymph node (LN) involvement than FBC.Materials and Methods
We sought to determine the prognostic role of the examined lymph node (LN), negative LN (NLN), and positive LN counts and the LN ratio (LNR), defined as (positive LNs/ENLs), on the survival rate among MBC patients. We performed a large population-based study using the data from the Surveillance, Epidemiology, and End Results program.Results
Older age, black race, stage IV disease, ≤ 1 NLN, and a > 31.3% LNR were significantly associated with worse survival across all prediction models. Moreover, we demonstrated a decreased risk of mortality in MBC patients across the MBC-specific survival model (hazard ratio, 0.98; 95% confidence interval, 0.96-0.998; P = .03) and 10-year MBC-specific survival model (hazard ratio, 0.98; 95% confidence interval, 0.96-0.999; P = .04).Conclusion
MBC has had an augmented incidence over the years. We found several independent predictors of MBC survival, including age, race, stage, NLNs, and the LNR. We strongly suggest adding the NLN count and/or LNR into the current staging system. Further studies are needed to provide information on the mechanisms underlying the association between the NLN count and MBC survival and the LNR and MBC survival. 相似文献15.
Lee S. Schwartzberg Sandra X. Franco Allison Florance Lisa O'Rourke Julie Maltzman Stephen Johnston 《The oncologist》2010,15(2):122-129
Objective.
To evaluate the efficacy and tolerability of letrozole plus lapatinib versus letrozole plus placebo in women with hormone receptor (HR)+ human epidermal growth factor receptor (HER)-2+ tumors receiving first-line therapy for metastatic breast cancer (MBC).Patients and Methods.
Postmenopausal women (n = 1,286) with HR+ MBC were randomized to daily oral treatment with letrozole (2.5 mg) plus lapatinib (1,500 mg) versus letrozole (2.5 mg) plus placebo. Of the 1,286 patients enrolled in the phase III study, 219 had HER-2+ tumors. The primary endpoint was progression-free survival (PFS) in HER-2+ patients.Results.
Results in the HR+ HER-2+ population (n = 219) are presented. The addition of lapatinib to letrozole resulted in a significantly lower risk for disease progression than with letrozole alone (hazard ratio, 0.71; 95% confidence interval, 0.53–0.96). The PFS time was 8.2 months, versus 3.0 months. The objective response rate (ORR) (28% versus 15%) and clinical benefit rate (CBR) (48% versus 29%) were also significantly greater in lapatinib-treated women. The most common adverse events in the lapatinib group were diarrhea (68%) and rash (46%), primarily grade 1 and 2.Conclusions.
The addition of lapatinib to letrozole is well tolerated and leads to a significantly greater PFS time, ORR, and CBR than with letrozole alone in women with MBC who coexpress HR and HER-2. 相似文献16.
Hope S. Rugo Henri Roche Eva Thomas Hyun C. Chung Guillermo L. Lerzo Igor Vasyutin Amit Patel Linda Vahdat 《Clinical breast cancer》2018,18(6):489-497
Introduction
The purpose of this study was to evaluate the safety and efficacy of ixabepilone plus capecitabine in patients with metastatic or locally advanced triple-negative breast cancer (TNBC).Patients and Methods
We conducted a pooled analysis of patients with TNBC enrolled in 2 phase III trials (NCT00080301 and NCT00082433), pretreated or resistant to an anthracycline and a taxane. In each study, patients were randomized to receive ixabepilone 40 mg/m2 (3-hour intravenous infusion, day 1), plus oral capecitabine 1000 mg/m2 twice daily (days 1-14), or capecitabine alone 1250 mg/m2 twice daily (days 1-14), every 3 weeks. Treatment was continued until disease progression or unacceptable toxicity.Results
In the subset of patients with TNBC (N = 443), the addition of ixabepilone to capecitabine compared with capecitabine alone prolonged median progression-free survival from 1.7 months to 4.2 months (hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.52-0.78; P < .0001), and doubled the objective response rate from 15% (95% CI, 10.4%-20.5%) to 31% (95% CI, 24.4%-38.0%). The median overall survival was similar (9.0 vs. 10.4 months; HR, 0.88; 95% CI, 0.72-1.08; P = .1802). A similar pattern of efficacy between arms was observed in the overall pooled population (N = 1973). The safety profile was comparable between the pooled TNBC subset and the overall pooled population. Adverse events observed with combination therapy were generally manageable and consistent with the safety profiles of the individual agents.Conclusion
Adding ixabepilone to capecitabine is effective in prolonging progression-free survival and improving objective response rate compared with capecitabine alone in patients with advanced TNBC previously treated with anthracyclines and taxanes. 相似文献17.
Background
Ixabepilone is now a Food and Drug Administration-approved therapeutic option for patients with metastatic breast cancer (MBC) whose disease has progressed despite prior anthracycline and taxane therapy. We conducted a systematic review and meta-analysis to systematically evaluate the efficacy and safety of ixabepilone for treating metastatic breast cancer.Methods
A systematic review and meta-analysis were conducted. Randomized controlled studies applying ixabepilone for treating MBC were included. The primary outcome was Overall Survival (OS). The authors of primary articles were contacted and methodological quality was evaluated. Subgroups were drawn based on intervention measures; heterogeneity and bias were discussed.Results
Eight studies with 5247 patients were included. Compared with a weekly schedule, a triweekly schedule of ixabepilone was better at improving overall response rate (ORR), while there were no differences in improving OS and progression-free survival (PFS). Ixabepilone plus capecitabine was superior to capecitabine monotherapy in improving OS, PFS and ORR. Paclitaxel was more effective than ixabepilone in terms of OS and PFS. There was no difference in the improvement of ORR, clinical benefit rate (CBR) and disease control rate (DCR) between ixabepilone and eribulin.Conclusions
Current evidence suggests that a triweekly schedule of ixabepilone is more effective than weekly dosing in improving ORR. Use of ixabepilone in combination with capecitabine possesses superior clinical efficacy to the use of capecitabine alone. Paclitaxel was more effective than ixabepilone in terms of OS and PFS. The efficacy and safety between ixabepilone and eribulin were identical.18.
Won Kyung Cho Doo Ho Choi Won Park Hyejung Cha Seok Jin Nam Seok Won Kim Jeong Eon Lee Jonghan Yu Young-Hyuck Im Jin Seok Ahn Yeon Hee Park Ji-Yeon Kim Soohyun Ahn 《Clinical breast cancer》2018,18(5):e1141-e1147
Purpose
To investigate the effect of body mass index (BMI) on survival in patients with breast cancer according to tumor subtype, metabolic syndrome, and systemic treatment.Patients and Methods
We identified 5668 patients who underwent curative surgery for breast cancer between 1996 and 2013 from the clinical data of a single institution. Disease-free survival (DFS) and overall survival (OS) were calculated and compared between the patients with BMI ≥ 25 kg/m2 and < 25 kg/m2 in all patients and in specific subgroups, including tumor subtype, metabolic syndrome, and systemic treatment.Results
In all patients, BMI ≥ 25 kg/m2 was an unfavorable factor for OS (P = .030) but not for DFS. In the HR+/HER2? subgroup, DFS and OS were longer in patients with BMI < 25 kg/m2 than ≥ 25 kg/m2 (P = .012 and .005, respectively). In patients with more than one metabolic syndrome, BMI was an unfavorable factor for OS (hazard ratio, 2.669; P < .001)Conclusion
BMI ≥ 25 kg/m2 was an unfavorable survival factor, particularly in patients with HR+/HER2? breast cancer. 相似文献19.
Fred R. Hirsch Ramaswamy Govindan Zanete Zvirbule Fadi Braiteh Achim Rittmeyer Cristóbal Belda-Iniesta Dolores Isla Thomas Cosgriff Michelle Boyer Masamichi Ueda See Phan David R. Gandara 《Clinical lung cancer》2017,18(1):43-49
Introduction
The treatment options for squamous cell non–small-cell lung cancer (NSCLC) are limited. We assessed the efficacy and safety of onartuzumab plus platinum-doublet chemotherapy in previously untreated advanced squamous cell NSCLC.Patients and Methods
The patients were randomized to receive onartuzumab plus paclitaxel plus carboplatin/cisplatin (n = 55) or placebo plus paclitaxel plus carboplatin/cisplatin (n = 54). Randomization was stratified by MET diagnostic status: MET immunohistochemistry (IHC)-positive (MET IHC 3+/2+) or MET IHC-negative (MET IHC 1+/0). The co-primary endpoints were investigator-assessed progression-free survival in the intent-to-treat and the MET IHC+ populations.Results
The risk of disease progression or death was similar between the 2 treatment arms in both the intent-to-treat (stratified hazard ratio, 0.95; 95% confidence interval, 0.63-1.43) and MET IHC+ populations (unstratified hazard ratio, 1.27; 95% confidence interval, 0.69-2.32). Comparable results were obtained for overall survival and the objective response rate. In all safety-evaluable patients, the grade 3 to 5 adverse events occurring at a > 5% greater incidence in the onartuzumab-containing versus the placebo-containing arm were neutropenia (14.8% vs. 5.8%) and pulmonary embolism (5.6% vs. 0%). Eight patients died as a result of adverse events: 1 case each of pneumonitis, pneumonia, cardiac failure, and unexplained death in the onartuzumab arm and 1 case each of hemorrhage, cardiac arrest, hemoptysis, and febrile neutropenia in the placebo arm.Conclusion
Studies using alternative assays of MET activation might help to clarify the role of onartuzumab. However, with the lack of clinical activity seen in the present study, the development of onartuzumab for squamous cell NSCLC will not be pursued further. 相似文献20.
Elias Jabbour Maral DerSarkissian Mei Sheng Duh Nora McCormick Wendy Y. Cheng Lisa J. McGarry Ariadne Souroutzidis Hui Huang Susan O’Brien Farhad Ravandi Hagop M. Kantarjian 《Clinical Lymphoma, Myeloma & Leukemia》2018,18(4):257-265