Patient characteristics, treatment received, and outcomes of non-metastatic breast cancer patients in Haiti: Report from retrospective cohort.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18196-e18196
Author(s):  
Temidayo Fadelu ◽  
Ruth Damuse ◽  
Liz Pecan ◽  
Cyrille Dubuisson ◽  
Lauren Greenberg ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Disease ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Patient Characteristics ◽  
University Hospital ◽  
Rank Test ◽  
Er Status

e18196 Background: Few studies have reported outcomes of breast cancer (BC) patients in Haiti. Since 2013, University Hospital Mirebalais, a tertiary government hospital, has offered treatment for BC, in partnership with Dana-Farber Cancer Institute and Zanmi Lasante, a Haitian non-profit. Standard chemotherapy and hormone therapy are available, but HER2 therapies and radiation are not. Here, we comprehensively describe patient characteristics, treatments delivered and outcomes of non-metastatic BC patients in this program. Methods: We conducted a retrospective observational study including 339 patients with non-metastatic BC, who presented between January 1, 2013 and June 30, 2016. We conducted detailed chart abstraction of patient characteristics, clinical diagnostic and treatment data, and outcomes. Our endpoint was disease-free survival (DFS) defined as time from presentation to cancer recurrence, progression or death. We used Kaplan-Meier estimation to plot survival curves, censoring at the time of last follow-up. Log-rank test was used to examine subgroup differences. Results: The median age in the cohort was 49, inter-quartile range of 42 to 58; 35.7% were post-menopausal. Invasive ductal carcinoma was the most common histology (65.5%). At presentation, 52.8% had T3/T4 disease, while 54.6% had locally advanced disease, and 37.5% were poorly differentiated. There was incomplete documentation of stage (18.3%), ER status (44.2%) and histologic grade (39.5%). 156 patients received neoadjuvant therapy with hormonal therapy (26.2%), chemotherapy (67.9%), or both (5.8%), while 227 received adjuvant therapy (25.5%, 26.5% and 48.0% respectively). 275 patients (81%) completed surgical resection. Median follow up time for the cohort was 24.8 months. 23 patients died; 75 had recurrences; and 9 had progression. Median DFS was 50.8 months (95% CI, 40.6 to 57.0). There was no DFS difference by ER status. Median DFS for early-stage patients was not reached compared to locally advanced patients of 40.4 months (95% CI, 34.0 to 49.7), P-value < 0.0001. Conclusions: Non-metastatic BC patients in Haiti present with more advanced disease and have poorer prognostic factors compared to high-income countries. Although these patients have comparatively worse outcome, curative treatment is feasible in Haiti.

Phase III study of doxorubicin-cyclophosphamide followed by paclitaxel or docetaxel given every 3 weeks or weekly in operable breast cancer: Results of Intergroup Trial E1199

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 516-516 ◽  
Author(s):  
J. A. Sparano ◽  
M. Wang ◽  
S. Martino ◽  
V. Jones ◽  
E. Perez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Disease Free Survival ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Axillary Lymph ◽  
Free Survival ◽  
Significant Difference ◽  
Phase Iii Study ◽  
Grade 3

516 Background: Evidence suggests that docetaxel is more effective than paclitaxel, and paclitaxel is more effective when given weekly than every 3 weeks in metastatic breast cancer (BC). Methods: Eligibility included axillary lymph node positive or high-risk (tumor at least 2 cm) node-negative BC. All patients received 4 cycles of AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2) every 3 weeks, followed by either: (1) paclitaxel 175 mg/m2 every 3 weeks × 4 (P3), (2) paclitaxel 80 mg/m2 weekly × 12 (P1), (3) docetaxel 100 mg/m2 every 3 weeks × 4 (D3), or (4) docetaxel 35 mg/m2 weekly × 12 (D1). The primary comparisons included taxane (P vs. D) and schedule (every 3 weeks vs. weekly), and secondary comparisons included P3 vs. other arms. The trial had 86% power to detect a 17.5% decrease in disease-free survival (DFS) for either primary comparison, and 80% power to detect a 22% decrease for the secondary comparisons (2-sided nomimal 5% level tests corrected for multiple comparisons). Results: A total of 4,950 eligible patients were accrued. There was no difference in the primary comparisons afer 856 DFS events and 483 deaths after a median follow-up of 46.5 months at the 4th interim analysis ( www.sabcs.org , abstract 48). This is the final pre-specified analysis for the primary comparisons after 1,042 DFS events and 650 deaths (with 1,020 DFS events at this time, to be updated at the meeting). After a median followup of 60.2 months, there remains no significant difference in the hazard ratio (HR) for the taxane (1.02; p=0.73) or schedule (1.07; p=0.30) (as in the first analysis). In secondary comparisons of the standard arm (P3) with the other arms (HR > 1 favoring the experimental arms), the HRs were 1.30 (p = 0.003) for arm P1, 1.24 (p=0.02) for arm D3, and 1.09 (p=0.33) for arm D1. Analysis of interaction by hormone-receptor status will be presented. The incidence of worst grade toxicity (grade 3/4) was 24%/6% for arm P3, 24%/3% for arm P1, 21%/50% for arm D3, and 38%/6% for arm D1. Conclusions: There were no differences in DFS when comparing taxane or schedule overall. DFS was significantly improved in the weekly paclitaxel and every 3-week docetaxel arms compared with the every 3-week paclitaxel arm. [Table: see text]

Gemcitabine plus docetaxel versus docetaxel in patients (pts) with HER2-negative locally advanced or metastatic breast cancer (MBC): A randomized phase III study

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 1015-1015
Author(s):  
D. L. Nielsen ◽  
S. T. Langkjer ◽  
K. Bjerre ◽  
S. Cold ◽  
L. Stenbygaard ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Single Agent ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Phase Iii ◽  
Rank Test ◽  
Hematologic Toxicity ◽  
Phase Iii Study ◽  
Her 2 ◽  
Grade 3

1015 Background: Gemcitabine (G), either as a single agent or in combination with taxanes, has demonstrated efficacy in MBC in phase II and III studies. We conducted a phase III study to compare time to progression (TTP) of G plus docetaxel (T) versus (vs.) T alone. The secondary endpoints included overall survival (OS), overall response rate (ORR), and toxicity. Methods: Females with HER-2-negative locally advanced or MBC and a WHO performance status ≤ 2 were randomized to GT (G 1,000mg/m2 day 1 + 8; T 75mg/m2 day 1) or T (100mg/m2 day 1) every 21 days. Pts were previously untreated, had prior anthracycline-based (neo)adjuvant chemotherapy or had received a single prior anthracycline-bsed chemotherapy regimen for MBC. Time-to-event endpoints were estimated using the Kaplan-Meier method, and the log-rank test was applied for comparisons between regimens. The planned sample size was 254 evaluable pts with α I and β of 0.05 and 0.90, respectively. Results: A total of 336 pts were randomized (170 GT; 166 T), data from one centre are yet missing and the present evaluation is based on data from 306 pts (155 GT; 151 T). The pts had a median age of 58 years in both regimens; range 36–73 years and 30–74 years, respectively. The median TTP was 7.5 months for the GT regimen vs. 6.5 months for the T regimen. The GT arm demonstrated an ORR of 44% vs. 38% in the T arm with 4 and 3 % complete responses, respectively. The OS was 13.4 vs. 13.2 months in the GT and T arm, respectively. Hematologic toxicity was common, especially grade 3–4 neutropenia (GT = 69%; T = 61%); infection was reported in 22 and 20% of the pts, respectively (none of the pts received G-CSF). The most commonly reported non-hematologic toxicities of grade 3–4 included mucositis (GT = 2%; T = 5%), diarrhea (GT = 4%; T = 7 %), fatigue (GT = 6%; T = 11%), oedema (GT = 10%; T = 3%), and peripheral neuropathy (GT = 9%; T = 28%). Conclusions: Preliminary data of GT as first- or second-line chemotherapy demonstrates a TTP advantage among HER-2-negative pts with advanced breast cancer. Updated results and proper statistical analyses will be presented. No significant financial relationships to disclose.

Propensity-score matched pair comparison of accelerated partial breast irradiation (APBI) and whole breast irradiation (WBI) for ductal carcinoma in situ (DCIS).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1123-1123
Author(s):  
John Ben Wilkinson ◽  
Ashley Fowler ◽  
Ovidiu Marina ◽  
Michelle Wallace ◽  
Kimberly Marvin ◽  
...  
Keyword(s):  
Tumor Size ◽  
Disease Free Survival ◽  
Contralateral Breast ◽  
Nuclear Grade ◽  
Matched Pair ◽  
Rank Test ◽  
Breast Irradiation ◽  
Treatment Type ◽  
Er Status

1123 Background: DCIS remains a cautionary criterion for APBI by the ASTRO APBI consensus statement. We performed a matched analysis to compare the efficacy of WBI and APBI for patients with DCIS. Methods: Women with DCIS treated with APBI or WBI were reviewed. APBI (n=102) patients with ≥2 y follow-up were matched 1:3 to WBI (n=546) patients with ≥5 y follow-up by age, tumor size, nuclear grade, ER status, margin status, and laterality. Ipsilateral breast tumor recurrence (IBTR), distant metastasis (DM), contralateral breast cancer (CLBC) and cause-specific survival (CSS) were compared by cumulative incidence (Gray’s) and competing risks regression (Fine and Gray’s), and overall survival (OS) and disease-free survival (DFS) by Kaplan-Meier (log-rank test). Results: Median follow-up was 4.6 y (2.0-14.7) for APBI and 9.0 y (5.4-27.0) for WBI. Median (range) or percentages are shown (Table). Patients did not differ by match criteria. There were 17 LR, 1 DM, 19 CLBC, 2 CSS, 22 OS, and 19 DFS events during follow-up. The patient groups had similar rates of cancer-related events including ipsilateral and contralateral breast recurrences at both five and eight years. Treatment type, age, tumor size, nuclear grade, ER status, and hormone therapy (HT) were not prognostic of LR or CLBC on uni- and multi-variate analyses. Conclusions: APBI provides equivalent and exemplary outcomes compared to WBI following breast-conserving surgery for DCIS. These findings support previous reports on the efficacy of APBI in the treatment of noninvasive breast carcinoma. Prospective randomized comparison of APBI to WBI for DCIS is needed. [Table: see text]

Patient characteristics and outcomes of colorectal cancer (CRC) at Butaro Cancer Center of Excellence (BCCOE): Results from a retrospective cohort.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16081-e16081
Author(s):  
Temidayo Fadelu ◽  
Fidel Sebahungu ◽  
Kevin Diasti ◽  
Cam Nguyen ◽  
Tiffany Yeh ◽  
...  
Keyword(s):  
Care Delivery ◽  
Disease Free Survival ◽  
Patient Characteristics ◽  
Sub Saharan Africa ◽  
Rank Test ◽  
Cancer Center ◽  
Cancer Type ◽  
Curative Intent ◽  
Duration Of Symptoms

e16081 Background: There are few studies on CRC in sub-Saharan Africa. BCCOE in Rwanda provides patients with CRC access to chemotherapy, surgery and radiotherapy referrals. Here, we describe patient characteristics, treatments delivered and outcomes. Methods: This retrospective observational study included 136 patients with CRC who presented between July 2012 and June 2018. We abstracted patient characteristics, diagnostic and treatment data, and outcomes from electronic and paper records. We compared baseline and treatment characteristics for colon cancer (CC) versus (vs.) rectal cancer (RC) patients. For patients treated with curative intent, we plotted Kaplan Meier estimation of disease free survival (DFS), defined as time from presentation to cancer recurrence, progression or death. Log-rank test was used to examine subgroup differences. Results: The mean age was 52.5, and 71 (52.2%) were female. 101 (74.2%) patients had RC. Compared to CC, patients with RC were older 54.5 vs. 46.9 (p = 0.0084), and more likely female 59.4 vs. 31.4 (p = 0.0043). All provinces in Rwanda were represented including 14 (10.3%) from outside Rwanda; 79 (58.1%) patients lived in rural areas. Median duration of symptoms prior to presentation was 12 months, and 57 (41.9%) had used traditional medicine prior to presentation. 72 (52.9%) patients were non-metastatic, 46 (33.8%) de novo metastatic, 4 (2.9%) recurrent, and 14 (10.2%) had indeterminate stage. Of the patients treated with curative intent, 54 (65.1%) had neoadjuvant and/or adjuvant chemotherapy, while only 34 (41.0%) had curative surgery. 40 (48.2%) patients received a permanent colostomy. 18 (27.7%) patients with RC received concurrent chemoradiation. Over the follow up period, 49 (36%) patients died or were referred for end of life care, 13 (9.3%) remain in surveillance, while 65 (47.8%) were lost to follow up. Median DFS for patients with non-metastatic disease was 22.2 months. On exploratory analyses, there were no statistically significant differences in DFS by cancer type, gender, or performance status, though these analyses were underpowered and follow-up short. Conclusions: CRC treatment requires multidisciplinary care, which is a challenge in low-resource settings. Our results highlight gaps in CRC care delivery and suboptimal patient outcomes; most striking gaps were the low rates of surgery and radiation, and high loss to follow up rates. Rigorous research is needed to understand the underlying causes, and to develop interventions to address these gaps.

PET-directed chemoradiation (CRT) with induction FOLFOX compared to induction carboplatin/paclitaxel (CP) in patients with locally advanced esophageal adenocarcinoma (EA).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4554-4554
Author(s):  
Rebecca Carr ◽  
Meier Hsu ◽  
Kay See Tan ◽  
Manjit S. Bains ◽  
Matthew Bott ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Multivariable Analysis ◽  
Disease Free Survival ◽  
Complete Response ◽  
Rank Test ◽  
Complication Rates ◽  
Trimodality Therapy ◽  
Kaplan Meier ◽  
Multivariable Analyses

4554 Background: Induction chemotherapy with PET-directed CRT and surgery is the standard treatment for locally advanced EA at our institution. Following results of the CALGB 80803 trial, FOLFOX has recently replaced CP as the preferred induction regimen. Methods: We retrospectively evaluated patients with locally advanced EA treated with induction CP vs FOLFOX, followed by trimodality therapy between January 2010 and June 2019. Patients treated with CP with RT followed by surgery without induction chemo were also included. We compared pathological complete response (pCR) and near pCR (ypN0 with ≥90% response) rates in the induction FOLFOX group to the induction CP and no-induction groups. Univariable and multivariable analyses were used to adjust for confounding factors. Disease-free survival (DFS) was estimated by the Kaplan-Meier method and compared between groups using max-combo weighted log rank test. Results: 445 patients were included. Patients in the induction FOLFOX group had significantly higher pCR and near pCR rates vs induction CP patients. Notably, pCR rate was 38% among FOLFOX PET responders vs 19% in non-responders. In multivariable analysis, compared to induction CP, induction FOLFOX administration was an independent predictor of near pCR (OR: 2.22, 95%CI: 1.20-4.20, p = 0.012). Compared to 24% pCR rate among no-induction patients, induction FOLFOX pCR rate was slightly higher at 32%. DFS by 2-years was higher in induction FOLFOX compared to no-induction-treated patients (62% vs. 42%, p = 0.05). Postoperative complication rates were similar among the three groups. Conclusions: PET-directed CRT with FOLFOX instead of CP improves pCR and near pCR rates. Improved DFS was observed in the FOLFOX vs no-induction patients. Longer follow-up is needed to confirm any survival benefits. [Table: see text]

scholarly journals Heregulin (HRG) assessment for clinical trial eligibility testing in a molecular registry (PRAEGNANT) in Germany

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Hanna Huebner ◽  
Christian M. Kurbacher ◽  
Geoffrey Kuesters ◽  
Andreas D. Hartkopf ◽  
Michael P. Lux ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Cancer Patients ◽  
Menopausal Status ◽  
Locally Advanced ◽  
Metastatic Breast ◽  
Patient Characteristics ◽  
Breast Cancer Patients ◽  
Patient Identification ◽  
Eligibility Criteria

Abstract Background Eligibility criteria are a critical part of clinical trials, as they define the patient population under investigation. Besides certain patient characteristics, clinical trials often include biomarker testing for eligibility. However, patient-identification mostly relies on the trial site itself and is often a time-consuming procedure, which could result in missing out on potentially eligible patients. Pre-selection of those patients using a registry could facilitate the process of eligibility testing and increase the number of identified patients. One aim with the PRAEGNANT registry (NCT02338167) is to identify patients for therapies based on clinical and molecular data. Here, we report eligibility testing for the SHERBOC trial using the German PRAEGNANT registry. Methods Heregulin (HRG) has been reported to identify patients with better responses to therapy with the anti-HER3 monoclonal antibody seribantumab (MM-121). The SHERBOC trial investigated adding seribantumab (MM-121) to standard therapy in patients with advanced HER2-negative, hormone receptor–positive (HR-positive) breast cancer and HRG overexpression. The PRAEGNANT registry was used for identification and tumor testing, helping to link potential HRG positive patients to the trial. Patients enrolled in PRAEGNANT have invasive and metastatic or locally advanced, inoperable breast cancer. Patients eligible for SHERBOC were identified by using the registry. Study aims were to describe the HRG positivity rate, screening procedures, and patient characteristics associated with inclusion and exclusion criteria. Results Among 2769 unselected advanced breast cancer patients, 650 were HER2-negative, HR-positive and currently receiving first- or second-line treatment, thus potentially eligible for SHERBOC at the end of current treatment; 125 patients also met further clinical eligibility criteria (e.g. menopausal status, ECOG). In the first/second treatment lines, patients selected for SHERBOC based on further eligibility criteria had a more favorable prognosis than those not selected. HRG status was tested in 38 patients, 14 of whom (36.8%) proved to be HRG-positive. Conclusion Using a real-world breast cancer registry allowed identification of potentially eligible patients for SHERBOC focusing on patients with HER3 overexpressing, HR-positive, HER2-negative metastatic breast cancer. This approach may provide insights into differences between patients eligible or non-eligible for clinical trials. Trial registration Clinicaltrials, NCT02338167, Registered 14 January 2015 - retrospectively registered.

Prognostic implications of YKL-40 overexpression in breast cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 20115-20115
Author(s):  
S. H. Kim ◽  
K. Das ◽  
S. Noreen ◽  
F. Coffman ◽  
M. Hameed
Keyword(s):  
Breast Cancer ◽  
Elevated Serum ◽  
Disease Free Survival ◽  
Immunohistochemical Analysis ◽  
Tissue Growth ◽  
University Hospital ◽  
Breast Cancer Patients ◽  
N Stage ◽  
Prognostic Implications

20115 Background: YKL-40 has been implicated as a connective tissue growth factor and a migratory factor for endothelial cells. Elevated serum levels of YKL-40 have been found to correlate with worse survival in a variety of malignancies including breast cancer. We wished to determine if tumor overexpression of this protein also had prognostic implications in breast cancer. Methods: A prospectively collected database of breast cancer patients treated at the University Hospital of Newark was used for analysis. Immunohistochemical analysis was performed on 115 patients for whom full clinical information and follow up was available. Specimens were categorized as lacking immunoreactivity (0), having focal sparse immunoreactivity (1), or strong more diffuse immunoreactivity (2). Results: YKL-40 expression was noted in 38 patients (33%). Of these, 24 demonstrated strong (2) immunoreactivity (21%). Strong (2) YKL-40 immunoreactivity significantly correlated with larger tumor size (p < .05). Tumors expressing any level of YKL-40 were also significantly more likely to be estrogen and/or progesterone receptor negative (p < .01). No significant correlation was demonstrated between YKL-40 status and nodal stage. At a mean follow up of 2.3 years, disease-free survival was significantly worse in the subset of patients whose tumors overexpressed any level of YKL-40 compared to the non-expressors (p < .01). In multivariate analysis, YKL-40 status was independent of T-stage and N-stage in predicting disease recurrence. Conclusions: Immunoreactivity for YKL-40 was a significant predictor of breast cancer relapse in this subset of patients. This was independent of T or N-stage and suggests that tumor immunohistochemistry for this protein may be a valuable prognostic marker in breast cancer. No significant financial relationships to disclose.

Randomized trial of amifostine in locally advanced non-small cell lung cancer (NSCLC) patients receiving chemotherapy and hyperfractionated radiation (HRT): Long-term survival results of Radiation Therapy Oncology Group (RTOG) 9801

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 7529-7529
Author(s):  
B. Movsas ◽  
J. Moughan ◽  
C. Langer ◽  
M. Werner-Wasik ◽  
N. Nicolaou ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Radiation Therapy Oncology Group ◽  
Disease Free Survival ◽  
Rank Test ◽  
Term Survival ◽  
Long Term Survival ◽  
Patient Reported ◽  
Nsclc Patients

7529 Purpose: This analysis was conducted to address the potential antitumor effect of amifostine (AM) in NSCLC patients enrolled on RTOG-9801. The long-term survival results of RTOG-9801 are presented here. Methods: 243 patients (pts) with stage II/IIIAB NSCLC received induction paclitaxel (P) 225 mg/m2IV days 1, 22 and carboplatin (C) AUC 6 days 1, 22 and then concurrent weekly P (50 mg/m2) and C (AUC 2) and HRT (69.6 Gy at 1.2 Gy BID). Pts were randomly assigned to AM 500 mg IV 4x/week or no-AM during chemoradiation. Treatment differences for overall and disease-free survival (OS & DFS) were analyzed with the log-rank test; Gray's test was used for time to progression (TTP). Results: 118 pts were randomly assigned to receive AM and 121 to no-AM (4 pts were ineligible). The median follow-up for pts still alive is 52.3 months (mo) for the AM-arm and 58.3 mo for the no-AM arm (16.6 vs 17.9 for all pts). There are no significant differences in OS, DFS or TTP between arms. The median survival, 3-yr, and 5-yr OS are 17.1 mo, 27% and 17% (AM-arm) vs 18.4 mo, 28% and 16% (no-AM arm) (p=0.97). Grade 3/4/5 late-RT toxicities are similar (11%/3%/2% AM-arm vs 14%/4%/2% no-AM arm). Conclusion: While an earlier publication reported that amifostine did not reduce objective measures of severe esophagitis in RTOG-9801, patient-reported outcome analyses suggested a possible advantage to AM with decreased pain and swallowing symptoms (J Clin Oncol 23:2145–2154, 2005). This long-term follow-up analysis on survival shows no evidence of tumor radioprotection due to amifostine. The promising 5-yr OS suggests that induction paclitaxel/carboplatin (P/C) followed by concurrent RT and weekly low-dose P/C is comparable to other regimens using cisplatin doublets at higher dosages every 3–4 weeks. Research supported by NCI and Medimmune Oncology. No significant financial relationships to disclose.

Peripheral neuropathy (PN) in patients (pts) with metastatic breast cancer treated with eribulin: Resolution and association with efficacy.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 147-147 ◽  
Author(s):  
Peter Kaufman ◽  
Martin Olivo ◽  
Yi He ◽  
Susan McCutcheon ◽  
Linda Vahdat
Keyword(s):  
Breast Cancer ◽  
Advanced Disease ◽  
Metastatic Breast ◽  
Progression Free Survival ◽  
Rank Test ◽  
Phase 2 ◽  
Eribulin Mesylate ◽  
Short Period ◽  
Grade 3 ◽  
Line Setting

147 Background: PN is a known adverse effect of various antimicrotubule agents, including eribulin. We report here the incidence and resolution of PN in breast cancer pts treated with eribulin in completed phase 2 and 3 studies, and the efficacy of eribulin in pts with PN in the phase 3 EMBRACE and 301 studies. Methods: In EMBRACE, women had received 2-5 lines of chemotherapy for advanced disease. In this ≥ 3rd-line setting, pts randomized to eribulin mesylate received it at 1.4 mg/m2 iv, days 1 and 8 every 21 days. The dosing schedule was the same in study 301, which involved pts who had received 0-2 prior chemotherapies for advanced disease. Overall survival (OS) and progression-free survival (PFS) were analyzed by stratified log-rank test. Data from EMBRACE and 301 were pooled with data from 2 phase 2 studies to assess time to improvement (a decrease of ≥ 1 grade) and resolution (decrease in grade to 0, 1 or baseline) of grade 3 or 4 PN. Results: In the pooled safety analysis, 7.7% (116/1503) of pts treated with eribulin had grade 3 or 4 PN; 63.8% of these experienced improvement in PN and 50% had resolution. Median time to improvement was 2.1 weeks and to resolution was 7.7 weeks. Characteristics were similar in pts with or without PN in EMBRACE and 301. Those with PN had longer exposure to eribulin vs pts without PN (median exposure [months], study 301: 4.9 vs 3.2; EMBRACE: 4.8 vs 2.9). OS and PFS were significantly longer in pts with PN (Table). Conclusions: Pts who had a favourable therapeutic response to eribulin, received a longer course of treatment and thus had a greater risk of PN. Severity of PN improved in most pts within a short period. Regarding PN, the risk–benefit ratio for eribulin supports treatment. Clinical trial information: NCT00337103, NCT00388726. [Table: see text]

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