Real-world analysis of eribulin in metastatic breast cancer (MBC): An assessment of time to treatment failure (TTF) in a community oncology setting.

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 174-174 ◽  
Author(s):  
George Dranitsaris ◽  
Debu Tripathy ◽  
Nancy L. Beegle ◽  
Traci L. Kalberer ◽  
John David Cox ◽  
...  

174 Background: There have been important advances in the treatment of patients with MBC. However, certain patient subgroups such as whose who are triple negative remain a therapeutic challenge. Eribulin is the newest cytotoxic to gain regulatory approval for MBC in the Unites States. In this analysis, the safety and efficacy of eribulin in TNBC patients and those with prior anthracycline exposure were assessed in an early cohort treated in a U.S. community oncology setting. Methods: Ninety patients treated in eight community oncology clinics across the U.S. were identified. Patients were followed from the first cycle of eribulin until disease progression, discontinuation due to toxicity, or death. Data collection included baseline patient and disease characteristics, prior and subsequent anticancer therapy, use of supportive care drugs, number and type of dose limiting toxicity, delivered dose intensity, duration of eribulin therapy and time to treatment failure (TTF). Results: Eribulin was administered after a median of three prior lines of chemotherapy (range 0 to 15). The drug was delivered as a single agent in 79 of 90 patients (88%) at the clinically approved dosage of 1.4 mg/m2on days 1 and 8 of a 21 day cycle. Patients received a median of 4 cycles (1 to 16) for an overall mean duration of 2.9 months (0 to 14.2 months). Approximately 17 of 90 patients (18.9%) were identified as triple negative and 57 of 90 (63.3%) had received prior anthracycline treatment. The median TTF (inter quartile range) was 4 mon (2.3 to 5.6) in all patients. There were no significant differences in TTF by triple negative status (HR=0.1.22, p = 0.49) and prior exposure to anthracyclines (HR=0.78, p = 0.15). In all patients, the most common dose limiting toxicities were neutropenia (32%), anemia (31%), neuropathy (21%) and febrile neutropenia (8.9%). These events led to the premature discontinuation of eribulin in 8 of 90 patients (8.9%). Conclusions: TTF with eribulin was comparable regardless of triple negative status and prior exposure to anthracyclines. These findings are consistent with results from previous clinical studies and warrant further real-world analyses in a larger population.

2018 ◽  
Vol 25 (6) ◽  
pp. 1374-1380 ◽  
Author(s):  
M Alexandra Schickli ◽  
Michael J Berger ◽  
Maryam Lustberg ◽  
Marilly Palettas ◽  
Craig A Vargo

Purpose The management of endocrine therapy resistance is one of the most challenging facets of advanced breast cancer treatment. Palbociclib is an inhibitor of cyclin-dependent kinases 4 and 6 approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with fulvestrant in postmenopausal women with disease progression following endocrine therapy. However, treatment responsiveness of tumors to palbociclib after multiple lines of endocrine therapy is not clearly established. The purpose of this study was to determine the efficacy of palbociclib and letrozole in patients pretreated with one or more lines of endocrine therapy. Methods This was a single-center, retrospective cohort study of all postmenopausal hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer patients who received palbociclib and letrozole as a second-line endocrine therapy or beyond (and no prior cyclin-dependent kinases 4 and 6 inhibitor therapy) between February 1, 2015, and July 31, 2016. The primary objective was to evaluate time to treatment failure of palbociclib in combination with letrozole as a second-line of therapy or beyond. Results Fifty-three patients meeting eligibility criteria were included in the analysis. For the primary outcome, the median time to treatment failure of palbociclib and letrozole was 6.3 months (95% CI 3.1–7.4 months). Progression-free survival of palbociclib and letrozole therapy was 6.4 months (95% CI 4.9–8.3 months). Conclusions Palbociclib and letrozole therapy is a viable, effective treatment option for metastatic breast cancer patients who were not exposed to cyclin-dependent kinases 4 and 6 inhibitors as a first-line endocrine therapy. The benefits of palbociclib and letrozole therapy were seen without excessive toxicity, and although neutropenia was common, it may be managed with dose reduction.


2018 ◽  
Vol 36 (15_suppl) ◽  
pp. 9578-9578 ◽  
Author(s):  
Rajeshwari Sridhara ◽  
Jiaxi Zhou ◽  
Marc Robert Theoret ◽  
Pallavi Shruti Mishra-Kalyani

2012 ◽  
Vol 1 (2) ◽  
pp. 225-230 ◽  
Author(s):  
KEIICHI KONTANI ◽  
SHIN-ICHIRO HASHIMOTO ◽  
CHISA MURAZAWA ◽  
SHOKO NORIMURA ◽  
HIROAKI TANAKA ◽  
...  

2003 ◽  
Vol 21 (9) ◽  
pp. 1819-1824 ◽  
Author(s):  
H.L. Parnes ◽  
C. Cirrincione ◽  
J. Aisner ◽  
D.A. Berry ◽  
S.L. Allen ◽  
...  

Purpose: To determine whether biochemical modulation with LV (leucovorin) enhances the efficacy of CAF (cyclophosphamide, doxorubicin, and fluorouracil) against metastatic breast cancer. Patients and Methods: Women with histologically confirmed stage IV breast cancer, Cancer and Leukemia Group B (CALGB) performance status 0 to 2, and no prior chemotherapy for metastatic disease were randomly assigned to receive CAF (cyclophosphamide 500 mg/m2 day 1, doxorubicin 40 mg/m2 day 1, and fluorouracil [FU] 200 mg/m2 intravenous bolus days 1 to 5) with or without LV (LV 200 mg/m2 over 30 minutes days 1 to 5 given 1 hour before FU). Results: Two hundred forty-two patients were randomly assigned to treatment; 124 patients had visceral crisis and 40 patients had a CALGB performance status score of 2. The median follow-up was 6 years. The two study arms were similar with regard to serious adverse events; four patients died from treatment-related causes, two patients on each study arm. Predictive variables for time to treatment failure and survival were visceral disease and performance status. The overall response rate was 29% for CAF versus 28% for CAF plus LV. The median time to treatment failure (9 months) and median survival (1.7 years) did not differ by treatment arm. Conclusion: Modulation of CAF with LV improved neither response rates nor survival among women with metastatic breast cancer, compared with CAF alone. Multivariate analyses confirmed the prognostic importance of performance status and visceral crisis. However, the overall and complete response rates, response durations, time to treatment failure, and survival were the same in the two treatment arms.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 1640-1640 ◽  
Author(s):  
Brian L. Burnette ◽  
Gregory Wiseman ◽  
Thomas M. Habermann ◽  
Stephen M. Ansell ◽  
Luis F. Porrata ◽  
...  

Abstract Abstract 1640 Background: The introduction of radioimmunotherapy (RIT) into clinical practice for the treatment of follicular lymphoma (FL) occurred at a time at which many patients did not have prior exposure to rituximab. Clinical trials in the relapsed/refractory setting, as well as consolidation in the upfront setting have included a small number of patients that had been previously treated with rituximab or a rituximab containing treatment regimen. We evaluated the effect of prior rituximab therapy on the efficacy of RIT. METHODS: The prospective lymphoma database was queried for all patients having received a single dose of yttrium-90 ibritumomab tiuxetan for relapsed/refractory FL which had previously been treated with systemic therapy (patients receiving only prior external beam radiation therapy were excluded). The database includes all consecutive adult patients diagnosed with lymphoma seen at Mayo Clinic Rochester. The diagnosis of follicular lymphoma was as by WHO classification and centrally reviewed. Patients with evidence of histologic transformation to diffuse large B cell lymphoma prior to RIT were excluded. Time to treatment failure (TTF) was defined as the time from RIT to next anti-lymphoma therapy. RESULTS: 111 patients were identified. 57 (51%) were male. Median age at time of RIT was 58 (19–88). Median time from diagnosis to RIT was 35 (6–281) months in patients having received prior treatment with rituximab and 47 (12–272) months in those who had not (p=0.19). 63 (57%) of patients received prior treatment with rituximab or rituximab containing chemotherapy. Median number of prior therapies was 2 (1–10), which was not different between the rituximab treated or untreated groups [2(1–6) vs 2(1–10) p=0.12]. Median TTF was 10.0 months in the patients having received prior rituximab and 10.1 months in those that had not (p=0.29). Figure 1. The median overall survival from RIT was not reached, but appeared similar (Kaplan-Meier estimate 125 months without prior rituximab exposure vs 95 months with prior rituximab exposure; p=0.33). CONCLUSIONS: Prior rituximab exposure does not seem to adversely impact the time to treatment failure or overall survival in those patients treated with RIT. While the data leading to the approval of RIT were accrued prior to the routine clinical use of rituximab, our data demonstrate similar clinical benefit of RIT in patients with prior exposure to rituximab or rituximab containing therapy. Disclosures: No relevant conflicts of interest to declare.


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