Real-world hematologic toxicities in patients > 70 versus < 69 with ER positive metastatic breast cancer on CDK 4/6 inhibitors: Single-institution retrospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13039-e13039
Author(s):  
Coral Olazagasti ◽  
Wingsze Liu ◽  
Chung-Shien Lee ◽  
Taylor Decina ◽  
Karalyn Pappas ◽  
...  

e13039 Background: Since 2015, CDK4/6 inhibitors (CDKi) have become part of standard of care in the treatment ER-positive, Her2Neu negative of metastatic breast cancer (MBC). Hematologic toxicity from CDKi are common. Pooled analysis of prior randomized trials did not show hematologic toxicity between younger and older adult age groups. We sought to review generalizability of these findings to our community population. Methods: We conducted a retrospective single institution retrospective study on patients who were treated with CDKi from 2015 to 2019. Patients were stratified according to age > 70 years and < 69 years. Data from absolute neutrophil count, hemoglobin and platelet count on Days 1 and 15 of the first 2 cycles were graded for hematologic toxicity according to CTCAE v 5.0. Our primary objective was to assess any difference in grade of hematologic toxicities in the different age groups. Our secondary objective was to analyze the association between hematologic toxicities with the presence or absence of bone metastasis and/or prior chemotherapy exposure. Results: A total of 220 patients were reviewed, 140 were < 69 years and 80 > 70 years. There was no significant effect of time (p = 0.91) with respect to the outcome of hematologic toxicity adjusting for age (p = 0.16). Seventy-seven percent (171/220) of patients had evidence of bone marrow (BM) involvement. There was no significant difference in the grade of any hematologic toxicities over time (p = 0.97) and underlying BM disease (p = 0.20). On the other hand, 50% (111/220) patients had previously received an average of one line of chemotherapy. There was significant positive correlation between lines of therapy and grade of neutropenia (rS= 0.25, p = 0.0028). Overall, the estimated median progression free survival (PFS) was 19.1 months. The median overall survival could not be estimated. Conclusions: Our single institution experience does not show significant hematologic toxicity between patient age groups nor evidence of bone metastasis. However, prior exposure to chemotherapy can have a significant effect in the grade of neutropenia. Our study revealed that there is no difference in PFS according to dosing or age which correlates with current literature.

2021 ◽  
Author(s):  
Yuichiro Kikawa ◽  
Takeshi Kotake ◽  
Shigeru Tsuyuki ◽  
Yookija Kang ◽  
Sachiko Takahara ◽  
...  

Abstract PurposeTo investigate the survival impact of eribulin use in first-line and second-line chemotherapy for patients with endocrine-resistant advanced or metastatic breast cancer (AMBC) in the real-world clinical setting. MethodsThis multi-institutional prospective cohort study enrolled patients with triple-negative AMBC or estrogen receptor (ER)-positive AMBC refractory to at least one previous endocrine therapy selected at the physician’s discretion. The overall survival from the start of first-line (OS1) and second-line chemotherapy (OS2) were assessed. Adjusted hazard ratio (HR) between eribulin and the other regimens (oral 5-fluorouracil [5-FU] and anthracycline/taxane) was calculated using a stratified proportional hazards model that included prespecified prognostic factors. ResultsOf the 201 patients enrolled, 180 were included in the final analysis. Baseline patient characteristics were quite diverse among regimens. The median OS1 was 2.25, 3.49, and 2.62 years for eribulin (n=46), oral 5-FU (n=57), and anthracycline/taxane (n=71), and the median OS2 was 1.75, 2.33, and 1.69 years for eribulin (n=70), oral 5-FU (n=26), and anthracycline/taxane (n=44), respectively. First-line eribulin had a worse adjusted HR for OS than the other regimens in the ER-negative cohort; second-line oral 5-FU had a better adjusted HR for OS than eribulin in the ER-positive cohort. There was no significant difference between regimens in the other subgroups.ConclusionsEribulin and anthracycline/taxane resulted in similar point estimates for OS, while oral 5-FU led to relatively longer survival. Adjusted HRs differed based on treatment line and ER status. However, caution should be exercised when interpreting the results due to the heterogamies in patient background.Trial registration number and date of registrationClinical Trials.gov (NCT 02551263), July 22, 2015.


2021 ◽  
Vol 32 ◽  
pp. S73
Author(s):  
C. Saavedra Serrano ◽  
B. Pérez Mies ◽  
M. Gion Cortes ◽  
A. Cortes Salgado ◽  
M. Fernández Abad ◽  
...  

1995 ◽  
Vol 13 (8) ◽  
pp. 2056-2065 ◽  
Author(s):  
J S Abrams ◽  
D A Vena ◽  
J Baltz ◽  
J Adams ◽  
M Montello ◽  
...  

PURPOSE To provide paclitaxel, an investigational drug at the inception of this study, to women with chemotherapy-refractory metastatic breast cancer and to evaluate response and toxicity in these patients. PATIENTS AND METHODS Two hundred sixty-seven patients with progressive disease (PD) following at least two chemotherapy regimens for metastatic breast cancer and a contraindication to further doxorubicin treatment received paclitaxel either at 175 mg/m2 intravenously (IV) over 24 hours or at 135 mg/m2 if they had prior irradiation to 30% of marrow-bearing bone or a cumulative dose of mitomycin > or = 20 mg/m2. RESULTS In a subgroup of patients (n = 172) with measurable disease, four complete responses (CRs) and 36 partial responses (PRs) occurred, for an overall response rate of 23% (95% confidence interval [CI], 17% to 30%). No differences in response rates were noted according either to the number of prior chemotherapy regimens received or to whether patients were considered refractory to doxorubicin. The dose and schedule used in this trial resulted in febrile neutropenia in 45% of patients and a hospitalization rate of 49%. CONCLUSION Paclitaxel's activity in this multiinstitutional trial in heavily pretreated patients confirms the encouraging results attained in single-institution trials. Although at this dose and schedule paclitaxel may be considered too myelosuppressive for palliative care, supportive measures such as colony-stimulating factors and antibiotics were not used prophylactically. Current research efforts are focusing on whether paclitaxel's activity against breast cancer is dose- and/or schedule-dependent, and on what role it has in patients with less advanced disease.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13056-e13056
Author(s):  
Michael Grimm ◽  
Bhuvaneswari Ramaswamy ◽  
Maryam B. Lustberg ◽  
Robert Wesolowski ◽  
Sagar D. Sardesai ◽  
...  

e13056 Background: Invasive lobular carcinoma (ILC) accounts for only 10-15% of all invasive breast cancers but has distinct clinicopathologic characteristics and genomic profiles. In particular, metastatic lobular cancers (mILC) have unique sites of metastasis and it is unclear if the response to initial endocrine therapy differs from metastatic ductal cancers (mIDC). Therefore we have undertaken a single-institution, retrospective analysis to compare overall outcomes and response to initial endocrine therapy (ET) in patients (pts) with metastatic ILC and IDC. Methods: An IRB approved retrospective review of medical records was conducted evaluating pts treated for metastatic IDC and ILC at The Ohio State University Comprehensive Cancer Center from January 1, 2004 to December 31, 2014. Pts diagnosed with mIDC were matched on age, year of diagnosis, estrogen receptor/progesterone receptor and HER2 status and site of metastasis 2:1 to patients diagnosed with mILC. Overall survival (OS) was defined as the time from metastasis to death or last known follow-up. Progression-free survival (PFS) was defined as time from metastasis to progression on first-line ET. Time to chemotherapy (TTC) was defined as time from starting ET for metastasis to initiation of chemotherapy. Kaplan Meier (KM) methods were used to calculate median OS, PFS and TTC. Results: A total of one hundred sixty one pts with metastatic breast cancer were included in this analysis. The demographic features between the two groups were well balanced and included in the table below. The median OS was 2.6 yrs (95% CI: 1.55, 3.22) for mILC and 2.2 yrs (95% CI: 1.95, 2.62) for mIDC. A subset of 111 patients who started on endocrine therapy were used in the PFS and TTC analyses. The median PFS following first-line ET was 2.2 yrs (95% CI: 0.1.0, 2.7) for mILC and 1.4 yrs (95% CI: 0.91, 1.90) for mIDC. Median TTC was 2.1 yrs (95% CI: 1.71, 4.92) for mILC and 2.4 yrs (95% CI: 1.90, 4.77) for mIDC. There was no statistically significant difference in outcomes between the two groups. Conclusions: Outcomes in patients with ILC and IDC have been varied, with several studies reporting that patients with ILC have worse outcomes and response to chemotherapy. Our retrospective study examining outcomes in mILC in comparison with mIDC showed no difference in OS. Given the concern of resistance to conventional therapies in patients with lobular cancers, it is reassuring to see that the median PFS on first line ET and TTC was similar to metastatic ductal cancers.[Table: see text]


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