Adjustments in relative dose intensity (RDI) for FECD chemotherapy in breast cancer: A population analysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 547-547 ◽  
Author(s):  
Zachary William Neil Veitch ◽  
Omar Farooq Khan ◽  
Derek Tilley ◽  
Kostaras Xanthoula ◽  
Patricia A. Tang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Retrospective Study ◽  
Adjuvant Chemotherapy ◽  
No Reduction ◽  
Population Analysis ◽  
Dose Intensity ◽  
Significant Decline ◽  
Taxane Chemotherapy ◽  
Alberta Cancer Registry ◽  
Dose Reductions

547 Background: Reductions in RDI of adjuvant chemotherapy for breast cancer (BC) has been associated with inferior survival. However, earlier studies may be confounded by uncharacterized BC subtype(s) (TNBC, HER2+) and non-taxane chemotherapy regimens (CMF, AC). This retrospective study evaluates survival (DFS/OS) outcomes for patients receiving RDI reductions for FECD adjuvant chemotherapy in Alberta, Canada. Methods: Patients with stage I-III, ER +/-, HER2- BC receiving adjuvant FECD chemotherapy from 2007-2014 were identified using the Alberta Cancer Registry. RDI of individual chemotherapeutics (cycle 1-6) were recorded. Average RDI was stratified by <85% vs ≥85% of total dose. Subgroup analysis for early (cycle 1-3) versus late (cycle 4-6) RDI reductions were evaluated. Events (recurrence/death) from any cause were identified. Results: FECD patients (n=1304) receiving an average RDI <85% (range 25-84%) compared to ≥85% demonstrated a significant decline in DFS (79% vs 85%; p<0.01) and OS (82% vs 89%; p<0.01). Early reductions (any) compared to no reduction in RDI were correlated with inferior DFS (77% vs 86%; p<0.01) and OS (79% vs 90%; p<0.01). Late reductions in RDI did not affect DFS/OS. Proportions of TNBC were non-significant for comparative cohorts. Significantly more N0 and N1-3 patients were seen in the any and no early reduction cohort respectively. Conclusions: In high risk BC patients, average RDI <85% is correlated with reduced DFS/OS for FECD. Early (FEC) compared with late (docetaxel) reductions in RDI are correlated with inferior survival. This data suggests that where possible, total (<85%) and early (FEC) dose reductions should be avoided in patients receiving adjuvant FEC-D chemotherapy. [Table: see text]

Randomized Phase II Adjuvant Trial of Dose-Dense Docetaxel Before or After Doxorubicin Plus Cyclophosphamide in Axillary Node-Positive Breast Cancer

2008 ◽  
Vol 26 (10) ◽  
pp. 1691-1697 ◽  
Author(s):  
Shannon Puhalla ◽  
Ewa Mrozek ◽  
Donn Young ◽  
Susan Ottman ◽  
Anne McVey ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Dose Intensity ◽  
Axillary Node ◽  
Node Positive ◽  
Randomized Phase Ii ◽  
Reverse Sequence ◽  
Group B ◽  
Dose Reductions

PurposeAn anthracycline-based combination followed by, or combined with, a taxane is the sequence used in most adjuvant chemotherapy regimens. We hypothesized that administering the taxane before the anthracycline combination would be associated with fewer dose reductions and delays than the reverse sequence. To test this hypothesis, a randomized phase II multicenter adjuvant chemotherapy trial was performed.Patients and MethodsFifty-six patients with axillary node-positive, nonmetastatic breast cancer were randomly assigned either to group A (docetaxel [DOC] 75 mg/m2intravenously [IV] every 14 days for four cycles followed by doxorubicin 60 mg/m2and cyclophosphamide 600 mg/m2[AC] IV every 14 days for four cycles); or to group B (AC followed by DOC) at the identical doses and schedule. Pegfilgrastim 6 mg subcutaneous injection was administered 1 day after the chemotherapy in all treatment cycles. The primary objective was to administer DOC without dose reductions or delays before or after AC and calculate the relative dose intensity (RDI) of DOC and AC.ResultsThe majority of toxicities were grade 0 to 2 irrespective of sequence. The RDI for DOC was 0.96 and 0.82, respectively, in groups A (DOC followed by AC) and B (AC followed by DOC), with more frequent dose reductions occurring in group B (46% v 18%). The RDI for AC was 0.95 and 0.98 in groups A and B, respectively.ConclusionThe administration of DOC before AC results in fewer DOC dose reductions and a higher RDI than the reverse sequence. Larger trials evaluating the sequence of DOC before anthracyclines are justified.

Trastuzumab mediated cardiotoxicity in the setting of adjuvant chemotherapy for breast cancer: a retrospective study

2008 ◽  
Vol 117 (2) ◽  
pp. 357-364 ◽  
Author(s):  
Deepa Wadhwa ◽  
Nazanin Fallah-Rad ◽  
Debjani Grenier ◽  
Marianne Krahn ◽  
Tielan Fang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Retrospective Study ◽  
Adjuvant Chemotherapy

scholarly journals Sequential Versus Concurrent Trastuzumab in Adjuvant Chemotherapy for Breast Cancer

2011 ◽  
Vol 29 (34) ◽  
pp. 4491-4497 ◽  
Author(s):  
Edith A. Perez ◽  
Vera J. Suman ◽  
Nancy E. Davidson ◽  
Julie R. Gralow ◽  
Peter A. Kaufman ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Growth Factor Receptor ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Phase Iii ◽  
P Value ◽  
Sequential Administration ◽  
Taxane Chemotherapy

Purpose NCCTG (North Central Cancer Treatment Group) N9831 is the only randomized phase III trial evaluating trastuzumab added sequentially or used concurrently with chemotherapy in resected stages I to III invasive human epidermal growth factor receptor 2–positive breast cancer. Patients and Methods Patients received doxorubicin and cyclophosphamide every 3 weeks for four cycles, followed by paclitaxel weekly for 12 weeks (arm A), paclitaxel plus sequential trastuzumab weekly for 52 weeks (arm B), or paclitaxel plus concurrent trastuzumab for 12 weeks followed by trastuzumab for 40 weeks (arm C). The primary end point was disease-free survival (DFS). Results Comparison of arm A (n = 1,087) and arm B (n = 1,097), with 6-year median follow-up and 390 events, revealed 5-year DFS rates of 71.8% and 80.1%, respectively. DFS was significantly increased with trastuzumab added sequentially to paclitaxel (log-rank P < .001; arm B/arm A hazard ratio [HR], 0.69; 95% CI, 0.57 to 0.85). Comparison of arm B (n = 954) and arm C (n = 949), with 6-year median follow-up and 313 events, revealed 5-year DFS rates of 80.1% and 84.4%, respectively. There was an increase in DFS with concurrent trastuzumab and paclitaxel relative to sequential administration (arm C/arm B HR, 0.77; 99.9% CI, 0.53 to 1.11), but the P value (.02) did not cross the prespecified O'Brien-Fleming boundary (.00116) for the interim analysis. Conclusion DFS was significantly improved with 52 weeks of trastuzumab added to adjuvant chemotherapy. On the basis of a positive risk-benefit ratio, we recommend that trastuzumab be incorporated into a concurrent regimen with taxane chemotherapy as an important standard-of-care treatment alternative to a sequential regimen.

Intensification of Adjuvant Chemotherapy: 5-Year Results of a Randomized Trial Comparing Conventional Doxorubicin and Cyclophosphamide With High-Dose Mitoxantrone and Cyclophosphamide With Filgrastim in Operable Breast Cancer With 10 or More Involved Axillary Nodes

2001 ◽  
Vol 19 (3) ◽  
pp. 612-620 ◽  
Author(s):  
Pierre Fumoleau ◽  
Franck Chauvin ◽  
Moïse Namer ◽  
Roland Bugat ◽  
Michèle Tubiana-Hulin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Randomized Trial ◽  
Disease Free Survival ◽  
Dose Intensity ◽  
High Dose ◽  
Free Survival ◽  
Axillary Nodes ◽  
Significant Difference ◽  
Disease Free

PURPOSE: To determine whether intensifying the dose of adjuvant chemotherapy improves the outcome of women with primary breast cancer and 10 or more involved axillary nodes. PATIENTS AND METHODS: Patients (n = 150) were randomized to receive either four cycles of standard doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks (arm A) or four courses of intensified mitoxantrone 23 mg/m2 plus cyclophosphamide 600 mg/m2, with filgrastim 5 g/kg/d from days 2 to 15, every 3 weeks (arm B). Disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) were determined using life-table estimates. RESULTS: There were no significant differences in DFS (P = .44), DDFS (P = .67), or OS (P = .99) between the two groups at 5 years; DDFS was 45% (arm A) versus 50% (arm B), and DFS was 41% versus 49%, respectively. Five-year survival was similar in both arms (61% v 60%, respectively). Failure to note an intergroup difference in outcome was unrelated to relative dose-intensity. Analysis of patients with 15 or more positive nodes revealed a significant difference in 5-year DDFS (19% v 49% in arm B; P = .01). Toxicity was generally mild in both groups, with no toxic death. The incidence of febrile neutropenia was low (0.3% v 3%). Alopecia was less frequent in arm B (P < .001). CONCLUSION: This randomized trial confirms the feasibility of administering mitoxantrone 23 mg/m2 with cyclophosphamide and filgrastim. Although there was no significant difference between conventional and intensified arms at 5 years, according to subgroup analysis, intensified treatment may decrease the risk of relapse in patients with 15 or more positive nodes compared with doxorubicin an cyclophosphamide.

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