Use of growth factors associated with docetaxel and paclitaxel in patients with early-stage breast cancer in a community oncology center

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17548-e17548
Author(s):  
S. H. Boklage ◽  
L. Chen ◽  
N. P. Christiansen ◽  
S. D. Sullivan ◽  
J. W. Hay ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Growth Factors ◽  
Negative Binomial ◽  
Multivariate Analyses ◽  
Early Stage ◽  
Descriptive Analysis ◽  
Wilcoxon Test ◽  
Hematologic Toxicity ◽  
Loss To Follow Up ◽  
Pharmacy Claims

e17548 Background: Docetaxel and paclitaxel are widely used in treating breast cancer (BC), and both have hematologic toxicity commonly managed by costly growth factors (GFs). However, the extent of GFs use in real-world clinical practice has not been well documented. Methods: The Georgia Oncology Specialist Database was used and contained chemotherapy, medical and pharmacy claims, and lab results for nearly 170,000 patients with various types of cancer (2003–2008). Patients with stage I-III BC receiving docetaxel- or paclitaxel-containing regimens as adjuvant therapy were followed from 1 week prior to docetaxel or paclitaxel (index drug) initiation to the earliest of death, loss to follow-up, switch in taxane, or end of 90-day period post last dose of index drug. Incidence of GFs use per person-year was compared using univariate negative binomial (NB) model, median time to first GFs use was compared using Wilcoxon test. Multivariate analyses were performed on number of utilizations and time to first utilization adjusting for potential confounders. Results: Compared with paclitaxel (n = 433), docetaxel cohort (n = 216) had lower incidence per person-year of erythroid stimulating agents (ESAs) use (8.01 vs. 11.72, p = 0.008), while similar incidence of myeloid growth factors (MGFs) use (8.51 vs. 5.07, p = 0.541). Lower MGFs utilization in docetaxel patients (ratio of number of utilization = 0.821, p = 0.033), and similar ESAs utilization (ratio of number of utilization = 0.920, p = 0.305) were found. While descriptive analysis showed paclitaxel patients received first ESAs sooner than docetaxel patients (median length: 23 vs. 7 days, p < 0.001), and no difference in time to first MGFs use (median 8 days for both); multivariate analyses found docetaxel patients received first MGFs sooner (ratio of days = 0.828, p = 0.039), and no difference in time to first ESAs use (ratio of days = 1.091, p = 0.419). Conclusions: This analysis suggests that docetaxel is associated with lower utilization of MGFs. Studies examining the economic impact of GFs use associated with taxanes will need to be conducted. A potential limitation of this study is that the potential selection bias may not be fully adjusted. [Table: see text]

scholarly journals Descriptive analysis of 192 cases of breast cancer occurring before age 40 in Yaounde, Cameroon

2017 ◽  
Vol 6 (7) ◽  
pp. 2704 ◽  
Author(s):  
Félix Essiben ◽  
Pascal Foumane ◽  
Esther JNU Meka ◽  
Michèle Tchakounté ◽  
Julius Sama Dohbit ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ductal Carcinoma ◽  
Early Stage ◽  
Descriptive Analysis ◽  
Survival Rates ◽  
The United States ◽  
Therapeutic Modalities ◽  
History Of ◽  
Case Files ◽  
Common Histological Type

Background: Breast cancer is today a global health problem. With 1,671,149 new cases diagnosed in 2012, it is the most common female cancer in the world and accounts for 11.9% of all cancers and it affects more people than prostate cancer. In 2008, The United States statistics showed that, for all cancer that affect women before 40 years, more than 40% of them concerned the breast. The aim of this study was to describe the clinical, histopathological and therapeutic aspects of breast cancer in women under 40 years of age in Yaoundé.Methods: This was a retrospective study with data collected from 192 medical case files of women treated over a period of 12 years, from January 2004 to December 2015 at the Yaounde General Hospital and the Yaounde Gyneco-Obstetric and Pediatric Hospital. Microsoft Epi Info version 3.4.5 and SPSS version 20.0 softwares were used for data analysis.Results: From 2004 to 2015, 1489 cases of breast cancer were treated in both hospitals. Of these, 462 women were less than 40 years old, representing a proportion of 31.0%. The mean age at diagnosis was 33.5±5.0 years and 17.7% of women had a family history of breast cancer. The average time before an initial consultation was 6.7±6.6 months.  Most cases were classified as T4 (46.1%). The most common histological type was ductal carcinoma (87.4%). Grades SBR II and SBR III were predominant (76.4%). Axillary dissection (64.4%) and neoadjuvant chemotherapy (43.9%) were the main therapeutic modalities. The overall survival rate at 5 years was 51.2%. Five-year survival rates with no local recurrence and no metastatic occurrence were 35.8% and 43.2% respectively.Conclusions: Breast cancer largely affects women under the age of 40 and is often discovered late, at an advanced stage. The prognosis appears poor. Only screening could facilitate diagnosis at an early stage of the disease for better outcomes.

NCIC CTG MA.17: Tolerability of letrozole among ethnic minority women

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6018-6018
Author(s):  
B. Moy ◽  
D. Tu ◽  
L. E. Shepherd ◽  
J. L. Pater ◽  
T. J. Whelan ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ethnic Minority ◽  
Early Stage ◽  
Bodily Pain ◽  
Disease Free Survival ◽  
Minority Women ◽  
Wilcoxon Test ◽  
Future Research ◽  
Change Scores ◽  
Sf 36

6018 Background: Disease free survival was significantly improved in women receiving letrozole after standard adjuvant tamoxifen in the MA.17 trial. Based on the results of MA.17 and of other trials of aromatase inhibitors in early stage breast cancer, chronic aromatase inhibitor therapy, in postmenopausal women free of breast cancer recurrence, is now being widely employed. We analyzed the toxicity of letrozole according to ethnic status among women enrolled in MA.17. Methods: The chi-square test was used for comparison of rates of side effects between the two groups, Caucasian vs. ethnic minority (defined as all non-Caucasians). In a subset of women, quality of life (QOL) was assessed by the SF-36 Health Survey. Mean change scores in QOL from baseline were compared between groups for summary measures and domains using the Wilcoxon test. Results: 352 minority women and 4,708 Caucasians were enrolled in MA.17, of which 183 minority women and 2,339 Caucasians were randomized to receive letrozole. Caucasians were older than minority women and had a slightly longer duration of treatment with prior tamoxifen. Tumor size and nodal status were not significantly different between the two groups. In women who received letrozole, minority women had significantly lower incidence of hot flashes (49% vs. 58%; p = 0.02), fatigue (29% vs. 39%; p = 0.005), and arthritis (2% vs. 7%; p = 0.006) compared with Caucasians. Mean QOL change scores of SF-36 domains for women who received letrozole were not different but minority women had better mental health at 6 month assessment (p = 0.02) and worse bodily pain at 12 month assessment (p = 0.046). Conclusions: Minority women tolerated letrozole considerably better than Caucasians in the MA.17 trial. These preliminary findings suggest that minority women respond differently to letrozole in terms of toxicity. Recent demonstration of genotypic variations in the aromatase gene in different ethnic groups plus likely pharmacogenomic differences suggests that further research is needed to clarify the clinical outcomes of aromatase inhibition in women of diverse ethnicities. Future research strategies should focus on examining in vivo genotype-phenotype correlations to determine the effects of genetic variation on response to anticancer therapy and on toxicities and end-organ effects. [Table: see text]

The clinical impact of ASCO “choosing wisely” recommendations on staging imaging for early stage breast cancers: An interrupted time-series analysis utilizing SEER-Medicare data.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 2078-2078
Author(s):  
Alan Baltz ◽  
Issam Makhoul ◽  
Eric R Siegel
Keyword(s):  
Breast Cancer ◽  
Cancer Diagnosis ◽  
Negative Binomial ◽  
Early Stage ◽  
Breast Cancer Diagnosis ◽  
Choosing Wisely ◽  
Breast Cancers ◽  
Interrupted Time Series Analysis ◽  
Medicare Data ◽  
The Impact

2078 Background: The “Choosing Wisely” (CW) list, released by the American Society for Clinical Oncology (ASCO), highlights low-value procedures. In 2012, the CW recommendations advised against the use of staging imaging, including Positron Emission Tomography (PET), Computerized Tomography (CT) and radionuclide bone scans, for the staging of early breast cancer at low risk for metastasis. The objective of this study was therefore to assess the impact of the ASCO CW recommendations on staging imaging among early stage breast cancers. Methods: Women above the age of 66 with an early stage incident breast cancer diagnoses between 2010 and 2015 were identified within the linked SEER-Medicare data. The primary outcome of interest was the proportion of patients with a claim for staging imaging in the six months following the breast cancer diagnosis. Negative binomial regression, adjusting for pre-recommendation trends, was performed to estimate the changes in the rate of imaging staging within each year following the release of the recommendation. Results: A total of 50,004 women were identified during the study period. Prior to the release of the recommendations in 2012, the staging imaging rates among women newly diagnosed with early stage breast cancers were 5% greater in 2010 (p<.01) and 4% greater in 2011 (p<.01). Following the release of the recommendations, staging imaging rates did not decrease significantly in 2013 (2%;p=0.18). Imaging rates did, however, significantly decrease by 13% in 2014 (p<0.01) and by 16% in 2015 (p<0.01). Conclusions: The CW recommendation was associated with a significant decrease in unadvised staging imaging among incident early stage breast cancer diagnosis in the second and third year following its release. These findings demonstrate an improvement in the proportion of potentially inappropriate staging imaging in early stage breast cancers. The creation and dissemination of resources, such as the CW recommendations, serves as a powerful tool to improve clinical practice, quality of care, and patient safety from secondary malignancies, anxiety, and overdiagnosis.

scholarly journals Effect of Pretreatment Renal Function on Treatment and Clinical Outcomes in the Adjuvant Treatment of Older Women With Breast Cancer: Alliance A171201, an Ancillary Study of CALGB/CTSU 49907

2016 ◽  
Vol 34 (7) ◽  
pp. 699-705 ◽  
Author(s):  
Stuart M. Lichtman ◽  
Constance T. Cirrincione ◽  
Arti Hurria ◽  
Aminah Jatoi ◽  
Maria Theodoulou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Renal Function ◽  
Renal Insufficiency ◽  
Early Stage ◽  
Single Agent ◽  
Hematologic Toxicity ◽  
End Points ◽  
Increased Risk ◽  
The Relationship

Purpose CALGB 49907 showed the superiority of standard therapy, which included either cyclophosphamide/doxorubicin (AC) or cyclophosphamide/methotrexate/fluorouracil over single-agent capecitabine in the treatment of patients age ≥ 65 with early-stage breast cancer. The treatment allowed dosing adjustments of methotrexate and capecitabine for pretreatment renal function. The purpose of the current analysis was to assess the relationship between pretreatment renal function and five end points: toxicity, dose modification, therapy completion, relapse-free survival, and overall survival. Methods Pretreatment renal function was defined as creatinine clearance (CrCl) using the Cockcroft-Gault equation. Multivariable logistic and proportional hazards regression were used to model separately for each regimen the relationship between CrCl and the first three binary end points and the last two time-to-event end points, respectively, after adjusting for variables of prognostic importance. Results Six hundred nineteen assessable patients were analyzed. The incidence of stage III (moderate) or stage IV (severe) renal dysfunction was 72%, 64%, and 75% for treatment with cyclophosphamide/methotrexate/fluorouracil, AC, and capecitabine, respectively. There was no relationship for any regimen between pretreatment renal function and the five end points. For AC, as CrCl increased, the odds of nonhematologic toxicity decreased (P = .008), whereas for capecitabine, as CrCl increased, the odds of experiencing toxicity of any type also increased (P = .035). Patients with renal insufficiency who received dose modifications were not at increased risk for complications compared with those who did not have renal insufficiency and received a full dose. Conclusion Excluding from clinical trials patients with renal insufficiency but good performance status on the basis of concern of excessive hematologic toxicity or poor outcomes may not be justified with appropriate dosing modifications. Results should be considered in the design of clinical trials for older patients.

Sequenced Compared With Simultaneous Anthracycline and Cyclophosphamide in High-Risk Stage I and II Breast Cancer: Final Analysis From INT-0137 (S9313)

2007 ◽  
Vol 25 (6) ◽  
pp. 656-661 ◽  
Author(s):  
Hannah M. Linden ◽  
Charles M. Haskell ◽  
Stephanie J. Green ◽  
C. Kent Osborne ◽  
George W. Sledge ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Total Dose ◽  
Early Stage ◽  
Randomized Study ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Node Negative

Purpose We conducted a phase III randomized study of two adjuvant treatment schedules of doxorubicin (A) and cyclophosphamide (C) in early-stage breast cancer to determine if administration of sequential single agents (A → C) results in superior disease-free survival (DFS) and overall survival (OS) versus the same total dose given in combination (AC). Patients and Methods High-risk node-negative or low-risk node-positive breast cancer patients received AC given: (arm I) concurrently (AC) doxorubicin 54 mg/m2 and cyclophosphamide 1.2 g/m2 intravenously (IV) every 3 weeks for six cycles; or (arm II) in sequence (A → C) doxorubicin 40.5 mg/m2 IV days 1 and 2 every 3 weeks for four cyles followed by cyclophosphamide 2.4 gm/m2 IV every 2 weeks for three cycles. Total dose and duration were identical, but the intensity of each drug was increased on A → C. Both arms included granulocyte colony-stimulating factor support and prophylactic antibiotics. All but premenopausal women with receptor negative tumors received tamoxifen after chemotherapy. Results Between 1994 and 1997, 3,176 patients were randomly assigned. Arms were well balanced; 48% of eligible patients were node-negative and 48% were estrogen receptor–positive. No significant differences in OS or DFS were observed; 5-year estimates of OS (95% CI) were 88% (87% to 90%) on AC and 89% (87% to 91%) on A → C. Grade 4 hematologic toxicity was greater on A → C, but nonhematological grade 4 was similar. Conclusion The overall result does not support superiority of dose-intense sequenced single agents. The greater toxicity of higher doses of single agents does not support their sequential use.

Dose-dense (DD) cyclophosphamide, methotrexate, and fluorouracil (CMF) at 14-day intervals: A pilot study of every 14- and 10–11-day dosing intervals for women with early-stage breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 590-590
Author(s):  
P. Drullinsky ◽  
M. N. Fornier ◽  
S. Sugarman ◽  
G. D'Andrea ◽  
T. Troso-Sandoval ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Hematologic Toxicity ◽  
Type I ◽  
Initial Cohort ◽  
Grade 3 ◽  
Dose Dense ◽  
Q 14 ◽  
Dosing Intervals

590 Background: CMF (C 600 mg/m2, M 40 mg/m2, F 600 mg/m2) is an option for adjuvant therapy for patients with low risk early stage breast cancer. DD regimens as predicted by mathematical models of cancer growth and treatment response are superior. We previously demonstrated the safety of DD EC (epirubicin/cyclophosphamide) followed by paclitaxel at 10–11 day (d) intervals. We investigated the feasibility of administering DD adjuvant CMF every 14 d and then every 10–11 d in a 2-stage phase II trial. Methods: An initial cohort (A) was treated q 14 d with PEG-filgrastim (Neulasta) support. A second cohort (B) was treated every 10–11 d with filgrastim/Neupogen x 5 d and then, based on feasibility, modified (cohort C) to use 7 d filgrastim. The primary end point was feasibility defined as having ANC > 1.5 x 103/uL on day 1 of planned treatment for all 8 cycles with no grade 3 or higher non-hematologic toxicity. All three cohorts were tested using a Simon's two-stage optimal design with type I and type II errors set at 10%. This design would effectively discriminate between true tolerability (as protocol-defined) rates of< 60% and> 80%. Cohort A: 38 pts with early stage breast cancer were accrued from 3/2008 though 6/2008. Cohort B: 7 pts were accrued from June 2008 through August 2008. Cohort C: Is still open with 16 pts accrued from August 2008 through December 5, 2008. Results: Median age 51: range 38 to 78. Cohort A: 29/38 pts completed 8 cycles of CMF. The regimen was considered feasible. 2 other pts completed 7 cycles and were withdrawn for depression and grade 2 transaminitis. The 7 other pts completed between 1 and 6 cycles of CMF were withdrawn as follows: 3 personal, 1 (grade 3) bone pain, 2 allergy unrelated to CMF, and 1 seizure. Cohort B: 7 pts were accrued. 6 out of 7 pts could not complete 8 cycles of chemotherapy secondary to neutropenia and 1 secondary to grade 3 ALT elevation. Cohort C: Accrual has not been completed. 16 pts are currently enrolled. Conclusions: Dose dense adjuvant CMF is feasible at 14 d intervals with PEG-filgrastim support. Adjuvant CMF every 10–11 days with filgrastim given for 5 days beginning day 2 is not feasible. Accrual is ongoing for CMF at 10–11 days with filgrastim x 7 days. Updated results will be available for Cohort C. [Table: see text]

Comparison of doxorubicin and cyclophosphamide (AC) versus single-agent paclitaxel (T) as adjuvant therapy for breast cancer in women with 0-3 positive axillary nodes: CALGB 40101.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1007-1007
Author(s):  
Lawrence N. Shulman ◽  
Donald A. Berry ◽  
Constance T. Cirrincione ◽  
Heather Becker ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Relative Effectiveness ◽  
Single Agent ◽  
Hazard Ratio ◽  
Hematologic Toxicity ◽  
Grade 3 ◽  
Reduced Toxicity ◽  
Absolute Advantage

1007 Background: Determining optimal adjuvant chemotherapy for early stage breast cancer depends on efficacy and toxicity. We sought to determine if T is equivalent to AC but with reduced toxicity. Methods: Pts with operable breast cancer with 0-3 positive nodes were enrolled on a 2x2 factorial design study which addressed (1) superiority of 6 vs. 4 cycles of therapy (previously reported, Shulman, JCO 2012) and (2) equivalence of single-agent T to standard AC, defined as upper bound of 95% confidence interval (CI) of hazard ratio (HR) of T vs. AC < 1.30 for the primary endpoint of relapse-free survival (RFS). A planned target of 567 RFS events required 4,646 pts with 4 yrs FU. At activation in 2002, T (80mg/m2) was q1wk for 12 or 18 wks and AC (60/600 mg/m2) was q3wk for 4 or 6 cycles. In 2003 (570 pts enrolled) schedules were revised to 4 or 6 cycles q2wk for both T (175 mg/m2) and AC. The 6-cycle arms were dropped in 2008 (3,171 pts enrolled) due to slow accrual. Relative effectiveness of T to AC is shown by hazard ratio (HR). Logrank p-values are measures of discordance but are not relevant for the equivalence question and are not adjusted for multiple comparisons. Results: After enrolling 3,871 pts, the study closed in 2010 due to slowing accrual. With a median follow-up of 6.1 yrs there are 437 RFS events. The HR of 1.26 (95% CI: 1.05-1.53; p = 0.02) does not allow a conclusion of equivalence of T with AC. With 266 deaths the HR for overall survival (OS) is 1.27 (95% CI=1.00-1.62; p = 0.05), favoring AC. The estimated absolute advantage of AC at 5 yrs is 3% (91 vs. 88%) for RFS and 1% (95 vs. 94%) for OS. All 9 treatment-related deaths were in pts receiving AC and are included in the survival analysis. The incidence of Grade 3+ toxicity for AC vs T was 33% vs. 4% for hematologic toxicity and 36% vs 22% for non-hematologic toxicity. Conclusions: This trial did not show equivalence of T to AC, a conclusion that is very unlikely to change with additional follow-up. T was less toxic than AC. Clinical trial information: CDR0000069444/NCT00041119.

Prognostic value of histopathology, stromal tumor infiltrating lymphocytes (sTILs) and adjuvant chemotherapy (AdjCT) in early stage triple negative breast cancer (TNBC).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 533-533
Author(s):  
Roberto Antonio Leon-Ferre ◽  
Mei-Yin Polley ◽  
Heshan Liu ◽  
Judith A. Gilbert ◽  
Victoria Cafourek ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Proportional Hazards ◽  
Multivariate Analyses ◽  
Early Stage ◽  
Tumor Infiltrating Lymphocytes ◽  
Invasive Disease ◽  
Cox Proportional Hazards ◽  
Prognostic Impact ◽  
N Stage ◽  
The Impact

533 Background: Current guidelines define TNBC as complete absence of estrogen (ER) and progesterone receptor (PR), without HER2 amplification. However, the prognostic impact of clinical and histopathological factors, sTILs, and AdjCT in TNBC meeting these strict criteria is unknown. Methods: From a cohort of 9985 women who underwent upfront surgery for M0 breast cancer (BC) at Mayo Clinic Rochester from 1985-2012, 1159 pts with ER negative or low (≤10%) BC were identified for central ER/PR/HER2 staining and HER2 FISH (IHC2+ only) to select those with TNBC by modern definitions. Cox proportional hazards models were used to assess the impact of clinicopathological variables on invasive disease-free (IDFS) and overall survival (OS). Results: Tumors from 605 pts (median age 56.3 yrs) met criteria for TNBC (ER < 1%, PR < 1% and HER2 0, 1 or 2+ and FISH negative). 51% were T1, 65% N0, 88% grade 3, and 75% had Ki67 > 15%. Histologically, 39% were anaplastic, 26% invasive ductal, 16% medullary, 8% metaplastic, 6% apocrine and 5% others. Median sTILs was 20% (0-90%). 55% pts received AdjCT [21% anthracycline (A), 19% A + taxane, and 15% other]. Median follow-up for IDFS and OS were 7.4 and 10.6 yrs, respectively. Multivariate analyses demonstrated that higher N stage (p < 0.01), lower sTILs (p = 0.01) and no AdjCT (p < 0.01) were independently associated with worse IDFS and OS. Histology (medullary subtype) was associated with better IDFS in univariate (HR 0.56, 95% CI, 0.35-0.89) but not in multivariate analyses, once sTILs were accounted for. Among systemically untreated pts (n = 182), higher N (p < 0.01) and lower sTILs (p = 0.04) were associated with worse IDFS. For systemically untreated T1N0 pts (n = 111), the 5-yr IDFS was 70% (95% CI, 61-81) [T1a: 83% (95% CI, 63-100), T1b: 68% (95% CI, 52-88) and T1c: 67% (95% CI, 55-83)], compared to 78% (95% CI, 68-84) for T1N0 pts treated with AdjCT. Conclusions: In TNBC pts, N stage, sTILs and receipt of AdjCT were independently prognostic for IDFS and OS. sTILs remained prognostic for IDFS in systemically untreated TNBC. In N0 TNBC, the risk of recurrence or death was substantial in the absence of chemotherapy, even for those with T1 tumors.

scholarly journals Comparison of Doxorubicin and Cyclophosphamide Versus Single-Agent Paclitaxel As Adjuvant Therapy for Breast Cancer in Women With 0 to 3 Positive Axillary Nodes: CALGB 40101 (Alliance)

2014 ◽  
Vol 32 (22) ◽  
pp. 2311-2317 ◽  
Author(s):  
Lawrence N. Shulman ◽  
Donald A. Berry ◽  
Constance T. Cirrincione ◽  
Heather P. Becker ◽  
Edith A. Perez ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Single Agent ◽  
Hematologic Toxicity ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Duration Of Therapy ◽  
The One ◽  
Absolute Advantage

Purpose Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity. Patients and Methods Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported. Results With 3,871 patients enrolled onto the trial, a median follow-up period of 6.1 years, and 437 RFS events, we achieved an HR of 1.26 (one sided 95% UCB, 1.48; favoring AC does not allow a conclusion of noninferiority of T with AC; UCB > 1.3). With 266 patient deaths, the HR for overall survival (OS) was 1.27 favoring AC (UCB, 1.56). The estimated absolute advantage of AC at 5 years is 3% for RFS (91 v 88%) and 1% for OS (95 v 94%). All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS. Hematologic toxicity was more common in patients treated with AC, and neuropathy was more common in patients treated with T. Conclusion This trial did not show noninferiority of T to AC, a conclusion that is unlikely to change with additional events and follow-up. T was less toxic than AC.

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