Randomized phase III study of adjuvant chemotherapy for high-risk, node-negative breast cancer (BC) comparing FAC with FAC followed by weekly paclitaxel: First efficacy analysis of the GEICAM/2003-02 trial.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1001-1001 ◽  
Author(s):  
Miguel Martin ◽  
Ana Lluch ◽  
Amparo Ruiz ◽  
Manuel Ruiz Borrego ◽  
Agust Barnadas ◽  
...  
Keyword(s):  
High Risk ◽  
Menopausal Status ◽  
Dose Intensity ◽  
Drop Out ◽  
Phase Iii ◽  
Weekly Paclitaxel ◽  
P Value ◽  
Her2 Positive ◽  
Node Negative

1001 Background: Adjuvant weekly paclitaxel (wP) sequential to anthracyclines improves the outcome of operable node-positive BC patients (pts) [Sparano NEJM 2008, Martin BCRT 2009]; however, most BC pts are currently node-negative at diagnosis. The role of wP in these pts is not well established yet. Methods: Pts aged 18-70, with T1-T3/N0 operable BC and at least one high-risk St Gallen 1998 criteria (size >2 cm, hormone-receptor [HR] negative, grade 2/3, age <35 years,) were eligible. HER2+ pts were allowed, after 792 entered the trial, the study was amended to exclude them. Pts were stratified by site, menopausal status, nodal status diagnostic method (sentinel-node biopsy versus lymphadenectomy) and HR status and randomized to receive FAC x6 (500/50/500 mg/m2 every 3w) or FAC x4→wP x8 (paclitaxel 100 mg/m2 weekly). The primary endpoint was DFS. The trial was designed to detect an absolute 5-y DFS increase of 5% (80% FAC, 85% FAC→wP); a sample size of 1812 evaluable patients (906 per arm) was required to detect this difference (α=0.05, β= 80%). Assuming a drop-out rate of 6%, 1929 pts were required. The first analysis of DFS was planned when a median follow-up of 5 years was reached. Results: Between September 2003 and October 2008, 1925 pts (FAC 974, FAC→wP 951) were randomized. Patient characteristics were well balanced between arms, median age was 50, 73% of pts were HR positive and 9% HER2 positive. 97% of pts with FAC and 85% of pts with FAC→wP completed all treatment as planned. The median dose intensity was 98% with FACx6, 99% with FACx4 and 98% with wP. The most frequent grade 3-4 toxicities (>3% in either arm) with FAC vs FAC→wP were neutropenia (25% vs 22%) with 4% vs 3% of febrile neutropenia, fatigue (3% vs 8%), sensory neuropathy (0 vs 5%), and vomiting (4% in each arm). After a median follow-up of 5.3 years, the proportion of patients disease free is 93% and 90% with FAC→wP and FAC (HR for relapse 0.732, 95% CI: 0.542 to 0.990; log-rank p-value=0.0423). Conclusions: For pts with high-risk node-negative BC, adjuvant FAC→wP was associated with a small but significant improvement in DFS compared with FAC, with manageable toxicity.

Randomized phase III study of adjuvant chemotherapy for node-positive early breast cancer (BC) patients (pts) comparing epirubicin plus cyclophosphamide followed by docetaxel (EC-T) versus epirubicin plus docetaxel followed by capecitabine (ET-X): Efficacy analysis of the GEICAM/2003-10 trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1027-1027
Author(s):  
Begoña Bermejo ◽  
Amparo Ruiz ◽  
Manuel Ruiz Borrego ◽  
Nuria Ribelles ◽  
Alvaro Rodriguez-Lescure ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Breast Cancer ◽  
Menopausal Status ◽  
Metastatic Breast ◽  
Dose Intensity ◽  
Drop Out ◽  
Phase Iii ◽  
P Value ◽  
Her2 Positive ◽  
Node Positive

1027 Background: X is an active drug in metastatic breast cancer. GEICAM/2003-10 is an adjuvant trial investigating the integration of capecitabine into an epirubicin and docetaxel containing regimen for node-positive early breast cancer pts. Methods: Pts aged 18-70, with T1-T3/N1-3 operable BC were eligible. HER2+ pts were initially allowed. In October 2005, after 803 pts were included in the trial, the study was amended to exclude them. Pts were stratified by site, menopausal status, number of axillary nodes (1-3, 4-9, >9) and hormonal receptor status and randomized to receive EC (90/600 mg/m2 x4) followed by T (100 mg/m2 x4) or ET (90/75 mg/m2 x4) followed by X (1,250 mg/m2 BID, d1–14, x 4) all every three weeks. The primary endpoint was DFS. The trial was designed to detect an absolute 5-y DFS increase of 7% (72% EC-T, 79% ET-X); a sample size of 1,184 evaluable pts (592 per arm) was required to detect this difference (a=0.05, β=80%). Assuming a drop-out rate of 17%, 1,382 pts were required. The first analysis of DFS was planned after 290 events. Results: Between February 2004 and February 2007, 1384 pts (EC-T 669, ET-X 715) were randomized. Patient characteristics were balanced between arms, median age was 51, 84% of pts were HR positive and 11% HER2 positive; 66, 25 and 9% had 1-3, 4-9 and > 9 nodes respectively. The median relative dose intensity was 99% for EC, 99% for T, 99% for ET and 94% for X. The most frequent grade 3-4 toxicities (>5% in either arm) with EC-T vs. ET-X were neutropenia (19% vs. 10%) with 7% febrile neutropenia in both arms, hand-foot syndrome (2% vs. 20%), fatigue (13% vs. 11%), diarrhea (3% vs. 11%), stomatitis (6% vs. 5%) and vomiting (5% vs. 5%). After a median follow-up of 6.6 years and 292 events, the proportion of patients disease free at 5 years is 86% and 82% with EC-T and ET-X (HR for relapse 1.314, 95% CI: 1.042 – 1.657); log-rank p-value=0.0208. Overall survival was not different between treatment arms (HR 1.113, 95% CI: 0.809 – 1.531); log rank p-value=0.511. Conclusions: DFS has been in favour of EC-T in pts with node-positive early BC. Clinical trial information: NCT00129935.

Primary results of NRG Oncology / NSABP B-43: Phase III trial comparing concurrent trastuzumab (T) and radiation therapy (RT) with RT alone for women with HER2-positive ductal carcinoma in situ (DCIS) after lumpectomy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 508-508
Author(s):  
Melody A. Cobleigh ◽  
Stewart J. Anderson ◽  
Kalliopi P. Siziopikou ◽  
Douglas W Arthur ◽  
Thomas B. Julian ◽  
...  
Keyword(s):  
Ductal Carcinoma ◽  
Performance Status ◽  
Menopausal Status ◽  
Phase Iii ◽  
P Value ◽  
Primary Analysis ◽  
Her2 Positive ◽  
Ecog Performance Status ◽  
Intent To Treat

508 Background: Preclinical studies report that T can boost RT effectiveness. The primary aim of this trial assessed the efficacy of concurrent T + RT vs RT alone in preventing recurrence of ipsilateral breast cancer, ipsilateral skin cancer, or ipsilateral DCIS (IBTR) in women with DCIS. Methods: Eligibility: Women ≥18 yrs, ECOG performance status 0 or 1, DCIS resected by lumpectomy, and clear margins. Whole-breast RT after randomization was with 25+ fractions or accelerated with 16-17 fractions. RT boost was allowed. Centralized HER2 testing and ER and/or PR were required before entry. Stratification was by menopausal status, adjuvant endocrine therapy plan, and nuclear grade. T was given at 8 mg/kg IV within 1 wk before and 5 days after RT began (Dose 1) and at 6 mg/kg IV 3 wks after Dose 1 (Dose 2). Definitive intent-to-treat primary analysis was to be conducted when either 163 IBTR events were recorded or when all accrued pts were on study for ≥5 yrs. Results: 2014 pts were randomized (11/9/08 to 12/8/14);1998 (99.2%) had follow-up information. Median follow-up time on 12/31/19 was 79.2 mos. 2001 pts had RT information, 1965 (98.2%) completed RT: 988 (98.3%) in the RT arm and 977 (98.1%) in the RT+T arm. 996 pts had T compliance information in the RT+T arm, 939 (94.3%) completed two doses of T, 25 (2.5%) had one dose of T, and 32 (3.2%) did not receive T. At primary definitive analysis, 114 IBTR events occurred: 63 in the RT arm and 51 in the RT+T arm (HR = 0.81 [95% CI: 0.56-1.17], p-value = 0.26). 38 were invasive: 18 in the RT arm and 20 in the RT+T arm (HR = 1.11 [95% CI: 0.59-2.10], p-value = 0.74). 76 were DCIS: 45 in the RT arm and 31 in the RT+T arm (HR = 0.68 [95% CI: 0.43-1.08], p-value = 0.10). Annual IBTR event rates were 0.99%/yr in the RT group and 0.80%/yr in the RT+T group. There were 288 events of any kind [iDFS-DCIS] (DFS): 155 in the RT arm and 133 in the RT+T arm (HR = 0.84 [95% CI: 0.66-1.05], p-value = 0.13) and 48 deaths: 26 in the RT arm and 22 in the RT+T arm (OS HR = 0.85 [95% CI: 0.48-1.51], p = 0.59). The study did not reach the 163 protocol-specified events, so the definitive analysis was triggered by all pts having been on study for ≥5 years. Conclusions: The addition of T to RT did not achieve the protocol objective of 36% reduction in the IBTR rate but did achieve a modest, statistically non-significant reduction of 19%. Support: U10-180868, -180822, UG1-189867; Genentech. The authors thank Elaina Harper and Marlon Jones for data management. Clinical trial information: NCT00769379 .

NSABP B-47: A phase III trial of adjuvant therapy comparing chemotherapy alone (six cycles of docetaxel plus cyclophosphamide or four cycles of doxorubicin plus cyclophosphamide followed by weekly paclitaxel) to chemotherapy plus trastuzumab in women with node-positive or high-risk, node-negative, HER2-low invasive breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS1142-TPS1142
Author(s):  
Louis Fehrenbacher ◽  
Jong-Hyeon Jeong ◽  
Priya Rastogi ◽  
Charles E. Geyer ◽  
Soonmyung Paik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Chemotherapy Regimen ◽  
Phase Iii ◽  
Weekly Paclitaxel ◽  
Loading Dose ◽  
Node Negative ◽  
Node Positive ◽  
Trastuzumab Therapy ◽  
Her2 Breast Cancer

TPS1142 Background: Adjuvant studies utilizing trastuzumab in early HER2+ breast cancer demonstrated a large reduction in recurrence and death. Post-enrollment central testing showed HER2 non-amplified participants derived similar benefit. Methods: Selection of one of the two chemotherapy regimens is by physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered IV every 3 weeks for 6 cycles; the anthracycline regimen is AC followed by WP (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered IV either every 3 weeks or every 2 weeks [per investigator discretion] for 4 cycles followed by paclitaxel 80 mg/m2 IV weekly for 12 doses). Patients are randomly assigned to receive chemotherapy with or without trastuzumab therapy. For patients receiving the TC chemotherapy regimen, trastuzumab is given every 3 weeks during and following chemotherapy until 1 year after the first trastuzumab dose (8 mg/kg loading dose; 6 mg/kg for the remaining doses). For patients receiving the AC followed by WP chemotherapy regimen, trastuzumab begins with the first dose of weekly paclitaxel and will be given weekly for 12 doses (4 mg/kg loading dose; 2 mg/kg for the remaining weekly doses). Following completion of WP, trastuzumab therapy continues with 6 mg/kg doses given every 3 weeks for a total of 1 year. Eligibility: Eligibility includes: node positive or high risk node negative female breast cancer patients; HER2 IHC 1+ or 2+ scores, but non amplified by FISH Statistical Design: The primary aim is to determine whether the addition of trastuzumab to chemotherapy improves invasive disease-free survival (IDFS). 3260 patients will be enrolled to provide statistical power of 0.9 to detect a 33% reduction in the hazard rate of IDFS using a one-sided alpha level of 0.025. Progress: Protocol was activated in January 2011. As of January 27, 2012, 486 of 3260 patients have been enrolled. Supported by NCI U10-12027, -37377, 69651, 69974, and Genentech, Inc.

Overall survival in patients with lung cancer using a web-application-guided follow-up compared to standard modalities: Results of phase III randomized trial.

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA9006-LBA9006 ◽  
Author(s):  
Fabrice Denis ◽  
Claire Lethrosne ◽  
Nicolas Pourel ◽  
Olivier Molinier ◽  
Yoann Pointreau ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Supportive Care ◽  
Cancer Patients ◽  
Web Application ◽  
Phase Iii ◽  
P Value ◽  
Lung Cancer Patients

LBA9006 Background: We developed a web-application for an early detection of symptomatic relapse, complications and early supportive care in high-risk lung cancer patients between visits. A dynamical analysis of the weekly self-reported symptoms automatically triggered physician visit. Methods: We performed a national multi-institutional phase 3 prospective randomized study to compare web-application follow-up (experimental arm) for which patient’s self-scored symptoms that were weekly sent (between planned visits) to the oncologist and a clinical routine assessment with a CT-scan (every 3-6 months or at investigator’s discretion - standard arm). High risk lung cancer patients without progression and with a 0-2 performance status (PS) after an initial treatment were included. Maintenance chemotherapy or TKI therapy were allowed. In the experimental arm, an email alert was sent to the oncologist when some predefined clinical criteria were fulfilled: an imaging was then quickly prescribed. Early supportive cares were provided if adequate. The primary endpoint was to detect an improvement of 12% in 9 months survival in favor of the experimental arm (α = 5%, β = 20%, unilateral test). The boundary for declaring superiority with respect to overall survival at the pre-planned interim analysis was a p-value of less than 0.006. The PS at relapse, the quality of life (QOL) and cost-effectiveness were also investigated. Results: 121 patients were included in the intent-to-test survival analysis (90% were stage III/IV, median age: 65 y): 60 (61) in the experimental (standard) arms with equivalent baseline characteristics. Median follow-up was 9 months. Median overall survival in months was 19 (11.8), p=0.0014 (n  =  121; HR  =  0.33; 95 % CI, 0.16-0.67) and the PS at the first relapse was 0-1 for 81.5% (35.3%) of the patients (p<0.001) in the experimental (standard) arm. Conclusions: This trial shows a significant survival improvement using Web-application-guided follow-up that allowed better PS at relapse, earlier supportive care and reduction of routine imaging. QOL and cost analysis results will be presented during the meeting. Clinical trial information: NCT02361099.

BCIRG 006: Docetaxel and trastuzumab-based regimens improve DFS and OS over AC-T in node positive and high risk node negative HER2 positive early breast cancer patients: Quality of life (QOL) at 36 months follow-up

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19647-19647 ◽  
Author(s):  
N. J. Robert ◽  
W. Eiermann ◽  
T. Pienkowski ◽  
J. Crown ◽  
M. Martin ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Early Breast Cancer ◽  
Relative Reduction ◽  
Breast Cancer Patients ◽  
Her2 Positive ◽  
Node Negative ◽  
Risk Of Death ◽  
Node Positive

19647 Background: The primary objective of the BCIRG 006 trial was to determine if the use of trastuzumab in early high-risk HER2-positive breast cancer significantly improved clinical outcomes. A secondary objective was to evaluate the QOL of patients receiving the 2 treatments. Methods: The BCIRG 006 trial compared adjuvant standard AC (doxorubicin/cyclophosphamide x 4 cycles) followed by docetaxel x 4 [AC-T] or 2 trastuzumab-containing regimens, AC followed by T with trastuzumab x 1 year [AC-TH] or TCarbo x 6 with trastuzumab x 1 year [TCH] in patients with node positive or high-risk node negative HER2-positive early breast cancer (n=3222). Results: The 2nd planned interim analysis, median follow-up at 36 months, showed that both AC-TH and TCH significantly improved the DFS and OS over the control (relative reduction risk of relapse 39% (P<0.0001) and 33% (P=0.0003) respectively, for AC-TH and TCH vs control). Relative reduction in the risk of death was 41% (P=0.0041) and 34% (P =0.017) respectively, for AC-TH and TCH vs control. Congestive heart failure occurred in 0.4% of patients in AC-T and TCH vs 1.9% of patients in AC-TH. Global safety profile was acceptable in all 3 arms and more favourable in TCH than AC-TH. QOL, a secondary endpoint of this trial, was assessed using the EORTC QLQC-30, BR-23, and EQ5D. We will present the primary QOL endpoints comparing Physical Function, Global Health Status, Future Perspectives, and Systemic Treatment Effects change scores from baseline to mid-chemotherapy, end of chemotherapy, and 12 months follow-up (with a 10% change considered clinically important). The proportion of patients with improved/stable/worsened QOL scores will be compared with chi-square tests. Other QOL exploratory analyses will be presented. [Table: see text]

Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC) Versus FAC Followed by Weekly Paclitaxel As Adjuvant Therapy for High-Risk, Node-Negative Breast Cancer: Results From the GEICAM/2003-02 Study

2013 ◽  
Vol 31 (20) ◽  
pp. 2593-2599 ◽  
Author(s):  
Miguel Martín ◽  
Amparo Ruiz ◽  
Manuel Ruiz Borrego ◽  
Agustí Barnadas ◽  
Sonia González ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Disease Free Survival ◽  
Sensory Neuropathy ◽  
Weekly Paclitaxel ◽  
Node Negative ◽  
Primary Surgery ◽  
Disease Free

Purpose Adding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reported so far showed a docetaxel benefit but significant toxicity. Here we tested the efficacy and safety of weekly paclitaxel (wP) in node-negative patients, which is yet to be established. Patients and Methods Patients with BC having T1-T3/N0 tumors and at least one high-risk factor for recurrence (according to St. Gallen 1998 criteria) were eligible. After primary surgery, 1,925 patients were randomly assigned to receive fluorouracil, doxorubicin, and cyclophosphamide (FAC) × 6 or FAC × 4 followed by wP × 8 (FAC-wP). The primary end point was disease-free survival (DFS) after a median follow-up of 5 years. Secondary end points included toxicity and overall survival. Results After a median follow-up of 63.3 months, 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free (hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04). Thirty-one patients receiving FAC-wP versus 40 patients receiving FAC died (one and seven from cardiovascular diseases, respectively; HR, 0.79; 95% CI, 0.49 to 1.26; log-rank P = .31). The most relevant grade 3 and 4 adverse events in the FAC-wP versus the FAC arm were febrile neutropenia (2.7% v 3.6%), fatigue (7.9% v 3.4%), and sensory neuropathy (5.5% v 0%). Conclusion For patients with high-risk node-negative BC, the adjuvant FAC-wP regimen was associated with a small but significant improvement in DFS compared with FAC therapy, in addition to manageable toxicity, especially regarding long-term cardiac effects.

Comparison of Radiation With or Without Concurrent Trastuzumab for HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy: A Phase III Clinical Trial

2021 ◽  
pp. JCO.20.02824
Author(s):  
Melody A. Cobleigh ◽  
Stewart J. Anderson ◽  
Kalliopi P. Siziopikou ◽  
Douglas W. Arthur ◽  
Rachel Rabinovitch ◽  
...  
Keyword(s):  
Ductal Carcinoma In Situ ◽  
Carcinoma In Situ ◽  
Ductal Carcinoma ◽  
Menopausal Status ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Her2 Status ◽  
P Value ◽  
Her2 Positive

PURPOSE Preclinical studies report that trastuzumab (T) can boost radiotherapy (RT) effectiveness. The primary aim of the B-43 trial was to assess the efficacy of RT alone vs concurrent RT plus T in preventing recurrence of ipsilateral breast cancer (IBTR) in women with ductal carcinoma in situ (DCIS). PATIENTS AND METHODS Eligibility: Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, DCIS resected by lumpectomy, known estrogen receptor (ER) and/or progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) status by centralized testing. Whole-breast RT was given concurrently with T. Stratification was by menopausal status, adjuvant endocrine therapy plan, and nuclear grade. Definitive intent-to-treat primary analysis was to be conducted when either 163 IBTR events occurred or all accrued patients were on study ≥ 5 years. RESULTS There were 2,014 participants who were randomly assigned. Median follow-up time as of December 31, 2019, was 79.2 months. At primary definitive analysis, 114 IBTR events occurred: RT arm, 63 and RT plus T arm, 51 (hazard ratio [HR], 0.81; 95% CI, 0.56 to 1.17; P value = .26). There were 34 who were invasive: RT arm, 18 and RT plus T arm, 20 (HR, 1.11; 95% CI, 0.59 to 2.10; P value = .71). Seventy-six were DCIS: RT arm, 45 and RT plus T arm, 31 (HR, 0.68; 95% CI, 0.43 to 1.08; P value = .11). Annual IBTR event rates were: RT arm, 0.99%/y and RT plus T arm, 0.79%/y. The study did not reach the 163 protocol-specified events, so the definitive analysis was triggered by all patients having been on study for ≥ 5 years. CONCLUSION Addition of T to RT did not achieve the objective of 36% reduction in IBTR rate but did achieve a modest but statistically nonsignificant reduction of 19%. Nonetheless, this trial had negative results. Further exploration of RT plus T is needed in HER2-positive DCIS before its routine delivery in patients with DCIS resected by lumpectomy.

Phase III trial comparing two dose levels of epirubicin combined with cyclophosphamide (EC or HEC) with cyclophosphamide, methotrexate, and fluorouracil (CMF) in 777 women with node-positive (N+) breast cancer (BC): 10-year follow-up results

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 568-568 ◽  
Author(s):  
E. Azambuja ◽  
M. Paesmans ◽  
C. Bernard-Marty ◽  
M. Beauduin ◽  
A. Vindevoghel ◽  
...  
Keyword(s):  
Cox Regression ◽  
Menopausal Status ◽  
Survival Rates ◽  
Dose Intensity ◽  
Phase Iii ◽  
Open Label ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Primary Hypothesis

568 Background: The purpose of this presentation is to provide an update, with longer follow up data, of the results of this Belgian multicentric trial, which had shown a dose response curve for epirubicin at a median follow up of 4 years (Piccart et al, J Clin Oncol 2001; 19:3103–3110) Methods: In this prospective, open label, randomized trial of the 1990’s, patients aged from 18 to 70 years were stratified by center, 1–3 vs 4 or more nodes, and menopausal status (pre- vs postmenopausal). The primary hypothesis was that HEC could be associated with an increase in event-free survival (EFS) compared with CMF. Patients received CMF (oral cyclophosphamide days 1–14) for six cycles, EC (epirubicin 60 mg/m2, cyclophosphamide 500 mg/m2 day 1 every 3 weeks) for eight cycles or HEC (epirubicin 100 mg/m2, cyclophosphamide 830 mg/m2 day 1 every 3 weeks) for eight cycles. Tamoxifen followed chemotherapy in postmenopausal women with positive or unknown hormone receptor (HR). Two hundred fifty-five, 267, and 255 eligible patients were treated with CMF, EC, and HEC, respectively. Results: The trial results are now updated, with an actuarial median follow-up of 12.2 years. Using Kaplan-Meier estimation, the 10-year EFS is 55% for patients who received CMF, 48% for EC patients, and 58% for HEC patients. The hazard ratios obtained from Cox regression models (HR) are, for EC vs HEC, 1.30 (95% confidence interval [CI], 1.02 to 1.67, P = .03); for CMF vs HEC, 1.12 (95% CI, 0.87 to 1.44, P = .39); and for CMF vs EC, 1.17 (95% CI, 0.92 to 1.48, P = .21). Kaplan-Meier estimates of the 10-year overall survival rates are 65% for patients who received CMF, 65% for EC patients, and 70% for HEC patients, with no significant differences among the three arms. Conclusions: The short term results of this trial are nicely confirmed at 10 years: in patients unselected for HR or HER-2 status, the dose intensity of epirubicin matters. Analysis in subsets of patients is ongoing, but will be only hypothesis-generating. [Table: see text]

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