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Annual Meeting Proceedings Part 1 - American Society of Clinical ...

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LBA1000 Oral Abstract Session, Tue, 9:45 AM-12:45 PM<br />

NSABP B-38: Definitive analysis <strong>of</strong> a randomized adjuvant trial comparing<br />

dose-dense (DD) AC followed by paclitaxel (P) plus gemcitabine (G) with<br />

DD AC followed by P and with docetaxel, doxorubicin, and cyclophosphamide<br />

(TAC) in women with operable, node-positive breast cancer. Presenting<br />

Author: Sandra M. Swain, National Surgical Adjuvant Breast and Bowel<br />

Project and Washington Cancer Institute, MedStar Washington Hospital<br />

Center, Washington, DC<br />

The full, final text <strong>of</strong> this abstract will be available at<br />

abstract.asco.org at 12:01 AM (EDT) on Monday, June 4,<br />

2012, and in the <strong>Annual</strong> <strong>Meeting</strong> <strong>Proceedings</strong> online<br />

supplement to the June 20, 2012, issue <strong>of</strong> Journal <strong>of</strong><br />

<strong>Clinical</strong> Oncology. Onsite at the <strong>Meeting</strong>, this abstract will<br />

be printed in the Monday edition <strong>of</strong> ASCO Daily News.<br />

CRA1002 Oral Abstract Session, Tue, 9:45 AM-12:45 PM<br />

CALGB 40502/NCCTG N063H: Randomized phase III trial <strong>of</strong> weekly<br />

paclitaxel (P) compared to weekly nanoparticle albumin bound nabpaclitaxel<br />

(NP) or ixabepilone (Ix) with or without bevacizumab (B) as<br />

first-line therapy for locally recurrent or metastatic breast cancer (MBC).<br />

Presenting Author: Hope S. Rugo, University <strong>of</strong> California, San Francisco<br />

Helen Diller Family Comprehensive Cancer Center, San Francisco, CA<br />

The full, final text <strong>of</strong> this abstract will be available at<br />

abstract.asco.org at 12:01 AM (EDT) on Monday, June 4,<br />

2012, and in the <strong>Annual</strong> <strong>Meeting</strong> <strong>Proceedings</strong> online<br />

supplement to the June 20, 2012, issue <strong>of</strong> Journal <strong>of</strong><br />

<strong>Clinical</strong> Oncology. Onsite at the <strong>Meeting</strong>, this abstract will<br />

be printed in the Monday edition <strong>of</strong> ASCO Daily News.<br />

Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy<br />

49s<br />

1001 Oral Abstract Session, Tue, 9:45 AM-12:45 PM<br />

Randomized phase III study <strong>of</strong> adjuvant chemotherapy for high-risk,<br />

node-negative breast cancer (BC) comparing FAC with FAC followed by<br />

weekly paclitaxel: First efficacy analysis <strong>of</strong> the GEICAM/2003-02 trial.<br />

Presenting Author: Miguel Martin, Hospital General Universitario Gregorio<br />

Marañón, Madrid, Spain<br />

Background: Adjuvant weekly paclitaxel (wP) sequential to anthracyclines<br />

improves the outcome <strong>of</strong> operable node-positive BC patients (pts) [Sparano<br />

NEJM 2008, Martin BCRT 2009]; however, most BC pts are currently<br />

node-negative at diagnosis. The role <strong>of</strong> wP in these pts is not well<br />

established yet. Methods: Pts aged 18-70, with T1-T3/N0 operable BC and<br />

at least one high-risk St Gallen 1998 criteria (size �2 cm, hormonereceptor<br />

[HR] negative, grade 2/3, age �35 years,) were eligible. HER2�<br />

pts were allowed, after 792 entered the trial, the study was amended to<br />

exclude them. Pts were stratified by site, menopausal status, nodal status<br />

diagnostic method (sentinel-node biopsy versus lymphadenectomy) and<br />

HR status and randomized to receive FAC x6 (500/50/500 mg/m2 every<br />

3w) or FAC x4¡wP x8 (paclitaxel 100 mg/m2 weekly). The primary<br />

endpoint was DFS. The trial was designed to detect an absolute 5-y DFS<br />

increase <strong>of</strong> 5% (80% FAC, 85% FAC¡wP); a sample size <strong>of</strong> 1812<br />

evaluable patients (906 per arm) was required to detect this difference<br />

(��0.05, �� 80%). Assuming a drop-out rate <strong>of</strong> 6%, 1929 pts were<br />

required. The first analysis <strong>of</strong> DFS was planned when a median follow-up <strong>of</strong><br />

5 years was reached. Results: Between September 2003 and October<br />

2008, 1925 pts (FAC 974, FAC¡wP 951) were randomized. Patient<br />

characteristics were well balanced between arms, median age was 50, 73%<br />

<strong>of</strong> pts were HR positive and 9% HER2 positive. 97% <strong>of</strong> pts with FAC and<br />

85% <strong>of</strong> pts with FAC¡wP completed all treatment as planned. The median<br />

dose intensity was 98% with FACx6, 99% with FACx4 and 98% with wP.<br />

The most frequent grade 3-4 toxicities (�3% in either arm) with FAC vs<br />

FAC¡wP were neutropenia (25% vs 22%) with 4% vs 3% <strong>of</strong> febrile<br />

neutropenia, fatigue (3% vs 8%), sensory neuropathy (0 vs 5%), and<br />

vomiting (4% in each arm). After a median follow-up <strong>of</strong> 5.3 years, the<br />

proportion <strong>of</strong> patients disease free is 93% and 90% with FAC¡wP and FAC<br />

(HR for relapse 0.732, 95% CI: 0.542 to 0.990; log-rank p-value�0.0423).<br />

Conclusions: For pts with high-risk node-negative BC, adjuvant FAC¡wP<br />

was associated with a small but significant improvement in DFS compared<br />

with FAC, with manageable toxicity.<br />

1003 Oral Abstract Session, Tue, 9:45 AM-12:45 PM<br />

A phase III, multicenter, randomized trial <strong>of</strong> maintenance versus observation<br />

after achieving clinical response in patients with metastatic breast<br />

cancer who received six cycles <strong>of</strong> gemcitabine plus paclitaxel as first-line<br />

chemotherapy (KCSG-BR 0702, NCT00561119). Presenting Author:<br />

Young-Hyuck Im, Samsung Medical Center, Seoul, South Korea<br />

Background: Chemotherapy provides a survival benefit in patients with<br />

metastatic breast cancer (MBC), but the optimal duration <strong>of</strong> chemotherapy<br />

remains controversial. Primary purpose <strong>of</strong> the study was to evaluate<br />

whether the maintenance chemotherapy with gemcitabine/paclitaxel (GP),<br />

which is one <strong>of</strong> the two regimens which showed a survival gain from a<br />

randomized trial, is superior to observation in terms <strong>of</strong> progression free<br />

survival (PFS) in responding patients with MBC after 6 cycles <strong>of</strong> GP as<br />

first-line treatment. Methods: This study is a prospective, randomized,<br />

multi-center, phase III study. Patients who achieved response (CR�PR�SD)<br />

following 6 cycles <strong>of</strong> GP chemotherapy (gemcitabine 1250 mg/m2 on day 1<br />

and 8 plus paclitaxel 175 mg/m2 on day 1 every 3 weeks) randomized to<br />

maintenance till progression or observation arm. The trial was conducted by<br />

the Korean Cancer Study Group (KCSG). Results: Among total 324 patients<br />

enrolled between 2007 and 2010 from 10 centers, 231 responding<br />

patients to were randomly assigned to maintenance chemotherapy (n�116)<br />

or observation (n�115). Median age was 49 (range 28-76). The numbers<br />

<strong>of</strong> hormone receptor (HR)�ve and HR-ve patients were 172 (74.5%) and<br />

59 (25.5%), respectively. The median No. <strong>of</strong> chemotherapy cycles in<br />

maintenance group was 12 (range 6-32). During median 33 months <strong>of</strong><br />

follow-up, median PFS was superior in maintenance than in observation<br />

(12.0 vs. 8.3 months, p�0.030). Patients � age 50 years (hazard ratio<br />

0.50, p�0.001) and HR-ve patients (hazard ratio 0.52, p�0.019)<br />

received more benefit from maintenance chemotherapy in terms <strong>of</strong> PFS.<br />

Median OS was superior in maintenance than in observation (36.8 vs 28.0<br />

months, p�0.047). Neurotoxicity (� grade 2) was more common in<br />

maintenance than in observation without statistical significance (41.7% vs<br />

33.3%, p�0.210). Serial assessment <strong>of</strong> Quality <strong>of</strong> Life (QoL) did not show<br />

any significant difference between two groups. Conclusions: Maintenance<br />

GP chemotherapy for responding patients with MBC showed clinical benefit<br />

in terms <strong>of</strong> PFS and OS without impairment <strong>of</strong> QoL.<br />

Visit abstract.asco.org and search by abstract for the full list <strong>of</strong> abstract authors and their disclosure information.

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