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

LBA1000 Oral Abstract Session, Tue, 9:45 AM-12:45 PM
NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing
dose-dense (DD) AC followed by paclitaxel (P) plus gemcitabine (G) with
DD AC followed by P and with docetaxel, doxorubicin, and cyclophosphamide
(TAC) in women with operable, node-positive breast cancer. Presenting
Author: Sandra M. Swain, National Surgical Adjuvant Breast and Bowel
Project and Washington Cancer Institute, MedStar Washington Hospital
Center, Washington, DC
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Monday, June 4,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Monday edition of ASCO Daily News.
CRA1002 Oral Abstract Session, Tue, 9:45 AM-12:45 PM
CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly
paclitaxel (P) compared to weekly nanoparticle albumin bound nabpaclitaxel
(NP) or ixabepilone (Ix) with or without bevacizumab (B) as
first-line therapy for locally recurrent or metastatic breast cancer (MBC).
Presenting Author: Hope S. Rugo, University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center, San Francisco, CA
The full, final text of this abstract will be available at
abstract.asco.org at 12:01 AM (EDT) on Monday, June 4,
2012, and in the Annual Meeting Proceedings online
supplement to the June 20, 2012, issue of Journal of
Clinical Oncology. Onsite at the Meeting, this abstract will
be printed in the Monday edition of ASCO Daily News.
Breast Cancer—Triple-Negative/Cytotoxics/Local Therapy
49s
1001 Oral Abstract Session, Tue, 9:45 AM-12:45 PM
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.
Presenting Author: Miguel Martin, Hospital General Universitario Gregorio
Marañón, Madrid, Spain
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, hormonereceptor
[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
(��0.05, �� 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.
1003 Oral Abstract Session, Tue, 9:45 AM-12:45 PM
A phase III, multicenter, randomized trial of maintenance versus observation
after achieving clinical response in patients with metastatic breast
cancer who received six cycles of gemcitabine plus paclitaxel as first-line
chemotherapy (KCSG-BR 0702, NCT00561119). Presenting Author:
Young-Hyuck Im, Samsung Medical Center, Seoul, South Korea
Background: Chemotherapy provides a survival benefit in patients with
metastatic breast cancer (MBC), but the optimal duration of chemotherapy
remains controversial. Primary purpose of the study was to evaluate
whether the maintenance chemotherapy with gemcitabine/paclitaxel (GP),
which is one of the two regimens which showed a survival gain from a
randomized trial, is superior to observation in terms of progression free
survival (PFS) in responding patients with MBC after 6 cycles of GP as
first-line treatment. Methods: This study is a prospective, randomized,
multi-center, phase III study. Patients who achieved response (CR�PR�SD)
following 6 cycles of GP chemotherapy (gemcitabine 1250 mg/m2 on day 1
and 8 plus paclitaxel 175 mg/m2 on day 1 every 3 weeks) randomized to
maintenance till progression or observation arm. The trial was conducted by
the Korean Cancer Study Group (KCSG). Results: Among total 324 patients
enrolled between 2007 and 2010 from 10 centers, 231 responding
patients to were randomly assigned to maintenance chemotherapy (n�116)
or observation (n�115). Median age was 49 (range 28-76). The numbers
of hormone receptor (HR)�ve and HR-ve patients were 172 (74.5%) and
59 (25.5%), respectively. The median No. of chemotherapy cycles in
maintenance group was 12 (range 6-32). During median 33 months of
follow-up, median PFS was superior in maintenance than in observation
(12.0 vs. 8.3 months, p�0.030). Patients � age 50 years (hazard ratio
0.50, p�0.001) and HR-ve patients (hazard ratio 0.52, p�0.019)
received more benefit from maintenance chemotherapy in terms of PFS.
Median OS was superior in maintenance than in observation (36.8 vs 28.0
months, p�0.047). Neurotoxicity (� grade 2) was more common in
maintenance than in observation without statistical significance (41.7% vs
33.3%, p�0.210). Serial assessment of Quality of Life (QoL) did not show
any significant difference between two groups. Conclusions: Maintenance
GP chemotherapy for responding patients with MBC showed clinical benefit
in terms of PFS and OS without impairment of QoL.
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