Abstract Types

CRA
Clinical Review Abstract

LBA
Late-Breaking Abstract

TPS
Trials in Progress Abstract

e
Abstracts selected for publication but not presentation at the Annual Meeting

^
Abstracts granted an exception in accordance with ASCO's Conflict of Interest Policy



Randomized phase II trial of gemcitabine versus gemcitabine and imatinib mesylate in patients with previously treated metastatic breast cancer.

Sub-category:
Cytotoxic Chemotherapy

Category:
Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy

Meeting:
2013 ASCO Annual Meeting

Abstract No:
1091

Citation:
J Clin Oncol 31, 2013 (suppl; abstr 1091)

Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Pashna Neville Munshi, Deborah Toppmeyer, Serena Tsan-Lai Wong, Shridar Ganesan, Katherine Hanna Tkaczuk, Mary E. Cianfrocca, Virginia G. Kaklamani, William John Gradishar, Robert A. Somer, Kanu Sharan, Generosa Grana, Pauline Marie O. Lerma, Lillian F. Pliner, Robert Wieder, Michael P. Kane, Sinae Kim, Antoinette R. Tan; University of Medicine and Dentistry of New Jersey-Robert Wood Johnson University Hospital, New Brunswick, NJ; The Cancer Institute of New Jersey, New Brunswick, NJ; University of Maryland, Marlene and Stewart Greenebaum Cancer Center, Baltimore, MD; Banner MD Anderson Cancer Center, Gilbert, AZ; Northwestern University, Chicago, IL; Cooper University Hospital, Camden, NJ; UMDNJ-New Jersey Medical School, Newark, NJ

Abstract Disclosures


Abstract:

Background: Gemcitabine (GEM) as a standard 30-min infusion has activity as a single-agent in metastatic breast cancer (mbc). Prolonged infusion of GEM at a fixed dose rate (FDR) of 10 mg/m2/min is associated with greater formation of active metabolite and may result in improved antitumor activity. Imatinib mesylate (IM)-mediated inhibition of PDGFR reduces tumor interstitial fluid pressure allowing for improved chemotherapy penetration into tumors. We evaluated the addition of IM to FDR GEM in patients (pts) with previously treated mbc. Methods: This was a randomized phase II trial in mbc pts who progressed after 1 but no more than 2 prior cytotoxic regimens. Eligibility included measurable disease; no prior GEM or IM exposure. Group 1 received FDR GEM IV 1250 mg/m2 at 10 mg/m2/min (over 120 min) on days 3 and 10 every 21 days; Group 2 received the same FDR GEM dose and schedule plus IM 400 mg orally daily on days 1-5 and 8-12 every 21 days. Primary endpoint was time to progression (TTP). Sample size of 40 pts per group was needed to detect an 8 mo increase in TTP with the combination (80% power, α = .05, 2-sided). Secondary endpoints included ORR and safety. Results: Between 5/2006-4/2011, 44 pts were randomized (22 per group). Study closed early due to slow accrual. Median age 54 (31-75); median ECOG PS 1 (0-2); 52% were hormone receptor-positive and HER2-negative; 27% triple-negative, and 20% HER2-positive. Median number of cycles was 2 in Group 1 (range 1-12) and 3.5 in Group 2 (range 1-13). Most common adverse events (%) of any grade, Group 1 vs Group 2 were neutropenia (68 vs. 78), anemia (48 vs. 65), thrombocytopenia (24 vs. 47), nausea (40 vs. 52) and vomiting (24 vs. 21). One gr 4 thrombotic thrombocytopenic purpura occurred in Group 2. Median TTP were 2 mo (95% CI: 1-5 mo) in Group 1 and 2.5 mo (95% CI: 1-5 mo) in Group 2 (p = 0.3 log rank test). ORR was 9.1% in each group (95% CI: 1.6-30.6%), with 2 PRs in each group. Stable disease (≥ 3 mo) was 32% in Group 1 and 41% in Group 2. Conclusions: This study was underpowered to draw any conclusion regarding a difference in TTP between the two groups at the time it was prematurely closed. Combination of IM and FDR GEM showed a trend to increased toxicity compared to FDR GEM alone. Clinical trial information: NCT00323063.

 

  Other Abstracts in this Sub-Category:

 

1. Time trends in the use of adjuvant chemotherapy (CTX) and outcomes in women with T1N0 breast cancer (BC) in the National Comprehensive Cancer Network (NCCN).

Meeting: 2013 ASCO Annual Meeting Abstract No: 1006 First Author: I. V. Luis
Category: Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy - Cytotoxic Chemotherapy

 

2. 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.

Meeting: 2013 ASCO Annual Meeting Abstract No: 1007 First Author: L. N. Shulman
Category: Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy - Cytotoxic Chemotherapy

 

3. S0221: Comparison of two schedules of paclitaxel as adjuvant therapy for breast cancer.

Meeting: 2013 ASCO Annual Meeting Abstract No: CRA1008 First Author: G. T. Budd
Category: Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy - Cytotoxic Chemotherapy

 

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