Abstract CT127: Can potential curability be reached in high risk/metastatic breast cancer patients with a treatment optimization strategy that includes a novel GNT (gemcitabine, vinorelbine, docetaxel) in front line combination chemotherapy

PURPOSE: We undertook a prospective, randomized phase III trial to evaluate the safety and efficacy of using a phase II agent before initiating therapy with standard combination chemotherapy in metastatic breast cancer patients. PATIENTS AND METHODS: A total of 365 women with measurable metastatic breast cancer, previously untreated with chemotherapy for their metastatic disease, were randomized to receive either immediate chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil (CAF) or up to four cycles of one of five sequential cohorts of single-agent drugs: trimetrexate, melphalan, amonafide, carboplatin, or elsamitrucin, followed by CAF. RESULTS: The toxicity of each single agent followed by CAF was comparable to that of CAF alone. The cumulative response rates for the single agent followed by CAF were not statistically different from those of CAF alone (44% v 52%; P = .24). However, in the multivariate analysis, patients with visceral disease had a trend toward lower response rates on the phase II agent plus CAF arm (P = .078). Although survival and response duration also were not statistically significantly different between the two study arms (P = .074 and P = .069, respectively), there was a suggestion of benefit for the CAF-only arm. CONCLUSION: The brief use of a phase II agent, regardless of its efficacy, followed by CAF resulted in response rates, toxicities, durations of response, and survival statistically equivalent to those seen with the use of CAF alone. These findings support the use of a new paradigm for the evaluation of phase II agents in the treatment of patients with metastatic breast cancer.

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Combination chemotherapy of irinotecan with fluoropyrimidine in taxane, anthracycline, and fluoropyrimidine-pretreated metastatic breast cancer

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.e12003 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. e12003-e12003

Author(s):

H. Chang ◽

S. Han ◽

D. Oh ◽

S. Im ◽

T. Kim ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Disease Control ◽

Cancer Patients ◽

Clinical Outcomes ◽

Combination Chemotherapy ◽

Metastatic Breast ◽

University Hospital ◽

Hematologic Toxicity ◽

Breast Cancer Patients

e12003 Background: Irinotecan (I) has some efficacy in taxane (T) and anthracycline (A)-refractory breast cancer, and combination of I and fluoropyrimidine (F) shows synergistic effects in preclinical model. We conducted this study to reveal the clinical outcomes of I and F combination therapy in T, A, and F-pretreated metastatic breast cancer. Methods: We consecutively enrolled metastatic breast cancer patients treated with I and F combination chemotherapy from 2000 to 2008 in Seoul National University Hospital. They all had been previously heavily treated with T, A, and F. We retrospectively analyzed the clinical outcomes. Results: Twenty-five patients were enrolled. The median age was 38 years (range: 30–56years). The performance status was: ECOG 1 (11 patients), 2 (13), and 3 (1). The most commonly involved site was bone (16 patients), liver (13), and lung (12). The biologic subtype was: hormone receptor (+) 17 patients, HER-2 (+) 2, triple-negative (TNBC) 6. The median time from diagnosis of metastatic breast cancer to the initiation of IF therapy was 34 months (range: 12–97 months). The used regimens were: FOLFIRI (18 patients), TS-1/ irinotecan (6), capecitabine/irinotecan (1). Response was evaluable in 24 patients. There was no CR/PR. Stable disease was shown in 29.2% and 70.8% was PD, that is disease control rate was 29.2% (95% CI:10–45%). The median duration of disease control was 3.9 months (95% CI 3.7–4.2, range 2.4–11). The progression-free survival was 1.4 months (95% CI:0.7–21, range: 0.5–11.4), and overall survival was 6 months (95% CI: 4.2–7.8, range: 1–23). According to the biologic subtypes, the median PFS was 2.0 vs. 1.3 months (p=0.895) and OS was 4 vs. 6 months (p=0.807) respectively in TNBC VS Non-TNBC. In multivariate analysis, patients with good PS showed longer OS (p = 0.035). The Gr 3/4 hematologic toxicity was: neutropenia 18.6%, anemia 1.3%, thrombocytopenia 1.3%. And the major Gr 3/4 non-hematologc toxicity was: diarrhea (4%), hand-foot syndrome (0%), fatigue (0%). No treatment-related death was occurred. Conclusions: Treatment of I combined with F might be an option in metastatic breast cancer patients heavily treated with T, A, and F, irrespective of TNBC. Further prospective studies are warranted. No significant financial relationships to disclose.

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