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June 1, 2013 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today reported on final results from a cooperative group and NCI-sponsored Phase 2 clinical trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer (mTNBC). Triple-negative breast cancer lacks progesterone and estrogen receptors and the HER2 biomarker that is present in most breast cancers, which makes standard therapy with hormone or targeted therapy ineffective. The rationale for the present study in TNBC is based on data the demonstrating that silencing of the breast cancer susceptibility gene(s) (BRCA) is associated with substantially enhanced sensitivity to brostallicin. BRCA is silenced or mutated in most patients with TNBC. In this study of 48 patients with heavily pretreated mTNBC, the 3-month progression free survival (PFS) was 51 percent with 10 confirmed responses (one complete response and nine partial responses). Among the 25 patients who received a reduced brostallicin dose, the overall response rate (ORR) was 28 percent, with 3-month progression-free survival (PFS) of 61.5 percent and median overall survival (OS) of 11.8 months. The final data are being presented during a poster session at the 2013 American Society for Clinical Oncology (ASCO) Meeting being held
May 31 to June 4, 2013 in
Abstract #1059: Final clinical results and correlative data from the phase II trial of cisplatin (C) and the novel agent brostallicin (B) in patients with metastatic triple negative breast cancer (mTNBC). Poster session, Saturday, June 1, 1:15 to 5:00 p.m. CDT in S Hall A2.
About the Study
The study enrolled women with confirmed measurable metastatic disease and triple-negative subtype breast cancer. A total of 48 women were enrolled in the study and 47 were evaluable for efficacy. Approximately half of the patients had received between two and four prior chemotherapy regimens in the metastatic setting. The primary endpoint of the trial was 3-month PFS. Secondary endpoints included ORR, duration of response, 6-month PFS, OS and safety. In this study, patients received cisplatin on Day 1, brostallicin on Day 2, and GCSF or pegylated-GCSF on Day 3, with the cycle repeated every 21 days. The study was led by investigators at the Mayo Clinic in
Florida. Key findings include:
As of this analysis, 10 of 47 evaluable patients achieved a confirmed tumor response. One patient had a complete response (CR) and nine patients had a partial response (PR),
3-month PFS was 51 percent and 6-month PFS was 28 percent; median time to progression was 3.2 months, and
Adverse events were mostly hematologic (75 percent) and consistent with other treatments in this setting.
In an exploratory analysis, patients who received a reduced dose of brostallicin had an apparent increase in efficacy (ORR= 28 percent; 3-month PFS=61.5 percent; median OS=11.8 months) with a significant decrease in febrile neutropenia compared to cycle 1.