In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 1055-1055
Abstract:
1055 Background: In pts with Her2 positive ABC, taxane or vinorelbine plus T are among the most widely applied options in the first line setting. We evaluated the efficacy and tolerability of TC in pts with Her2 positive ABC after anthracycline and docetaxel or vinorelbine failure. Methods: Forty consecutive pts (median age 57.5 years) were included. As of December 2006, all are evaluable for toxicity and 35 for response. C was administered at a daily dose of 2,500 mg for two consecutive weeks (w) every 3 w, with dose modifications if necessary. T was administered in 3 w cycles at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Time to progression (TTP) was defined as primary endpoint. Response was evaluated every three months (m) using UICC criteria. TTP and overall survival (OS) were estimated using the Kaplan-Meier product limit method. Differences in TTP for 2 nd line and beyond 2 nd line were analyzed with the log-rang test. Results: All pts had prior exposure to an anthracycline and at least one anti-microtuble agent (i.e. a taxane or vinorelbine). All had at least one earlier T containing treatment line for ABC. Median time of observation was 18.5 m. We observed a complete response in 2.9%, partial response in 20%, stable disease = 6 months in 48.6%, and progression in 28.6% of pts. OS was median 24 m (95% CI 20.3–27.7), and TTP 8 m (95% CI 5.8–10.1). No significant difference was found for 2 nd and beyond 2 nd line treatment. Diarrhoea (5%) and hand foot syndrome (16%) were the only treatment-related adverse events that occurred with grade 3 or 4 intensity. A dose reduction was necessary in 22.5%. Two pts developed brain metastases (BM) while on therapy, 6 had BM at time of treatment initiation, a further 5 developed BM during follow up. Of 6 pts with BM, 3 gained clinical benefit from treatment (one pt not yet evaluable). Conclusions: TC appears to be an effective and safe option as salvage therapy in a heavily pretreated population. TTP and response rates are similar to results from C plus lapatinib. Of note is the activity in pts with BM. Further, only 2 pts (5%) developed BM while on treatment. Therefore, a direct comparison of TC with C plus lapatinib or T plus lapatinib seems warranted. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.1055
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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