Cardiac safety and efficacy of TLC D99 (D, Myocet™) and Herceptin® (H) in advanced breast cancer (ABC) Meeting Abstract
| Authors: | Theodoulou, M.; Campos, S.; Welles, L.; Almonte, A.; Batist, G.; Winer, E.; Hudis, C. |
| Abstract Title: | Cardiac safety and efficacy of TLC D99 (D, Myocet™) and Herceptin® (H) in advanced breast cancer (ABC) |
| Meeting Title: | 24th Annual San Antonio Breast Cancer Symposium (SABCS) |
| Abstract: | Rationale: D is a liposomal doxorubicin (dox) with significantly reduced cardiotoxicity compared to conventional dox (Batist et al, JCO, 2001,19 (5): 1444). H has been associated with cardiac dysfunction (CD) similar to that of dox. H and dox in combination have additive or synergistic efficacy in ABC, but cause more CD than with either agent alone. To determine the safety of DH, and to obtain preliminary efficacy data in ABC, we performed this phase I/II study in patients (pts) with tumors HER2+: 2/3+ by immunohistochemistry (IHC) or (+) gene amplification by fluorescence in situ hybridization (FISH). Methods: left ventricular ejection fraction (LVEF) assessed by multigated acquisition (MUGA) scan at baseline and after every even cycle; cardiotoxicity=LVEF decline >20 to > lower limit of normal (LLN); or > 10 to <LNN; or congestive heart failure. Regimen: D: 60 mg/m2 intravenously (IV) every 3 weeks; H: 4 mg/kg IV week 1 followed by 2 mg/kg IV weekly. Eligibility: HER2+ (see above); ABC; <1 prior H regimen; <2 cytotoxic regimens for ABC; prior adjuvant dox (maximum 240 mg/m2). Results: n=31.13 pts had prior dox; 13 pts had prior chemotherapy for ABC; 6 had H. To date: total # cycles: 146: median #cycles/pt: 5.5 (range 1-11). 23 pts have had lifetime cumulative dox dose >360mg/m2 (range 60-780 mg/m2). No cardiotoxicity has been seen, and other toxicities (chiefly neutropenia) have been manageable. Responses (secondary objective): 25/31 pts evaluable; 1 complete response; 14 partial responses; overall RR 60% (95% confidence interval: 39%-79%). 4 pts had stable disease; 6 progressed on study (2 who had previously progressed on H); 2 pts with non-measurable disease 'improved' and 1 was stable; 3 pts are not yet evaluable for R. Conclusions: D/H appears to be a well tolerated active regimen in pts with HER2+ tumors. No cardiotoxicity has been seen to date in 31 pts. |
| Journal Title: | Breast Cancer Research and Treatment |
| Volume: | 69 |
| Issue: | 3 |
| Meeting Dates: | 2001 Dec 10-13 |
| Meeting Location: | San Antonio, TX |
| ISSN: | 0167-6806 |
| Publisher: | Springer |
| Date Published: | 2001-10-01 |
| Start Page: | 283 |
| Language: | English |
| PROVIDER: | scopus |
| PUBMED: | 11762328 |
| DOI: | 10.1023/A:1017475415273 |
| DOI/URL: | |
| Notes: | Meeting Abstract: 427 -- Export Date: 21 May 2015 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
MSK Authors
Related MSK Work