In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4539-4539
Abstract:
4539 Background: Several retrospective studies have investigated the sequential use of SO and SU. Some smaller trials support the use of SO followed by SU forming the rationale for this study. Methods: Pts with metastatic RCC unsuitable for cytokines without prior systemic therapy, ECOG PS 0/1, MSKCC score low or intermediate, and ≥1 measurable lesion (CT/MRI every 12 weeks) were randomized to SO- 〉 SU or SU- 〉 SO in standard dosage (primary endpoint total PFS from randomization to event during 2 nd line therapy). Treatment continues until progression or intolerability. Monitoring includes echocardiography and NT pro-BNP. Results: Baseline characteristics of 361 randomized pts (116 completed) are balanced between arms. Safety data of 333 pts are evaluable. AE occurring in 〉 10% of pts are listed in tab. 1. Left-ventricular ejection fraction (LVEF) at screening, switch of treatment, and end of study are given in tab. 1. AE occurred in 93.4% and 92.8%; grade 3/4 AE in 59.9% and 50%; and SAE in 46.7% and 42.2% in the SO- 〉 SU and SU- 〉 SO arm, respectively. Updated results will be presented. Conclusions: AE frequencies are higher in 1 st than in 2 nd line treatments. Typical AE profiles for SO and SU are observed. LVEF values are in a similar range. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.4539
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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