In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 17 ( 2011-06-10), p. 2416-2423
Abstract:
To investigate response, survival, and safety profile of the somatostatin-based radiopeptide 90 yttrium-labeled tetraazacyclododecane-tetraacetic acid modified Tyr-octreotide ([ 90 Y-DOTA]-TOC) in neuroendocrine cancers. Patients and Methods In a clinical phase II single-center open-label trial, patients with neuroendocrine cancers were treated with repeated cycles of [ 90 Y-DOTA]-TOC. Each cycle consisted of a single intravenous injection of 3.7GBq/m 2 body-surface [ 90 Y-DOTA]-TOC. Additional cycles were withheld in case of tumor progression and/or permanent toxicity. Results Overall, 1,109 patients received 2,472 cycles of [ 90 Y-DOTA]-TOC (median, two; range, one to 10 cycles per patient). Of the 1,109 patients, 378 (34.1%) experienced morphologic response; 172 (15.5%), biochemical response; and 329 (29.7%), clinical response. During a median follow-up of 23 months, 491 patients (44.3%) died. Longer survival was correlated with each: morphologic (hazard ratio [HR] , 0.46; 95% CI, 0.38 to 0.56; median survival, 44.7 v 18.3 months; P 〈 .001), biochemical (HR, 0.75; 95% CI, 0.59 to 0.96; 35.3 v 25.7 months; P = .023), and clinical response (HR, 0.68; 95% CI, 0.56 to 0.82; 36.8 v 23.5 months; P 〈 .001). Overall, 142 patients (12.8%) developed grade 3 to 4 transient hematologic toxicities, and 103 patients (9.2%) experienced grade 4 to 5 permanent renal toxicity. Multivariable regression revealed that tumoral uptake in the initial imaging study was predictive for overall survival (HR, 0.45; 95% CI, 0.29 to 0.69; P 〈 .001), whereas the initial kidney uptake was predictive for severe renal toxicity (HR, 1.59; 95% CI, 1.17 to 2.17; P = .003). Conclusion This study documents the long-term outcome of [ 90 Y-DOTA]-TOC treatment in a large cohort. Response to [ 90 Y-DOTA]-TOC is associated with longer survival. Somatostatin receptor imaging is predictive for both survival after [ 90 Y-DOTA]-TOC treatment and occurrence of renal toxicity.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2010.33.7873
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2011
detail.hit.zdb_id:
2005181-5
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