Growth modulation index (GMI) as a metric of clinical benefit assessment among advanced soft tissue sarcoma (ASTS) patients receiving trabectedin as salvage therapy.

Medientyp: E-Artikel
Titel: Growth modulation index (GMI) as a metric of clinical benefit assessment among advanced soft tissue sarcoma (ASTS) patients receiving trabectedin as salvage therapy
Beteiligte: Penel, Nicolas; Demetri, George D.; Blay, Jean-Yves; Cousin, Sophie; Maki, Robert G.; Chawla, Sant P.; Judson, Ian Robert; von Mehren, Margaret; Schoffski, Patrick; Verweij, Jaap; Casali, Paolo Giovanni; Rodenhuis, Sjoerd; Gomez, Javier; Nieto, Antonio; Zintl, Patrik; Pontes Valero, Maria Jose; Cassar, Alexia; Le Cesne, Axel
Erschienen: American Society of Clinical Oncology (ASCO), 2012
Erschienen in: Journal of Clinical Oncology
Sprache: Englisch
DOI: 10.1200/jco.2012.30.15_suppl.10013
ISSN: 0732-183X; 1527-7755
Schlagwörter: Cancer Research ; Oncology
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Beschreibung: <jats:p> 10013 </jats:p><jats:p> Background: Von Hoff has proposed GMI >1.33 in cancer clinical trials as a sign of drug activity. GMI is the ratio between time to progression (TTP) with the nth line (TTP<jats:sub>n</jats:sub>) of therapy divided by the TTP<jats:sub>n-1</jats:sub> with the n-1th line of therapy. With this endpoint, each patient is his/her own control. Methods: We have carried out a retrospective analysis of 279 pretreated ASTS patients treated in four consecutive phase II trials with trabectedin 1.5 mg/m², given as a 24-hour infusion every 3 weeks. Results: The study population consisted of 170 women and 109 men with a median age of 52. The two most common histologies were leiomyosarcoma (145 patients, 52%) and liposarcoma (59, 21%). 142 (51%) patients received one prior line and 137 (49%) ≥2 lines. The median TTP<jats:sub>n</jats:sub> was 2.8 months (range: 0.2-26.8), whereas the median TTP<jats:sub>n-1</jats:sub> was 4.0 months (range: 0.3-79.5). The Spearman correlation coefficient between TTP<jats:sub>n-1</jats:sub> and TTP<jats:sub>n</jats:sub> was 0.07 (p=0.23). The median GMI was 0.6 (range: 0.0-14.4). 177 patients (63%) had a GMI <1, 21 (8%) a GMI = 1-1.33 and 81 (29%) a GMI >1.33. The median overall survival (OS) strongly correlated with GMI groups: OS was 9.1, 13.9 and 23.8 months, respectively (p=0.0005, log-rank test). There were also a strong correlations between response rate and GMI (p<0.0001, Fisher exact test), and between GMI and progression-free survival (<0.0001, log-rank test). The logistic regression analysis retained only performance status (PS) [OR=1.76 if PS=0; p<0.04] associated with GMI>1.33. Sarcoma grade (p=0.21), histological subtype (p=0.16), and number of prior chemotherapy lines (p=0.95) were not associated with GMI>1.33. Conclusions: Overall,≈30% of patients experienced GMI>1.33 regardless of histological subtype or grade, and number of prior lines of chemotherapy. Patients with PS=0 benefit more from trabectedin. GMI>1.33 is associated with longer OS (median ≈24 months). GMI is better defined than previously described parameter such as "Tumor Growth Rate" (Lopez-Martin, Abstract 3293, ASCO 2003). GMI as an indicator of drug activity merits further exploration in this setting. </jats:p>
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