Journal Article

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

N. Penel, G. D. Demetri, J. Y. Blay, S. Cousin, R. G. Maki, S. P. Chawla, I. Judson, M. von Mehren, P. Schöffski, J. Verweij, P. Casali, S. Rodenhuis, H. J. Schütte, A. Cassar, J. Gomez, A. Nieto, P. Zintl, M. J. Pontes and A. Le Cesne

in Annals of Oncology

Published on behalf of European Society for Medical Oncology

Volume 24, issue 2, pages 537-542
Published in print February 2013 | ISSN: 0923-7534
Published online November 2012 | e-ISSN: 1569-8041 | DOI: https://dx.doi.org/10.1093/annonc/mds470
Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy

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Background

The growth modulation index (GMI) is the ratio of time to progression with the nth line (TTPn) of therapy to the TTPn−1 with the n-1th line. GMI >1.33 is considered as a sign of activity in phase II trials.

Patients and Methods

This retrospective analysis evaluated the concordance between the GMI and the efficacy outcomes in 279 patients with advanced soft tissue sarcoma (ASTS) treated with trabectedin 1.5 mg/m² (24-h infusion every 3 weeks) in four phase II trials.

Results

One hundred and forty-two (51%) patients received one prior line and 137 ≥2 lines. The median TTPn was 2.8 months (range 0.2–26.8), whereas the median TTPn−1 was 4.0 months (0.3–79.5). The median GMI was 0.6 (0.0–14.4). Overall, 177 patients (63%) had a GMI <1; 21 (8%) a GMI equal to 1–1.33 and 81 (29%) a GMI >1.33, which correlated with the median overall survival in those patients (9.1, 13.9 and 23.8 months, respectively, P = 0.0005). A high concordance rate between the GMI and response rate (P < 0.0001) and progression-free survival (PFS, P < 0.0001) was observed. Good performance status (PS) was the only factor associated with GMI >1.33 (PS = 0; P < 0.04).

Conclusions

A high GMI was associated with favorable efficacy outcomes in patients treated with trabectedin. Further research is needed to assess GMI as an indicator in this setting.

Keywords: growth modulation index; sarcoma; time-to-progression ratio; trabectedin

Journal Article.  2990 words.  Illustrated.

Subjects: Medical Oncology

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