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, A. Le Cesne

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Abstract

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-1 th 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 1.33, 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.

Original languageEnglish
Article numbermds470
Pages (from-to)537-542
Number of pages6
JournalAnnals of Oncology
Volume24
Issue number2
DOIs
Publication statusPublished - Feb 2013

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Keywords

  • Growth modulation index
  • Sarcoma
  • Time-to-progression ratio
  • Trabectedin

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Penel, N., Demetri, G. D., Blay, J. Y., Cousin, S., Maki, R. G., Chawla, S. P., Judson, I., von Mehren, M., Schöffski, P., Verweij, J., Casali, P., Rodenhuis, S., Schütte, H. J., Cassar, A., Gomez, J., Nieto, A., Zintl, P., Pontes, M. J., & Le Cesne, A. (2013). Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy. Annals of Oncology, 24(2), 537-542. [mds470]. https://doi.org/10.1093/annonc/mds470