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

N Penel; GD Demetri; JY Blay; S Cousin; RG Maki; SP Chawla; I Judson; M von Mehren; P Schoffski; Jaap Verweij; P Casali; S Rodenhuis; HJ Schutte; A Cassar; J Gomez; A Nieto; P Zintl; MJ Pontes; A le Cesne

doi: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

N Penel, GD Demetri, JY Blay, S Cousin, RG Maki, SP Chawla, I Judson, M von Mehren, P Schoffski, Jaap Verweij, P Casali, S Rodenhuis, HJ Schutte, A Cassar, J Gomez, A Nieto, P Zintl, MJ Pontes, A le Cesne

Medical Oncology

Research output: Contribution to journal › Article › Academic › peer-review

40 Citations (Scopus)

Abstract

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. 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/m superset of (24-h infusion every 3 weeks) in four phase II trials. 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 ra 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 language	Undefined/Unknown
Pages (from-to)	537-542
Number of pages	6
Journal	Annals of Oncology
Volume	24
Issue number	2
DOIs	https://doi.org/10.1093/annonc/mds470
Publication status	Published - 2013

Research programs

EMC MM-03-86-01
EMC MM-03-86-08

Access to Document

10.1093/annonc/mds470

http://hdl.handle.net/1765/60703

Cite this

Penel, N., Demetri, GD., Blay, JY., Cousin, S., Maki, RG., Chawla, SP., Judson, I., von Mehren, M., Schoffski, P., Verweij, J., Casali, P., Rodenhuis, S., Schutte, HJ., Cassar, A., Gomez, J., Nieto, A., Zintl, P., Pontes, MJ., & 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. https://doi.org/10.1093/annonc/mds470

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

abstract = "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. 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/m superset of (24-h infusion every 3 weeks) in four phase II trials. 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 ra 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.",

author = "N Penel and GD Demetri and JY Blay and S Cousin and RG Maki and SP Chawla and I Judson and {von Mehren}, M and P Schoffski and Jaap Verweij and P Casali and S Rodenhuis and HJ Schutte and A Cassar and J Gomez and A Nieto and P Zintl and MJ Pontes and {le Cesne}, A",

year = "2013",

doi = "10.1093/annonc/mds470",

language = "Undefined/Unknown",

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pages = "537--542",

journal = "Annals of Oncology",

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Penel, N, Demetri, GD, Blay, JY, Cousin, S, Maki, RG, Chawla, SP, Judson, I, von Mehren, M, Schoffski, P, Verweij, J, Casali, P, Rodenhuis, S, Schutte, HJ, Cassar, A, Gomez, J, Nieto, A, Zintl, P, Pontes, MJ & 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, vol. 24, no. 2, pp. 537-542. https://doi.org/10.1093/annonc/mds470

TY - JOUR

T1 - Growth modulation index as metric of clinical benefit assessment among advanced soft tissue sarcoma patients receiving trabectedin as a salvage therapy

AU - Penel, N

AU - Demetri, GD

AU - Blay, JY

AU - Cousin, S

AU - Maki, RG

AU - Chawla, SP

AU - Judson, I

AU - von Mehren, M

AU - Schoffski, P

AU - Verweij, Jaap

AU - Casali, P

AU - Rodenhuis, S

AU - Schutte, HJ

AU - Cassar, A

AU - Gomez, J

AU - Nieto, A

AU - Zintl, P

AU - Pontes, MJ

AU - le Cesne, A

PY - 2013

Y1 - 2013

N2 - 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. 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/m superset of (24-h infusion every 3 weeks) in four phase II trials. 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 ra 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.

AB - 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. 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/m superset of (24-h infusion every 3 weeks) in four phase II trials. 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 ra 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.

U2 - 10.1093/annonc/mds470

DO - 10.1093/annonc/mds470

M3 - Article

C2 - 23117071

SN - 0923-7534

VL - 24

SP - 537

EP - 542

JO - Annals of Oncology

JF - Annals of Oncology

IS - 2

ER -