Correlation between overall survival and growth modulation index in pre-treated sarcoma patients: a study from the French Sarcoma Group

被引:19
作者
Cousin, S. [1 ]
Blay, J. Y. [2 ]
Bertucci, F. [3 ]
Isambert, N. [4 ]
Italiano, A. [5 ]
Bompas, E. [6 ]
Ray-Coquard, I. [2 ]
Perrot, D. [3 ]
Chaix, M. [4 ]
Bui-Nguyen, B. [5 ]
Chaigneau, L. [7 ]
Corradini, N. [8 ]
Penel, N. [1 ,9 ]
机构
[1] Ctr Oscar Lambret, Dept Gen Oncol, F-59020 Lille, France
[2] Leon Berard Ctr, Dept Med Oncol, Lyon, France
[3] Inst J Paoli I Calmettes, Dept Med Oncol, F-13009 Marseille, France
[4] Georges Francois Leclerc Ctr, Dept Med Oncol, Dijon, France
[5] Bergonie Inst, Dept Med Oncol, Bordeaux, France
[6] Rene Gauducheau Ctr, Dept Med Oncol, St Herblain, France
[7] Jean Minjoz Univ Hosp, Dept Med Oncol, Besancon, France
[8] Nantes Univ Hosp, Dept Paediat Oncol, Nantes, France
[9] Lille Nord de France Univ, Med Sch Univ, Res Unit, EA 2694, Lille, France
关键词
end point; growth modulation index; soft tissue sarcoma; time to progression; SOFT-TISSUE SARCOMA; PHASE-II TRIALS; END-POINT; EUROPEAN ORGANIZATION; RESPONSE EVALUATION; COLORECTAL-CANCER; ANTICANCER AGENTS; SOLID TUMORS; PROGRESSION; THERAPY;
D O I
10.1093/annonc/mdt278
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Growth modulation index (GMI), the ratio of two times to progression measured in patients receiving two successive treatments (GMI = TTP2/TTP1), has been proposed as a criterion of phase II clinical trials. Nevertheless, its use has been limited until now. We carried out a retrospective multicentre study in soft tissue sarcoma patients receiving a second-line treatment after doxorubicin-based regimens to evaluate the link between overall survival and GMI. Second-line treatments were classified as 'active' according to the EORTC-STBSG criteria (3-month progression-free rate > 40% or 6-month PFR > 14%). Comparisons used chi-squared and log-rank tests. The population consisted in 106 men and 121 women, 110 patients (48%) received 'active drugs'. Median OS from the second-line start was 317 days. Sixty-nine patients experienced GMI > 1.33 (30.4%). Treatments with 'active drug' were not associated with OS improvement: 490 versus 407 days (P = 0.524). Median OS was highly correlated with GMI: 324, 302 and 710 days with GMI < 1, GMI = [1.00-1.33], and GMI > 1.33, respectively (P < 0.0001). In logistic regression analysis, the sole predictive factor was the number of doxorubicin-based chemotherapy cycles. GMI seems to be an interesting end point that provides additional information compared with classical criteria. GMI > 1.33 is associated with significant OS improvement.
引用
收藏
页码:2681 / 2685
页数:5
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