1442P - Choi vs. RECIST assessment of tumor response in a retrospective analysis of patients (pts) receiving trabectedin (T) for advanced soft tissue sarco...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Cytotoxic agents
Soft Tissue Sarcomas
Therapy
Biological therapy
Presenter Sophie Taieb
Citation Annals of Oncology (2014) 25 (suppl_4): iv494-iv510. 10.1093/annonc/mdu354
Authors S. Taieb1, E. Saada2, E. Tresch3, T. Ryckewaert4, E. Bompas5, A. Italiano6, C. Guillemet7, C. Peugniez4, S. Piperno-Neumann8, A. Thyss2, S. Clisant4, A. Cassar9, D. Nommay9, N. Penel4
  • 1Medical Imaging, Centre Oscar Lambret, 59000 - Lille/FR
  • 2Medical Oncology, institut Lacassagne, nice/FR
  • 3Biostatistics Unit, Centre Oscar Lambret, 59000 - Lille/FR
  • 4Medical Oncology, Centre Oscar Lambret, 59000 - Lille/FR
  • 5Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, Nantes/FR
  • 6Medical Oncology, Institut Bergonié, Bordeaux/FR
  • 7Medical Oncology, Centre H Becquerel, Rouen/FR
  • 8Medical Oncology, Institut Curie, 75248 - Paris/FR
  • 9Pharmamar Representative, Pharmamar Representative, Paris/FR

Abstract

Aim

Post-hoc analyses conducted in pts receiving T (Yondelis®) in clinical trials suggested that tumor assessment based on both size and density at portal time of contrast-enhancement sequences (Choi assessment) provides more valuable information than size measurement only (RECIST). We carried out a retrospective analysis in a real-life cohort of pts, treated in 6 French centers to explore the added value of Choi to RECIST assessment.

Methods

All baseline and 1st assessment CT-scans have been centrally reviewed by an experienced radiologist. Eligible criteria included ASTS pts (age ≥18) treated between 01/2007-12/2011, with at least 2 T cycles after failure or intolerance to doxorubicin/ifosfamide.

Results

The cohort consists of 134 (61 men; 133 eligible) pts treated with T according to the marketing authorization. Pts had median age of 56 years. Most pts had primary sites in limbs/trunk (61, 45%) and uterus (26, 19%) and histologies of leiomyosarcoma (52, 38%), liposarcoma (24, 18%) and synovial sarcoma (21, 15%). Metastases were present in 113 cases (84%), mainly in lung (85, 63%) and liver (25, 18%). Most pts had previously received doxorubicin (133, 99%) and ifosfamide (99, 74%). Median number of T cycles was 5 (2-33) and the main cause of discontinuation was progressive disease (PD) (105, 78%). RECIST assessment was feasible in 128 cases (96%), whereas Choi assessment in 92 (69%), mainly due to inadequate sequences or exclusive lung met. Concordance between both methods was low (Kappa=0.290). We identified five false-PD (PD according to RECIST but stable disease [SD]/partial response [PR] as per Choi). Univariate analysis did not identify predictive factors for false PD. Median OS of pts with false-PD was better than pts with PD according to both RECIST and Choi (14 vs. 8 months; p=0.052).

(n) RECIST in column Choi in row PR SD PD
PR 3 30 3
SD 1 15 2
PD 0 11 27

Conclusions

Choi assessment was feasible in 69% of cases; this method could identify pts with false-PD that having better outcome, suggesting that T may slow down the tumor course among pts experiencing PD according to RECIST and that response to treatment should also include Choi assessment.

Disclosure

A. Cassar: Employee by Pharmamar; D. Nommay: Employee by Pharmamar N. Penel: Research Grant from Pharmamar No Drug Supply. All other authors have declared no conflicts of interest.