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 Anti-Cancer Agents & Biologic Therapy
Soft Tissue Sarcomas
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.