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Clinical Trial
. 2014 Jul 8;111(1):17-24.
doi: 10.1038/bjc.2014.211. Epub 2014 Apr 24.

Randomised proof-of-concept phase II trial comparing targeted therapy based on tumour molecular profiling vs conventional therapy in patients with refractory cancer: results of the feasibility part of the SHIVA trial

C Le Tourneau  1 , X Paoletti  2 , N Servant  2 , I Bièche  3 , D Gentien  3 , T Rio Frio  3 , A Vincent-Salomon  3 , V Servois  3 , J Romejon  2 , O Mariani  3 , V Bernard  3 , P Huppe  2 , G Pierron  3 , F Mulot  3 , C Callens  3 , J Wong  3 , C Mauborgne  3 , E Rouleau  3 , C Reyes  3 , E Henry  3 , Q Leroy  3 , P Gestraud  2 , P La Rosa  2 , L Escalup  3 , E Mitry  4 , O Trédan  5 , J-P Delord  6 , M Campone  7 , A Goncalves  8 , N Isambert  9 , C Gavoille  10 , M Kamal  3
Affiliations
Clinical Trial

Randomised proof-of-concept phase II trial comparing targeted therapy based on tumour molecular profiling vs conventional therapy in patients with refractory cancer: results of the feasibility part of the SHIVA trial

C Le Tourneau et al. Br J Cancer. .

Abstract

Background: The SHIVA trial is a multicentric randomised proof-of-concept phase II trial comparing molecularly targeted therapy based on tumour molecular profiling vs conventional therapy in patients with any type of refractory cancer. RESULTS of the feasibility study on the first 100 enrolled patients are presented.

Methods: Adult patients with any type of metastatic cancer who failed standard therapy were eligible for the study. The molecular profile was performed on a mandatory biopsy, and included mutations and gene copy number alteration analyses using high-throughput technologies, as well as the determination of oestrogen, progesterone, and androgen receptors by immunohistochemistry (IHC).

Results: Biopsy was safely performed in 95 of the first 100 included patients. Median time between the biopsy and the therapeutic decision taken during a weekly molecular biology board was 26 days. Mutations, gene copy number alterations, and IHC analyses were successful in 63 (66%), 65 (68%), and 87 (92%) patients, respectively. A druggable molecular abnormality was present in 38 patients (40%).

Conclusions: The establishment of a comprehensive tumour molecular profile was safe, feasible, and compatible with clinical practice in refractory cancer patients.

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Figures

Figure 1
Figure 1
Timelines for the establishment of the tumour molecular profile in the SHIVA trial. IHC=immunohistochemistry; MBB=Molecular Biology Board.
Figure 2
Figure 2
CONSORT diagram for the 100 patients included in the feasibility part of the SHIVA trial. AR=androgen receptor; ER=oestrogen receptor; PR=progesterone receptor.
See this image and copyright information in PMC

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