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.
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.
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France [3] Institut Curie, Saint-Cloud, France.
C
C
Le Tourneau
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
X
X
Paoletti
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
N
N
Servant
Institut Curie, Paris, France.
I
I
Bièche
Institut Curie, Paris, France.
D
D
Gentien
Institut Curie, Paris, France.
T
T
Rio Frio
Institut Curie, Paris, France.
A
A
Vincent-Salomon
Institut Curie, Paris, France.
V
V
Servois
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
J
J
Romejon
Institut Curie, Paris, France.
O
O
Mariani
Institut Curie, Paris, France.
V
V
Bernard
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
P
P
Huppe
Institut Curie, Paris, France.
G
G
Pierron
Institut Curie, Paris, France.
F
F
Mulot
Institut Curie, Paris, France.
C
C
Callens
Institut Curie, Paris, France.
J
J
Wong
Institut Curie, Paris, France.
C
C
Mauborgne
Institut Curie, Paris, France.
E
E
Rouleau
Institut Curie, Paris, France.
C
C
Reyes
Institut Curie, Paris, France.
E
E
Henry
Institut Curie, Paris, France.
Q
Q
Leroy
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
P
P
Gestraud
1] Institut Curie, Paris, France [2] Unité INSERM/Institut Curie U900, Paris, France.
P
P
La Rosa
Institut Curie, Paris, France.
L
L
Escalup
Institut Curie, Saint-Cloud, France.
E
E
Mitry
Centre Léon Bérard, Lyon, France.
O
O
Trédan
Institut Claudius Régaud, Toulouse, France.
J-P
JP
Delord
Centre René Gauducheau, Nantes, France.
M
M
Campone
Institut Paoli-Calmettes, Marseille, France.
A
A
Goncalves
Centre Georges-François Leclerc, Dijon, France.
N
N
Isambert
Centre Alexis Vautrin, Nancy, France.
C
C
Gavoille
Institut Curie, Paris, France.
M
M
Kamal
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D004252:DNA Mutational Analysis; D005260:Female; D018628:Gene Dosage; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000378:metabolism; D057285:Precision Medicine / Q000379:methods