Designs and challenges for personalized medicine studies in oncology: Focus on the SHIVA trial

Targeted Oncology

Volumn 7, Issue 4, 2012, Pages 253-265

  Le Tourneau, Christophe ^a,i   Kamal, Maud ^a   Trédan, Olivier ^b   Delord, Jean Pierre ^c   Campone, Mario ^d   Goncalves, Anthony ^e   Isambert, Nicolas ^f   Conroy, Thierry ^g   Gentien, David ^a   Vincent Salomon, Anne ^a   Pouliquen, Anne Lise ^a   Servant, Nicolas ^a   Stern, Marc Henri ^a   Le Corroller, Anne Gaëlle ^h   Armanet, Sébastien ^a   Rio Frio, Thomas ^a   Paoletti, Xavier ^a,i  

^a INSTITUT CURIE   (France)

^b CENTRE LÉON BÉRARD   (France)

^c INSTITUT CLAUDIUS REGAUD   (France)

^d CENTRE RENÉ GAUDUCHEAU   (France)

^e INSTITUT PAOLI CALMETTES   (France)

^f CENTRE GEORGES FRANÇOIS LECLERC   (France)

^g UNIVERSITÉ DE LORRAINE   (France)

^h INSERM   (France)

ⁱ INSERM U900   (France)

Author keywords

Cancer; Challenges; Molecular profile; Personalized medicine; Randomized study; Sequencing; SHIVA trial

Indexed keywords

ABIRATERONE; CIRCULATING TUMORAL DNA; DASATINIB; DNA; ERLOTINIB; EVEROLIMUS; IMATINIB; LAPATINIB; LETROZOLE; SORAFENIB; TAMOXIFEN; TRASTUZUMAB; UNCLASSIFIED DRUG; VEMURAFENIB;

BIOINFORMATICS; BIOSTATISTICS; BREAST CANCER; CANCER SURVIVAL; CLINICAL TRIAL (TOPIC); ECONOMIC EVALUATION; GENE MUTATION; GENE SEQUENCE; GENOTYPE; HEALTH CARE ACCESS; HEALTH ECONOMICS; HUMAN; MEDICAL ETHICS; MOLECULARLY TARGETED THERAPY; OBSERVATIONAL STUDY; ONCOLOGY; PATIENT SELECTION; PERSONALIZED MEDICINE; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLE SIZE; STUDY DESIGN;

BIOMARKERS, PHARMACOLOGICAL; CLINICAL TRIALS, PHASE II AS TOPIC; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR TARGETED THERAPY; NEOPLASMS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 84874501540     PISSN: 17762596     EISSN: 1776260X     Source Type: Journal    
DOI: 10.1007/s11523-012-0237-6     Document Type: Review

References (17)

1. Tran B, Dancey JE, Kamel-Reid S et al (2012) Cancer genomics: technology, discovery, and translation. J Clin Oncol 30:647-660
2. Tsimberidou AM, Iskander NG, Hong DS et al. (2011) Personalized medicine in a phase I clinical trials program: The M.D. Anderson Cancer Center Initiative. J Clin Oncol 29 (suppl; abstr CRA2500).
3. Arnedos M, André F, Farace F et al (2012) The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: the case of the institut gustave roussy. Mol Oncol 6:204-210
4. Von Hoff DD, Stephenson JJ Jr, Rosen P et al (2010) Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers. J Clin Oncol 28:4877-4883
5. WIN consortium (2012). Available at http://www.winconsortium.org/press- releases-detail.jsp?id=700
6. Doroshow JH (2010) Selecting systemic cancer therapy one patient at a time: is there a role for molecular profiling of individual patients with advanced solid tumors? J Clin Oncol 28:4869-4871
7. Buyse M, Quinaux E, Hendlisz A et al (2011) Progression-free survival ratio as end point for phase II trials in advanced solid tumors. J Clin Oncol 29:451-452
8. Le Tourneau C, Servois V, Diéras V et al (2012) Tumour growth kinetics assessment: added value to RECIST in cancer patients treated with molecularly targeted agents. Br J Cancer 106:854-857
9. Blackwell KL, Burstein HJ, Storniolo AM et al (2012) Overall survival benefit with lapatinib in combination with trastuzumab for patients with human epidermal growth factor receptor 2-positive metastatic breast cancer: final results from the EGF104900 Study. J Clin Oncol 30:2585-2592
10. Arkenau HT, Barriuso J, Olmos D et al (2009) Prospective validation of a prognostic score to improve patient selection for oncology phase I trials. J Clin Oncol 27:2692-2696
11. Horstmann E, McCabe MS, Grochow L et al (2005) Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 352:895-904 (Pubitemid 40300298)
12. Schwarzenbach H, Hoon DS, Pantel K (2011) Cell-free nucleic acids as biomarkers in cancer patients. Nat Rev Cancer 11:426-437
13. Parkinson DR, Dracopoli N, Gumbs Petty B et al (2012) Considerations in the development of circulating tumor cell technology for clinical use. J Transl Med 10:138
14. Higgins MJ, Jelovac D, Barnathan E et al (2012) Detection of tumor PIK3CA status in metastatic breast cancer using peripheral blood. Clin Cancer Res 18:3462-3469
15. Soria JC, Massard C, Izzedine H (2009) From theoretical synergy to clinical supra-additive toxicity. J Clin Oncol 27:1359-1361
16. Gerlinger M, Rowan AJ, Horswell S et al (2012) Intratumor heterogeneity and branched evolution revealed by multiregion sequencing. N Engl J Med 366:883-892
17. Eisenhauer EA, Therasse P, Bogaerts J et al (2009) New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 45:228-247