1. Overview : therapeutic biomarkers in cancer / Sherry X. Yang and Janet E. Dancey -- 2. Statistical considerations in the development and evaluation of therapeutic biomarkers in cancer / Lisa M. McShane, Edward L. Korn, and Boris Freidlin -- 3. Role of biomarkers in clinical development of cancer therapies / Helen X. Chen -- 4. HER-2 as a prognostic and predictive biomarker in cancer / Suparna B. Wedam and Stanley Lipkowitz -- 5. Hormone receptors and endocrine therapy in breast cancer / Sherry X. Yang -- 6. Predictive biomarkers for epidermal growth factor receptor agents in non-small cell lung cancer / John Hilton, Penelope A. Bradbury, and Janet Dancey -- 7. Markers of sensitivity and resistance to EGFR inhibitors in colorectal cancer / Jose G. Monzon and Janet Dancey -- 8. Targeting BCR-ABL for molecular therapy of chronic myelogenous leukemia / Shamudheen Rafiyath, Guoqing Wei, and Delong Liu -- 9. Gastrointestinal stromal tumors : from molecular pathogenesis to therapy / Joaquina Baranda, Rashna Madan, and Andrew K. Godwin -- 10. PML/RARa fusion gene and response to retinoic acid and arsenic trioxide treatment / Alicja M. Gruszka and Myriam Alcalay -- 11. Dihydropyrimidine dehydrogenase deficiency and 5-fluorouracil toxicity -- 12. UGT1A1 polymorphisms and mutations lead to irinotecan-induced toxicity / K.M. Reece and W.D. Figg -- 13. The 21-gene recurrence score and benefit of chemotherapy in estrogen receptor-positive breast cancer / Petra Rietschel and Joseph A. Sparano -- 14. Mammaprint for individualized recurrence risk assessment and treatment recommendations for early-stage breast cancer patients / Sonal J. Desai and Tianhong Li -- 15. BRCA mutation and PARP inhibitors / Marcie K. Weil. [et al.] -- 16. EML4-ALK fusion gene and therapy with ALK-targeted agents in non-small cell lung cancer / Vimal Patel and Biren Saraiya -- 17. BRAF-targeted therapy in metastatic melanoma / Noori Kim and April Deng.