Precision oncology: neither a silver bullet nor a dream

Current treatment options and investigational drugs for Waldenstrom’s Macroglobulinemia

(2017) Maria Gavriatopoulou et al.   EXPERT OPINION ON INVESTIGATIONAL DRUGS

Clinical Predictors of Venetoclax Pharmacokinetics in Chronic Lymphocytic Leukemia and Non-Hodgkin’s Lymphoma Patients: a Pooled Population Pharmacokinetic Analysis

(2016) Aksana K. Jones et al.   AAPS Journal

Selective expansion of regulatory T cells during lenalidomide treatment of myelodysplastic syndrome with isolated deletion 5q

(2016) Ekaterina Balaian et al.   ANNALS OF HEMATOLOGY

Cobimetinib

(2016) Jessie Signorelli et al.   ANNALS OF PHARMACOTHERAPY

The impact of multiple low-level BCR-ABL1 mutations on response to ponatinib

(2016) W. T. Parker et al.   BLOOD

Cancer statistics, 2016

(2016) Rebecca L. Siegel et al.   CA-A CANCER JOURNAL FOR CLINICIANS

Randomized study of FOLFIRI plus either panitumumab or bevacizumab for wild-type KRAS colorectal cancer-WJOG 6210G

(2016) Kohei Shitara et al.   CANCER SCIENCE

Clinical trial designs incorporating predictive biomarkers

(2016) Lindsay A. Renfro et al.   CANCER TREATMENT REVIEWS

FDA Approval: Alectinib for the Treatment of Metastatic, ALK-Positive Non-Small Cell Lung Cancer Following Crizotinib

(2016) E. Larkins et al.   CLINICAL CANCER RESEARCH

Profile of the therascreen® EGFR RGQ PCR kit as a companion diagnostic for gefitinib in non-small cell lung cancer

(2016) Emily Han-Chung Hsiue et al.   EXPERT REVIEW OF MOLECULAR DIAGNOSTICS

PARP inhibition and gynecologic malignancies: A review of current literature and on-going trials

(2016) S.M. Crafton et al.   GYNECOLOGIC ONCOLOGY

Activity and safety of ceritinib in patients with ALK -rearranged non-small-cell lung cancer (ASCEND-1): updated results from the multicentre, open-label, phase 1 trial

(2016) Dong-Wan Kim et al.   LANCET ONCOLOGY

Ibrutinib for patients with relapsed or refractory chronic lymphocytic leukaemia with 17p deletion (RESONATE-17): a phase 2, open-label, multicentre study

(2016) Susan O'Brien et al.   LANCET ONCOLOGY

Alectinib in ALK -positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial

(2016) Alice T Shaw et al.   LANCET ONCOLOGY

Efficacy and safety of rechallenge treatment with gefitinib in patients with advanced non-small cell lung cancer

(2016) Federico Cappuzzo et al.   LUNG CANCER

therascreen ® EGFR RGQ PCR Kit: A Companion Diagnostic for Afatinib and Gefitinib in Non-Small Cell Lung Cancer

(2016) Yahiya Y. Syed   Molecular Diagnosis & Therapy

Perspective: The precision-oncology illusion

(2016) Vinay Prasad   NATURE

Limits to Personalized Cancer Medicine

(2016) Ian F. Tannock et al.   NEW ENGLAND JOURNAL OF MEDICINE

Targeting BCL2 with Venetoclax in Relapsed Chronic Lymphocytic Leukemia

(2016) Andrew W. Roberts et al.   NEW ENGLAND JOURNAL OF MEDICINE

Ponatinib in the therapy of chronic myeloid leukemia

(2016) Marc Poch Martell et al.   Expert Review of Hematology

NCI-MATCH Trial Draws Strong Interest

(2016)   Cancer Discovery

Detection rate of actionable mutations in diverse cancers using a biopsy-free (blood) circulating tumor cell DNA assay

(2016) Maria Schwaederle et al.   Oncotarget

Waldenström's macroglobulinemia: a clinical perspective in the era of novel therapeutics

(2015) M. A. Dimopoulos et al.   ANNALS OF ONCOLOGY

Safety and efficacy of the addition of simvastatin to panitumumab in previously treated KRAS mutant metastatic colorectal cancer patients

(2015) Jara M. Baas et al.   ANTI-CANCER DRUGS

Ibrutinib : applications cliniques et perspectives de développement dans les hémopathies malignes B

(2015) Catherine Thieblemont   BULLETIN DU CANCER

Development of Olaparib for BRCA-Deficient Recurrent Epithelial Ovarian Cancer

(2015) K. S. Tewari et al.   CLINICAL CANCER RESEARCH

FDA Approval Summary: Olaparib Monotherapy in Patients with Deleterious Germline BRCA-Mutated Advanced Ovarian Cancer Treated with Three or More Lines of Chemotherapy

(2015) G. Kim et al.   CLINICAL CANCER RESEARCH

ALCHEMIST Trials: A Golden Opportunity to Transform Outcomes in Early-Stage Non-Small Cell Lung Cancer

(2015) R. Govindan et al.   CLINICAL CANCER RESEARCH

Analysis of KRAS/NRAS Mutations in a Phase III Study of Panitumumab with FOLFIRI Compared with FOLFIRI Alone as Second-line Treatment for Metastatic Colorectal Cancer

(2015) M. Peeters et al.   CLINICAL CANCER RESEARCH

Lung Master Protocol (Lung-MAP)--A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400

(2015) R. S. Herbst et al.   CLINICAL CANCER RESEARCH

FDA Approval: Ceritinib for the Treatment of Metastatic Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer

(2015) S. Khozin et al.   CLINICAL CANCER RESEARCH

Innovative Clinical Trials: The LUNG-MAP Study

(2015) CE Steuer et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

ALCHEMIST: Bringing genomic discovery and targeted therapies to early-stage lung cancer

(2015) DE Gerber et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Phase II Pilot Study of Vemurafenib in Patients With Metastatic BRAF-Mutated Colorectal Cancer

(2015) Scott Kopetz et al.   JOURNAL OF CLINICAL ONCOLOGY

Olaparib Monotherapy in Patients With Advanced Cancer and a GermlineBRCA1/2Mutation

(2015) Bella Kaufman et al.   JOURNAL OF CLINICAL ONCOLOGY

NCI-MATCH Launch Highlights New Trial Design in Precision-Medicine Era:

(2015) Caroline McNeil   JNCI-Journal of the National Cancer Institute

Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial

(2015) Georgina V Long et al.   LANCET

Precision medicine: lessons learned from the SHIVA trial

(2015) Apostolia M Tsimberidou et al.   LANCET ONCOLOGY

Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials

(2015) James Chih-Hsin Yang et al.   LANCET ONCOLOGY

Molecularly targeted therapy based on tumour molecular profiling versus conventional therapy for advanced cancer (SHIVA): a multicentre, open-label, proof-of-concept, randomised, controlled phase 2 trial

(2015) Christophe Le Tourneau et al.   LANCET ONCOLOGY

Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial

(2015) Jean Jacques Grob et al.   LANCET ONCOLOGY

The Brave New World of clinical cancer research: Adaptive biomarker-driven trials integrating clinical practice with clinical research

(2015) Donald A. Berry   Molecular Oncology

Patient-centric trials for therapeutic development in precision oncology

(2015) Andrew V. Biankin et al.   NATURE

NCI-MATCH pairs tumor mutations with matching drugs

(2015) Vicki Brower   NATURE BIOTECHNOLOGY

Improved Overall Survival in Melanoma with Combined Dabrafenib and Trametinib

(2015) Caroline Robert et al.   NEW ENGLAND JOURNAL OF MEDICINE

AZD9291 in EGFR Inhibitor–Resistant Non–Small-Cell Lung Cancer

(2015) Pasi A. Jänne et al.   NEW ENGLAND JOURNAL OF MEDICINE

NCI-MATCH Launch Highlights New Trial Design in Precision-Medicine Era:

(2015) Caroline McNeil   JNCI-Journal of the National Cancer Institute

Alectinib: a novel second generation anaplastic lymphoma kinase (ALK) inhibitor for overcoming clinically-acquired resistance

(2015) Zilan Song et al.   Acta Pharmaceutica Sinica B

Safety of bosutinib versus imatinib in the phase 3 BELA trial in newly diagnosed chronic phase chronic myeloid leukemia

(2014) Carlo Gambacorti-Passerini et al.   AMERICAN JOURNAL OF HEMATOLOGY

Concomitant ALK translocation and EGFR mutation in lung cancer: a comparison of direct sequencing and sensitive assays and the impact on responsiveness to tyrosine kinase inhibitor

(2014) J. K. Won et al.   ANNALS OF ONCOLOGY

I-SPY2 trial yields first results on combination therapy for triple-negative breast cancer

(2014) Carrie Printz   CANCER

A Single-Arm, Open-Label, Expanded Access Study of Vemurafenib in Patients With Metastatic Melanoma in the United States

(2014) Lawrence Flaherty et al.   CANCER JOURNAL

U.S. Food and Drug Administration Approval: Crizotinib for Treatment of Advanced or Metastatic Non-Small Cell Lung Cancer That Is Anaplastic Lymphoma Kinase Positive

(2014) S. M. Malik et al.   CLINICAL CANCER RESEARCH

FDA Approval: Ado-Trastuzumab Emtansine for the Treatment of Patients with HER2-Positive Metastatic Breast Cancer

(2014) L. Amiri-Kordestani et al.   CLINICAL CANCER RESEARCH

Ibrutinib: First Global Approval

(2014) Fiona Cameron et al.   DRUGS

PARP inhibitors in ovarian cancer: Current status and future promise

(2014) Joyce F. Liu et al.   GYNECOLOGIC ONCOLOGY

Using Multiplexed Assays of Oncogenic Drivers in Lung Cancers to Select Targeted Drugs

(2014) Mark G. Kris et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Combined BRAF (Dabrafenib) and MEK Inhibition (Trametinib) in Patients WithBRAFV600-Mutant Melanoma Experiencing Progression With Single-Agent BRAF Inhibitor

(2014) Douglas B. Johnson et al.   JOURNAL OF CLINICAL ONCOLOGY

Combination of vemurafenib and cobimetinib in patients with advanced BRAFV600-mutated melanoma: a phase 1b study

(2014) Antoni Ribas et al.   LANCET ONCOLOGY

Clinical development success rates for investigational drugs

(2014) Michael Hay et al.   NATURE BIOTECHNOLOGY

Ceritinib in ALK-Rearranged Non–Small-Cell Lung Cancer

(2014) Alice T. Shaw et al.   NEW ENGLAND JOURNAL OF MEDICINE

Crizotinib in ROS1-Rearranged Non–Small-Cell Lung Cancer

(2014) Alice T. Shaw et al.   NEW ENGLAND JOURNAL OF MEDICINE

Combined BRAF and MEK Inhibition versus BRAF Inhibition Alone in Melanoma

(2014) Georgina V. Long et al.   NEW ENGLAND JOURNAL OF MEDICINE

Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma

(2014) James Larkin et al.   NEW ENGLAND JOURNAL OF MEDICINE

FDA Approval Summary: Crizotinib for the Treatment of Metastatic Non-Small Cell Lung Cancer With Anaplastic Lymphoma Kinase Rearrangements

(2014) D. Kazandjian et al.   ONCOLOGIST

Molecular Analysis for Therapy Choice: NCI MATCH

(2014) Barbara A. Conley et al.   SEMINARS IN ONCOLOGY

NCI Launches ALCHEMIST

(2014)   Cancer Discovery

Ado-trastuzumab emtansine approved for advanced breast cancer

(2013) K. Traynor   AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

ROS1 Immunohistochemistry for Detection of ROS1-Rearranged Lung Adenocarcinomas

(2013) Lynette M. Sholl et al.   AMERICAN JOURNAL OF SURGICAL PATHOLOGY

Adaptive enrichment designs for clinical trials

(2013) N. Simon et al.   BIOSTATISTICS

A Critical Review of Trials of First-Line BCR-ABL Inhibitor Treatment in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

(2013) Elias Jabbour et al.   Clinical Lymphoma Myeloma & Leukemia

Designing Transformative Clinical Trials in the Cancer Genome Era

(2013) Stefan Sleijfer et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma

(2013) Paolo A. Ascierto et al.   JOURNAL OF CLINICAL ONCOLOGY

Phase III Study of Afatinib or Cisplatin Plus Pemetrexed in Patients With Metastatic Lung Adenocarcinoma WithEGFRMutations

(2013) Lecia V. Sequist et al.   JOURNAL OF CLINICAL ONCOLOGY

Biomarker enrichment strategies: matching trial design to biomarker credentials

(2013) Boris Freidlin et al.   Nature Reviews Clinical Oncology

Crizotinib versus Chemotherapy in Advanced ALK-Positive Lung Cancer

(2013) Alice T. Shaw et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Phase 2 Trial of Ponatinib in Philadelphia Chromosome–Positive Leukemias

(2013) J.E. Cortes et al.   NEW ENGLAND JOURNAL OF MEDICINE

Approval Summary: Cetuximab in Combination With Cisplatin or Carboplatin and 5-Fluorouracil for the First-Line Treatment of Patients With Recurrent Locoregional or Metastatic Squamous Cell Head and Neck Cancer

(2013) M. H. Cohen et al.   ONCOLOGIST

Comparison of Testing Methods for the Detection of BRAF V600E Mutations in Malignant Melanoma: Pre-Approval Validation Study of the Companion Diagnostic Test for Vemurafenib

(2013) Fernando Lopez-Rios et al.   PLoS One

Targeted therapies in medical oncology: successes, failures and next steps

(2013) Gordon Mallarkey et al.   Therapeutic Advances in Medical Oncology

Food and Drug Administration Approval of Cetuximab and a New KRAS Genetic Test for Metastatic Colorectal Cancer

(2012) Ronald Lieberman   AMERICAN JOURNAL OF THERAPEUTICS

Reports from the 2010 Clinical and Translational Cancer Research Think Tank Meeting: Design Strategies for Personalized Therapy Trials

(2012) D. A. Berry et al.   CLINICAL CANCER RESEARCH

Cost Analysis of Erlotinib Versus Chemotherapy for First-Line Treatment of Non–Small-Cell Lung Cancer in Frail Elderly Patients Participating in a Prospective Phase 2 Study (GFPC 0505)

(2012) Christos Chouaid et al.   Clinical Lung Cancer

Vemurafenib in Patients With BRAF V600E Mutation–Positive Advanced Melanoma

(2012) Marcus C. Ravnan et al.   CLINICAL THERAPEUTICS

ROS1 Rearrangements Define a Unique Molecular Class of Lung Cancers

(2012) Kristin Bergethon et al.   JOURNAL OF CLINICAL ONCOLOGY

Bosutinib Versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: Results From the BELA Trial

(2012) Jorge E. Cortes et al.   JOURNAL OF CLINICAL ONCOLOGY

Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial

(2012) Gerald S Falchook et al.   LANCET

Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial

(2012) José Baselga et al.   LANCET

Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial

(2012) Axel Hauschild et al.   LANCET

Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial

(2012) Vincent A Miller et al.   LANCET ONCOLOGY

Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial

(2012) James Chih-Hsin Yang et al.   LANCET ONCOLOGY

Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial

(2012) Rafael Rosell et al.   LANCET ONCOLOGY

Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial

(2012) Georgina V Long et al.   LANCET ONCOLOGY

Ponatinib in Refractory Philadelphia Chromosome–Positive Leukemias

(2012) Jorge E. Cortes et al.   NEW ENGLAND JOURNAL OF MEDICINE

Cost Effectiveness of Personalized Therapy for First-Line Treatment of Stage IV and Recurrent Incurable Adenocarcinoma of the Lung

(2012) Elizabeth A. Handorf et al.   Journal of Oncology Practice

Rituximab in chronic lymphocytic leukemia

(2011) Danelle F. James et al.   ADVANCES IN THERAPY

New melanoma drug requires gene mutation test

(2011) C. A. Thompson   AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY

Vemurafenib (PLX4032): An Orally Available Inhibitor of Mutated BRAF for the Treatment of Metastatic Melanoma

(2011) Yasser Heakal et al.   ANNALS OF PHARMACOTHERAPY

CH5424802, a Selective ALK Inhibitor Capable of Blocking the Resistant Gatekeeper Mutant

(2011) Hiroshi Sakamoto et al.   CANCER CELL

Fulvestrant Revisited: Efficacy and Safety of the 500-mg Dose

(2011) Anthony Howell et al.   Clinical Breast Cancer

Cetuximab in the treatment of patients with colorectal cancer

(2011) Christopher R Garrett et al.   EXPERT OPINION ON BIOLOGICAL THERAPY

Emerging data on the efficacy and safety of fulvestrant, a unique antiestrogen therapy for advanced breast cancer

(2011) Sarah M Scott et al.   Expert Opinion On Drug Safety

The LUX-Lung clinical trial program of afatinib for non-small-cell lung cancer

(2011) Giulio Metro et al.   Expert Review of Anticancer Therapy

Biomarker Analyses and Final Overall Survival Results From a Phase III, Randomized, Open-Label, First-Line Study of Gefitinib Versus Carboplatin/Paclitaxel in Clinically Selected Patients With Advanced Non–Small-Cell Lung Cancer in Asia (IPASS)

(2011) Masahiro Fukuoka et al.   JOURNAL OF CLINICAL ONCOLOGY

Four-Year Follow-Up of Trastuzumab Plus Adjuvant Chemotherapy for Operable Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Joint Analysis of Data From NCCTG N9831 and NSABP B-31

(2011) Edith A. Perez et al.   JOURNAL OF CLINICAL ONCOLOGY

Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation

(2011) Paul B. Chapman et al.   NEW ENGLAND JOURNAL OF MEDICINE

The BATTLE Trial: A Bold Step toward Improving the Efficiency of Biomarker-Based Drug Development

(2011) Eric H. Rubin et al.   Cancer Discovery

The BATTLE Trial: Personalizing Therapy for Lung Cancer

(2011) Edward S. Kim et al.   Cancer Discovery

BATTLE to personalize lung cancer treatment

(2010) Carrie Printz   CANCER

Fulvestrant 250 mg versus anastrozole for Chinese patients with advanced breast cancer: results of a multicentre, double-blind, randomised phase III trial

(2010) Binghe Xu et al.   CANCER CHEMOTHERAPY AND PHARMACOLOGY

Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin's Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study

(2010) Marinus H.J. van Oers et al.   JOURNAL OF CLINICAL ONCOLOGY

Randomized Clinical Trials With Biomarkers: Design Issues

(2010) B. Freidlin et al.   JNCI-Journal of the National Cancer Institute

Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial

(2010) Yung-Jue Bang et al.   LANCET

Adaptive BATTLE trial uses biomarkers to guide lung cancer treatment

(2010)   NATURE REVIEWS DRUG DISCOVERY

Dasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia

(2010) Hagop Kantarjian et al.   NEW ENGLAND JOURNAL OF MEDICINE

Gefitinib or Chemotherapy for Non–Small-Cell Lung Cancer with Mutated EGFR

(2010) Makoto Maemondo et al.   NEW ENGLAND JOURNAL OF MEDICINE

Clinical Features and Outcome of Patients With Non–Small-Cell Lung Cancer Who Harbor EML4-ALK

(2009) Alice T. Shaw et al.   JOURNAL OF CLINICAL ONCOLOGY

Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial

(2009) Tetsuya Mitsudomi et al.   LANCET ONCOLOGY

Cetuximab and Chemotherapy as Initial Treatment for Metastatic Colorectal Cancer

(2009) Eric Van Cutsem et al.   NEW ENGLAND JOURNAL OF MEDICINE

Fulvestrant: Expanding the endocrine treatment options for patients with hormone receptor-positive advanced breast cancer

(2008) Stephen Chia et al.   BREAST

A History of Cancer Chemotherapy

(2008) Vincent T. DeVita et al.   CANCER RESEARCH

Randomized Phase III Clinical Trial Designs for Targeted Agents

(2008) A. Hoering et al.   CLINICAL CANCER RESEARCH

Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial

(2008) Edward S Kim et al.   LANCET

BIBW2992, an irreversible EGFR/HER2 inhibitor highly effective in preclinical lung cancer models

(2008) D Li et al.   ONCOGENE

The Potential Clinical and Economic Outcomes of Pharmacogenomic Approaches to EGFR-Tyrosine Kinase Inhibitor Therapy in Non–Small-Cell Lung Cancer

(2008) Josh J. Carlson et al.   VALUE IN HEALTH