Assessment of PIK3CA mutations in human epidermal growth factor receptor 2-positive breast cancer: Clinical validity but not utility

Journal of Clinical Oncology

Volumn 32, Issue 29, 2014, Pages 3207-3209

  Henry, N Lynn ^a   Schott, Anne F ^a   Hayes, Daniel F ^a  

^a UNIVERSITY OF MICHIGAN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

LAPATINIB; PERTUZUMAB; TRASTUZUMAB; TUMOR MARKER; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERBB2 PROTEIN, HUMAN; PHOSPHATIDYLINOSITOL 3 KINASE; PIK3CA PROTEIN, HUMAN;

BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER HORMONE THERAPY; CANCER PATIENT; CONTROLLED CLINICAL TRIAL (TOPIC); DISEASE FREE SURVIVAL; EDITORIAL; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HUMAN; MUTATOR GENE; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERSONAL EXPERIENCE; PIK3CA GENE; PROSPECTIVE STUDY; RETROSPECTIVE STUDY; STUDY DESIGN; TREATMENT RESPONSE; VALIDATION STUDY; ANTAGONISTS AND INHIBITORS; BREAST NEOPLASMS; FEMALE; GENETICS; MUTATION;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; FEMALE; HUMANS; MUTATION; PHOSPHATIDYLINOSITOL 3-KINASES; RECEPTOR, ERBB-2;

EID: 84907487853     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.57.6132     Document Type: Editorial

References (14)

1. Wolff AC, Hammond ME, Hicks DG, et al: Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol 31:3997-4013, 2013
2. Loibl S, Von Minckwitz G, Schneeweiss A, et al: PIK3CA mutations are associated with lower rates of pathologic complete response to anti-human epidermal growth factor receptor 2 (HER2) therapy in primary HER2-overexpressing breast cancer. J Clin Oncol 32:3212-3220, 2014
3. Hayes DF, Allen J, Compton C, et al: Breaking a vicious cycle. Sci Transl Med 5:196cm6, 2013
4. Micheel CM, Nass SJ, Omenn GS, et al: Evolution of Translational Omics: Lessons Learned and the Path Forward. Washington, DC, National Academies Press, 2012
5. Teutsch SM, Bradley LA, Palomaki GE, et al: The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: Methods of the EGAPP Working Group. Genet Med 11:3-14, 2009
6. Henry NL, Hayes DF: Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast cancer. Oncologist 11:541-552, 2006
7. Simon RM, Paik S, Hayes DF: Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 101:1446-1452, 2009
8. Sargent DJ, Conley BA, Allegra C, et al: Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 23:2020-2027, 2005
9. Freidlin B, McShane LM, Korn EL: Randomized clinical trials with biomarkers: Design issues. J Natl Cancer Inst 102:152-160, 2010
10. Von Minckwitz G, Untch M, Blohmer JU, et al: Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol 30:1796-1804, 2012
11. Cortazar P, Zhang L, Untch M, et al: Pathological complete response and long-term clinical benefit in breast cancer: The CTNeoBC pooled analysis. Lancet 384:164-172, 2014
12. US Food and Drug Administration: Code of Federal Regulations Title 21: Section 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf
13. US Food and Drug Administration: Code of Federal Regulations Title 21: Section 314.510 - Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity. http://www.fda.gov/downloads/Drugs/NewsEvents/UCM344999.pdf
14. Piccart-Gebhart MJ, Holmes AP, Baselga J, et al: First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T-"L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol 32:4s, 2014(suppl; abstr LBA4)