Neoadjuvant therapy in breast cancer as a basis for drug approval

JAMA Oncology

Volumn 1, Issue 7, 2015, Pages 875-876

  Berry, Donald A ^a   Hudis, Clifford A ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ADJUVANT THERAPY; ADVERSE EFFECTS; BREAST NEOPLASMS; DISEASE COURSE; DISEASE FREE SURVIVAL; DRUG APPROVAL; FEMALE; FOOD AND DRUG ADMINISTRATION; HUMAN; MORTALITY; PATHOLOGY; REPRODUCIBILITY; RISK ASSESSMENT; RISK FACTOR; STATISTICAL ANALYSIS; SURVIVAL; TIME; TREATMENT OUTCOME; TUMOR RECURRENCE; UNITED STATES;

ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DATA INTERPRETATION, STATISTICAL; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DRUG APPROVAL; FEMALE; HUMANS; NEOADJUVANT THERAPY; NEOPLASM RECURRENCE, LOCAL; REPRODUCIBILITY OF RESULTS; RISK ASSESSMENT; RISK FACTORS; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84965094393     PISSN: 23742437     EISSN: 23742445     Source Type: Journal    
DOI: 10.1001/jamaoncol.2015.1293     Document Type: Short Survey

References (4)

1. US Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry: pathological complete response in neoadjuvant treatment of high-risk early-stage breast cancer: use as an end point to support accelerated approval. October 2014. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm305501.pdf. Accessed March 19, 2015.
2. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014;384(9938):164-172.
3. Baselga J, Bradbury I, Eidtmann H, et al; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012;379(9816):633-640. doi:10.1016/S0140-6736(11)61847-3.
4. Piccart-Gebhart MJ. 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). ASCO website. http://meetinglibrary.asco.org/content/94401.Accessed March 19, 2015.