Evidence map›Paper›PMID 27098150›Full record

Trial reportJournal of the National Cancer Institute2016

Lapatinib-Related Rash and Breast Cancer Outcome in the ALTTO Phase III Randomized Trial.

Amir Sonnenblick, Evandro de Azambuja, Dominique Agbor-Tarh, Ian Bradbury, Christine Campbell, Yingjie Huang, Amylou C Dueck, Kathleen I Pritchard, Antonio C Wolff, Christian Jackisch and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the National Cancer Institute, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
  9. Dual contribution of the gut microbiome to immunotherapy efficacy and toxicity: supportive care implications and recommendations.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Frontiers in pharmacology · 2018
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 14 institutions in 9 countries.

Amir SonnenblickDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Evandro de AzambujaDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Dominique Agbor-TarhDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Ian BradburyDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Christine CampbellDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Yingjie HuangDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Amylou C DueckDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Kathleen I PritchardDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Antonio C WolffDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Christian JackischDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Istvan LangDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Michael UntchDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Ian SmithDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Frances BoyleDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Binghe XuDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Henry GomezDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Edith A PerezDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Martine PiccartDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP).
Hatem A AzimDepartment of Medicine, Breast European Adjuvant Study Team (BrEAST) Data Centre, Institut Jules Bordet, Université Libre de Bruxelles (ULB), Brussels, Belgium (AS, EdA, MP, HAAJr); Frontier Science (Scotland) Ltd, Grampian View, Kincraig, Kingussie, UK (DAt, IB, CC); Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Alliance Statistics and Data Center, Mayo Clinic, Section of Biostatistics, Scottsdale, AZ (ACD); Sunnybrook Odette Cancer Centre, the University of Toronto and the NCIC Clinical Trials Group, Toronto, Ontario, Canada (KIP); The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD (ACW); Sana Klinikum Offenbach, Offenbach, Germany (CJ); National Institute of Oncology, Budapest, Hungary (IL); Helios Klinikum Berlin-Buch, Berlin, Germany (MU); Royal Marsden Hospital NHS Trust, Sutton/Surrey, UK (IS); Patricia Ritchie Centre for Cancer Care and Research, The University of Sydney, Mater Hospital, North Sydney, Australia (FB); Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China (BX); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (HG); Mayo Clinic, Jacksonville, FL (EAP) hatemazim@icloud.com.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNFrontier Agriculture (United Kingdom) · GBHelios Hospital Berlin-Buch · DEInstitut Jules Bordet · BETris Pharma (United States) · USInstituto Nacional de Enfermedades Neoplásicas · PEJacksonville College · USMater Health Services · AUMayo Clinic in Florida · USRoyal Marsden Hospital · GBSunnybrook Health Science Centre · CAUniversité Libre de Bruxelles · BEUniversity of Sydney · AUWinnMed · US

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
Johns Hopkins University NCTN Lead Academic Site ProgramU10CA180802 · NCI · JOHNS HOPKINS UNIVERSITY · PI ARMSTRONG, DEBORAH K, BRAHMER, JULIE RENEE · 2014 to 2018
$3.3M
NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA233196
6 · The paper itself

Abstract

backgroundPreviously we have shown that early development of rash is associated with a higher chance of achieving pathological complete response to neoadjuvant lapatinib. In the current analysis, we investigate its impact on survival in the ALTTO phase III adjuvant trial.

methodsIn ALTTO, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomly assigned to adjuvant trastuzumab, lapatinib, their sequence, or their combination for a total duration of one year. We evaluated whether the development of early lapatinib-related rash (ie, within 6 weeks) is associated with disease-free (DFS) and overall survival (OS). Landmark analysis at eight weeks and time-dependent analysis were tested in a multivariable model stratifying on trial's stratification factors. All statistical tests were two-sided.

resultsOut of 6098 lapatinib-treated patients, 3973(65.2%) were included in the landmark analysis, of whom 1389 (35.0%) had developed early rash. After median follow-up of 4.5 years, the development of early rash was associated with a trend of improved DFS (multivariable: hazard ratio [HR] = 0.87, 95% confidence interval [CI] = 0.73 to 1.03,P= .10) and statistically significantly improved OS (multivariable: HR = 0.63, 95% CI = 0.48 to 0.82,P< .001) compared with subjects without early rash. Compared with patients randomly assigned to trastuzumab (n = 2051), patients who were randomly assigned to trastuzumab/lapatinib combination and developed early rash (n = 692) had superior DFS (multivariable: HR = 0.72, 95% CI = 0.55 to 0.92,P= .01) and OS (multivariable: HR = 0.59, 95% CI = 0.39 to 0.90,P= .01). Time-dependent analysis suggests that the occurrence of rash is predictive of lapatinib benefit, both when given in combination or sequential to trastuzumab.

conclusionsOur results indicate that early development of rash identifies patients who derive superior benefit from lapatinib-based therapy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDrug EruptionsErb-b2 Receptor Tyrosine KinasesExanthemaFemaleFollow-Up StudiesHumansLapatinibMiddle AgedQuinazolinesSurvival RateTime FactorsTrastuzumabTreatment OutcomeERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesLapatinibQuinazolinesTrastuzumab

Identifiers

PMID27098150
PMCPMC5017935
OpenAlexW2338010368

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.