VOLUME 32 䡠 NUMBER 25 䡠 SEPTEMBER 1 2014
JOURNAL OF CLINICAL ONCOLOGY
C O R R E S P O N D E N C E
Partner Diagnostics and the “Choosing Wisely” Campaign
of diagnostic testing in this time of increasing demand and declining funding.
Jodie E. Battley, Dearbhaile Collins, and Seamus O’Reilly
TO THE EDITOR: The recent article by Schnipper et al1 is a welcome contribution to the important discussion regarding optimum stewardship of precious health care resources. Their fifth recommendation regarding targeted therapy use only when the patient’s tumor has been tested with a validated test is prescient but would be enhanced, we believe, by highlighting the importance of quality assurance in testing. Past experience with the detection of biomarkers has been far from perfect. Erroneous estrogen receptor (ER) immunohistochemical assessment in breast cancer has come to the fore on a number of occasions; an estimated 40% of 2,000 retested specimens in the United States in 2006 has been incorrectly identified as ER negative.2 Additional data from the United Kingdom National External Quality Assessment Scheme for Immunocytochemistry reveals significant interlaboratory discrepancies.3 Points of weakness include the specimen preparation process, antigen retrieval, and antibody staining along with postanalytic failures. ER is not alone in this regard. Central testing for human epidermal growth factor receptor 2 (HER2) status in patients with breast cancer enrolled in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation trial demonstrated that up to 6% of patients who were enrolled were not subsequently confirmed as being HER2 positive.4 A similar story exists for other biomarkers.5-7 Although guidelines such as those developed for HER2 testing in breast cancer8 have reduced false-positive results, it is reasonable to assume that similar issues pertain to other targeted therapy–associated biomarkers, leading to costly inappropriate therapy for patients. Previous experience with targeted agents carries important lessons for more recently developed agents, which are increasingly used. The oncology community needs to place greater emphasis on an awareness
Cork University Hospital, Cork, Ireland
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
The author(s) indicated no potential conflicts of interest. REFERENCES 1. Schnipper LE, Lyman GH, Blayney DW et al: American Society of Clinical Oncology 2013 top five list in oncology. J Clin Oncol 31:4362-4370, 2013 2. Allred DC: Commentary: Hormone receptor testing in breast cancer—A distress signal from Canada. Oncologist 13:1134-1136, 2008 3. Rhodes A, Jasani B, Balaton AJ, et al: Study of interlaboratory reliability and reproducibility of estrogen and progesterone receptor assays in Europe: Documentation of poor reliability and identification of insufficient microwave antigen retrieval time as a major contributory element of unreliable assays. Am J Clin Path 115:44-58, 2001 4. McCullough AE, Dell’Orto P, Reinholz MM, et al: Concordance of Her2 central assessment by two international central laboratories: A ring study within the framework of the adjuvant Her2 positive ALTTO trial (BIG2-06/NO63D/ EGF106708). Cancer Res 70, 2010 (suppl 2; abstr P3-10-36) 5. Warneke VS, Behrens HM, Bo¨ger C, et al: Her2/neu testing in gastric cancer: Evaluating the risk of sampling errors. Ann Oncol 24:725-733, 2013 6. Wallander ML, Geiersbach KB, Tripp SR, et al: Comparison of reverse transcription-polymerase chain reaction, immunohistochemistry, and fluorescence in situ hybridization methodologies for detection of echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase fusion-positive non-small cell lung carcinoma: Implications for optimal clinical testing. Arch Pathol Lab Med 136:796-803, 2012 7. Lanthaler AJ, Spizzo G, Mitterer M, et al: Interlaboratory comparison of K-ras testing by real time PCR and RFLP in colorectal cancer samples. Diagn Mol Pathol 20:90-93, 2011 8. 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
DOI: 10.1200/JCO.2013.54.7638; published online ahead of print at www.jco.org on July 14, 2014
■ ■ ■
2812
© 2014 by American Society of Clinical Oncology
Journal of Clinical Oncology, Vol 32, No 25 (September 1), 2014: pp 2812
Information downloaded from jco.ascopubs.org and provided by at UNIVERSITY MICHIGAN on June 26, 2015 from Copyright © 2014 American Society of Clinical Oncology. All rights reserved. 141.211.4.224
JOURNAL OF CLINICAL ONCOLOGY
C O R R E S P O N D E N C E
Partner Diagnostics and the “Choosing Wisely” Campaign
of diagnostic testing in this time of increasing demand and declining funding.
Jodie E. Battley, Dearbhaile Collins, and Seamus O’Reilly
TO THE EDITOR: The recent article by Schnipper et al1 is a welcome contribution to the important discussion regarding optimum stewardship of precious health care resources. Their fifth recommendation regarding targeted therapy use only when the patient’s tumor has been tested with a validated test is prescient but would be enhanced, we believe, by highlighting the importance of quality assurance in testing. Past experience with the detection of biomarkers has been far from perfect. Erroneous estrogen receptor (ER) immunohistochemical assessment in breast cancer has come to the fore on a number of occasions; an estimated 40% of 2,000 retested specimens in the United States in 2006 has been incorrectly identified as ER negative.2 Additional data from the United Kingdom National External Quality Assessment Scheme for Immunocytochemistry reveals significant interlaboratory discrepancies.3 Points of weakness include the specimen preparation process, antigen retrieval, and antibody staining along with postanalytic failures. ER is not alone in this regard. Central testing for human epidermal growth factor receptor 2 (HER2) status in patients with breast cancer enrolled in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation trial demonstrated that up to 6% of patients who were enrolled were not subsequently confirmed as being HER2 positive.4 A similar story exists for other biomarkers.5-7 Although guidelines such as those developed for HER2 testing in breast cancer8 have reduced false-positive results, it is reasonable to assume that similar issues pertain to other targeted therapy–associated biomarkers, leading to costly inappropriate therapy for patients. Previous experience with targeted agents carries important lessons for more recently developed agents, which are increasingly used. The oncology community needs to place greater emphasis on an awareness
Cork University Hospital, Cork, Ireland
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST
The author(s) indicated no potential conflicts of interest. REFERENCES 1. Schnipper LE, Lyman GH, Blayney DW et al: American Society of Clinical Oncology 2013 top five list in oncology. J Clin Oncol 31:4362-4370, 2013 2. Allred DC: Commentary: Hormone receptor testing in breast cancer—A distress signal from Canada. Oncologist 13:1134-1136, 2008 3. Rhodes A, Jasani B, Balaton AJ, et al: Study of interlaboratory reliability and reproducibility of estrogen and progesterone receptor assays in Europe: Documentation of poor reliability and identification of insufficient microwave antigen retrieval time as a major contributory element of unreliable assays. Am J Clin Path 115:44-58, 2001 4. McCullough AE, Dell’Orto P, Reinholz MM, et al: Concordance of Her2 central assessment by two international central laboratories: A ring study within the framework of the adjuvant Her2 positive ALTTO trial (BIG2-06/NO63D/ EGF106708). Cancer Res 70, 2010 (suppl 2; abstr P3-10-36) 5. Warneke VS, Behrens HM, Bo¨ger C, et al: Her2/neu testing in gastric cancer: Evaluating the risk of sampling errors. Ann Oncol 24:725-733, 2013 6. Wallander ML, Geiersbach KB, Tripp SR, et al: Comparison of reverse transcription-polymerase chain reaction, immunohistochemistry, and fluorescence in situ hybridization methodologies for detection of echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase fusion-positive non-small cell lung carcinoma: Implications for optimal clinical testing. Arch Pathol Lab Med 136:796-803, 2012 7. Lanthaler AJ, Spizzo G, Mitterer M, et al: Interlaboratory comparison of K-ras testing by real time PCR and RFLP in colorectal cancer samples. Diagn Mol Pathol 20:90-93, 2011 8. 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
DOI: 10.1200/JCO.2013.54.7638; published online ahead of print at www.jco.org on July 14, 2014
■ ■ ■
2812
© 2014 by American Society of Clinical Oncology
Journal of Clinical Oncology, Vol 32, No 25 (September 1), 2014: pp 2812
Information downloaded from jco.ascopubs.org and provided by at UNIVERSITY MICHIGAN on June 26, 2015 from Copyright © 2014 American Society of Clinical Oncology. All rights reserved. 141.211.4.224
