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Breast Cancer Research and Treatment

, Volume 165, Issue 3, pp 545–553 | Cite as

Does biomarker information impact breast cancer patients’ preferences and physician recommendation for adjuvant chemotherapy?

  • Ann H. PartridgeEmail author
  • Karen Sepucha
  • Anne O’Neill
  • Kathy D. Miller
  • Emily Baker
  • Chau T. Dang
  • Donald W. Northfelt
  • George W. Sledge
  • Bryan P. Schneider
Clinical trial

Abstract

Purpose

This study aimed to examine how biomarker information would impact patients’ preferences and physicians’ recommendations for adjuvant breast cancer therapy.

Methods

At the 18-month follow-up, participants in a large, double-blind randomized controlled trial of adjuvant chemotherapy with bevacizumab or placebo (E5103) were surveyed about their preferred treatment (either chemotherapy A alone or chemotherapy A+B) in two hypothetical scenarios: (1) without biomarker information; and (2) after learning that they tested positive for a “B-receptor” which modestly increased both the benefit and toxicity expected with chemotherapy A+B. We performed a cross-sectional analysis of the prospectively collected survey data and used the McNemar’s test to examine changes in treatment preferences. A one-time survey of clinical investigators who enrolled patients on the trial evaluated physician recommendations in response to the same biomarker information.

Results

439 patients completed both scenarios on 18-month survey. Most participants preferred A+B in both scenario 1 and 2 (77 and 76% respectively). The increase in benefit and toxicity associated with the positive biomarker information in scenario 2 led 60/439 (14%) of patients to switch their treatment preference. The corresponding physician survey revealed that most physicians chose regimen A+B in scenario 1 (77%), and moreso after the biomarker information was available in scenario 2 (84%).

Conclusions

Information about a positive biomarker indicating increased benefit and toxicity from additional chemotherapy did not change many participants’ preferred treatment. The majority preferred the most effective course in both scenarios. Similarly, most investigators discounted increased toxicity and valued increased benefit. Parent Trial Registration: NCT00433511

Keywords

Breast cancer Biomarkers Patient preferences Adjuvant therapy Risk Toxicity 

Notes

Funding

This study was coordinated by the ECOG-ACRIN Cancer Research Group (Robert L. Comis, MD and Mitchell D. Schnall, MD, PhD, Group Co-Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA21115, CA180794, CA23318, CA66636, CA025224, CA031946, CA077651, CA180821, CA180790, CA13650, CA180791, CA180795, CA49883, CA180816, CA180867. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government. Also supported by a Susan G. Komen for the Cure, Promise Award (Bryan P. Schneider).

Compliance with ethical standards

Conflict of interest

Ann Partridge declares that she has no conflict of interest. Karen Sepucha declares that she has no conflict of interest. Anne O’Neill declares that she has no conflict of interest. Kathy D. Miller declares that she has no conflict of interest. Emily Baker declares that she has no conflict of interest. Chau T. Dang reports funding from Roche/Genentech. Donald W. Northfelt declares that he has no conflict of interest. George W. Sledge declares that he has no conflict of interest. Bryan P. Schneider declares that he has no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

References

  1. 1.
    Schneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD (2008) Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol 26:4672–4678. doi: 10.1200/JCO.2008.16.1612 CrossRefPubMedPubMedCentralGoogle Scholar
  2. 2.
    Schneider BP, Gray RJ, Radovich M, Shen F, Vance G, Li L, Jiang G, Miller KD, Gralow JR, Dickler MN, Cobleigh MA, Perez EA, Shenkier TN, Vang Nielsen K, Muller S, Thor A, Sledge GW Jr, Sparano JA, Davidson NE, Badve SS (2013) Prognostic and predictive value of tumor vascular endothelial growth factor gene amplification in metastatic breast cancer treated with paclitaxel with and without bevacizumab; results from ECOG 2100 trial. Clin Cancer Res 19:1281–1289. doi: 10.1158/1078-0432.CCR-12-3029 CrossRefPubMedPubMedCentralGoogle Scholar
  3. 3.
    Collins FS, Varmus H (2015) A new initiative on precision medicine. N Engl J Med 372:793–795. doi: 10.1056/NEJMp1500523 CrossRefPubMedPubMedCentralGoogle Scholar
  4. 4.
    Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM, Hammond EH, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Bast RC, Hayes DF (2016) Use of biomarkers to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 34:1134–1150. doi: 10.1200/JCO.2015.65.2289 CrossRefPubMedPubMedCentralGoogle Scholar
  5. 5.
    Duffy MJ, Sturgeon CM, Soletormos G, Barak V, Molina R, Hayes DF, Diamandis EP, Bossuyt PM (2015) Validation of new cancer biomarkers: a position statement from the European group on tumor markers. Clin Chem 61:809–820. doi: 10.1373/clinchem.2015.239863 CrossRefPubMedGoogle Scholar
  6. 6.
    Precision Medicine Initiative Cohort Program. http://www.nih.gov/precisionmedicine/. Accessed June 14 2015
  7. 7.
    Nalejska E, Maczynska E, Lewandowska MA (2014) Prognostic and predictive biomarkers: tools in personalized oncology. Mol Diagn Ther 18:273–284. doi: 10.1007/s40291-013-0077-9 CrossRefPubMedPubMedCentralGoogle Scholar
  8. 8.
    Yusuf RA, Rogith D, Hovick SR, Peterson SK, Burton-Chase AM, Fellman BM, Li Y, McKinney C, Bernstam EV, Meric-Bernstam F (2015) Attitudes toward molecular testing for personalized cancer therapy. Cancer 121:243–250. doi: 10.1002/cncr.28966 CrossRefPubMedGoogle Scholar
  9. 9.
    Ngoi N, Lee SC, Hartman M, Khin LW, Wong A (2013) Interest and attitudes of patients, cancer physicians, medical students and cancer researchers towards a spectrum of genetic tests relevant to breast cancer patients. Breast 22:47–52. doi: 10.1016/j.breast.2012.04.003 CrossRefPubMedGoogle Scholar
  10. 10.
    Leggett LE, Lorenzetti DL, Noseworthy T, Tiwana S, Mackean G, Clement F (2014) Experiences and attitudes toward risk of recurrence testing in women with breast cancer: a systematic review. Breast Cancer Res Treat 144:457–465. doi: 10.1007/s10549-014-2900-3 CrossRefPubMedGoogle Scholar
  11. 11.
    Brewer NT, Edwards AS, O’Neill SC, Tzeng JP, Carey LA, Rimer BK (2009) When genomic and standard test results diverge: implications for breast cancer patients’ preference for chemotherapy. Breast Cancer Res Treat 117:25–29. doi: 10.1007/s10549-008-0175-2 CrossRefPubMedGoogle Scholar
  12. 12.
    Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A, Albain KS (2010) Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol 28:1671–1676. doi: 10.1200/JCO.2008.20.2119 CrossRefPubMedGoogle Scholar
  13. 13.
    Britton A, McKee M, Black N, McPherson K, Sanderson C, Bain C (1999) Threats to applicability of randomised trials: exclusions and selective participation. J Health Serv Res Policy 4:112–121CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2017

Authors and Affiliations

  • Ann H. Partridge
    • 1
    • 2
    Email author
  • Karen Sepucha
    • 2
    • 3
  • Anne O’Neill
    • 1
  • Kathy D. Miller
    • 4
  • Emily Baker
    • 1
  • Chau T. Dang
    • 5
  • Donald W. Northfelt
    • 6
  • George W. Sledge
    • 4
    • 7
  • Bryan P. Schneider
    • 4
  1. 1.Dana-Farber Cancer InstituteBostonUSA
  2. 2.Harvard Medical SchoolBostonUSA
  3. 3.Massachusetts General HospitalBostonUSA
  4. 4.Indiana University Melvin and Bren Simon Cancer CenterIndianapolisUSA
  5. 5.Memorial Sloan Kettering Cancer CenterNew YorkUSA
  6. 6.Mayo ClinicScottsdaleUSA
  7. 7.Stanford UniversityStanfordUSA

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