Skip to main content
Top
Published in: Supportive Care in Cancer 6/2017

01-06-2017 | Original Article

Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients

Authors: Carmel Jacobs, Mark Clemons, Sasha Mazzarello, Brian Hutton, Anil A. Joy, Muriel Brackstone, Orit Freedman, Lisa Vandermeer, Mohammed Ibrahim, Dean Fergusson, John Hilton

Published in: Supportive Care in Cancer | Issue 6/2017

Login to get access

Abstract

Purpose

The optimal chemotherapy regimen for patients with early stage triple-negative breast cancer (TNBC) remains unknown. The purpose of the study is to survey physicians and breast cancer patients about preferred chemotherapy regimens for early stage TNBC and clinical trial strategies.

Methods

A standardised online questionnaire was developed and circulated to medical oncologists known to treat breast cancer. A separate questionnaire was given to patients who had received chemotherapy for breast cancer.

Results

The questionnaire was completed by 41/84 medical oncologists (48.8% response rate) and 74 patients. The most commonly used neoadjuvant and adjuvant chemotherapy regimens for TNBC were dose-dense doxorubicin and cyclophosphamide (AC)–paclitaxel (P), dose-dense AC followed by weekly P and fluorouracil, epirubicin, cyclophosphamide–docetaxel (FEC-D). The majority of medical oncologists (80%) would be willing to enrol patients in trials evaluating the most effective chemotherapy regimen for TNBC. Oncologists favoured a three arm trial design comparing currently available standard of care treatments (36%) and trials of novel or non-standard of care agents 22% (9/41). Sixty percent (41/74) of patients indicated that they would be willing to be enrolled in trials evaluating various adjuvant regimens for TNBC. Both oncologists and patients were interested in novel consent approaches such as using the integrated consent model.

Conclusion

Optimisation of chemotherapy for TNBC is an important and unmet clinical need. It is apparent that various chemotherapy regimens are used for patients with early stage TNBC. The majority of medical oncologists and patients are interested in entering trials to optimise chemotherapy choices.
Appendix
Available only for authorised users
Literature
1.
go back to reference Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S et al (2010) American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 28(16):2784–2795CrossRef Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S et al (2010) American Society of Clinical Oncology/College Of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 28(16):2784–2795CrossRef
2.
go back to reference Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ et al (2007) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 25(1):118–145CrossRef Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ et al (2007) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol Off J Am Soc Clin Oncol 25(1):118–145CrossRef
3.
go back to reference Trivers KF, Lund MJ, Porter PL, Liff JM, Flagg EW, Coates RJ et al (2009) The epidemiology of triple-negative breast cancer, including race. Cancer Causes Control: CCC 20(7):1071–1082CrossRefPubMedPubMedCentral Trivers KF, Lund MJ, Porter PL, Liff JM, Flagg EW, Coates RJ et al (2009) The epidemiology of triple-negative breast cancer, including race. Cancer Causes Control: CCC 20(7):1071–1082CrossRefPubMedPubMedCentral
4.
go back to reference Lin NU, Vanderplas A, Hughes ME, Theriault RL, Edge SB, Wong YN et al (2012) Clinicopathologic features, patterns of recurrence, and survival among women with triple-negative breast cancer in the National Comprehensive Cancer Network. Cancer 118(22):5463–5472CrossRefPubMedPubMedCentral Lin NU, Vanderplas A, Hughes ME, Theriault RL, Edge SB, Wong YN et al (2012) Clinicopathologic features, patterns of recurrence, and survival among women with triple-negative breast cancer in the National Comprehensive Cancer Network. Cancer 118(22):5463–5472CrossRefPubMedPubMedCentral
5.
go back to reference Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ et al (2006) Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA 295(14):1658–1667CrossRefPubMedPubMedCentral Berry DA, Cirrincione C, Henderson IC, Citron ML, Budman DR, Goldstein LJ et al (2006) Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA 295(14):1658–1667CrossRefPubMedPubMedCentral
6.
go back to reference Villarreal-Garza C, Khalaf D, Bouganim N, Clemons M, Pena-Curiel O, Baez-Revueltas B et al (2014) Platinum-based chemotherapy in triple-negative advanced breast cancer. Breast Cancer Res Treat 146(3):567–572CrossRefPubMed Villarreal-Garza C, Khalaf D, Bouganim N, Clemons M, Pena-Curiel O, Baez-Revueltas B et al (2014) Platinum-based chemotherapy in triple-negative advanced breast cancer. Breast Cancer Res Treat 146(3):567–572CrossRefPubMed
7.
go back to reference Khalaf D, Hilton JF, Clemons M, Azoulay L, Yin H, Vandermeer L et al (2014) Investigating the discernible and distinct effects of platinum-based chemotherapy regimens for metastatic triple-negative breast cancer on time to progression. Oncol Lett 7(3):866–870PubMedPubMedCentral Khalaf D, Hilton JF, Clemons M, Azoulay L, Yin H, Vandermeer L et al (2014) Investigating the discernible and distinct effects of platinum-based chemotherapy regimens for metastatic triple-negative breast cancer on time to progression. Oncol Lett 7(3):866–870PubMedPubMedCentral
8.
go back to reference Kassam F, Enright K, Dent R, Dranitsaris G, Myers J, Flynn C et al (2009) Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design. Clinical Breast Cancer 9(1):29–33CrossRefPubMed Kassam F, Enright K, Dent R, Dranitsaris G, Myers J, Flynn C et al (2009) Survival outcomes for patients with metastatic triple-negative breast cancer: implications for clinical practice and trial design. Clinical Breast Cancer 9(1):29–33CrossRefPubMed
10.
go back to reference Amir E, Ocana A, Freedman O, Clemons M, Seruga B (2010) Chemotherapy: dose-dense treatment for triple-negative breast cancer. Nat Rev Clin Oncol 7(2):79–80CrossRefPubMed Amir E, Ocana A, Freedman O, Clemons M, Seruga B (2010) Chemotherapy: dose-dense treatment for triple-negative breast cancer. Nat Rev Clin Oncol 7(2):79–80CrossRefPubMed
11.
go back to reference von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M et al (2014) Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncology 15(7):747–756CrossRef von Minckwitz G, Schneeweiss A, Loibl S, Salat C, Denkert C, Rezai M et al (2014) Neoadjuvant carboplatin in patients with triple-negative and HER2-positive early breast cancer (GeparSixto; GBG 66): a randomised phase 2 trial. Lancet Oncology 15(7):747–756CrossRef
12.
go back to reference Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM et al (2015) Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol Off J Am Soc Clin Oncol 33(1):13–21CrossRef Sikov WM, Berry DA, Perou CM, Singh B, Cirrincione CT, Tolaney SM et al (2015) Impact of the addition of carboplatin and/or bevacizumab to neoadjuvant once-per-week paclitaxel followed by dose-dense doxorubicin and cyclophosphamide on pathologic complete response rates in stage II to III triple-negative breast cancer: CALGB 40603 (Alliance). J Clin Oncol Off J Am Soc Clin Oncol 33(1):13–21CrossRef
13.
go back to reference Kim SY, Miller FG (2014) Informed consent for pragmatic trials—the integrated consent model. N Engl J Med 370(8):769–772CrossRefPubMed Kim SY, Miller FG (2014) Informed consent for pragmatic trials—the integrated consent model. N Engl J Med 370(8):769–772CrossRefPubMed
14.
go back to reference Hilton J, Mazzarello S, Fergusson D, Joy AA, Robinson A, Arnaout A, et al. (2016) Novel methodology for comparing standard-of-care interventions in patients with cancer. J Oncol Pract 12(12):e1016–e1024 Hilton J, Mazzarello S, Fergusson D, Joy AA, Robinson A, Arnaout A, et al. (2016) Novel methodology for comparing standard-of-care interventions in patients with cancer. J Oncol Pract 12(12):e1016–e1024
15.
go back to reference Sugarman J, Califf RM (2014) Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311(23):2381–2382CrossRefPubMed Sugarman J, Califf RM (2014) Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311(23):2381–2382CrossRefPubMed
16.
go back to reference Bouganim N, Tsvetkova E, Clemons M, Amir E (2013) Evolution of sites of recurrence after early breast cancer over the last 20 years: implications for patient care and future research. Breast Cancer Res Treat 139(2):603–606CrossRefPubMed Bouganim N, Tsvetkova E, Clemons M, Amir E (2013) Evolution of sites of recurrence after early breast cancer over the last 20 years: implications for patient care and future research. Breast Cancer Res Treat 139(2):603–606CrossRefPubMed
17.
go back to reference Ibrahim MFK MS, Hilton J, Ferguson D, Robinson A, Califaretti N, Hutton B, Vandermeer L, Clemons M (2016) A multi centre study to determine the feasibility of using an integrated consent model to compare schedules of G-CSF (filgrastim) for primary prophylaxis of chemotherapy-induced febrile neutropenia (FN) in early stage breast cancer (REaCT-G Study). 2016 CAMO Annual Scientific Meeting, Toronto, Ontario, Canada Ibrahim MFK MS, Hilton J, Ferguson D, Robinson A, Califaretti N, Hutton B, Vandermeer L, Clemons M (2016) A multi centre study to determine the feasibility of using an integrated consent model to compare schedules of G-CSF (filgrastim) for primary prophylaxis of chemotherapy-induced febrile neutropenia (FN) in early stage breast cancer (REaCT-G Study). 2016 CAMO Annual Scientific Meeting, Toronto, Ontario, Canada
18.
go back to reference Mazzarello S IM, Hilton J, Joy AA, Arnaout A, Vandermeer L, Hutton B, Fergusson D, Clemons M (2016) Feasibility of using a pragmatic trials model to compare two standard of care regimens (ciprofloxacin versus G-CSF) for primary prophylaxis of taxotere/cyclophosphamide-induced febrile neutropenia (REaCT-TC). 2016 CAMO Scientific Meeting, Toronto, Ontario, Canada Mazzarello S IM, Hilton J, Joy AA, Arnaout A, Vandermeer L, Hutton B, Fergusson D, Clemons M (2016) Feasibility of using a pragmatic trials model to compare two standard of care regimens (ciprofloxacin versus G-CSF) for primary prophylaxis of taxotere/cyclophosphamide-induced febrile neutropenia (REaCT-TC). 2016 CAMO Scientific Meeting, Toronto, Ontario, Canada
19.
go back to reference Mazzarello S FD, Arnaout A, Hilton J, Joy AA, Robinson A, Hutton B, Vandermeer L, Clemons M (2016) A novel methodology for comparing standard of care interventions in cancer patients—the Rethinking Clinical Trials (REaCT) Program. Applied Research in Cancer Control Conference 2016, Toronto, Ontario, Canada Mazzarello S FD, Arnaout A, Hilton J, Joy AA, Robinson A, Hutton B, Vandermeer L, Clemons M (2016) A novel methodology for comparing standard of care interventions in cancer patients—the Rethinking Clinical Trials (REaCT) Program. Applied Research in Cancer Control Conference 2016, Toronto, Ontario, Canada
20.
go back to reference Jacobs C, Ibrahim MF, Clemons M, Hutton B, Simos D, Caudrelier JM et al (2015) Treatment choices for patients with invasive lobular breast cancer: a doctor survey. J Eval Clin Pract 21(4):740–748CrossRefPubMed Jacobs C, Ibrahim MF, Clemons M, Hutton B, Simos D, Caudrelier JM et al (2015) Treatment choices for patients with invasive lobular breast cancer: a doctor survey. J Eval Clin Pract 21(4):740–748CrossRefPubMed
21.
go back to reference Jacobs C, Hutton B, Mazzarello S, Smith S, Joy A, Amir E et al (2015) Optimisation of steroid prophylaxis schedules in breast cancer patients receiving docetaxel chemotherapy-a survey of health care providers and patients. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer 23(11):3269–3275CrossRef Jacobs C, Hutton B, Mazzarello S, Smith S, Joy A, Amir E et al (2015) Optimisation of steroid prophylaxis schedules in breast cancer patients receiving docetaxel chemotherapy-a survey of health care providers and patients. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer 23(11):3269–3275CrossRef
22.
go back to reference Hutton B, Addison C, Mazzarello S, Joy AA, Bouganim N, Fergusson D et al (2013) De-escalated administration of bone-targeted agents in patients with breast and prostate cancer—a survey of Canadian oncologists. J Bone Oncol 2(2):77–83CrossRefPubMedPubMedCentral Hutton B, Addison C, Mazzarello S, Joy AA, Bouganim N, Fergusson D et al (2013) De-escalated administration of bone-targeted agents in patients with breast and prostate cancer—a survey of Canadian oncologists. J Bone Oncol 2(2):77–83CrossRefPubMedPubMedCentral
23.
go back to reference Hernandez Torres C, Mazzarello S, Ng T, Dranitsaris G, Hutton B, Smith S, et al. (2015) Defining optimal control of chemotherapy-induced nausea and vomiting-based on patients’ experience. Support Care Cancer 23(11):3341–3359 Hernandez Torres C, Mazzarello S, Ng T, Dranitsaris G, Hutton B, Smith S, et al. (2015) Defining optimal control of chemotherapy-induced nausea and vomiting-based on patients’ experience. Support Care Cancer 23(11):3341–3359
24.
go back to reference Dillman DA (2000) Mail and internet surveys: the tailored design method. Wiley, New York Dillman DA (2000) Mail and internet surveys: the tailored design method. Wiley, New York
25.
go back to reference ClinicalTrials.gov. A multi centre study to determine the feasibility of using an integrated consent model to compare standard of care administration schedules of G-CSF (Filgrastim) for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer (React-G Study) NCT02428114 2015 [cited 2015 December 14]. Available from: https://clinicaltrials.gov/ct2/show/NCT02428114 ClinicalTrials.gov. A multi centre study to determine the feasibility of using an integrated consent model to compare standard of care administration schedules of G-CSF (Filgrastim) for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer (React-G Study) NCT02428114 2015 [cited 2015 December 14]. Available from: https://​clinicaltrials.​gov/​ct2/​show/​NCT02428114
26.
go back to reference Dykema J, Jones NR, Piche T, Stevenson J (2013) Surveying clinicians by web: current issues in design and administration. Eval Health Prof 36(3):352–381CrossRefPubMed Dykema J, Jones NR, Piche T, Stevenson J (2013) Surveying clinicians by web: current issues in design and administration. Eval Health Prof 36(3):352–381CrossRefPubMed
27.
go back to reference Klabunde CN, Willis GB, Casalino LP (2013) Facilitators and barriers to survey participation by physicians: a call to action for researchers. Eval Health Prof 36(3):279–295CrossRefPubMed Klabunde CN, Willis GB, Casalino LP (2013) Facilitators and barriers to survey participation by physicians: a call to action for researchers. Eval Health Prof 36(3):279–295CrossRefPubMed
28.
go back to reference Fernandes R, Mazzarello S, Stober C, Vandermeer L, Dudani S, Ibrahim MF, et al. (2017) Optimal primary febrile neutropenia prophylaxis for patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer: a systematic review. Breast Cancer Res Treat 161(1):1–10 Fernandes R, Mazzarello S, Stober C, Vandermeer L, Dudani S, Ibrahim MF, et al. (2017) Optimal primary febrile neutropenia prophylaxis for patients receiving docetaxel-cyclophosphamide chemotherapy for breast cancer: a systematic review. Breast Cancer Res Treat 161(1):1–10
29.
go back to reference Mazzarello S, Clemons M, Graham ID, Jacobs C (2015) Surviving surveys. J Oncol Pract 11(1):44–46 Mazzarello S, Clemons M, Graham ID, Jacobs C (2015) Surviving surveys. J Oncol Pract 11(1):44–46
Metadata
Title
Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients
Authors
Carmel Jacobs
Mark Clemons
Sasha Mazzarello
Brian Hutton
Anil A. Joy
Muriel Brackstone
Orit Freedman
Lisa Vandermeer
Mohammed Ibrahim
Dean Fergusson
John Hilton
Publication date
01-06-2017
Publisher
Springer Berlin Heidelberg
Published in
Supportive Care in Cancer / Issue 6/2017
Print ISSN: 0941-4355
Electronic ISSN: 1433-7339
DOI
https://doi.org/10.1007/s00520-017-3580-4

Other articles of this Issue 6/2017

Supportive Care in Cancer 6/2017 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine