Enhancing accrual to chemotherapy trials for patients with early stage triple-negative breast cancer: a survey of physicians and patients
- 238 Downloads
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.
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.
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.
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.
KeywordsBreast cancer Triple negative Trial design Chemotherapy
Compliance with ethical standards
Local research ethics board approval was obtained from the Ottawa Health Science Network Research Ethics Board for both surveys.
Conflict of interest
The authors declare that they have no conflict of interest.
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.
- 1.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):2784–2795CrossRefGoogle Scholar
- 2.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):118–145CrossRefGoogle Scholar
- 4.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):5463–5472CrossRefPubMedPubMedCentralGoogle Scholar
- 9.NCCN Clinical Practice Guidelines. 2014 [cited 2015 September 16]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- 12.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):13–21CrossRefGoogle Scholar
- 14.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–e1024Google Scholar
- 17.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, CanadaGoogle Scholar
- 18.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, CanadaGoogle Scholar
- 19.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, CanadaGoogle Scholar
- 21.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):3269–3275CrossRefGoogle Scholar
- 23.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):3341–3359Google Scholar
- 24.Dillman DA (2000) Mail and internet surveys: the tailored design method. Wiley, New YorkGoogle Scholar
- 25.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
- 28.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):1–10Google Scholar
- 29.Mazzarello S, Clemons M, Graham ID, Jacobs C (2015) Surviving surveys. J Oncol Pract 11(1):44–46Google Scholar