Steven Zecola Files a Citizen’s Petition with the FDA to Halt the Use of ACT Chemotherapy for BRCA1 Breast Cancer

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Since its discovery over 18 years ago, there have been over 1000 studies published on genetic-related BRCA1 breast cancer. Nevertheless, these cancer victims continue to be lumped into a broader category of cancer patients for purposes of treatment. Based upon the current state of knowledge of this disease, Steven Zecola has filed a Petition with the Food and Drug Administration (FDA) requesting that BRCA1-related breast cancer be treated as a separate category of breast cancer and that the use of ACT chemotherapy for these cancer patients be rescinded.

The National Cancer Institute (NCI) explains that because most BRCA1-associated breast cancers are triple negative, they are usually treated with adjuvant chemotherapy. 1 The chemotherapy regime for these patients usually consists of an Anthracycline, a Cyclophosphamide and a Taxane (ACT) regimen. 2 The stated rationale for this practice is that BRCA1 mutation carriers who do not receive the chemotherapy may have a worse prognosis. 3

However, the Petitioner finds that the evidence of any benefits to BRCA1 patients from ACT chemotherapy is scanty at best.

For example, the one study cited by the NCI says: “BRCA1 mutations were independently associated with worse disease-specific survival. The poorer prognosis was not observed in women who received chemotherapy.” 4 However, upon closer inspection, the underlying facts derived from the study were:
                                                                                                     Overall Survival (10 years)

BRCA1 Patients with AT Chemotherapy                                               59%
BRCA1 Patients without Chemotherapy                             76%

Other more recent studies also claim benefits for BRCA1 cancer victims, but upon closer inspection these studies do not show any statistically significant correlation between ACT chemotherapy and the overall survival rate in this unique category of patients. And the studies do not provide the raw data for a simple statistical comparison. 5,6

Equally peculiar, a large pharmaceutical company recently ran a Phase III trial of a promising new drug for BRCA1 patients, but inexplicitly included triple negative patients without the BRCA1 mutation, and the trial failed. 7

Zecola cites research that shows that BRCA1 cancer victims have a distinct type of cancer for which better remedies are currently available to them than the generic approach derived for triple negative patients.

The Petition can be read at: http://www.regulations.gov/#!documentDetail;D=FDA-2012-P-1160-0001

The FDA is now accepting online comments from the public on the Petition at the above location.

Zecola encourages commenters to ask the FDA to gather and separately report the raw survival statistics for BRCA1 cancer victims who have and have not received ACT chemotherapy.

1.    http://www.cancer.gov/cancertopics/pdq/genetics/breast-and-ovarian/HealthProfessional/page2#Section_408

2.    See, for example, http://www.tnbcfoundation.org/State-of-the-Art%20Treatment%20for%20TNBC.pdf
3.    Ibid, note 1.
4.    Robson ME, Chappuis PO, Satagopan J, et al.: A combined analysis of outcome following breast cancer: differences in survival based on BRCA1/BRCA2 mutation status and administration of adjuvant treatment. Breast Cancer Res 6 (1): R8-R17, 2004.
5.    Arun B, Bayraktar S, Liu DD, Gutierrez Barrera AM, Atchley D, Pusztai L, Litton JK, Valero V, Meric-Bernstam F, Hortobagyi GN, Albarracin C: Response to neoadjuvant systemic therapy for breast cancer in BRCA mutation carriers and noncarriers: a single-institution experience. J Clin Oncol 2011, 29:3739-3746
6.    Gonzalez-Angulo AM, Timms KM, Liu S, Chen H, Litton JK, Potter J, Lanchbury JS, Stemke-Hale K, Hennessy BT, Arun BK, Hortobagyi GN, Do KA, Mills GB, Meric-Bernstam F: Incidence and outcome of BRCA mutations in unselected patients with triple receptor-negative breast cancer. Clin Cancer Res 2011, 17:1082-1089
7.    See, e.g., O’Shaughnessy J, Schwartzberg LS, Danso MA et al. “A randomized phase III study of Iniparib (BSI-201) in combination with gemcitabine/carboplatin (G/C) in metastatic triple-negative breast cancer (TNBC)”, presented at the 2011 annual meeting of the American Society of Clinical Oncology. Chicago, IL. June 3-7, 2011.

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Steven Zecola

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