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PARP inhibitors: the journey from research hypothesis to clinical approval
Naipal, KA and van Gent, DC, Personalized Medicine Vol. 12, No. 2, pp. 139-154, 2015.

Overview of the science and research that led to the development of PARP inhibitors as treatment for cancers in people with BRCA mutations and other genes responsible for DNA repair.

Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial.
Ledermann, J, Harter, P, Gourley, C, et al., Lancet Oncology, Vol. 15, No.8, pp. 852-862, July 2014.

Updated results from a study on lynparza (olaparib) as maintenance therapy for women with ovarian cancer.

Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomized phase 2 study.
Liu, JF, Barry, WT, Birrer, M. et al., Lancet Oncology, Vol. 15, No. 11, pp. 1207-1214, October 2014.

Phase I study looked at the combination of cediranib and olaparib vs. olaparib alone in women with recurrent ovarian cancer.

Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer
Ledermann J, et. al. N Engl J Med. Volume 366:15 (2012): 1382-1392.

Conclusion: Olaparib as maintenance treatment significantly improved progression-free survival among patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer. Interim analysis showed no overall survival benefit.

Final results of a phase 1 study of single-agent veliparib (V) in patients (pts) with either BRCA1/2-mutated cancer (BRCA+), platinum-refractory ovarian, or basal-like breast cancer (BRCA-wt)
Puhalla, S., Beumer, JH, Pahuja, S et al., Journal of Clinical Oncology, Vol. 32, No. (Suppl; abstr 2570), 2014.

Results from study of veliparib shows that the drug is well-tolerated and has activity against tumors in people with and without BRCA mutations.

First-in-human trial of novel oral PARP inhibitor BMN 673 is patients with solid tumors
De Bono, JS, Mina, LA, Gonzalez, M, et al., Journal of Clinical Oncology, Vol. 31, No. (suppl: abstr 2580), 2013.

Results from first clinical trial with talazoparib show the PARP inhibitor is well-tolerated and has anti-tumor activity.

Final results of the phase I trial of niraparib (MK4827), a PARP inhibitor incorporating proof of concept biomarker studies and expansion cohorts involving BRCA1/2 mutation carriers, sporadic ovarian, and castration resistant prostate
Michie, CO, Sandhu, SK, Schelman, WR, et al., Journal of Clinical Oncology, Vol. 31, No. (suppl: abstr 2513O), 2013.

Results of a phase I study with niraparib showed that the PARP inhibitor is active in BRCA mutation carriers with breast or ovarian cancer and in patients without mutations who had serous ovarian cancer or castration resistant prostate cancer.

Appraising iniparib, the PARP inhibitor that never was—what must we learn?
Mateo, J., Ong, M., Tan, DSP, and de Bono, JS, Nature Reviews Clinical Oncology, Vol. 10, No. 10, pp. 688-696, 2013.

Overview of the errors made in the development of iniparib as a treatment for cancer.


Failure of iniparib to inhibit poly(ADP-Ribose) polymerase in vitro.
Failure of iniparib to inhibit poly(ADP-Ribose) polymerase in vitro.
Patel AG, et. al. Clin. Cancer Res. Volume 18:6 (2012): 1655-1662.

Conclusion: While iniparib kills normal and neoplastic cells at high (>40 µM) concentrations, its effects are unlikely to reflect PARP inhibition and should not be used to guide decisions about
other PARP inhibitors.

BRCA mutation testing in determining breast cancer therapy
Smith, KL and Isaacs, C. Cancer J. 17(6):2011 Nov-Dec; Pages: 492-499.

This article reviews surgical and treatment options for management of affected BRCA mutation carriers with breast cancer.

Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer
Kaye SB, et. al. J. Clin. Oncol. Volume 30:4 (2012): 372-379.

Conclusion: The efficacy of olaparib was consistent with previous studies. However, the efficacy of PLD (Doxil) was greater than expected. Olaparib 400 mg twice per day is a suitable dose to explore in further studies in this patient population.

Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: a phase 2, multicentre, open-label, non-randomised study
Gelmon KA, et. al. Lancet Oncology. Volume 12:9 (2011): 852-861.

Conclusion: Our study suggests that olaparib is a promising treatment for women with ovarian cancer and further assessment of the drug in clinical trials is needed.

A combined analysis of outcome following breast cancer: differences in survival based on BRCA1/BRCA2 mutation status and administration of adjuvant treatment
Mark E Robson et. al. Breast Cancer Research. Volume 6:1 2004. Pages R8-R17.

Conclusion: BRCA1 mutations, but not BRCA2 mutations, are associated with reduced survival in Ashkenazi women undergoing breast-conserving treatment for invasive breast cancer, but the poor prognosis associated with germline BRCA1 mutations is mitigated by adjuvant chemotherapy.

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