Olaparib for the treatment of breast cancer

References

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66:7–30.
   PubMed Web of Science ®Google Scholar
• Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490:61–70.
   PubMed Web of Science ®Google Scholar
• Dawson SJ, Provenzano E, Caldas C. Triple negative breast cancers: clinical and prognostic implications. Eur J Cancer Oxf Engl 1990. 2009;45(Suppl 1):27–40.
   PubMedGoogle Scholar
• Turner N, Tutt A, Ashworth A. Hallmarks of “BRCAness” in sporadic cancers. Nat Rev Cancer. 2004;4:814–819..
   PubMed Web of Science ®Google Scholar
• Bianchini G, Balko JM, Mayer IA, et al. Triple-negative breast cancer: challenges and opportunities of a heterogeneous disease. Nat Rev Clin Oncol. 2016;13:674–690.
   PubMed Web of Science ®Google Scholar
• Dizdar O, Arslan C, Altundag K. Advances in PARP inhibitors for the treatment of breast cancer. Expert Opin Pharmacother. 2015;16:2751–2758.
   PubMed Web of Science ®Google Scholar
• Couch FJ, Nathanson KL, Offit K. Two decades after BRCA: setting paradigms in personalized cancer care and prevention. Science. 2014;343:1466–1470.
   PubMed Web of Science ®Google Scholar
• King M-C. “The race” to clone BRCA1. Science. 2014;343:1462–1465.
   PubMed Web of Science ®Google Scholar
• Lord CJ, Ashworth A. BRCAness revisited. Nat Rev Cancer. 2016;16:110–120.
   PubMed Web of Science ®Google Scholar
• Thompson D, Easton D. The genetic epidemiology of breast cancer genes. J Mammary Gland Biol Neoplasia. 2004;9:221–236.
   PubMed Web of Science ®Google Scholar
• D’Andrea AD. Susceptibility pathways in Fanconi’s anemia and breast cancer. N Engl J Med. 2010;362:1909–1919.
   PubMed Web of Science ®Google Scholar
• Penault-Llorca F, Arnould L. [Adjuvant breast cancer: which clinical and pathological characteristics in 2007?]. Bull Cancer (Paris). 2010;97:1421–1426.
   PubMed Web of Science ®Google Scholar
• Ashworth A. A synthetic lethal therapeutic approach: poly(ADP) ribose polymerase inhibitors for the treatment of cancers deficient in DNA double-strand break repair. J Clin Oncol Off J Am Soc Clin Oncol. 2008;26:3785–3790..
   PubMed Web of Science ®Google Scholar
• Murai J, Huang SN, Das BB, et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res. 2012;72:5588–5599.
   PubMed Web of Science ®Google Scholar
• Scott CL, Swisher EM, Kaufmann SH. Poly (ADP-ribose) polymerase inhibitors: recent advances and future development. J Clin Oncol Off J Am Soc Clin Oncol. 2015;33:1397–1406.
   PubMed Web of Science ®Google Scholar
• Ceccaldi R, Liu JC, Amunugama R, et al. Homologous-recombination-deficient tumours are dependent on Polθ-mediated repair. Nature. 2015;518:258–262.
   PubMed Web of Science ®Google Scholar
• O’Shaughnessy J, Osborne C, Pippen JE, et al. Iniparib plus chemotherapy in metastatic triple-negative breast cancer. N Engl J Med. 2011;364:205–214.
   PubMed Web of Science ®Google Scholar
• O’Shaughnessy J, Schwartzberg L, Danso MA, et al. Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2014;32:3840–3847.
   PubMed Web of Science ®Google Scholar
• Mateo J, Ong M, Tan DSP, et al. Appraising iniparib, the PARP inhibitor that never was – what must we learn?. Nat Rev Clin Oncol. 2013;10:688–696.
   PubMed Web of Science ®Google Scholar
• Liu X, Shi Y, Maag DX, et al. Iniparib nonselectively modifies cysteine-containing proteins in tumor cells and is not a bona fide PARP inhibitor. Clin Cancer Res Off J Am Assoc Cancer Res. 2012;18:510–523.
   PubMed Web of Science ®Google Scholar
• Fong PC, Boss DS, Yap TA, et al. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009;361:123–134.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Breast Edinb Scotl. 2014;23:489–502.
   PubMed Web of Science ®Google Scholar
• Partridge AH, Rumble RB, Carey LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol Off J Am Soc Clin Oncol. 2014;32(29):3307–3329.
   PubMed Web of Science ®Google Scholar
• Bonotto M, Gerratana L, Poletto E, et al. Measures of outcome in metastatic breast cancer: insights from a real-world scenario. Oncologist. 2014;19:608–615.
   PubMed Web of Science ®Google Scholar
• Menear KA, Adcock C, Boulter R, et al. 4-[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorobenzyl]-2H-phthalazin-1-one: a novel bioavailable inhibitor of poly(ADP-ribose) polymerase-1. J Med Chem. 2008;51:6581–6591.
   PubMed Web of Science ®Google Scholar
• Yuan Z, Chen J, Li W, et al. PARP inhibitors as antitumor agents: a patent update (2013-2015). Expert Opin Ther Pat. 2016:363–382.
   PubMed Web of Science ®Google Scholar
• Farmer H, McCabe N, Lord CJ,T, et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature. 2005;434:917–921.
   PubMed Web of Science ®Google Scholar
• Bryant HE, Schultz N, Thomas HD, et al. Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature. 2005;434:913–917.
   PubMed Web of Science ®Google Scholar
• Evers B, Drost R, Schut E, et al. Selective inhibition of BRCA2-deficient mammary tumor cell growth by AZD2281 and cisplatin. Clin Cancer Res Off J Am Assoc Cancer Res. 2008;14:3916–3925.
   PubMed Web of Science ®Google Scholar
• McLachlan J, Banerjee S. Olaparib for the treatment of epithelial ovarian cancer. Expert Opin Pharmacother. 2016;17:995–1003.
   PubMed Web of Science ®Google Scholar
• Rottenberg S, Jaspers JE, Kersbergen A, et al. High sensitivity of BRCA1-deficient mammary tumors to the PARP inhibitor AZD2281 alone and in combination with platinum drugs. Proc Natl Acad Sci U S A. 2008;105:17079–17084.
   PubMed Web of Science ®Google Scholar
• Molife LR, Mateo J, McGoldrick T, et al. Safety and efficacy results from two randomized expansions of a phase I study of a tablet formulation of the PARP inhibitor, olaparib, in ovarian and breast cancer patients with BRCA1/2 mutations. J Clin Oncol. 2012;30(suppl;abstr 3048).
   PubMed Web of Science ®Google Scholar
• Molife LR, Forster MD, Krebs M, et al. A phase I study to determine the comparative bioavailability of two different oral formulations of the PARP inhibitor, olaparib (AZD2281), in patients with advanced solid tumors. J Clin Oncol. 2010;28:15s.(suppl; abstr 2599)
   Google Scholar
• Plummer R, Swaisland H, Leunen K, et al. Olaparib tablet formulation: effect of food on the pharmacokinetics after oral dosing in patients with advanced solid tumours. Cancer Chemother Pharmacol. 2015;76:723–729.
   PubMed Web of Science ®Google Scholar
• Lee J-M, Hays JL, Annunziata CM, et al. Phase I/Ib study of olaparib and carboplatin in BRCA1 or BRCA2 mutation-associated breast or ovarian cancer with biomarker analyses. J Natl Cancer Inst. 2014;106(6): dju089.
   Google Scholar
• van der Noll R, Ang JE, Jager A, et al. Phase I study of olaparib in combination with carboplatin and/or paclitaxel in patients with advanced solid tumors. J Clin Oncol. 2013;31suppl;abstr 2579:31.
   Google Scholar
• Balmaña J, Tung NM, Isakoff SJ, et al. Phase I trial of olaparib in combination with cisplatin for the treatment of patients with advanced breast, ovarian and other solid tumors. Ann Oncol Off J Eur Soc Med Oncol. 2014;25:1656–1663.
   PubMed Web of Science ®Google Scholar
• Dent RA, Lindeman GJ, Clemons M, et al. Phase I trial of the oral PARP inhibitor olaparib in combination with paclitaxel for first- or second-line treatment of patients with metastatic triple-negative breast cancer. Breast Cancer Res BCR. 2013;15:R88.
   PubMed Web of Science ®Google Scholar
• De P, Sun Y, Carlson JH, et al. Doubling down on the PI3K-AKT-mTOR pathway enhances the antitumor efficacy of PARP inhibitor in triple negative breast cancer model beyond BRCA-ness. Neoplasia N Y N. 2014;16:43–72.
   PubMed Web of Science ®Google Scholar
• Michalarea V, Roda D, Drew Y, et al. Phase I trial combining the PARP inhibitor olaparib and AKT inhibitor AZD5363 in germline BRCA and non BRCA mutant advanced cancer patients incorporating noninvasive monitoring of cancer mutation. Cancer Res. 2016 Jul 15;76(14 Supplement):CT010-CT010.
   Google Scholar
• van der Noll R, Marchetti S, Steeghs N, et al. Long-term safety and anti-tumour activity of olaparib monotherapy after combination with carboplatin and paclitaxel in patients with advanced breast, ovarian or fallopian tube cancer. Br J Cancer. 2015;113:396–402.
   PubMed Web of Science ®Google Scholar
• Dungey FA, Löser DA, Chalmers AJ. Replication-dependent radiosensitization of human glioma cells by inhibition of poly(ADP-ribose) polymerase: mechanisms and therapeutic potential. Int J Radiat Oncol Biol Phys. 2008;72:1188–1197.
   PubMed Web of Science ®Google Scholar
• Albert JM, Cao C, Kim KW, et al. Inhibition of poly(ADP-ribose) polymerase enhances cell death and improves tumor growth delay in irradiated lung cancer models. Clin Cancer Res Off J Am Assoc Cancer Res. 2007;13:3033–3042.
   PubMed Web of Science ®Google Scholar
• Schouten PC, Dackus GMHE, Marchetti S, et al. A phase I followed by a randomized phase II trial of two cycles carboplatin-olaparib followed by olaparib monotherapy versus capecitabine in BRCA1- or BRCA2-mutated HER2-negative advanced breast cancer as first line treatment (REVIVAL): study protocol for a randomized controlled trial. Trials. 2016;17:293.
   PubMed Web of Science ®Google Scholar
• Tutt A, Robson M, Garber JE, et al. Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: a proof-of-concept trial. Lancet Lond Engl. 2010;376:235–244.
   PubMed Web of Science ®Google Scholar
• Kaufman B, Shapira-Frommer R, Schmutzler RK, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol Off J Am Soc Clin Oncol. 2015;33:244–250.
   PubMed Web of Science ®Google Scholar
• Gelmon KA, Tischkowitz M, Mackay H, et al. 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. Lancet Oncol. 2011;12:852–861.
   PubMed Web of Science ®Google Scholar
• Ledermann JA, Harter P, Gourley C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016;17:1579–1589.
   PubMed Web of Science ®Google Scholar
• Fong PC, Yap TA, Boss DS, et al. Poly(ADP)-ribose polymerase inhibition: frequent durable responses in BRCA carrier ovarian cancer correlating with platinum-free interval. J Clin Oncol Off J Am Soc Clin Oncol. 2010;28:2512–2519.
   PubMed Web of Science ®Google Scholar
• McCabe N, Turner NC, Lord CJ, et al. Deficiency in the repair of DNA damage by homologous recombination and sensitivity to poly(ADP-ribose) polymerase inhibition. Cancer Res. 2006;66:8109–8115.
   PubMed Web of Science ®Google Scholar
• Watkins J, Weekes D, Shah V, et al. Genomic complexity profiling reveals that HORMAD1 overexpression contributes to homologous recombination deficiency in triple-negative breast cancers. Cancer Discov. 2015;5:488–505.
   PubMed Web of Science ®Google Scholar
• Lord CJ, Tutt ANJ, Ashworth A. Synthetic lethality and cancer therapy: lessons learned from the development of PARP inhibitors. Annu Rev Med. 2015;66:455–470.
   PubMed Web of Science ®Google Scholar
• Montoni A, Robu M, Pouliot E, et al. Resistance to PARP-inhibitors in cancer therapy. Front Pharmacol. 2013;4:18.
   PubMed Web of Science ®Google Scholar
• Lord CJ, Ashworth A. Mechanisms of resistance to therapies targeting BRCA-mutant cancers. Nat Med. 2013;19:1381–1388.
   PubMed Web of Science ®Google Scholar
• Patel AG, Sarkaria JN, Kaufmann SH. Nonhomologous end joining drives poly(ADP-ribose) polymerase (PARP) inhibitor lethality in homologous recombination-deficient cells. Proc Natl Acad Sci U S A. 2011;108:3406–3411.
   PubMed Web of Science ®Google Scholar
• Jaspers JE, Kersbergen A, Boon U,S, et al. Loss of 53BP1 causes PARP inhibitor resistance in BRCA1-mutated mouse mammary tumors. Cancer Discov. 2013;3:68–81.
   PubMed Web of Science ®Google Scholar
• Xu G, Chapman JR, Brandsma I, et al. REV7 counteracts DNA double-strand break resection and affects PARP inhibition. Nature. 2015;521:541–544.
   PubMed Web of Science ®Google Scholar
• Murai J, Zhang Y, Morris J, et al. Rationale for poly(ADP-ribose) polymerase (PARP) inhibitors in combination therapy with camptothecins or temozolomide based on PARP trapping versus catalytic inhibition. J Pharmacol Exp Ther. 2014;349:408–416.
   PubMed Web of Science ®Google Scholar
• Berger NA. Poly(ADP-ribose) in the cellular response to DNA damage. Radiat Res. 1985;101:4–15.
   PubMed Web of Science ®Google Scholar
• Durkacz BW, Omidiji O, Gray DA, et al. (ADP-ribose)n participates in DNA excision repair. Nature. 1980;283:593–596.
   PubMed Web of Science ®Google Scholar
• Lau T, Chan E, Callow M, et al. A novel tankyrase small-molecule inhibitor suppresses APC mutation-driven colorectal tumor growth. Cancer Res. 2013;73:3132–3144.
   PubMed Web of Science ®Google Scholar
• Riffell JL, Lord CJ, Ashworth A. Tankyrase-targeted therapeutics: expanding opportunities in the PARP family. Nat Rev Drug Discov. 2012;11:923–936.
   PubMed Web of Science ®Google Scholar