REFERENCES
1. Flohr C, Bürkle A, Radicella JP, Epe B. Poly (ADP-ribosyl) ation accelerates DNA repair in a pathway dependent on Cockayne syndrome B protein. Nucleic Acids Res 2003;31:5332-37.
2. 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;108:3406-11.
3. Couto CA, Wang HY, Green JC, Kiely R, Siddaway R, et al. PARP regulates nonhomologous end joining through retention of Ku at double-strand breaks. J Cell Biol 2011;194:367-75.
4. Konstantinopoulos PA, Ceccaldi R, Shapiro GI, D’Andrea AD. Homologous recombination deficiency: exploiting the fundamental vulnerability of ovarian cancer. Cancer Discov 2015;5:1137-54.
5. Sfeir A, Symington LS. Microhomology-mediated end joining: a back-up survival mechanism or dedicated pathway? Trends Biochem Sci 2015;40:701-14.
6. Bryant HE, Schultz N, Thomas HD, Parker KM, Flower D, et al. Specific killing of BRCA2-deficient tumours with inhibitors of poly (ADP-ribose) polymerase. Nature 2005;434:913-7.
7. Farmer H, McCabe N, Lord CJ, Tutt AN, Johnson DA, et al. Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 2005;434:917-21.
8. Durkacz BW, Omidiji O, Gray DA, Shall S. (ADP-ribose) n participates in DNA excision repair. Nature 1980;283:593-6.
9. Purnell MR, Whish WJ. Novel inhibitors of poly (ADP-ribose) synthetase. Biochem J 1980;185:775-7.
10. Calvert H, Azzariti A. The clinical development of inhibitors of poly (ADP-ribose) polymerase. Ann Oncol 2011;22:i53-9.
11. Calabrese CR, Batey MA, Thomas HD, Durkacz BW, Wang LZ, et al. Identification of potent nontoxic poly (ADP-Ribose) polymerase-1 inhibitors: chemopotentiation and pharmacological studies. Clin Cancer Res 2003;9:2711-8.
12. Plummer R1, Jones C, Middleton M, Wilson R, Evans J, et al. Phase I study of the poly (ADP-ribose) polymerase inhibitor, AG014699, in combination with temozolomide in patients with advanced solid tumors. Clin Cancer Res 2008;14:7917-7923.
13. Rottenberg S, Jaspers JE, Kersbergen A, van der Burg E, Nygren AO, 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;105:17079-84.
14. Fong PC, Yap TA, Boss DS, Carden CP, Mergui-Roelvink M, et al. Poly (ADP)-ribose polymerase inhibition: frequent durable responses in BRCA carrier ovarian cancer correlating with platinum-free interval. J Clin Oncol 2010;28:2512-9.
15. Kaye SB, Lubinski J, Matulonis U, Ang JE. 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. J Clin Oncol 2011;30:372-9.
16. Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, et al. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol 2016;140:199-203.
17. Audeh MW, Carmichael J, Penson RT, Friedlander M, Powell B, et al. Oral poly (ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. The Lancet 2010;376:245-51.
18. Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol 2014;33:244-50.
19. Kristeleit RS, Shapira-Frommer R, Oaknin A, Balmaña J, Ray-Coquard IL, et al. Clinical activity of the poly (ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with high-grade ovarian carcinoma (HGOC) and a BRCA mutation (BRCAmut): Analysis of pooled data from Study 10 (parts 1, 2a, and 3) and ARIEL2 (parts 1 and 2). Ann Oncol 2016;27:856O.
20. Kristeleit R, Shapiro GI, Burris HA, Oza AM, LoRusso P, et al. A phase I-II study of the oral PARP inhibitor rucaparib in patients with germline BRCA1/2-mutated ovarian carcinoma or other solid tumors. Clin Cancer Res 2017;23:4095-106.
21. Swisher EM, Lin KK, Oza AM, Scott CL, Giordano H, et al. Rucaparib in relapsed, platinum-sensitive high-grade ovarian carcinoma (ARIEL2 Part 1): an international, multicentre, open-label, phase 2 trial. Lancet Oncol 2017;18:75-87.
22. Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 2012;366:1382-92.
23. Mirza MR, Monk BJ, Herrstedt J, S DM, Oza AM, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med 2016;375:2154-64.
24. Coleman RL, Oza AM, Lorusso D, Aghajanian C, Oza AM, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet 2017;390:1949-61.
25. Aghajanian C, Blank SV, Goff BA, Judson PL, Teneriello MG, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012;30:2039-45.
26. Coleman RL, Brady MF, JHerzog T, Sabbatini P, ArmstrongColeman DK, et al. Bevacizumab and paclitaxel-carboplatin chemotherapy and secondary cytoreduction in recurrent, platinum-sensitive ovarian cancer (NRG Oncology/Gynecologic Oncology Group study GOG-0213): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol 2017;18:779-791.
27. Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, et al. Maintenance Olaparib in patients with newly diagnosed advanced ovarian Cancer. N Engl J Med 2018;379:2495-505.
29. Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2017;18:1274-84.
30. Liu JF, Barry WT, Birrer M, Lee JM, Buckanovich RJ, et al. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study. Lancet Oncol 2014;15:1207-14.
31. Oza AM, Cibula D, Benzaquen AO, Poole C, Mathijssen RH, et al. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial. Lancet Oncol 2015;16:87-97.
32. Konstantinopoulos PA, Waggoner SE, Vidal GA, Mita MM, Fleming GF, et al. TOPACIO/Keynote-162 (NCT02657889): A phase 1/2 study of niraparib+ pembrolizumab in patients (pts) with advanced triple-negative breast cancer or recurrent ovarian cancer (ROC)—Results from ROC cohort. J Clin Oncol 2018;36:106.
33. Robson M, Im SA, Senkus E, Xu B, Domchek SM, et al. Olaparib for metastatic breast cancer in patients with a germline BRCA mutation. N Engl J Med 2017;377:523-33.
34. Litton JK, Rugo HS, Ettl J, Hurvitz SA, Gonçalves A, et al. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med 2018;379:753-63.
35. Pahuja S, Beumer JH, Appleman LJ, Tawbi HAH, Stoller RG, et al. A phase I study of veliparib (ABT-888) in combination with weekly carboplatin and paclitaxel in advanced solid malignancies and enriched for triple-negative breast cancer (TNBC). J Clin Oncol 2015;33:1015.
36. Kummar S, Ji J, Morgan R, Lenz HJ, Puhalla SL, et al. A phase I study of veliparib in combination with metronomic cyclophosphamide in adults with refractory solid tumors and lymphomas. Clin Cancer Res 2012;18:1726-34.
37. Coleman RL, Sill MW, Bell-McGuinn K, Aghajanian C, Gray HJ, et al. A phase II evaluation of the potent, highly selective PARP inhibitor veliparib in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who carry a germline BRCA1 or BRCA2 mutation—an NRG oncology/gynecologic oncology group study. Gynecol Oncol 2015;137:386-91.
38. Murai J, Huang SY, Renaud A, Zhang Y, Ji J, et al. Stereospecific PARP trapping by BMN 673 and comparison with olaparib and rucaparib. Mol Cancer Ther 2014;13:433-43.
39. Plummer ER, Dua D, Cresti N, Suder A, Drew Y, et al. First-in-human phase 1 study of the PARP/tankyrase inhibitor 2X-121 (E7449) as monotherapy in patients with advanced solid tumors and validation of a novel drug response predictor (DRP) mRNA biomarker. J Clin Oncol 2018;36:2505.
40. Plummer R, Stephens P, Aissat-Daudigny L, Cambois A, Moachon G, et al. Phase 1 dose-escalation study of the PARP inhibitor CEP-9722 as monotherapy or in combination with temozolomide in patients with solid tumors. Cancer Chemoth Pharm 2014;74:257-65.
41. Awada A, Campone M, Varga A, Aftimos P, Frenel JS, et al. An open-label, dose-escalation study to evaluate the safety and pharmacokinetics of CEP-9722 (a PARP-1 and PARP-2 inhibitor) in combination with gemcitabine and cisplatin in patients with advanced solid tumors. Anti-cancer Drugs 2016;27:342-8.
42. O’Shaughnessy J, Schwartzberg L, Danso MA, Miller KD, Rugo HS, 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 2014;32:3840-7.
43. Patel AG, De Lorenzo SB, Flatten KS, Poirier GG, Kaufmann SH. Failure of iniparib to inhibit poly(ADP-Ribose) polymerase in vitro. Clin Cancer Res 2012;18:1655-62.
44. Gagné JP, Isabelle M, Lo KS, Bourassa S, Hendzel MJ, et al. Proteome-wide identification of poly(ADP-ribose) binding proteins and poly(ADP-ribose)-associated protein complexes. Nucleic Acids Res 2008;36:6959-76.
45. El-Khamisy SF, Masutani M, Suzuki H, Caldecott KW. A requirement for PARP-1 for the assembly or stability of XRCC1 nuclear foci at sites of oxidative DNA damage. Nucleic Acids Res 2003;31:5526-33.
46. Ceccaldi R, Liu JC, Amunugama R, Hajdu I, Primack B, et al. Homologous-recombination-deficient tumours are dependent on Polθ-mediated repair. Nature 2015;518:258-62.
47. Mateos-Gomez PA, Gong F, Nair N, Miller KM, Lazzerini-Denchi E, et al. Mammalian polymerase θ promotes alternative NHEJ and suppresses recombination. Nature 2015;518:254-7.
48. Murai J, Huang SN, Das BB, Renaud A, Zhang Y, et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res 2012;72:5588-99.
49. Caldecott KW. Protein ADP-ribosylation and the cellular response to DNA strand breaks. DNA repair 2014;19:108-113.
50. Hopkins TA, Shi Y, Rodriguez LE, Solomon LR, Donawho CK, et al. Mechanistic Dissection of PARP1 Trapping and the Impact on In Vivo Tolerability and Efficacy of PARP Inhibitors. Mol Cancer Res 2015;13:1465-77.
51. Hopkins TA, Ainsworth WB, Ellis PA, Donawho CK, DiGiammarino EL, et al. PARP1 Trapping by PARP Inhibitors Drives Cytotoxicity in Both Cancer Cells and Healthy Bone Marrow. Mol Cancer Res 2019;17:409-419.
52. Grundy GJ, Polo LM, Zeng Z, Rulten SL, Hoch NC, et al. PARP3 is a sensor of nicked nucleosomes and monoribosylates histone H2B(Glu2). Nat Commun 2016;7:12404.
53. Knezevic CE, Wright G, Rix LLR, Kim W, Kuenzi BM, et al. Proteome-wide Profiling of Clinical PARP Inhibitors Reveals Compound-Specific Secondary Targets. Cell Chem Biol 2016;23:1490-1503.
54. Puhalla S, Beumer JH, Pahuja S, Appleman LJ, Tawbi HAH, et al. 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). J Clin Oncol 2014;32:2570.
55. Li J, Kim S, Sha X, Wiegand R, Wu J, et al. Complex disease-, gene-, and drug-drug interactions: impacts of renal function, CYP2D6 phenotype, and OCT2 activity on veliparib pharmacokinetics. Clin Cancer Res 2014;20:3931-44.
56. Norquist B, Wurz KA, Pennil CC, Garcia R, Gross J, et al. Secondary somatic mutations restoring BRCA1/2 predict chemotherapy resistance in hereditary ovarian carcinomas. J Clin Oncol 2011;29:3008-15.
57. Barber LJ, Sandhu S, Chen L, Campbell J, Kozarewa I, et al. Secondary mutations in BRCA2 associated with clinical resistance to a PARP inhibitor. J Pathol 2013;229:422-9.
58. Kondrashova O, Nguyen M, Shield-Artin K, Tinker AV, Teng NNH, et al. Secondary Somatic Mutations Restoring RAD51C and RAD51D Associated with Acquired Resistance to the PARP Inhibitor Rucaparib in High-grade ovarian carcinoma. Cancer Discov 2017;7:984-998.
59. Goodall J, Mateo J, Yuan W, Mossop H, Porta N, et al. Circulating cell-free DNA to guide prostate cancer treatment with PARP inhibition. Cancer Discov 2017;7:1006-17.
60. Quigley D, Alumkal JJ, Wyatt AW, Kothari V, Foye A, et al. Analysis of Circulating Cell-Free DNA Identifies Multiclonal Heterogeneity of BRCA2 Reversion Mutations Associated with Resistance to PARP Inhibitors. Cancer Discov 2017;7:999-1005.
61. Isono M, Niimi A, Oike T, Hagiwara Y, Sato H, et al. BRCA1 Directs the Repair Pathway to Homologous Recombination by Promoting 53BP1 Dephosphorylation. Cell Rep 2017;18:520-32.
62. Bunting SF, Callén E, Wong N, Chen HT, Polato F, et al. 53BP1 inhibits homologous recombination in Brca1-deficient cells by blocking resection of DNA breaks. Cell 2010;141:243-54.
63. Hurley RM, Wahner Hendrickson AE, Visscher DW, Ansell P, Harrell MI, et al. 53BP1 as a potential predictor of response in PARP inhibitor-treated homologous recombination-deficient ovarian cancer. Gynecol Oncol 2019;153:127-134.
64. Xu G, Chapman JR, Brandsma I, Yuan J, Mistrik M, et al. REV7 counteracts DNA double-strand break resection and affects PARP inhibition. Nature 2015;521:541-4.
65. Chaudhuri AR, Callen E, Ding X, Gogola E, Duarte AA, et al. Replication fork stability confers chemoresistance in BRCA-deficient cells. Nature 2016;535:382-7.
66. Hill SJ, Decker B, Roberts EA, Horowitz NS, Muto MG, et al. Prediction of DNA Repair Inhibitor Response in Short-Term Patient-Derived Ovarian Cancer Organoids. Cancer Discov 2018;8:1404-21.
67. Gogola E, Duarte AA, de Ruiter JR, Wiegant WW, Schmid JA, et al. Selective Loss of PARG Restores PARylation and Counteracts PARP Inhibitor-Mediated Synthetic Lethality. Cancer Cell 2019;35:950-952.
68. Godoy H, Mhawech-Fauceglia P, Beck A, Miller A, Lele S, et al. Expression of poly (adenosine diphosphate-ribose) polymerase and p53 in epithelial ovarian cancer and their role in prognosis and disease outcome. Int J Gynecol Pathol 2011;30:139-44.
69. Mazzotta A, Partipilo G, De Summa S, Giotta F, Simone G, et al. Nuclear PARP1 expression and its prognostic significance in breast cancer patients. Tumour Biol 2016;37:6143-53.
70. Bitler BG, Watson ZL, Wheeler LJ, Behbakht K. PARP inhibitors: Clinical utility and possibilities of overcoming resistance. Gynecol Oncol 2017;147:695-704.
71. Kondrashova O, Topp M, Nesic K, Lieschke E, Ho GY, et al. Methylation of all BRCA1 copies predicts response to the PARP inhibitor rucaparib in ovarian carcinoma. Nat Commun 2018;9:3970.
72. Neijenhuis S, Bajrami I, Miller R, Lord CJ, Ashworth A. Identification of miRNA modulators to PARP inhibitor response. DNA Repair 2013;12:394-402.
73. Do K, Wilsker D, Ji J, Zlott J, Freshwater T, et al. Phase I study of single-agent AZD1775 (MK-1775), a Wee1 kinase inhibitor, in patients with refractory solid tumors. J Clin Oncol 2015;33:3409-15.
74. Moore KN, Secord AA, Geller MA, Miller DS, Cloven NG, et al. QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received≥ 3 prior chemotherapy regimens. J Clin Oncol 2018;36:5514.
75. Jiao S, Xia W, Yamaguchi H, Wei Y, Chen MK, et al. PARP inhibitor upregulates PD-L1 expression and enhances cancer-associated immunosuppression. Clin Cancer Res 2017;23:3711-20.
76. Vinayak S, Tolaney SM, Schwartzberg LS, Mita MM, McCann GAL, et al. TOPACIO/Keynote-162: Niraparib+ pembrolizumab in patients (pts) with metastatic triple-negative breast cancer (TNBC), a phase 2 trial. J Clin Oncol 2018;36:1011.
77. Teo MY, Seier K, Ostrovnaya I, Regazzi AM, Kania BE, et al. Alterations in DNA damage response and repair genes as potential marker of clinical benefit from PD-1/PD-L1 blockade in advanced urothelial cancers. J Clin Oncol 2018;36:1685-94.
78. Nolan E, Savas P, Policheni AN, Darcy PK, Vaillant F, et al. Combined immune checkpoint blockade as a therapeutic strategy for BRCA1-mutated breast cancer. Sci Transl Med 2017;9:eaal4922.
79. Turner NC, Balmaña J, Fasching PA, Hurvitz SA, Telli ML, et al. A phase 2 study (2-stage, 2-cohort) of the oral PARP inhibitor talazoparib (BMN 673) in patients with germline BRCA mutation and locally advanced and/or metastatic breast cancer (ABRAZO). J Clin Oncol 2015;33:TPS1108.