A phase i trial of pegylated liposomal doxorubicin (PLD), carboplatin, bevacizumab and veliparib in recurrent, platinum-sensitive ovarian, primary peritoneal, and fallopian tube cancer: An NRG Oncology/Gynecologic Oncology Group study

Gynecologic Oncology

Volumn 140, Issue 2, 2016, Pages 204-209

  Landrum, Lisa M ^a   Brady, William E ^b   Armstrong, Deborah K ^c   Moore, Kathleen N ^a   Disilvestro, Paul A ^d   O'Malley, David M ^e   Tenney, Meaghan E ^f   Rose, Peter G ^g   Fracasso, Paula M ^h,i  

^a UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

^b Buffalo Niagara Enterprise   (United States)

^c JOHNS HOPKINS UNIVERSITY   (United States)

^d WOMEN AND INFANTS HOSPITAL   (United States)

^e OHIO STATE UNIVERSITY   (United States)

^f UNIVERSITY OF CHICAGO   (United States)

^g LERNER RESEARCH INSTITUTE   (United States)

^h UNIVERSITY OF VIRGINIA   (United States)

ⁱ BRISTOL MYERS SQUIBB   (United States)

Author keywords

PARP inhibitors; Thrombocytopenia; VEGF inhibitors

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; DOXORUBICIN; VELIPARIB; ANTINEOPLASTIC AGENT; BENZIMIDAZOLE DERIVATIVE; MACROGOL DERIVATIVE;

ADULT; AGED; ARTICLE; ASCITES; BONE MARROW SUPPRESSION; CLINICAL ARTICLE; DRUG DOSE ESCALATION; DRUG TOLERABILITY; DYSPNEA; FALLOPIAN TUBE CANCER; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERTENSION; HYPONATREMIA; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVARY CANCER; OVARY CARCINOMA; PERITONEUM CANCER; PHASE 1 CLINICAL TRIAL; PLATINUM SENSITIVE OVARIAN CANCER; PRIMARY PERITONEAL CANCER; PRIORITY JOURNAL; SEPSIS; THROMBOCYTOPENIA; UTERINE TUBE CARCINOMA; VERY ELDERLY; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; FALLOPIAN TUBE NEOPLASMS; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; TUMOR RECURRENCE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZIMIDAZOLES; BEVACIZUMAB; CARBOPLATIN; DOSE-RESPONSE RELATIONSHIP, DRUG; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FALLOPIAN TUBE NEOPLASMS; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; POLYETHYLENE GLYCOLS;

EID: 84961155071     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2015.11.024     Document Type: Article

References (30)

1. R.L. Siegel, K.D. Miller, and A. Jemal Cancer statistics, 2015 CA Cancer J. Clin. 65 1 2015 Jan 5 29
2. M. Markman, R. Rothman, T. Hakes, B. Reichman, W. Hoskins, S. Rubin, and et al. Second-line platinum therapy in patients with ovarian cancer previously treated with cisplatin J. Clin. Oncol. 9 3 1991 Mar 389 393
3. M. Markman, J. Markman, K. Webster, K. Zanotti, B. Kulp, G. Peterson, and et al. Duration of response to second-line, platinum-based chemotherapy for ovarian cancer: implications for patient management and clinical trial design J. Clin. Oncol. 22 15 2004 Aug 1 3120 3125
4. J. Pfisterer, M. Plante, I. Vergote, A. du Bois, H. Hirte, A.J. Lacave, and et al. Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG J. Clin. Oncol. 24 29 2006 Oct 10 4699 4707
5. E. Pujade-Lauraine, U. Wagner, E. avall-Lundqvist, V. Gebski, M. Heywood, P.A. Vasey, and et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse J. Clin. Oncol. 28 20 2010 Jul 10 3323 3329
6. M.K. Parmar, J.A. Ledermann, N. Colombo, A. du Bois, J.F. Delaloye, G.B. Kristensen, and et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial Lancet 361 9375 2003 Jun 21 2099 2106
7. P.C. Fong, D.S. Boss, T.A. Yap, A. Tutt, P. Wu, M. Mergui-Roelvink, and et al. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers N. Engl. J. Med. 361 2 2009 Jul 9 123 134
8. P.C. Fong, T.A. Yap, D.S. Boss, C.P. Carden, M. Mergui-Roelvink, C. Gourley, and et al. Poly(ADP)-ribose polymerase inhibition: frequent durable responses in BRCA carrier ovarian cancer correlating with platinum-free interval J. Clin. Oncol. 28 15 2010 May 20 2512 2519
9. J.H. Hoeijmakers Genome maintenance mechanisms for preventing cancer Nature 411 6835 2001 May 17 366 374
10. A.J. Chalmers The potential role and application of PARP inhibitors in cancer treatment Br. Med. Bull. 89 2009 23 40
11. E. Bolderson, D.J. Richard, B.B. Zhou, and K.K. Khanna Recent advances in cancer therapy targeting proteins involved in DNA double-strand break repair Clin. Cancer Res. 15 20 2009 Oct 15 6314 6320
12. A. Ashworth 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. 26 22 2008 Aug 1 3785 3790
13. C.K. Donawho, Y. Luo, Y. Luo, T.D. Penning, J.L. Bauch, J.J. Bouska, and et al. ABT-888, an orally active poly(ADP-ribose) polymerase inhibitor that potentiates DNA-damaging agents in preclinical tumor models Clin. Cancer Res. 13 9 2007 May 1 2728 2737
14. N.J. Curtin, and C. Szabo Therapeutic applications of PARP inhibitors: anticancer therapy and beyond Mol. Asp. Med. 34 6 2013 Dec 1217 1256
15. L. Tentori, P.M. Lacal, A. Muzi, A.S. Dorio, C. Leonetti, M. Scarsella, and et al. Poly(ADP-ribose) polymerase (PARP) inhibition or PARP-1 gene deletion reduces angiogenesis Eur. J. Cancer 43 14 2007 Sep 2124 2133
16. R.S. Bindra, S.L. Gibson, A. Meng, U. Westermark, M. Jasin, A.J. Pierce, and et al. Hypoxia-induced down-regulation of BRCA1 expression by E2Fs Cancer Res. 65 24 2005 Dec 15 11597 11604
17. J.J. Lim, K. Yang, B. Taylor-Harding, W.R. Wiedemeyer, and R.J. Buckanovich VEGFR3 inhibition chemosensitizes ovarian cancer stemlike cells through down-regulation of BRCA1 and BRCA2 Neoplasia 16 4 2014 Apr 343 353
18. E. Pujade-Lauraine, F. Hilpert, B. Weber, A. Reuss, A. Poveda, G. Kristensen, and et al. Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: the AURELIA open-label randomized phase III trial J. Clin. Oncol. 32 13 2014 May 1 1302 1308
19. C. Aghajanian, S.V. Blank, B.A. Goff, P.L. Judson, M.G. Teneriello, A. Husain, and 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. 30 17 2012 Jun 10 2039 2045
20. E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, and et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) Eur. J. Cancer 45 2 2009 Jan 228 247
21. U. Wagner, C. Marth, R. Largillier, J. Kaern, C. Brown, M. Heywood, and et al. Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients Br. J. Cancer 107 4 2012 Aug 7 588 591
22. M. Brundage, M. Gropp, F. Mefti, K. Mann, B. Lund, V. Gebski, and et al. Health-related quality of life in recurrent platinum-sensitive ovarian cancer-results from the CALYPSO trial Ann. Oncol. 23 8 2012 Aug 2020 2027
23. J. Ledermann, P. Harter, C. Gourley, M. Friedlander, I. Vergote, G. Rustin, and et al. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer N. Engl. J. Med. 366 15 2012 Apr 12 1382 1392
24. J. Ledermann, P. Harter, C. Gourley, M. Friedlander, I. Vergote, G. Rustin, and et al. Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial Lancet Oncol. 15 8 2014 Jul 852 861
25. J.F. Liu, W.T. Barry, M. Birrer, J.M. Lee, R.J. Buckanovich, G.F. Fleming, and et al. Combination cediranib and olaparib versus olaparib alone for women with recurrent platinum-sensitive ovarian cancer: a randomised phase 2 study Lancet Oncol. 15 11 2014 Oct 1207 1214
26. A.M. Oza, D. Cibula, A.O. Benzaquen, C. Poole, R.H. Mathijssen, G.S. Sonke, and et al. Olaparib combined with chemotherapy for recurrent platinum-sensitive ovarian cancer: a randomised phase 2 trial Lancet Oncol. 16 1 2015 Jan 87 97
27. K. Alsop, S. Fereday, C. Meldrum, A. DeFazio, C. Emmanuel, J. George, and et al. BRCA mutation frequency and patterns of treatment response in BRCA mutation-positive women with ovarian cancer: a report from the Australian Ovarian Cancer Study Group J. Clin. Oncol. 30 21 2012 Jul 20 2654 2663
28. K.P. Pennington, T. Walsh, M.I. Harrell, M.K. Lee, C.C. Pennil, M.H. Rendi, and et al. Germline and somatic mutations in homologous recombination genes predict platinum response and survival in ovarian, fallopian tube, and peritoneal carcinomas Clin. Cancer Res. 20 3 2014 Feb 1 764 775
29. C.S. Walsh Two decades beyond BRCA1/2: homologous recombination, hereditary cancer risk and a target for ovarian cancer therapy Gynecol. Oncol. 137 2 2015 May 343 350
30. M.G. Del Carmen, J. Micha, L. Small, D.G. Street, A. Londhe, and T. McGowan A phase II clinical trial of pegylated liposomal doxorubicin and carboplatin plus bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer Gynecol. Oncol. 126 3 2012 Sep 369 374