The complexity of cancer chemotherapy requires pharmacists be familiar with the complicated regimens and highly toxic agents used. This column reviews various issues related to preparation, dispensing, and administration of antineoplastic therapy, and the agents, both commercially available and investigational, used to treat malignant diseases.
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References
1.
OkazakiT., HonjoT.PD-1 and PD-1 ligands: From discovery to clinical application. Int Immunol.2007; 19: 813–824.
2.
DongH., ZhuG., TamadaK.B7-H1, a third member of the B7 family, co-stimulates T-cell proliferation and interleukin-10 secretion. Nat Med.1999; 5: 1365–1369.
3.
FreemanG.J., LongA.J., IwaiY.Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member lease to negative regulation of lymphocyte activation. J Exp Med.2000; 192: 1027–1034.
TopalianS.L., SznolM., BrahmerJ.R.Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with advanced solid tumors: Survival and long-term safety in a phase 1 trial [abstract 3002]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113545-132. Accessed February 4,2015.
9.
GrossoJ., HorakC.E., InzunzaD.Association of tumor PD-L1 expression and immune biomarkers with clinical activity in patients (pts) with advanced tumors treated with nivolumab (anti-PD-1; BMS-936558; ONO-4538) [abstract 3016]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113904-132. Accessed February 4, 2015.
10.
SznolM., KlugerH.M., HodiF.S.Survival and long-term follow-up of safety and response in patients (pts) with advanced melanoma (MEL) in a phase I trial of nivolumab. (anti-PD-1; BMS-936558; ONO-4538) [abstract CRA9006]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113607-132. Accessed February 4, 2015.
11.
HodiF.S., SznolM., KlugerH.M.Long-term survival of ipilimumab-naïve patients (pts) with advanced melanoma (MEL) treated with nivolumab (anti-PD-1, BMS-936558, ONO-4538) in a phase I trial [abstract 9002. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125578-144. Accessed February 4, 2015.
12.
SangroB., CrocenziT.S., WellingT.H.Phase I escalation of nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients (pts) with advanced hepatocellular carcinoma (HCC) with or without chronic viral hepatitis [abstract TPS3111]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113499-132. Accessed February 4, 2015.
13.
PorkkaK., MauroM.J., LiptonJH.An open-label, phase Ib, dose-escalation study (CA180-373) of dasatinib plus nivolumab, an investigational anti-programmed cell death 1 (PD-1) antibody, in patients (pts) with previously treated chronic myeloid leukemia (CML) [abstract TPS7110]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/127155-144. Accessed February 4, 2015.
14.
WolchokJ.D., KlugerH.M., CallahanM.K.safety and activity of nivolumab (anti-PD1, BMS-936558, OJO-4538) in combination with ipilimumab in patients (pts) with advanced melanoma (MEL) [abstract 9012]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/107862-132. Accessed February 4, 2015.
15.
SznolM., Kluger HM CallahanM.K.Survival, response duration, and activity by BRAF mutation (MT) status of nivolumab (NIVO, anti-PD-1, BMS-936558, ONO_4538) and ipilimumab (IPI) concurrent therapy in advanced melanoma (MEL) [abstract LBA9003]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/126008-144. Accessed February 4, 2015.
16.
MotzerR.J., RiniB.I., McDermottD.F.Nivolumab for metastatic renal cell carcinoma (mRCC): Results of a randomized, dose-ranging phase II trial [abstract 5009]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125893-144. Accessed February 4, 2015.
17.
ChoueiriT.K., FishmanM.N., EscudierB.J.Immunotherapy activity of nivolumab in previously treated and untreated metastatic renal cell carcinoma (mRCC): Biomarker-based results from a randomized clinical trial [abstract 5012]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125914-144. Accessed February 4, 2015.
18.
WolchokJ.D., KlugerH., CallahanM.K.Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med.2013; 369(2): 122–133.
19.
BrahmerJ.R., TykodiS.S., ChowL.Q.M.Safety and efficacy of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med.2012; 366(26): 2455–2465.
20.
TopalianS.L., SznolM., McDermottD.E.Survival, durable tumor remission, and long-term safety in patients with advanced melanoma receiving nivolumab. J Clin Oncol.2014; 32(10): 1020–1030.
21.
HamanishiJ., MandaiM., IkedaT.Efficacy and safety of anti-PD-1 antibody (Nivolumab; BMS-936558; ONO-4538) in patients with platinum-resistant ovarian cancer [abstract 5511]. Proc Am Soc Clin Oncol.2014.). http://meetinglibrary.asco.org/content/130814-144. Accessed February 4, 2015.
22.
LesokhinA.M., GutierrezM., HalwaniA.S.A phase I dose-escalation study evaluating the effects of nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients with select relapsed or refractory hematologic malignancies [abstract TPS3113]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113548-132. Accessed February 4, 2015.
23.
GibneyG.T., WeberJ.S., KudchadkarR.R.Safety and efficacy of adjuvant anti-PD-1 therapy (nivolumab) in combination with vaccine in resected high-risk metastatic melanoma [abstract 9056]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112620-132. Accessed February 4, 2015.
24.
WeberJ.S., KudchadkarR.R., GibneyG.T.Phase I/II trial of PD-1 antibody nivolumab with peptide vaccine in patients naïve to or that failed ipilimumab [abstract 9011]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112287-132. Accessed February 4, 2015.
25.
DrakeC.G., McDermottD.E., SznolM.Survival, safety, and response duration results of nivolumab (anti-PD-1; BMS-936558; ONO-4538) in a phase I trial in patients with previously treated metastatic renal cell carcinoma (mRCC): Long term patient follow-up [abstract 4514]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113579-132. Accessed February 4, 2015.
26.
WeberJ.S., KudchadkarR.R., YuB.Safety, efficacy, and biomarkers of nivolumab with vaccine in ipilimumab-refractory or -naïve melanoma. J Clin Oncol.2013; 31(34): 4311–4318.
27.
HammersH.J., PlimackE.R., InfanteJ.R.Phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma (mRCC) [abstract 4504]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/129458-144. Accessed February 4, 2015.
28.
AntoniaS.J., GettingerS.N., ChowL.Q.M.Nivolumab (anti-PD-1; BMS-936558; Ono-4538) and ipilimumab in first-line NSCLC: Interim phase I results [abstract 8023]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125736-144. Accessed February 4, 2015.
29.
SampsonJ.H., VlahovicG., DesjardinsA.Randomized phase IIb study of nivolumab (anti-{D-1; BMS-036558; ONO-4538) alone or in combination with ipilumumab versus bevacizumab in patients (pts) with recurrent glioblastoma (GBM) [abstract YPS2101]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125698-144. Accessed February 4, 2015.
30.
CallahanM.K., BendellJ.C., ChanE.Phase I/II open-label study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) as monotherapy or combined with ipilimumab in advanced or metastatic solid tumors [abstract TPS3114]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125706-144. Accessed February 4, 2015.
31.
AminA., PlimackE.R., InfanteJ.R.Nivolumab (anti-PD-1; BMS-936558; ONO-4538) in combination with sunitinib or pazopanib in patients (pts) with metastatic renal cell carcinoma (mRCC) [abstract 5010]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125881-144. Accessed February 4, 2015.
32.
RobertC., LongG.V., BradyB.Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med.2015; 372(4): 320–330.
33.
ChowL.Q.M., GordonM.S., LoganT.F.Phase I dose escalation study of recombinant interleukin-21 (rIL-21; BMS-982470) in combination with nivolumab (anti-PD-1; BMS-936558;ONO-4538) in patients (pts) with advanced or metastatic solid tumors [abstract TPS3112]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113524-132. Accessed February 4, 2015.
34.
SosmanJ.A., Martin-AlgarraS., WolchokJ.D.An exploratory study of the biologic effects of nivolumab (anti-PD-1; BMS-936558; ONO-4538) treatment in patients (pts) with advanced (unresectable or metastatic) melanoma (MEL) [abstract TPS3114]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113623-132. Accessed February 4, 2015.
35.
MotzerR.J., BonoP., HidesG.R.A phase III comparative study of nivolumab (anti-PD-1; BMS-936558; Ono-4538) versus everolimus in patients (pts) with advanced or metastatic renal cell carcinoma (mRCC) previously treated with antiangiogenic therapy [abstract TPS4592]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113341-132 URL. Accessed February 4, 2015.
36.
RizviN.A., ChowL.Q.M., BorghaeiH.Safety and response with nivolumab (anti-PD-1; BMS-936558; ONO-4538) plus erlotinib in patients (pts) with epidermal growth factor receptor mutant (EGFR MT) advanced NSCLC [abstract 8022]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125751-144. Accessed February 4, 2015.
37.
GettingerS.N., ShepherdF.A., AntoniaS.J.First-line nivolumab (anti-PD-1; BMS-936558; ONO-4538) monotherapy in advanced NSCLC: Safety, efficacy, and correlation of outcomes with PD-L1 status [abstract 8024]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125745-144. Accessed February 4, 2015.
38.
SegalN.H., HodiS., SanbornR.E.A phase I dose escalation and cohort expansion study of lirilumab (anti-KIR; BMS-986015) in combination with nivolumab (anti-PD-1; BMS-936558; ONO-4538) in advanced solid tumors [abstract TPS3115]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125708-144. Accessed February 4, 2015.
39.
GettingerS.N., BrahmerJ.R., RizviN.A.A phase III comparative study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) versus docetaxel in patients (pts) with previously treated advances/metastatic nonsquamous non-small-cell lung cancer NSCLC) [abstract TPS8121]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112426-132. Accessed February 4, 2015.
40.
BorghaeiH., LynchT.J., RizviN.A.A phase III comparative study of nivolumab (anti-PD-1; BMS936558; Ono-4538) versus docetaxel in patients with previously treated advanced or metastatic squamous cell non-small cell lung cancer (NSCLC) [abstract TPS8122]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.Org/content/113595-132. Accessed February 4, 2015.
41.
CarboneD.P., SocinskiM.A., ChenA.C.A phase III, randomized, open-label trial of nivolumab (andi-PD-1; BMS-936558; ONO-4538) versus investigator's choice chemotherapy (ICC) as first-line therapy for stage IV or recurrent PD-L+non-small cell lung cancer (NSCLC) [abstract TPS8128]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125773-144. Accessed February 4, 2015.
42.
ChmielowskiB., HamidO., MinorD.R.A phase III open-label study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) versus investigator's choice in advanced melanoma patients progressing post anti-CTLA-4 therapy [abstract TPS9105]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112577-132. Accessed February 4, 2015.
43.
HodiF.S., BaudeletC., ChenA.C.An open-label, randomized, phase II study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) given sequentially with ipilimumab in patients (pts) with advanced or metastatic melanoma (MEL) [abstract TPS9107]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/117295-132. Accessed February 4, 2015.
44.
AnsellS.M., LesokhinA.M., BorrelloI.PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma. New Engl J Med.2015; 372(4): 311–319.
45.
RizviN.A., AntoniaS.J., ChowL.Q.M.A phase I study of nivolumab (anti-PD-1; BMS-936558; ONO-4538) plus platinum-based doublet chemotherapy (PT-doublet) chemotherapy-naïve non-small cell lung cancer (NSCLC) patients (pts) [abstract 8072]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/113504-132. Accessed February 4,2015.
46.
AntoniaS.J., BrahmerJ.R., GettingerS.N.Nivolumab (anti-PD-1; BMS-936558, ONO-4538) in combination with platinum-based doublet chemotherapy (PT-DC) in advanced non-small cell lung cancer (NSCLC) [abstract 8113]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/125962-144. Accessed February 4, 2015.
47.
ArneJ.C., SpenlehauerC., de MurciaG.The PARP super-family. Bioessays.2004; 26(8): 882–893.
48.
DantzerF., de La RubiaG., Menissier-De MurciaJ.Base excision repair is impaired in mammalian cells lacking poly(ADP-ribose) polymerase-1. Biochemistry.2000; 39(25): 7559–7569.
49.
McCabeN., TurnerN.C., LordJ.C.Deficiency in the repair of DNA damage by homologous recombination and sensitivity to poly(ADP-ribose) polymerase inhibition. Cancer Res.2006; 66(16): 8109–8115.
50.
FongP.C., BossD.S., YapT.A.Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med.2009; 361(2): 123–134.
51.
YamamotoN., NokiharaH., YamadaY.A phase I, dose-finding and pharmacokinetic study of olaparnib (AZD2281) in Japanese patients with advanced solid tumors. Cancer Sci.2012; 103(3): 504–509.
52.
Lynparza [prescribing information].Wilmington, DE: Astra-Zeneca Pharmaceuticals LP; 2014.
53.
DeanE., MiddletonM.R., PwintT.Phase I study to assess the safety and tolerability of olaparib in combination with bevacizumab in patients with advanced solid tumors. Br J Cancer.2012; 106(3): 468–474.
54.
Del ConteG., SessaC., von MoosR.Phase I study of olaparib in combination with liposomal doxorubicin in patients with advanced solid tumors. Br J Cancer.2014; 111(4): 651–659.
55.
RajanA., CarterC.A., KellyR.J.A phase I combination study of olaparnib with cisplatin and gemcitabine in adults with solid tumors. Clin Cancer Res.2012; 18(8): 2344–2351.
56.
VergoteI., RuttenA., RolfoC.D.Effect of food on the pharmacokinetics (PK) of olaparib after oral dosing of the capsule formulation [abstract 2599]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/133511-144. Accessed February 4, 2015.
57.
KahnO.A., GoreM., LoriganP.A phase I study of the safety and tolerability of olaparib (AZD2281, KU0059436) and dacarbazine in patients with advanced solid tumors. Br J Cancer.2011; 104(5): 750–755.
58.
BundredN., GardovskaJ., JaskiewiczEvaluation of the pharmacodynamics and pharmacokinetics of the PARP inhibitor olaparib: A phase I multicenter trial in patients scheduled for elective breast cancer surgery. Invest New Drugs.2013; 31(4): 949–958.
59.
SamolJ., RansonM., ScottE.Safety and tolerability of the poly(ADP-ribose) polymerase (PARP) inhibitor, olaparnib (AZD2281) in combination with topotecan for the treatment of patients with advanced solid tumors: A phase I study. Invest New Drugs.2012; 30(4): 1493–1500.
60.
BalmañaJ., TungN.M., IsakoffS.J.Phase I, open-label study of olaparib plus cisplatin in patients with advanced solid tumors [abstract 1009]. Proc Am Soc Clin Oncol.2012. http://meetinglibrary.asco.org/content/95087-114. Accessed February 4, 2015.
61.
AudehM.W., CarmichaelJ., PensonR.T.Oral poly(ADP-ribose) polymerase inhibitor olaparib in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer: a proof-of-concept trial. Lancet.2010; 376(9737): 245–251.
62.
LeeJ.M., HaysJ.L., AnnunziataC.M.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.
63.
LiuJ.E., TolaneyS.M., BirrerM.A phase 1 trial of the PARP inhibitor olaparib (AZD2281) in combination with the anti-angiogenic cedranib (AZD2171) in recurrent epithelial ovarian or triple-negative breast cancer. Eur J Cancer.2013; 49(14): 2972–2978.
64.
TuttA., RobsonM., GarberJ.E.Oral poly(ADP-ribose) polymerase inhibitor olaparnib in patients with BRCA1 or BRCA2 mutations and advanced breast cancer: A proof-of-concept trial. Lancet.2010; 376(9737): 235–244.
65.
AudehM.W., PensonR.T., FriedlanderM.Phase II trial of the oral PARP inhibitor olaparib (AZD2281) in BRCA-deficient advanced ovarian cancer [abstract 5500]. Proc Am Soc Clin Oncol.2009. http://meetinglibrary.asco.org/content/30781-65. Accessed February 4, 2015.
66.
TuttA., RobsonM., GarberJ.E.Phase II trial of the oral PARP inhibitor olaparib in BRCA-deficient advanced breast cancer [abstract CRA501]. Proc Am Soc Clin Oncol.2009. http://meetinglibrary.asco.org/content/30774-65. Accessed February 4, 2015.
67.
LeeJ., AnnunziataC.M., MinasianL.M.Phase I study of the PARP inhibitor olaparib (O) in combination with carboplatin (C) in BRCA1/2 mutation carriers with breast (Br) or ovarian (Ov) cancer (Ca) [abstract 2520]. Proc Am Soc Clin Oncol.2011. http://meetinglibrary.asco.org/content/81876-102. Accessed February 4, 2015.
68.
LiuJ., FlemingG.F., TolaneyS.M.A phase I trial of the PARP inhibitor olaparib (AZD2281) in combination with the antiangiogenic cedranib (AZD2171) in recurrent ovarian or triple-negative breast cancer [abstract 5028]. Proc Am Soc Clin Oncol.2011. http://meetinglibrary.asco.org/content/80769-102. Accessed February 4, 2015.
69.
Van derNoll, AngJ.E., JagerA.Phase I study of olaparib in combination with carboplatin and/or paclitaxel in patients with advanced solid tumors [abstract 2579]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/111375-132. Accessed February 4, 2015.
70.
MatulonisU., WulfG.M., BirrerM.J.Phase I study of oral BKM120 and oral olaparib for high-grade serous ovarian cancer (HGSC) or triple-negative breast cancer (TNBC) [abstract 2510]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/130302-144. Accessed February 4, 2015.
71.
RivkinS.E., IriarteD., SloanH.Phase Ib/II with expansion of patients at the mTD study of olaparib plus weekly (metronomic) carboplatin and paclitaxel in relapsed ovarian cancer patients [abstract 5527]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.Org/content/134486-144. Accessed February 4, 2015.
72.
CampeloR.G., FelipE., MassutiB.Phase IB study to evaluate efficacy and tolerability of olaparib (AZD2281) plus gefitinib in patients (P) with epidermal growth factor (EGFR) mutation positive advanced non-small cell lung cancer (NSCLC) (NCT=1513174/GECP-GOAL) [abstract 8079]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/133231-144. Accessed February 4, 2015.
73.
GiacconeG., Raj anA., KellyR.J.A phase I combination study of olaparib (AZD2281);KU-0059436) and cisplatin (C) plus gemcitabine (G) in adults with solid tumors [abstract 3027]. Proc Am Soc Clin Oncol.2010. http://meetinglibrary.asco.org/content/51495-74. Accessed February 4, 2015.
74.
ChalmersA.J., JacksonA., SwaislandH.Results of stage I of the oparatic trial: A phase I study of olaparib in combination with temozolomide in patients with relapsed glioblastoma [abstract 2025]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/126101-144. Accessed February 4, 2015.
75.
LeeJ., AnnunziataC.M., HaysJ.L.Phase I/Ib study of the PARP inhibitor olaparib (O) with carboplatin (C) in BRCA1/2 mutation carriers with breast or ovarian cancer (Bb/OvCa) (NCT00647062) [abstract 2514]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112646-132. Accessed February 4, 2015.
76.
BangY.J., IMS.A., LeeK.W.Olaparib plus paclitaxel in patients with recurrent or metastatic gastric cancer: A randomized double-blind phase I trial [abstract 4013]. Proc Am Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/111323-132. Accessed February 4, 2015.
77.
LiuJ.F., BarryW.T., BirrerM.Combination cediranib and olaparnib versus olaparnib alone for women with recurrent platinum-sensitive ovarian cancer: A randomised phase 2 study. Lancet Oncol.2014; 15(11): 1207–1214.
78.
MolifeL.R., MateoJ., McGoldrickT.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 [abstract 3048]. Proc Am Soc Clin Oncol.2012. http://meetinglibrary.asco.org/content/95143-114. Accessed February 4, 2015.
79.
GuptaA., MorenoV., DeanE.J.Phase I study to determine the bioavailability and tolerability of a tablet formulation of the PARP inhibitor olaparib in patients with advanced solid tumors: Dose-escalation phase [abstract 3051]. Proc Am Soc Clin Oncol.2012. http://meetinglibrary.asco.org/content/96456-114. Accessed February 4, 2015.
80.
LeeJ.M., LiuJ., ChoykeP.L.Biomarker correlates from the randomized phase 2 trial of the PARP inhibitor olaparib (O) with or without the antiangiogenic TKI cedrinib (C) in recurrent platinum-sensitive ovarian cancer (NCT01116648) [abstract 5535]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/132327-144. Accessed February 4, 2015.
81.
LiuJ., BarryW.T., BirrerM.J.A randomized phase 2 trial comparing efficacy of the combination of the PARP inhibitor olaparib and the antiangiogenic cediranib against olaparib alone in recurrent platinum-sensitive ovarian cancer [abstract LBA5500]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.org/content/130933-144. Accessed February 4, 2015.
82.
KayeS.B., LubinskiJ., MatulonisU.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.2012; 30(4): 372–379.
83.
OzaA.M., CibulaD., OakninA.Olaparib plus paclitaxel plus carboplatin (P/C) followed by olaparib maintenance treatment in patients (pts) with platinum-sensitive recurrent serous ovarian cancer (PSR SOC): A randomized, open-label phase II study [abstract 5001]. ProcAm Soc Clin Oncol.2012. http://meetinglibrary.asco.org/content/94600-114. Accessed February 4, 2015.
84.
DentR.A., LindemanG.J., ClemonsM.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.2013; 15(5): R88
85.
MassutiB., CampeloR.G., AbreuD.R.Open, phase II randomized trial of gefitinib alone versus olaparib (AZD2281) plus gefitinib in advanced non-small cell lung cancer (NSCLC) patients (P) with epidermal growth factor receptor (EGFR) mutations: Spanish Lung Cancer Group trial (NCT=1513174/GECP-GOL) [abstract TPS8127]. Proc Am Soc Clin Oncol.2014. http://meetinglibrary.asco.Org/content/134492-144. Accessed February 4, 2015.
86.
MooreK.N., DiSilvestroP., LoweE.S.SOLO1 and O-SLO2: Randomized phase III trials of olaparib in patients (pts) with ovarian cancer and a BRCA1/2 mutation (BRCAm) [abstract TPS5616]. ProcAm Soc Clin Oncol.2014). http://meetinglibrary.asco.org/content/131636-144. Accessed February 4, 2015.
87.
GelmonK.A., TischkowitzM., MackayH.Olaparib in patients with recurrent high-grade serous or poorly differentiated ovarian carcinoma or triple-negative breast cancer: A phase 2, multicenter, open-label, non-randomized study. Lancet Oncol.2011; 12(9): 852–861.
88.
LedermannJ., HarterP., GourleyC.Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med.2012; 366(15): 1382–1392.
89.
LedermannJ., HarterP., GourleyC.Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer: A preplanned retrospective analysis of outcomes by BRCA status in a randomized phase 2 trial. Lancet Oncol.2014; 15(8): 852–861.
90.
KaufmannB., Shapira-FrommerR., SchmutzlerR.K.Olaparib monotherapy in patients with advanced cancer and a germ-line BRCA1/2 mutation: An open-label phase II study [abstract 11024]. ProcAm Soc Clin Oncol.2013. http://meetinglibrary.asco.org/content/112220-132. Accessed February 4, 2015.
91.
KellyR.J., RobeyR.W., ChenC.C.A pharmacodynamics study of the P-glycoprotein antagonist CBT-1 in combination with paclitaxel in solid tumors. Oncologist.2012; 17(4): 512–e523.