A phase I study of docetaxel plus synthetic lycopene in metastatic prostate cancer patients

Michael B. Lilly , Chunli Wu , Yu Ke , Wen-Pin Chen , Adam C. Soloff , Kent Armeson , Noriko N. Yokoyama , Xiaotian Li , Liankun Song , Ying Yuan , Christine E. McLaren , Xiaolin Zi

Clinical and Translational Medicine ›› 2024, Vol. 14 ›› Issue (3) : e1627

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Clinical and Translational Medicine ›› 2024, Vol. 14 ›› Issue (3) : e1627 DOI: 10.1002/ctm2.1627
RESEARCH ARTICLE

A phase I study of docetaxel plus synthetic lycopene in metastatic prostate cancer patients

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Abstract

• The maximum tolerated dose was identified as 150 mg/day of lycopene in combination with docetaxel/ADT for the treatment of metastatic prostate cancer patients.

• Small increases in plasma exposure to docetaxel were observed with lycopene co-administration.

• Mechanistically significant effects were seen on angiogenesis and insulin-like growth factor 1 signalling by lycopene co-administration with docetaxel/ADT.

Keywords

docetaxel / lycopene / phase I trial / prostate cancer

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Michael B. Lilly, Chunli Wu, Yu Ke, Wen-Pin Chen, Adam C. Soloff, Kent Armeson, Noriko N. Yokoyama, Xiaotian Li, Liankun Song, Ying Yuan, Christine E. McLaren, Xiaolin Zi. A phase I study of docetaxel plus synthetic lycopene in metastatic prostate cancer patients. Clinical and Translational Medicine, 2024, 14(3): e1627 DOI:10.1002/ctm2.1627

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References

[1]

TannockIF, de WitR, BerryWR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.

[2]

KyriakopoulosCE, ChenYH, CarducciMA, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer: long-term survival analysis of the randomized phase III E3805 CHAARTED trial. J Clin Oncol. 2018;36:1080-1087.

[3]

FizaziK, FoulonS, CarlesJ, et al. Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomized, phase 3 study with a 2 × 2 factorial design. Lancet. 2022;399:1695-1707.

[4]

HussainM, TombalB, SaadF, et al. Darolutamide plus androgen-deprivation therapy and docetaxel in metastatic hormone-sensitive prostate cancer by disease volume and risk subgroups in the phase III ARASENS trial. J Clin Oncol. 2023;41(20):3595-3607.

[5]

CornPG, Agarwal N, AraujoJC, SonpavdeG. Taxane-based combination therapies for metastatic prostate cancer. Eur Urol Focus. 2019;5:369-380.

[6]

SerugaB, Tannock IF. Chemotherapy-based treatment for castration-resistant prostate cancer. J Clin Oncol. 2011;29:3686-3694.

[7]

BeerTM, RyanCW, VennerPM, et al. Double-blinded randomized study of high-dose calcitriol plus docetaxel compared with placebo plus docetaxel in androgen-independent prostate cancer: a report from the ASCENT investigators. J Clin Oncol. 2007;25:669-674.

[8]

Passildas-JahanmohanJ, Eymard JC, PougetM, et al. Multicenter randomized phase II study comparing docetaxel plus curcumin versus docetaxel plus placebo in first-line treatment of metastatic castration-resistant prostate cancer. Cancer Med. 2021;10:2332-2340.

[9]

MartinMP, Borchiellini D, ThamphyaB, et al. TAXOMET: a French prospective multicentric randomized phase II study of docetaxel plus metformin versus docetaxel plus placebo in metastatic castration-resistant prostate cancer. Clin Genitourin Cancer. 2021;19:501-509.

[10]

ClintonSK, Emenhiser C, SchwartzSJ, et al. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996;5:823-833.

[11]

GiovannucciE, Ascherio A, RimmEB, StampferMJ, Colditz GA, WillettWC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst 1995;87:1767-1776.

[12]

EtminanM, Takkouche B, Caamano-IsornaF. The role of tomato products and lycopene in the prevention of prostate cancer: a meta-analysis of observational studies. Cancer Epidemiol Biomarkers Prev. 2004;13:340-345.

[13]

WuK, ErdmanJW, SchwartzSJ, et al. Plasma and dietary carotenoids, and the risk of prostate cancer: a nested case-control study. Cancer Epidemiol Biomarkers Prev. 2004;13:260-269.

[14]

KirshVA, MayneST, PetersU, et al. A prospective study of lycopene and tomato product intake and risk of prostate cancer. Cancer Epidemiol Biomarkers Prev. 2006;15:92-98.

[15]

KarppiJ, KurlS, NurmiT, Rissanen TH, PukkalaE, NyyssönenK. Serum lycopene and the risk of cancer: the Kuopio Ischaemic Heart Disease Risk Factor (KIHD) study. Ann Epidemiol. 2009;19:512-518.

[16]

GiovannucciE. Does prostate-specific antigen screening influence the results of studies of tomatoes, lycopene, and prostate cancer risk? J Natl Cancer Inst. 2007;99:1060-1062.

[17]

ZuK, MucciL, RosnerBA, et al. Dietary lycopene, angiogenesis, and prostate cancer: a prospective study in the prostate-specific antigen era. J Natl Cancer Inst. 2014;106:djt430.

[18]

GiovannucciE. Commentary: serum lycopene and prostate cancer progression: a re-consideration of findings from the prostate cancer prevention trial. Cancer Causes Control. 2011;22:1055-1059.

[19]

WangY, JacobsEJ, NewtonCC, McCullough ML. Lycopene, tomato products and prostate cancer-specific mortality among men diagnosed with nonmetastatic prostate cancer in the cancer prevention study II nutrition cohort. Int J Cancer. 2016;138:2846-2855.

[20]

van BreemenRB, Sharifi R, VianaM, et al. Antioxidant effects of lycopene in African American men with prostate cancer or benign prostate hyperplasia: a randomized, controlled trial. Cancer Prev Res. 2011;4:711-718.

[21]

SchwenkeC, UbrigB, ThürmannP, EggersmannC, RothS. Lycopene for advanced hormone-refractory prostate cancer: a prospective, open phase II pilot study. J Urol. 2009;181:1098-1103.

[22]

KumarNB, Besterman-Dahan K, KangL, et al. Results of a randomized clinical trial of the action of several doses of lycopene in localized prostate cancer: administration prior to radical prostatectomy. Clin Med Urol. 2008;1:1-14.

[23]

JatoiA, BurchP, HillmanD, et al. A tomato-based, lycopene-containing intervention for androgen-independent prostate cancer: results of a phase II study from the North Central Cancer Treatment Group. Urology. 2007;69:289-294.

[24]

ClarkPE, HallMC, BordenLS, et al. Phase I-II prospective dose-escalating trial of lycopene in patients with biochemical relapse of prostate cancer after definitive local therapy. Urology. 2006;67:1257-1261.

[25]

KucukO, SarkarFH, SakrW, et al. Phase II randomized clinical trial of lycopene supplementation before radical prostatectomy. Cancer Epidemiol Biomarkers Prev. 2001;10:861-868.

[26]

ChanJM, ElkinEP, SilvaSJ, et al. Total and specific complementary and alternative medicine use in a large cohort of men with prostate cancer. Urology. 2005;66:1223-1228.

[27]

TangY, Parmakhtiar B, SimoneauAR, et al. Lycopene enhances docetaxel's effect in castration-resistant prostate cancer associated with insulin-like growth factor I receptor levels. Neoplasia. 2011;13:108-119.

[28]

WertzK, SilerU, GoralczykR. Lycopene: modes of action to promote prostate health. Arch Biochem Biophys. 2004;430:127-134.

[29]

TzelepiV, Efstathiou E, WenS, et al. Persistent, biologically meaningful prostate cancer after 1 year of androgen ablation and docetaxel treatment. J Clin Oncol. 2011;29:2574-2581.

[30]

UzohCC, HollyJM, BiernackaKM, et al. Insulin-like growth factor-binding protein-2 promotes prostate cancer cell growth via IGF-dependent or -independent mechanisms and reduces the efficacy of docetaxel. Br J Cancer. 2011;104:1587-1593.

[31]

LymanGH, AbeliaE, PettengellR. Risk factors for febrile neutropenia among patients with cancer receiving chemotherapy: a systematic review. Crit Rev Oncol Hematol. 2014;90:190-199.

[32]

O'QuigleyJ, PepeM, FisherL. Continual reassessment method: a practical design for phase I clinical trials in cancer. Biometrics. 1990;46:33-48.

[33]

YinG, YuanY. Bayesian model averaging continual reassessment method in phase I clinical trials. J Am Stat Assoc. 2009;104:954-968.

[34]

FangL, Pajkovc N, WangY, GuC, van Breemen RB. Quantitative analysis of lycopene isomers in human plasma using high-performance liquid chromatography-tandem mass spectrometry. Anal Chem. 2003;75:812-817.

[35]

ArdietCJ, Tranchand B, ZanettaS, et al. A sensitive docetaxel assay in plasma by solid-phase extraction and high performance liquid chromatography-UV detection: validation and suitability in phase I clinical trial pharmacokinetics. Invest New Drugs. 1999;17:325-333.

[36]

MariucciS, RovatiB, BencardinoK, Manzoni M, DanovaM. Flow cytometric detection of circulating endothelial cells and endothelial progenitor cells in healthy subjects. Int J Lab Hematol. 2010;32(1 pt 1):e40-e48.

[37]

R Core Team. R: A Language and Environment for Statistical Computing. Vienna, Austria: R Foundation for Statistical Computing. 2022.

[38]

LenthRV. Emmeans: Estimated Marginal Means, aka Least-Squares Means. R package version 1.8.5. 2023.

[39]

SeahTC, TayYL, TanHK, et al. Determination of CYP3A4 inducing properties of compounds using a laboratory-developed cell-based assay. Int J Toxicol. 2015;34:454-468.

[40]

PaoliniM, PoulL, BerjaudC, et al. Nano-sized cytochrome P450 3A4 inhibitors to block hepatic metabolism of docetaxel. Int J Nanomedicine. 2017;12:5537-5556.

[41]

OudardS, FizaziK, SengeløvL, et al. Cabazitaxel versus docetaxel as first-line therapy for patients with metastatic castration-resistant prostate cancer: a randomized phase III trial-FIRSTANA. J Clin Oncol. 2017;35:3189-3197.

[42]

PanX, NiuX, LiY, YaoY, HanL. Preventive mechanism of lycopene on intestinal toxicity caused by cyclophosphamide chemotherapy in mice by regulating TLR4-MyD88/TRIF-TRAF6 signaling pathway and gut-liver axis. Nutrients. 2022;14:4467.

[43]

YucelY, TaburS, GozeneliO, et al. The effects of lycopene on intestinal injury due to methotrexate in rats. Redox Rep. 2016;21:113-118.

[44]

ChenML, LinYH, YangCM, Hu ML. Lycopene inhibits angiogenesis both in vitro and in vivo by inhibiting MMP-2/uPA system through VEGFR2-mediated PI3K-Akt and ERK/p38 signaling pathways. Mol Nutr Food Res. 2012;56:889-899.

[45]

CalabreseEJ. Cancer biology and hormesis: human tumor cell lines commonly display hormetic (biphasic) dose responses. Crit Rev Toxicol. 2005;35:463-582.

[46]

AndersonLM. Cancer biology and hormesis: comments on calabrese (2005). Crit Rev Toxicol. 2005;35:583-586.

[47]

BorrielloA, Bencivenga D, CaldarelliI, et al. Resveratrol and cancer treatment: is hormesis a yet unsolved matter? Curr Pharm Des. 2013;19:5384-5393.

[48]

SessaC, Lorusso P, TolcherA, et al. Phase I safety, pharmacokinetic and pharmacodynamic evaluation of the vascular disrupting agent ombrabulin (AVE8062) in patients with advanced solid tumors. Clin Cancer Res. 2013;19:4832-4842.

[49]

AlessioAM, Beltrame MP, NascimentoMC, et al. Circulating progenitor and mature endothelial cells in deep vein thrombosis. Int J Med Sci. 2013;10:1746-1754.

[50]

GiordanoG, Napolitano M, CelluraleM, et al. Circulating endothelial cell levels correlate with treatment outcomes of splanchnic vein thrombosis in patients with chronic myeloproliferative neoplasms. J Pers Med. 2022;12:364.

[51]

GoonPK, LipGY, StonelakePS, Blann AD. Circulating endothelial cells and circulating progenitor cells in breast cancer: relationship to endothelial damage/dysfunction/apoptosis, clinicopathologic factors, and the Nottingham Prognostic Index. Neoplasia. 2009;11:771-779.

[52]

MalkaD, BoigeV, JacquesN, et al. Clinical value of circulating endothelial cell levels in metastatic colorectal cancer patients treated with first-line chemotherapy and bevacizumab. Ann Oncol. 2012;23:919-927.

[53]

BoosCJ, Balakrishnan B, BlannAD, LipGY. The relationship of circulating endothelial cells to plasma indices of endothelial damage/dysfunction and apoptosis in acute coronary syndromes: implications for prognosis. J Thromb Haemost. 2008;6:1841-1850.

[54]

ErdbrueggerU, Woywodt A, KirschT, HallerH, Haubitz M. Circulating endothelial cells as a prognostic marker in thrombotic microangiopathy. Am J Kidney Dis. 2006;48:564-570.

[55]

YuEY, LiH, HiganoCS, et al. A randomized phase II study of androgen deprivation combined with cixutumumab versus androgen deprivation alone in patients with new metastatic hormone-sensitive prostate cancer. J Clin Oncol. 2015;33:1601-1608.

[56]

MeyerHJ, WienkeA, SurovA. Incidental pulmonary embolism in oncologic patients—a systematic review and meta-analysis. Support Care Cancer. 2021;29:1293-1302.

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2024 The Authors. Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.

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