Safety and tolerability of etirinotecan pegol in advanced breast cancer: analysis of the randomized, phase 3 BEACON trial

SpringerPlus

Volumn 5, Issue 1, 2016, Pages

  Cortés, Javier ^a,b   Rugo, Hope S ^c   Twelves, Chris ^d   Awada, Ahmad ^e   Perez, Edith A ^f   Im, Seock Ah ^g   Zhao, Carol ^h   Hoch, Ute ^h   Tomkinson, Denise ^h   Buchanan, James ^h   Tagliaferri, Mary ^h   Hannah, Alison ⁱ   O’Shaughnessy, Joyce ^j  

^a HOSPITAL RAMÓN Y CAJAL   (Spain)

^b VALL D HEBRON UNIVERSITY HOSPITAL   (Spain)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^e JULES BORDET INSTITUTE   (Belgium)

^f MAYO CLINIC   (United States)

^g Seoul National University Hospital   (South Korea)

^h NEKTAR THERAPEUTICS   (United States)

ⁱ Consultant ^*  (United States)

^j TEXAS ONCOLOGY   (United States)

more..

Author keywords

Chemotherapy safety; Chemotherapy side effects; Etirinotecan pegol; Metastatic breast cancer

Indexed keywords

EID: 84978149875     PISSN: None     EISSN: 21931801     Source Type: Journal    
DOI: 10.1186/s40064-016-2446-4     Document Type: Article

References (14)

1. Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, Mehdi A, O’Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young DE, Zhao C, Chia YL, Hoch U, Hannah AL, Perez EA, NKTR-102 Study Group (2013) Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol 14:1216–1225. doi:10.1016/S1470-2045(13)70429-7
2. Chabot GG (1997) Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet 33(4):245–259
3. Cortes J, Awada A, Perez EA A, Rugo HS S, Twelves C, Im S-A, Zhao C, Hoch U, Ney J, Hannah AL (2015) Impact of treatment on quality of life (QOL) in the BEACON study, a randomized phase III trial of etirinotecan pegol (EP) versus treatment of physician’s choice (TPC) in patients (pts) with advanced breast cancer (aBC) whose disease has progressed following anthracycline (A), taxane (T) and capecitabine (C). https://www.sabcs.org/Portals/SABCS/Documents/SABCS-2015-Abstracts.pdf?v=5. Accessed 7 Jan 2016
4. Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, Garrett-Mayer E, Herbst RS, Lilenbaum RC, Sima C, Venook AP, Gonen M, Schilsky RL, Meropol NJ, Schnipper LE (2014) American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 32(12):1277–1280. doi:10.1200/JCO.2013.53.8009
5. Herben VM, Schellens JH, Swart M, Gruia G, Vernillet L, Beijnen JH, ten Bokkel Huinink WW (1999) Phase I and pharmacokinetic study of irinotecan administered as a low-dose, continuous intravenous infusion over 14 days in patients with malignant solid tumors. J Clin Oncol 17(6):1897–1905
6. Hoch U, Staschen C-M, Johnson R, Eldon MA (2014) Nonclinical pharmacokinetics and activity of etirinotecan pegol (NKTR-102), a long-acting topoisomerase 1 inhibitor, in multiple cancer models. Cancer Chemother Pharmacol 74:1125–1137. doi:10.1007/s00280-014-2577-7
7. Jameson GS, Hamm JT, Weiss GJ, Alemany C, Anthony S, Basche M, Ramanathan RK, Borad MJ, Tibes R, Cohn A, Hinshaw I, Jotte R, Rosen LS, Hoch U, Eldon MA, Medve R, Schroeder K, White E, Von Hoff DD (2013) Multicenter, phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of etirinotecan pegol in patients with refractory solid tumors. Clin Cancer Res 19:268–278. doi:10.1158/1078-0432.CCR-12-1201
8. Kehrer DF, Yamamoto W, Verweij J, de Jonge MJ, de Bruijn P, Sparreboom A (2000) Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies. Clin Cancer Res 6(9):3451–3458
9. Masi G, Falcone A, Di Paolo A, Allegrini G, Danesi R, Barbara C, Cupini S, Del Tacca M (2004) A phase I and pharmacokinetic study of irinotecan given as a 7-day continuous infusion in metastatic colorectal cancer patients pretreated with 5-fluorouracil or raltitrexed. Clin Cancer Res 10(5):1657–1663
10. National Comprehensive Cancer Network (2015) NCCN Clinical Practice Guidelines in Oncology: Breast Cancer, version 3. http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed 23 Oct 2015
11. Perez EA, Awada A, O’Shaughnessy J, Rugo HS, Twelves C, Im SA, Gómez-Pardo P, Schwartzberg LS, Diéras V, Yardley DA, Potter DA, Mailliez A, Moreno-Aspitia A, Ahn JS, Zhao C, Hoch U, Tagliaferri M, Hannah AL, Cortes J (2015) Etirinotecan pegol (NKTR-102) versus treatment of physician’s choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine (BEACON): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. doi:10.1016/S1470-2045(15)00332-0
12. Pitot HC, Goldberg RM, Reid JM, Sloan JA, Skaff PA, Erlichman C, Rubin J, Burch PA, Adjei AA, Alberts SA, Schaaf LJ, Elfring G, Miller LL (2000) Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy. Clin Cancer Res 6(6):2236–2244
13. Takimoto CH, Morrison G, Harold N, Quinn M, Monahan BP, Band RA, Cottrell J, Guemei A, Llorens V, Hehman H, Ismail AS, Flemming D, Gosky DM, Hirota H, Berger SJ, Berger NA, Chen AP, Shapiro JD, Arbuck SG, Wright J, Hamilton JM, Allegra CJ, Grem JL (2000) Phase I and pharmacologic study of irinotecan administered as a 96-hour infusion weekly to adult cancer patients. J Clin Oncol 18(3):659–667
14. Von Hoff DD, Jameson GS, Borad MJ, Rosen LS, Utz J, Basche M, Alemany C, Dhar S, Acosta L, Barker T, Walling J, Hamm JT (2008) First phase I trial of NKTR-102 (PEG irinotecan) reveals early evidence of broad antitumor activity in three schedules. Eur J Cancer 6:595