Randomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer

Ignace B Vergote; Agustin Garcia; John Micha; Charles Pippitt; Johanna Bendell; Daniel Spitz; Nicholas Reed; Graham Dark; Paula M Fracasso; Emad N Ibrahim; Vincent A Armenio; Linda Duska; Chris Poole; Christine Gennigens; Luc Y Dirix; Abraham C.F Leung; Carol Zhao; Raoudha Soufi-Mahjoubi; Gordon Rustin

doi:10.1200/JCO.2012.45.1278

$Randomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer$

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Randomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer

Ignace B Vergote, Agustin Garcia, John Micha, Charles Pippitt, Johanna Bendell, Daniel Spitz, Nicholas Reed, Graham Dark, Paula M Fracasso, Emad N Ibrahim, …

Journal of clinical oncology, Vol.31(32), pp.4060-4066

2013-11-10

DOI: https://doi.org/10.1200/JCO.2012.45.1278

PMCID: PMC4878105

PMID: 24081946

Abstract

Purpose Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan. This randomized phase II trial investigated two dosing schedules of etirinotecan pegol in patients with platinum-resistant/refractory ovarian carcinoma. Patients and Methods A total of 71 eligible patients were randomly assigned to receive etirinotecan pegol 145 mg/m2 every 14 or 21 days until progression or unacceptable adverse events (AEs). The primary end point was objective response rate (ORR) by RECIST (version 1.0). Secondary end points included response by Gynecologic Cancer Intergroup criteria, duration of ORR, progression-free survival (PFS), and overall survival (OS). Results The overall confirmed ORR was 20% (95% CI, 10% to 30%): 20% for once every 14 days, and 19% for once every 21 days. Median response duration was 4.1 months for once every 14 days and 4.0 months for once every 21 days. Median PFS for every 14 and every 21 days was 4.1 and 5.3 months, respectively, and median OS was 10.0 and 11.7 months, respectively. Etirinotecan pegol was well tolerated, with the most common grade 3 to 4 AEs being dehydration (24%) and diarrhea (23%). Diarrhea, dehydration, nausea, and neutropenia were less frequent with the schedule of once every 21 days than with that of once every 14 days. Conclusion Both schedules of etirinotecan pegol showed activity in patients with heavily pretreated ovarian cancer, with encouraging ORR and PFS rates. The schedule of once every 21 days was better tolerated and had slightly longer PFS and OS rates. The treatment schedule of etirinotecan pegol 145 mg/m2 once every 21 days was selected for the expanded phase II study and is preferred for future phase III studies. These findings provide support to directly compare etirinotecan pegol versus one of the approved drugs (eg, pegylated liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer.

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.128 Fertility, Endometriosis & Hysterectomy; 1.128.390 Ovarian Cancer
Web Of Science research areas: Oncology
ESI research areas: Clinical Medicine

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Title: Randomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer
Creators: Ignace B Vergote - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Agustin Garcia - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
John Micha - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Charles Pippitt - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Johanna Bendell - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Daniel Spitz - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Nicholas Reed - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Graham Dark - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Paula M Fracasso - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Emad N Ibrahim - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Vincent A Armenio - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Linda Duska - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Chris Poole - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Christine Gennigens - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Luc Y Dirix - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Abraham C.F Leung - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Carol Zhao - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Raoudha Soufi-Mahjoubi - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Gordon Rustin - Ignace B. Vergote, University Hospital Leuven, Leuven; Christine Gennigens, Centre Hospitalier Universitaire de Liège, Liège; Luc Y. Dirix, Gasthuis Zusters Antwerpen, Antwerp, Belgium; Agustin Garcia, University of Southern California Norris Comprehensive Cancer Center and Hospital, Los Angeles; John Micha, Gynecologic Oncology Associates, Newport Beach; Emad N. Ibrahim, Beaver Medical Group, Redlands; Abraham C.F. Leung, Carol Zhao, and Raoudha Soufi-Mahjoubi, Nektar Therapeutics, San Francisco, CA
Publication Details: Journal of clinical oncology, Vol.31(32), pp.4060-4066
Academic Unit: Miller School of Medicine; UMMG Department of Urology
Language: English
Resource Type: Journal article
PMID: 24081946
PMCID: PMC4878105
Record Identifier: 991031598907602976