Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial.
Abstract
In this open-label, randomised, controlled, phase 3 trial (ICON8), women aged 18 years or older with newly diagnosed stage IC-IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma (here collectively termed ovarian cancer, as defined by International Federation of Gynecology and Obstetrics [FIGO] 1988 criteria) and an Eastern Cooperative Oncology Group performance status of 0-2 were recruited from 117 hospitals with oncology departments in the UK, Australia and New Zealand, Mexico, South Korea, and Ireland. Patients could enter the trial after immediate primary surgery (IPS) or with planned delayed primary surgery (DPS) during chemotherapy, or could have no planned surgery. Participants were randomly assigned (1:1:1), using the Medical Research Council Clinical Trials Unit at University College London randomisation line with stratification by Gynecologic Cancer Intergroup group, FIGO disease stage, and outcome and timing of surgery, to either 3-weekly carboplatin area under the curve (AUC)5 or AUC6 and 3-weekly paclitaxel 175 mg/m2 (control; group 1), 3-weekly carboplatin AUC5 or AUC6 and weekly paclitaxel 80 mg/m2 (group 2), or weekly carboplatin AUC2 and weekly paclitaxel 80 mg/m2 (group 3), all administered via intravenous infusion for a total of six 21-day cycles. Coprimary outcomes were progression-free survival and overall survival, with comparisons done between group 2 and group 1, and group 3 and group 1, in the intention-to-treat population. Safety was assessed in all patients who started at least one chemotherapy cycle. The trial is registered on ClinicalTrials.gov, NCT01654146, and ISRCTN registry, ISRCTN10356387, and is closed to accrual.
Author
Clamp, Andrew R
James, Elizabeth C
McNeish, Iain A
Dean, Andrew
Kim, Jae-Won
O'Donnell, Dearbhaile M
Gallardo-Rincon, Dolores
Blagden, Sarah
Brenton, James
Perren, Tim J
Sundar, Sudha
Lord, Rosemary
Dark, Graham
Hall, Marcia
Banerjee, Susana
Glasspool, Rosalind M
Hanna, C Louise
Williams, Sarah
Scatchard, Kate M
Nam, Helena
Essapen, Sharadah
Parkinson, Christine
McAvan, Lucy
Swart, Ann Marie
Popoola, Babasola
Schiavone, Francesca
Badrock, Jonathan
Fananapazir, Fuad
Cook, Adrian D
Parmar, Mahesh
Kaplan, Richard
Ledermann, Jonathan A
James, Elizabeth C
McNeish, Iain A
Dean, Andrew
Kim, Jae-Won
O'Donnell, Dearbhaile M
Gallardo-Rincon, Dolores
Blagden, Sarah
Brenton, James
Perren, Tim J
Sundar, Sudha
Lord, Rosemary
Dark, Graham
Hall, Marcia
Banerjee, Susana
Glasspool, Rosalind M
Hanna, C Louise
Williams, Sarah
Scatchard, Kate M
Nam, Helena
Essapen, Sharadah
Parkinson, Christine
McAvan, Lucy
Swart, Ann Marie
Popoola, Babasola
Schiavone, Francesca
Badrock, Jonathan
Fananapazir, Fuad
Cook, Adrian D
Parmar, Mahesh
Kaplan, Richard
Ledermann, Jonathan A
Citations
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Date
2022-06-09
Type
Article
Subject
Gynaecology
Collections
Citation
Clamp AR, James EC, McNeish IA, Dean A, Kim JW, O'Donnell DM, Gallardo-Rincon D, Blagden S, Brenton J, Perren TJ, Sundar S, Lord R, Dark G, Hall M, Banerjee S, Glasspool RM, Hanna CL, Williams S, Scatchard KM, Nam H, Essapen S, Parkinson C, McAvan L, Swart AM, Popoola B, Schiavone F, Badrock J, Fananapazir F, Cook AD, Parmar M, Kaplan R, Ledermann JA. Weekly dose-dense chemotherapy in first-line epithelial ovarian, fallopian tube, or primary peritoneal cancer treatment (ICON8): overall survival results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2022 Jul;23(7):919-930.
Journal / Source Title
The Lancet Oncology
DOI
10.1016/S1470-2045(22)00283-2
PMID
35690073
Publisher
Elsevier