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Gynaecological cancers

4427 - ICON8: A GCIG Phase III randomised trial evaluating weekly dose- dense chemotherapy integration in first-line Epithelial Ovarian/ Fallopian Tube/ Primary Peritoneal Carcinoma (EOC) treatment: Results of Primary Progression- Free Survival (PFS) analysis

Date

08 Sep 2017

Session

Gynaecological cancers

Topics

Cytotoxic Therapy;  Ovarian Cancer

Presenters

Andrew Clamp

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

A.R. Clamp1, I. McNeish2, A. Dean3, D. Gallardo4, J. Weon- Kim5, D. O'Donnell6, J. Hook7, C. Coyle8, S.P. Blagden9, J. Brenton10, R. Naik11, T. Perren12, S. Sundar13, A. Cook8, E. James14, A.M. Swart15, S. Stenning8, R. Kaplan8, J. Ledermann16

Author affiliations

  • 1 Medical Oncology, The Christie NHS Foundation Trust and University of Manchester, M20 4BX - Manchester/GB
  • 2 Institute Of Cancer Sciences, University of Glasgow, Glasgow/GB
  • 3 Oncology, St John of God Hospital, Subiaco/AU
  • 4 Clinical Oncology, Instituto Nacional de Cancerologia, Mexico/MX
  • 5 Obstetrics And Gynaecology, Seoul National University Hospital, 110-744 - Seoul/KR
  • 6 Department Of Medical Oncology, Cancer Trials Ireland, 8 - Dublin/IE
  • 7 Oncology, St. James's University Hospital Leeds, LS9 7TF - Leeds/GB
  • 8 Mrc Clinical Trials Unit, Institute of Clinical Trials and Methodology-UCL, WC2B6NH - London/GB
  • 9 Early Phase Clinical Trials Unit, Churchill Hospital University of Oxford, OX3 7LE - Oxford/GB
  • 10 Cruk-ci, Li Ka Shing Centre, Cancer Research UK, Cambridge Research Institute Addenbrooke's Hospital, CB2 0RE - Cambridge/GB
  • 11 Northern Gynaecology Oncology Centre, Queen Elizabeth Hospital, NE96SX - Gateshead/GB
  • 12 Leeds Institute Of Cancer And Pathology, St. James's University Hospital Leeds, LS9 7TF - Leeds/GB
  • 13 Pan- Birmingham Gynaecological Cancer Centre, University of Birmingham, B152SY - Birmingham/GB
  • 14 Statistics, Institute of Clinical Trials and Methodology-UCL, WC2B6NH - London/GB
  • 15 Norwich Clinical Trials Unit, University of East Anglia, Norwich/GB
  • 16 Cancer Research Uk & Ucl Cancer Trials Centre, UCL Cancer Institute, WC1 E 6BT - London/GB
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Abstract 4427

Background

For several decades, standard first-line chemotherapy for EOC has been carboplatin (C) and paclitaxel (T), administered 3-weekly (q3w). The JGOG3016 trial reported clinically significant lengthening of PFS and overall survival in Japanese women using dose-dense weekly (q1w) T but with increased toxicity. ICON8 is a 3-arm trial, comparing standard q3w CT with dose-dense q1w regimens in a predominantly European patient group.

Methods

Eligible women with FIGO stage IcG3- IV EOC were randomised 1:1:1 to Arm 1 (standard) - q3w C AUC5/6 + q3w T 175mg/m2; Arm 2 - q3w C AUC5/6 + q1w T 80mg/m2; Arm 3 - q1w C AUC2 + q1w T 80 mg/m2. Patients entered ICON8 after immediate primary surgery (IPS), or received neo-adjuvant chemotherapy with planned delayed primary surgery (DPS). Primary intention to treat analysis compared arm 2v1 and arm 3v1 using methods for data with non-proportional hazards.

Results

1566 women were randomised Jun 2011-Nov 2014. Median age- 62 years, 72% serous histology, 93% ECOG performance status 0/1. 48% had IPS, 50% planned DPS, 2% inoperable. 72%, 60%, 63% completed 6 cycles protocol-defined treatment in arms 1, 2, 3. Completion rate for 6 cycles platinum was 88% (90%; 89%; 85%). Paclitaxel dose-intensification was achieved (median total dose T (mg/m2)-1011; 1234; 1274). Grade (G) 3/4 toxicity (predominantly uncomplicated low neutrophils) was seen in 42%; 63%; 53% patients. Incidence of G3/4 febrile neutropenia (4%; 6%; 3%) and ≥G2 sensory neuropathy (28%; 25%; 23%) were similar across arms. At Feb 2017, 64% patients had experienced disease progression. No significant increase in PFS was observed with either weekly treatment (log-rank arm 2v1 p = 0.45; arm 3v1 p = 0.56, non-proportionality p = 0.02, restricted mean survival time=24.4; 24.9; 25.3 months in arms 1, 2, 3, median PFS- 17.9; 20.6; 21.1months, HR = 0.92 arm 2v1, HR = 0.94 arm 3v1).

Conclusions

Although weekly dose-dense chemotherapy can be delivered successfully as first-line EOC treatment without substantial toxicity increase, it does not significantly improve PFS compared to standard 3-weekly CT.

Clinical trial identification

ISRCTN: ISRCTN10356387 EUDRACT: 2010-022209-16 CTA: 2010-022209-16 ENGOT: OV-13 MREC: 11/LO/0043

Legal entity responsible for the study

Medical Research Council Clinical Trials Unit at University College London

Funding

Cancer Research UK; Medical Research Council

Disclosure

All authors have declared no conflicts of interest.

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