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Poster Discussion session - Gynaecological cancers

2118 - Response to Neoadjuvant Chemotherapy in 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


20 Oct 2018


Poster Discussion session - Gynaecological cancers


Cytotoxic Therapy

Tumour Site

Ovarian Cancer


Andrew Clamp


Annals of Oncology (2018) 29 (suppl_8): viii332-viii358. 10.1093/annonc/mdy285


A.R. Clamp1, I.A. McNeish2, A. Dean3, D. Gallardo-Rincon4, J. Kim5, D.M. O'Donnell6, J. Hook7, S. Blagden8, J.D. Brenton9, R. Naik10, T.J. Perren7, S. Sundar11, A.D. Cook12, E.C. James13, H. Gabra14, R. Lord15, M. Hall16, G. Dark17, R.S. Kaplan13, J.A. Ledermann18

Author affiliations

  • 1 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 2 Department Of Surgery And Cancer, Imperial College London, W12 0HS - London/GB
  • 3 Medical Oncology, Saint John of God Hospital Subiaco, 6008 - Subiaco/AU
  • 4 Gynecology Oncology Clinic, Instituto Nacional de Cancerologia - Mexico, 14080 - Ciudad de México/MX
  • 5 Gynecologic Oncology, KGOG & Seoul National University, Seoul/KP
  • 6 Medical Oncology, Cancer Trials Ireland, 8 - Dublin/IE
  • 7 Leeds Cancer Centre, Leeds Teaching Hospitals NHS Trust, Leeds/GB
  • 8 Oncology, Churchill Hospital University of Oxford, OX3 7LE - Oxford/GB
  • 9 Li Ka Shing Centre, Cancer Research UK, Cambridge Research Institute Addenbrooke's Hospital, CB2 0RE - Cambridge/GB
  • 10 Northern Gynaecological Oncology Centre, Gateshead Health NHS Foundation Trust, Gateshead/GB
  • 11 Birmingham Gynaecological Cancer Centre, University of Birmingham, Birmingham/GB
  • 12 Mrc Clinical Trials Unit At Ucl, Institute of Clinical Trials and Methodology-UCL, WC2B6NH - London/GB
  • 13 Mrc, Institute of Clinical Trials and Methodology-UCL, WC1V6LJ - London/GB
  • 14 Surgery And Cancer, Imperial College London - Hammersmith Hospital, W12 0HS - London/GB
  • 15 Clatterbridge Cancer Centre, The Clatterbridge Cancer Centre NHS Foundation Trust, CH63 4JY - Wirral/GB
  • 16 Medical Oncology, Mount Vernon Cancer Centre, HA6 2RN - Northwood/GB
  • 17 Northern Cancer For Cancer Care, Newcastle University, Newcastle/GB
  • 18 Cancer Trials Centre, University College London Cancer Institute, WC1E6BT - London/GB


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Abstract 2118


Neoadjuvant carboplatin-paclitaxel (CT) with delayed primary surgery (DPS) after 3 cycles is a standard-of-care option for women with bulky FIGO stage IIIc-IV EOC. However, radiological and biochemical response to neoadjuvant CT has not been prospectively evaluated nor compared with DPS outcome and progression-free survival (PFS).


ICON8 is a phase III randomised trial that compared standard 3-weekly CT with 2 dose-dense weekly CT regimens. Patients could enter after primary surgery or receive neoadjuvant treatment with planned DPS. Radiological response to neoadjuvant CT was evaluated using RECIST v1.1. Serum CA125 was measured 3-weekly per protocol and evaluated using GCIG criteria.


779 patients entered ICON8 with planned DPS after neoadjuvant CT. DPS was performed in 602 (536 after 3-4 cycles; 65 after 5/6 cycles; data missing 1). RECIST and CA125 response data were available for 531 and 726 respectively. No differences in response were noted between trial arms, so a combined analysis was performed. Best RECIST response (RR) pre-DPS was 61% (CR 4%, PR 57%, SD 33%, PD 6%). Median pre-operative change in marker lesions was -14.5% in patients with SD. GCIG CA125 response rate was 84%, including 71% (123/173) in patients with RECIST SD. Comparison of surgical feasibility, cytoreductive outcomes and PFS with ORR are presented in the table.Table: 943PD

DPS Outcome by RECIST GroupPD N = 32SD N = 177PR/CR N = 322Total N = 531
Surgery not performed8 (31%)28 (17%)28 (9%)64 (13%)
Inoperable03 (2%)5 (2%)8 (2%)
Debulked to no visible residual disease14 (54%)69 (42%)166 (54%)249 (50%)
Debulked to ≤ 1cm residual disease2 (8%)41 (25%)74 (25%)117 (23%)
Debulked to > 1cm residual disease2 (8%)24 (15%)34 (11%)60 (12%)
Surgical outcome missing6121533
Median PFS (months)5.014.716.4


RR to neoadjuvant CT in ICON8 was 61% and was not improved by dose-dense CT. PD is rare following neoadjuvant CT and SD by RECIST incorporates many women with definite reduction in disease burden. GCIG CA125 criteria overestimate response compared to RECIST. Both PFS and complete/optimal debulking rates were similar in SD and CR/PR groups, reinforcing that patients with SD should be offered DPS.

Clinical trial identification

ISRCTN: ISRCTN10356387; EudraCT: 2010-02209-16.

Legal entity responsible for the study

University College London.


Cancer Research UK.

Editorial Acknowledgement


A.R. Clamp: Research grants, travel expenses and advisory board: AstraZenenca, I.A. McNeish: Advisory boards: AstraZeneca, Clovis Oncology, Tesaro, Takeda. All other authors have declared no conflicts of interest.

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