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Neoadjuvant chemotherapy versus debulking surgery in advanced tubo-ovarian cancers: pooled analysis of individual patient data from the EORTC 55971 and CHORUS trials - 19/12/18

Doi : 10.1016/S1470-2045(18)30566-7 
Ignace Vergote, ProfMD a, ⁎ , Corneel Coens, MSc b, Matthew Nankivell, MSc d, Gunnar B Kristensen, MD e, Mahesh K B Parmar, ProfDPhil c, Tom Ehlen, MD f, Gordon C Jayson, ProfPhD g, Nick Johnson, MRCOG h, Ann Marie Swart, ProfMBBS i, René Verheijen, ProfMD j, W Glenn McCluggage, ProfFRCPath k, Tim Perren, ProfMD l, Pierluigi Benedetti Panici, PhD m, Gemma Kenter, ProfMD n, Antonio Casado, MD o, Cesar Mendiola, MD p, Gavin Stuart, ProfMD f, Nick S Reed, ProfMBBS q, Sean Kehoe, MD r
and the

EORTC

and

MRC CHORUS study investigators

Claes Tropé G., Stephen Dobbs, Sharadah Essapen, P. Hoskins, John Green, E. Gilby, M. Van Baal, Jeremy Twigg, Maria E.L. Van Der Burg, Keith Godfrey, Angel J. Lacave, R. Angioli, Rahul Nath, Kirk Chin, Charles Redman, R. Lotocki, Adeola Olaitan, B. Mosgaard, G. Rustin, Thomas Ind, Mojca Persic, Martin Hogg, J. Van Der Velden, J. Ledermann, Peter Sykes Peter Sykes, Krishnawam Madhavan, P. Kannisto, Vicky Hird, A. Evans, R. Sandvei R., P. Gauthier, D.J. Cruickshank, P.B. Ottevanger, Sheila Pearson, Henry Kitchener, Marcia Hall, P. Bessette, S. Pecorelli, E. Gerdin, Tito Lopes, Andrew Fish, Clare Barlow., K. Van Eygen, A. Floquet, B. Tholander, N. Gul, Robert Gornall, David Luesley, Philip Kirwan, Paul Symonds, Richard Henry, David Poole, Ian McNeish, Mark Hocking, Al Sammaraie, P. Speiser, E. Leblanc, J.A. Green, C.F. De Oliveira, R. Grimshaw, P. Zola, David Parkin, David Luesley, Martin Lamb, Anne Hong, Alan Gillespie, Abdel Hamid, Ahmed Ahmed, M. Plante, B. De Valk, A. Nordin, Andrew Clamp, David Perez, Graham Dark Graham Dark, Michelle Ferguson, Carol MacGregor, Geraldine Skailes, Rachel Jones, Alan Gillespie, G. Cawdell, Simon Leeson, L. Elit, C. Dittrich, W. Gotlieb, David Poole, John Cullimore, Barbara Crosse, Paul Ridley, Anthony Head, Joaquin Nieto, Saif Awwad, Dirk Brinkmann, Damian Eustace, Andrew Hindley, D. Katsaros, C. Popadiuk, Tome Kristeller, C. Redman, S. Chan, C. Marth, Dennis Yiannakis, Kate Lankaster, Gareth Beynon, Anwar Suhail, Fernando Indrajit, Anne Hong, Mary Quigley, Olu Adeyemi, Mojca Persic, Fiona Lofts, Orla McNally, Amanda Tristam, Martin Lee, R. Counsell, N. Gleeson, A. Papadopoulos, T. Maggino, A. Honkoop, P. Ghatage, J.B. Vermorken, J. De Greve, K. Boman, E Petru, F. Amant

a University Hospitals Leuven, Department of Obstetrics and Gynaecology, Leuven, Belgium 
b European Organisation for Research and Treatment of Cancer, Gynecological Cancer Group, Brussels, Belgium 
c Institute of Clinical Trials and Methodology, London, UK 
d Medical Research Council Clinical Trials Unit at University College London, London, UK 
e Norwegian Radium Hospital and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo, Norway 
f Department of Gynecologic Oncology, University of British Columbia, Vancouver, BC, Canada 
g Department of Medical Oncology, Christie Hospital and University of Manchester, Manchester, UK 
h Department of Gynecologic Oncology, Royal United Hospitals Bath, Bath, UK 
i Norwich Clinical Trials Unit and Norwich Medical School, University of East Anglia, Norwich, UK 
j Department of Gynecological Oncology, Vrije Universiteit Medical Center, Amsterdam, Netherlands 
k Department of Pathology, Queen’s University, Belfast Health and Social Care Trust, Belfast, UK 
l Institute of Cancer and Pathology, St James’s University Hospital, Leeds, UK 
m Department of Gynecology-Obstetrics, University of Rome “Sapienza”, Rome, Italy 
n Department of Gynecological Oncology, Center Gynaecologic Oncology Amsterdam, University of Amsterdam, Amsterdam, Netherlands 
o Department of Medical Oncology, Hospital Universitario San Carlos, Madrid, Spain 
p Department of Medical Oncology, Hospital Universitario Doce de Octubre, Madrid, Spain 
q Department of Clinical Oncology, Beatson Oncology Centre, Glasgow, UK 
r Department of Gynaecological Cancer, University of Birmingham, Birmingham, UK 

* Correspondence to: Prof Ignace Vergote, University Hospitals Leuven, Department of Obstetrics and Gynaecology, Division of Gynaecological Oncology, Leuven Cancer Institute, B-3000 Leuven, Belgium University Hospitals Leuven Department of Obstetrics and Gynaecology Division of Gynaecological Oncology Leuven Cancer Institute Leuven B-3000 Belgium

Summary

Background

Individual patient data from two randomised trials comparing neoadjuvant chemotherapy with upfront debulking surgery in advanced tubo-ovarian cancer were analysed to examine long-term outcomes for patients and to identify any preferable therapeutic approaches for subgroup populations.

Methods

We did a per-protocol pooled analysis of individual patient data from the European Organisation for Research and Treatment of Cancer (EORTC) 55971 trial (NCT00003636) and the Medical Research Council Chemotherapy Or Upfront Surgery (CHORUS) trial (ISRCTN74802813). In the EORTC trial, eligible women had biopsy-proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or IV invasive epithelial tubo-ovarian carcinoma. In the CHORUS trial, inclusion criteria were similar to those of the EORTC trial, and women with apparent FIGO stage IIIA and IIIB disease were also eligible. The main aim of the pooled analysis was to show non-inferiority in overall survival with neoadjuvant chemotherapy compared with upfront debulking surgery, using the reverse Kaplan-Meier method. Tests for heterogeneity were based on Cochran’s Q heterogeneity statistic.

Findings

Data for 1220 women were included in the pooled analysis, 670 from the EORTC trial and 550 from the CHORUS trial. 612 women were randomly allocated to receive upfront debulking surgery and 608 to receive neoadjuvant chemotherapy. Median follow-up was 7·6 years (IQR 6·0–9·6; EORTC, 9·2 years [IQR 7·3–10·4]; CHORUS, 5·9 years [IQR 4·3–7·4]). Median age was 63 years (IQR 56–71) and median size of the largest metastatic tumour at diagnosis was 8 cm (IQR 4·8–13·0). 55 (5%) women had FIGO stage II–IIIB disease, 831 (68%) had stage IIIC disease, and 230 (19%) had stage IV disease, with staging data missing for 104 (9%) women. In the entire population, no difference in median overall survival was noted between patients who underwent neoadjuvant chemotherapy and upfront debulking surgery (27·6 months [IQR 14·1–51·3] and 26·9 months [12·7–50·1], respectively; hazard ratio [HR] 0·97, 95% CI 0·86–1·09; p=0·586). Median overall survival for EORTC and CHORUS patients was significantly different at 30·2 months (IQR 15·7–53·7) and 23·6 months (10·5–46·9), respectively (HR 1·20, 95% CI 1·06–1·36; p=0·004), but was not heterogeneous (Cochran’s Q, p=0·17). Women with stage IV disease had significantly better outcomes with neoadjuvant chemotherapy compared with upfront debulking surgery (median overall survival 24·3 months [IQR 14·1–47·6] and 21·2 months [10·0–36·4], respectively; HR 0·76, 95% CI 0·58–1·00; p=0·048; median progression-free survival 10·6 months [7·9–15·0] and 9·7 months [5·2–13·2], respectively; HR 0·77, 95% CI 0·59–1·00; p=0·049).

Interpretation

Long-term follow-up data substantiate previous results showing that neoadjuvant chemotherapy and upfront debulking surgery result in similar overall survival in advanced tubo-ovarian cancer, with better survival in women with stage IV disease with neoadjuvant chemotherapy. This pooled analysis, with long-term follow-up, shows that neoadjuvant chemotherapy is a valuable treatment option for patients with stage IIIC–IV tubo-ovarian cancer, particularly in patients with a high tumour burden at presentation or poor performance status.

Funding

National Cancer Institute and Vlaamse Liga tegen kanker (Flemish League against Cancer).

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Vol 19 - N° 12

P. 1680-1687 - décembre 2018 Retour au numéro
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