Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Display session 2

3251 - Surrogate endpoint of progression-free (PFS) and overall survival (OS) for advanced ovarian cancer (AOC) patients (pts) treated with neo-adjuvant chemotherapy (NACT): Results of the CHIVA randomized phase II GINECO study

Date

29 Sep 2019

Session

Poster Display session 2

Topics

Tumour Site

Ovarian Cancer

Presenters

Fabrice Lecuru

Citation

Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250

Authors

F. Lecuru1, E. Pujade-Lauraine2, S. Hamizi3, A. Caumont-Prim4, N. Raban5, E. Malaurie6, P. Pautier7, M. Kaminsky-Forrett8, J. Meunier9, J. Alexandre10, D. Berton-Rigaud11, N. Dohollou12, C. Dubot13, A. Floquet14, L. Favier15, L. Venat-Bouvet16, M. Fabbro17, C. Louvet18, A. Lortholary19, G. Ferron20

Author affiliations

  • 1 Service De Cancérologie, Hopital European George Pompidou, 750908 - Paris Cedex /FR
  • 2 Medical Oncology, Clinical Research, ARCAGY-GINECO, 75008 - Paris/FR
  • 3 Oncologie Médicale - Pavillon 1f, Centre Hospitalier Lyon Sud, 69495 - Pierre Bénite Cédex/FR
  • 4 Biostatistique, Exystat, 92240 - Malakoff/FR
  • 5 Pôle Régional De Cancérologie, Service D'oncologie, Hôpital de la Milétrie - CHU de Poitiers, 86021 - Poitiers Cédex/FR
  • 6 Oncologie, Radiothérapie, CHI de Créteil, 94010 - Créteil Cédex/FR
  • 7 Gynécologie Médicale, Gustave Roussy, 94805 - Villejuif Cédex/FR
  • 8 Oncologie Médicale, ICL Institut de Cancérologie de Lorraine, 54511 - Vandoeuvre-les-Nancy Cédex/FR
  • 9 Service D'oncologie Médicale, Centre Hospitalier Régional d'Orléans, 45067 - Orleans Cédex/FR
  • 10 Unité D'oncologie Médicale, Hôpital Cochin, 75014 - PARIS Cédex /FR
  • 11 Oncologie Médicale, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 12 Oncologie - Radiothérapie, Polyclinique Bordeaux Nord, 33300 - Bordeaux/FR
  • 13 Oncologie Médicale, Hôpital René Huguenin - Institut Curie, 92210 - St. Cloud/FR
  • 14 Oncologie Médicale, Institute Bergonié, 33076 - Bordeaux/FR
  • 15 Oncologie Médicale, Centre Georges François Leclerc, 21079 - Dijon Cédex/FR
  • 16 Oncologie Médicale, Centre Hospitalier Universitaire Dupuytren, 87042 - Limoges Cédex/FR
  • 17 Parc Euromedecine, Oncologie Médicale, ICM Val d'Aurelle, 34298 - Montpellier/FR
  • 18 Service D'oncologie, Institut Mutualiste Montsouris, 75014 - Paris/FR
  • 19 Oncologie Médicale, Hôpital Privé du Confluent S.A.S., 44277 - Nantes Cédex /FR
  • 20 Département De Chirurgie Oncologique, Institut Claudius Regaud, 31059 - Toulouse Cédex /FR

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3251

Background

NACT is increasingly used as a model to explore new targeted therapy in combination with CT in AOC. Whether an intermediate endpoint could be used as surrogate of PFS and/or OS in pts treated with NACT remains currently elusive and was explored retrospectively in the CHIVA trial.

Methods

Patients (pts) with FIGO stage IIIC-IV AOC considered as unresectable after laparoscopic (Lap) evaluation were treated with 3 to 4 cycles of platinum-taxane NACT + oral nintedanib before interval debulking surgery (IDS). CT (up to 6 cycles in total) and nintedanib were pursued post-operatively. Were measured response rates at the end of NACT according to RECIST (ORR) with CT-scan and to GCIG with CA125, initial Peritoneal Cancer Index (PCI) and its evolution at IDS, complete surgical resection rate (CC0), pathologic complete or near complete response rate (pCR). These covariates in univariate analysis were included together with other prognostic clinical covariates:age, FIGO stage, ECOG, tumor size, ascitis, neutrophil/lymphocyte ratio, platelet and hemoglobin counts and symptoms (pain).

Results

A total of 163/188 pts included in the CHIVA trial were evaluable for the analysis. Median follow-up is 42. 6 mos (95% CI: 39.9-44.8). In the univariate Cox model, ECOG, ascitis, neutrophil/lymphocyte ratio, PCI at baseline, RECIST ORR, CC0 at IDS, pCR and treatment arm were correlated (p < 0.05) to PFS and/or OS. In the multivariate Cox model, RECIST ORR (p < 0.01) and CC0 at IDS (p < 0.01) were the only variables predictive of both PFS and OS. The median PFS was respectively 10.4, 15.1 and 18.3 mos among the 3 groups of pts with 1) No ORR and no CC0; 2)only CC0 or only ORR; 3)ORR and CC0. PFS Hazard Ratio was 0.33 [0.20; 0.52], 0.43 [0.32; 0.70] and 0.68 [0.44; 1.06] for group 3v1, 2vs1 and 2v3 respectively. Median OS was 25.4, 41.0 mos and not reached for group 1, 2, and 3 respectively (p < 0.001).

Conclusions

Results from the CHIVA trial suggest that the rate of patients who achieve both a RECIST response to NACT and a complete surgical resection (CC0) at IDS could be used as the main primary endpoint for future NACT trials.

Clinical trial identification

2011-006288-23.

Editorial acknowledgement

Legal entity responsible for the study

ARCAGY-GINECO.

Funding

Boehringer Ingelheim.

Disclosure

F. Lecuru: Advisory / Consultancy, Board: AstraZeneca; Advisory / Consultancy, Proctoring: Intuitive Surgical. E. Pujade-Lauraine: Honoraria (self), Self: AstraZeneca; Honoraria (self), Self: Tesaro; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Tesaro. N. Raban: Travel / Accommodation / Expenses: Roche. P. Pautier: Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: Genentech; Research grant / Funding (institution): PharmaMar; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Tesaro. J. Alexandre: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Janssen; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Novartis. N. Dohollou: Research grant / Funding (institution): Roche; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Lilly. A. Floquet: Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche. C. Louvet: Advisory / Consultancy: MSD; Advisory / Consultancy: Roche; Advisory / Consultancy: Halozyme; Advisory / Consultancy: Servier; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: MSD. A. Lortholary: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro. G. Ferron: Honoraria (self): Olympus Europe; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Tesaro; Travel / Accommodation / Expenses: Roche. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.