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Impact of depth of response (DpR) on survival in patients (pts) with RAS wild-type (WT) metastatic colorectal cancer (mCRC) receiving first-line panitumumab + FOLFOX4 vs FOLFOX4

Date

08 Oct 2016

Session

Poster Display

Presenters

Salvatore Siena

Citation

Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370

Authors

S. Siena1, F. Rivera Herrero2, J. Douillard3, J. Taieb4, R. Koukakis5, G. Demonty6, M. Peeters7

Author affiliations

  • 1 Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda and Università degli Studi di Milano, 20162 - Milano/IT
  • 2 Medical Oncology, University Hospital Marques de Valdecilla, Santander/ES
  • 3 Oncologie Médicale, ICO R. Gauducheau, 44805 - St Herblain/FR
  • 4 Department Of Gastroenterology And Digestive Oncology, Hôpital Européen Georges Pompidou, 75015 - Paris/FR
  • 5 Biostatistics, Amgen Ltd, Uxbridge/GB
  • 6 Medical Development - Oncology, Amgen (Europe) GmbH, Zug/CH
  • 7 Department Of Oncology, University Hospital Antwerp, 2650 - Edegem/BE
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Background

DpR has been associated with overall survival (OS) in first-line trials of epidermal growth factor receptor inhibitors + chemotherapy in pts with mCRC. Here we evaluate the impact of DpR on progression-free survival (PFS) and OS in pts with RAS WT mCRC from the PRIME trial.

Methods

PRIME (NCT00364013) was a randomised, phase III trial of first-line panitumumumab + FOLFOX4 vs FOLFOX4 in pts with mCRC. DpR was calculated as the maximal % change from baseline to nadir in pts who had tumour shrinkage. In pts with tumour growth, DpR was defined as

Results

Overall, 460 pts with RAS   WT mCRC who had measurable disease at baseline and calculable DpR post-baseline, were included in the analysis. Median DpR was higher in pts receiving panitumumab + FOLFOX4 vs FOLFOX4 (54% vs 46%; p = 0.0149). In the simple regression model, DpR was associated with PFS (p 

Conclusions

These exploratory analyses from PRIME suggest that deeper responses are significantly associated with longer OS and PFS in pts with RAS WT mCRC.

Clinical trial identification

NCT00364013

Legal entity responsible for the study

Amgen

Funding

Amgen (Europe) GmbH

Disclosure

S. Siena: Member of advisory boards or steering committees or principal investigator for Amgen, Bayer, Boehringer Ingelheim, Celgene, Genentech, Ignyta, Merck, Merrimack, Novartis, Pfzer, Roche, and SanofiAventis. F. Rivera Herrero: Acted on advisory boards and received research funding from Amgen, Sanofi, Merck-Serono and Roche. J-Y. Douillard: Honoraria/travel/accommodation/expenses while performing consulting/advisory roles for Amgen, Bayer, Roche and Merck and has also received research funding from Merck Serono. J. Taieb: Honoraria/consulting/advisory role for Roche, Amgen, Merck, Lilly, Sanofi, Celgene, Sirtex R. Koukakis: Employee of Amgen Ltd and stockowner. G. Demonty: Employee of Amgen (Europe) GmbH and stockholder. M. Peeters: Received research funding and acted in consultancy/advisory roles for Amgen and received research funding and participated in symposia for Merck Serono.

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