Importance of tumour symptoms and extent of disease on efficacy of first-line FOLFOX4 ± panitumumab (pmab) in patients (pts) with RAS wild-type (WT)/BRAF WT metastatic colorectal cancer (mCRC) in the PRIME study

Date

08 Oct 2016

Session

Poster Display

Presenters

Julien Taieb

Citation

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

Authors

J. Taieb1, M. Peeters2, S. Siena3, F. Rivera Herrero4, R. Koukakis5, G. Demonty6, J. Douillard7

Author affiliations

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

Pt- and tumour-related characteristics may dictate goal of treatment in first-line mCRC, as suggested by updated ESMO guidelines (previewed at WCGIC 2015). Addition of epidermal growth factor receptor inhibitors to chemotherapy improves objective response rates (ORR) and may improve resection rates but their role in pts requiring disease control is less clear. This exploratory analysis from the PRIME trial assessed the efficacy of pmab + FOLFOX4 vs FOLFOX4 according to the goal of treatment (cytoreduction or disease control).

Methods

PRIME (NCT00364013) was an open-label randomised phase III trial of first-line pmab + FOLFOX4 vs FOLFOX4. Pts with RAS WT/BRAF WT mCRC were retrospectively classified using baseline characteristics to define the goal of treatment. Cytoreduction Group: liver-limited disease (LLD) and/or symptomatic; Disease Control Group: non-LLD and asymptomatic. Tumour-related symptoms were defined as an EQ-5D pain/discomfort scale score >1 at baseline or an Eastern Cooperative Oncology Group score of 1.

Results

Overall 439 pts had RAS WT/BRAF WT mCRC. Progression-free (PFS) and overall survival (OS) were longer for pmab + FOLFOX4 vs FOLFOX4 in both groups (Table). Results were similar when the ECOG = 1 definition was used (Cytoreduction Group [n = 214] PFS hazard ratio [HR]: 0.77, OS HR: 0.76; Disease Control Group [n = 197] PFS HR: 0.64, OS HR: 0.68). ORR were higher for pmab + FOLFOX4 compared with FOLFOX4 in both groups (Table).

Median, months
PFS OS ORR
Cytoreduction Group (n = 252)
Pmab + FOLFOX4 10.0 23.8 80/124 (64.5%)
FOLFOX4 9.3 20.2 63/122 (51.6%)
HR (95% CI) 0.73 (0.56-0.96) 0.78 (0.60-1.03)
Disease Control Group (n = 172)
Pmab + FOLFOX4 12.9 31.1 56/87 (64.4%)
FOLFOX4 9.9 24.0 41/83 (49.4%)
HR (95% CI) 0.68 (0.49-0.94) 0.62 (0.44-0.88)

CI = confidence intervals

Conclusions

Although the definition of tumour-related symptoms used in this study has some limitations, this exploratory analysis suggests that first-line pmab + FOLFOX4 treatment significantly improves PFS and OS vs FOLFOX4 alone in pts with RAS WT/BRAF WT mCRC who are candidates for disease control.

Clinical trial identification

NCT00364013

Legal entity responsible for the study

Amgen

Funding

Amgen (Europe) GmbH

Disclosure

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

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