Hopital Henri Mondor, UPEC, Creteil, France
Christophe Tournigand , Benoist Chibaudel , Benoit Samson , Werner Scheithauer , Gérard Lledo , Frederic Viret , Thierry André , Jean François Ramée , Nicole Tubiana-Mathieu , Jérôme Dauba , Olivier Dupuis , Yves Rinaldi , May Mabro , Nathalie Aucoin , Ahmed Khalil , Jean Latreille , Christophe Louvet , David Brusquant , Franck Bonnetain , Aimery de Gramont
Background: The primary analysis of DREAM demonstrated that a maintenance therapy (MT) with bevacizumab (Bev) + EGFR TKI erlotinib (E) significantly improved progression-free survival (PFS) after a 1st-line Bev-based induction therapy (IT) in patients (pts) with unresectable mCRC. Methods: Pts were randomized to MT after an IT with FOLFOX-bev or XELOX-bev or FOLFIRI-bev between Bev alone (Bev 7.5 mg/kg q3w; arm A) or Bev+E (Bev 7.5 mg/kg q3w, E 150 mg/d ; arm B) until PD or unacceptable toxicity. Primary endpoint was PFS on MT. Secondary endpoints included PFS from inclusion, overall survival (OS) and safety. The impact of KRAS tumor status on treatment efficacy was evaluated in an exploratory analysis. Results: 700 pts were registered and 452 pts were randomized (228 in arm A, 224 in arm B). KRAS status was available for 413/452 (91%) pts. The median duration of MT was 3.6 m. Results for MT are presented below (Table). In the registered population, median OS was 24.9m (22.5 – 27.3). Conclusions: Maintenance treatment with bev + erlotinib increases PFS over maintenance with bev alone in pts with mCRC but does not prolong OS. Further follow-up will determine the impact of 2nd or 3rd line anti-EGFR Mabs in this study. Contrasting with anti-EGFR Mabs, KRAS tumor status is not mandatory to select pts with mCRC for treatment with erlotinib. Clinical trial information: NCT00265824.
Endpoints, months (95% CI) | Arm A | Arm B | HR (95% CI) | P value |
---|---|---|---|---|
Maintenance population (MP) (n = 452) |
n = 228 | n = 224 | ||
Median maintenance PFS | 4.8 (4.1 - 5.7) | 5.9 (4.5 - 6.4) | 0.76 (0.61-0.94) | 0.010 |
Median PFS | 9.3 (8.7 – 10.1) | 10.2 (9.5 – 11.5) | 0.76 (0.61 - 0.94) | 0.009 |
Median OS | 27.9 (24.1 – 31.1) | 28.5 (25.1 – 33.9) | 0.89 (0.70-1.12) | 0.312 |
MP - WT KRAS | n = 111 | n = 129 | ||
Median maintenance PFS | 5.9 (4.0 – 6.5) | 6.0 (4.5 – 7.8) | 0.86 (0.64-0.1.16) | 0.135 |
Median PFS | 9.7 (8.7 – 11.0) | 10.9 (9.8 – 12.6) | 0.83 (0.61 - 1.11) | 0.197 |
Median OS | 31.5 (27.5 – 38.0) | 31.8 (26.6 – 37.8) | 0.92 (0.66 – 1.30) | 0.644 |
MP - Mut KRAS (n = 173) | n = 95 | n = 78 | ||
Median maintenance PFS | 4.4 (3.9 – 5.3) | 4.7 (3.6 – 7.1) | 0.77 (0.54 – 1.08) | 0.124 |
Median PFS | 9.9 (8.6 – 10.8) | 9.8 (8.4 – 12.2) | 0.80 (0.57 – 1.13) | 0.212 |
Median OS | 26.9 (22.4 – 33.2) | 26.3 (21.0 – 34.4) | 1.06 (0.72 - 1.55) | 0.767 |
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