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*Carsten Bokemeyer , Elzbieta Staroslawska, Marek Nowacki, Irina Mitashok, Elena Kuznetsova,

Cetuximab plus 5-FU/FA/oxaliplatin (FOLFOX-4) in the first-line treatment of mCRC: OPUS, a phase II study. *Carsten Bokemeyer , Elzbieta Staroslawska, Marek Nowacki, Irina Mitashok, Elena Kuznetsova, Paolo Cortes, Carlos Garcia Girón, Oksana Tarasova, Angela Zubel, Yaroslav Shparyk

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*Carsten Bokemeyer , Elzbieta Staroslawska, Marek Nowacki, Irina Mitashok, Elena Kuznetsova,

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  1. Cetuximab plus 5-FU/FA/oxaliplatin (FOLFOX-4) in the first-line treatment of mCRC: OPUS, a phase II study *Carsten Bokemeyer , Elzbieta Staroslawska, Marek Nowacki, Irina Mitashok, Elena Kuznetsova, Paolo Cortes, Carlos Garcia Girón, Oksana Tarasova, Angela Zubel, Yaroslav Shparyk *University Medical Center Hamburg-Eppendorf, Martinistrasse 52, 20246 Hamburg, Germany

  2. OPUS study design Cetuximab + FOLFOX-4 400 mg/m2 initial IV infusion (day 1) then 250 mg/m2 weekly + oxaliplatin 85 mg/m2 + 5-FU/FA every 2 weeks EGFR-expressing metastatic CRC R FOLFOX-4 oxaliplatin 85 mg/m2 + 5-FU/FA every 2 weeks Stratification factors: ECOG PS 0-1, 2 Treatment until progression, symptomatic deterioration or unacceptable toxicity

  3. Best overall confirmed responses (IRC) FOLFOX-4 Cetuximab + FOLFOX-4 Odds ratio = 1.516, p=0.064* * Cochran-Mantel-Haenszel (CMH) test

  4. Efficacy: response rate all patients and ECOG 0-1 stratum * p=0.032**, Odds ratio: 1.648 [95% CI:1.043, 2.604] **Cochran-Mantel-Haenszel (CMH) test

  5. Efficacy by subgroups OR [95% CI] 1.516 [0.97, 2.35] All ITT subjects (n= 169 vs 168) Subgroup (number of patients) 1.648 [1.043, 2.604] ECOG 0/1 Age <65 years (96 vs 109) 1.82 [1.03, 3.21] ≥65 years (73 vs 59) 1.14 [0.57, 2.31] Leucocytes ≤10 000 / mm3 (124 vs 131) 2.00 [1.19, 3.35] Liver metastasis only Yes (50 vs 39) 2.11 [0.88, 5.07] One metastatic site 1 (74 vs 69) 2.00 [1.02, 3.93] Region Western Europe (72 vs 75) 2.29 [1.18, 4.46] Eastern Europe (97 vs 93) 1.12 [0.61, 2.04] LDH >upper normal limit (82 vs 63) 2.07 [1.03, 4.14] Alkaline phosphatase <300 U/L (128 vs 128) 2.04 [1.22, 3.42] 1 10 5 2 0.1 Favors Cetuximab + FOLFOX Favors FOLFOX

  6. Association between skin reactions and response rate Cetuximab + FOLFOX-4, n=168 (IRC data) n=23 n=59 n=62 n=24 Maximum skin reactions during first 21 days of treatment *There were no grade 4 skin reactions

  7. Safety in treated patients †Includes peripheral sensory neuropathy and neuropathy.*Special AE category**There were no grade 4 skin reactions or acne-like rash

  8. Conclusions • The addition of cetuximab to FOLFOX-4 increased the RR of FOLFOX-4 by approximately 10% (45.6% vs 35.7%). There was an approximately 50% higher chance of achieving a CR or PR for those patients receiving cetuximab plus FOLFOX-4 (OR = 1.52) • Patients with baseline ECOG PS 0-1 had a statistically significant higher (65%; OR = 1.65) chance for response (49.0% vs 36.8%) • Analysis of prognostic factors for response uniformly showed an increased chance of a response by 50 to >100% in most subgroups under cetuximab plus FOLFOX-4 compared to FOLFOX-4 alone • Cetuximab in combination with FOLFOX - 4 was generally well-tolerated

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