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Efficacy and Safety of Sorafenib in Metastatic Colorectal Cancer: RESPECT Phase IIb Study

The RESPECT Phase IIb study, led by J. Tabernero et al., evaluated the efficacy and safety of sorafenib (SOR) combined with modified FOLFOX6 chemotherapy for first-line treatment in patients with metastatic colorectal cancer (mCRC). This double-blind, randomized trial included 200 participants, focusing on progression-free survival (PFS) as the primary outcome. Results indicated no improvement in PFS for the sorafenib group, alongside increased rates of Grade 3/4 toxicity, which adversely affected chemotherapy delivery. Overall, sorafenib did not enhance treatment outcomes in mCRC.

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Efficacy and Safety of Sorafenib in Metastatic Colorectal Cancer: RESPECT Phase IIb Study

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  1. EMCC ECCO ESMO 2011 GI CancerUpdates RESPECT Phase IIb Study Author: J Tabernero et al Reviewed by: Dr. Scott Berry Date posted: October 20, 2011

  2. A Phase 2b, Double-Blind, Randomized Study Evaluating the Efficacy and Safety of Sorafenib (SOR) Compared With Placebo (PBO) When Administered in Combination With Chemotherapy (Modified FOLFOX6) for First-line Treatment (tx) of Patients (Pts) With Metastatic Colorectal Cancer (mCRC). The RESPECT Trial Author: J Tabernero et al

  3. Study Design N=200 Primary Outcome: PFS Sorafenib 400 mg po BID + mFOLFOX6 R Placebo +mFOLFOX6 Untreated Metastatic Colorectal Cancer ECOG 0/1

  4. RESULTS

  5. GR 3/4 TOXICITY

  6. GR 3/4 TOXICITY

  7. STUDY COMMENTARY • The excess toxicity seen in the sorafenib arm had a major impact on the delivery of chemo in that arm • Sorafenib arm – no improvement in PFS, reduced RR and more toxic

  8. BOTTOM LINE FOR MEDICAL ONCOLOGISTS • Another VEGF TKI (along with PTK787, sunitininb and cediranib) that has failed to make an impact in the treatment of mCRC

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