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Authors: Dr. C. Ascehle on behalf of the STAR Network Investigators

Preoperative fluorouracil (FU)-based chemoradiation +/- weekly oxaliplatin in locally advanced rectal cancer. Pathologic response analysis of the STAR (Studio Terapia Adiuvante Retto)-01 randomized phase III trial. Authors: Dr. C. Ascehle on behalf of the STAR Network Investigators

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Authors: Dr. C. Ascehle on behalf of the STAR Network Investigators

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  1. Preoperative fluorouracil (FU)-based chemoradiation +/- weekly oxaliplatin in locally advanced rectal cancer. Pathologic response analysis of the STAR (Studio Terapia Adiuvante Retto)-01 randomized phase III trial Authors: Dr. C. Ascehle on behalf of the STAR Network Investigators Date posted: ASCO Oral Presentation June 2009 Reviewed by Dr. Christopher Booth

  2. Treatment A: 50.4 Gy with 5-FU CIV 225 mg/m2/d R Treatment B: 50.4 Gy with 5-FU CIV 225 mg/m2/d PLUS Oxaliplatin 60 mg/m2 weekly x 6 cT3/4 or cN+ resectable rectal cancer N=747 All cases had TME 6-8 weeks later and post-op adjuvant 5-FU chemo as per centre policy Primary EP was OS

  3. RESULTS

  4. STUDY COMMENTARY • This trial sought to improve on outcomes in rectal cancer by adding oxaliplatin to standard 5-FU based CRT • The trial primary EP was OS which is not yet reported • This presentation related to the secondary EP of pathologic CR and toxicity • Surprisingly, these data do not show ANY improvement in rate of pathologic CR when oxaliplatin is added to standard 5-FU based neoadjuvant CRT • Oxaliplatin added substantial toxicity to treatment

  5. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Standard of care for stage II/III rectal cancer remains 5-FU based neoadjuvant CRT without oxaliplatin.

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