The Impact of Capecitabine and Oxaliplatin in the Preoperative Multimodality Treatment of Patients with Carcinoma of the Rectum: NSABP R-04

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The Impact of Capecitabine and Oxaliplatin in the
Preoperative Multimodality Treatment of Patients
with Carcinoma of the Rectum NSABP R-04

• AuthorsRoh et al
• Reviewed By Scott Berry
• Date posted June 2011

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Study Design
N1608 (293 2 arm phase 1315 4 arm
phase) Surgical Oucomes Presented at ASCO 2011
Pre Op
5FU (CVI 225mg/m2 5d/week) 4600cGy
540-1080cGy
R
Oct 2005 /- 50 mg/m2 weekly oxalipaltin
Capecitabine 825 mg/m2 PO BID 4600cGy
540-1080cGy
Resectable Stage II or III AdenoCA of Rectum
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RESULTS
Cape vs 5FU Oxali vs None
pCR 22.2 vs 18.8 p0.12 20.9 vs 19.1 p0.46
Surgical Downstaging 23.0 vs 20.7 p0.62 19.2 vs 23 P0.48
Sphincter Saving Surgery 62.7 vs 61.2 p0.59 60.4 vs 63.6 p0.28
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TOXICITY
Oxali vs None
Grade 3/4 Diarrhea 15.4 vs 6.6 P0.0001
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Surgical Complications
Complication 5FU 5FUOx Cape CapeOx
Any Complication 34.92 37.00 36.89 40.20
Urinary Complication 9.91 9.32 8.79 7.12
Bowel Obstruction/ Ileus 7.27 7.72 7.47 9.06
Re-operation Necessary 5.47 6.00 6.70 5.32
Urinary Retention 5.73 4.82 6.59 4.85
Perineal Wound Infection 4.85 5.47 3.30 5.18
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Study Commentary

• Administration of capecitabine with preoperative
  RT achieved rates similar to continuous infusion
  5-FU for
• Surgical downstaging
• Sphincter saving surgery
• Pathologic complete response
• Addition of oxaliplatin did not improve outcomes
  and added significant toxicity
• This is consitent with the results of the STAR
  and ACCORD trials
• Longer follow up will be needed to assess
  local-regional tumor relapse, DFS and OS

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• Capecitabine has already started to replace
  infusional 5FU in combination with radiation in
  practice and as a standard in large randomized
  clinical trials based on
• the results of phase II trials
• population based outcome studies
• Preliminary results of phase III trials

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BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• The results of this large randomized phase III
  trials affirms the practice of offering
  capecitabine as an alternative to infusional 5FU
  in combination with rads for the neoadjuvant
  treatment of resectable stage II and III rectal
  cancer