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Preoperative chemoradiotherapy WITH CVI 5FU is the standard of care for T3-4 rectal CANCER

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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Preoperative chemoradiotherapy WITH CVI 5FU is the standard of care for T3-4 rectal CANCER

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  1. The Impact of Capecitabine and Oxaliplatin in the Preoperative Multimodality Treatment of Patients with Carcinoma of the Rectum: NSABP R-04 MS Roh, GA Yothers, MJ O'Connell, RW Beart, HC Pitot, AF Shields, DS Parda, S Sharif, CJ Allegra, NJ Petrelli, JC Landry, DP Ryan, A Arora, TL Evans, GS Soori, L Chu, RV Landes, M Mohiuddin, S Lopa, N Wolmark ASCO June 4, 2011 1 pm

  2. Preoperative chemoradiotherapy WITH CVI 5FU is the standard of care for T3-4 rectal CANCER Distant relapse rate is 24-30% Suboptimal compliance to adjuvant therapy Deliver effective systemic chemotherapy during radiation therapy Better compliance Early treatment of systemic disease Decrease local-regional tumor relapse and improve survival NSABP R-04 Background

  3. July 23, 2004 ACTIVATION 2 arm study comparing 5-FU and Capecitabine October 27, 2005 AMENDMENT Added oxaliplatin 2 x 2 factorial design 5-FU and Capecitabine reduced from 7 days per week to 5 days per week during radiation therapy August 16, 2010CLOSED 1,608 accrued patients NSABP R-04

  4. NSABP R-04Surgical Goals Determine if capecitabine administered concurrently with preoperative radiotherapy is similar to continuous IV infusion of 5-FU administered concurrently with preoperative radiotherapy in attaining 1. local-regional disease control 2. sphincter preservation

  5. Compare the rate of local-regional relapse in patients receiving preoperative capecitabine with RT to patients receiving preoperative CVI 5-FU with RT Compare the rate of local-regional relapse in patients receiving preoperative oxaliplatin with those not receiving preoperative oxaliplatin NSABP R-04 Primary Aims

  6. Evaluate if preop administration of capecitabine with or without oxaliplatin given concurrently with RT is similar to the preop administration of CVI 5-FU with or without oxaliplatin given concurrently with RT by Rate of pathologic CR Number of patients undergoing sphincter saving surgery Disease free and overall survival Quality of Life Toxicity Correlating genetic patterns and specific tissue biomarkers with response and prognosis NSABP R-04 Secondary Aims

  7. A collaborative national NCI protocol conducted by NSABP, NCCTG, ECOG, CALGB and SWOG Non-inferiority of capecitabine compared to continuous infusion of 5-FU Superiority FOR the addition of oxaliplatin TO EITHER CAPECITABINE OR 5FU NSABP R-04 Study Design

  8. Adenocarcinoma of rectum amenable to surgical resection located < 12 cm from anal verge STRATIFICATION Gender Clinical Tumor Stage II or III Intent for Type of Surgery (sphincter saving; non-sphincter saving) RANDOMIZATION Group 1 5FU (CVI 225mg/m2 5d/week) + 4600cGy + 540-1080cGy Group 2 5FU (CVI 225mg/m2 5d/week) + Oxaliplatin 50 mg/m2/week X 5 + 4600cGy + 540-1080cGy Group 3 Capecitabine 825 mg/m2 PO BID + 4600cGy + 540-1080cGy Group 4 Capecitabine 825 mg/m2 PO BID + Oxaliplatin 50 mg/m2/week X 5 + 4600cGy + 540-1080cGy SURGERY

  9. Patient Characteristics ** as reported at the time of randomization

  10. NSABP R-04Patient Entry *as of November 30, 2010

  11. Surgical Complications

  12. Gastrointestinal Toxicity5-Fu or CAPE vs addition of Oxaliplatin **CTCAE Version 3.0 No Oxali Oxali 0.04 0.08 0.12 0.16 0.2

  13. 5-FU Cape 0.15 0.2 0.25 0.3 Surgical Downstaging (SD) by Treatment5-FU vs Capecitabine *Restricted to patients without pre-trial intent for SSS

  14. No Oxali Oxali 0.1 0.15 0.2 0.25 0.3 0.35 Surgical Downstaging (SD) by TreatmentOxaliplatin vs None *Restricted to patients without pre-trial intent for SSS

  15. 5-FU Cape 0.56 0.58 0.6 0.62 0.64 0.66 0.68 Sphincter Saving Surgery by Treatment5-FU vs Capecitabine

  16. No Oxali Oxali 0.56 0.58 0.6 0.62 0.64 0.66 0.68 Sphincter Saving Surgery by TreatmentOxaliplatin vs None

  17. 5-FU Cape 0.14 0.16 0.18 0.2 0.22 0.24 0.26 Pathologic Complete Response by Treatment5-FU vs Capecitabine

  18. No Oxali Oxali 0.16 0.18 0.2 0.22 0.24 0.26 Pathologic Complete Response by TreatmentOxaliplatin vs None

  19. NSABP R-04Conclusions 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 Longer follow up will be needed to assess local-regional tumor relapse, DFS and OS

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