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Authors: Hofheinz et al Reviewed By: Scott Berry Date posted: June 2011

Capecitabine versus 5-fluorouracil-based (neo-)adjuvant chemo-radiotherapy for locally advanced rectal cancer: Long term results of a randomized phase III trial. Authors: Hofheinz et al Reviewed By: Scott Berry Date posted: June 2011.

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Authors: Hofheinz et al Reviewed By: Scott Berry Date posted: June 2011

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  1. Capecitabine versus 5-fluorouracil-based (neo-)adjuvant chemo-radiotherapy for locally advanced rectal cancer:Long term results of a randomized phase III trial Authors: Hofheinz et al Reviewed By: Scott Berry Date posted: June 2011

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Scott Berry when using these slides.

  3. Study Design N=392 Resectable Stage II/II Rectal Cancer Primary Outcome: 5 Yr OS (non-inferiority) Mar 2002-July2005 Post-Op Treatment

  4. Study Design N=392 Resectable Stage II/II Rectal Cancer Primary Outcome: 5 Yr OS (non-inferiority) Post July 2005 After Publication of Sauer Trial Neoadjuvant Treatment Arms Added

  5. Study Design Arm A Chemoradiotherapy 50.4 Gy + Cape 1,650 mg/m² days 1 – 38 plus 5 cycles of Cape 2,500 mg/m² d 1 – 14, rep. d 22 S I: 2 x Cape  CRT  3 x Cape S II: CRT  TME surgery (4 – 6 weeks after CRT)  Cape x 5 Arm B Chemoradiotherapy 50.4 Gy + 5-FU 225 mg/m² c.i. daily [S I] or 5-FU 1,000 mg/m² c.i. d 1 – 5 and 29 – 33 [S II] plus 4 cycles of bolus 5-FU 500mg/m² d 1 – 5, rep. d 29 S I: 2 x 5-FU  CRT  2 x 5-FU S II: CRT  TME surgery (4 – 6 weeks after CRT)  5-FU x 4 Cape: capecitabine; CRT: chemoradiotherapy; TME: total mesorectal excision; 5-FU: 5-fluorouracil

  6. Study Design

  7. RESULTS % of Patients Receiving All Scheduled Cycles

  8. RESULTS

  9. Neoadjuvant Group – Trend of Improved Downstaging with Capecitabine Patients receiving capecitabine exhibited • less ypN-positive tumors (p = 0.09) • improved T-downstaging (i.e. ypT0 – 2) (p = 0.07) • more pCR (ypT0 ypN0): 13.2 % vs. 5.4% (p = 0.16)

  10. Hand-foot skin reaction (HFS) Comparison of 3-y DFS and 5-y OS

  11. TOXICITY

  12. TOXICITY

  13. Diarrhea Cycles without radiotherapy Cycles with radiotherapy

  14. TOXICITY

  15. Author’s Conclusions • Both treatment regimens were well tolerated. Cape patients had more all grade HFS, proctitis, diarrhea and fatigue, while alopecia and leukopenia were more frequently observed with 5-FU. • In the neo-adjuvant stratum Cape led by trend to improved downstaging and a numerical higher rate of pCR. • Cape was non-inferior to 5-FU regarding 5-year survival. • Exploratory test for superiority was borderline significant. • 3-year DFS was significantly better with Cape. • HFS indicated superior 3-year DFS and 5-year OS. • Capecitabine may replace 5-FU in the perioperative treatment of locally advanced rectal cancer.

  16. Bottom Line For Canadian Medical Oncologists • Many Canadian oncologists have already started using capecitabine as the systemic therapy component of neo-adjuvant and adjuvant therapy of rectal cancer based on • Extrapolation from adjuvant colon cancer trials for the chemotherapy component • Based on the results of phase II trials, population based outcome studies and interim results of phase III trials for the chemorads component • This results of this study affirm that practice

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