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Post G.I. ASCO Update: Colorectal Cancer

Post G.I. ASCO Update: Colorectal Cancer. Ronald Burkes, M.D. Disclosure of Potential Conflicts of Interest. Honoraria:. Amgen Inc., Eli Lilly and Company, Hoffmann-La Roche, AstraZeneca, Sanofi-Aventis. Speaker:. Amgen Inc., Eli Lilly and Company, Hoffmann-La Roche, AstraZeneca.

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Post G.I. ASCO Update: Colorectal Cancer

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  1. Post G.I. ASCO Update:Colorectal Cancer Ronald Burkes, M.D.

  2. Disclosure of Potential Conflicts of Interest Honoraria: Amgen Inc., Eli Lilly and Company, Hoffmann-La Roche, AstraZeneca, Sanofi-Aventis Speaker: Amgen Inc., Eli Lilly and Company, Hoffmann-La Roche, AstraZeneca Dr. Ronald Burkes Advisory board: Amgen Inc., Eli Lilly and Company, Hoffmann-La Roche, AstraZeneca, Sanofi-Aventis

  3. Objective(s) Review what was new and interesting from G.I. ASCO, 2012 Put these results in perspective Studies to be reviewed: 181 study – FOLFIRI +/- Panitumumab as 2nd-line treatment of mCRC NCIC CO.20 study – Cetuximab +/-Brivanib in KRAS WT mCRC (3rd-line) CORRECT trial – BSC +/- Regorafenib in mCRC (4th-line) XELOXA trial (N016968) – role of adjuvant XELOX for stage III CRC ACCORD 12 trial – Capox in rectal cancer Assessment of the prognostic and predictive value of mutant KRAS codons 12 & 13

  4. FOLFIRI +/- Panitumumab as 2nd-line Therapy of mCRC: 181 studySobrero GI ASCO (#387), 2012

  5. Comments: 181 Final analysis is consistent with the primary analysis There is an improvement in PFS and RR but not OS Not likely to be used as a 2nd-line option since no OS but may be appropriate for some pts when response is necessary (? still potentially resectable) Rash/efficacy interaction seems to be important, but not well understood The inability to mount a skin reaction to an anti- EGFR antibody seems to be associated with a shorter survival → what should we do with patients who don’t develop a rash (should they stop the anti-EGFR MoAb) ?

  6. Brivanib – anti-VEGFR2 inhibitor and also targets fibroblast growth receptors

  7. Cetuximab +/- Brivanib in Refractory KRAS WT mCRC: NCIC CO.20Siu GI ASCO (#386), 2012

  8. Comments: CO.20 • PFS and RR benefit but no OS benefit (primary endpoint!) → no significant x-over • Toxicity of the combination may have confounded efficacy → DI; D/C Rx 20 AEs • Potential biological antagonism → PACCE and CAIRO-2 • Unlikely to gain regulatory approval and/or use in combination with cetuximab • Phase III HCC monotherapy trials are ongoing

  9. NB: no PS 2 patients on study

  10. BSC +/- Regorafinib in Refractory mCRC: CORRECT Trial (no PS2, no x-over)Grothey GI ASCO (#385), 2012

  11. Comments: CORRECT • OS and PFS benefit • Statistically significant • Clinically meaningful • Toxicity profile not insiginificant (H/F, diarrhea, fatigue, ↑BP) but acceptable • Lack of x-over helped achieve endpoints • Clinical impact • Likely to become an available standard for refractory mCRC – when??? (unmet need) • Role in PS 2 patients is unknown • Role of continuous dosing is unknown

  12. X-ACT vs XELOXA X-ACT XELOXA Twelves GI ASCO (#274), 2008

  13. Twelves GI ASCO (#274), 2008

  14. Comments: XELOXA • XELOX improves DFS and OS compared to bolus 5-FU in patients with stage III colon cancer (median follow-up of 7 years) • Benefit is less in patients > 70 years • XELOX should be considered a treatment option in the adjuvant therapy of stage III colon cancer • q3weeks • less infusion time (impact on chemo unit) • less need for central lines • it is not for everyone – keep a close watch for toxicity

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