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V. Heinemann University of Munich – Klinikum Großhadern, Munich, Germany

Cetuximab + Capecitabine + Irinotecan (CCI) Versus Cetuximab + Capecitabine + Oxaliplatin (CCO) as 1st-Line Therapy for Patients With Metastatic Colorectal Cancer (CRC): Randomized Phase II Trial of the AIO CRC Study Group. V. Heinemann

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V. Heinemann University of Munich – Klinikum Großhadern, Munich, Germany

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  1. Cetuximab + Capecitabine + Irinotecan (CCI) Versus Cetuximab + Capecitabine + Oxaliplatin (CCO) as 1st-Line Therapy for Patients With Metastatic Colorectal Cancer (CRC): Randomized Phase II Trial of the AIO CRC Study Group. V. Heinemann University of Munich – Klinikum Großhadern, Munich, Germany

  2. Recruiting Centres

  3. Treatment Regimens Day: 1 8 15 21 Arm A:(*) Irinotecan 200mg/m², 30min i.v. Cetuximab (**) 250mg/m², 60min i.v. Capecitabine 800mg/m² p.o., twice daily Arm B: Oxaliplatin 130mg/m², 120min i.v. Cetuximab (**) 250mg/m², 60min i.v. Capecitabine 1000mg/m² p.o., twice daily (*): 20% dose reduction for patients > 65 years, arm A (**): Cetuximab loading dose (only week 1): 400mg/m², 120min q 3 weeks

  4. Primary Endpoint:Response rate. Secondary Endpoints:Time to progression Disease stabilisation rate (CR+PR+SD) Tolerability Grade 3/4- toxicities.

  5. Recruitment and Evaluation * The recruitment goal was extended with an amendment of the protocol

  6. Patient Characteristics

  7. Type of Adjuvant Pretreatment

  8. Location of Metastases

  9. EGF-Receptor Status

  10. Dose Reductions / Delayed Cycles

  11. Allergic Reactions Related to Cetuximab (Manifestation at First Application)

  12. CCI CCO 12 10,8 10,8 10 8,1 8 5,4 6 4 2,7 2,7 2 0,0 0,0 0,0 0,0 0,0 0,0 0 Anemia Fever Fever Neutrop. Leukopenia Neutropenia Thrombopenia Non-Hematological Toxicityper patient analysis %

  13. 35 29,7 30 25 21,6 18,9 20 18,9 18,9 16,2 15 13,5 10,8 10 5,4 5,4 5 2,7 2,7 2,7 2,7 0,0 0,0 0,0 0,0 0 Pain Fatigue Diarrhoe Alopecia Stomatitis Obstipation Skin Toxicity Neurotoxicity Nausea/Vomiting CCI CCO Hematological Toxicityper patient analysis %

  14. Best Response During Treatment

  15. Conclusions: • Both treatment arms – CCI and CCO – are feasible and highly effective. • In the CCI arm, most common Grade 3-4 toxicities were diarrhea (19%), skin toxicity (19%), nausea and vomiting (14%), pain (11%), and anemia (11%). • In the CCO arm, most common Grade 3-4 toxicities were skin toxicity (30%), diarrhea (22%), neurotoxicity (19%) and nausea and vomiting (16%). • Non-hematological toxicity appears to be greater in the CCO arm, possibly also related to the higher dose of capecitabine used in this arm. • Hematological toxicity appears to be greater in the CCI arm. • Disease control rates are equally high: 88.9% in the CCI arm and 92.0% in the CCO arm (p=1.0). • The accrual of the CIOX-trial is ongoing.

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