1 / 15

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

juana
Télécharger la présentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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.

More Related