605P - Phase II trial of panitumumab in combination with oxaliplatin and capecitabine chemotherapy as 1st line therapy in patients with colorectal cancer a...

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Francesco Leone
Authors F. Leone1, D. Marino2, S. Artale3, C. Cagnazzo2, S. Cascinu4, A.A. Martoni5, A. Sobrero6, M. Tampellini7, S. Siena3, M. Aglietta8
  • 1Oncological Sciences, Fondazione Piemontese per la Ricerca sul Cancro Onlus, IT-10060 - Candiolo/IT
  • 2Medical Oncology, Fondazione Piemontese per la Ricerca sul Cancro Onlus-IRCC Institute for Cancer Research and Treatment, 10060 - Candiolo/IT
  • 3Struttura Complessa Di Oncologia Falck, A.O. Ospedale Niguarda Ca' Granda, Milano/IT
  • 4Dipartimento Di Medicina Clinica E Biotecnologie A, AOU Ospedali Riuniti Ancona Università Politecnica delle Marche, 60126 - Ancona/IT
  • 5Medical Oncology Unit, S. Orsola-Malpighi University Hospital, Bologna, ITALY, 40138 - Bologna/IT
  • 6Oncologia Medica, Azienda Ospedaliera Universitaria S. Martino di Genova, Genova/IT
  • 7Dipartimento Di Oncologia Medica, Azienda Ospedaliera San Luigi, Orbassano/IT
  • 8Div Oncologia Ed Ematologia, Fondazione Piemontese per la Ricerca sul Cancro Onlus, IT-10060 - Candiolo/IT

Abstract

Background

Preoperative chemotherapy improves outcome in potentially resectable colorectal cancer with liver metastases. We evaluated the activity of a neoadiuvant treatment with capecitabine–oxaliplatin (XELOX) associated with the anti-EGFR antibody Panitumumab in patients with unresectable, liver-only, metastatic colorectal cancer (CRC).

Patients and methods

Chemotherapy-naïve patients with unresectable liver metastases of CRC and no other metastatic sites were enrolled. Criteria of unresectability were defined as: more than 3 liver metastases including > 50% hepatic involvement and requiring a major hepatectomy with controlateral wedge resection or any metastases requiring a resection that does not preserve two contiguous hepatic segments. Since November 2008 only patients bearing wild type KRAS were included. All patients received neoadjuvant XELOX plus panitumumab (P-XELOX) and were reevaluated for resectability every four cycles. Primary endpoint was radiological objective response rate (ORR). Secondary endpoints were overall survival (OS), progression free survival (PFS), percentage of patients whose disease became radically resectable, and safety.

Results

Forty-nine patients were recruited, of which 35 were KRAS wild type, and 14 (enrolled before study amendment), were unknown (9 patients) or mutated (5 patients). Forty-six were evaluable for response. Following neoadjuvant P-XELOX, the ORR in the general population was 54%, with 3 CR, 22 PR, 14 SD. In wild type KRAS patients ORR reached 65% (3 CR, 18 PR, 7 SD), and this allowed 15 patients with initial unresectable liver metastasis to be converted to resectability. Survival analysis showed median PFS and OS of 8.5 months and 22.1 months, respectively. Resected patients had significantly better OS if compared to unresected (p = 0.00014). The most common toxicities were cutaneous, gastrointestinal, and neurologic.

Conclusion

Neoadjuvant P-XELOX yields high response rates for patients with metastatic CRC and extensive liver involvement, and leads to remarkable conversion to resectability of liver metastasis.

Disclosure

All authors have declared no conflicts of interest.