Erbitux - Abstract 642: Cetuximab plus oxaliplatin/5-fluorouracil (5-FU)/folinic acid (FA) (FOLFOX-4) for the epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC) in the first-line setting: a phase II study
Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 181
A. Cervantes1, E. Casado2, E. Van Cutsem3, J. Sastre4, T. André5, Y. Humblet6, J. Van Laethem7, A. Zubel8, N. Gascón9, A. de Gramont10
1Hospital Clínico Universitario de Valencia, Servicio Oncología Médica, Valencia, Spain
2Vall d'Hebron University Hospital, Barcelona, Spain
3Univ. Hosp Gasthuisberg, Leuven, Belgium
4Hosp Clínico San Carlos, Madrid, Spain
5Hôpital Tenon, Paris, France
6Cliniques Universitaires St. Luc, Brussels, Belgium
7Hôpital Universitaire Erasme, Brussels, Belgium
8Merck KGaA, Darmstadt, Germany
9Merck Farma y Química, Barcelona, Spain
10Hosp. Saint-Antoine, Paris, France
Background:
The EGFR is highly expressed in mCRC and is commonly associated with more aggressive disease and resistance to radiotherapy.
Cetuximab (Erbitux®) is an IgG1 monoclonal antibody (MAb) that specifically targets the EGFR. FOLFOX-4 is a standard option for the first-line treatment of mCRC.
The aim of this phase II study was to investigate the safety and efficacy of combining cetuximab and FOLFOX-4 in EGFR-expressing mCRC in this setting.
Materials and methods:
Patients with non-resectable EGFR-expressing mCRC, who had not received previous chemotherapy, were treated with cetuximab (400 mg/m2 week 1 and 250 mg/m2 weekly thereafter) plus FOLFOX-4 (every 2 weeks: oxaliplatin 85 mg/m2, day 1; FA 200 mg/m2 IV 2h and 5-FU 400 mg/m2 IV bolus followed by 600 mg/m2 IV for 22 h, days 1 and 2) until progressive disease or unacceptable toxicity.
Results:
Of the 62 patients enrolled, 52 (84%) had EGFR-expressing disease.
Among 42 evaluable patients, there was an objective response rate of 81% (34/42), with 4 complete (CR) and 30 partial responses (PR). The disease control rate (CR+PR+stable disease) was 98%.
The median duration of response (n = 31) was 330 days (10.9 months) and the median progression-free survival (PFS) was 12.3 months, with a 12-month PFS rate of 52%.
4 patients remain on treatment. 9 patients (21%) with initially unresectable metastases underwent surgery with curative intent.
In 8 of these, complete resections (R0) were achieved.
Treatment was well tolerated and there were no unexpected toxicities.
The main grade 3/4 adverse events observed per patient were: neurotoxicity and acne-like rash (30% each), diarrhoea (26%), neutropenia (21%) and asthenia (9%). There were no cetuximab-related deaths.
Conclusions:
This study shows that combining FOLFOX-4 with cetuximab is safe and active in the first-line treatment of EGFR-expressing mCRC.
In addition to achieving high response and disease control rates, the combination enabled one-fifth of patients to undergo resection of liver metastases.
A simplified independent read is in process to provide an objective review of the responses reported by the investigators. The results of independent read will be presented at ECCO.
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