BACKGROUND: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC). PATIENTS AND METHODS: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles. RESULTS:Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B. CONCLUSION: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.
RCT Entities:
BACKGROUND: To determine the activity and tolerability of adding cetuximab to the oxaliplatin and capecitabine (XELOX) combination in first-line treatment of metastatic colorectal cancer (MCC). PATIENTS AND METHODS: In a multicenter two-arm phase II trial, patients were randomized to receive oxaliplatin 130 mg/m(2) on day 1 and capecitabine 1000 mg/m(2) twice daily on days 1-14 every 3 weeks alone or in combination with standard dose cetuximab. Treatment was limited to a maximum of six cycles. RESULTS: Seventy-four patients with good performance status entered the trial. Objective partial response rates after external review and radiological confirmation were 14% and 41% in the XELOX and in the XELOX + Cetuximab arm, respectively. Stable disease has been observed in 62% and 35% of the patients, with 76% disease control in both arms. Cetuximab led to skin rash in 65% of the patients. The median overall survival was 16.5 months for arm A and 20.5 months for arm B. The median time to progression was 5.8 months for arm A and 7.2 months for arm B. CONCLUSION: Differences in response rates between the treatment arms indicate that cetuximab may improve outcome with XELOX. The correct place of the cetuximab, oxaliplatin and fluoropyrimidine combinations in first-line treatment of MCC has to be assessed in phase III trials.
Authors: Roy S Herbst; Karen Kelly; Kari Chansky; Philip C Mack; Wilbur A Franklin; Fred R Hirsch; James N Atkins; Shaker R Dakhil; Kathy S Albain; Edward S Kim; Mary Redman; John J Crowley; David R Gandara Journal: J Clin Oncol Date: 2010-10-04 Impact factor: 44.544
Authors: George Papaxoinis; Vassiliki Kotoula; Eleni Giannoulatou; Georgia-Angeliki Koliou; Vasilios Karavasilis; Sotirios Lakis; Andreas Koureas; Mattheos Bobos; Elpida Chalaralambous; Emily Daskalaki; Kyriakos Chatzopoulos; George Tsironis; Elisavet Pazarli; Sofia Chrisafi; Epaminontas Samantas; Ioannis G Kaklamanos; Ioannis Varthalitis; Athina Konstantara; Konstantinos N Syrigos; George Pentheroudakis; Dimitrios Pectasides; George Fountzilas Journal: Med Oncol Date: 2018-05-31 Impact factor: 3.064