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In this regard, it should be reminded that both MABEL and Bond trials were also conducted without previous k-RAS testing.
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13 A large multinational trial was designed to confirm the results of the BOND trial in a heavily pretreated population with patients progressing on irinotecan-containing regimens.
The response rate seen in this trial is very similar to that observed with weekly cetuximab administration in the BOND trial (Cunningham et al, 2004).
Based on a phase II-study and the mono-arm of the BOND trial cetuximab was introduced as monotherapy option in irinotecan-refractory colorectal cancer.
27 A similar design to the BOND trial, but with the addition of bevacizumab, was tested in irinotecan-refractory patients in a small phase II study.
10 The so-called BOND trial investigated cetuximab either as monotherapy or in combination with irinotecan in patients refractory to irinotecan.
The BOND trial assigned patients with disease progression within three months after irinotecan-based chemotherapy to receive cetuximab with or without irinotecan.
Both studies included mainly pts with a good performance status (ECOG 0 1) and a median age in the Bond trial of 59 years and of 62 years in the MABEL study.
This stands in contrast to the Bond and MABEL trials, which recruited pts in a similar therapeutic situation, but with better performance status: in the Bond trial, 87.7% of all pts showed a Karnofsky Performance Status (KPS) score of 80 100% (Cunningham et al, 2004).
Cetuximab was licensed for use in epidermal growth factor receptor (EGFR -expressing ACRC on thEGFR -expressinghACRCII BonD theal (Cunningham et al, 2004) in which 218 irinotecan-refractory patients received cetuximabasis irinofecan combinathen theraphased 111 receIIed cetuximaBONDnotrialpy.
In the Bond trial (329 pts), the combination of cetuximab plus irinotecan showed an improved response rate (RR) of 23% and a prolonged time to progression (TTP) of 4.1 months compared with cetuximab monotherapy (RR 10.8% and TTP 1.5 months) in irinotecan-refractory pts (Cunningham et al, 2004).
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