Cetuximab Plus @entity2600 in pretreated metastatic @entity14 progressing on XXXX : the LABEL study.

@entity1 @entity137 @entity2600 @entity1910 @entity3145 @entity470 @entity294 @entity1398 @entity14 @entity1349
BACKGROUND: The aim of this multicenter phase II study was to demonstrate the activity of the @entity470 ( @entity470 )-targeting monoclonal antibody cetuximab combined with @entity2600 in the treatment of Latin American @entity1 with @entity470 -expressing metastatic @entity14 (mCRC) in whom previous treatment with an @entity2600 -containing regimen had failed. @entity1 AND METHODS: @entity1 received cetuximab, as a 400 mg/m2 initial infusion followed by 250 mg/m2 weekly, plus the same @entity2600 regimen that had previously failed, until the occurrence of disease progression or unacceptable @entity137 . The primary endpoint was response. Secondary endpoints included progression-free survival (PFS), duration of response, @entity1349 ( @entity1349 ), and safety. RESULTS: Seventy-nine @entity1 received treatment. One @entity1 had a complete response, 20 had partial responses, and disease was stabilized in 23 @entity1 , giving an overall response rate of 27% and a disease control rate of 56%. The median duration of response was 23.9 weeks. Median PFS was 17.4 weeks, median @entity1349 was 9.2 months, and the 12-month @entity1349 rate was 38%. The most common adverse events according to System Organ Class were skin and @entity3145 (91% of the @entity1 ). Grade 3/4 adverse events occurred in 45 @entity1 (57%), with the most common being @entity294 (20%), @entity1398 (11%), and @entity1910 (6%). Seven @entity1 (9%) had grade 3/4 acne-like @entity1910 . No grade 3/4 infusion-related reactions were reported. CONCLUSION: Cetuximab in combination with @entity2600 is active and tolerable in Latin American @entity1 with mCRC progressing on @entity2600 , with a safety profile similar to that described in European studies.
