Baseline Site and Patient Characteristics
The study involved 34 medical centers across seven European countries, with a final sample of 255 patients. Most patients were female (58.4%), with a median age of 66.0 years at the start of first-line treatment. The majority had right-sided primary tumors (52.5%) and presented with stage IV disease at diagnosis (66.4%). The liver was the most common site of metastasis (58.0%).
Treatment Patterns
For first-line therapy, 74.5% of patients received doublet chemotherapy, either alone or in combination with targeted therapy. The main treatments were FOLFOX plus bevacizumab, FOLFOX alone, and FOLFOXIRI plus bevacizumab. The median duration of treatment was 4.9 months. Subsequently, 52.5% and 30.2% of patients received second- and third-line treatments, respectively.
Effectiveness
Median progression-free survival (PFS) across all first-line regimens was 6.0 months, and median overall survival (OS) was 12.7 months. The presence of three or more metastatic sites and liver metastases were significant predictors of OS. The overall response rate (ORR) was 32.9%, with higher response rates observed in patients receiving triplet chemotherapy plus targeted therapy.
Safety
A total of 51.4% of patients experienced at least one relevant adverse event during first-line treatment, with the highest rate associated with triplet chemotherapy plus targeted treatment. The most frequent adverse events were diarrhea, peripheral neuropathy, asthenia, and neutropenia.
Discussion
The CAPSTAN CRC study provides valuable insights into the real-world management of BRAFV600E-mutant mCRC in Europe. It highlights the aggressive biology of this disease and the importance of early detection and personalized treatment strategies. The study also underscores the need for more effective first-line treatments and the potential of targeted agents and immunotherapy in improving outcomes for these patients.
