Trial confirms irinotecan role in metastatic colorectal cancer
Data presented for the first time in Europe reinforce the position of irinotecan as a key component of first line therapy in the management of patients with metastatic colorectal cancer (mCRC). The Crystal trial, just presented at the 9th World Congress on Gastrointestinal Cancer, evaluated cetuximab combined with the irinotecan-based chemotherapy regimen Folfiri versus Folfiri alone, in patients with mCRC. Results showed that the risk of cancer spreading or growing was reduced by 15 percent for patients in the Folfiri plus cetuximab arm (p=0.0479), and that significantly more patients in this arm experienced a shrink in tumour size (46.9 versus 38.7 percent in the Folfiri only arm, p=0.0038).

Furthermore, in a subgroup analysis of patients who had liver-limited disease (patients who had liver metastases only), the positive effect of the addition of cetuximab was even more pronounced, resulting in a progression-free survival of 11.4 months with cetuximab versus 9.2 months in the control arm, and a 36 percent reduction in the risk of mCRC growing or spreading. The number of complete resections of the metastases in the subgroup who had liver metastases only was more than double with cetuximab plus FOLFIRI versus the control arm (9.8 versus 4.5 percent). The number of complete resections in the overall population was three times higher in the cetuximab plus Folfiri arm.

“The results of this trial confirm the benefits of improving and refining treatment regimens to get better patient outcomes,” said Markus Moehler, assistant professor for GI oncology, Johannes Gutenberg University, Mainz, Germany. “Additionally, this trial confirms the evidence of the updated BICC-C trial, presented at ASCO in 2007, which assessed first line therapy with Folfiri and bevacizumab in patients with mCRC.”

The Crsytal and BICC-C data continue to reinforce evidence from previous clinical studies, demonstrating the efficacy of irinotecan as a first line therapy of choice for patients with mCRC, as Folfiri alone, or combined with these targeted agents.