Data presented today at the annual meeting of the American Society of Clinical Oncology (ASCO) demonstrated that CAMPTOSAR® (irinotecan HCL injection), when given in the infusional regimen FOLFIRI , provided statistically significant longer progression free survival (PFS) compared to bolus mIFL and CapeIRI , two alternative chemotherapeutic regimens containing CAMPTOSAR used to treat metastatic colorectal cancer (mCRC). The study also demonstrated a statistically significant benefit in overall survival (OS) for patients treated with FOLFIRI plus bevacizumab when compared with those who received mIFL plus bevacizumab. These new data highlight the central role of FOLFIRI in the first line setting of mCRC to maximize patient benefit with CAMPTOSAR.

The predefined analysis of the primary endpoint showed FOLFIRI provided a statistically significant benefit in PFS (8.2 months) when compared with mIFL (6.0 months) or CapeIRI (5.7 months). In addition the median OS for FOLFIRI was 23.1 months, for mIFL - 17.6 months and for CapeIRI - 18.9 months. Though it did not reach statistical significance, there was a trend favoring FOLFIRI. OS benefit reflects all therapies patients may have received, including 2nd and 3rd lines. The most frequent grade 3/4 adverse events in all arms were diarrhea and neutropenia. In general the toxicity profile favored the FOLFIRI arm. Each arm had a secondary randomization to celecoxib or a placebo. In general, celecoxib neither improved efficacy nor reduced chemotherapy toxicity.

"This study provides strong evidence demonstrating the value of FOLFIRI in the management of metastatic colorectal cancer patients," said Charles Fuchs, M.D., MPH at Dana-Farber Cancer Center in Boston, MA and the lead investigator of the trial. "The data show that FOLFIRI significantly improved PFS when compared with mIFL and CapeIRI and also achieved a median OS of 23.1 months with a manageable safety profile."

The study also evaluated the impact of adding bevacizumab to FOLFIRI and mIFL. A statistically significant improvement in OS for patients treated with FOLFIRI plus bevacizumab was seen when compared with those receiving mIFL plus bevacizumab. A total of 87 percent of patients were still alive after one year compared to 61 percent of patients given mIFL plus bevacizumab. The most frequent grade 3/4 adverse events in both arms were diarrhea, neutropenia and hypertension, with neutropenia and hypertension being higher in the FOLFIRI plus bevacizumab arm.

"This study enhances our understanding of combining FOLFIRI with the targeted agent bevacizumab as a standard treatment in first-line metastatic colorectal cancer patients," said Dr. Fuchs. "FOLFIRI plus bevacizumab significantly improved OS when compared to mIFL plus bevacizumab and both regimens were tolerable."

Rachel Leopold
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Edelman Public Relations
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