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news.New clinical data has demonstrated that Pfizer's Campto, when given in the infusional regimen 'Folfiri', provided statistically significant longer progression free survival compared to two alternative chemotherapeutic regimens containing Campto.
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In the phase III, open-label study, 430 patients with metastatic colorectal cancer (mCRC) were randomized to receive first-line treatment with one of three Campto-based regimens: Folfiri, mIFL or CapeIRI. The primary endpoint was progression free survival (PFS) of Folfiri compared to mIFL.
In another part of the study, 117 patients with mCRC were randomized to receive first-line treatment with Folfiri plus bevacizumab or mIFL plus bevacizumab.
An analysis showed that the Folfiri regimen provided a statistically significant benefit in PFS (8.2 months) compared with mIFL (six months) or CapeIRI (5.7 months). Pfizer believes that these new data highlight the central role of Folfiri in the first line setting of mCRC to maximize patient benefit with Campto (irinotecan HCL injection).
The study also evaluated the impact of adding bevacizumab to Folfiri and mIFL. A statistically significant improvement in overall survival for patients treated with Folfiri plus bevacizumab was seen when compared with those receiving mIFL plus bevacizumab. A total of 87% of patients were still alive after one year compared to 61% of patients given mIFL plus bevacizumab.