Researchers involved in a multi-center US randomized Phase II trial have reported that Neulasta® (pegfilgrastim) was effective in preventing grade 3-4 neutropenia in patients with locally advanced or metastatic colorectal cancer receiving one of three chemotherapy regimens. The details of this study were presented at the 9th World Congress on Gastrointestinal Cancer in Barcelona, June 28- July 1. 

Single dose Neulasta for prevention of neutropenia has primarily been studied in patients with hematologic malignancies and breast cancer. Neulasta has been found effective for preventing neutropenia in patients receiving dose-dense regimens on an every 2 week schedule for the treatment of lymphomas and breast cancer.

The current study included 241 patients with locally advanced or metastatic colorectal cancer who were treated with 5-FU, oxaliplatin, leucovorin (FOLFOX, 49%); 5-FU, irinotecan and leucovorin (FOLFIRI, 26%); or 5-FU, irinotecan, oxaliplatin and leucovorin (FOIL, 25%) as first or second-line therapy. Cycles of therapy were administered every 2 weeks. Neulasta, 6 mg or placebo was administered on the day after completion of 5-FU. After 4 cycles of therapy the incidence of grade 3-4 neutropenia was 43% in the placebo group and 13% in the Neulasta group. Febrile neutropenia rates were low in both arms of the study. Significant adverse events were 35% in the placebo group and 31% in the Neulasta group. These authors concluded that Neulasta was well tolerated and reduced the incidence of grade 3-4 neuropenia.  

Comments: These data confirm that Neulasta can effectively support chemotherapy administered every 2 weeks.

Reference: Hecht J, Malik I, Gollard R, et al. Pegfilgrastim reduces the incidence of neutropenia in patients with locally advanced or metastatic colorectal cancer receiving chemotherapy administered every 2 weeks as first- or second-line treatment: A Phase II, double-blind, placebo controlled study. Proceedings from The 9th World Congress on Gastrointestinal Cancer. Barcelona, Spain. 2007 June 28- July 1, Abstract # PD-0025.

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