Source: DGNews  |  Posted 8 years ago

There was an error in a recent article from our coverage of the 94th Annual Meeting of the American Association for Cancer Research.

The original text read:
The experimental antiangiogenesis agent Avastin was added to 5-fluorouracil/leucovorin chemotherapy (FU/LV/BV) as part of the third arm of a study on the drug. This third-arm study randomised 403 patients to receive Avastin plus the standard of care chemotherapy (Saltz regimen) with 5-FU/leucovorin/irinotecan (5-FU/LV/CPT-11); 412 received the Saltz regimen plus placebo; and 110 patients received Avastin plus 5-FU/leucovorin/CPT-11 chemotherapy.

The latest results reported by Dr. Folkman were based on the results obtained in the 110 patients who received Avastin plus 5-FU/leucovorin/CPT-11, which were compared to previous results in 101 patients randomised to the Saltz regimen plus Avastin and a further 101 patients randomised to Saltz plus placebo "during the time that the third arm was recruiting patients." (The third arm was dropped, as pre-specified, once safety of the Saltz regimen was established.)

Median survival for FU/LV/BV patients was 18.3 months compared to 15.6 months for patients treated with 5-FU/LV/CPT-11 (IFL) and placebo. Median survival for patients randomised to IFL plus Avastin (IFL/BV) was 20.3 months, which was statistically significant.

The corrected text now reads:

The primary experimental arms of the study compared the addition of the antiangiogenesis agent Avastin to the standard of care chemotherapy (Saltz regimen), irinotecan/5-fluorouracil/leucovorin (IFL). 403 patients were randomized to receive Avastin vs 412 who received the Saltz regimen plus placebo. Initially, 110 patients were randomized to a third arm of the study in which they received Avastin plus 5FU/leucovorin (5FU/LV). This third arm was discontinued at a prespecified safety analysis when it was demonstrated that the addition of Avastin to IFL did not significantly increase toxicity compared to IFL plus placebo.

The latest results presented by Dr. Hurwitz at AACR were based on the results obtained in the 110 patients who received Avastin plus 5-FU/LV, which were compared to previous results in 101 patients randomized to IFL plus Avastin and a further 101 patients randomized to IFL plus placebo "during the time that the third arm was recruiting patients." (The third arm was dropped, as prespecified, once safety of the IFL regimen was established.)

Median survival for Avastin plus 5-FU/LV patients was 18.3 months compared to 15.6 months for patients treated with IFL and placebo. Median survival for patients randomized to IFL plus Avastin was 20.3 months, a statistically significant increase over IFL plus placebo."

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