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- W2247121148 abstract "6508 Background: The ethical issues of conducting phase I trials revolve around the purported aim of phase I trials to assess safety/toxicity of new cancer therapies without having benefit of patients as one of the stated goals. However, the existing, albeit limited, empirical data do point that patients enrolled in phase I trials can in effect benefit from novel therapies. In the most comprehensive study to date, Horstmann et al (NEJM 2005; 352:895) found that 4–18% of patient tumors do respond to therapy. In their study, treatment-related mortality was 0.49%. However, neither this, nor any other study in the literature reported data on patients' survival, which is clearly a most important outcome for patients. Methods: Data from 1,361 individual consecutive patients enrolled from January 1998 to October 2007 in 159 trials at the Moffitt Cancer Center were available for the analysis. 244 patients enrolled in more than 1 phase I trials and were excluded from this analysis. Both high-dose and standard dose single agent and combination chemotherapy trials with investigational agents were available for the analysis. Kaplan-Meier survival analyses were used to calculate duration of survival (benefits), while the proportion of patients dying during first 30 days was employed as a surrogate for treatment-related mortality (risks). Results: Patients with all cancers are included in the analysis, but the majority of patients had a hematological malignancy (N=389), lung cancer (N=245) or a gastrointestinal malignancy (N=114). Median survival for the entire cohort was 1.2 years, but approximately 25% of the patients lived longer than 3 years with about 10% surviving at 6 years or beyond. 10.7% (96/895) of patients died during first 30 days of treatment from all causes including rapid tumor progression. Conclusions: A substantial number of patients enrolled in phase I trials have a meaningful survival. The notion that phase I trials enroll dying patients with no prospect for benefits should be dispelled. No significant financial relationships to disclose." @default.
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- W2247121148 date "2008-05-20" @default.
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- W2247121148 title "Benefits (survival) and risks (30 days mortality) of phase I trials in oncology" @default.
- W2247121148 doi "https://doi.org/10.1200/jco.2008.26.15_suppl.6508" @default.
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