Objective responses in patients with malignant melanoma or renal cell cancer in early clinical studies do not predict regulatory approval.

摘要: Purpose: Tumor responses in early-phase trials are used to determine whether new agents warrant further study. Given that spontaneous regressions observed melanoma and renal cell carcinoma, this study assessed tumor responses, particularly these two types, predict for future regulatory drug approval. Experimental Design: The literature was reviewed assess response rates cytotoxic phase I II the following solid tumors: melanoma, non–small-cell lung cancer, breast ovarian colorectal other tumors. Response were categorized relationship of categories end point approval determined. Results: Fifty-eight drugs 100 trials, 46 also studied 499 trials. Higher overall both ( P = 0.03) Conclusions: For agents, although objective reliably subsequent marketing approval, isolated carcinoma not predictive.