Survival of patients in a phase I clinic: The M. D. Anderson Cancer Center experience

Outcomes of Patients with Advanced Non-Small Cell Lung Cancer Treated in a Phase I Clinic

“…Several retrospective studies evaluated prognostic factors for survival to determine the risks for early mortality in the phase I setting [43][44][45][46][47][48]. A group from Royal Marsden Hospital in London developed a prognostic score for predicting survival, which included albumin, LDH, and number of metastatic sites, and validated it in a prospective study with 78 patients [49].…”

“…A group from Royal Marsden Hospital in London developed a prognostic score for predicting survival, which included albumin, LDH, and number of metastatic sites, and validated it in a prospective study with 78 patients [49]. Previously, we reported a retrospectively developed prognostic score that included the presence of liver metastases, a history of thromboembolism, and an elevated platelet count (Ͼ440 ϫ 10 9 /L) [44]. In our retrospective study, among other prognostic factors, we evaluated both prognostic scores in pa- tients with NSCLC.…”

Risks and Benefits of Phase 1 Clinical Trial Participation

“…21 In an effort to select which patients might reasonably survive long enough to accrue safety data for phase 1 studies, many scoring systems have been formulated to help select patients with the lowest risk of mortality. 22,23 For instance, Wheler et al 24 retrospectively determined that a history of thromboembolism, the presence of liver metastasis, and thrombocytosis predicted a shorter survival rate in patients enrolled in phase 1 clinical trials, with each parameter bearing comparable risk of death and weighed equally. From these data, they developed a risk score with corresponding risk groups and 6-and 12-month survival rates (low risk = 73%, 51%; intermediate risk = 65%, 34%; high risk = 35%, 6%, respectively).…”

“…From these data, they developed a risk score with corresponding risk groups and 6-and 12-month survival rates (low risk = 73%, 51%; intermediate risk = 65%, 34%; high risk = 35%, 6%, respectively). 24 This study was the first to report the survival rate of phase 1 participants in the era of biologically and molecularly targeted therapy. A median overall survival (OS) rate of 9 months was reported in this study, 24 which is in contrast to the median OS rate of 5 months in the era of cytotoxic therapy and ECOG PS and LDH levels.…”

Role of Platelet Counts in Prognostication of Head And Neck Squamous Cell Carcinoma.

“…2,3,4,5 Surgery is the preferred treatment for these malignancies. However, even after great progress in chemotherapy, radiotherapy and targeted therapy, prognosis of head and neck squamous cell carcinoma is poor owing to aggressive local invasion and metastasis leading to recurrence.…”