Abstract
BackgroundFew studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials.Methods and FindingsWe searched for trials that were reported between January 1981 and August 2008. Phase III randomized controlled trials were eligible if they compared first-line, systemic chemotherapy for ED-SCLC. Data were evaluated by using a linear regression analysis. Results: In total, 52 trials were identified that had been initiated between 1980 and 2006; these studies involved 10,262 patients with 110 chemotherapy arms. The number of randomized patients and the proportion of patients with good performance status (PS) increased over time. Cisplatin-based regimens, especially cisplatin and etoposide (PE) regimen, have increasingly been studied, whereas cyclophosphamide, doxorubicin, and vincristine–based regimens have been less investigated. Multiple regression analysis showed no significant improvement in survival over the years. Additionally, the use of a PE regimen did not affect survival, whereas the proportion of patients with good PS and the trial design of assigning prophylactic cranial irradiation were significantly associated with favorable outcome.Conclusions and SignificanceThe survival of patients with ED-SCLC enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care.
Highlights
Lung cancer is a leading cause of cancer-related mortality in many industrialized countries
The survival of patients with extensive disease small-cell lung cancer (ED-Small-cell lung cancer (SCLC)) enrolled in phase III trials did not improve significantly over the years, suggesting the need for further development of novel targets, newer agents, and comprehensive patient care
The number of randomized patients and the proportion of patients with good performance status (PS) increased over time (13.9 patient increase/year, P,0.001; and 1.32% increase/year, P,0.001, respectively; Figures 2A and 2B), whereas the proportion of male patients remained consistent (0.47% decrease/year, P = 0.114; Figure 2C)
Summary
Lung cancer is a leading cause of cancer-related mortality in many industrialized countries. In 1999, the results of a systemic review indicated a modest improvement over the years in the survival time of patients with ED-SCLC treated with chemotherapy between 1972 and 1994 [3]. This improvement was potentially attributable to (i) introduction of the PE regimen in the late 1980s and (ii) improvements in the supportive care and general management of the patients. Few studies have formally assessed whether treatment outcomes have improved substantially over the years for patients with extensive disease small-cell lung cancer (ED-SCLC) enrolled in phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials
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