Omar Abdel-Rahman1,2. 1. Clinical Oncology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt. 2. Department of Oncology, University of Calgary and Tom Baker Cancer Center, Calgary, Alberta, Canada.
Abstract
BACKGROUND: The purpose of the current study is to investigate the impact of baseline characteristics on the outcomes of extensive-stage small cell lung cancer (SCLC) patients recruited into a clinical trial. METHODS: This is a secondary analysis of the control arm (etoposide/carboplatin arm) of the 'NCT00363415' study which is a phase III study conducted between 2006 and 2007. Univariate analysis of factors affecting overall and progression-free survival (PFS) was conducted through Cox regression analysis [including age, race, gender, Eastern Cooperative Oncology Group performance score, body mass index, Lactate dehydrogenase, number of metastatic sites and brain metastases]. Factors with P < .05 in the univariate analysis were then included in the multivariate analysis. RESULTS: All patients within the control arm (etoposide/carboplatin) were included in the analysis (N = 455 patients). The following factors were predictive of worse overall survival (OS) in univariate analysis (P < .05): performance score = 2, LDH > upper limit of normal and ≥3 metastatic sites. Multivariate Cox regression analysis incorporating these three factors showed that only number of metastatic sites predicts worse OS (P < .0001). Likewise, the following factors were associated with worse PFS in univariate analysis (P < .05): performance score = 2 and ≥ 3 metastatic sites predict worse PFS (P < .05). Multivariate analysis incorporating these two factors showed that only number of metastatic sites predicts worse PFS (P < .0001). CONCLUSION: Number of metastatic sites is the most important predictive factor for overall and PFS among patients with extensive-stage SCLC treated withsystemic chemotherapy within a clinical trial.
RCT Entities:
BACKGROUND: The purpose of the current study is to investigate the impact of baseline characteristics on the outcomes of extensive-stage small cell lung cancer (SCLC) patients recruited into a clinical trial. METHODS: This is a secondary analysis of the control arm (etoposide/carboplatin arm) of the 'NCT00363415' study which is a phase III study conducted between 2006 and 2007. Univariate analysis of factors affecting overall and progression-free survival (PFS) was conducted through Cox regression analysis [including age, race, gender, Eastern Cooperative Oncology Group performance score, body mass index, Lactate dehydrogenase, number of metastatic sites and brain metastases]. Factors with P < .05 in the univariate analysis were then included in the multivariate analysis. RESULTS: All patients within the control arm (etoposide/carboplatin) were included in the analysis (N = 455 patients). The following factors were predictive of worse overall survival (OS) in univariate analysis (P < .05): performance score = 2, LDH > upper limit of normal and ≥3 metastatic sites. Multivariate Cox regression analysis incorporating these three factors showed that only number of metastatic sites predicts worse OS (P < .0001). Likewise, the following factors were associated with worse PFS in univariate analysis (P < .05): performance score = 2 and ≥ 3 metastatic sites predict worse PFS (P < .05). Multivariate analysis incorporating these two factors showed that only number of metastatic sites predicts worse PFS (P < .0001). CONCLUSION: Number of metastatic sites is the most important predictive factor for overall and PFS among patients with extensive-stage SCLC treated with systemic chemotherapy within a clinical trial.
Authors: Daniel Shepshelovich; Wei Xu; Lin Lu; Aline Fares; Ping Yang; David Christiani; Jie Zhang; Kouya Shiraishi; Brid M Ryan; Chu Chen; Ann G Schwartz; Adonina Tardon; Xifeng Wu; Matthew B Schabath; M Dawn Teare; Loic Le Marchand; Zuo-Feng Zhang; John K Field; Hermann Brenner; Nancy Diao; Juntao Xie; Takashi Kohno; Curtis C Harris; Angela S Wenzlaff; Guillermo Fernandez-Tardon; Yuanqing Ye; Fiona Taylor; Lynne R Wilkens; Michael Davies; Yi Liu; Matt J Barnett; Gary E Goodman; Hal Morgenstern; Bernd Holleczek; M Catherine Brown; Geoffrey Liu; Rayjean J Hung Journal: J Thorac Oncol Date: 2019-06-01 Impact factor: 15.609