Quality Of Life (Qol) Supercedes The Classic Predictors Of Survival In Locally Advanced Non-Small Cell Lung Cancer (Nsclc): An Analysis Of Radiation Therapy Oncology Group (Rtog) 9801

Purpose/Objective(s)This analysis was conducted to determine the added value of QOL as a prognostic factor for overall survival (OS) for patients (pts) with locally advanced NSCLC treated on RTOG 9801.Materials/MethodsThe following pre-treatment factors were analyzed as predictors for OS on univariate and multivariate analysis (MVA): KPS (70–80 vs. 90–100), AJCC stage (II/IIIA vs. IIIB), gender, age, race, marital status, histology (squamous vs. other), tumor location (lower vs. other), hemoglobin (<12 vs. ≥12 g/dL), treatment arm (amifostine [AM] vs. no-AM) and global QOL score (from the EORTC-QLQ-C30 instrument). Only pts with <5% weight loss within 3 months were eligible for enrollment. 243 pts with stage II/IIIAB NSCLC received induction paclitaxel (P) and carboplatin (C) on days 1, 22 and then concurrent weekly P/C and hyperfractionated radiation (69.6 Gy at 1.2 Gy BID). Patients were randomly assigned to AM 500 mg 4×/week or no-AM during chemoradiation. A multivariate Cox proportional hazards model was performed. The models were built using a backwards selection process, eliminating variables that have p-value >0.05.ResultsOf the 239 analyzable patients, 91% had pre-treatment QOL. The median follow-up time for patients still alive was 58.7 months (mo) and 17.3 mo for all patients. The median baseline global QOL score was 66.7 on both treatment arms. Whether the global QOL score was treated as a dichotomized variable (based on the median score of 66.7) or a continuous variable, all other variables fell out of the MVA for OS, except for the global QOL score. Patients with a global QOL score less than the median (66.7) had a 69% higher rate of death than patients with a QOL score ≥ 66.7 (p = 0.002). A clinically meaningful increase in the QOL score (of 10 points) corresponded to a decrease in the hazard of death by 10% (p = 0.002). Patients who were married or had a partner had higher QOL scores than those who were not (p = 0.004).ConclusionsWhen added to known prognostic factors, the baseline global QOL score replaced them all as the sole predictor of OS for patients with locally advanced NSCLC. This highlights the need to incorporate QOL measures into clinical oncology trials. The significantly lower QOL score for single/divorced/widowed patients deserves further study.Supported by grants U10 CA21661, U10 CA37422, and U10 CA32115 from the NCI. Also supported by Medimmune Oncology. This abstract's contents are the sole responsibility of the authors. Purpose/Objective(s)This analysis was conducted to determine the added value of QOL as a prognostic factor for overall survival (OS) for patients (pts) with locally advanced NSCLC treated on RTOG 9801. This analysis was conducted to determine the added value of QOL as a prognostic factor for overall survival (OS) for patients (pts) with locally advanced NSCLC treated on RTOG 9801. Materials/MethodsThe following pre-treatment factors were analyzed as predictors for OS on univariate and multivariate analysis (MVA): KPS (70–80 vs. 90–100), AJCC stage (II/IIIA vs. IIIB), gender, age, race, marital status, histology (squamous vs. other), tumor location (lower vs. other), hemoglobin (<12 vs. ≥12 g/dL), treatment arm (amifostine [AM] vs. no-AM) and global QOL score (from the EORTC-QLQ-C30 instrument). Only pts with <5% weight loss within 3 months were eligible for enrollment. 243 pts with stage II/IIIAB NSCLC received induction paclitaxel (P) and carboplatin (C) on days 1, 22 and then concurrent weekly P/C and hyperfractionated radiation (69.6 Gy at 1.2 Gy BID). Patients were randomly assigned to AM 500 mg 4×/week or no-AM during chemoradiation. A multivariate Cox proportional hazards model was performed. The models were built using a backwards selection process, eliminating variables that have p-value >0.05. The following pre-treatment factors were analyzed as predictors for OS on univariate and multivariate analysis (MVA): KPS (70–80 vs. 90–100), AJCC stage (II/IIIA vs. IIIB), gender, age, race, marital status, histology (squamous vs. other), tumor location (lower vs. other), hemoglobin (<12 vs. ≥12 g/dL), treatment arm (amifostine [AM] vs. no-AM) and global QOL score (from the EORTC-QLQ-C30 instrument). Only pts with <5% weight loss within 3 months were eligible for enrollment. 243 pts with stage II/IIIAB NSCLC received induction paclitaxel (P) and carboplatin (C) on days 1, 22 and then concurrent weekly P/C and hyperfractionated radiation (69.6 Gy at 1.2 Gy BID). Patients were randomly assigned to AM 500 mg 4×/week or no-AM during chemoradiation. A multivariate Cox proportional hazards model was performed. The models were built using a backwards selection process, eliminating variables that have p-value >0.05. ResultsOf the 239 analyzable patients, 91% had pre-treatment QOL. The median follow-up time for patients still alive was 58.7 months (mo) and 17.3 mo for all patients. The median baseline global QOL score was 66.7 on both treatment arms. Whether the global QOL score was treated as a dichotomized variable (based on the median score of 66.7) or a continuous variable, all other variables fell out of the MVA for OS, except for the global QOL score. Patients with a global QOL score less than the median (66.7) had a 69% higher rate of death than patients with a QOL score ≥ 66.7 (p = 0.002). A clinically meaningful increase in the QOL score (of 10 points) corresponded to a decrease in the hazard of death by 10% (p = 0.002). Patients who were married or had a partner had higher QOL scores than those who were not (p = 0.004). Of the 239 analyzable patients, 91% had pre-treatment QOL. The median follow-up time for patients still alive was 58.7 months (mo) and 17.3 mo for all patients. The median baseline global QOL score was 66.7 on both treatment arms. Whether the global QOL score was treated as a dichotomized variable (based on the median score of 66.7) or a continuous variable, all other variables fell out of the MVA for OS, except for the global QOL score. Patients with a global QOL score less than the median (66.7) had a 69% higher rate of death than patients with a QOL score ≥ 66.7 (p = 0.002). A clinically meaningful increase in the QOL score (of 10 points) corresponded to a decrease in the hazard of death by 10% (p = 0.002). Patients who were married or had a partner had higher QOL scores than those who were not (p = 0.004). ConclusionsWhen added to known prognostic factors, the baseline global QOL score replaced them all as the sole predictor of OS for patients with locally advanced NSCLC. This highlights the need to incorporate QOL measures into clinical oncology trials. The significantly lower QOL score for single/divorced/widowed patients deserves further study.Supported by grants U10 CA21661, U10 CA37422, and U10 CA32115 from the NCI. Also supported by Medimmune Oncology. This abstract's contents are the sole responsibility of the authors. When added to known prognostic factors, the baseline global QOL score replaced them all as the sole predictor of OS for patients with locally advanced NSCLC. This highlights the need to incorporate QOL measures into clinical oncology trials. The significantly lower QOL score for single/divorced/widowed patients deserves further study.