Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2 : prognostic factors and treatment selection based on two large randomized clinical trials

Lilenbaum, Rogerio, Villaflor, Victoria M., Langer, Corey, O'Byrne, Kenneth J., O'Brien, Mary, Ross, Helen J., Socinski, Mark, Oldham, Fred B., Sandilac, Larissa, Singer, Jack W., & Bonomi, Philip (2009) Single-agent versus combination chemotherapy in patients with advanced non-small cell lung cancer and a performance status of 2 : prognostic factors and treatment selection based on two large randomized clinical trials. Journal of Thoracic Oncology, 4(7), pp. 869-874.

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Abstract

Purpose: Data from two randomized phase III trials were analyzed to evaluate prognostic factors and treatment selection in the first-line management of advanced non-small cell lung cancer patients with performance status (PS) 2.

Patients and Methods: Patients randomized to combination chemotherapy (carboplatin and paclitaxel) in one trial and single-agent therapy (gemcitabine or vinorelbine) in the second were included in these analyses. Both studies had identical eligibility criteria and were conducted simultaneously. Comparison of efficacy and safety was performed between the two cohorts. A regression analysis identified prognostic factors and subgroups of patients that may benefit from combination or single-agent therapy.

Results: Two hundred one patients were treated with combination and 190 with single-agent therapy. Objective responses were 37 and 15%, respectively. Median time to progression was 4.6 months in the combination arm and 3.5 months in the single-agent arm (p < 0.001). Median survival imes were 8.0 and 6.6 months, and 1-year survival rates were 31 and 26%, respectively. Albumin <3.5 g, extrathoracic metastases, lactate dehydrogenase ≥200 IU, and 2 comorbid conditions predicted outcome. Patients with 0-2 risk factors had similar outcomes independent of treatment, whereas patients with 3-4 factors had a nonsignificant improvement in median survival with combination chemotherapy.

Conclusion: Our results show that PS2 non-small cell lung cancer patients are a heterogeneous group who have significantly different outcomes. Patients treated with first-line combination chemotherapy had a higher response and longer time to progression, whereas overall survival did not appear significantly different. A prognostic model may be helpful in selecting PS 2 patients for either treatment strategy. © 2009 by the International Association for the Study of Lung Cancer.

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ID Code: 65223
Item Type: Journal Article
Refereed: No
Additional URLs:
Keywords: Combination chemotherapy, Gemcitabine, NSCLC, Paclitaxel poliglumex, Performance status 2, Prognostic model, Single-agent chemotherapy, STELLAR, Vinorelbine, albumin, carboplatin, lactate dehydrogenase, navelbine, paclitaxel, adult, advanced cancer, aged, albumin blood level, anemia, article, brain metastasis, cancer combination chemotherapy, clinical trial, cohort analysis, comorbidity, controlled clinical trial, controlled study, diarrhea, disease course, drug dose reduction, drug efficacy, drug safety, drug tolerability, fatigue, febrile neutropenia, female, human, lactate dehydrogenase blood level, lung non small cell cancer, major clinical study, male, multiple cycle treatment, nausea, neutropenia, outcome assessment, peripheral neuropathy, phase 3 clinical trial, predictor variable, priority journal, prognosis, randomized controlled trial, risk factor, survival rate, survival time, thorax disease, thrombocytopenia, treatment indication, treatment response, Antineoplastic Combined Chemotherapy Protocols, Area Under Curve, Biological Markers, Carcinoma, Non-Small-Cell Lung, Clinical Trials, Phase III as Topic, Deoxycytidine, Disease Progression, Humans, Lung Neoplasms, Middle Aged, Proportional Hazards Models, Randomized Controlled Trials as Topic, Regression Analysis, Vinblastine
DOI: 10.1097/JTO.0b013e3181a9a020
ISSN: 1556-0864
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: © 2009 by the International Association for the Study of Lung Cancer
Deposited On: 09 Dec 2013 03:41
Last Modified: 12 Mar 2014 06:27

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