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BMC Cancer. 2012; 12: 14.
Published online Jan 13, 2012. doi:  10.1186/1471-2407-12-14
PMCID: PMC3293714
Second-line Treatment of Stage III/IV Non-Small-Cell Lung Cancer (NSCLC) with pemetrexed in routine clinical practice: Evaluation of performance status and health-related quality of life
Wolfgang Schuette,1 Hans Tesch,2 Hartwig Büttner,3 Thomas Krause,3 Victoria Soldatenkova,4 and Clemens Stoffregencorresponding author3
1Hospital Martha-Maria, Halle-Doelau, Department of Internal Medicine II, Halle, Germany
2Hospital Bethanien, Group Practice Oncology, Frankfurt, Germany
3Medical Department, Lilly Deutschland GmbH, Bad Homburg, Werner-Reimers Straße 2-4, 61352 Bad Homburg, Germany
4Statistics Oncology, Lilly Deutschland GmbH, Bad Homburg, Germany
corresponding authorCorresponding author.
Wolfgang Schuette: Wolfgang.Schuette/at/Martha-Maria.de; Hans Tesch: Hans.Tesch/at/telemed.de; Hartwig Büttner: Buettner_hartwig/at/lilly.com; Thomas Krause: Krause_thomas/at/lilly.com; Victoria Soldatenkova: Soldatenkova_victoria_vs/at/lilly.com; Clemens Stoffregen: Stoffregen_clemens/at/lilly.com
Received June 8, 2011; Accepted January 13, 2012.
Abstract
Background
Second-line treatment of advanced non-small-cell lung cancer (NSCLC) improves overall survival. There is a lack of data regarding the impact on patients' overall health condition. This prospective, non-interventional study evaluated performance status (PS) and health-related quality of life (HR-QoL) during second-line pemetrexed treatment in routine clinical practice.
Methods
Stage III/IV NSCLC patients who initiated second-line pemetrexed (standard vitamin and dexamethasone supplementation) were observed for a maximum of 9 treatment cycles. The primary objective was to evaluate the proportion of patients achieving improvement of Karnofsky Index (KI) of ≥ 10% (absolute) or maintaining KI ≥ 80% after the second treatment cycle ("KI benefit response"). HR-QoL was self-rated using the EuroQoL-5D questionnaire (EQ-5D). Factors potentially associated with KI benefit response were evaluated using logistic regression models.
Results
Of 521 eligible patients (73.5% Stage IV, median age 66.3 yrs, 36.1% ≥ 70 yrs, 62.0% with KI ≥ 80%), 471 (90.4%) completed at least 2 treatment cycles. 58.0% (95%CI 53.6%;62.2%) achieved KI benefit response after the second cycle. Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response. EQ-5D scores improved over time. Grade 3/4 toxicities were reported in 23.8% of patients (mainly fatigue/asthenia 15.9%, neutropenia 8.7%).
Conclusions
In this large prospective, non-interventional study of second-line pemetrexed treatment in patients with advanced NSCLC, including 36% elderly patients ( ≥ 70 years), physician-rated PS and self-rated HR-QoL were maintained or improved in the majority of patients.
Trial registration
Registered on ClinicalTrials.gov (NCT00540241) on October 4, 2007
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