Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy
Introduction
Advanced non-small cell lung cancer (NSCLC) occurs in the majority of patients and is associated with an extremely poor prognosis. Multiple randomized studies and a meta-analysis of these studies [1], [2], [3] showed that chemotherapy prolongs survival time in advanced non-small cell lung cancer, but only by 4–8 weeks at the median with improved 1-year survival from 10 to 20–30% [3], [4], [5], [6]. One of these randomized studies from Canada showed that chemotherapy with CAP cost less than supportive therapy in metastatic non-small cell lung cancer. None of these studies reported quality of life information which is extremely important given the small survival advantage and the toxicity of chemotherapy.
Recently, several investigators were concerned about the real benefit of chemotherapy in the treatment of non-small cell lung cancer. The main question was regarding the prolonged survival, that is whether prolonging survival time was good enough for the patients to cope with the side effects of chemotherapy? The introduction of quality of life assesment into clinical studies was considered one of the measures to answer the question [7], [8], [9], [10], [11].
At our hospital, in Northern Thailand we have about 1000 new cases of NSCLC per year [12]. Most of these cases are advanced stage. Thus, we started a randomized study to assess the quality of life of NSCLC treated with best supportive care (BSC) versus best supportive care plus chemotherapy. We selected two combination chemotherapy regimens: IEP and MVP. Both of these regimens were routinely administered in our hospital. The response rate and survival time of the two regimens were not different [13].
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Patients and methods
Patients with inoperable clinical stage IIIb and IV, histologically or cytologically verified NSCLC (squamous cell carcinoma, adenocarcinoma, or large cell carcinoma), aged less than 75 years, with ECOG performance status of 0–2, were eligible for this study. Patients with initial symptoms and/or signs of brain metastases, cord compression, superior vena caval syndrome or pathological bone fracture were excluded. Patients who had been previously treated with cytotoxic agents or radiation
Results
Both FLIC and QLI questionnaires, were translated into Thai language and tested in the Thai population. The reliability and consistency of the modified questionnaires (T-FLIC and T-QLI) were reported previously [14]. Internal consistency (Cronbach’s α coefficient) was 0.78–0.83. Construct validity was supported by testing the correlation between T-FLIC and T-QLI (r=0.62). The criterion-related validity of these questionnaires was tested by Pearson’s correlation coefficient to Karnofsky
Association of quality of life and clinical outcomes
We correlated the initial KPS, T-FLIC, and T-QLI with survival time. All three correlations were significant (For PS1, r=0.26770, P=0.0001; for FLIC1, r=0.18298, P=0.0103; and for QLI1, r=0.15090, P=0.0348).
As patients with cancer are followed with serial quality of life assessments, individuals are lost from the mean calculations due to death and loss to follow-up. Since survival is usually related to initial quality of life assessment, the means can increase simply because the patients with
Discussion
Quality of life is a new parameter for assessing disease outcome. Previously most clinicians believed that only objective parameters such as response, survival and toxicity were useful for the assessment of clinical outcomes in cancer treatment. Recently several investigators have changed their ideas and have been using the quality of life as a parameter for assessing tumor response [9], [10], [15].
Several quality of life questionnaires have been developed and widely used. This study was
Conclusion
Modified T-FLIC and T-QLI scales are useful for the assessment of quality of life. Patients with advanced lung cancer treated with chemotherapy had benefit both in prolonged survival and improvement in quality of life. Besides tumor response both T-FLIC and T-QLI are useful in measuring quality of life. The above two questionnaires should be considered as a parameter of the clinical response. This study confirmed the importance of chemotherapy for the treatment of advance non-small cell lung
Acknowledgements
We thank Professor Paul Bunn for his kindly advice on the manuscript, Asta Medica Co. for supporting part of the study and Farmitalia Carlo Erba for supporting part of the study.
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2011, Journal of Thoracic OncologyCitation Excerpt :An analysis of BSC data would be useful, thus we reviewed the results of our literature search. Only one study from Asia was identified,16 and no difference in OS was seen between this study and the Caucasian studies of BSC (data not shown). In our analysis, we found a significant difference in the median OS of patients from Asian compared with Caucasian studies regardless of the number of chemotherapy drugs administered.