Elsevier

Lung Cancer

Volume 24, Issue 1, April 1999, Pages 17-24
Lung Cancer

Relationship between quality of life and clinical outcomes in advanced non-small cell lung cancer: best supportive care (BSC) versus BSC plus chemotherapy

https://doi.org/10.1016/S0169-5002(99)00017-3Get rights and content

Abstract

In a prospective randomized study, 287 patients with advanced non-small cell lung cancer (NSCLC) stage IIIb or IV with ECOG performance status (PS) 0–1 or 2 were randomly assigned to receive either best supportive care (BSC) or supportive care plus combination chemotherapy (IEP regimen: ifosfamide 3 gm/m2 IV with mesna uroprotection, epirubicin 60 mg/m2 IV on day 1 and cisplatin 60 mg/m2 IV on day 2; or MVP regimen: mitomycin-C 8 mg/m2, cisplatin 100 mg/m2 IV on day 1, vinblastine 4 mg/m2 IV on days 1 and 15). Serial assessment of Karnofsky performance status (KPS), modified Functional Living Index-Cancer (T-FLIC) and modified Quality of Life-Index (T-QLI) were used to estimate the quality of life. Interviews were done at entry, at the third month and at 2 months post complete treatment. At least two courses of chemotherapy were considered to be adequate for response evaluation. Patients were treated for a total of four to six courses or until progression of disease. Partial response rates were 40 and 41.7% in IEP and MVP arms. Median survival durations were 5.9 and 8.1 months for the IEP and MVP chemotherapy arms, and 4.1 months for BSC (log-rank test: P=0.0003). One year survival was 13, 29.8 and 39.3% for the BSC, IEP and MVP regimens, respectively. Two years survival was 7.8, 6.4 and 13.1% for the BSC, IEP and MVP regimens, respectively. Improvement in quality of life (QOL) scores at the first, second and third interview were seen in chemotherapy arms only, not in the BSC arm. We conclude that combination chemotherapy improves the quality of life as well as prolonging the survival of patients with advanced NSCLC.

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].

Section snippets

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.

References (19)

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