Elsevier

Lung Cancer

Volume 77, Issue 1, July 2012, Pages 205-211
Lung Cancer

Health-related quality of life in patients with lung cancer: Validation of the Mexican-Spanish version and association with prognosis of the EORTC QLQ-LC13 questionnaire

https://doi.org/10.1016/j.lungcan.2012.02.005Get rights and content

Abstract

Introduction

Lung cancer (LC) is the first cause of cancer-related mortality worldwide and health-related quality of life (HRQL) is a fundamental outcome for evaluating treatment results. Our objective was to validate the Mexican-Spanish versions of the European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life QLQ-LC13 disease-specific questionnaire module in Mexican patients with LC; and to explore the possible prognostic role of HRQL data.

Methods

Translation procedures followed EORTC guidelines. Both instruments were completed by patients with LC. Tests for reliability and validity were performed. A subset of patients was administered HRQL evaluations before and after chemotherapy. HRQL was associated with prognosis in chemotherapy-naïve patients. The protocol was approved by the Institute's Ethics Committee.

Results

One hundred fifty three patients (mean age, 60.3 years; 84 females and 69 males) completed both questionnaires. Compliance rates were high, and the questionnaires were well accepted. Nine of 10 multi-item scales of both questionnaires presented Cronbach's alpha coefficients > 0.7. Multi-trait scaling analysis demonstrated good convergent and discriminant validity. Patients with better Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status reported better functional HRQL scores. Different scales in the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires were accurately related with clinical characteristics. Functional as well as disease-symptom scales improved after chemotherapy, but treatment side-effects scales worsened in test–retest analysis. Better role functioning and absence of thoracic pain scales were associated with longer overall survival (OS) (p = 0.009 and p = 0.035, respectively).

Conclusion

The Mexican-Spanish versions of the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires are reliable and valid for HRQL measurement in Mexican patients with LC and can be used in clinical trials.

Introduction

Worldwide, lung cancer (LC) is the first cause of cancer-related mortality [1], [2]. In contrast, it is the fourth cause, after prostate, breast, and cervix uteri cancers in Mexico [1]. Clinical stages and histopathology determine both treatment selection and overall prognosis. In Mexico, as occurs in the majority of countries, most patients with LC present locally advanced stages or metastatic disease [3]. Therefore, the majority of treatments aim to improve quality of life and survival, providing the clinical benefit of chemotherapy [4], [5].

Conventionally, the results of LC treatments are measured depending on tumor response rates (RR), relapse-free survival (RFS), or even progression-free survival (PFS). However, the adverse events and toxicity associated with these treatments exert a substantial impact on the well-being of patients, requiring the need of adequate instruments to measure treatment impact of as well as the impact of disease itself. These instruments could define which treatment modalities improve survival while conserving or improving quality of life [6]. Currently, attention is being focused on the measurement perception of the patient regarding disease impact and treatments [7]. Hence, the health-related quality of life (HRQL) concept proposes to fulfill this aim.

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group has developed an instrument to measure HRQL in patients with cancer, denominated the EORTC QLQ-C30, which has been translated and validated in multicultural and multinational studies [8]. An LC-specific module has been developed (EORTC QLQ-LC13) that assesses specific symptoms related to LC and its treatments [9]. The HRQL data obtained employing EORTC QLQ-C30 and EORTC QLQ-LC13 instruments have been used as primary outcome in recent randomized clinical trials [10], [11]; additionally, a prognostic role for the HRQL data acquired by these instruments has been reported in patients with LC [12], [13]. There is scarce information regarding HRQL outcomes in patients with cancer in Mexico, and this is particularly true regarding to patients with LC. Therefore, the objective of this study was to report the clinical validation of the EORTC QLQ-LC13 instrument in Mexican patients with LC; and to explore the possible prognostic role of HRQL data.

Section snippets

Patients

Patients with LC with confirmed histological diagnosis who attended the out-patient Thoracic Oncology Clinic at the “Instituto Nacional de Cancerología” (INCan) at Mexico City from July 2010 to February 2011 were invited to participate in this study. All patients were asked to read and sign the written consent form.

Exclusion criteria comprised the presence of concurrent secondary malignancy and the inability to understand or complete the questionnaires. Study purpose and safety protection

Patients

One hundred fifty three patients were included in this study: 69 males and 94 females (mean age, 60.3 years; standard deviation [SD], 12 years). Distribution of clinical stages was as follows: IA, 0.65%; IIA, 1.96%; IIB, 0.65%; IIIA, 12.41%; IIIB, 13.72%; and IV, 70.58%. Histological type was distributed as small-cell lung cancer in 5.2%, non-small-cell lung cancer in 83%, and as mesothelioma in 11.8%. These non-small-cell carcinomas correspond to adenocarcinoma in 62.7%, squamous cell

Discussion

LC is a serious public health problem in Mexico. The majority of patients present for medical evaluation at very advanced disease stages, determining high mortality. Recently, there has been rapid development of new drugs that promise effective treatments with better prognosis in the immediate future. However, the effect of current treatment designed to treat patients with LC have not reached significant results regarding improvement of survival. Therefore, there is a trend for Oncologists to

Conclusion

We concluded that the Mexican-Spanish Version of the EORTC QLQ-C30 and EORTC QLQ-LC13 questionnaires are valid and reliable adaptations of the original version but must be considered carefully in studies with early lung cancer, because this subgroup is under-represented in this cohort. Moreover, they are useful for evaluating HRQL associated with the disease itself or with its treatment, exhibiting an impact on the prognosis of patients with LC. These questionnaires can be widely employed in

Conflict of interest statement

The authors have no conflict of interest, and this study was conducted under the auspices of the INCan Psycho-oncology Department and the Thoracic Oncology Clinic.

Acknowledgments

This work was partly supported by the Consejo Nacional de Ciencia y Tecnologia, México (grants CONACyT-014147 and CONACyT-044395). Also thank the EORTC Quality of Life Group, especially to Petra Jeglikova for their support during the translation and adaptation of the EORTC QLQ-LC13.

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