Elsevier

The Lancet Oncology

Volume 10, Issue 12, December 2009, Pages 1160-1170
The Lancet Oncology

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Quality of life after successful treatment of early-stage Hodgkin's lymphoma: 10-year follow-up of the EORTC–GELA H8 randomised controlled trial

https://doi.org/10.1016/S1470-2045(09)70258-XGet rights and content

Summary

Background

Little is known about the longitudinal course of health-related quality of life (HRQoL) in patients with Hodgkin's lymphoma during their post-treatment follow-up and re-adaptation to normal life. We report on the HRQoL of patients treated in the randomised H8 trial of the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group and the Groupe d'Études des Lymphomes de l'Adulte (GELA). We aimed to assess HRQoL and fatigue following treatment, to analyse relations with treatment, and to identify factors that predict persistent fatigue.

Methods

Patients received HRQoL questionnaires at the end of primary therapy and during follow-up. The EORTC QLQ-C30 was used to assess HRQoL, and the Multidimensional Fatigue Inventory (MFI-20) was used to assess fatigue. Changes of mean HRQoL scores over time were analysed with mixed models. Multiple polytomic nominal logistic regression was done to identify independent baseline predictors of fatigue within MFI-20 dimensions. Analyses were done on an intention-to-treat basis. This study is registered with www.ClinicalTrials.gov, number NCT00379041.

Findings

2666 assessments from 935 patients were analysed. Mean follow-up was 90 months (range 52–118). Age affected all functioning and symptom scores except emotional functioning, with younger age associated with higher functioning and lower severity of symptoms; improvement with time showed similar patterns between age groups. Women reported lower HRQoL and higher symptom scores than did men. Overall, 3·2% (14/439 for role functioning) to 9·7% (43/442 for social functioning) and 5·8% (29/498 for reduced motivation) to 9·9% (49/498 for general fatigue) of patients reported impairments of 10 points or more (on a 0–100 scale) in QLQ-C30 and MFI-20 scores, respectively, independent of age and sex. Emotional domains were more affected than physical ones. There was no relation between HRQoL outcome and type of treatment. Fatigue (MFI-20 scores) at the end of treatment was the only predictive variable for persistent fatigue, with odds ratios varying from 2·58 (95% CI 1·00–6·67) to 41·51 (12·02–143·33; p≤0·0001). Sensitivity analyses adjusting for missing data were much the same as the main results.

Interpretation

HRQoL data after treatment for early-stage Hodgkin's lymphoma show that patients experience strain and limitations in all subdomains apart from cognitive functioning (QLQ-C30), and also have reduced motivation (MFI-20). Differences in HRQoL improvement with time were linked to age and sex, but not type of treatment. Fatigue status at the end of treatment seems to predict subsequent HRQoL.

Funding

French Ministry of Health, Programme Hospitalier de Recherche Clinique 1994, and French National League Against Cancer.

Introduction

Assessing the quality of life of patients with Hodgkin's lymphoma received little attention before the 1990s, probably because of the low incidence of the disease and its high probability of cure. Over the past two decades there has been increasing interest in late treatment-related effects, but almost all studies focusing on health-related quality of life (HRQoL) in adults with Hodgkin's lymphoma have used a cross-sectional approach, even in long-term survivors.1 To study the course of psychosocial consequences over time from diagnosis and treatment, most studies used population-based registry and hospital-based cohorts that included subgroups of patients with various follow-up periods. However, in such cohorts, medical histories including detailed treatment data are difficult to analyse. By contrast, longitudinal studies closely connected to clinical trials are able to provide the necessary bases for adequate analysis, particularly with regard to clinically relevant subgroups of patients.2

In 1993, the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group and the Groupe d'Études des Lymphomes de l'Adulte (GELA) initiated a randomised, non-blinded trial in patients with early-stage Hodgkin's lymphoma (the H8 trial).3 Here we report the results of the accompanying longitudinal prospective survey of HRQoL and fatigue in patients in complete remission. The objectives of this study were to analyse the relations between treatment, HRQoL, and fatigue, and to identify factors that predict persistent fatigue.

Section snippets

Patients

Patients with previously untreated clinical stage I or II supradiaphragmatic Hodgkin's lymphoma were eligible for the trial.3 After stratification by prognostic factors (figure 1), patients in the very favourable group were treated with mantle-field radiotherapy. Those in the favourable group (H8-F) were randomly assigned to either subtotal nodal radiotherapy (STNI) or three cycles of mechlorethamine, vincristine, procarbazine, prednisone, doxorubicin, bleomycin, and vinblastine (MOPP-ABV) and

Results

Of the 1577 patients included in the EORTC-GELA H8 trial by 91 hospitals, 1407 successfully responded to treatment, of whom 1014 participated in the HRQoL survey, contributing 4877 assessments. From these, 2211 were excluded: 219 because they were done before the end of treatment, 90 because they were done after a relapse had occurred (79 patients), and 1902 (449 patients) because they were classed as doublets within time periods. For these 449 patients with two or more HRQoL assessments in a

Discussion

We report the results of a longitudinal prospective survey on HRQoL in a large cohort of patients with Hodgkin's lymphoma who were included in a European clinical trial. Key findings include a significant improvement in most HRQoL domains within 18 months of the end of treatment, except for cognitive functioning and reduced motivation (table 3), suggesting that neither the treatment nor the disease affect these two dimensions. By contrast, very few (<10%) patients show HRQoL impairment. Scores

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