QUALITY OF LIFE IN PATIENTS WITH CHOROIDAL MELANOMA

Transcription

1 ARCH SOC ESP OFTALMOL 2008; 83: ORIGINAL ARTICLE QUALITY OF LIFE IN PATIENTS WITH CHOROIDAL MELANOMA CALIDAD DE VIDA EN PACIENTES CON MELANOMA DE COROIDES BLANCO-RIVERA C 1, CAPEÁNS-TOMÉ C 2, OTERO-CEPEDA XL 3 ABSTRACT RESUMEN Purpose: To determine whether iodine 125 brachytherapy or enucleation is better for quality of life in patients treated for choroidal melanoma. Patients and methods: Sixty-five patients with choroidal melanoma were treated with a modified version of VF-14 iodine 125 brachytherapy, enucleation or both. Results of this treatment were then statistically analyzed. Results: Statistically significant differences were found between visual acuity in the affected eye and binocular vision (initial and final), with an important decline after the treatment. The global medial score in the VF questionnaire decreased in a statistically significant manner after the treatment. Conclusion: We can confirm that patients treated with brachytherapy had better health-related quality of life than those who had their eye enucleated and were more likely to have higher (better) scores on the VF questionnaire items. On the other hand, the binocular vision and time after the treatment correlated with the quality of life in long-term follow-up (Arch Soc Esp Oftalmol 2008; 83: ). Key words: Quality of life, choroidal melanoma, brachytherapy, enucleation, VF-14. Objetivo: Determinar qué tratamiento, la braquiterapia con I 125 o la enucleación, aporta una mayor calidad de vida a los pacientes tratados de melanoma de coroides. Pacientes y método: Se administró una versión modificada del cuestionario VF-14 a 65 pacientes tratados de melanoma coroideo mediante braquiterapia, enucleación o ambos. Los datos obtenidos fueron sometidos a un estudio estadístico. Resultados: Se encontraron diferencias estadísticamente significativas entre la agudeza visual media del ojo afecto y la visión binocular, inicial y final, sufriendo ambas un importante descenso después del tratamiento. La puntuación media global del cuestionario VF sufrió también un descenso estadísticamente significativo después del tratamiento. Conclusión: Se puede afirmar que los pacientes tratados mediante braquiterapia tuvieron una mejor percepción de su salud general que los pacientes enucleados, alcanzando mejores puntuaciones en las tareas del cuestionario VF. Por otra parte, la agudeza visual binocular y el tiempo transcurrido después del tratamiento se presentaron como factores influyentes en la calidad de vida percibida por los pacientes. Palabras clave: Calidad de vida, melanoma de coroides, braquiterapia, enucleación, VF-14. Received: May 25, Accepted: April 14, Ophthalmology Service of the Santiago University Hospital Complex. Santiago de Compostela. La Coruña. Spain. 1 Ph.D. in Medicine. Ophthalmology Service of the Vigo University Hospital Complex (CHUVI). 2 Ph.D. in Medicine. 3 Chair of the Biostatistical Dept. Santiago de Compostela University. Paper presented at the LXXX Congress of SEO (Valencia 2004). Correspondence: M.ª Carmen Blanco Rivera C/. Salvadas, 31, 2.º C Santiago de Compostela (Coruña) Spain mcarmenbr@wanadoo.es

2 BLANCO-RIVERA C, et al. INTRODUCTION Uveal melanoma is the most frequent malignant intraocular tumor in adults, with an annual prevalence that ranges between six and seven cases per million inhabitants/year in the United States (1). Despite the diagnostic and therapeutic advances of recent years, the prevalence of metastasis has not been substantially reduced (2). In the 70 s, Zimmerman s theories had us believe that treatment by enucleation favored metastasic spreading, but the most recent studies seem to demonstrate that this is not correct, and micrometastasis could already exist at the time of enucleation (3).On the other hand, the studies carried out by the Collaborative Ocular Melanoma Study Group (COMS) concluded with a similar survival rate between patients treated for choroidal melanoma by means of brachytherapy with I 125 and some that were enucleated (4,5). If we take into account the COMS data there is now controversy with respect to which of these two treatments gives a greater quality of life to the patients treated for choroidal melanoma. So, in recent years studies aiming to resolve this incognito have proliferated (1,6,7), with the study carried out by the COMS being the most extensive (8-10). On the other hand, quality of life is a concept that is becoming more and more important to modern medicine. In 1994, the World Health Organization (WHO) defined it as «the personal perception of an individual s situation in life, within the cultural context and the values of life in which we live, and in regard to individual objectives, expectations, values and interests» (11). Quality of life can be also defined as the subjective evaluation of the impact of a disease or treatment on the physical, mental and social well-being of the individual (6). Its measurement is complex and for this the researcher has a series of questionnaires that meet some of the requirements with each one having distinct characteristics (12). This study selected the VF-14 questionnaire that was then modified and changed to VF-19, which was fully validated before being used (13). The decision to use the VF-14 was mainly based on the characteristics of this questionnaire, which was designed to be used on patients with cataracts and that has been employed in numerous studies of diverse ocular pathologies (12,13). SUBJECTS, MATERIALS AND METHODS A selection among the patients treated for choroidal melanoma was carried out on the basis of a series of inclusion and exclusion criteria. The patients should meet the following criteria to be accepted for the study: having received the treatment for at least 6 months, the treatment was brachytherapy I 125, enucleation or both, and that the tumor involvement was monocular. Patients that presented melanoma with extension to the ciliar and/or iris body, and those patients with severely affected vision of the other eye and diseases of old age, or with psychological problems that would hinder the questionnaire were excluded from this study. The selected patients had a complete ophthalmological examination, registering the best visual acuity in both eyes. The binocular vision was also calculated by means of an considered average of the vision of the best eye (multiplied by 0.75) and the worst eye (multiplied by 0.25). Patient authorization was obtained with an informed consent. The selected questionnaire was the VF-14, to which modifications were made changing it into the VF-19, also adding questions to evaluate patient satisfaction with the care received, their opinion on the information administered with respect to their disease, on the evaluation of their personal experience during the treatment, and to know the patients opinion on the general state of health and their perceived quality of life (Annex 1). The interview was personally carried out in 50 cases when the patient went to consultation and in 15 cases by telephone. In all cases it was the same person who carried out the interview (the author of this work), who had previously received training in questionnaire handling, as well as in the manner of asking the questions. Finally, a statistical study was carried out from the obtained data. The correlation of Pearson and Spearman coefficient was used to evaluate the relationship between visual acuity (VA) and the answers of the VF questionnaire. The matching t-student test was applied to compare the values of the variables before and after treatment. The ANOVA of repeated measurements was applied to compare treatments, and the SPSS 12.0 (SPSS for Windows, SPSS Inc., Chicago, USA) program was employed for statistical analysis. 302 ARCH SOC ESP OFTALMOL 2008; 83:

3 Quality of life and choroids melanoma Annex A: VF-19 Model questionnaire (VF-14 modified) used in the study. RESULTS Finally, 65 patients were selected for the study: 29 males and 36 females. The average age of those interviewed was years. 45 patients were treated with brachytherapy, 14 patients were enucleated and six patients were treated first with radiotherapy and were later enucleated. It is interesting to note that only 12.3% of the patients belonged to the health area and 69.23% were sent from other communities. The patient follow-up ranged between 6 and 120 months. At 3 years of radiotherapy treatment (100% of patients radiated reached this survival time as compared to 80% of those who were enucleated) there was a significant statistical decrease in vision compared to before treatment (p=0.002). At 3 years the visual acuity in 64% of the radiated patients was equal or less than Binocular vision also showed a statistically significant decrease in the group ARCH SOC ESP OFTALMOL 2008; 83: of radiated patients (p<0.001). However, there were no statistically significant differences between the group of radiated patients and those that were enucleated (p =0.768). Figure 1 shows the relationship between the initial and final binocular vision values in the three treatment groups. There is a statistically significant deterioration in visual acuity. In terms of the questionnaire, there was a decrease in the score previous to treatment (3.,89 SD 0.24) and after treatment (3.66 SD 0.30), that was statistically significant (p<0.001). The differences between the enucleated and radiated groups were statistically significant in favor of the latter group (p =0.008). Table 1 shows the VF score values before and after treatment in each one of the treatment groups and their statistical significance. The correlation between binocular visual acuity and global VF score was greater with the Spearman coefficient than with the Pearson, both before (0.23) and after treatment (0.20). The correlation of the 303

4 BLANCO-RIVERA C, et al. with the treatment received from the professionals of the centre. The majority of the enucleated patients affirmed that they accepted the organ loss and were happy with the prosthesis. A relationship between the subjective quality of life perceived by the patients and the binocular visual acuity was observed to such an extent that the greater the visual acuity after treatment, the better the quality of life perceived by the patients (fig. 2). The existing relationship between the subjective quality of life perceived by the patients and the time passed since the intervention was also appreciated, so that the longer the time after the intervention the greater was the perception of quality of life (less stress, fear, anxiety ) (fig. 3). Fig. 1: Relationship between initial and final binocular visual acuity values in the three treatment groups. vision of affected eye and the global VF score was also greater with the Spearman coefficient, above all after treatment (0.43). The most affected tasks were those of driving (day and night), reading, noticing steps or slopes, revising cheques or documents (p<0.001), recognizing people at a short distance (p =0.017) and performing professional tasks (p =0.027). There were only statistically significant differences between the enucleated group and the radiated group in the tasks of: reading, noticing steps or slopes, revising cheques or documents and recognizing people at a short distance (p =0.015). There were also statistically significant differences (p =0.002) between the evaluation of the general state of health that radiated patients had as opposed to the enucleated, with the radiated group having a far better perception. It also showed that the patients began to accept their disease, although 87.5% of the enucleated knew that the disease negatively affected their life, as against 64% of the radiated patients. However, although 61.5% of the patients were aware of the significance of their disease, only 33.8% recognized that it put their lives in danger. The majority of the patients were satisfied DISCUSSION Three years after treatment the radiated patients suffered an important loss of visual acuity, the same as in the studies realized by C.O.M.S. (14), where, at 3 years, 49% of the patients presented worse vision than and in those realized by Shields et al (14) where after 10 years of follow-up, 68% of the radiated patients presented very bad visual acuity. With respect to binocular vision, there were no statistically significant differences between the treatment groups, although binocular visual acuity significantly diminished after treatment. We wish to highlight that no patient refused to answer the VF questionnaire, which was easily applied and understood by patients, as well as proving to be an efficient instrument in evaluating the functional vision, and correlating their scores with the visual acuity that the patients presented. A significant decrease in the task scores that required a greater visual discrimination was shown: such as driving, where differences were found between the radiated group and the enucleated. The same occurred in the study carried out by Cruickshanks et al (1). With respect to the perception of the general state of health, it is important to highlight that it was Table I. Values of the VF questionnaire scores before and after treatment Treatment type Initial mark Final mark Significance Enucleation 3.81 SD SD 0.35 P= Radiotherapy l SD SD 0.26 P< Both treatments SD 0.20 P= ARCH SOC ESP OFTALMOL 2008; 83:

5 Quality of life and choroids melanoma Fig. 2: Relationship between binocular visual acuity and the evolution of subjective quality of life perceived by patients. more positive for the radiated group, in a similar way to the study carried out by Cruickshanks et al (1). Reimer et al (6) found that the level of mental stress was related to the level of visual acuity, being more deficient in the group of nucleated patients. However, paradoxically the nucleated patients perceived a more important improvement in their subjective quality of life than those who were radiated. This could be explained by the Damocles syndrome (fear of disease recurrence that would be less in those patients with the organ removed, the opposite of the radiated patients that conserve it). With time, the majority of patients stated that they accepted their disease and this explains the improvement in the perception of their quality of life. The final COMS results (10) showed similar conclusions to those presented in our work. They found that their patients had the greatest difficulties in driving and in peripheral vision, this being slightly less difficult for the radiated patients as opposed to the enucleated. On the other hand, they coincided with our work in that the radiated patients exhibited higher levels of anxiety than the enucleated, and this diminished as time passed after the intervention and their quality of life improved. Therefore, there are various conclusions to be made. On the one hand, VF was an efficient instrument in evaluating the quality of life in patients treated for choroidal melanoma and its application was simple and easy to perform in the practice. On the other hand, radiated patients presented less difficulty than those who were enucleated in carrying out task of intermediate difficulties, such as seeing steps or slopes, reading, revising official documents and recognizing people at a short distance. Although both patient groups had great difficulties in carrying out more delicate tasks they had practically no difficulties in carrying out the more basic ones. The final visual acuity and the time of evolution of the disease are revealed as the factors that were most influential in the patient perception of their quality of life. Thus, as both treatments offer similar survival, and as can be shown form recent studies, such as ours, have similar patient perception of quality of life, the choice between the two should be a personal and individual one. Fig. 3: Relationship between the subjective quality of life perceived by the patients and time passed since receiving treatment. ARCH SOC ESP OFTALMOL 2008; 83: REFERENCES 1. Cruickshanks KJ, Fryback DG, Nondahl DM, Robinson N, Keesey U, Dalton DS, et al. Treatment choice and quality of life in patients with choroidal melanoma. Arch Ophthalmol 1999; 117: Capeans C. Melanomas de la úvea. Madrid: Sociedad Española de Oftalmología; Singh AD, Rennie IG, Kivela T, Seregard S, Grossniklaus H. The Zimmerman-McLean-Foster hypothesis: 25 years later. Br J Ophthalmol 2004; 88: The Collaborative Ocular Melanoma Study (COMS) randomized trial of pre- enucleation radiation of large cho- 305

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