Meriel P Burns

Evaluation of the LENT-SOMA scales for the prospective assessment of treatment morbidity in cervical carcinoma

PURPOSE To examine the Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA) scales prospectively in carcinoma of the cervix treated curatively with radiotherapy (RT) using interviews and postal questionnaires and to test the sensitivity of the scales in assessing the radiation effects. METHODS AND MATERIALS A consecutive series of 100 patients completed questionnaires to score the subjective part of the published LENT-SOMA scales. Assessments were made before RT and at approximately 21, 70, 200, 400, 600, and 800 days after the start of treatment. The acceptability and feasibility of using the scales was examined using compliance in completion of the questionnaires. The scales were validated by evaluating the concordance of data obtained by two independent scorers and by examining the ability of the scales to measure radiation-related symptoms. RESULTS Questionnaires were completed for 89 patients before RT. The level of noncompliance was 11%. The concordance between scores when two people completed the questionnaires independently was excellent. Subjective subsite scores were highest 21 days after treatment but generally fell by 70 days. The average baseline overall LENT-SOMA subjective scores increased with advancing stage (p = 0.008) and were higher for patients treated with RT alone (p = 0.044). CONCLUSION In cervical carcinoma, the LENT-SOMA scales were acceptable and feasible to administer in the clinic and appropriate in the measurement of early subjective morbidity from RT.

Scoring of treatment-related late effects in prostate cancer

BACKGROUND AND PURPOSE To assess the correlation between different general and organ specific quality of life and morbidity scoring methods in a cohort of men treated with radical radiotherapy for prostate cancer. MATERIALS AND METHODS Men who had been treated with radical radiotherapy (50 Gy in 16 fractions over 21 days) for localized prostate cancer more than 3 years previously and who had no evidence of recurrent disease were invited to take part in the study. A total of 101 of 135 invited patients agreed and completed LENT/SOMA, UCLA Prostate Cancer Index, and 36 item RAND Health survey questionnaires. RESULTS The patients had comparable results with other published series with respect to the UCLA and SF-36 indices. There was significant correlation between the corresponding parts of the UCLA and LENT/SOMA scales (P<0.0005). However, for the same symptoms, a patient tended to score lower (worse) on the UCLA scale in comparison to LENT/SOMA. The relationship between the average LENT/SOMA score and maximum score was also not straightforward with each set of data revealing different information. CONCLUSIONS The LENT/SOMA questions were, in the main, more wide-ranging and informative than the UCLA index. It is helpful to give both the overall and maximum LENT/SOMA scores to most efficiently use all of the data. There may need to be a further LENT/SOMA question to allow both symptoms of tenesmus and faecal urgency to be fully addressed.

The impact of radiotherapy for carcinoma of the cervix on sexual function assessed using the LENT SOMA scales

BACKGROUND AND PURPOSE As there are few studies examining the impact of radiotherapy on sexuality, we assessed the effect of radiotherapy for carcinoma of the cervix on sexual health and the ability of the LENT system to assess sexual function. MATERIALS AND METHODS Using the vagina and sexual dysfunction scales of the LENT SOMA scales, subjective scores were measured prospectively before initiation of radiotherapy for 89 women, and at the following times after the start of treatment: 21, 70, 200, 400, 600 and 800 days. RESULTS There was considerable variation in pre-radiotherapy scores that was not related to disease stage (P=0.054), but was related to patient age (P=0.037, for the average vagina scores and P=0.039 for the maximum vagina scores) The scores were influenced by prior surgery (P<0.0005 for maximum and average vagina scores, P=0.042 average and 0.017 maximum sexual dysfunction scores). For 48 patients for whom data were available at the first three time points, the vagina scores decreased significantly by 70 days compared to pre-radiotherapy scores, but not for sexual dysfunction. There was heterogeneity in the pattern of changes of scores over time: for some women there was no change in vagina subsection score, some increased, and some decreased. CONCLUSIONS The work has shown variation both in pre-treatment sexual function and in the pattern of changes seen following radiotherapy. Our questionnaire proved useful to score subjective sexual and vaginal problems as given in the LENT subjective scales. Further study is needed to assess the effectiveness of the scales in assessing late effects.

Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer

BACKGROUND AND PURPOSE As late radiotherapy toxicity impacts negatively on the quality-of-life of cancer survivors and is often under reported, a study was set up to prospectively collect patient-reported data in an unselected series of patients with gynaecological malignancy. Aim 1 - To provide 3 year results for the longitudinal study. Aim 2 - To improve the questionnaire used to collect data by identifying redundant items and modifying for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data. MATERIAL AND METHODS Aim 1 - Patient reported outcome data were collected prospectively by 226 patients before and up to 3 years following radiotherapy for gynaecological cancer using a questionnaire developed to collect LENT subjective data. Aim 2 - A factor analysis was performed to identify which questions gave the most and least information. RESULTS Aim 1 - Faecal urgency and incontinence (all grades) peaked at 79% and 24%, respectively at 1 year then settled to 69% and 18% at 3 years, respectively. Urinary urgency (all grades) increased with time and was described in 75% at 3 years. Other symptoms reported at 3 years include diarrhoea in 12%, urinary incontinence in 27% and vaginal dryness in 29%. A third of patients did not feel their sex life had changed following treatment, while a quarter felt that it had. Aim 2 - some questions overlapped and others were non-specific. The questionnaire has subsequently been altered. CONCLUSIONS The extent of late toxicity is substantial. This detailed information is important for both patients and clinicians in terms of treatment decisions and follow-up care. The LENT questionnaire provides a feasible tool for capture of this information in the clinic.

Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy.

PURPOSE To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity. MATERIALS AND METHODS Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbachs α coefficient was used to measure reliability. RESULTS Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbachs α across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data. CONCLUSIONS A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy.