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.

Comparison of patient-reported late treatment toxicity (LENT-SOMA) with quality of life (EORTC QLQ-C30 and QLQ-H&N35) assessment after head and neck radiotherapy.

PURPOSE: The patient's role in toxicity reporting is increasingly acknowledged but requires the adaptation and validation of toxicity reporting instruments for patient use as most toxicity scales are designed for physician use. Recording of radiotherapy related late toxicity is important and needs to be improved. A patient-scored symptom questionnaire of late treatment effects using LENT-SOMA was compared with a recognised quality of life tool (EORTC QLQ-C30/H&N35). MATERIALS/METHODS: LENT-SOMA and EORTC QLQ-C30 patient questionnaires were prospectively completed by 220 head and neck cancer patients over 3 years and 72 completed EORTC QLQ-H&N35 questionnaires at 2 years post-radiotherapy. RESULTS: Endpoints common to both questionnaires (pain, swallowing, dental pain, dry mouth, opening mouth, analgesics) were matched. Spearman rank correlation coefficients with ρ>0.6 (P<0.001) were obtained for all "matched" scales except for analgesics scale, ρ=0.267 (P<0.05). There was good agreement between LENT-SOMA and EORTC QLQ-H&N35 except for analgesic endpoints. Global quality of life scores correlated negatively with average LENT-SOMA scores (P<0.001). Significant differences in average LENT-SOMA scores between treatment modalities were found. The LENT-SOMA questionnaire has demonstrated a high Cronbach's α value (0.786) indicating good reliability. CONCLUSIONS: LENT-SOMA patient questionnaire results agreed well with those from the EORTC QLQ-H&N35 questionnaire for toxicity items where they could be compared explicitly, particularly for subjective endpoints. Patient-reported late toxicity had a negative impact on quality of life. The LENT-SOMA patient questionnaire is both reliable and sensitive to differences between patients treated with different modalities. A patient-based questionnaire is an important contributor to capturing late radiotherapy effects.

Assessment of morbidity in carcinoma of the cervix: a comparison of the LENT SOMA scales and the Franco-Italian glossary.

BACKGROUND AND PURPOSE: To assess the correlation between the LENT (late effects on normal tissue) SOMA (subjective objective management analytic) system and the Franco-Italian glossary scores of late morbidity in cervical cancer patients treated with radiation, and to compare the ability of the scoring systems to detect differences between radiation treatment groups. MATERIALS AND METHODS: The study was retrospective. Patients, invited to take part in the study, had radiotherapy for cervical cancer and had a minimum of 3 years follow-up with no evidence of recurrence. One hundred patients agreed to take part. LENT subjective data were obtained using a patient questionnaire approach in order to complete the scales as published. The LENT objective, management and Franco-Italian glossary scores were obtained by a physician. Correlations between scores and differences between treatment groups were examined using non-parametric tests. RESULTS: The average LENT SOMA scores had a greater resolution than the maximum scores, and using the maximum score alone underestimated treatment morbidity. The Franco-Italian glossary scores correlated strongly with the LENT objective scores (rho=0.61, P<0.0005), and less strongly with the LENT subjective scores (rho=0.45, P<0.0005). Significant differences in morbidity between the radiation treatment groups were measured using both the LENT SOMA system and the Franco-Italian glossary. CONCLUSIONS: The maximum and average LENT scores should be reported for each subsite. The LENT objective scores correlated well with the scores obtained using the established Franco-Italian glossary, but the LENT system provided additional information on subjective treatment effects. Both systems were able to measure significant differences in morbidity between radiation treatment groups. In conclusion, the LENT SOMA system is a valid and comprehensive approach for scoring the late normal tissue effects of radiotherapy.

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.

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.