Efficacy and safety of Dentoxol® in the prevention of radiation-induced oral mucositis in head and neck cancer patients (ESDOM): a randomized, multicenter, double-blind, placebo-controlled, phase II trial.

PURPOSE: The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. METHODS: A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. RESULTS: The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. CONCLUSION: The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.

Intensity-modulated radiotherapy versus radical prostatectomy in patients with localized prostate cancer: long-term follow-up.

BACKGROUND: The objective of this work was to assess the overall survival, cause-specific survival and biochemical failure-free survival of a contemporary cohort of patients with localized prostate cancer (PCa) treated with intensity-modulated radiation therapy (IMRT) or radical prostatectomy (RP). METHODS: We did a retrospective cohort study of our institution's registry of patients undergoing either IMRT or RP between January 1999 and March 2010, and assessed Prostate Specific Antigen (PSA), age at diagnosis, Gleason score, and digital rectal examination. Two groups were separated according to RP or IMRT treatment and these groups were in turn divided into risk groups according to the D'Amico classification. Overall survival (OS), cause-specific survival (CSS), mortality from other causes (MOC), and biochemical disease-free survival (BDFS) were assessed. RESULTS: Twelve-hundred patients were included: 993 in the RP group and 207 in the IMRT group.The IMRT group had older age, PSA at diagnosis and a significantly higher percentage of cancer on the needle biopsy (p <0.001). Of the 207 patients who underwent IMRT, 54% presented comorbidities. Median follow-up was 91.7 months for the RP group and 76 months for the IMRT group. The OS at 5 and 7 was 96.2, and 93.7 for the RP group respectively and 88.4, and 83.1 for the IMRT group respectively (p <0.001). There were no significant differences in the CSS in relation to treatment received among the low- and high-risk groups, while in the intermediate-risk group, patients who underwent to RP had a higher CSS than patients who underwent IMRT (99.6% vs 94.1%, p=0.003). The IMRT group had a significantly better BDFS than the RP group (86.4% vs. 74.3%, respectively, p=0.016). CONCLUSIONS: Patients treated with RP were significantly younger and had a better prognosis than patients treated using IMRT, and according to our results, RP had better outcomes in terms of OS while IMRT had greater MOC. Treatment modality did not affect the CSS.

Primary Bladder Sarcoma: A multi-institutional experience from the Rare Cancer Network.

PURPOSE OR OBJECTIVE: Primary sarcoma of the urinary bladder (SUB) is a rare but aggressive form of bladder cancer (BCa). Available evidence on SUB is limited to case reports and small series. The aim of the present multi-institutional study was to assess the clinical features, treatments, and outcomes of patients with SUB. MATERIALS AND METHODS: Using a standardized database, 7 institutions retrospectively collected the demographics, risk factors, clinical presentation, treatment modalities and follow-up data on patients with SUB between January 1994 and September 2021. The main inclusion criteria included BCa with soft tissue tumor histology and sarcomatoid differentiation. RESULTS: Fifty-three patients (38 men and 15 women) were identified. Median follow-up was 18 months (range 1-263 months). Median age at presentation was 69 years (range 16-89 years). Twenty-six percent of patients had a prior history of pelvic radiotherapy (RT), and 37% were previous smokers. The main presenting symptoms at diagnosis were hematuria (52%), pelvic pain (27%), and both hematuria and pelvic pain (10%). American Joint Committee on Cancer (AJCC) 8 th edition stage II, III and IV at diagnosis were 21%, 63% and 16%, respectively. Treatment modalities included surgery alone (45%), surgery plus neo- or adjuvant-chemotherapy (17%), surgery plus neo- or adjuvant-RT (11%), RT with concurrent chemotherapy (4%), neo-adjuvant chemotherapy plus surgery plus adjuvant RT (2%) and palliative treatment (21%). Rates of local and distant recurrences were 49% and 37%, respectively. Five-year overall survival and progression-free survival (PFS) were 66.5% and 37.6%, respectively. No statistically significant differences in PFS between the treatment modalities were observed. CONCLUSIONS: Primary SUB is a heterogeneous disease group, commonly presenting at advanced stages and exhibiting aggressive disease evolution. In contrast to urothelial carcinoma, the primary pattern of recurrence of SUB is local, suggesting the need for multimodal approaches. Continuous international collaborative efforts seem warranted to provide guidance on how to best tailor treatments based on SUB-specific indices.

Calidad de vida a largo plazo en una cohorte de adultos mayores chilenos, tratados de cáncer de próstata con radioterapia de intensidad modulada (IMRT) / Long-term quality of life in a cohort of Chilean older adults, treated for Prostate cancer with modulated intensity radiotherapy (IMRT)

Introducción: El cáncer de próstata (CP) presenta una alta prevalencia. La radioterapia con intensidad modulada (IMRT) esuna nueva técnica con impacto poco conocido en la calidad de vida a largo plazo (CDVALP) de estos pacientes. El objetivo fue evaluar CDVALP en este grupo. Materiales y Método: Se incluyeron pacientes tratados entre 2000-2010, con más de 1 año de seguimiento. Se utilizó cuestionario EPIC, que fue completado directamente por el paciente. Se evaluaron dominios objetivos y subjetivos de hábitos urinarios, intestinales, hormonales y sexuales. Estudio aprobado por el comité de ética. Resultados: Se analizaron 45 encuestas. La mediana de edad fue 75 años (rango 55-90), seguimiento 4,4 años (rango 1,5-8,5). Tasa respuesta promedio fue de 96,9 por ciento. La toxicidad moderada-importante objetiva para dominio urinario fue: escape urinario 8,8 por ciento, disuria 4,4 por ciento, incontinencia 4,4 por ciento, uso pañales 2,2 por ciento, hematuria 6,6por ciento. En lo subjetivo, la polaquiuria fue "un problema grande" en 6,7 por ciento. La toxicidad intestinal objetiva moderada-importante fue: frecuencia deposición 8,9 por ciento, diarrea 4,4 por ciento, pujo 6,6 por ciento, incontinencia 4,4 por ciento, hematoquezia 0 por ciento. En el dominio hormonal: bochornos significativos 11,1 por ciento. En dominio sexual: compromiso importante del deseo 57,6 por ciento, erección 66,7 por ciento, orgasmo 55,6 por ciento, en globo 62,4 por ciento, Subjetivamente la disfunción eréctil se consideró "un problema grande" en 31,1 por ciento . En globo, la disfunción sexual subjetiva se consideró importante en 24,4 por ciento y moderada en 17,8 por ciento. Conclusiones: La radioterapia con IMRT se asocia a buena CDVALP en dominios urinario, intestinal, hormonal. La alta toxicidad sexual podría estar asociada a la edad avanzada de los pacientes tratados con radioterapia.(AU)

Background: Prostate cancer has a high prevalence. Intensity modulated radiation therapy (IMRT) is a new technique with little known impact on quality of life (QOL) in the long term of these patients. The objective was to evaluate QOL in this group. Materials and Methods: We included patients from 2000 to 2010, with more than 1 year follow-up. EPIC questionnaire was completed by the patient directly. We evaluated objective and subjective domains urinary and bowel habits, hormonal and sexual symptoms. Study approved by the ethics committee. Results: 45 surveys were analyzed. The median age was 75 years (range 55-90); follow up was 4.4 years (range 1.5-8.5). Average response rate was 96.9 percent. Toxicity moderately important objective for urinary domain was: urinary escape 8,8 percent, dysuria 4,4 percent, incontinence 4.4 percent, use diapers 2,2, hematuria 6,6 percent. In the subjective, polakiuria was "a big problem" in 6,7 percent. Objective Intestinal toxicity moderately important was: deposition rate 8,9. percent, diarrhea 4.4 percent, incontinence 4.4 percent, hematochezia 0 percent. In the hormonal domain clinical significant hot flashes in was 11.1 percent. In sexual domain: significant desire dysfunction in 57.6 percent, erection 66.7, orgasm 55.6 percent, Sexual overall 62.4 percent, subjectively erectile dysfunction was considered "a big problem" in 31.1 percent. Overall, subjective sexual dysfunction was considered important by 24.4 percent and moderate in 17.8 percent. Conclusions: IMRT radiation therapy is associated with good CDVALP in domains urinary, bowel, hormonal. The sexual high toxicity may be associated with older age of patients treated with radiotherapy.(AU)