Purpose: We performed a randomized trial to compare the GI and urogenital toxicity of radiotherapy (RT) for localized (confined to the organ), early-stage (T1-T2N0M0, TNM classification) carcinoma of ...the prostate, using a conventional (64 Gy in 32 fractions within 6.5 weeks) vs. a hypofractionated (55 Gy in 20 fractions within 4 weeks) schedule and to determine the efficacy of the respective treatment schedules.
Methods and Materials: This report is based on an interim analysis of the first 120 consecutive patients in this Phase III trial after a median follow-up of 43.5 months (range 23–62). RT planning was based on two-dimensional CT data, and the treatment was delivered using a three- or four-field 6–23-MV photon technique. GI and urogenital toxicity (symptom questionnaires incorporating the subjective elements of the late effects of normal tissues—subjective, objective, management, analytic classification of late effects and the European Organization for Research and Treatment of Cancer sexual function questionnaire) were evaluated before RT and 1 month, 1 year, and 2 years after RT completion. The efficacy of RT was assessed clinically (digital rectal examination and radiologic imaging) and biochemically (prostate-specific antigen assay) at baseline, and every 3 months for 2 years after RT and every 6 months subsequently.
Results: RT, whether conventional or hypofractionated, resulted in an increase in all six symptom categories used to characterize GI toxicity and in four of five symptom categories used to document urinary morbidity 1 month after therapy completion. Sexual dysfunction (based on limited data), which existed in more than one-third of patients before RT, also increased to just more than one-half of patients 1 month after RT. The increase in urinary toxicity after RT was not sustained (diurnal urinary frequency had decreased significantly at 2 years). In contrast, all six symptom categories of GI toxicity remained increased 1 year after RT. Four of the six GI symptom categories (rectal pain, mucous discharge, urgency of defecation, and rectal bleeding) were still increased at 2 years compared with baseline. Except for a slightly greater percentage of patients experiencing mild rectal bleeding at 2 years among those who received hypofractionated RT, no differences were noted in toxicity between the conventional and hypofractionated RT schedule. The mean prostate-specific antigen level was 14.0 ± 1.0 ng/mL at baseline and declined to a nadir of 1.3 ± 0.2 ng/mL at a median of 16.8 months (range 0.8–28.3) after RT completion. However, it then rose in 17 patients (8 in the hypofractionated and 9 in the conventional treatment group). Only 8 of these 17 patients were found to have signs of clinical relapse (5 local, 1 regional lymph node, and 2 systemic bony metastases) after histopathologic and radiologic reassessment). The remaining 9 patients had biochemical relapse only (defined as three consecutive rises in prostate-specific antigen after nadir). The 4-year biochemical relapse-free survival rate was 85.8% for all patients and did not differ significantly between the two radiation dose schedules (86.2% for the hypofractionated and 85.5% for the conventional fractionation group).
Conclusion: RT for prostate carcinoma, using a three- or four-field 6–23-MV photon technique without posterior shielding of the lateral fields, is an underestimated cause of persistent GI morbidity. The incidence of clinically significant GI and urogenital toxicity after conventional and hypofractionated RT appears to be similar. Hypofractionated RT for carcinoma of the prostate seems just as effective as conventional RT after a median follow-up approaching 4 years.
Purpose: To evaluate prospectively the prevalence and pathophysiology of anorectal dysfunction following radiation therapy (RTH) for localized carcinoma of the prostate.
Methods and Materials: The ...following parameters of anorectal function were evaluated in each of 35 patients (aged 55–82 years) with localized prostatic carcinoma treated with RTH either to a dose of 55 Gy/20 fractions/4 weeks (18 patients) or 64 Gy/32 fractions/6.5 weeks (17 patients), before RTH and 4–6 weeks and at a mean (± SD) of 1.4 (± 0.2) years after its completion: (
1) anorectal symptoms (questionnaire), (
2) anorectal pressures at rest and in response to voluntary squeeze and increases in intra-abdominal pressure (multiport anorectal manometry), (
3) rectal sensation (balloon distension) and (
4) anal sphincteric morphology (endoanal ultrasound).
Results: All but 1 patient completed three series of measurements. RTH had no effect on anal sphincteric morphology. The increase in frequency of defecation and fecal urgency and incontinence scores previously reported in the patients 4–6 weeks after RTH were sustained 1 year later (
p < 0.001,
p < 0.001, and
p < 0.05, cf. baseline, respectively). At this time, 56% (19 of 34), 50% (17 of 34) and 26% (9 of 34) of the patients had increased frequency of defecation, fecal urgency, and incontinence, respectively. Decreases in anal sphincteric pressures at rest and in response to voluntary squeeze recorded in the patients 4–6 weeks after RTH were not sustained 1 year later but the volumes of rectal distension associated with perception of the stimulus and desire to defecate were lower compared with baseline volumes (
p < 0.01 and
p < 0.05, respectively), reflecting heightened rectal sensitivity in the patients. There was no difference in measurements between the two radiation dose regimens. Univariate logistical regression analysis was performed on patients who had experienced increased symptom scores or decreases in recorded motor and sensory manometric parameters at 1 year, cf. baseline. The predictor variables used included individual patient tumor and treatment characteristics as well as individual patient symptom scores and parameters of anorectal motor and sensory function at baseline and 4–6 weeks after RTH. The results of the univariate logistical regression analysis showed that (
1) frequency of defecation at 4–6 weeks and (
2) rectal volumes at baseline both for (
a) perception (
p < 0.001) and (
b) desire to defecate (
p < 0.001), predicted significantly for the patients who had symptoms and signs of anorectal dysfunction at 1 year. Individual patient tumor and treatment-related variables tested, in contrast, had no predictive significance.
Conclusions: Anorectal symptoms following RTH for prostatic carcinoma are common and persist at least until 1 year after its completion and are associated with objective evidence of heightened rectal sensitivity.
In response to Dr. Vordermark Yeoh, Eric E.K; Botten, Rochelle; McGowan, Roz ...
International journal of radiation oncology, biology, physics,
2001, 2001-1-00, Letnik:
49, Številka:
1
Journal Article
myfood24 is an online 24 hr dietary recall tool developed for nutritional epidemiological research. Its clinical application has been unexplored. This mixed methods study explores the feasibility and ...usability of myfood24 as a food record in a clinical population, women with gestational diabetes (GDM). Women were asked to complete five myfood24 food records, followed by a user questionnaire (including the System Usability Scale (SUS), a measure of usability), and were invited to participate in a semi-structured interview. Of the 199 participants, the mean age was 33 years, mean booking body mass index (BMI) 29.7 kg/m², 36% primiparous, 57% White, 33% Asian. Of these, 121 (61%) completed myfood24 at least once and 73 (37%) completed the user questionnaire; 15 were interviewed. The SUS was found to be good (mean 70.9, 95% CI 67.1, 74.6). Interviews identified areas for improvement, including optimisation for mobile devices, and as a clinical management tool. This study demonstrates that myfood24 can be used as an online food record in a clinical population, and has the potential to support self-management in women with GDM. However, results should be interpreted cautiously given the responders' demographic characteristics. Further research to explore the barriers and facilitators of uptake in people from ethnic minority and lower socioeconomic backgrounds is recommended.
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