Purpose Men with localized prostate cancer often are treated with external radiotherapy (RT) over 8 to 9 weeks. Hypofractionated RT is given over a shorter time with larger doses per treatment than standard RT. We hypothesized that hypofractionation versus conventional fractionation is similar in efficacy without increased toxicity. Patients and Methods We conducted a multicenter randomized noninferiority trial in intermediate-risk prostate cancer (T1 to 2a, Gleason score ≤ 6, and prostate-specific antigen [PSA] 10.1 to 20 ng/mL; T2b to 2c, Gleason ≤ 6, and PSA ≤ 20 ng/mL; or T1 to 2, Gleason = 7, and PSA ≤ 20 ng/mL). Patients were allocated to conventional RT of 78 Gy in 39 fractions over 8 weeks or to hypofractionated RT of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted with therapy. The primary outcome was biochemical-clinical failure (BCF) defined by any of the following: PSA failure (nadir + 2), hormonal intervention, clinical local or distant failure, or death as a result of prostate cancer. The noninferiority margin was 7.5% (hazard ratio, < 1.32). Results Median follow-up was 6.0 years. One hundred nine of 608 patients in the hypofractionated arm versus 117 of 598 in the standard arm experienced BCF. Most of the events were PSA failures. The 5-year BCF disease-free survival was 85% in both arms (hazard ratio [short v standard], 0.96; 90% CI, 0.77 to 1.2). Ten deaths as a result of prostate cancer occurred in the short arm and 12 in the standard arm. No significant differences were detected between arms for grade ≥ 3 late genitourinary and GI toxicity. Conclusion The hypofractionated RT regimen used in this trial was not inferior to conventional RT and was not associated with increased late toxicity. Hypofractionated RT is more convenient for patients and should be considered for intermediate-risk prostate cancer.
The delay in surgical resection necessary to complete preoperative radiation does not seem to increase the risk of lethal metastatic spread. The risk of local recurrence may be lower after preoperative radiation. These findings must be interpreted with caution because of the heterogeneity and bias in the available studies.
Our results support a role of activated M P-EGFR, (but not total EGFR), as a predictor of OS in locally advanced-NSCLC. It is suggested that detailed evaluation of the subcellular distribution and activation state of EGFR and its downstream effectors is required to unravel the predictive value of these markers in NSCLC.
Objectives: We set out to determine the optimal treatment options—surgery, radiation therapy (RT), systemic therapy, or any combinations thereof—for patients with desmoid tumours once the decision to undergo active treatment has been made (that is, monitoring and observation have been determined to be inadequate); provide clinical-expert consensus opinions on follow-up strategies in patients with desmoid tumours after primary interventional management. Methods: This guideline was developed by Cancer Care Ontario’s Program in Evidence-Based Care and the Sarcoma Disease Site Group. The MEDLINE, EMBASE, and Cochrane Library databases, main guideline Web sites, and abstracts of relevant annual meetings (1990 to September 2012) were searched. Internal and external reviews were conducted, with final approval by the Program in Evidence-Based Care and the Sarcoma Disease Site Group. Recommendations: Treatments: Surgery with or without RT can be a reasonable treatment option for patients with desmoid tumours whose surgical morbidity is deemed to be low; The decision about whether RT should be offered in conjunction with surgery should be made by clinicians and patients after weighing the potential benefit of improved local control against the potential harms and toxicity associated with RT; Depending on individual patient preferences, systemic therapy alone or RT alone might also be reasonable treatment options, regardless of whether the desmoid tumours are deemed to be resectable. Follow-Up Strategies: Undergo evaluation for rehabilitation (occupational therapy or physical therapy, or both); Continue with rehabilitation until maximal function is achieved; Undergo history and physical examinations with appropriate imaging every 3–6 months for 2–3 years, and then annually.
BackgroundRecruitment is a challenge in developing population-representative pregnancy and birth cohorts.MethodsWe developed a collaborative recruitment infrastructure (CRI) to recruit pregnant women for 4 pregnancy cohorts using: faxes from obstetrical offices, in-clinic recruiters, university and funder-driven free-media events, paid-media, and attendance at relevant tradeshows. Recruitment rates and demographic differences were compared between recruitment methods.ResultsWe received 5008 referrals over 40 months. Compared to fax, free-media referrals were 13 times more likely to be recruited (OR 13.0, 95% CI 4.2, 40.4: p < 0.001) and paid-media referrals were 4 times more likely to be recruited (OR 4.6, 95% CI 2.1, 10.3: p < 0.001). Among paid-media advertisements, free-to-read print (e.g. Metro) was the most effective (OR 3.3, 95% CI 2.3, 4.5: p < 0.05). Several demographic differences were identified between recruitment methods and against a reference population. Between recruitment methods, media recruits had a similar proportion families with incomes ≥ $40,000 (paid-media: 94.4%; free-media: 93.3%) compared to fax recruits (95.7%), while in-clinic recruits were less likely to have family incomes ≥ $40,000 (88.8%, p < 0.05). Maternal recruits from fax and in-clinic were more likely to attend university (Fax: 92.6%, in-clinic 89.8%) versus the reference population (52.0%; p < 0.05 for both) and both were less likely to smoke (Fax: 6.8%, in-clinic 4.2%) versus reference (18.6%; p < 0.05 for both). However, while fax referrals were more likely to be Caucasian (85.9% versus reference 77.5%; p < 0.05), in-clinic referrals were not significantly different (78.2%; P > 0.05).ConclusionRecruitment methods result in different recruitment rates and participant demographics. A variety of methods are required to recruit a generalizable sample.
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