Abstract Background Several conservative (i.e., nonpharmacologic, nonsurgical) treatments exist for secondary lymphedema. The optimal treatment is unknown. We examined the effectiveness of conservative treatments for secondary lymphedema, as well as harms related to these treatments. Methods We searched MEDLINE ® , EMBASE ® , Cochrane Central Register of Controlled Trials ® , AMED, and CINAHL from 1990 to January 19, 2010. We obtained English- and non-English-language randomized controlled trials or observational studies (with comparison groups) that reported primary effectiveness data on conservative treatments for secondary lymphedema. For English-language studies, we extracted data in tabular form and summarized the tables descriptively. For non-English-language studies, we summarized the results descriptively and discussed similarities with the English-language studies. Results Thirty-six English-language and eight non-English-language studies were included in the review. Most of these studies involved upper-limb lymphedema secondary to breast cancer. Despite lymphedema's chronicity, lengths of follow-up in most studies were under 6 months. Many trial reports contained inadequate descriptions of randomization, blinding, and methods to assess harms. Most observational studies did not control for confounding. Many studies showed that active treatments reduced the size of lymphatic limbs, although extensive between-study heterogeneity in areas such as treatment comparisons and protocols, and outcome measures, prevented us from assessing whether any one treatment was superior. This heterogeneity also precluded us from statistically pooling results. Harms were rare (< 1% incidence) and mostly minor (e.g., headache, arm pain). Conclusions The literature contains no evidence to suggest the most effective treatment for secondary lymphedema. Harms are few and unlikely to cause major clinical problems.
Purpose Because of its morbidity and chronicity, arm lymphedema remains a concerning complication of breast cancer treatment. Although massage-based decongestive therapy is often recommended, randomized trials have not consistently demonstrated benefit over more conservative measures. Patients and Methods Women previously treated for breast cancer with lymphedema were enrolled from six institutions. Volumes were calculated from circumference measurements. Patients with a minimum of 10% volume difference between their arms were randomly assigned to either compression garments (control) or daily manual lymphatic drainage and bandaging followed by compression garments (experimental). The primary outcome was percent reduction in excess arm volume from baseline to 6 weeks. Results A total of 103 women were randomly assigned, and 95 were evaluable. Mean reduction of excess arm volume was 29.0% in the experimental group and 22.6% in the control group (difference, 6.4%; 95% CI, −6.8% to 20.5%; P = .34). Absolute volume loss was 250 mL and 143 mL in the experimental and control groups, respectively (difference, 107 mL; 95% CI, 13 to 203 mL; P = .03). There was no difference between groups in the proportion of patients losing 50% or greater excess arm volume. Quality of life (Short Form-36 Health Survey) and arm function were not different between groups. Conclusion This trial was unable to demonstrate a significant improvement in lymphedema with decongestive therapy compared with a more conservative approach. The failure to detect a difference may have been a result of the relatively small size of our trial.
Human epidermal growth factor receptor 2-positive (HER2+) breast cancer is an aggressive subtype of breast cancer associated with a poor prognosis when sub-optimally treated. Recent advances include new and effective targeted therapies that have significantly improved outcomes for patients. Despite these advances, there are significant gaps across Canada, underscoring the need for evidence-based consensus guidance to inform treatment decisions. Addressing these gaps is crucial to ensuring that effective therapies are integrated into clinical practice, so as to improve the lives of patients affected by this aggressive form of breast cancer. The Research Excellence, Active Leadership (REAL) Canadian Breast Cancer Alliance is a standing nucleus committee of clinical-academic oncologists across Canada and Breast Cancer Canada, a patient organization. The mandate of this group is to provide evidence-based guidance on best practices in the management of patients with breast cancer. These consensus recommendations were developed using a modified Delphi process with up to three rounds of anonymous voting. Consensus was defined a priori as ≥75% of voters agreeing with the recommendation as written. There are 9 recommendations in the early setting; 7 recommendations in the metastatic setting; and 10 recommendations for patients with brain metastases.
Whether stereotactic body radiotherapy (SBRT) is noninferior to conventionally or moderately hypofractionated regimens with respect to biochemical or clinical failure in patients with localized prostate cancer is unclear.
There has been particular interest in assessing UHR, such as 5-12 fractions (fr) in treating CaP based on potential radiobiological advantages, patient convenience and resource allocation benefits. Prior to comparison with standard RT regimens (SRTR), NRG Oncology embarked on a study in which patients (pts) were treated with 5 or 12 fr UHR and to show both regimens had acceptable toxicity rates. RTOG 0938 is a randomized phase II study of CaP pts, (Gleason score 2-6, stage T1-2a, and PSA < 10 ng/mL) receiving 36.25 Gy (5 fr of 7.25 Gy in 2wks), or 51.6 Gy (12 fr of 4.3 Gy in 2.5wks). Health-related quality of life (HRQOL), as measured by the Expanded Prostate Cancer Index Composite (EPIC) instrument, GI and GU toxicity, time to PSA failure, and disease-free survival (DFS) were assessed once all pats had 5 years on study. A change in EPIC-B (bowel) domain score (baseline to 5-years) worse than 5 points and a change in EPIC-U (urinary) domain score worse than 2 points were felt to be clinically significant. One-sided one-sample z-test was used to compare the observed rates vs. the protocol-specified unacceptable rates of 55% (EPIC-B) and 60% (EPIC-U). PSA failure was estimated using cumulative incidence with death without an event treated as a competing risk. DFS was estimated using Kaplan-Meier. The 1- and 2-year EPIC and toxicity results have been previously published (Lukka, IJROBP, 2018). This abstract focuses on the 5-year results. 240 eligible pts were enrolled. The compliance for completion of the 5 years HRQOL was 57%. The 1, 2- and 5-year EPIC-B for the 5 fr arm was 30% (p = 0.14), 30% (p = 0.18) and 38% (p = 0.33), and the 12 fr arm was 29% (p = 0.09), 27% (p = 0.06) and 22% (p = 0.01). The 1, 2- and 5-year EPIC-U for the 5 fr arm was 46% (p = 0.13), 56% (p = 0.001) and 47% (p = 0.11) and the 12 fr arm was 43% (p = 0.29), 48% (p = 0.07) and 38% (p = 0.37) respectively. There were no reported Grade 4 or 5 acute or late toxicities in either arm attributable to treatment. There were 2(2%) pts with grade 3 acute GU/GI toxicities in each arm. In the 5 fr and 12 fr arms there were late GU/GI Grade 3 toxicities reported in 2(2%) and 3(2%) pts respectively. The 5-year PSA failure rates in the 5 and 12 fr arms were 3% (95% confidence interval [CI]: 1.1-8.0) and 3% (95% CI: 1.1-8.0), respectively. The 5-year DFS rates in these 2 arms were 90% (95% CI: 84.0-95.2) and 92% (95% CI: 87.4-97.1), respectively. This study confirms that based on changes in EPIC-B and EPIC-U, acute and late toxicity, both the 5 and 12 fr regimens are well tolerated. These UHR need to be compared to current SRTR in the context of an RCT with efficacy and toxicity endpoints.
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