Citations

Consensus abstract Background The management of primary rectal cancer beyond total mesorectal excision planes (PRC-bTME) and recurrent rectal cancer (RRC) is challenging. There is global variation in standards and no guidelines exist. To achieve cure most patients require extended, multivisceral, exenterative surgery, beyond conventional total mesorectal excision planes. The aim of the Beyond TME Group was to achieve consensus on the definitions and principles of management, and to identify areas of research priority. Methods Delphi methodology was used to achieve consensus. The Group consisted of invited experts from surgery, radiology, oncology and pathology. The process included two international dedicated discussion conferences, formal feedback, three rounds of editing and two rounds of anonymized web-based voting. Consensus was achieved with more than 80 per cent agreement; less than 80 per cent agreement indicated low consensus. During conferences held in September 2011 and March 2012, open discussion took place on areas in which there is a low level of consensus. Results The final consensus document included 51 voted statements, making recommendations on ten key areas of PRC-bTME and RRC. Consensus agreement was achieved on the recommendations of 49 statements, with 34 achieving consensus in over 95 per cent. The lowest level of consensus obtained was 76 per cent. There was clear identification of the need for referral to a specialist multidisciplinary team for diagnosis, assessment and further management. Conclusion The consensus process has provided guidance for the management of patients with PRC-bTME or RRC, taking into account global variations in surgical techniques and technology. It has further identified areas of research priority.

Key PointsRadiation is appropriate primary therapy in approximately 25% of cases. Radiation provides long-term remissions in more than 50% of patients.

Purpose The aim of the International Myeloma Working Group was to develop practice recommendations for the management of multiple myeloma (MM) –related bone disease. Methodology An interdisciplinary panel of clinical experts on MM and myeloma bone disease developed recommendations based on published data through August 2012. Expert consensus was used to propose additional recommendations in situations where there were insufficient published data. Levels of evidence and grades of recommendations were assigned and approved by panel members. Recommendations Bisphosphonates (BPs) should be considered in all patients with MM receiving first-line antimyeloma therapy, regardless of presence of osteolytic bone lesions on conventional radiography. However, it is unknown if BPs offer any advantage in patients with no bone disease assessed by magnetic resonance imaging or positron emission tomography/computed tomography. Intravenous (IV) zoledronic acid (ZOL) or pamidronate (PAM) is recommended for preventing skeletal-related events in patients with MM. ZOL is preferred over oral clodronate in newly diagnosed patients with MM because of its potential antimyeloma effects and survival benefits. BPs should be administered every 3 to 4 weeks IV during initial therapy. ZOL or PAM should be continued in patients with active disease and should be resumed after disease relapse, if discontinued in patients achieving complete or very good partial response. BPs are well tolerated, but preventive strategies must be instituted to avoid renal toxicity or osteonecrosis of the jaw. Kyphoplasty should be considered for symptomatic vertebral compression fractures. Low-dose radiation therapy can be used for palliation of uncontrolled pain, impending pathologic fracture, or spinal cord compression. Orthopedic consultation should be sought for long-bone fractures, spinal cord compression, and vertebral column instability.

AbstractWe previously reported an increased risk of monoclonal gammopathy of undetermined significance (MGUS) in first‐degree relatives of MGUS and multiple myeloma patients. Here, we examine whether primary cytogenetic categories of myeloma differ between patients with and without a family history of MGUS or myeloma. We studied 201 myeloma patients with available data on family history and molecular cytogenetic classification. Myeloma with trisomies was more common in probands who had an affected first‐degree relative with MGUS or myeloma compared with those without a family history (46.9% vs. 33.5%, P = 0.125); however, the difference was not statistically significant. Additional studies on the cytogenetic types of myeloma associated with familial tendency are needed.

AbstractUtilizing billing records, we identified patients seen at Mayo Clinic with a diagnosis or history of fibromyalgia who were then contacted for enrollment in a fibromyalgia research registry. Fibromyalgia was confirmed through medical record review. Eligible patients were mailed an invitation that included a demographic questionnaire and the Fibromyalgia Research Survey. The Fibromyalgia Research Survey yields a widespread pain score (scale range 0–19) and a symptom severity score (scale range 0–12). A total of 4,034 patients returned the completed survey; 92.8% were female, their mean age was 57.4 (±13.4), and 83.7% were from the Midwest region of the United States. The mean widespread pain score for all participants was 11.3 (±4.5) and the mean symptom severity score was 8.2 (±2.4), indicating moderate‐to‐severe fibromyalgia symptoms, which is not unusual for patients presenting to a tertiary care center. Using a systematic process, we describe the creation of a fibromyalgia registry for future research.

Objective There are few data regarding the effect of the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial results on the management of intracranial atherosclerotic disease (ICAD). We sought to understand the impact of the SAMMPRIS trial on current ICAD clinical practices and future trial design. Methods During the ICAD symposium at the 2012 International Stroke Conference, electronic data were collected regarding attendees’ clinical management of ICAD and opinions on the feasibility of future trials post-SAMMPRIS. Results 217 attendees from different specialties, including neurologists (57%), neurointerventionalists (9%) and neurosurgeons (5%), participated in the session. The majority of respondents (77%) indicated that the results of SAMMPRIS have impacted their consideration for intracranial stenting. Post-SAMMPRIS, 84% selected ‘SAMMPRIS-style’ medical management for the treatment of ICAD. For patients with ICAD who failed aggressive medical therapy, 82% would consider an alternative approach to continuing medical therapy (30% considered clinical trial enrollment, 28% suggested angioplasty and stenting and 24% angioplasty). The majority of participants (85%) were willing to randomize patients with symptomatic ICAD in future trials. For the next ICAD trial, 29% indicated that angioplasty alone should be compared with aggressive medical therapy. Conclusions Our polling results suggest that the SAMMPRIS trial has had an impact on the current treatment of ICAD. Treatment of patients who failed medical therapy varied widely from aggressive medical therapy to balloon angioplasty, stenting or enrollment in future clinical trials. The willingness to continue clinical trials and randomize patients supports the need for future ICAD studies.

BACKGROUNDApproximately 1.7 million individuals per year are affected with health care‐associated infections (HAIs) in the United States. The authors examined trends in the incidence of HAI after major cancer surgery (MCS) and risk factors for HAI to describe the effects of HAI on mortality after MCS.METHODSPatients undergoing 1 of 8 MCS procedures within the Nationwide Inpatient Sample between 1999 and 2009 were identified (n = 2,502,686). Generalized linear regression models were used to estimate the impact of the primary predictors (procedure type, age, sex, race, insurance status, Charlson comorbidity index, hospital volume, and hospital bed size) on the odds of HAI and in‐hospital mortality. Trends in incidence were evaluated with linear regression.RESULTSOverall, MCS‐associated HAI incidence increased 2.7% per year (P < .001), whereas mortality decreased 1.3% per year (P < .001). Male gender (odds ratio [OR], 1.12, 95% confidence interval [CI], 1.10‐1.14), advancing age (OR, 1.02; 95% CI, 1.02‐1.02), black race (OR, 1.26; 95% CI, 1.21‐1.31), ≥1 comorbidities (OR, from 1.08 [95% CI, 1.04‐1.13] to 1.31 [95% CI, 1.27‐1.35]), and nonprivate insurance (OR, from 1.18 [95% CI, 1.15‐1.22] to 1.67 [95% CI, 1.59‐1.76]) were associated with an increased odds of HAI on multivariable analysis. Conversely, increasing hospital volume was associated with lower odds of HAI (OR, 0.999; 95% CI, 0.99‐0.99). Patients with MCS‐associated HAI had increased odds of mortality (OR, 8.66; 95% CI, 8.51‐8.82).CONCLUSIONSBetween 1999 and 2009, the incidence of MCS‐associated HAI events increased; however, HAI‐associated mortality decreased. That said, significant disparities exist in the hospital and demographic attributes associated with MCS‐associated HAI, with attendant health policy implications. Moreover, HAI remains detrimentally linked to mortality during hospitalization. Cancer 2013;119:2317–2324. © 2013 American Cancer Society.

Coverage with evidence development and parallel review for molecular diagnostics aid regulation and reimbursement.