Outcomes of rectal cancer patients who refuse surgery after incomplete clinical response to neoadjuvant therapy.

BACKGROUND AND OBJECTIVES: Total mesorectal excision (TME) remains the standard of care for patients with rectal cancer who have an incomplete response to total neoadjuvant therapy (TNT). A minority of patients will refuse curative intent resection. The aim of this study is to examine the outcomes for these patients. METHODS: A retrospective cohort study of stage 1-3 rectal adenocarcinoma patients who underwent neoadjuvant chemoradiation therapy or TNT at a single institution. Patients either underwent TME, watch-and-wait protocol, or if they refused TME, were counseled and watched (RCW). Clinical outcomes and resource utilization were examined in each group. RESULTS: One hundred seventy-one patients (Male 59%) were included with a median surveillance of 43 months. Twenty-nine patients (17%) refused TME and had shortened overall survival (OS). Twelve patients who refused TME converted to a complete clinical response (cCR) on subsequent staging with a prolonged OS. 92% of these patients had a near cCR at initial staging endoscopy. Increased physician visits and testing was utilized in RCW and WW groups. CONCLUSION: A significant portion of patients convert to cCR and have prolonged OS. Lengthening the time to declare cCR may be considered in select patients, such as those with a near cCR at initial endoscopic staging.

Combined Liver and Colon Resection of Synchronous Colorectal Liver Metastases at a Quaternary Center.

INTRODUCTION: Existing literature on the safety of combined liver and colorectal resections for synchronous colorectal liver metastases is mixed. Using a retrospective review of our institutional data, we aimed to show that combined colorectal and liver resections for synchronous metastases is both feasible and safe in a quaternary center. METHODS: A retrospective review of combined resections for synchronous colorectal liver metastases at a quaternary referral center from 2015 to 2020 was completed. Clinicopathologic and perioperative data was collected. Univariate and multivariable analyses were performed to identify risk factors for major postoperative complications. RESULTS: One hundred one patients were identified, with 35 undergoing major liver resections ( ≥ 3 segments) and 66 undergoing minor liver resections. The vast majority of patients (94%) received neoadjuvant therapy. There was no difference in postoperative major complications (Clavien-Dindo grade 3+) between major and minor liver resections (23.9% versus 12.1%, P = 0.16). On univariate analysis, Albumin-Bilirubin (ALBI) score >1 (P < 0.05) was predictive of major complication. However, on multivariable regression analysis, no factor was associated with significantly increased odds of major complication. CONCLUSIONS: This work demonstrates that with thoughtful patient selection, combined resection for synchronous colorectal liver metastases can be safely performed at a quaternary referral center.

Tumor extent impacts survival benefit in minimally invasive colectomy for T4 colon cancer: A propensity matched national cohort analysis.

BACKGROUND: T4 colon cancers have been underrepresented in randomized trials comparing minimally invasive colectomy (MC) versus open colectomy (OC). Retrospective studies suggest improved survival with MC versus OC, but have not addressed the impact of tumor extent. METHODS: Using the National Cancer Database (NCDB), we analyzed patients undergoing colectomy for T4 colon adenocarcinoma from 2010 to 2014. Propensity score matching was performed between MC and OC patients. Tumor extent was defined by zones based on adjacent organ involvement. RESULTS: Of the 19 178 eligible patients, 6564 (34%) underwent MC. After matching, MC was associated with improved overall survival (hazard ratios: 0.71, 95% confidence interval: 0.67-0.76; median OS 59 vs. 42 months, p < 0.001). Compared to MC patients, those undergoing OC had: a higher margin positive rate (p = 0.009); lower median nodes examined (p < 0.001); a lower rate of adjuvant chemotherapy (p < 0.001); and a longer median time to chemotherapy (p < 0.001). Stratified survival analyses demonstrated that MC was associated with improved overall survival compared to OC in all zones except zone 3 and 4. CONCLUSIONS: Compared to OC, MC for T4 colon cancer is associated with improved oncologic outcomes when performed for zone 0-2 tumors. For, zone 3 and 4 tumors MC and OC have similar oncologic outcomes and patients should be cautiously selected.

Disparate and Alarming Impact of Gastrointestinal Cancers in Young Adult Patients.

BACKGROUND: The rise in the incidence of gastric cancer (GC) and colorectal cancer (CRC) in young adults (YA) remains unexplained. We aim to identify differences in these malignancies between YA and older patients. PATIENTS AND METHODS: We retrospectively analyzed the California Cancer Registry for all GC and CRC cases from 2000 to 2012. Pearson's Chi square analysis and stepwise regression model with backward elimination were used to analyze differences in demographic, clinical, and histopathologic features, and log-rank test to compare survival between young (≤ 40 years) and older adults (41-90 years) with GC or CRC, separately. RESULTS: We analyzed 19,368 cases of GC and 117,415 cases of CRC. YA accounted for 4.6% of GC (n = 883) and 2.8% of CRC (n = 3273) patients. Compared with older patients, YA were more likely to be Hispanic (P < 0.0001) and have poorly differentiated (P < 0.0001), higher histologic grade (P < 0.0001), and signet ring features (P < 0.0001). Synchronous peritoneal metastases were more common in YA patients (32.1% vs. 14.1% GC, 8.8% vs. 5.4% CRC, P < 0.0001). The 5-year overall survival (OS) of YA with CRC or GC was longer than that of older patients with the same stage of malignancy; except YA with stage I GC, who demonstrated poor OS and disease-specific survival (DSS) (65.1% and 67.9%, respectively) which were significantly worse than those of adults aged 41-49 years (70.7% and 76.2%, respectively) and 50-64 years (69.1% and 78.1%, respectively). CONCLUSIONS: YA with GC or CRC have distinctly worse clinical and histopathologic features compared with older patients and are disproportionately of Hispanic ethnicity. These results contribute to improving understanding of younger versus older GI cancer patients.

Metachronous peritoneal metastases following curative resection for colon cancer: Understanding risk factors and patterns of recurrence.

BACKGROUND: A subset of metachronous colon cancer recurrence manifests as peritoneal metastases (PM). Risk factors for metachronous PM recurrence are not well-defined in patients with stage II or III colon cancers after curative resection and standard adjuvant treatments. METHODS: Population data from the California Cancer Registry for patients with Stage II or III colon cancer were collected between 2004 and 2012. Multivariate analysis was used to identify factors associated with metachronous PM. RESULTS: Of the 2077 patients with stage II or III colon cancer, female patients (odds ratio [OR] = 1.84, p = 0.02), T4 primary tumor (OR = 2.36, p = 0.02), mucinous (OR = 3.97, p < 0.01) or signet-ring histology (OR = 6.01, p = 0.01), and right-sided cancer (OR = 2.2, p < 0.01) were found with increased risk of metachronous isolated PM recurrence after curative resection. Median survival after diagnosis for patients without PM recurrence was 22 months, compared with 12 months for PM recurrence (p < 0.001). CONCLUSION: PM recurrence groups have a worse overall survival than patients with recurrent disease in other sites. A better understanding of the tumor biology and molecular characteristics of colon cancers likely to recur as PM is needed to explain behavior and identify potential targeted therapy.

A preliminary prospective study of health-related quality of life among Chinese-American breast cancer survivors.

PURPOSE: This study examined the predictors of health-related quality of life (HRQOL) and changes in HRQOL over a 1-year period among Chinese-American breast cancer survivors (BCS). METHODS: A two-wave longitudinal research design included participants from hospital-based cancer registries and community organizations in Los Angeles. Participants completed mailed questionnaires at baseline and 12-month follow-up. HRQOL was measured using the Functional Assessment of Cancer Therapy-General (FACT-G v.4). Change in HRQOL was assessed using a 7-point meaningful change score. RESULTS: Participants were 73 Chinese-American BCS, a majority of whom were middle-aged (M = 54.6, SD = 9.2), lower income (63% < 45K), and diagnosed with stage I-II (83%) breast cancer. Regression analyses showed that multilevel contextual factors including general health perception, quality of care, life stress, and improvement in general health perception significantly predicted HRQOL at baseline and follow-up. The final model explained 72% of the variance of HRQOL. The examination of meaningful change indicated that improvement was reported by 32% (n = 22) and deterioration by 25% (n = 17); the majority indicated minimal change (43%, n = 30). Improvement was associated with increases in family communication, social support, and general health perception, while deterioration was associated with declines in social support, family communication, and general health perception. CONCLUSION: Findings indicate that among Chinese-American BCS, HRQOL is influenced by socioecological factors such as family communication and life stress. Results suggest that cancer survivorship outcomes research may benefit from theoretical foundations that examine the broader contextual dimensions that seem to impact and predict HRQOL. Implications for research are discussed.

Feasibility of Remote Occupational Therapy Services via Telemedicine in a Breast Cancer Recovery Program.

IMPORTANCE: Access to perioperative breast surgery occupational therapy services remains limited in remote areas. OBJECTIVE: To assess the feasibility and acceptance of occupational therapy services using a "hub-and-spoke" telemedicine model. DESIGN: Prospective study using videoconferencing to connect the occupational therapist, located at the hub site, with the patient, located at the spoke site. SETTING: National Cancer Institute Comprehensive Cancer Center (hub site) and affiliated community cancer center (spoke site). The sites are 75 mi apart. PARTICIPANTS: Female breast cancer patients (N = 26) scheduled for breast surgery were asked to participate in telemedicine occupation therapy sessions. Patients lived in a geographically remote region and travelled a mean of 16 miles (range = 3-85) to the hub site. The majority (56%) of the patients had public insurance. INTERVENTION: Perioperative occupational therapy sessions completed through videoconferencing. OUTCOMES AND MEASURES: Outcome measures were participation in and completion rate for the sessions, number of sessions required to return to baseline, and time interval from surgery to return to baseline function. Patient satisfaction was assessed with a questionnaire. RESULTS: Of the patients who enrolled in the study, 18 completed all postoperative sessions in which functional assessments, exercises, and education were provided. Patients regained baseline function within a mean of 42.4 days after surgery and after an average of three sessions. Patients reported high satisfaction with the sessions. CONCLUSIONS AND RELEVANCE: Videoconference telemedicine in breast perioperative rehabilitation is feasible, effective, and acceptable to patients. This study adds to the emerging use of telemedicine for rehabilitative services. WHAT THIS ARTICLE ADDS: This study, by demonstrating the acceptability, practicality, and efficacy of breast perioperative occupational therapy services offered through a videoconferencing platform, supports continued research to evaluate the value of telemedicine. Issues with access to medical care may be mitigated through creative use of technology.

Time to Adjuvant Radiotherapy in Breast Cancer Affects Survival: Implications for the American College of Surgeons Commission on Cancer Quality Metrics.

BACKGROUND: To optimize breast cancer care, the American College of Surgeons Commission on Cancer developed quality measures regarding receipt and timing of adjuvant radiotherapy (RT). Nationwide compliance with these measures and its impact on overall survival (OS) are evaluated herein. PATIENTS AND METHODS: Patients (n = 285,291) diagnosed with invasive breast cancer from 2004 to 2012 were identified from the National Cancer Database. Compliance with RT administration within 365 days from diagnosis was determined for patients with stage III disease with ≥ 4 positive lymph nodes post mastectomy and stage I-III disease post breast-conserving surgery (BCS). Univariate and multivariate logistic regression and Cox proportional hazard models were used to assess factors associated with compliance and OS, respectively. RESULTS: In the mastectomy cohort, 66.9% received timely RT, showing improved OS versus no RT patients (HR 0.70, 95% CI 0.67-0.73). Delayed RT patients (≥ 365 days) achieved equivalent OS to those receiving timely RT (HR 1.07, 95% CI 0.93-1.23) and superior OS to no RT patients (HR 0.74, 95% CI 0.65-0.85). In the BCS cohort, 89.4% received timely RT, showing improved OS versus no RT patients (HR 0.47, 95% CI 0.45-0.49). Delayed RT was associated with improved OS versus no RT (HR 0.64, 95% CI 0.56-0.74) and decreased OS versus timely RT (HR 1.37, 95% CI 1.19-1.58). Factors associated with noncompliance included insurance type and distance to hospital. CONCLUSIONS: Quality measure compliance with adjuvant RT improves OS, regardless of timing after mastectomy. However, timeliness does impact OS after BCS. Focus on modifiable factors to improve compliance such as access to care may lead to improved compliance and OS.

National postoperative and oncologic outcomes after pelvic exenteration for T4b rectal cancer.

BACKGROUND AND OBJECTIVES: Studies reporting outcomes after pelvic exenteration for rectal cancer are limited. The objective of this study was to evaluate early postoperative and oncologic outcomes in a national multi-institutional cohort. METHODS: Using the National Cancer Database (NCDB), which collects data from over 1500 commission on cancer (CoC)-accredited hospitals, we analyzed patients undergoing pelvic exenteration for T4b rectal adenocarcinoma. RESULTS: There were 1367 pelvic exenterations performed in 552 hospitals. Median age was 60 years, the majority of patients (n = 831; 60.8%) were female. Neoadjuvant radiation was used only in 57%; 24.3% of resections had positive margins. Following exenteration, 30-day mortality rate, 90-day mortality rate, and readmission rates were: 1.8%, 4.4%, and 7.4%. Age ≥ 60 years and higher Charlson-Deyo comorbidity index were independently associated with increased 90-day mortality (P < .001). Overall survival (OS) was 50 months. After adjustment of significant covariates, negative margin status (adjusted HR, 0.6, 95% CI, 0.5-0.8; P < .001) and receipt of perioperative radiation or chemoradiation (adjusted HR, 0.5; 95% CI, 0.4-0.6; P < .001) were significantly associated with decreased risk of death. Only 71% of the patients received perioperative radiation. CONCLUSIONS: Pelvic exenterations are being performed safely in Coc-accredited hospitals. However, up to one fourth of patients undergo resections with positive margins or are subject to underutilization of perioperative radiation therapy. Increased use of radiation may increase negative margin resections and improve patient outcomes.

Health-related quality of life and oncologic outcomes after surgery in older adults with colorectal cancer.

PURPOSE: Data regarding changes in functional status and health-related quality of life (HRQOL) before and after surgery are lacking. We identified colorectal cancer patients from the SEER-Medicare Health Outcomes Survey (MHOS) linked database to evaluate the association between HRQOL and survival. METHODS: HRQOL survey data captured physical/mental health, activities of daily living (ADLs), and medical comorbidities. Patients who underwent surgery with HRQOL surveys prior to cancer diagnosis and ≥ 1 year after diagnosis were selected. Patient, disease, and HRQOL measures were analyzed in regard to overall survival (OS), disease-specific survival (DSS), and non-DSS. RESULTS: Of 590 patients included, 55% were female, 75% were Caucasian, and 83% had colonic primary. Disease extent was localized for 52%, regional for 41%, and distant for 7%. Median OS was 83 months. Decreased OS was independently associated with age ≥ 75 (HR 1.7, p < 0.0001), male sex (HR 1.4, p = 0.011), advanced disease (regional-HR 2.0, p < 0.0001; distant-HR 7.0, p < 0.0001), and decreased mental HRQOL (HR 1.4, p = 0.005). Decreased DSS was independently associated with advanced disease (regional-HR 4.1, p < 0.0001; distant-HR 16.5, p < 0.0001) and rectal primary (HR 1.6, p = 0.047). Decreased non-DSS was independently associated with age ≥ 75 (HR 2.2, p < 0.0001), male sex (HR 1.4, p = 0.03), decreased mental HRQOL (HR 1.4, p = 0.02), and increased comorbidities (HR 1.4, p = 0.04). CONCLUSIONS: The potential overall survival benefit of oncologic surgery is diminished by declines in physical and mental health. Early identification of older surgical patients at risk for functional and HRQOL declines may improve survival following colorectal cancer surgery.

Exploring the association between diabetes and breast cancer morbidity: considerations for quality care improvements among Latinas.

OBJECTIVE: Cancer and diabetes are two severe chronic illnesses that often co-occur. In cancer patients, diabetes increases the risk for treatment complexities and mortality. Yet patient-reported outcomes with co-occurring chronic illness are understudied. DESIGN: This preliminary study investigated the association of diabetes with breast cancer-related morbidity among underserved Latina breast cancer survivors (BCS). PARTICIPANTS: 137 Latina BCS were recruited from the California Cancer Registry and hospitals.Setting and Main Outcome Measure(s): BCS completed a self-administered mailed questionnaire assessing demographic and medical characteristics e.g. Type2 diabetes mellitus (T2DM). RESULTS: 28% Latina BCS reported co-occurring T2DM at twice the general population rate. Diabetes was most prevalent among Latina BCS > 65 years (43%). Latina BCS with diabetes were more likely to report advanced cancer staging at diagnosis (P = 0.036) and more lymphedema symptoms (P = 0.036). Results suggest non-significant but lower general health and greater physical functioning limitations among BCS with T2DM. CONCLUSIONS: This study has relevance for precision population medicine by (i) consideration of routine diabetes screening in Latina BCS, (ii) underscoring attention to disease co-occurrence in treatment planning and care delivery and (iii) informing follow-up care and survivorship care planning e.g. patient self-management, oncology and primarily care surveillance and specialty care. Our findings can inform providers, survivors and caregivers about the impact of disease co-occurrence that influence clinically and patient responsive care for both initial treatment and long-term follow-up care to address disparities.

Robotic surgery trends in general surgical oncology from the National Inpatient Sample.

BACKGROUND: Robotic surgery is offered at most major medical institutions. The extent of its use within general surgical oncology, however, is poorly understood. We hypothesized that robotic surgery adoption in surgical oncology is increasing annually, that is occurring in all surgical sites, and all regions of the US. STUDY DESIGN: We identified patients with site-specific malignancies treated with surgical resection from the National Inpatient Sample 2010-2014 databases. Operations were considered robotic if any ICD-9-CM robotic procedure code was used. RESULTS: We identified 147,259 patients representing the following sites: esophageal (3%), stomach (5%), small bowel (5%), pancreas (7%), liver (5%), and colorectal (75%). Most operations were open (71%), followed by laparoscopic (26%), and robotic (3%). In 2010, only 1.1% of operations were robotic; over the 5-year study period, there was a 5.0-fold increase in robotic surgery, compared to 1.1-fold increase in laparoscopy and 1.2-fold decrease in open surgery (< 0.001). These trends were observed for all surgical sites and in all regions of the US, they were strongest for esophageal and colorectal operations, and in the Northeast. Adjusting for age and comorbidities, odds of having a robotic operation increased annually (5.6 times more likely by 2014), with similar length of stay (6.9 ± 6.5 vs 7.0 ± 6.5, p = 0.52) and rate of complications (OR 0.91, 95% CI 0.83-1.01, p = 0.08) compared to laparoscopy. CONCLUSIONS: Robotic surgery as a platform for minimally invasive surgery is increasing over time for oncologic operations. The growing use of robotic surgery will affect surgical oncology practice in the future, warranting further study of its impact on cost, outcomes, and surgical training.

Elevated risk of human papillomavirus-related second cancers in survivors of anal canal cancer.

BACKGROUND: Over the last decade, the causal link between human papillomavirus (HPV) infection and squamous cell carcinoma of the anus (SCCA) has been well described. Because HPV infection in one site is often associated with other sites of infection, it then follows that patients with SCCA may have an increased risk of additional HPV-related cancers. Identifying and targeting at-risk sites through cancer screening and surveillance may help to guide best practices. The current study sought to ascertain sites and risk of HPV-related second primary malignancies (SPMs) in survivors of SCCA. METHODS: Using population-based data from 1992 through 2012, the authors identified patients with SCCA and determined their risk of HPV-related SPMs, including anal, oral, and genital cancers. Standardized incidence ratios (SIRs), defined as observed to expected cases, were calculated to determine excess risk. RESULTS: Of 10,537 patients with SCCA, 416 developed HPV-related SPMs, which corresponded to an overall SIR of 21.5 (99% confidence interval [99% CI], 19.0-24.2). Men were found to have a higher SIR (35.8; 99% CI, 30.7-41.6) compared with women (12.8; 99% CI, 10.4-15.5). SIRs for a second SCCA were markedly higher in men (127.5; 99% CI, 108.1-149.2) compared with women (47.0; 99% CI, 34.7-62.1), whereas SIRs for oral cavity and pharyngeal cancers were elevated in men (3.1; 99% CI, 1.5-5.7) and women (4.4; 99% CI, 1.5-9.7). SIRs for sex-specific sites also were elevated, with male genital cancers having an SIR of 19.6 (99% CI, 8.7-37.6) and female genital cancers an SIR of 8.3 (99% CI, 6.1-11.0). CONCLUSIONS: Patients with index SCCA are at an increased risk of subsequent HPV-related SPMs. The elevated risk is most striking in patients with second primary SCCAs; however, the risk of second cancers also appears to be increased in other HPV-related sites. Cancer 2017;123:4013-21. © 2017 American Cancer Society.

Exploring characteristics, predictors, and consequences of fear of cancer recurrence among Asian-American breast cancer survivors.

BACKGROUND: To address the fear of cancer recurrence (FCR) research gap, we used prospective data to explore FCR predictors and FCR associations with health-related quality of life among Asian-American breast cancer survivors (BCS). METHODS: A total of 208 diverse Asian-American BCS completed T1 survey, and 137 completed T2 survey after 1 year. RESULTS: Fear of cancer recurrence scores (range = 0-4) were 2.01 at T1 and 1.99 at T2 reflecting low-to-moderate FCR. Scores of FCR were stable over the 1-year period (t(126) = .144, P = .886). Multiple regression analyses showed that Chinese women reported lower FCR both at T1 (t(193) = -2.92, P = .004) and T2 (t(128) = -2.56, P = .012) compared to other Asian women. Also, more positive health care experience at T1 predicted lower FCR at T2 (ß = -.18, P = .041). Controlling for other covariates, greater FCR at T1 predicted poorer outcomes 1 year later including lower physical (ß = -.31, P < .001), emotional (ß = -.37, P < .001) and functional (ß = -.16, P = .044) well-being and health-related quality of life specific to breast cancer at T2 (ß = -.31, P < .001). CONCLUSIONS: We found substantial consistencies and some divergences between our findings with Asian-American BCS and the existing literature. This prospective investigation reveals new information suggesting that Asian-American subgroup variation exists and health care system factors may influence FCR. Thus, FCR studies should consider Asian subgroupings, cultural aspects, ie, level of acculturation and health care system factors including provider-patient communication and treatment setting. Future research may benefit from contextualizing FCR within a broader distress framework to advance the science and practice of patient-centered and whole-person care.

Time to Treatment: Measuring Quality Breast Cancer Care.

BACKGROUND: To optimize breast cancer care, several organizations have crafted guidelines to define best practices for treating breast cancer. In addition to recommended therapies, 'timeliness of treatment' has been proposed as a quality metric. Our study evaluates time to surgical treatment and its effect on overall survival (OS). METHODS: The National Cancer Data Base (NCDB) was used to identify women diagnosed with invasive breast cancer between 2004 and 2012. Time from diagnosis to surgical treatment was calculated and grouped according to predetermined time intervals. Univariate and multivariate Cox proportional hazard models were used to assess patient and treatment factors related to OS. RESULTS: Overall, 420,792 patients initially treated with surgery were identified. Increased time to surgical treatment >12 weeks was associated with decreased OS [hazard ratio (HR) 1.14, 95 % confidence interval (CI) 1.09-1.20]. When stratified by pathologic stage, stage I patients treated at 8 to <12 weeks (HR 1.07, 95 % CI 1.02-1.13) and >12 weeks (HR 1.19, 95 % CI 1.11-1.28), as well as stage II patients treated at >12 weeks (HR 1.16, 95 % CI 1.08-1.25), had decreased OS compared with patients treated at <4 weeks. Other variables associated with decreased survival were treatment at a community cancer program, Medicaid or Medicare insurance, Black race, increasing age, mastectomy, moderately and poorly differentiated tumor grade, increasing T and N stage, and higher Charlson Index Group. CONCLUSION: The survival benefit of expedited time to initial surgical treatment varies by stage and appears to have the greatest impact in early-stage disease. Prior to establishing standard metrics, further quantification of the impact on patient outcomes is needed.

Neoadjuvant Therapy for Rectal Cancer Affects Lymph Node Yield and Status Without Clear Implications on Outcome: The Case for Eliminating a Metric and Using Preoperative Staging to Guide Therapy.

BACKGROUND: Nodal status has long been considered pivotal to oncologic care, staging, and management. This has resulted in the establishment of rudimentary metrics regarding adequate lymph node yield in colon and rectal cancers for accurate cancer staging. In the era of neoadjuvant treatment, the implications of lymph node yield and status on patient outcomes remains unclear. PATIENT AND METHODS: This study included 1,680 patients with locally advanced rectal cancer from the NCCN prospective oncology database stratified into 3 groups based on preoperative therapy received: no neoadjuvant therapy, neoadjuvant chemoradiation, and neoadjuvant chemotherapy. Clinicopathologic characteristics and survival were compared between the groups, with univariate and multivariate analyses undertaken. RESULTS: The clinicopathologic characteristics demonstrated statistically significant differences and heterogeneity among the 3 groups. The neoadjuvant chemoradiation group demonstrated the statistically lowest median lymph node yield (n=15) compared with 17 and 18 for no-neoadjuvant and neoadjuvant chemotherapy, respectively (P<.0001). Neoadjuvant treatment did impact survival, with chemoradiation demonstrating increased median overall survival of 42.7 compared with 37.3 and 26.6 months for neoadjuvant chemotherapy and no-neoadjuvant therapy, respectively (P<.0001). Patients with a yield of fewer than 12 lymph nodes had improved median overall survival of 43.3 months compared with 36.6 months in patients with 12 or more lymph nodes (P=.009). Multivariate analysis demonstrated that neither node yield nor status were predictors for overall survival. DISCUSSION: This analysis reiterates that nodal yield in rectal cancer is multifactorial, with neoadjuvant therapy being a significant factor. Node yield and status were not significant predictors of overall survival. A nodal metric may not be clinically relevant in the era of neoadjuvant therapy, and guidelines for perioperative therapy may need reconsideration.

Clinical effects of a standardized Chinese herbal remedy, Qili Qiangxin, as an adjuvant treatment in heart failure: systematic review and meta-analysis.

BACKGROUND: Qili Qiangxin capsule is a standardized Chinese herbal treatment that is commonly used in China for heart failure (HF) alongside conventional medical care. In 2014, Chinese guidelines for the treatment of chronic HF highlighted Qili Qiangxin capsules as a potentially effective medicine. However, there is at present no high quality review to evaluate the effects and safety of Qili Qiangxin for patients with HF. METHODS: We conducted a systematic review and meta-analysis and followed methods described in our registered protocol [PROSPERO registration: CRD42013006106]. We searched 6 electronic databases to identify randomized clinical trials (RCTs) irrespective of blinding or placebo control of Qili Qiangxin used as an adjuvant treatment for HF. RESULTS: We included a total of 129 RCTs published between 2005 and 2015, involving 11,547 patients, aged 18 to 98 years. Meta-analysis showed no significant difference between Qili Qiangxin plus conventional treatment and conventional treatment alone for mortality (RR 0.53, 95 % CI 0.27 to 1.07). However, compared with conventional treatment alone, Qili Qiangxin plus conventional treatment demonstrated a significant reduction in major cardiovascular events (RR 0.46, 95 % CI 0.34 to 0.64) and a significant reduction in re-hospitalization rate due to HF (RR 0.49, 95 % CI 0.38 to 0.64). Qili Qiangxin also showed significant improvement in cardiac function measured by the New York Heart Association scale (RR 1.38, 95 % CI 1.29 to 1.48) and quality of life as measured by Minnesota Living with Heart Failure Questionnaire (MD -8.48 scores, 95 % CI -9.56 to -7.39). There were no reports of serious adverse events relating to Qili Qiangxin administration. The majority of included trials were of poor methodological quality. CONCLUSIONS: When compared with conventional treatment alone, Qili Qiangxin combined with conventional treatment demonstrated a significant effect in reducing cardiovascular events and re-hospitalization rate, though not in mortality. It appeared to significantly improve quality of life in patients with HF and data from RCTs suggested that Qili Qiangxin is likely safe. This data was drawn from low quality trials and the results of this review must therefore be interpreted with caution. Further research is warranted, ideally involving large, prospective, rigorous trials, in order to confirm these findings.