Think Twice: De-implementation of Laboratory Testing After Colorectal Surgery.

BACKGROUND: Clinically unindicated laboratory testing contributes to low-value care. Most postoperative day 1 laboratory tests after colorectal surgery are normal. However, no published interventions have shown that reducing overall postoperative laboratory testing is safe. OBJECTIVE: This study aimed to investigate the impact of reducing postoperative laboratory testing after colorectal surgery. DESIGN: This is a quality improvement study. SETTINGS: The study was conducted at an academic center with an enhanced recovery after surgery program that included 5 daily laboratory tests until discharge. PATIENTS: All adults undergoing colorectal or small-bowel surgery formed intervention and nonintervention cohorts based on surgeons who chose to opt into the study. Preimplementation (November 2019-October 2021), there were 545 intervention and 577 nonintervention patients. Postimplementation (November 2021-March 2023), there were 448 intervention and 437 nonintervention patients. INTERVENTIONS: The intervention included 3 postoperative day 1 laboratory tests and subsequent clinically indicated laboratory tests. MAIN OUTCOME MEASURES: Outcome measures included laboratory tests and days free of laboratory work. RESULTS: Postintervention, the intervention group had a 33% reduction in laboratory tests per hospital stay, a 26% reduction in laboratory tests per day, and a 49% increase in laboratory test-free days. There was no difference in length of stay (4 vs 4; p = 0.79) or readmissions (14.9% vs 12.9%; p = 0.39). The nonintervention group had no significant changes in laboratory work or laboratory test-free days, with no differences in length of stay (4 vs 4; p = 0.49) or readmissions (11.1% vs 11.0%; p = 0.96). LIMITATIONS: Demographics and complication rates were not reported. CONCLUSIONS: An intervention targeting reflexive laboratory testing after colorectal surgery resulted in safe, significant, sustained reductions in postoperative laboratory work, with substantial cost savings. These findings prompted a change in the laboratory order set to an opt-out system, and laboratory work reduction approaches have been implemented within other surgical divisions. Continuation and spread of these efforts are instrumental for prioritization of high-value surgical care. See Video Abstract . PINSELO DOS VECES ELIMINACIN DE LAS PRUEBAS DE LABORATORIO DESPUS DE LA CIRUGA COLORRECTAL: ANTECEDENTES:Las pruebas de laboratorio clínicamente no indicadas contribuyen a una atención de bajo valor. La mayoría de los análisis de laboratorio del primer día post operatorios de una cirugía colorrectal son normales. Sin embargo, ninguna intervención publicada ha demostrado que reducir las pruebas de laboratorio post operatorias generales sea seguro.OBJETIVO:El objetivo de este estudio fue investigar el impacto de reducir las pruebas de laboratorio pos toperatorias después de la cirugía colorrectal.DISEÑO:Este es un estudio de mejora de la calidad.AJUSTES:El estudio se llevó a cabo en un centro académico con un programa mejorado de recuperación después de la cirugía que incluye 5 laboratorios diarios hasta el alta.PACIENTES:Todos los adultos sometidos a cirugía colorrectal o de intestino delgado formaron cohortes de intervención y no intervención basadas en los cirujanos que optaron por participar en el estudio. Antes de la implementación (noviembre de 2019 - octubre de 2021) había 545 pacientes con intervención y 577 sin intervención. Después de la implementación (noviembre de 2021 - marzo de 2023) hubo 448 pacientes con intervención y 437 sin intervención.INTERVENCIONES:La intervención incluyó 3 laboratorios post operatorios del primer día y laboratorios posteriores clínicamente indicados.PRINCIPALES MEDIDAS DE RESULTADO:Las medidas de resultado incluyeron pruebas de laboratorio y días sin laboratorio.RESULTADOS:Después de la intervención, el grupo de intervención tuvo una reducción del 33 % en laboratorios por estancia hospitalaria, una reducción del 26 % en laboratorios por día y un aumento del 49 % en los días sin laboratorio. No hubo diferencias en la duración de la estancia hospitalaria (4 frente a 4; p = 0,79) ni en los reingresos (14,9% frente a 12,9%; p = 0,39). El grupo de no intervención no tuvo cambios significativos en el trabajo de laboratorio o en los días sin laboratorio, sin diferencias en la duración de la estadía (4 versus 4; p = 0,49) o reingresos (11,1% versus 11,0%; p = 0,96).LIMITACIONES:No se informaron datos demográficos ni tasa de complicaciones.CONCLUSIONES:Una intervención dirigida a pruebas de laboratorio reflexivas después de la cirugía colorrectal resultó en reducciones seguras, significativas y sostenidas en el trabajo de laboratorio post operatorio, con ahorros sustanciales de costos. Estos hallazgos provocaron un cambio en el orden del laboratorio establecido hacia un sistema de exclusión voluntaria, y se han implementado enfoques de reducción del trabajo de laboratorio en otras divisiones quirúrgicas. La continuación y difusión de estos esfuerzos son fundamentales para priorizar la atención quirúrgica de alto valor. (Traducción-Dr. Mauricio Santamaria ).

Conversations for providers caring for patients with rectal cancer: Comparison of long-term patient-centered outcomes for patients with low rectal cancer facing ostomy or sphincter-sparing surgery.

For some patients with low rectal cancer, ostomy (with elimination into a pouch) may be the only realistic surgical option. However, some patients have a choice between ostomy and sphincter-sparing surgery. Sphincter-sparing surgery has been preferred over ostomy because it offers preservation of normal bowel function. However, this surgery can cause incontinence and bowel dysfunction. Increasingly, it has become evident that certain patients who are eligible for sphincter-sparing surgery may not be well served by the surgery, and construction of an ostomy may be better. No validated assessment tool or decision aid has been published to help newly diagnosed patients decide between the two surgeries or to help physicians elicit long-term surgical outcomes. Furthermore, comparison of long-term outcomes and late effects after the two surgeries has not been synthesized. Therefore, this systematic review summarizes controlled studies that compared long-term survivorship outcomes between these two surgical groups. The goals are: 1) to improve understanding and shared decision-making among surgeons, oncologists, primary care providers, patients, and caregivers; 2) to increase the patient's participation in the decision; 3) to alert the primary care provider to patient challenges that could be addressed by provider attention and intervention; and 4) ultimately, to improve patients' long-term quality of life. This report includes discussion points for health care providers to use with their patients during initial discussions of ostomy and sphincter-sparing surgery as well as questions to ask during follow-up examinations to ascertain any long-term challenges facing the patient. CA Cancer J Clin 2016;66:387-397. © 2016 American Cancer Society.

Survival After Induction Chemotherapy and Chemoradiation Versus Chemoradiation and Adjuvant Chemotherapy for Locally Advanced Rectal Cancer.

BACKGROUND: Total neoadjuvant therapy (TNT) improves tumor response in locally advanced rectal cancer (LARC) patients compared to neoadjuvant chemoradiotherapy alone. The effect of TNT on patient survival has not been fully investigated. MATERIALS AND METHODS: This was a retrospective case series of patients with LARC at a comprehensive cancer center. Three hundred and eleven patients received chemoradiotherapy (chemoRT) as the sole neoadjuvant treatment and planned adjuvant chemotherapy, and 313 received TNT (induction fluorouracil and oxaliplatin-based chemotherapy followed by chemoradiotherapy in the neoadjuvant setting). These patients then underwent total mesorectal excision or were entered in a watch-and-wait protocol. The proportion of patients with complete response (CR) after neoadjuvant therapy (defined as pathological CR or clinical CR sustained for 2 years) was compared by the χ2 test. Disease-free survival (DFS), local recurrence-free survival, distant metastasis-free survival, and overall survival were assessed by Kaplan-Meier analysis and log-rank test. Cox regression models were used to further evaluate DFS. RESULTS: The rate of CR was 20% for chemoRT and 27% for TNT (P=.05). DFS, local recurrence-free survival, metastasis-free survival, and overall survival were no different. Disease-free survival was not associated with the type of neoadjuvant treatment (hazard ratio [HR] 1.3; 95% confidence interval [CI] 0.93-1.80; P = .12). CONCLUSIONS: Although TNT does not prolong survival than neoadjuvant chemoradiotherapy plus intended postoperative chemotherapy, the higher response rate associated with TNT may create opportunities to preserve the rectum in more patients with LARC.

A qualitative analysis of caregiver burden during the recovery process in ambulatory cancer surgery.

PURPOSE: Cancer impacts caregivers as well as patients. Ambulatory oncology surgeries requiring a short hospital stay place additional responsibility on informal caregivers as they help patients navigate their post-operative recovery at home, and determine if symptoms are expected or emergent. Our objective was to explore the experience of informal caregivers during patients' ambulatory cancer surgery and then recovery at home with remote monitoring of symptoms via web-based patient-reported outcomes questionnaire ("Recovery Tracker"). METHODS: Semi-structured interviews were conducted with caregivers from a larger sample participating in a randomized trial of the Recovery Tracker. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software (QSR International Inc.). Recruitment was conducted iteratively to ensure a heterogenous sample and thematic saturation. RESULTS: Twenty-three semi-structured interviews were conducted. Four main themes emerged: (1) Predictability reduced stress among caregivers; (2) Unexpected events caused stress for caregivers; (3) The importance of a caregiver being present during the recovery process; and (4) Caregiver involvement in remote monitoring of symptoms was minimal. CONCLUSION: Caregivers report not being overly burdened by the ambulatory surgery process, but they are very sensitive to any deviations from what they expected to happen. Further research and clinical practice on caregivers in the ambulatory setting should focus on how to set expectations and avoid unexpected events.

Physical activity, bowel function, and quality of life among rectal cancer survivors.

PURPOSE: Physical activity (PA) is positively associated with numerous health benefits among cancer survivors. This study examined insufficiently investigated relationships among PA, health-related quality of life (HRQOL), and bowel function (BF) in rectal cancer survivors. METHODS: RC survivors (n = 1063) ≥5 years from diagnosis in two Kaiser permanente regions were mailed a multidimensional survey to assess HRQOL and BF. PA was assessed by a modified Godin Leisure-Time Exercise Questionnaire. PA minutes were categorized into weighted categories based on guidelines: (1) not active (zero PA minutes); (2) insufficiently active (1-149 PA minutes); (3) meeting guidelines (150-299 PA minutes); and (4) above guidelines (≥300 PA minutes). Relationships of PA with HRQOL and BF were evaluated using multiple linear regression, stratified by sex and ostomy status for BF. Types of PA identified as helpful for BF and symptoms addressed were summarized. RESULTS: Response rate was 60.5%. Of 557 participants, 40% met or exceeded PA guidelines, 34% were not active, and 26% were insufficiently active. Aerobic activities, specifically walking and cycling, were most commonly reported to help BF. Higher PA was associated with better psychological wellbeing and multiple SF12 scales, worse BF scores in men with ostomies, and better BF scores in women. CONCLUSIONS: Meeting or exceeding PA guidelines was associated with higher HRQOL. Although the BF findings are exploratory, they suggest women may benefit from increased PA, whereas men with ostomies may face challenges that require more study. Identifying PA strategies that will lead to improved patient compliance and benefit are needed.

Reliability and validity of a survey to measure bowel function and quality of life in long-term rectal cancer survivors.

PURPOSE: Examination of reliability and validity of a specialized health-related quality of life questionnaire for rectal cancer (RC) survivors (≥5 years post-diagnosis). METHODS: We mailed 1,063 Kaiser Permanente (KP) RC survivors (313 ostomy and 750 anastomosis) a questionnaire containing the Modified City of Hope Quality of Life-Ostomy (mCOH-QOL-O), SF-12v2, Duke-UNC Functional Social Support Questionnaire (FSSQ), and Memorial Sloan-Kettering Cancer Center Bowel Function Index (BFI). We adapted certain BFI items for use by subjects with intestinal ostomies. We evaluated reliability for all instruments with inter-item correlations and Cronbach's alpha. We assessed construct validity only for the BFI in the ostomy group, because such use has not been reported. RESULTS: The overall response rate was 60.5 % (577 respondents/953 eligible). Compared with non-responders, participants were on average 2 years younger and more likely non-Hispanic white, resided in educationally non-deprived areas, and had KP membership through a group. The mCOH-QOL-O, SF-12, and FSSQ were found to be highly reliable for RC survivors. In the ostomy group, BFI Urgency/Soilage and Dietary subscales were found to be reliable, but Frequency was not. Factor analysis supported the construct of Urgency/Soilage and Dietary subscales in the ostomy group, although one item had a moderate correlation with all three factors. The BFI also demonstrated good concurrent validity with other instruments in the ostomy group. CONCLUSIONS: With possible exception of the BFI Frequency subscale in populations with ostomies, components of our survey can be used for the entire population of RC survivors, no matter whether they received anastomosis or ostomy.

Patient-Reported Outcome Measures Within a National Multispecialty Surgical Quality Improvement Program.

Importance: Patient-reported outcome measures (PROMs) are increasingly recognized for their ability to promote patient-centered care, but concerted health information technology (HIT)-enabled PROM implementations have yet to be achieved for national surgical quality improvement. Objective: To evaluate the feasibility of collecting PROMs within a national surgical quality improvement program. Design, Setting, and Participants: This was a pragmatic implementation cohort study conducted from February 2020 to March 2023. Hospitals in the US participating in the American College of Surgeons National Surgical Quality Improvement Program and their patients were included in this analysis. Exposures: Strategies to increase PROM collection rates were identified using the Institute for Healthcare Improvement (IHI) Framework for Spread and the Consolidated Framework for Implementation Research and operationalized with the IHI Model for Improvement's Plan-Do-Study-Act (PDSA) cycles. Main Outcomes and Measures: The primary goal was to accrue more than 30 hospitals and achieve collection rates of 30% or greater in the first 3 years. Logistic regression was used to identify hospital-level factors associated with achieving collection rates of 30% or greater and to identify patient-level factors associated with response to PROMs. Results: At project close, 65 hospitals administered PROMs to 130 365 patients (median [IQR] age, 60.1 [46.2-70.0] years; 77 369 female [59.4%]). Fifteen PDSA cycles were conducted to facilitate implementation, primarily targeting the Consolidated Framework for Implementation Research domains of Inner Setting (ie, HIT platform) and Individuals (ie, patients). The target collection rate was exceeded in quarter 3 (2022). Fifty-eight hospitals (89.2%) achieved collection rates of 30% or greater, and 9 (13.8%) achieved collection rates of 50% or greater. The median (IQR) maximum hospital-level collection rate was 40.7% (34.6%-46.7%). The greatest increases in collection rates occurred when both email and short-message service text messaging were used, communications to patients were personalized with their surgeon's and hospital's information, and the number of reminders increased from 2 to 5. No identifiable hospital characteristic was associated with achieving the target collection rate. Patient age and insurance status contributed to nonresponse. Conclusions and Relevance: Results of this cohort study suggest that the large-scale electronic collection of PROMs into a national multispecialty surgical registry was feasible. Findings suggest that HIT platform functionality and earning patient trust were the keys to success; although, iterative opportunities to increase collection rates and address nonresponse remain. Future work to drive continuous surgical quality improvement with PROMs are ongoing.

A Remote Symptom Monitoring Tool As Part of Ambulatory Cancer Surgery Recovery: A Qualitative Analysis of Patient Experience.

PURPOSE: Patients recovering from ambulatory cancer surgery at home may find it difficult to determine whether their postoperative symptoms are normal or potentially serious. We developed the Recovery Tracker to help patients navigate such issues. The Recovery Tracker is a 10-day, web-based electronic survey that monitors symptoms daily and provides feedback as to whether reported symptoms are expected or require follow-up. We sought to examine patient perceptions using this tool. METHODS: Semistructured interviews were conducted from August 2017 to September 2019 with a convenience sample of patients from a larger randomized controlled trial of the Recovery Tracker. Patients undergoing surgery at an ambulatory cancer center dedicated to the surgical treatment of breast, gynecologic, urologic, head, and neck cancers and benign tumors were included. Thematic analysis was applied to derive key themes and codes via NVivo qualitative analysis software. Recruitment was conducted iteratively until thematic saturation. RESULTS: Forty-three patients were interviewed. Interview responses were organized into five main themes: (1) The Recovery Tracker led to more seamless communication with the care team; (2) symptoms not expected or not listed on the Recovery Tracker caused stress; (3) the Recovery Tracker was perceived as an extension of care, prompting reflection about symptoms and recovery; (4) Enhanced Feedback provided reassurance and helped set expectations; and (5) the Recovery Tracker was easy to use. CONCLUSION: The patient experience of electronic symptom monitoring and feedback is congruent with the aims of such monitoring and feedback. Further qualitative research is required in more diverse populations.

Rate of residual disease after complete endoscopic resection of malignant colonic polyp.

BACKGROUND: Following polypectomy, colectomy is performed selectively to ensure complete clearance of neoplasia. OBJECTIVE: This study aimed to determine the risk factors associated with residual disease at colectomy following malignant polypectomy. DESIGN: This is a retrospective study. SETTING: This investigation took place at a tertiary teaching cancer center. PATIENTS: Consecutive patients undergoing polypectomy followed by colectomy from 1990 to 2007 were identified from a prospective database. MAIN OUTCOME MEASURES: Factors associated with residual disease at colectomy were associated with clinicopathologic features. RESULTS: Colectomy following polypectomy was performed in 143 patients: 127 with clear invasion of polyp submucosa (invasive disease), and 16 suspicious for submucosal invasion. Residual disease after colectomy was diagnosed in 27 (19%) of 143 patients. Disease was present in the colonic wall in 19 patients (13%): invasive in 16 (11%), and noninvasive in 3 (2.1%). Of the 16 patients with residual invasive disease at colectomy, 15 had clearly invasive disease at polypectomy and 1 was suspicious for invasive disease at polypectomy. Lymph node metastasis was noted in 10 (7.0%) patients. When analyzing patients with clearly invasive disease at polypectomy by margin status, residual invasive disease in the colon wall was noted in 8 of 50 (16%) with <1 mm (positive) polypectomy margin, 7 of 33 (21%) with indeterminate polypectomy margin, and 0 of 44 with ≥1 mm (negative) polypectomy margin (p = 0.009). Nodal metastasis was associated with the presence of lymphovascular invasion (p = 0.01). LIMITATIONS: This study is limited by its retrospective nature and selection bias. CONCLUSIONS: Following malignant polypectomy, colectomy should be considered in medically fit patients if the polypectomy margin is positive (≤1 mm) or unknown, or if lymphovascular invasion is present.

Sexual function after treatment for rectal cancer: a review.

Sexual function is one element of QOL that may be significantly altered following treatment for rectal cancer, but the incidence and contributing risk factors are generally poorly understood. Nevertheless, the impact of rectal cancer therapy on sexual function should be conveyed to patients preoperatively. In addition to helping patients evolve realistic expectations, it will help clinicians identify those for whom interventions may be appropriate. In the past 10 years, there has been an increase in the number of studies reporting sexual dysfunction following rectal cancer treatment. However, these studies are difficult to interpret collectively for a variety of reasons. Most importantly, sexual dysfunction lacks a standardized definition, which leads to poor comparability between studies. The best inclusive definitions describe sexual dysfunction as a collection of distinct symptoms, which differ for men and women. The absence of sexual activity is sometimes used as a surrogate for sexual dysfunction, but this is confounded by an individual's desire and opportunity for sexual activity, and may not be an accurate reflection of physiologic functionality. Additional factors complicating assimilation of studies include the absence of baseline data, missing data, small sample sizes, and heterogeneity in use of validated and nonvalidated instruments. The purpose of this article is to systematically review the contemporary literature reporting sexual function after rectal surgery to determine the overall risk of sexual dysfunction, evaluate possible contributing factors, and identify questions that should be addressed in future studies.

Implementing Quality Colon Cancer Survivorship Care: A Practical Proposal for a Path Forward.

There are currently close to 17 million survivors of cancer in the United States. This number is expected to grow as both an aging population and improved treatment increase the number of survivors. Consequently, the importance of quality survivorship care has been recognized, but implementing, measuring, and paying for this care in a highly fragmented health care system, across a broad spectrum of diseases, is difficult. Quality measurement tied to payment is one approach that has commonly been used to improve the quality of care in the US health care system, but the complexity of applying quality measurement metrics across the spectrum of cancer survivorship care had led to stalemate. In this article, we draw on prior work to develop a quality cancer survivorship framework and propose a practical path forward with a focus on the provision of colon cancer survivorship care within integrated health care delivery networks. With this narrowly defined approach, we hope that we can promote a practical solution that can be extended to other diseases and payment systems over time.

Feasibility of ex vivo FDG PET of the colon.

To facilitate future direct correlations between fluorine 18 fluorodeoxyglucose (FDG)-avid colonic lesions and immunohistochemical assay findings, the authors tested the feasibility of ex vivo FDG positron emission tomography (PET) of the colon resected from humans. In this institutional review board-approved, HIPAA-compliant study, the authors, after obtaining informed patient consent, injected FDG intraoperatively in five patients with neoplasms and imaged their resected colons approximately 3 hours later. The colon could be imaged during this fairly limited time interval, and polyps and cancers could be identified. No biologic tissue degradation occurred. The authors concluded that ex vivo FDG PET of the colon is feasible and, when combined with careful histologic and immunohistochemical analyses, may serve as a research tool to determine the mechanisms of the normal colonic uptake of FDG and the localization of FDG in polyps and cancers.

Assessment of a Watch-and-Wait Strategy for Rectal Cancer in Patients With a Complete Response After Neoadjuvant Therapy.

IMPORTANCE: The watch-and-wait (WW) strategy aims to spare patients with rectal cancer unnecessary resection. OBJECTIVE: To analyze the outcomes of WW among patients with rectal cancer who had a clinical complete response to neoadjuvant therapy. DESIGN, SETTING, AND PARTICIPANTS: This retrospective case series analysis conducted at a comprehensive cancer center in New York included patients who received a diagnosis of rectal adenocarcinoma between January 1, 2006, and January 31, 2015. The median follow-up was 43 months. Data analyses were conducted from June 1, 2016, to October 1, 2018. EXPOSURES: Patients had a clinical complete response after completing neoadjuvant therapy and agreed to a WW strategy of active surveillance and possible salvage surgery (n = 113), or patients underwent total mesorectal excision and were found to have a pathologic complete response (pCR) at resection (n = 136). MAIN OUTCOMES AND MEASURES: Kaplan-Meier estimates were used for analyses of local regrowth and 5-year rates of overall survival, disease-free survival, and disease-specific survival. RESULTS: Compared with the 136 patients in the pCR group, the 113 patients in the WW group were older (median [range], 67.2 [32.1-90.9] vs 57.3 [25.0-87.9] years, P < .001) with cancers closer to the anal verge (median [range] height from anal verge, 5.5 [0.0-15.0] vs 7.0 [0.0-13.0] cm). All 22 local regrowths in the WW group were detected on routine surveillance and treated by salvage surgery (20 total mesorectal excisions plus 2 transanal excisions). Pelvic control after salvage surgery was maintained in 20 of 22 patients (91%). No pelvic recurrences occurred in the pCR group. Rectal preservation was achieved in 93 of 113 patients (82%) in the WW group (91 patients with no local regrowths plus 2 patients with local regrowths salvaged with transanal excision). At 5 years, overall survival was 73% (95% CI, 60%-89%) in the WW group and 94% (95% CI, 90%-99%) in the pCR group; disease-free survival was 75% (95% CI, 62%-90%) in the WW group and 92% (95% CI, 87%-98%) in the pCR group; and disease-specific survival was 90% (95% CI, 81%-99%) in the WW group and 98% (95% CI, 95%-100%) in the pCR group. A higher rate of distant metastasis was observed among patients in the WW group who had local regrowth vs those who did not have local regrowth (36% vs 1%, P < .001). CONCLUSIONS AND RELEVANCE: A WW strategy for select rectal cancer patients who had a clinical complete response after neoadjuvant therapy resulted in excellent rectal preservation and pelvic tumor control; however, in the WW group, worse survival was noted along with a higher incidence of distant progression in patients with local regrowth vs those without local regrowth.

Adoption of Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer.

Importance: Treatment of locally advanced rectal (LARC) cancer involves chemoradiation, surgery, and chemotherapy. The concept of total neoadjuvant therapy (TNT), in which chemoradiation and chemotherapy are administered prior to surgery, has been developed to optimize delivery of effective systemic therapy aimed at micrometastases. Objective: To compare the traditional approach of preoperative chemoradiation (chemoRT) followed by postoperative adjuvant chemotherapy with the more recent TNT approach for LARC. Design, Setting, and Participants: A retrospective cohort analysis using Memorial Sloan Kettering Cancer Center (MSK) records from 2009 to 2015 was carried out. A total of 811 patients who presented with LARC (T3/4 or node-positive) were identified. Exposures: Of the 811 patients, 320 received chemoRT with planned adjuvant chemotherapy and 308 received TNT (induction fluorouracil- and oxaliplatin-based chemotherapy followed by chemoRT). Main Outcomes and Measures: Treatment and outcome data for the 2 cohorts were compared. Dosing and completion of prescribed chemotherapy were assessed on the subset of patients who received all therapy at MSK. Results: Of the 628 patients overall, 373 (59%) were men and 255 (41%) were women, with a mean (SD) age of 56.7 (12.9) years. Of the 308 patients in the TNT cohort, 181 (49%) were men and 127 (49%) were women. Of the 320 patients in the chemoRT with planned adjuvant chemotherapy cohort, 192 (60%) were men and 128 (40%) were women. Patients in the TNT cohort received greater percentages of the planned oxaliplatin and fluorouracil prescribed dose than those in the chemoRT with planned adjuvant chemotherapy cohort. The complete response (CR) rate, including both pathologic CR (pCR) in those who underwent surgery and sustained clinical CR (cCR) for at least 12 months posttreatment in those who did not undergo surgery, was 36% in the TNT cohort compared with 21% in the chemoRT with planned adjuvant chemotherapy cohort. Conclusions and Relevance: Our findings provide additional support for the National Comprehensive Cancer Network (NCCN) guidelines that categorize TNT as a viable treatment strategy for rectal cancer. Our data suggest that TNT facilitates delivery of planned systemic therapy. Long-term follow-up will determine if this finding translates into improved survival. In addition, given its high CR rate, TNT may facilitate nonoperative treatment strategies aimed at organ preservation.

Clinical examination following preoperative chemoradiation for rectal cancer is not a reliable surrogate end point.

PURPOSE: Clinical assessment of rectal cancer response to preoperative combined-modality therapy (CMT) using digital rectal examination (DRE) has been proposed as a means of assessing efficacy of therapy. However, because the accuracy of this approach has not been established, we conducted a prospective analysis to determine the operating surgeon's ability to assess response using DRE. PATIENTS AND METHODS: Ninety-four prospectively accrued patients with locally advanced rectal cancer (T3/4 or N1) were evaluated with DRE and sigmoidoscopy in order to determine the following tumor characteristics: size, location, mobility, morphology, and circumference. Following preoperative CMT (50.40 Gy with fluorouracil-based chemotherapy) and under general anesthesia, the same surgeon estimated tumor response based on changes in these tumor characteristics, assessed via DRE. Percent pathologic tumor response was determined prospectively by a single pathologist using whole mount sections of the resected cancer. RESULTS: Clinical assessment using DRE underestimated pathologic response in 73 cases (78%). In addition, DRE was able to identify only 3 of 14 cases (21%) with a pathologic complete response. There were no clinical overestimates of response. None of the clinicopathologic tumor characteristics examined had a significant impact on DRE estimation of response. CONCLUSION: Clinical examination underestimates the extent of rectal cancer response to preoperative CMT. Given the inaccuracy of DRE following preoperative CMT, it should not be used as a sole means of assessing efficacy of therapy nor for selecting patients following CMT for local surgical therapies.

Use of surgery among elderly patients with stage IV colorectal cancer.

PURPOSE: The role of surgery to remove the primary tumor among patients with stage IV colorectal cancer (CRC) is controversial. The purpose of this study was to evaluate surgical practice patterns for patients > or = 65 years of age with stage IV CRC in a US population-based cohort. PATIENTS AND METHODS: We used the Surveillance, Epidemiology, and End Results-Medicare-linked database to evaluate the patterns of cancer treatment for 9,011 Medicare beneficiaries presenting with stage IV CRC from 1991 to 1999. Patients were categorized according to whether they had primary-cancer-directed surgery (CDS) or no CDS within 4 months of diagnosis. The use of other treatment modalities, including metastasectomy, chemotherapy, and radiation, was evaluated in relationship to whether patients belonged to the CDS or no CDS group. RESULTS: Seventy-two percent (6,469 of 9,011) of patients received CDS, and their 30-day postoperative mortality was 10%. Patients with left-sided or rectal lesions, patients older than age 75 years, blacks, and those of lower socioeconomic status were less likely to undergo CDS; but even among those older than age 75, the CDS rate was 69% (3,378 of 4,909). In contrast, chemotherapy use was less common (47% for patients who had CDS and 31% for those who did not). Metastasectomy was rare; only 3.9% of patients underwent these operations at any point from diagnosis to death. CONCLUSION: Palliative resection of the primary tumor is often performed for elderly US patients with stage IV colorectal cancer. This practice pattern merits re-evaluation, given the improvement in the efficacy of systemic chemotherapy.