Phase 1/2 study of epacadostat in combination with durvalumab in patients with metastatic solid tumors.

BACKGROUND: Targeting programmed cell death protein 1 (PD-1) and indoleamine 2,3-dioxygenase (IDO1) pathways is an appealing option for cancer treatment. METHODS: The open-label, phase 1/2 ECHO-203 study evaluated the safety, tolerability, and efficacy of the IDO1 inhibitor epacadostat in combination with durvalumab, a human anti-PD-L1 monoclonal antibody in adult patients with advanced solid tumors. RESULTS: The most common treatment-related adverse events were fatigue (30.7%), nausea (21.0%), decreased appetite (13.1%), pruritus (12.5%), maculopapular rash (10.8%), and diarrhea (10.2%). Objective response rate (ORR) in the overall phase 2 population was 12.0%. Higher ORR was observed in immune checkpoint inhibitor (CPI)-naïve patients (16.1%) compared with patients who had received previous CPI (4.1%). Epacadostat pharmacodynamics were evaluated by comparing baseline kynurenine levels with those on therapy at various time points. Only the 300-mg epacadostat dose showed evidence of kynurenine modulation, albeit unsustained. CONCLUSIONS: Epacadostat plus durvalumab was generally well tolerated in patients with advanced solid tumors. ORR was low, and evaluation of kynurenine concentration from baseline to cycle 2, day 1, and cycle 5, day 1, suggested >300 mg epacadostat twice daily is needed to ensure sufficient drug effect. CLINICAL TRIAL INFORMATION: A study of epacadostat (INCB024360) in combination with durvalumab (MEDI4736) in subjects with selected advanced solid tumors (ECHO-203) (NCT02318277).

Are current credentialing requirements for robotic surgery adequate to ensure surgeon proficiency?

BACKGROUND: Robotic surgery has seen unprecedented growth, requiring hospitals to establish or update credentialing policies regarding this technology. Concerns about verification of robotic surgeon proficiency and the adequacy of current credentialing criteria to maintain patient safety have arisen. The aim of this project was to examine existing institutional credentialing requirements for robotic surgery and evaluate their adequacy in ensuring surgeon proficiency. METHODS: Robotic credentialing policies for community and academic surgery programs were acquired and reviewed. Common criteria across institutions related to credentialing and recredentialing were identified and the average, standard deviation, and range of numeric requirements, if defined, was calculated. Criteria for proctors and assistants were also analyzed. RESULTS: Policies from 42 geographically dispersed US hospitals were reviewed. The majority of policies relied on a defined number of proctored cases as a surrogate for proficiency with an average of 3.24 ± 1.69 and a range of 1-10 cases required for initial credentialing. While 34 policies (81%) addressed maintenance of privileges requirements, there was wide variability in the average number of required robotic cases (7.19 ± 3.28 per year) and range (1-15 cases per year). Only 11 policies (26%) addressed the maximum allowable time gap between robotic cases. CONCLUSION: Significant variability in credentialing policies exists in a representative sample of US hospitals. Most policies require completion of a robotic surgery training course and a small number of proctored cases; however, ongoing objective performance assessments and patient outcome monitoring was rarely described. Existing credentialing policies are likely inadequate to ensure surgeon proficiency; therefore, development and wide implementation of robust credentialing guidelines is recommended to optimize patient safety and outcomes.

A single surgeon's experience transitioning to robotic-assisted right colectomy with intracorporeal anastomosis.

BACKGROUND: Despite substantial evidence demonstrating benefits of minimally invasive surgery, a large percentage of right colectomies are still performed via an open technique. Most laparoscopic right colectomies are completed as a hybrid procedure with extracorporeal anastomosis. As part of a pure minimally invasive procedure, intracorporeal anastomosis (ICA) may confer additional benefits for patients. The robotic platform may shorten the learning curve for minimally invasive right colectomy with ICA. METHODS: From January 2014 to May 2016, 49 patients underwent robotic-assisted right colectomy by a board-certified colorectal surgeon (S.R). Extracorporeal anastomosis (ECA) was used in the first 20 procedures, whereas ICA was used in all subsequent procedures. Outcomes recorded in a database for retrospective review included operating time (OT), estimated blood loss (EBL), length of stay (LOS), conversion rate, complications, readmissions, and mortality rate. RESULTS: Comparison of average OT, EBL, and LOS between extracorporeal and intracorporeal groups demonstrated no significant differences. For all patients, average OT was 141.6 ± 25.8 (range 86-192) min, average EBL was 59.5 ± 83.3 (range 0-500) mL, and average LOS was 3.4 ± 1.19 (range 1.5-8) days. Four patients required conversion, all of which occurred in the extracorporeal group. There were no conversions after the 18th procedure. The 60-day mortality rate was 0%. There were no anastomotic leaks, ostomies created, or readmissions. As the surgeon gained experience, a statistically significant increase in lymph node sampling was observed in oncologic cases (p = .02). CONCLUSIONS: The robotic platform may help more surgeons safely and efficiently transition to a purely minimally invasive procedure, enabling more patients to reap the benefits of less invasive surgery. Transitioning from ECA to ICA during robotic right colectomy resulted in no significant change in OT or LOS. A lower rate of conversion to open surgery was noted with increased experience.

Management of a Complex Fistula Involving Abdominal Wall, Small Bowel, Colon, and Bladder.

Successful surgical management of a chronic complex abdominal fistula requires thoughtful pre-operative evaluation and planning and often benefits from a multi-disciplinary approach. Initially, attention is focused on controlling sepsis and ensuring adequate hydration and electrolyte replacement. Next, efforts to optimize nutrition and engage the patient in prehabilitation are prioritized. Simultaneously, imaging is used to gain detailed assessment of anatomy. We present a challenging case involving a Jackson-Pratt (JP) drain from prior surgery causing a complex intra-abdominal fistula. The JP drain traversed multiple small bowel loops and the sigmoid colon before terminating in the bladder. Management required multi-disciplinary coordination involving colorectal surgery and urology. The patient's definitive surgery included anterior resection, colostomy takedown, right colectomy, three small bowel resections, and bladder repair. The use of JP drains after abdominal surgery is not without risk. Clinicians should have standardized indications for placement of JP drains and consistent protocols regarding timing of removal.

Quantification of surgical workflow during robotic proctectomy.

BACKGROUND: Surgical workflow assessments offer insight regarding procedure variability. We utilised an objective method to evaluate workflow during robotic proctectomy (RP). METHODS: We annotated 31 RPs and used Spearman's correlation to measure the correlation of step time and step visit frequency with console time (CT) and total operative time (TOT). RESULTS: Strong correlations were seen with CT and step times for inferior mesenteric vein dissection and ligation (ρ = 0.60, ρ = 0.60), lateral-to-medial splenic flexure mobilisation (SFM) (ρ = 0.63), left rectal dissection (ρ = 0.64) and mesorectal division (ρ = 0.71). CT correlated strongly with medial-to-lateral (ρ = 0.75) and supracolic SFM visit frequency (ρ = 0.65). TOT correlated strongly with initial exposure time (ρ = 0.60), and medial-to-lateral (ρ = 0.67) and supracolic SFM visit frequency (ρ = 0.65). CONCLUSION: This study correlates surgical steps with CT and TOT through standardised annotation, providing an objective approach to quantify workflow.

Quantification of Surgical Workflow during Robotic Proctectomy.

Aim: Assessments of surgical workflow offer insight regarding procedure variability, case complexity and surgeon proficiency. We utilize an objective method to evaluate step-by-step workflow and step transitions during robotic proctectomy (RP). Methods: We annotated 31 RPs using a procedure-specific annotation card. Using Spearman's correlation, we measured strength of association of step time and step visit frequency with console time (CT) and total operative time (TOT). Results: Across 31 RPs, a mean (± standard deviation) of 49.0 (± 20.3) steps occurred per procedure. Mean CT and TOT were 213 (± 90) and 283 (± 108) minutes. Posterior mesorectal dissection required most visits (8.7 ± 5.0), while anastomosis required most time (18.0 [± 8.5] minutes). Inferior mesenteric vein (IMV) ligation required least visits (1.0 ± 0.0) and lowest duration (0.9 [± 0.5] minutes). Strong correlations were seen with CT and step times for IMV dissection and ligation (ρ = 0.60 for both), lateral-to-medial splenic flexure mobilization (SFM) (ρ = 0.63), left rectal dissection (ρ = 0.64) and mesorectal division (ρ = 0.71). CT correlated strongly with medial-to-lateral and supracolic SFM visit frequency (ρ = 0.75 and ρ = 0.65). There were strong correlations with TOT and initial exposure time (ρ = 0.60), as well as visit frequency for medial-to-lateral (ρ = 0.67) and supracolic SFM (ρ = 0.65). Descending colon mobilization was nodal, rectal mobilization convergent and rectal transection divergent. Conclusion: This study correlates individual surgical steps with CT and TOT through standardized annotation. It provides an objective approach to quantify workflow.

Ratio of Economy of Motion: A New Objective Performance Indicator to Assign Consoles During Dual-Console Robotic Proctectomy.

BACKGROUND: Our group investigates objective performance indicators (OPIs) to analyze robotic colorectal surgery. Analyses of OPI data are difficult in dual-console procedures (DCPs) as there is currently no reliable, efficient, or scalable technique to assign console-specific OPIs during a DCP. We developed and validated a novel metric to assign tasks to appropriate surgeons during DCPs. METHODS: A colorectal surgeon and fellow reviewed 21 unedited, dual-console proctectomy videos with no information to identify the operating surgeons. The reviewers watched a small number of random tasks and assigned "attending" or "trainee" to each task. Based on this sampling, the remainder of task assignments for each procedure was extrapolated. In parallel, we applied our newly developed OPI, ratio of economy of motion (rEOM), to assign consoles. Results from the 2 methods were compared. RESULTS: A total of 1811 individual surgical tasks were recorded during 21 proctectomy videos. A median of 6.5 random tasks (137 total) were reviewed during each video, and the remainder of task assignments were extrapolated based on the 7.6% of tasks audited. The task assignment agreement was 91.2% for video review vs rEOM, with rEOM providing ground truth. It took 2.5 hours to manually review video and assign tasks. Ratio of economy of motion task assignment was immediately available based on OPI recordings and automated calculation. DISCUSSION: We developed and validated rEOM as an accurate, efficient, and scalable OPI to assign individual surgical tasks to appropriate surgeons during DCPs. This new resource will be useful to everyone involved in OPI research across all surgical specialties.

Robotic Proctectomy: Beyond the Initial Learning Curve.

BACKGROUND: Multiple authors have described an initial learning curve (LC) for robotic proctectomy (RP), but there is scant literature regarding continued technical progression beyond this stage. Total operating time is the most commonly used metric to measure proficiency. Our goal was to examine RP experience after the initial LC looking for evidence of further technical progression. METHODS: We reviewed our robotic surgery database for a single surgeon during operations 100 through 550 to identify 83 RPs for tumor. These were divided into quartiles by series order, indicating surgeon experience level over time. Demographics and outcomes were compared among the groups. We defined percent console time (PCT) as a new metric. PCT was defined as console time divided by total operative time (TOT). RESULTS: From March 2014 through March 2019, 450 robotic colorectal operations were performed, including 83 RPs for polyp or cancer. No significant differences were found among the quartiles in regard to demographics, tumor features, hospital stay, conversions, or readmissions. As experience was gained, there were significant increases in intracorporeal anastomosis (ICA), TOT, and PCT. Complications decreased with experience. Number of lymph nodes in the specimen increased. On multivariate analysis, later experience group, body mass index ≥30, and ICA were associated with increased PCT. DISCUSSION: ICA became a routine part of RP after the initial LC, with increases in TOT and PCT. Number of lymph nodes increased and number and severity of complications decreased with experience. Increased PCT may indicate increased expertise during RP.

Case report of surgical management of a locally invasive colostomy adenocarcinoma.

INTRODUCTION: This case report involves the presentation and management of a locally invasive adenocarcinoma at the site of a colostomy in a patient with multiple comorbidities and anatomic constraints. PRESENTATION OF CASE: 63 year-old woman with a complicated medical and surgical history, including imperforate anus and permanent colostomy, who presented with a fungating mass at the site of her colostomy. Evaluation revealed a locally invasive adenocarcinoma requiring surgical management for symptom control and oncologic treatment. DISCUSSION: Due to the patient's medical comorbidities, body habitus, prior surgery, prior radiation and locally invasive cancer, there were numerous physiologic and anatomic issues that required a multi-disciplinary approach. Specifically, consideration of the patient's prior radiation to the left chest, history of cystectomy and ileal conduit, history of prior colon resection, as well as her short stature and severe kyphosis required input from urology, plastic surgery and colorectal surgery for operative planning. The patient's chronic renal insufficiency, recurrent urinary tract infections and history of thromboembolic disease further complicated her perioperative management. Oncologic resection with wide local excision at the skin and abdominal wall were performed with mass closure of the midline and peristomal abdominoplasty, using mesh underlay. The patient's postoperative course was complicated by gastric outlet obstruction and recurrent urosepsis. CONCLUSIONS: Patients with chronic colostomies require colon cancer screening similar to their non-stoma peers, in accordance with national guidelines. Oncologic resection of cancers involving colostomies is feasible, but may require multi-disciplinary planning to manage complicated anatomic concerns.

Development of 2 Bromodomain and Extraterminal Inhibitors With Distinct Pharmacokinetic and Pharmacodynamic Profiles for the Treatment of Advanced Malignancies.

PURPOSE: Bromodomain and extraterminal (BET) proteins are key epigenetic transcriptional regulators, inhibition of which may suppress oncogene expression. We report results from 2 independent first-in-human phase 1/2 dose-escalation and expansion, safety and tolerability studies of BET inhibitors INCB054329 (study INCB 54329-101; NCT02431260) and INCB057643 (study INCB 57643-101; NCT02711137). PATIENTS AND METHODS: Patients (≥18 years) with advanced malignancies, ≥1 prior therapy, and adequate organ functions received oral INCB054329 (monotherapy) or INCB057643 (monotherapy or in combination with standard-of-care) in 21-day cycles (or 28-day cycles depending on standard-of-care combination). Primary endpoints were safety and tolerability. RESULTS: Sixty-nine and 134 patients received INCB054329 and INCB057643, respectively. Study INCB 54329-101 has been completed; INCB 57643-101 is currently active, but not recruiting (no patients were receiving treatment as of January 8, 2019). Terminal elimination half-life was shorter for INCB054329 versus INCB057643 (mean [SD], 2.24 [2.03] vs. 11.1 [8.27] hours). INCB054329 demonstrated higher interpatient variability in oral clearance versus INCB057643 (CV%, 142% vs. 45.5%). Most common (>20%) any-grade treatment-related adverse events were similar for both drugs (INCB054329; INCB057643): nausea (35%; 30%), thrombocytopenia (33%; 32%), fatigue (29%; 30%), decreased appetite (26%; 22%). Two confirmed complete responses and 4 confirmed partial responses with INCB057643 were reported as best responses. CONCLUSIONS: INCB057643 exhibited a more favorable PK profile versus INCB054329; exposure-dependent thrombocytopenia was observed with both drugs which limited the target inhibition that could be safely maintained. Further efforts are required to identify patient populations that can benefit most, and an optimal dosing scheme to maximize therapeutic index.

How robotics is changing and will change the field of colorectal surgery.

During the last decade there has been a significant upward trend in colon and rectal minimally invasive surgery which can be attributed largely to the acceptance of robotic surgery platforms such as the da Vinci® robotic system. The fourth generation da Vinci® system, introduced in 2014, includes integrated table motion, intelligent laser targeted docking and more sophisticated instrumentation and imaging. These developments have enabled more surgeons to efficiently and safely perform multi-quadrant operations. Firefly® technology allows assessment of colon perfusion and identification of ureters, and has shown potential in detecting occult recurrence or metastasis using molecular-labelled tumor markers. Wristed instrumentation has increased the technical ease of intracorporeal anastomosis (ICA) for many surgeons, leading to more common use of ICA during right colectomy. Advanced imaging has shown potential to decrease the incidence of presacral nerve injury and improve urogenital outcomes after pelvic surgery, as has been the case in robotic urologic procedures. Finally, the robotic platform lends itself to surgical simulation for surgical trainees, as a pre-operative tool for mock operations and as an ongoing assessment tool for established colorectal surgeons. Given these advantages, surgeons should anticipate continued and increased utilization of this beneficial technology.

Robotic-assisted surgery for complicated and non-complicated diverticulitis: a single-surgeon case series.

Laparoscopic colectomy is the preferred approach for surgical management of non-complicated diverticulitis, with lower complication rates, shorter length of stay, and decreased narcotic use compared with open surgery. Complicated diverticulitis, characterized by abscess, fistula or stricture, is more difficult to manage with minimally invasive surgery, with reports of higher conversion rates, prolonged operative time, longer length of stay, and increased complication rates. The robotic platform may provide an alternative safe and feasible option for managing complicated diverticulitis with minimally invasive surgery. A prospectively maintained database of robotic-assisted colorectal surgery performed at our university-affiliated community hospital was used to identify consecutive patients who underwent robotic-assisted surgery for complicated or non-complicated diverticulitis. Thirty-two patients with non-complicated diverticulitis and 36 patients with complicated diverticulitis had surgery between January, 1, 2014 and September 30, 2017. The database was used to compare the two groups of patients in regard to operative time, estimated blood loss, ureteral stent usage, conversions, ostomies, pelvic drains, post-operative complications, length of stay, return of bowel function, and post-operative narcotic use. Comparison of the two groups revealed significant differences in operative times (172 vs. 196 min, p = 0.01), conversions (3.1% vs. 22.2%, p = 0.03), ostomies (9.4% vs. 33.3%, p = 0.04), and pelvic drains (3.2% vs. 28.6%, p = 0.02). No significant differences were noted for estimated blood loss, complications, return of bowel function, narcotic use, length of stay, or readmissions. Four complicated diverticulitis patients had intra-operative ureteral stents, and there were no ureteral injuries in either group. Patients with complicated diverticulitis required longer operative time, and more often required conversion, an ostomy, and a pelvic drain. Robotic-assisted surgery is safe and feasible for both non-complicated and complicated diverticulitis.

A Curious Case of Autoimmune Pancreatitis with IgG4-related Sclerosing Cholangitis.

Immunoglobulin G4-related sclerosing cholangitis (IgG4-SC) is a novel entity that belongs to the immune-mediated fibroinflammatory class of IgG4-related diseases (IgG4-RD). IgG4-SC is noted to be one of the most frequent manifestations of extra-pancreatic disease among IgG4-RD, which is significantly different from primary SC (PSC) and cholangiocarcinoma (CC) as is evident in the varied approaches to treatment. IgG4-RD includes IgG4-SC and autoimmune pancreatitis (AIP). Herein, we presented a case of IgG4-SC in a patient with obstructive jaundice secondary to AIP. We have also discussed the current recommendations for diagnostic and treatment modalities, with an emphasis on the issues that arise in obtaining a definitive classification of disease.

Do patients followed in anticoagulation clinics for antiphospholipid syndrome meet criteria for the disorder?

Although specific criteria for diagnosing the antiphospholipid syndrome (APS) exist (the Sapporo Criteria), most physicians are not aware these include repeat testing and documentation of either a lupus anticoagulant or medium to high levels of anti-cardiolipin antibody. Incorrect diagnosis of APS may result in unnecessary long-term anticoagulation. The purpose of this study was to determine the clinical and serological characteristics of patients being treated for APS and concordance with published criteria. This cross-sectional study identified APS patients who were being treated with warfarin at one of three university-based anticoagulation clinics. Levels of anticardiolipin antibody were classified as low-positive if abnormal but < 40 GPL/MPL units and medium/high-positive if > or = 40 units. Strength of meeting Sapporo criteria was graded as definite, possible, and not meeting criteria. Of 103 cases, 97 had clinical and laboratory data available. Only 10 cases (10%, 95% Confidence Interval 5 - 19) met criteria for definite APS, 16 (16%, 10 - 26) had a possible diagnosis, and 71 (73%, 63 - 81) did not meet criteria. Of 70 cases that had abnormal anticardiolipin antibody results, only 32 (46%, 34 - 58) had medium/high-positive levels. Repeat laboratory testing was performed in only 49 cases (51%, 40 - 61). We conclude that few patients treated forAPS met Sapporo criteria. Abnormal levels of anticardiolipin antibody were frequently in the low-positive range, and repeat testing was often absent. A quality improvement program that includes review of cases referred for chronic anticoagulation care is recommended to ensure appropriate testing and treatment of patients with suspected APS.

Not all inflammation in the right lower quadrant is appendicitis: a case report of Escherichia coli O157:H7 with a review of the literature.

Although significant work has been presented on this subject in pediatric, infectious disease, and epidemiologic literature, there is a noteworthy lack of information on Escherichia coli O157:H7 in any surgical journals. As this disease can present with signs and symptoms often ascribed to the acute abdomen, it is imperative that the general surgeon, pediatric surgeon, and colorectal surgeon are all familiar with this infection and its clinical ramifications. A case report followed by a review of the literature is presented.

Horseshoe abscesses and fistulas: how are we doing?

BACKGROUND: Various surgical treatments exist for horseshoe abscesses and fistulae, including posterior midline sphincterotomy, catheter drainage, cutting and draining setons, and advancement flaps. The aim of this study was to evaluate the long-term results of patients treated for these complex anorectal problems. METHODS: A retrospective review was undertaken of patients with a diagnosis of horseshoe abscess, horseshoe fistula, postanal space abscess, or postanal space fistula from 1990 to 2001. Long-term follow-up was accomplished by telephone questionnaire. RESULTS: Thirty-one patients were identified, of whom 17 (54.8%) had a diagnosis of Crohn disease. The diagnosis at presentation included unilateral (ischiorectal) abscess (32.3%), bilateral horseshoe abscess (51.6%), bilateral horseshoe fistula (9.7%), and postanal space abscess (6.4%). Endoanal ultrasonography was used during the preoperative evaluation in 11 patients (35.5%). After referral to our institution, patients underwent a median of four operations (range, 1 to 9). At a mean follow-up of 49.3 months, 60.7% of patients had either healed perineal disease or were asymptomatic with controlled disease. Patients who had a posterior midline sphincterotomy were more likely to be asymptomatic (P=.047). Patients who had a diagnosis of Crohn disease required more operations than those without Crohn disease (3 vs 1.86, P=.02). Only patients who had a diagnosis of Crohn disease had a stoma at their last follow-up (4 of 17, 23.5% vs 0 of 11, 0%; P=.05). CONCLUSIONS: Patients with horseshoe abscess or fistulae often require multiple operations for treatment but can expect reasonable rates of long-term success in controlling or curing their disease. Those who undergo posterior midline sphincterotomy seem to benefit with higher rates of improved symptoms. Patients with a diagnosis of Crohn disease may fare less well. The role of endoanal ultrasonography in directing therapy remains to be defined.

Pelvic outlet obstruction.

Despite the wide variety of definitions and descriptions of constipation, ideally, the diagnostic approach should be uniform. The evaluation process should begin with a careful and thorough patient history and physical exam; appropriate efforts should be made to exclude organic causes of constipation. Patients suffering from pelvic outlet obstruction often respond poorly to conservative treatment. Diagnostic tests include intestinal transit studies, anorectal manometry, defecography, balloon expulsion, and anal sphincter electromyography. For many patients constipation is multifactorial and accordingly, so is the treatment. In our opinion the first line of treatment should be based on conservative measures including adequate intake of fluids, dietary fiber supplementation, and laxatives. Biofeedback training should be offered, particularly to patients with paradoxical puborectalis contraction. Surgical management can, in very limited circumstances, be offered only to those patients with disabling symptoms who have failed other standard therapeutic measures.

Isolated pulmonary recurrence after resection of colorectal hepatic metastases--is resection indicated?

BACKGROUND: Resection of colorectal hepatic metastases is an accepted treatment modality for stage IV colorectal cancer. Concurrent or sequential pulmonary metastasectomy continues to be a controversial strategy. We analyzed factors that predicted pulmonary recurrence in patients with resected hepatic metastases and examined the efficacy of these combined interventions in the treatment of metastatic colorectal cancer. METHODS: A retrospective review of a database of patients who underwent resection of colorectal hepatic metastases was performed to identify patients who either had synchronous pulmonary metastases (defined as pulmonary recurrence at the time of or within 3 months of hepatic metastasectomy) or subsequently experienced pulmonary metastases. Patient demographics, operative interventions, and overall survival were analyzed. Statistical methods included unpaired Student's t-test, actuarial survival and log-rank analysis. RESULTS: Twenty-one patients (19%) had pulmonary metastases after hepatic resection, of which 12/21(57%) underwent pulmonary resection. No differences were observed between the resection group, the nine patients with pulmonary metastases who did not undergo resection, and the 87 patients without pulmonary metastases with regard to age, sex, race, or extent of hepatic metastases. When comparing the resected versus the unresected pulmonary recurrences, the disease-free interval from hepatic resection to detection of pulmonary metastases was 21 +/- 20 months (range, 3-72 months) versus 16 +/- 8 months (range, 4-25 months), respectively. All patients with pulmonary recurrence who underwent pulmonary metastasectomy had unilateral disease. Seven of 12 (58%) underwent wedge/segmental resections, and the remaining five (42%) required lobectomy in order to obtain a complete resection. Four patients who underwent pulmonary resection had multiple lung metastases (two to four lesions), and eight had isolated metastasis. There were no perioperative deaths in the pulmonary metastasectomy group. Contraindications to pulmonary resection included extensive pulmonary disease and concurrent extrapulmonary disease. A survival benefit was noted at 3 years for the resected versus the unresected group (60% vs 31%). Survival was no different between the resected pulmonary recurrence patients and the resected hepatic metastases only patients (60% vs 54%). CONCLUSIONS: Pulmonary metastasectomy can be performed safely and effectively in patients with recurrent disease after hepatic resection for colorectal metastases. Prolonged survival can be achieved with resection of isolated pulmonary recurrence after hepatic resection for colorectal cancer. Further studies that delineate selection criteria for pulmonary resection of colorectal metastases are warranted.