To develop an evidence-based clinical practice guideline to assist in clinical decision making for patients with resected biliary tract cancer.
ASCO convened an Expert Panel to conduct a systematic ...review of the literature on adjuvant therapy for resected biliary tract cancer and provide recommended care options for this patient population.
Three phase III randomized controlled trials, one phase II trial, and 16 retrospective studies met the inclusion criteria.
Based on evidence from a phase III randomized controlled trial, patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy for a duration of 6 months. The dosing used in this trial is described in the qualifying statements, while it should be noted that the dose of capecitabine may also be determined by institutional and regional practices. Patients with extrahepatic cholangiocarcinoma or gallbladder cancer and a microscopically positive surgical resection margin (R1 resection) may be offered chemoradiation therapy. A shared decision-making approach is recommended, considering the risk of harm and potential for benefit associated with radiation therapy for patients with extrahepatic cholangiocarcinoma or gallbladder cancer. Additional information is available at www.asco.org/gastrointestinal-cancer-guidelines .
The Landmark Series: Gallbladder Cancer Gamboa, Adriana C.; Maithel, Shishir K.
Annals of surgical oncology,
08/2020, Letnik:
27, Številka:
8
Journal Article
Recenzirano
Given the rarity of gallbladder carcinoma, level I evidence to guide the multimodal treatment of this disease is lacking. Since 2010, four randomized phase III clinical trials including ABC-02, ...PRODIGE-12/ACCORD-18, BILCAP, and BCAT, and a single-arm phase II trial (SWOG0809) have been reported on the use of adjuvant strategies for biliary malignancies. These trials have led to the recommendation that patients with resected biliary tract cancer should be offered adjuvant capecitabine chemotherapy and those with R1 margins could be considered for chemoradiotherapy. Because there is no level I evidence to guide neoadjuvant therapy or surgical management, current consensus is based on strong retrospective data. The following review summarizes available trials and highlights the best available evidence that form the basis of consensus statements for the multimodal management of gallbladder carcinoma.
Background The decision as to whether a patient can tolerate surgery is often subjective and can misjudge a patient's true physiologic state. The concept of frailty is an important assessment tool in ...the geriatric medical population, but has only recently gained attention in surgical patients. Frailty potentially represents a measureable phenotype, which, if quantified with a standardized protocol, could reliably estimate the risk of adverse surgical outcomes. Study Design Frailty was prospectively evaluated in the clinic setting in patients consenting for major general, oncologic, and urologic procedures. Evaluation included an established assessment tool (Hopkins Frailty Score), self-administered questionnaires, clinical assessment of performance status, and biochemical measures. Primary outcome was 30-day postoperative complications. Results There were189 patients evaluated: 117 from urology, 52 from surgical oncology, and 20 from general surgery clinics. Mean age was 62 years, 59.8% were male, and 71.4% were Caucasian. Patients who scored intermediately frail or frail on the Hopkins Frailty Score were more likely to experience postoperative complications (odds ratio OR 2.07, 95% CI 1.05 to 4.08, p = 0.036). Of all other preoperative assessment tools, only higher hemoglobin (p = 0.033) had a significant association and was protective for 30-day complications. Conclusions The aggregate score of patients as “intermediately frail or frail” on the Hopkins Frailty Score was predictive of a patient experiencing a postoperative complication. This preoperative assessment tool may prove beneficial when weighing the risks and benefits of surgery, allowing objective data to guide surgical decision-making and patient counseling.
IMPORTANCE: Composite measures may be superior to individual measures for the analysis of hospital performance and quality of surgical care. OBJECTIVE: To determine the incidence of a so-called ...textbook outcome, a composite measure of the quality of surgical care, among patients undergoing curative-intent resection of intrahepatic cholangiocarcinoma. DESIGN, SETTING, AND PARTICIPANTS: This cohort study involved an analysis of a multinational, multi-institutional cohort of patient from 15 major hepatobiliary centers in North America, Europe, Australia, and Asia who underwent curative-intent resection of intrahepatic cholangiocarcinoma between 1993 and 2015. Data analysis was conducted from April 2018 to May 2018. MAIN OUTCOMES AND MEASURES: Hospital variation in the composite end point of textbook outcome, defined as negative margins, no perioperative transfusion, no postoperative surgical complications, no prolonged length of stay, no 30-day readmissions, and no 30-day mortality. Secondary end points were factors associated with achieving textbook outcomes. RESULTS: Among 687 patients (of whom 370 53.9% were men; median patient age, 61 range, 18-86 years) undergoing curative-intent resection of intrahepatic cholangiocarcinoma, a textbook outcome was achieved in 175 patients (25.5%). Being 60 years or younger (odds ratio OR, 1.61 95% CI, 1.04-2.49; P = .03), absence of preoperative jaundice (OR, 4.40 95% CI, 1.28-15.15; P = .02), no neoadjuvant chemotherapy (OR, 2.57 95% CI, 1.05-6.29; P = .04), T1a/T1b-stage disease (OR, 1.58 95% CI, 1.01-2.49; P = .049), N0 status (OR, 3.89 95% CI, 1.77-8.54; P = .001), and no bile duct resection (OR, 2.46 95% CI, 1.25-4.84; P = .009) were independently associated with achieving a textbook outcome after resection. A prolonged length of stay had the greatest negative association with a textbook outcome. A nomogram to assess the probability of textbook outcome was developed and had good accuracy in both the training data set (area under the curve, 0.755) and validation data set (area under the curve, 0.763). CONCLUSIONS AND RELEVANCE: In this study, while hepatic resection for intrahepatic cholangiocarcinoma was performed with less than 5% mortality in specialized centers, a textbook outcome was achieved in only approximately 26% of patients. A textbook outcome may be useful for the reporting of patient-level hospital performance and hospital variation, leading to quality improvement efforts after resection of intrahepatic cholangiocarcinoma.
OBJECTIVES:To determine the prognostic implication of the number and station of LNM, and the minimal number of LNs needed for evaluation to accurately stage patients with intrahepatic ...cholangiocarcinoma (ICC).
BACKGROUND:Impact of the number and station of LNM on long-term survival, and the minimal number of LNs needed for accurate staging of ICC patients remain poorly defined.
METHODS:Data on patients who underwent curative-intent resection for ICC was collected from 15 high-volume centers worldwide. External validation was performed using the SEER registry. Primary outcomes included overall (OS), disease-specific, and recurrence-free survival.
RESULTS:Among 603 patients who underwent curative-intent resection, median and 5-year OS were 30.6 months and 30.4%. Patients with 1 or 2 LNM had comparable worse OS versus patients with no nodal disease (median OS, 1 LNM 18.0, 2 LNM 20.0 vs no LNM 45.0 months, both P < 0.001), yet better OS versus patients with 3 or more LNM (median OS, 1–2 LNM 19.8 vs ≥3 LNM 16.0 months, P < 0.01). On multivariable analysis, a proposed new nodal staging with N1 (1–2 LNM) (Ref. N0, HR 2.40, P < 0.001) and N2 (≥3 LNM) Ref. N0, hazard ratio (HR) 3.85, P < 0.001 categories were independently associated with incrementally worse OS. Patients with no nodal metastasis, 1–2 LNM and ≥3 LNM also had an increasingly worse disease-specific survival, and recurrence-free survival (both P < 0.05). Total number of LNs examined ≥6 had the greatest discriminatory power relative to OS among patients with 1–2 LNM, and patients with ≥3 LNM in both the multi-institutional (area under the curve 0.780) and SEER database (area under the curve 0.820) (n = 1036). Among patients who underwent an adequate regional lymphadenectomy (total number of LNs examined ≥6), LNM beyond the HDL was associated with worse OS versus LNM within the HDL only (median OS, 14.0 vs 24.0 months, HR 2.41, P = 0.003).
CONCLUSION:Standard lymphadenectomy of at least 6 LNs is strongly recommended and should include examination beyond station 12 to have the greatest chance of accurate staging. The proposed new nodal staging of N0, N1, and N2 should be considered to stratify outcomes among patients after curative-intent resection of ICC.
Background Reports on recurrence and outcomes of US patients with gastric cancer are scarce. The aim of this study was to determine incidence and pattern of recurrence after curative intent surgery ...for gastric cancer. Study Design Using the multi-institutional US Gastric Cancer Collaborative database, we identified 817 patients undergoing curative intent resection for gastric cancer between 2000 and 2012. Patterns and rates of recurrence along with associated risk factors were identified using adjusted regression analysis. Recurrences were classified as locoregional, peritoneal, or hematogenous. Results Median patient age was 65.8 years (interquartile range IQR 56.4, 74.7); the majority of patients were male (n = 462, 56.6%) and white (n = 511, 62.5%). At the time of surgery, the majority of patients underwent a partial gastrectomy (n = 481, 59.2%) with a complete R0 resection achieved in 91.6% (n = 748) of patients. At the time of last follow-up, 244 (29.9%) of 817 patients developed a recurrence; 163 (66.8%) patients had recurrence at only a single site; the remaining 81 (33.2%) had multiple sites of initial recurrence. Among patients who recurred at a single site, recurrence was most common at a distant location and included hematogenous (n = 57, 23.4%) or peritoneal (n = 47, 19.3%) only metastasis. Tumors at the gastroesophageal junction (odds ratio OR 3.18, 95% CI 1.08 to 9.40; p = 0.04) were associated with higher risk of locoregional recurrence, while the presence of multiple lesions (OR 10.82, 95% CI 3.56 to 32.85; p < 0.001) remained associated with an increased risk of distant hematogenous recurrence after adjusted analysis. Recurrence was associated with worse survival, with a median recurrence-free survival of 10.8 months (IQR 8.9, 12.8) among those who experienced a recurrence. Conclusions Nearly one-third of patients experienced recurrence after gastric cancer surgery. The most common site of recurrence was distant.
Background
Recurrence of intrahepatic cholangiocarcinoma (ICC) after curative resection is common.
Objective
The aim of this study was to investigate the patterns, timing and risk factors of disease ...recurrence after curative-intent resection for ICC.
Methods
Patients undergoing curative resection for ICC were identified from a multi-institutional database. Data on clinicopathological and initial operation information, timing and first sites of recurrence, recurrence management, and long-term outcomes were analyzed.
Results
A total of 920 patients were included. With a median follow-up of 38 months, 607 patients (66.0%) experienced ICC recurrence. In the cohort, 145 patients (23.9%) recurred at the surgical margin, 178 (29.3%) recurred within the liver away from the surgical margin, 90 (14.8%) recurred at extraheptatic sites, and 194 (32.0%) developed both intrahepatic and extrahepatic recurrence. Intrahepatic margin recurrence (median 6.0 m) and extrahepatic-only recurrence (median 8.0 m) tended to occur early, while intrahepatic recurrence at non-margin sites occurred later (median 14.0 m;
p
< 0.05). On multivariate analysis, surgical margin < 10 mm was associated with increased margin recurrence (hazard ratio HR 1.70, 95% confidence interval CI 1.11–2.60;
p
= 0.014), whereas female sex (HR 2.12, 95% CI 1.40–3.22;
p
< 0.001) and liver cirrhosis (HR 2.36, 95% CI 1.31–4.25;
p
= 0.004) were both associated with an increased risk of intrahepatic recurrence at other sites. Median survival after recurrence was better among patients who underwent repeat curative-intent surgery (48.7 months) versus other treatments (9.7 months)
p
< 0.001.
Conclusions
Different recurrence patterns and timing of recurrence suggest biological heterogeneity of ICC tumor recurrence. Understanding timing and risk factors associated with different types of recurrence can hopefully inform discussions around adjuvant therapy, surveillance, and treatment of recurrent disease.
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