Surgeon Assessment of Gastric Cancer Lymph Node Specimens with a Video of Technique.

INTRODUCTION: In the majority of US institutions, gastrectomy specimens are sent for pathologic examination without surgeon assessment or standardized technique of lymph node (LN) assessment for gastric cancer. We conducted a quality improvement project at a US cancer center utilizing surgeon assessment of gastric LNs, and created a video to illustrate a technique of standardized lymph node assessment. METHODS: Convenience sampling was employed among patients with gastric adenocarcinomas who underwent curative-intent D2 gastrectomy between July 2016 and June 2017. For each patient, a surgeon assessed gastric LNs by harvesting individual LNs, followed by conventional evaluation by a pathologist. RESULTS: We enrolled 17 patients for this quality improvement project. Eight patients underwent total gastrectomy, and nine patients underwent subtotal gastrectomy. Twelve patients underwent preoperative chemoradiation therapy, three underwent preoperative chemotherapy alone, and two underwent upfront surgery. The median number of examined LNs was 43. All patients had ≥ 16 LNs examined, and 88% of patients had ≥ 30 LNs examined. CONCLUSION: Surgeon assessment of gastric LN specimens was feasible and effective to provide high-quality pathologic LN assessment after gastrectomy in gastric adenocarcinoma patients. Standardization of the technical methods for gastric LN evaluation is needed to improve the accuracy and quality of gastric cancer staging in the US. The provided video can help inform standardization of gastric LN assessment.

Patterns of relapse in patients with localized gastric adenocarcinoma who had surgery with or without adjunctive therapy: costs and effectiveness of surveillance.

PURPOSE: After therapy of localized gastric adenocarcinoma (GAC) patients, the costs of surveillance, relapse patterns, and possibility of salvage are unknown. MATERIALS AND METHODS: We identified 246 patients, who after having a negative peritoneal staging, received therapy (any therapy which included surgery) and were surveyed (every 3-6 months in the first 3 years, then yearly; ∼10 CTs and ∼7 endoscopies per patient). We used the 2016 Medicare dollars reimbursed as the "costs" for surveillance. RESULTS: Common features were: Caucasians (57%), men (60%), poorly differentiated histology (76%), preoperative chemotherapy (74%), preoperative chemoradiation (59%), and had surgery (100%). At a median follow-up of 3.7 years (range, 0.1 to 18.3), the median overall survival (OS) was 9.2 years (95% CI, 6.0 to 11.2). Tumor grade (p = 0.02), p/yp stage (p < 0.001), % residual GAC (p = 0.05), the R status (p = 0.01), total gastrectomy (p = 0.001), and relapse type (p = 0.02) were associated with OS. Relapse occurred in 79 (32%) patients (only 8% were local-regional) and 90% occurred within 36 months of surgery. P/yp stage (p < 0.001) and total gastrectomy (p = 0.01) were independent prognosticators for OS in the multivariate analysis. Only 1 relapsed patient had successful salvage therapy. The estimated reimbursement for imaging studies and endoscopies was $1,761,221.91 (marked underestimation of actual costs). CONCLUSIONS: The median OS of localized GAC patients was excellent with infrequent local-regional relapses. Rigorous surveillance had a low yield and high "costs". Our data suggest that less frequent surveillance intervals and limiting expensive investigations to symptomatic patients may be warranted.

Goblet cell carcinoid tumor, mixed goblet cell carcinoid-adenocarcinoma, and adenocarcinoma of the appendix: comparison of clinicopathologic features and prognosis.

CONTEXT: The prognosis of appendiceal goblet cell carcinoid tumors (GCTs) is believed to be intermediate between appendiceal adenocarcinomas and conventional carcinoid tumors. However, GCTs can have mixed morphologic patterns, with variable amount of adenocarcinoma. OBJECTIVE: To evaluate the behavior of GCTs and related entities with variable components of adenocarcinoma. DESIGN: We classified 74 cases of appendiceal tumors into 3 groups: group 1, GCTs or GCTs with less than 25% adenocarcinoma; group 2, GCTs with 25% to 50% adenocarcinoma; group 3, GCTs with more than 50% adenocarcinoma; and a comparison group of 68 adenocarcinomas without a GCT component (group 4). Well-differentiated mucinous adenocarcinomas were excluded. Clinicopathologic features and follow-up were obtained from computerized medical records and the US Social Security Death Index. RESULTS: Of the 142 tumors studied, 23 tumors (16%) were classified as group 1; 27 (19%) as group 2; 24 (17%) as group 3; and 68 (48%) as group 4. Staging and survival differed significantly among these groups. Among 140 patients (99%) with available staging data, stages II, III, and IV were present in 87%, 4%, and 4% of patients in group 1 patients; 67%, 7%, and 22% of patients in group 2; 29%, 4%, and 67% of patients in group 3; and 19%, 6%, and 75% of patients in group 4, respectively (P = .01). Mean (SD) overall survival was 83.8 (34.6), 60.6 (30.3), 45.6 (39.7), and 33.6 (27.6) months for groups 1, 2, 3, and 4, respectively (P = .01). By multivariate analysis, only stage and tumor category were independent predictors of overall survival. CONCLUSION: Our data highlight the importance of subclassifying the proportion of adenocarcinoma in appendiceal tumors with GCT morphology because that finding reflects disease stage and affects survival.

A Simplified Preoperative Assessment Predicts Complete Cytoreduction and Outcomes in Patients with Low-Grade Mucinous Adenocarcinoma of the Appendix.

BACKGROUND: Complete cytoreduction with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) has been shown to improve survival in patients with low-grade mucinous adenocarcinoma (LGMA). However, incomplete cytoreduction exposes patients to significant morbidity without a similar survival benefit. Preoperative assessment of the ability to achieve CRS is therefore a critical step in selecting patients for CRS/HIPEC. OBJECTIVE: The aim of this study was to develop and validate a preoperative scoring system to accurately predict the ability to achieve complete cytoreduction in patients with LGMA of the appendix. METHODS: A simplified preoperative assessment for appendix tumor (SPAAT) score was developed based on computed tomography scan findings thought to predict incomplete cytoreduction. We applied the SPAAT score to patients with LGMA to determine the ability of the score to predict complete cytoreduction. This scoring system was then applied to a separate cohort of patients from a different institution. Sensitivity and specificity were determined for the SPAAT score. Survival was calculated and correlated with the SPAAT score and the completeness of cytoreduction score. RESULTS: A SPAAT score of <3 is a significant predictor of complete cytoreduction in the derivation cohort. In the validation cohort, 40 of 42 patients with a SPAAT score <3 achieved a complete cytoreduction, for a positive predictive value of 95.2 % and a negative predictive value of 100 %. Additionally, the SPAAT score was a significant predictor of disease-free survival. CONCLUSIONS: The SPAAT score is a useful tool in the preoperative assessment of patients with LGMA who are under consideration for cytoreductive surgery. Prospective analysis of this scoring system is warranted to appropriately select patients who will benefit from CRS/HIPEC.

Serious postoperative infections following resection of common solid tumors: outcomes, costs, and impact of hospital surgical volume.

PURPOSE: Unlike infections related to chemotherapy-induced neutropenia, postoperative infections occurring in patients with solid malignancy remain largely understudied. Our aim is to evaluate the outcomes and the volume-outcomes relationship associated with postoperative infections following resection of common solid tumors. METHODS: We used Texas Discharge Data to study patients undergoing resection of cancer of the lung, esophagus, stomach, pancreas, colon, or rectum from 01/2002 to 11/2006. From their billing records, we identified ICD-9 codes indicating a diagnosis of serious postoperative infection (SPI), i.e., bacteremia/sepsis, pneumonia, and wound infection, occurring during surgical admission or leading to readmission within 30 days of surgery. Using regression-based techniques, we estimated the impact of SPI on mortality, resource utilization, and costs, as well as the relationship between hospital volume and SPI, after adjusting for confounders and data clustering. RESULTS: SPI occurred following 9.4 % of the 37,582 eligible tumor resections and was independently associated with nearly 12-fold increased odds of in-hospital mortality [95 % confidence interval (95 % CI), 7.2-19.5, P < 0.001]. Patients with SPI required six additional hospital days (95 % CI, 5.9-6.2) at an incremental cost of $16,991 (95 % CI, $16,495-$17,497). Patients who underwent resection at high-volume hospitals had a 16 % decreased odds of developing SPI than those at low-volume hospitals (P = 0.03). CONCLUSIONS: Due to the substantial burden associated with SPI following common solid tumor resections, hospitals must identify more effective prophylactic measures to avert these potentially preventable infections. Additional volume-outcomes research is needed to identify infection prevention processes that can be transferred from high- to lower-volume providers.

Fibrin sealant does not decrease seroma output or time to drain removal following inguino-femoral lymph node dissection in melanoma patients: a randomized controlled trial (NCT00506311).

BACKGROUND: This study assessed the impact of closed suction drains and evaluated whether the intraoperative use of a fibrin sealant decreased time to drain removal and wound complications in melanoma patients undergoing inguino-femoral lymph node dissection. METHODS: A pilot study (n = 18) assessed the impact of a closed suction drain following inguino-femoral lymph node dissection. A single-institution, prospective trial was then performed in which patients were randomized to a group that received intraoperative application of a fibrin sealant following inguino-femoral lymph node dissection or to a control group that did not receive sealant. RESULTS: The majority of the patients enrolled felt the drains caused moderate or severe discomfort and difficulties with activities of daily living. Thirty patients were then randomized; the median time to drain removal in the control group (n = 14) was 30 days (range, 13-74) compared to 29 days (range, 11-45) in the fibrin sealant group (n = 16; P = 0.6). Major and minor complications were similar in the two groups. CONCLUSION: Postoperative closed suction drains were associated with major patient inconvenience. Applying a fibrin sealant at the time of inguino-femoral lymph node dissection in melanoma patients did not reduce the time to drain removal or postoperative morbidity. Alternative strategies are needed.

Prospective assessment of the reliability, validity, and sensitivity to change of the Functional Assessment of Cancer Therapy-Melanoma questionnaire.

BACKGROUND: The authors previously developed a melanoma-specific module for the Functional Assessment of Cancer Therapy (FACT-Melanoma), a tool for the assessment of quality of life (QOL) in patients with melanoma. The reliability and validity of the FACT-Melanoma was examined in this study. METHODS: Patients with melanoma (N = 273; stages I-IV) completed a battery of questionnaires at the time of enrollment. The validity of the instrument was examined by comparing FACT-Melanoma scores with performance status, disease stage, treatment status, and other scales, including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Melanoma Module, the Profile of Mood States, and the Marlowe-Crowne Social Desirability Scale. Patients were assessed after 1 week to assess test-retest reliability and at 3 months to determine the sensitivity of the instrument to change in performance status. RESULTS: The internal consistency and test-retest reliability (r) of the melanoma subscale (Cronbach alpha = .85; r = .81) and the total FACT-Melanoma (alpha = .95; r = .90) were excellent. Overall, the scales were correlated with other measures, as anticipated. Total FACT-Melanoma scores, along with scores for physical well-being, emotional well-being, functional well-being, and melanoma-specific scales, were lower for patients with advanced (stage III/IV) melanoma, poor performance status, and patients who were receiving active treatment. The FACT-Melanoma total score and the score for physical well-being were sensitive to changes in performance status (P = .0012 and P = .004, respectively). CONCLUSIONS: The results of the current study indicated that the FACT-Melanoma questionnaire is a reliable and valid instrument for patients with melanoma that can be used for the assessment of QOL in clinical trials.

Cost effectiveness of adjuvant interferon in node-positive melanoma.

PURPOSE: To assess the benefits of adjuvant high-dose interferon alfa (HDI) treatment for patients with high-risk melanoma. METHODS: We designed a decision-analytic probabilistic Markov model to simulate the natural history of patients with stage IIIA, IIIB, and IIIC melanoma and evaluate the outcomes with and without HDI treatment. Outcomes were in quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Probability estimates and costs were derived from primary patient level data, while the efficacy of HDI and associated utilities were determined from published reports. The base-case analysis was a cohort of 50-year-old patients. RESULTS: HDI increased the median life expectancy in patients with stage III melanoma from 3.75 years in the observation cohort to 4.42 years in the HDI cohort. The difference in QALYs ranged from 0.31 years for stage IIIA patients to 0.60 years for stage IIIC patients treated with HDI. HDI was cost effective in patients with stage IIIB and IIIC melanoma, with ICERs of $95,304 and $76,068 per QALY gained, respectively. Using a threshold of $100,000 per QALY gained, HDI was cost effective for all stage III patients younger than 52 years. HDI was not cost effective for patients with stage IIIA disease and for subsets of patients older than 63 years with stage IIIB disease. CONCLUSION: Our model demonstrates that the probability of HDI being cost effective varies substantially by melanoma substage. HDI showed the greatest benefit in terms of QALYs and was most cost effective in patients younger than 60 years with stage IIIC disease.

Assessment of the role of sentinel lymph node biopsy for primary cutaneous desmoplastic melanoma.

BACKGROUND: The role of sentinel lymph node biopsy (SLNB) in the treatment of desmoplastic melanoma (DM) remains undefined. The purpose of this study was to evaluate the use of SLNB for DM. METHODS: In all, 1850 patients with cutaneous melanoma underwent wide local excision and SLNB. Patients with DM were identified and stratified as 'pure' DM or 'mixed' DM (i.e., DM associated with at least one other common histologic subtype). RESULTS: Of the 1850 patients, 65 (3.5%) had DM. Of these, 46 (70.8%) had pure DM and 19 (29.2%) had mixed DM. Patients with pure DM had a median tumor thickness of 3.5 mm and 6.5% were ulcerated. Compared with patients with pure DM, patients with either mixed DM or non-DM (n = 1785) had thinner primary tumors (median, 1.7 mm and 1.5 mm, respectively, each P < 0.001 vs. pure DM) that were more likely to be ulcerated (27.7% and 21.3%, respectively, each P < 0.05 vs. pure DM). Although the incidence of a positive SLN was similar in patients with mixed DM (15.8%) and non-DM (17.5%), patients with pure DM were less likely to have a positive SLN (2.2%) (each P < 0.01 vs. non-DM and mixed DM). At a median follow-up of 2.9 years, no patient with pure DM had recurred. CONCLUSIONS: Despite having thicker primary tumors, patients with pure DM have a lower incidence of positive SLNs compared with patients with non-DM. Whereas the treatment approach for patients with mixed DM should be similar to that of other melanoma patients, patients with pure DM are unlikely to have metastatic disease in regional lymph nodes and SLNB may not be warranted.

Population-based assessment of surgical treatment trends for patients with melanoma in the era of sentinel lymph node biopsy.

PURPOSE: The surgical staging of melanoma dramatically changed with the introduction of sentinel lymph node (SLN) biopsy. In this study, Surveillance, Epidemiology, and End Results (SEER) data were examined to determine how surgical treatment is being carried out and whether SLN biopsy is being performed in melanoma patients in conformance with National Comprehensive Cancer Network (NCCN) guidelines. PATIENTS AND METHODS: The SEER database (1998 to 2001) was searched for all patients with invasive melanoma. NCCN guidelines were used to define optimal stage-specific surgical treatment. Treatment trends in patients with stages I to III disease were summarized, and multivariate analyses were performed to identify factors associated with nonadherence with treatment guidelines. RESULTS: A total of 21,867 melanoma patients were identified; 18,499 of these patients met the inclusion criteria. The number of patients diagnosed with stage III melanoma increased by 55.7% over the study period, and this corresponded to a 53% increase in the number of SLN biopsies performed annually. The odds ratios for nonadherence were 2.32, 2.27, and 1.54 for stages IB, II, and III disease, respectively, compared with stage IA melanoma. Multivariate analyses revealed that age more than 65 years, marital status, minority populations, and primary tumor location were associated with nonadherence with guidelines. Treatment patterns among tumor registries also varied significantly. CONCLUSION: Stage migration is evident in the SEER registries in consort with increasing use of SLN biopsy. Although treatment trends are improving, SLN biopsy continues to be underused, particularly in the elderly and minority populations, in patients with truncal and head/neck melanomas, and also in some geographic regions of the United States.

A critical assessment of adjuvant radiotherapy for inguinal lymph node metastases from melanoma.

BACKGROUND: Although patients with inguinal or pelvic lymph node (LN) metastases from melanoma may develop regional recurrence after dissection, the role of adjuvant radiotherapy remains controversial. METHODS: The medical records of 40 patients with inguinal and/or pelvic lymph node metastases from melanoma were reviewed retrospectively. Indications for adjuvant radiotherapy included the following nodal characteristics: extracapsular extension, LNs > or =3 cm in diameter, > or =4 involved LNs, and LN recurrence after prior nodal surgery. Thirty-seven of 40 patients underwent formal LN dissection. Three patients had only local excision of gross disease for recurrence after prior dissection. All patients received radiation to a median dose of 30 Gy at six Gy/fraction delivered twice weekly. RESULTS: With a median follow-up time of 22.5 months, the 3-year actuarial distant metastasis-free and overall survival rates were 35% and 38%, respectively. The 3-year regional control rate was 74%. Univariate analyses of patient, tumor, and treatment characteristics failed to reveal any association with distant metastasis-free survival, overall survival, or regional control. Regional failures occurred in nine patients; seven of these were isolated dermal failures within the field of irradiation. Only two patients (5%) had LN basin recurrences; one of these patients also developed dermal recurrence. Fifteen of 40 patients developed lymphedema; in seven of these, lymphedema was present before initiation of radiation therapy. CONCLUSIONS: Radiation may prevent recurrence of nodal disease in patients at high risk for regional failure, but in-field dermal recurrences may sometimes occur (8 of 40, 20%). Treatment-related lymphedema and death from metastatic melanoma were common.