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Complete lymph node dissection is recommended in patients with positive sentinel lymph node biopsy results. To date, the effect of complete lymph node dissection on prognosis is controversial. In the DeCOG-SLT trial, we assessed whether complete lymph node dissection resulted in increased survival compared with observation. In this multicentre, randomised, phase 3 trial, we enrolled patients with cutaneous melanoma of the torso, arms, or legs from 41 German skin cancer centres. Patients with positive sentinel lymph node biopsy results were eligible. Patients were randomly assigned (1:1) to undergo complete lymph node dissection or observation with permuted blocks of variable size and stratified by primary tumour thickness, ulceration of primary tumour, and intended adjuvant interferon therapy. Treatment assignment was not masked. The primary endpoint was distant metastasis-free survival and analysed by intention to treat. All patients in the intention-to-treat population of the complete lymph node dissection group were included in the safety analysis. This trial is registered with ClinicalTrials.gov, number NCT02434107. Follow-up is ongoing, but the trial no longer recruiting patients. Between Jan 1, 2006, and Dec 1, 2014, 5547 patients were screened with sentinel lymph node biopsy and 1269 (23%) patients were positive for micrometastasis. Of these, 483 (39%) agreed to randomisation into the clinical trial; due to difficulties enrolling and a low event rate the trial closed early on Dec 1, 2014. 241 patients were randomly assigned to the observation group and 242 to the complete lymph node dissection group. Ten patients did not meet the inclusion criteria, so 233 patients were analysed in the observation group and 240 patients were analysed in the complete lymph node dissection group, as the intention-to-treat population. 311 (66%) patients (158 in the observation group and 153 in the dissection group) had sentinel lymph node metastases of 1 mm or less. Median follow-up was 35 months (IQR 20–54). Distant metastasis-free survival at 3 years was 77·0% (90% CI 71·9–82·1; 55 events) in the observation group and 74·9% (69·5–80·3; 54 events) in the complete lymph node dissection group. In the complete lymph node dissection group, grade 3 and 4 events occurred in 15 patients (6%) and 19 patients (8%) patients, respectively. Adverse events included lymph oedema (grade 3 in seven patients, grade 4 in 13 patients), lymph fistula (grade 3 in one patient, grade 4 in two patients), seroma (grade 3 in three patients, no grade 4), infection (grade 3 in three patients, no grade 4), and delayed wound healing (grade 3 in one patient, grade 4 in four patients); no serious adverse events were reported. Although we did not achieve the required number of events, leading to the trial being underpowered, our results showed no difference in survival in patients treated with complete lymph node dissection compared with observation only. Consequently, complete lymph node dissection should not be recommended in patients with melanoma with lymph node micrometastases of at least a diameter of 1 mm or smaller. German Cancer Aid.

This randomized trial compared preoperative with postoperative chemoradiotherapy for locally advanced rectal cancer. Overall survival was similar in the two groups, but patients assigned to preoperative chemoradiotherapy had lower rates of local recurrence and fewer long-term toxic effects than patients in the postoperative group. In this trial of nearly 800 patients, those assigned to preoperative chemoradiotherapy had lower rates of local recurrence and fewer toxic effects. Adjuvant radiotherapy with or without chemotherapy has been used widely to improve outcomes in patients with rectal cancer. For locally advanced disease, postoperative chemoradiotherapy significantly improves both local control and overall survival as compared with surgery alone or surgery plus irradiation. 1 , 2 This information prompted a National Institutes of Health consensus conference, convened in 1990, to recommend postoperative adjuvant chemoradiotherapy as standard treatment for patients with rectal cancer classified as tumor–node–metastasis (TNM) stage II (i.e., a tumor penetrating the rectal wall, without regional lymph-node involvement) or stage III (i.e., any tumor with regional lymph-node involvement). 3 Several randomized studies have found . . .

Background A number of studies have demonstrated that lymph node metastasis is a poor prognostic factor in colon cancer. Advances of surgical procedure have improved the outcomes of colon cancer treatment. The aim of this study was to compare the characteristics of surgery for stage III colon cancer between England, Germany, and Japan. Methods Using the data of patients with colon cancer from one English, one German, and two Japanese centers, the characteristics of clinicopathologic features were compared. Conventional surgery, complete mesocolic excision (CME) with central vascular ligation, and D3 lymph node dissection were performed in England, Germany, and Japan, respectively. Results Nineteen English, 26 German, and 60 Japanese patients were enrolled. There was no difference in tumor location, pT, and pN factors among the three groups. The length of resected bowel and the area of resected mesentery of the English and CME specimens were significantly greater than those of the D3 specimens ( P  < 0.0001 and P  < 0.0001, respectively), whereas the length of the vascular tie to the bowel wall was similar between the CME and D3 specimens ( P  = 0.87), which was longer than that of the English specimens. The number of lymph nodes retrieved in the CME specimens was greatest among three groups ( P  < 0.0001), although the number of positive nodes was comparable ( P  = 0.64). The rates of mesocolic plane surgery in the English, CME, and D3 specimens were 47.4, 88.5, and 71.7 %, respectively ( P  = 0.022). Conclusions Three types of surgery for colon cancer differed in terms of the length of the resected bowel and the area of mesentery, although the length of the vascular tie to the bowel wall was similar between CME and D3 specimens. The high rates of mesocolic plane surgery were demonstrated in the CME and D3 specimens.

Purpose Complete mesocolic excision (CME) is nowadays state of the art in the treatment of colon cancer. In cases of carcinoma of transverse colon and of both flexures an extramesocolic lymph node metastasis can be found in the infrapancreatic lymph node region (ILR) and across the gastroepiploic arcade (GLR). These direct metastatic routes were not previously systematically considered. In order to validate our hypothesis of these direct metastatic pathways and to obtain evidence of our approach of including dissection of these areas as part of CME, we initiated a prospective study evaluating these lymph node regions during surgery. Methods Forty-five consecutive patients with primary tumour manifestation in transverse colon and both flexures between May 2010 and January 2013 were prospectively analyzed. Patients were followed up for at least 6 months. Mode of surgery, histopathology, morbidity and mortality were evaluated. Results Twenty-six patients had a carcinoma of transverse colon, 16 patients one of hepatic flexure and four patients one of splenic flexure. The median lymph node yield was 40. Occurrence of lymph node metastasis in ILR was registered in five patients and in GLR in four patients. The mean lymph node ratio was 0.085. Postoperative complications occurred in nine patients, and postoperative mortality was 2 %. Conclusions We were able to demonstrate this novel metastatic route of carcinomas of the transverse colon and of both flexures in ILR and GLR. These could be considered as regional lymph node regions and have to be included into surgery for cancer of the transverse colon including both flexures.

Background and objectives The purpose of this study is to analyze major complication rates and different aspects of health-related quality of life (HRQoL) in extremity soft tissue sarcoma (STS) patients treated with or without radio (chemo) therapy and surgery. Methods We performed a retrospective analysis of all patients who underwent Extremity STS excision from 2004 to 2014 (182 patients included). Patients’ data were collected from patients’ records. HRQoL was assessed by using EORTC QLQ-C30. Results A total of 182 patients underwent sarcoma resection. After neoadjuvant radiochemotherapy (RCT), the major-complication rate amounted to 28% (vs. 7%, no radiotherapy, p  <  0.001). Major-complication rates after adjuvant radiotherapy (RT) occurred in 8% (vs. 7%, no radiotherapy, p  = 0.265). Comparison QoL scores between treating with neoadjuvant RCT or without RT revealed significant worse scores with neoadjuvant RCT. Further stratification of disease control of these patients showed significant reduced scores in the group of disease-free patients with neoadjuvant RCT compared to irradiated disease-free patients. Discussion To date, there have only been a few investigations of QoL in STS. Retrospective study on quality of life have limitations, like a lack of baseline evaluation of QoL. Patient candidated to radiation therapy could have had worse QoL baseline due to more advanced disease. Disease status of the patients who answered the questionnaires could have been an influence of QoL and we could show reduced scores in the group of disease-free patients with neoadjuvant RCT, but not for the patients with recurrence or metastasis, so it is very hard to discriminate whether radiation therapy could really have an impact or not. Conclusion This study might assist in further improving the understanding of QoL in STS patients and may animate for prospective studies examining the oncological therapies impact on HRQoL.

Surgery has become a recognized therapeutic means in selected patients with pulmonary metastases from colorectal origin. We reviewed our experience in the surgical treatment of 153 patients with pulmonary colorectal metastases and investigated factors affecting survival. A retrospective analysis of the records of all patients (n = 153) with pulmonary metastases from colorectal cancer who underwent thoracotomy between 1978 and 2003 at a single surgical center was performed. One hundred fifty-three patients with pulmonary metastases from colon (n = 61) or rectal (n = 92) cancer underwent 180 thoracotomies. The 2- and 5-year probabilities of survival after the first thoracotomy were 64% and 37%, respectively. Sex, age, site, International Union Against Cancer stage of the primary tumor, prethoracotomy carcinoembryonic antigen level, size of metastases, and previous resection of hepatic metastases were not found to be statistically significant prognostic factors. Number of metastases (solitary vs. multiple), mode of operation (wedge vs. anatomical resection), disease-free interval (DFI; > 36 months), negative hilar or mediastinal lymph node status, resection margin > 10 mm, and administration of intraoperative blood substitution were predictors of a longer survival duration by univariate analysis, but only number of metastases (P = .019), mode of operation (P = .004), DFI (P = .027), and intraoperative blood substitution (P = .002) were identified as independent prognostic factors by multivariate analysis. Pulmonary resection for metastases from colorectal cancer is safe and results in long-term survival in selected patients. Single metastases, anatomical resection, intraoperative blood substitution, and DFI > 36 months seem to be the most reliable predictors of survival.

Background: Duodenal gastrointestinal stromal tumors (GIST) are a rare subset of GIST. Their surgical management in this anatomically complex region consists of varied approaches, and the administration of imatinib mesylate (IM) has not been clarified. Methods: We retrospectively reviewed patients with duodenal GIST treated during a 10-year-period. We analysed the clinicopathological characteristics and survival factors and evaluated the perioperative and long-term outcomes based on the extent of resection ((ocal-resection (LR) versus pancreaticoduodenectomy (PD)) and the IM-administration. The median follow-up period was 60 months (range, 12–140). Results: A total of thirteen patients (M:F = 7:6) with median age of 64 years (range, 42–77) underwent resection of duodenal GIST. Median tumor size was 5.2 cm (range, 1.5–13.3). Eight patients (61.5%) underwent LR and five patients (38.5%) PD. R0-resection was achieved in 92.5%. Neoadjuvant IM-therapy was administered in five patients leading to tumor downsizing and in 40% to less-extended resection. The PD group consisted of larger tumors with higher mitotic count, mostly located in D2 (p = 0.031). The PD group had longer operative time (p = 0.026), longer hospital stay (p = 0.016), and higher rate of postoperative complications (p = 0.128). The actuarial 1-, 3-, and 5-year overall survival were 92.5%, 84%, and 73.5%, respectively, whereas the disease-free survival rates at 1, 3, and 5 years were 91.5%, 83%, and 72%, respectively. A tendency towards increased risk of disease recurrence was demonstrated for patients with tumor >5 cm and high-risk potential. There was not statistic survival benefit for one or the other surgical approach. Conclusion: The type of resection depends on duodenal site of origin and tumor size. LR can be the treatment of choice for duodenal GIST whenever technically feasible. Recurrence of duodenal GIST is dependent on tumor biology rather than surgical approach. Administration of IM in neaodjuvant setting should be considered in cases with high-risk GIST scheduled for PD since it might facilitate less-extended resection.

Background Elective surgery for liver hemangioma is controversial. We reviewed long-term outcomes following elective hepatectomy or observation only for symptomatic and asymptomatic liver hemangioma. Methods All patients ( n  = 307) with liver hemangioma referred to our hospital for surgical evaluation from January 1988 to December 2009 were identified, and imaging results, tumor characteristics, surgical indication, surgical mode, outcome of observation, clinical and/or postoperative outcome, and adverse events were retrospectively evaluated. Results Complete median follow-up for 246 patients was 124 months. Elective surgery was performed in 103 patients (symptomatic [ n  = 62] and asymptomatic [ n  = 41]). Postoperative morbidity occurred in 17 % of the patients and was significantly lower in asymptomatic patients ( p  = 0.002). No perioperative mortality was registered. Surgery relieved complaints in most (88 %) patients. In the observation group ( n  = 143), 56 % of patients had persistent or new onset of hemangioma-associated symptoms. Major hemangioma-related complications occurred in 12 patients (9 %) during the follow-up period, and 2 patients died after traumatic hemangioma rupture. Overall the rate of adverse events was by trend lower in the surgical group than in the observation group (35 versus 57 %; p  = 0.08). Conclusions The majority of patients with liver hemangioma can be safely managed by clinical observation. In a subset of patients, especially those with giant hemangioma and/or occurrence of symptoms, surgical treatment could be considered and is justified in high-volume centers.

Background Recent evidence suggests that CD4 + CD25 + FoxP3 + regulatory T-cells (Treg) may be responsible for the failure of host anti-tumour immunity by suppressing cytotoxic T- cells. We assessed the prognostic significance of tumour infiltrating lymphocytes (TIL) in intestinal-type gastric cardiac cancer. Methods Tumour infiltrating lymphocyte (TIL) subsets and tumour infiltrating macrophages (TIM) were investigated in 52 cases using tissue microarrays. The interrelationship between the cell populations (CD3+, CD8+, CD20+, CD68+, GranzymeB+, FoxP3+) in different compartments and NED-survival was investigated (median follow-up time: 61 months). Results Intraepithelial infiltration with TIL and TIM including Treg was generally low and not related to NED-survival. However, patients with large numbers of FoxP3 + Treg in the tumour stroma (>125.9 FoxP3 + TILs/mm 2 ) had a median survival time of 58 months while those with low FoxP3 + TIL counts (<125.9 FoxP3 + TILs/mm 2 ) had a median survival time of 32 months (p = 0.006). Patients with high versus low stromal CD68 + /FoxP3 + cell ratios in primary tumour displayed median survivals of 32 and 55 months, respectively (p = 0.008). Conclusion Our results suggest that inflammatory processes within the tumour stroma of gastric intestinal-type adenocarcinomas located at the gastric cardia may affect outcome in two ways. Tumour-infiltrating macrophages are likely to promote carcinogenesis while large numbers of Treg are associated with improved outcome probably by inhibiting local inflammatory processes promoting carcinogenesis. Thus, inhibition of Treg may not be a feasible treatment option in gastric adenocarcinoma.