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Preoperative magnetic resonance imaging (MRI) allows highly reliable imaging of the mesorectal fascia (mrMRF) and its relationship to the tumor. The prospective multicenter observational study OCUM uses these findings to indicate neoadjuvant chemoradiotherapy (nCRT) in rectal carcinoma. nCRT was indicated in patients with positive mrMRF (≤ 1 mm) in cT4 and cT3 carcinomas of the lower rectal third. A total of 527 patients (60.2%) underwent primary total mesorectal excision, and 348 patients (39.8%) underwent long-term nCRT followed by surgery. The mrMRF was involved in 4.6% of the primary surgery group and 80.7% of the nCRT group. Rates of resections within the mesorectal plane (90.8%), sparing of pelvic nerves on both sides (97.8%), and number of regional lymph nodes (95.3% with ≥ 12 lymph nodes examined) are indicative of high-quality surgery. Resection was classified as R0 in 98.3%, the pathological circumferential resection margin (pCRM) was negative in 95.1%. Patients in the nCRT group had more advanced carcinomas with a significantly higher rate of abdominoperineal excision. Independent risk factors for pCRM positivity were advanced stage (T4), metastatic lymph nodes, resection in the muscularis propria plane, and location in the lower third. The risk classification of rectal cancer patients by MRI seems to be highly reliable and allows the restriction of nCRT to approximately half of the patients with clinical stage II and III rectal carcinoma, provided there is a high-quality MRI diagnostic protocol, high-quality surgery, and standardized examination of the resected specimen.

Background Neoadjuvant chemoradiotherapy (nCRT) in patients with rectal cancer carries a high risk of adverse effects. The aim of this study was to examine the selective application of nCRT based on patient risk profile, as determined by MRI, to find the optimal range between undertreatment and overtreatment. Study Design In this prospective multicenter observational study, nCRT before total mesorectal excision (TME) was indicated in high-risk patients with involved or threatened mesorectal fascia (≤1 mm), or cT4 or cT3 carcinomas of the lower rectal third. All other patients received primary surgery. Results Of the 1,093 patients, 878 (80.3%) were treated according to the protocol, 526 patients (59.9%) underwent primary surgery, and 352 patients (40.1%) underwent nCRT followed by surgery. The 3-year locoregional recurrence (LR) rate was 3.1%. Of 604 patients with clinical stages II and III, 267 (44.2%) had primary surgery; 337 (55.8%) received nCRT followed by TME. The 3-year LR rate was 3.9%, without significant differences between groups. In patients with clinical stages II and III who underwent primary surgery, 27.3% were diagnosed with pathological stage I. Conclusions The results justify the restriction of nCRT to high-risk patients with rectal cancer classified by pretreatment MRI. Provided that a high-quality MRI diagnosis, TME surgery, and standardized examination of the resected specimen are performed, nCRT, with its adverse effects, costs, and treatment time can be avoided in more than 40% of patients with stage II or III rectal cancer with minimal risk of undertreatment. ( clinicaltrials.gov NCT325649)

Background It is not clear whether all patients with rectal cancer need chemoradiotherapy. A restrictive use of neoadjuvant chemoradiotherapy (nCRT) based on MRI findings for rectal cancer was investigated in this study. Methods This prospective multicentre observational study included patients with stage cT2–4 rectal cancer, with any cN and cM0 status. Carcinomas in the middle and lower third that were 1 mm or less from the mesorectal fascia, all cT4 tumours, and all cT3 tumours of the lower third were classified as high risk, and these patients received nCRT followed by total mesorectal excision (TME). All other carcinomas with a minimum distance of more than 1 mm from the mesorectal fascia and those in the upper third were classified as low risk; these patients underwent TME alone (no nCRT). Patients were followed for at least 3 years. Outcomes were the rates of local recurrence, distant metastasis and survival. Results Among 545 patients included, 428 were treated according to the study protocol: 254 (59·3 per cent) had TME alone and 174 (40·7 per cent) received nCRT and TME. Median follow-up was 60 months. The 3- and 5-year local recurrence rates were 1·3 and 2·7 per cent respectively, with no differences between the two treatment protocols. Patients with disease requiring nCRT had higher 3- and 5-year rates of distant metastasis (17·3 and 24·9 per cent respectively versus 8·9 and 14·4 per cent in patients who had TME alone; P = 0·005) and worse disease-free survival compared with that in patients who did not need nCRT (3- and 5-year rates 76·7 and 66·7 per cent, versus 84·9 and 76·0 per cent in the TME-alone group; P = 0·016). Conclusion Restriction of nCRT to high-risk patients achieved good results.

Introduction of total mesorectal excision (TME) surgery for rectal cancer decreased local recurrence dramatically. Additional neoadjuvant chemoradiation (nCR) is frequently given in UICC II and III tumors based on TNM staging which is of limited accuracy. We aimed to evaluate determination of circumferential margin by magnetic resonance imaging (mrCRM) as an alternative criterium for nCR.Multicenter prospective cohort study which enrolled 642 patients in 13 centers with non-metastasized rectal adenocarcinoma. Patients with T4 tumors or patients with a mrCRM of 1 mm or less were treated by neoadjuvant chemoradiation. All others proceeded directly to surgery when inclusion criteria and no exclusion criteria were met. Quality of TME and accuracy of mrCRM determination were assessed during pathology workup.TME was complete in 381 of 389 patients after surgery without nCR (97.9%) and in 245 of 253 patients (96.8%) after nCR. Negative pathology circumferential margins (pCRM) were seen in 97.4% without nCR and in 89% of patients after nCR. Negative pCRM was predicted by negative mrCRM in 98.3% of rectal cancers. NCR was given to 253 of 642 patients (39.5%). Lymph node count was 23 (range 7-79; median/range) for surgery without nCR and 19 (range 2-56) for surgery after nCR.Surgical quality determined by pathology workup of specimen was very good in this study. Magnetic resonance imaging guided indication for nCR allows to achieve superb results concerning surrogate parameters for good oncological outcome. Thus, use of neoadjuvant chemoradiation with its potential detrimental side effects may be substantially reduced in selected patients.

Introduction The OCUM trial (NCT01325649) aims to clarify whether low rates of local recurrence are also achieved when the indications for neoadjuvant radiochemotherapy are not based on the clinical TNM staging but on preoperative magnetic resonance imaging with measurement of the tumor distance to the circumferential resection margin. In this interim analysis the lymph node status in OCUM patients was investigated as a surrogate parameter for quality of surgery and histopathological work-up. Material and methods Until now a total of 560 patients have been included in this study. Total mesorectal excision (TME) without pretreatment was undertaken in 338 patients (60.4 %) and neoadjuvant radiochemotherapy was administered in 222 (39.6 %) patients. The histological work-up was performed according to the guidelines of the German Association of Pathologists. Data are given as median values and ranges in brackets. Results The lymph node yield was 24 (7-79) in 338 patients undergoing primary TME surgery without pretreatment, while 20 (3-56) lymph nodes were identified in patients after neoadjuvant radiochemotherapy (p = 0.001). A minimum of 12 lymph nodes were analyzed in 335 out of 338 patients (99.1 %) and in 209 out of 222 patients (94.1 %) following neoadjuvant radiochemotherapy (p = 0.001). Lymph node metastasis was identified (p = 0.362) in 116 out of 338 patients without pretreatment (34.3 %) and in 71 out of 222 patients after neoadjuvant radiochemotherapy (32.0 %). Patient age did not influence the number of identified lymph nodes or rate of lymph node metastasis. Conclusion In this trial the number of identified lymph nodes suggests that the quality of surgery and histopathological work-up were adequate compared to the standards defined by national guidelines. Neoadjuvant radiochemotherapy led to a reduced lymph node yield compared to surgery without pretreatment; however, this did not influence the rate of lymph node metastasis.

In einer prospektiven multizentrischen Beobachtungsstudie zur selektiven MRT-basierten Indikation zur neoadjuvanten Radiochemotherapie (nRCT) des Rektumkarzinoms (OCUM) wurden nicht alle bisher eingeschlossenen Patienten studienkonform behandelt. Die Indikation zur nRCT wurde auf Basis einer pratherapeutischen MRT gestellt. Studienkonform und nichtstudienkonform behandelte Patienten wurden hinsichtlich Surrogatindikatoren der Langzeitprognose, des postoperativen Verlaufs und der pathologischen Stadienverteilung nach multimodaler Therapie und nach primarer Chirurgie verglichen. Die wichtigsten Surrogatindikatoren einer ungunstigen Langzeitprognose (Resektion im muscularis propria plane of surgery und positiver pathologischer zirkumferentieller Resektionsrand) waren bei nichtstudienkonformer Therapie signifikant haufiger als bei studienkonformer Therapie (13,2 vs. 5,6 %, p = 0,001, bzw. 4,0 vs. 1,2 %, p = 0,016). Nach studienkonformer neoadjuvanter Therapie ist das Downstaging in die pathologischen Stadien y0, yis und yI haufiger als bei nichtstudienkonformer neoadjuvanter Therapie (Kurzzeit- oder Langzeitradiotherapie) (36,8 vs. 17 %, p = 0,070). Im postoperativen Verlauf fanden sich nur zwischen Patienten mit studienkonformer nRCT und solchen mit nichtstudienkonformen anderen Formen einer neoadjuvanten Therapie wie Kurzzeit- oder Langzeitradiotherapie signifikante Unterschiede in der Haufigkeit postoperativer Komplikationen (24,5 vs. 57 %, p = 0,001).

Survival is an important indicator of outcome quality in rectal carcinoma. The 5-year survival rate is the typical outcome measurement. In patients with neoadjuvant chemoradiation followed by curative surgery, 7 years of follow-up is recommended. Different methods of survival analysis lead to different results. Here, we compared four different methods. The data of 439 patients with rectal carcinoma treated with neoadjuvant chemoradiation followed by curative total mesorectal excision (TME) surgery between 1995 and 2010 were analysed. After stratifying by stage, relative survival (RS), cancer-related survival (CRS), overall survival (OS) and disease-free survival (DFS) were compared. In particular, the 3-year disease-free survival rate was compared to the 5- and 7-year overall survival rates. In the total cohort, the 5-year survival rates ranged from 90% (RS), over 84% (CRS) and 83% (OS) to 72% (DFS). Depending on the stage of disease, the differences between the 5-year survival rates varied between 10 and 32 percentage points. The differences were lowest in UICC stage y0 and highest in UICC stage yIV. The 3-year DFS-rate was always lower (worse) than the 5-year OS rate and higher (better) than the 7-year OS rate, with the exception of stage yIV. Comparisons of survival are only meaningful if the same methods are applied. The 3-year rate of DFS was always worse than the rate of 5-year OS. Therefore, the 3-year rate of DFS appears to be a useful surrogate indicator in rectal carcinoma treatment studies.

An Resektionspraparaten mit Rektumkarzinom ist heute die makroskopische Beurteilung der Qualitat der Mesorektumexzision durch den Pathologen obligatorisch. Dabei wird der „plane of surgery“ beurteilt, wobei insbesondere die Haufigkeit der Operation im Muscularis propria Plane of Surgery (fruher als inkomplette Mesorektumexzision bezeichnet) interessiert. Die Qualitat der Mesorektumexzision ist von prognostischer Bedeutung, da vor allem Lokalrezidive nach Operation im Muscularis propria Plane of Surgery haufiger beobachtet werden. Daten von insgesamt 13 zwischen 2006 und 2012 publizierten Studien mit jeweils mehr als 100 Patienten und entsprechender Spezialisierung und Erfahrung der Operateure (5413 Patienten), Daten der prospektiven multizentrischen Beobachtungsstudie „Qualitatssicherung – Rektumkarzinome“ des An-Instituts fur Qualitatssicherung in der operativen Medizin an der Otto-von-Guericke-Universitat Magdeburg der Jahre 2005–2010 (8044 Patienten) sowie Daten der Chirurgischen Klinik am Universitatsklinikum Erlangen aus der Zeit zwischen 1998 und 2011 (991 Patienten) wurden analysiert, um eine Definition fur Qualitatsziele zu erarbeiten. Dabei ergab sich eine Gesamthaufigkeit von Operationen im Muscularis propria Plane of Surgery von 721/14 448 (5,0 %). Die Haufigkeit von Operationen im Muscularis propria Plane ist auch bei entsprechender Spezialisierung und Erfahrung bei abdominoperinealen Exstirpationen groser als bei Operationen mit Sphinktererhalt (8,4 vs. 2,8 %, p

For many years, the impact of the surgeon volume on short- and long-term outcome after rectal carcinoma surgery is controversially discussed. Literature and own department data were reviewed in order to clarify the impact of surgeon volume in the current era of total mesorectal excision surgery, multimodal therapy, quality management, and centralization of cancer care. Uni- and multivariate analysis of data from 1,028 patients with solitary rectal carcinoma, treated between 1995 and 2010 at the Department of Surgery, University Hospital, Erlangen, Germany, was performed. Surgeons were subdivided according to the number of operations/year into high- (at least seven/year), medium- (three to six), and low- (less than three) volume surgeons. Of 1,028 patients, 800 (77.8 %) were operated by five high-volume surgeons, 193 (18.8 %) by seven medium-volume surgeons, and 35 (3.4 %) by 12 low-volume surgeons. Surgeon volume was significantly associated with postoperative mortality and the rate of positive pathological circumferential resection margin. In risk-adjusted analysis, after primary surgery, surgeon volume had a significant impact on observed overall survival and disease-free survival, but not on locoregional recurrence. After neoadjuvant radiochemotherapy, only observed overall survival was significantly influenced by surgeon volume. In surgical departments with special interest in rectal carcinoma, surgeon volume has some influence on short- and long-term outcome. Irrespective of this fact, specialization, experience, individual skill, hospital organization, and regular quality assurance are essential prognostic factors ensuring good results in rectal carcinoma surgery.

Hintergrund Der Einfluss von Operationsprinzipien und neoadjuvanter Therapie auf die Haufigkeit einer intraoperativen lokalen Tumorzelldissemination (LTZD) in der Rektumkarzinomchirurgie und deren Folgen bez. Lokalrezidiv- und Uberlebensraten wurden untersucht.

Aim In most institutions neoadjuvant chemoradiation for middle and lower rectal carcinoma is currently given to patients with tumours of clinical stages II or III (cT3,4 and/or N1,2). The possibility of a reduction in the use of neoadjuvant chemoradiation by an individualized magnetic resonance imaging (MRI)-based indication for neoadjuvant chemoradiation was analysed. Method Assessment of the pathological and oncological principles indicating for neoadjuvant treatment was used to determine the prognostic importance of the distance between the tumour and the circumferential resection margin and pretherapeutic assessment using modern MRI. Results Based on the results of pretreatment MRI scanning, a proposal is presented for the treatment of middle and lower rectal carcinoma with neoadjuvant chemoradiation. Adopting this proposal, the frequency of neoadjuvant chemoradiation decreased from 70% to 35% and the early and late adverse effects of this therapy were reduced. In contrast, the expected locoregional recurrence rate increased from 6% to 11% if all quality criteria were met and to 18% if not. Conclusion An MRI-based indication for neoadjuvant chemoradiation is justified only for centres with regular quality assurance of MRI, surgery, radiotherapy and pathology. The proposal needs confirmation by long-term follow up and by prospective studies with larger numbers of patients.

AIM: This review comments on the diagnosis and treatment of gastric cancer in the classical -mean-ing - excluding adenocarcinoma of the -oesophagogastric junction. Algorithms of diagnosis and care with respect to tumour stage are present-ed. PREOPERATIVE DIAGNOSIS: Besides oesophagogastroduodenoscopy, endoscopic ultrasonography is necessary for the accurate diagnosis of T categories and as a selection criterion for neoadjuvant chemotherapy. Computed tomography is recom-mended for preoperative evaluation of tumours > T1, laparoscopy has become an effective stag-ing tool in T3 and T4 tumours avoiding unneces-sary laparotomies and improving the detection of small -liver and peritoneal metastases. TREATMENT: Endoscopic mucosal resection and submucosal dissection are indicated in superficial cancer confined to the mucosa with special characteristics (T1 a / no ulcer / G1, 2 / Lauren intestinal / L0 / V0 / tumour size < 2 cm). In all other cases total gastrectomy or distal subtotal gastric resection are indicated, the latter in cases of tumours located in the distal two-thirds of the stomach. Standard lymphadenectomy (LAD) is the D2 LAD without distal pancreatectomy and splenectomy. The Roux-en-Y oesophagojejunostomy is still the preferred type of reconstruction. An additional pouch reconstruction should be considered in -patients with favourable prognosis, this also -applies for the preservation of the duodenal passage by jejunum interposition. Extended organ resections are only indicated in cases where a R0-resection is possible. Hepatic resection for metachronous or synchronous liver metastases is rarely advised since 50 % of patients with liver metastases show concomitant peritoneal dis-semination of the dis-ease. DISCUSSION AND CONCLUSIONS: Undergoing gastrectomy at a high-volume centre is associated with lower in-hospital mortality and a better prognosis, however, clear thresholds for case load cannot be given. Perioperative chemotherapy and postoperative chemoradiotherapy are based on the MAGIC and MacDonald trials. Perioperative chemotherapy should be performed in patients with T3 and T4 tumours with the aim to increase the likelihood of curative R0-resection by downsizing the tumour. Adjuvant postoperative chemotherapy cannot be recommended since its benefit has so far not been -proven in randomised trials. In selected patients with incomplete lymph-node dissection and questionable R0-resection postoper-ative chemoradiotherapy may be debated.

A cohort study was carried out to analyse quality indicators in the diagnosis and treatment of rectal carcinoma.A total of 2,470 patients with rectal carcinoma treated between 1985 and 2007 at the Department of Surgery, University of Erlangen, were analysed and compared within four time intervals.Most of the indicators analysed from 2004 to 2007 fulfilled the defined target values. The indicators for process quality of surgical treatment and the surrogate indicators of outcome quality in surgery showed excellent results. Comparing this to previous data, it displays the new developments such as introduction of multimodal treatment for high-risk patients. While the rate of locoregional recurrences decreased, no significant improvement in survival was found.Careful analysis of quality indicators is important for both quality management and comparison of treatment results. The progress in diagnosis and treatment requires a continuous update of definitions and target values.

Is it possible to reduce the frequency of neoadjuvant therapy for rectal carcinoma and nevertheless achieve a rate of more than 90% circumferential resection margin (CRM)-negative resection specimens by a novel concept of magnetic resonance imaging (MRI)-based therapy planning?One hundred eighty-one patients from Berlin and Mainz, Germany, with primary rectal carcinoma, without distant metastasis, underwent radical surgery with curative intention. Surgical procedures applied were anterior resection with total mesorectal excision (TME) or partial mesorectal excision (PME; PME for tumours of the upper rectum) or abdominoperineal excision with TME.With MRI selection of the highest-risk cases, neoadjuvant therapy was given to only 62 of 181 (34.3%). The rate of CRM-negative resection specimens on histology was 170 of 181 (93.9%) for all patients, and in Berlin, only 1 of 93 (1%) specimens was CRM-positive. Patients selected for primary surgery had CRM-negative specimens on histology in 114 of 119 (95.8%). Those selected for neoadjuvant therapy had a lower rate of clear margin: 56 of 62 (90%).By applying a MRI-based indication, the frequency of neoadjuvant treatment with its acute and late adverse effects can be reduced to 30-35% without reduction of pathologically CRM-negative resection specimens and, thus, without the danger of worsening the oncological long-term results. This concept should be confirmed in prospective multicentre observation studies with quality assurance of MRI, surgery and pathology.

In a prospective multi-centre study data were collected on 1,999 patients (1273 men, 726 women; mean age 62.3 [19-99] years) with gastric carcinoma, admitted to one of 19 surgical departments in Germany between 1.4. 1986 to 30. 6. 1989. Previously treated patients as well as those with synchronous or metachronous tumours and carcinoma of the gastric stump had been excluded. The resection rate for gastric carcinoma was 82.7%, i.e. resection was no longer possible because of the advanced tumour stage in nearly 20%. The tumour was located in the upper third of the stomach in 30%, the antrum in 26.3%. An intestinal type of growth was present in 51.9%. An early carcinoma was diagnosed in 16.9% of operated patients; it had already metastasized to regional lymph nodes in 16.5%. Nearly 70% of patients with resectable tumours had metastases to the regional lymph-nodes, with distant metastases in 30%. An advanced tumour stage (UICC stage IIIB or IV) was present in 43%. Exclusively surgical treatment is not effective in these cases.

The task force "workflow rectal cancer II" defined operative techniques in lower rectal cancer, especially the total mesorectal excision and an improved technique of abdominalperineal resection. New aspects for treatment of rectal cancer with primary distant metastases are described. Due to newer publications a concept of bidirectional procedure with surgery and radiochemotherapy is recommended, where the operation must not be inevitably the first step. In anastomoses below 6 cm of the anocutaneous verge a reservoir should be performed on principle due to better functional results. The colon-j-pouch with a maximal loop length of 6 cm is best investigated under these conditions, the other procedures should be further evaluated.

Diagnostic and treatment of rectal cancer need a continuous quality assessment. Indicators of quality were compiled as indicator profile for a summarizing evaluation. The indicators selected should potentially show an appreciable variation of the quality target and in addition should be decisive for the outcome. For the evaluation of the clinical diagnostic the frequency of the determination of the pretherapeutic T, N and M categories and the proportion of pT 1-tumors were chosen, for the pathological diagnostic the number of histologically examined lymph nodes and the proportion of lymphnode positive patients. Process quality of treatment was defined by the following indicators: proportion of tumor excision, of definite therapy by local tumor removal, of neo-adjuvant long-term radiochemotherapy, of adjuvant treatment in patients not selected for neoadjuvant therapy, of total / partial mesorectal excision, of abdomino-perineal resection, postoperative mortality, frequency of clinically apparent anastomotic leakage, and of neurogenic bladder dysfunction at hospital discharge. The indicators for the quality of the performance of treatment were differentiated between surrogate indicators that can be determined immediately after accomplishment of primary surgical therapy giving strong clues for the further course of disease at an early date, and definite indicators. Important surrogate indicators comprise the occurrence of intraoperative local tumor cell dissemination, R 1 / 2-resection, pathohistologically CRM-positive tumor resection, and the quality of mesorectal excision (proportion of incomplete mesorectal excision). The definite indicators include the 5-year local recurrence rate and the 5-year overall survival rate. The corresponding quantifying parameters for the individual indicators are specified in this paper with precise figures.

The present-day optimised surgery (concept of total mesorectal excision) with quality assurance by standardized pathologic examination, advances in radiotherapy and the possibilities of high-spatial-resolution MR imaging require reconsideration of pros and contras of neoadjuvant therapy and respective data. According to the resulting new proposal neoadjuvant long-course radiochemotherapy is indicated for patients with 1) fixed questionably R0 resectable tumors, 2) mobile tumors with the MRT finding of tumor involving the mesorectal fascia or 1 mm or less from it, 3) low rectal tumors extending below the levator origin and invading beyond the muscularis propria. If a high risk of local recurrence becomes apparent during surgery (tumor perforation, incision into or through tumor) or after pathologic examination (incomplete mesorectal excision, tumor 1 mm or less from the circumferential resection margin) adjuvant radiochemotherapy is indicated. In case of lymph node metastasis postoperative chemotherapy is given.

Experts on different specialties (surgery, pathology, molecular biology and medical statistics) discussed the evaluation of prognostic factors during a workshop. The most important results presented are: (1) the prognostic relevance of new biological or molecular markers must be evaluated in a phase-III prognostic study. To establish such a marker in the UICC-TNM-classification in at least two different centers, two multivariate analyses according to defined criteria are necessary; (2) the standards of laboratory methods have to be defined, e.g.,which method to apply for RNA-analysis,which materials to used, etc; (3) intensive data analysis should be done before using methods of multivariate analysis. The criteria for the presentation of survival curves are given in detail; (4) in multivariate analysis, the Cox proportional hazard regression for survival outcomes is discussed with explanations and examples of the terms relative risk, odds-ratio, hazard and relative hazard. The arrangement and interpretation of a good prognostic study should be performed as an interdisciplinary approach.

To obtain data on locoregional recurrence and survival rates in prognostically inhomogeneous pT3 rectal carcinomas we analyzed the data on 853 patients of the Erlangen Registry for Colo-Rectal Carcinomas (ERCRC) and 600 patients of the Study Group for Colo-Rectal Carcinoma (SGCRC), stage I–III, treated by radical surgery alone. The category pT3 was subdivided according to the histological measurement of the maximal tumor invasion beyond the outer border of the muscularis propria: pT3a (up to 5 mm) and pT3b (more than 5 mm). In the ERCRC locoregional recurrence rates were 10.4% (95% confidence interval 6.0–14.6) for pT3a and 26.3% (20.6–31.6) for pT3b (P

Einleitung: Ziel einer Weichteiltumor-Registerstudie der Chirurgischen Arbeitsgemeinschaft Onkologie (CAO) der Deutschen Gesellschaft fur Chirurgie war die Erfassung der Behandlungsstrategien bei malignen Weichteiltumoren des Erwachsenen. Methodik: In 19 Monaten wurden Daten von 292 Patienten von 99 chirurgischen Kliniken Deutschlands nach einem speziell entwickelten Dokumentationsbogen prospektiv zur pratherapeutischen Biopsie, Vorbehandlung, definitiven chirurgischen Therapie, zu multimodalen Masnahmen und zum pathohistologischen Befund erhoben. Ergebnisse: 39 % der Tumoren wurden in Universitatskliniken, 36 % in Schwerpunktkrankenhausern und 24 % in Krankenhausern der Grundversorgung behandelt. Im Median behandelten die Kliniken 2 Patienten im Beobachtungszeitraum. Bei Extremitatentumoren kam in 96 % ein extremitatenerhaltendes Vorgehen zur Anwendung. Die Haufigkeit einer R0-Resektion unterschied sich in den einzelnen Kliniken nicht signifikant. An Universitatskliniken kamen lokal ausgedehntere Verfahren und additive Masnahmen haufiger zur Anwendung. Die Indikation zur adjuvanten Radiotherapie wurde unterschiedlich gestellt. Nach Kompartmentresektion kam sie in 39 % (19/49) zur Anwendung, nach weiter Excision bei high grade-Tumoren wurde auf sie in 45 % (20/44) verzichtet. Obwohl bei Tumoren des Korperstamms die Radikalitat des operativen Eingriffs geringer war, kam eine erganzende Strahlentherapie nicht haufiger zum Einsatz. Schlussfolgerung: Ansatzpunkte fur eine Verbesserung der Behandlungsqualitat bei Weichteiltumoren sind die Vermeidung einer inadaquaten Vorbehandlung (18 %), die Einhaltung der Regeln der onkologischen Chirurgie (Tumoreinriss in 7 %), die Verbesserung der pathohistologischen Aufarbeitung (fehlende R-Klassifikation in 5–12 %) und die Entwicklung von Leitlinien zur interdisziplinaren Therapie.

BACKGROUND The prognosis of patients with Stage III colorectal carcinoma seems to be inhomogeneous. Therefore a subdivision of Stage III was performed. METHODS Data from 850 patients of the Erlangen Registry of Colo-Rectal Carcinomas and 603 patients of the Study Group Colo-Rectal Carcinoma (SGCRC) with Stage III colorectal carcinoma were analyzed. Three different subdivisions of Stage III were performed according to pT, pN, and pTpN. Observed 5-year survival rates for all possible substages were calculated according to Kaplan-Meier. To compare the predictive value of several possible substages, Brier-Score and receiver operator charcteristics (ROC) analysis were applied. RESULTS The subdivision according to pT (pT1,2pN1,2 versus pT3 pN1,2 versus pT4 pN1,2) as well as the subdivision according to pN (any pT pN1 vs. any pT pN2) resulted in significant differences of observed 5-year survival rates. However, subdivision according to pT and pN (pT1,2 pN1 vs. pT3,4pN1 and pT1,2pN2 vs. pT3,4 pN2) was found to be superior. The three substages, IIIA, IIIB, and IIIC, identified 10%, 50%, and 40% of the patients with observed 5-year survival rates of 80%, 60%, and 30%, respectively. Using Brier-Score and ROC analysis an increase in predictive power was found, especially for the patients of the Erlangen Registry, but less clearly for SGCRC patients. CONCLUSION Subdivision of Stage III colorectal carcinoma into three substages according to the pT and pN categories resulted in subgroups which differed significantly in prognosis. This may be important for comparing treatment results, especially in adjuvant treatment and patient care evaluation studies. Cancer 2001;92:2754–9. © 2001 American Cancer Society.

Increasingly, data are being accumulated on the influence of intersurgeon variability on outcome after curative surgical treatment of rectal carcinoma. Thus, today the individual surgeon has to be considered as an independent factor influencing locoregional recurrence, as well as survival rates. In general, higher local control and survival can be expected for specialized colorectal surgeons. There are no clear correlations between surgical volume and outcome. Interinstitutional variability in treatment results reflects intersurgeon variability, but analysis is generally more difficult because of a lack of homogeneity with respect to different confounding factors. There are several factors in surgical technique that are important for long-term outcome. Of greatest apparent importance is the adequacy of mesorectal excision (for carcinomas of the middle and lower third, total mesorectal excision; for carcinomas of the upper third, mesorectal excision down to a mesorectal plane 5 cm distal to the gross tumor margin detected by the surgeon in situ). Furthermore, intraoperative local tumor spillage (tumor perforation during mobilization, incision into the tumor), en bloc resection technique, skill, and the extent of regional lymphadenectomy may influence outcome. For quality assurance, detailed operative reports are required, as well as histopathology examinations concerning indicators of surgical oncologic quality discernable from the resection specimens. In future clinical trials of multimodal treatment of rectal cancer, quality assurance of surgery and pathology is necessary for consideration of the surgeon and surgical technique prognostic factors.

The data of the German prospective multicenter study of the Study Group for Colo-Rectal Carcinoma (SGCRC) were analyzed by uni- and multivariate methods with regard to surgeon-related prognostic factors. The parameters were frequency of intraoperative local tumor spillage, surgical volume, and department and surgical quality group. The results obtained from the data of the SGCRC implicate consequences for analyses and comparisons of therapy results and studies on adjuvant therapy in colon and rectal cancer. All identified prognostic factors must be regarded and respectively considered in study designs. Colon and rectal cancer patients must also be distinguished and separate analyses are necessary for these.

Background Findings of isolated (disseminated or circulating) tumor cells (ITC) by immunocytochemistry and molecular pathology methods have led to varied interpretations and different applications of the TNM system. Methods An analysis of the relevant literature was undertaken. In addition, optional proposals for the classification of ITC, micrometastasis, and cytologic results in pleural and peritoneal washings are presented. Results Immunocytochemistry has a lower false-positive rate than nonmorphologic methods such as flow cytometry or the polymerase chain reaction; therefore the method(s) used always should be recorded. At the current time, the independent prognostic significance of ITC in regional lymph nodes and in the general circulation (blood, bone marrow, and other distant sites) is difficult to assess. To enable comparisons of treatment results and to avoid variation in staging, a finding of ITC should not be considered in the TNM and residual tumor (R) classifications, at least not at the current time. However, for future evaluation of their prognostic significance, the respective findings should be documented according to uniform criteria. Conclusions ITC should be distinguished from micrometastasis. To investigate the independent prognostic significance of ITC and of positive lavage cytology, uniform data collection according to the proposed coding schema is recommended.

PURPOSE: The aim of this study was to analyze the impact of institutions and individual surgeons on long-term prognosis after curative resection of rectal carcinoma. METHODS: We used univariate and multivariate analysis of data from a German prospective, multicenter, patient-care evaluation study. RESULTS: The locoregional recurrence rates and the observed and cancer-related survival rates showed a considerable interinstitutional and intersurgeon variability. Multivariate analysis confirmed the institution and the individual surgeon as significant independent factors influencing locoregional recurrence and survival. There was a statistically highly significant correlation between the rate of locoregional recurrence and survival rate. CONCLUSIONS: The surgeon's technique and skill has to focus on prevention of locoregional recurrence to achieve good long-term outcome after curative resection for rectal carcinoma. New clinical trials on adjuvant treatment have to include quality assurance for surgery and pathology and documentation of the surgeon (as local code).

The prognosis of solid tumors is predominantly influenced by the anatomic extent before and after initial treatment. It is defined by the TNM/pTNM system and the residual tumor (R) classification as internationally agreed on and published by the International Union Against Cancer (UICC). However, there are several independent factors effective in prognosis in addition to TNM and R. Their identification is the first objective in prognostic factor research. Correctly applied multivariate methods appropriate for the specific situation play a key role. Cooperation between clinical oncologists and experienced medical statisticians is indispensable. Putative new prognostic factors have to be carefully evaluated before they can be accepted for general use in clinical oncology. In the future, we have to focus on the development of prognostic systems. Such systems integrate multiple independent prognostic factors with present staging (TNM, R) to improve the assessment of prognosis.

Anhand der Daten der prospektiven deutschen Multizenterstudie der Studiengruppe Kolorektales Karzinom (SGKRK) wurden die Klinikunterschiede im 5-Jahres-Uberleben mit speziellen fur ein sog. Ranking geeigneten biometrischen Methoden unter Wahrung der Anonymitat analysiert. Weiterhin wurde nach sog. Surrogatendpunkten gesucht, die bereits fruher als 5 Jahre nach Ersttherapie eine Aussage uber die Ergebnisqualitat der chirurgischen Therapie ermoglichen. Hierzu ist eine gesonderte Analyse fur Rectum- und Coloncarcinompatienten erforderlich. Fur das Rectumcarcinom ist die Kombination von Haufigkeit ortlicher Tumorzelldissemination bei Tumorresektion (intraoperativer Einris im Tumor und/oder Schnitt in oder durch Tumorgewebe) und Rate locoregionarer Rezidive (innerhalb von 2 Jahren) nach Operation als verlaslicher Surrogatendpunkt anzusehen. Beim Coloncarcinom konnte ein solcher nicht gefunden werden. Die postoperative Morbiditat ist als Indikator fur die definitive Ergebnisqualitat ungeeignet. Eine sehr niedrige Rate postoperativer Todesfalle bietet keine Gewahr auf zufriedenstellende Langzeitergebnisse in der colorectalen Carcinomchirurgie.

The value of grading tumor regression after neoadjuvant therapy of rectal carcinoma was evaluated.Analysis was carried out using prospective data of 225 patients with rectal carcinoma treated by neoadjuvant radiochemotherapy followed by radical resection with curative intent. For the histological regression grading, the method of Dworak et al. (1997) was used with a slight modification.After neoadjuvant radiochemotherapy, the most important prognostic factors are pathologically assessed circumferential resection margin, quality of surgery (plane of surgery), and the ypT and ypN classification. In addition, the histological regression grade of primary tumor and regional lymph nodes influence outcome, especially the local recurrence rate.After neoadjuvant therapy, the histological tumor regression grading should be assessed. A regression grading system based on the proposals of Dworak et al. (1997) is recommended.

Background Dysplasia is the precancerous lesion of the stomach and is classified according to different criteria. Dysplasias are rarely found alone, most commonly in association with carcinoma. Methods The established classification of gastric carcinoma includes site, histological tumour type, histological grade of differentiation, residual (R) tumour classification and pTNM classification with stage grouping. Results The Lauren classification is important in operative planning (extent of operation on the stomach and esophagus). Additional conventional classification parameters and those belonging to the “New Pathology” are at present not proven independent prognostic factors and have no influence on treatment methods. Conclusions The basic information provided by the pathologist's assessment is nowadays well-defined, and a desirable extended documentation of resection specimen findings is presented.

Purpose: To study the accuracy of different cutoffs for an involved circumferential resection margin (CRM) compared with T and N categories measured by MRI as basis for selective application of neoadjuvant radiochemotherapy (nRCT) in rectal carcinoma. Materials and Methods: In a prospective multicenter observational study involving 153 primarily operated patients, the preoperative results of MRI with pathohistological findings of resected specimens were compared. Results: For a cutoff of ≤1 mm for involvement of the CRM, the accuracy of preoperative MRI was 90.9% (139/153). The negative predictive value was 98.5% (134/136). The four participating departments did not differ significantly. For a cutoff of >2 mm and >5 mm, the rates of false-positive findings increased significantly from 5% to 12% and 35% with a decrease in accuracy to 82% and 62%, respectively. In contrast, the accuracy in predicting T (69.3%) and N categories (61.4%) was much lower. Conclusion: The indication for nRCT should be based on the determination of the minimal distance of the tumor from mesorectal fascia with a cutoff point of >1 mm as measured by MRI. J. Magn. Reson. Imaging 2013;37:1122–1128. © 2013 Wiley Periodicals, Inc.

Nine medical centres with different practices in elective lymph node dissection (ELND) but comparable standards regarding diagnosis, excision of the primary tumour, classification, and follow-up, have collected their data on 3616 patients with primary melanoma of the skin (tumour category pT 2 to pT 4 a, N 0, M 0 [UICC 1987]) with the aim of producing an unbiased analysis of the prognostic benefit of ELND. The multivariate risk analysis (Cox's proportional hazard model) revealed tumour thickness (Breslow or alternative pT categories), sex, anatomic site of the primary tumour, and ELND therapy ("yes" or "no") as independent prognostic factors. Observed survival curves (Kaplan-Meier) show a significant difference of prognosis with regard to ELND therapy in the following risk groups: women with melanomas over 2.5 to 4 mm thick on head, neck, thorax, and in acral locations; men with melanomas over 1.5 to 4 mm thick on head, neck, thorax, and in acral locations; and finally men with melanomas over 2.5 to 4 mm thick on abdomen and extremities. Further investigations and the discovery of additional prognostic factors would help in more precisely formulation of guidelines for ELND.

This study evaluated use of circumferential resection margin status in preoperative MRI (mrCRM) as an indication for neoadjuvant radiochemotherapy (nRCT) in rectal carcinoma patients.In a multicenter prospective study, nRCT was given to patients with carcinoma of the middle rectum with positive mrCRM (≤1 mm), with cT3 low rectal carcinoma, and all patients with cT4 tumors. The short-term endpoints were pathologic pCRM (≤1 mm) as a strong predictor of local recurrence rate and the quality of total mesorectal excision according to the plane of surgery. These endpoints were compared in patients with and without nRCT.Of 230 patients that met the inclusion criteria, 96 (41.7%) received a long course of nRCT and 134 (58.3%) were primarily operated on. The pCRM was positive in 13 of 230 (5.7%) (primarily operated on, 2 of 134 [1.5%]; after nRCT, 11 of 96 [11%]). In 1 of 134 (0.7%) case, the mrCRM was falsely negative. Patients at participating centers varied in terms of preoperative stage but not in pCRM positivity (0%-13%, P = .340). The plane of surgery was mesorectal (good) in 209 of 230 (90.9%), intramesorectal (moderate) in 16 of 230 (7%), and the muscularis propria plane (poor) in 2.2% (5 of 230).Low pCRM positivity and the high quality of mesorectal excision support use of MRI-based nRCT in rectal carcinoma. nRCT was avoidable in 45% of patients with stage II and III disease without significant risk of undertreatment. Preoperative MRI thus allows identification of patients with high risk of local recurrence and use of selective nRCT.

Background. The impact of patient- and tumor-dependent factors and the postoperative course on the prognosis of patients who underwent resection for gastric carcinoma between 1986 and 1989 were analyzed in a prospective multicenter observation study. Methods. Resection techniques, the extent of lymph node dissection, and the histopathologic assessment of the specimen were standardized at all participating centers. A total of 1654 patients were enrolled. Follow-up is complete for 99.2% of the patients, with a median follow-up time of 48 months. Prognostic factors were assessed by multivariate analysis. Results. In the total patient population there was an independent prognostic effect of nodal status, a International Union Against Cancer (UICC)-R0 resection, distant metastases, the pT category, three or more risk factors on preoperative risk analysis, and the presence of postoperative complications. Multivariate analysis in the subgroup of patients who had a UICC-R0 resection confirmed the nodal status as the major independent prognostic factor. Conclusion. These data suggest that the prognosis of patients who undergo gastrectomy for gastric carcinoma may be improved by a complete resection of the primary tumor and its lymphatic drainage, resulting in a UICC-R0 resection. In addition, a detailed preoperative risk analysis and identification of high-risk patients and meticulous attention to the technical details of the surgical procedure to reduce the frequency of postoperative complications may improve the prognosis.

In a prospective multicentre study of 2394 patients with gastric carcinoma the prognostic relevance of systematic lymph node dissection was evaluated. Of 1654 patients undergoing resection, 558 had a standard lymph node dissection, defined as fewer than 26 nodes in the specimen, and 1096 underwent radical lymphadenectomy, i.e. 26 or more nodes in the specimen. Radical dissection signficantly improved the survival rate in patients with Union Internacional Contra la Cancrum (UICC) stages II and IIIA tumours. Multivariate analysis identified radical dissection as an independent prognostic factor in the subgroups of patients with UICC tumour stages II and IIIA. Radical dissection conferred no survival advantage in patients with pN2 tumours. There was no significant difference in morbidity and mortality rates between radical and standard lymph node dissection. Radical lymphadenectomy improves survival in patients with UICC gastric cancer stages II and IIIA, and should be the recommended treatment for such patients.

Background. The benefit of elective lymph node dissection (ELND) for the treatment of the nonmetastasized malignant melanoma has been assessed differently until today. Methods. Nine medical centers with a different ELND practice but comparable standards regarding diagnosis, excision of the primary tumors, classification, and follow-up, have collected their data (primarily ascertained prospectively) of 3616 patients of the tumor categories pT2 to pT4N0M0 to produce an unbiased analysis of the prognostic benefit of ELND, and to find the indications for its application. The data are based on patients 70 years of age and younger with a primary melanoma of the skin, who have been followed for at least 4 years (median, 9.6 years). The stratification (according to pT category [alternatively, tumor thickness], sex, anatomic site) was in accordance with the results of the multivariate risk analysis (Cox hazard model). Imbalances of other criteria such as ulceration, type, and age were excluded by chi-square tests of the individual strata. The results are based on the observed survival rates according to Kaplan-Meier analysis of the different strata. Results. A prognostic benefit of the ELND group (improvement of the 5-year survival rate of about 20%) can be claimed for male patients with axial and acral melanomas (excluding lentigo maligna melanoma [LMM] and ulcerated tumors) of the categories pT3a up to pT4a (tumor thickness of > 1.5–4.5 mm, respectively) (P 2.5–5 mm, excluding LMM) (P = 0.016). Conclusions. This retrospective study strongly suggests the efficacy of ELND in subgroups of melanoma patients.

As a result of Japanese reports of improved survival of gastric cancer patients after extended lymph node dissection, a study was undertaken to evaluate factors that might influence these results. The influence of staging was evaluated by stratifying 1085 patients of the National Cancer Center of Japan and grouping them according to the three commonly used systems; UICC's old and new TNM systems (fourth edition) and the system of the Japanese Research Society for the study of Gastric Cancer (JRSGC). No survival difference was found between the stages of the three systems, except for stage II, where the new TNM and the JRSGC differed (p