Dokument: Evaluation der neoadjuvanten Chemotherapie bei Adenokarzinom des ösophagogastralen Übergangs
| Titel: | Evaluation der neoadjuvanten Chemotherapie bei Adenokarzinom des ösophagogastralen Übergangs | |||||||
| Weiterer Titel: | Evaluation of neoadjuvant chemotherapy in esophagogastric junction adenocarcinoma | |||||||
| URL für Lesezeichen: | https://docserv.uni-duesseldorf.de/servlets/DocumentServlet?id=66412 | |||||||
| URN (NBN): | urn:nbn:de:hbz:061-20240729-113222-4 | |||||||
| Kollektion: | Dissertationen | |||||||
| Sprache: | Deutsch | |||||||
| Dokumententyp: | Wissenschaftliche Abschlussarbeiten » Dissertation | |||||||
| Medientyp: | Text | |||||||
| Autor: | Fedarenka, Liubou [Autor] | |||||||
| Dateien: |
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| Beitragende: | Prof. Dr. Rehders Alexander [Gutachter] PD Dr. med. Kirchner, Julian [Gutachter] | |||||||
| Stichwörter: | Adenokarzinom des ösophagogastralen Übergangs, neoadjuvante Chemotherapie | |||||||
| Dewey Dezimal-Klassifikation: | 600 Technik, Medizin, angewandte Wissenschaften » 610 Medizin und Gesundheit | |||||||
| Beschreibungen: | Das Adenokarzinom des ösophago-gastralen Übergangs (AEG) stellt aufgrund seiner anatomischen, epidemiologischen und therapeutischen Besonderheiten eine gesonderte Entität dar. Im Gegensatz zu Adenokarzinomen des Magens, nimmt die Inzidenz der Karzinome des Ösophago-Gastralen-Übergangs seit Jahrzehnten kontinuierlich zu. Die Ursache dafür ist weiterhin unklar. Jedoch wird eine Reihe von Ursachen diskutiert, wie das maligne Potenzial der Barrett-Mukosa und ätiologische Faktoren, wie Adipositas, Ernährungsfaktoren, Alkohol, Medikamente und Tabak.
Aufgrund der frühen lymphatischen Metastasierung ist die Prognose bei Adenokarzinomen des AEG insgesamt schlecht und abhängig von der lokalen Tumorinfiltrationstiefe (T- Kategorie) und dem Grad der lymphatischen Aussaat (N-Kategorie). In den aktuellen Leitlinien wird daher bei Verdacht auf Vorliegen einer N1-Situation im prätherapeutischen Staging oder bei Verdacht auf wandüberschreitendes Tumorwachstum die Durchführung einer neoadjuvanten Therapie empfohlen. Wegweisend hierfür war insbesondere die multizentrische MAGIC Studie. Dennoch ist diese Vorgehensweise nicht unumstritten, da die Tumorregressionsrate trotz aggressiver Chemotherapie nach dem FLOT-Schema gering ist. Die Rate an Nebenwirkungen dagegen ist hoch. Im Vordergrund stehen hier Blutbildveränderungen wie Neutropenie, Thrombozytopenie, Anämie, Anorexie, Sarkopenie, Fatigue, Übelkeit und Emesis bis Dehydratation. Die direkte Umsetzung der Empfehlungen der S3-Leitlinie ist jedoch im klinischen Alltag nicht immer möglich, da bei einigen Patienten Kontraindikationen bestehen, insbesondere bei den Patienten, die über 70 Jahre alt sind. Eine britische Studie zeigte keine relevante Verbesserung der Gesamt- sowie Rezidiv-freien- Überlebenszeit bei Patienten über 65 Jahren, die neoadjuvant vorbehandelt wurden im Vergleich zu den Patienten, die primär operiert wurden. Hinzu kommt auch, dass das prätherapeutische Staging häufig ungenau ist und ein signifikanter Anteil der Patienten möglichweise overstaged ist, so dass die Indikation zur neoadjuvanten Therapie in manchen Fällen etwas zu großzügig gestellt wird. Die Datenlage hinsichtlich des Stellenwertes der neoadjuvanten Therapie bei AEG- Karzinomen ist noch immer unzureichend. Insbesondere bleibt unklar welche Patienten wirklich von der Therapie profitieren, ob das Nebenwirkungsprofil der Therapie in einem sinnvollen Verhältnis zum Nutzen steht, wie hoch die Tumorregressionsraten unter der neoadjuvanten Therapie sind und ob es bestimmte Subgruppen von Patienten gibt, die mehr als andere von der Therapie profitieren. Viele der publizierten Daten beruhen auf multizentrischen Studien, bei denen das chirurgische Therapiekonzept, insbesondere das Ausmaß der lokalen Radikalität (Lymphadenektomie) kaum miteinander verglichen werden kann. In dieser Arbeit wurden retrospektiv an einer universitären Institution klinisch pathologische Parameter zu Patienten mit AEG-Karzinomen in der Ära der neoadjuvanten Therapie evaluiert. Zielparameter sind hierbei die Tumorregressionsrate, das Langzeitüberleben sowie perioperative Parameter wie die behandlungsspezifische Morbidität und Mortalität. Der klinische Datensatz umfasst demographische Daten wie Alter und Geschlecht. Die krankheitsbezogenen Angaben schließen die folgenden Parameter ein: Präoperatives Staging sowie der postoperative histologische Befund, pTNM, G, R, ypT, ypN, den histologischen Typ, und den Grad der Tumorregression nach der Becker-Klassifikation. Desweiteren wurden Parameter wie perineurale Invasion, Lymphknotenratio, Anzahl der entfernten Lymphknoten, Lokalisation des Tumors, OP-Dauer, Art der Gastrektomie oder Ösophagektomie, Lokalisation der Anastomose (intraabdominell oder intrathorakal), Durchführung einer multiviszeralen Resektion ja/nein, Dauer des Aufenthalts auf der Intensivstation, Dauer des Krankenhausaufenthalts, Komplettierung oder Abbruch der Therapie, Rezidivrate, allgemeines und tumor-spezifisches Überleben erfasst. Durch Subgruppenanalysen wurde der Versuch vorgenommen, die Patienten zu identifizieren, die besonders von neoadjuvanten Behandlungskonzepten profitieren. Analog wurden Rückschlüsse darüber gezogen, bei welchen Patienten die neoadjuvante Therapie eine vermeidbare Belastung darstellt, so dass hier einer primären Tumorresektion der Vorzug gegeben werden sollte. Die Ergebnisse dieser Arbeit stellen die Daten zur Verfügung, auf deren Grundlage neue Studien zu alternativen Therapiemodalitäten und individualisierten Behandlungskonzepten etabliert werden könnten. Es wurden alle Patienten zwischen 2010 und 2022, die an der Universitätsklinik Düsseldorf mit diesem Krankheitsbild behandelt wurden, analysiert. Im Zentrum wurden 74 Patienten mit Karzinomen im Bereich des ösophago-gastralen Übergangs kurativ behandelt. Das mittlere Alter bei Diagnostizierung des AEG-Karzinoms der gesamten Kohorte lag bei 65,68 Jahren (43-84 Jahre) und 84,8% der untersuchten Patienten waren männlich. Die maximale Beobachtungszeit in dieser Arbeit betrug 144 Monate (12 Jahre). Das Follow-up der Patienten lag im Median bei 73,95 Monaten. Die Patientengruppe mit einer neoadjuvanten Therapie zeigte ein medianes Gesamtüberleben (overall survival, OS) von 70 Monaten (95%-KI:27- 125), die Patientengruppe mit Operation allein zeigte ein medianes OS von 67 Monaten (95%- KI:38-106). Der Unterschied zwischen den Behandlungsgruppen war nicht signifikant (Long Rank p=0,655). Es konnte auch gezeigt werden, dass das 5-Jahres Gesamt- sowie das rezidivfreie Überleben in beiden Behandlungsgruppen (Operation allein und Neoadjuvanz- Gruppe) vergleichbar war. Des Weiteren wurde die Analyse der Überlebensparameter in Abhängigkeit von der pathologischen Remission durchgeführt. Die Patienten, die eine neoadjuvante Therapie erhielten, aber keinen Respons gezeigt hatten, zeigten ein 5-Jahres Gesamt- sowie rezidivfreies Überleben von 32% sowie 27%. Wiederum zeigte die „Operation- allein-Gruppe“ ein 5-Jahres Gesamt- sowie rezidivfreies Überleben von 51% und 46%. Eine exzellente 5-jahres Gesamt- sowie rezidivfreie Überlebensrate mit 82% und 76% konnte bei Vorliegen eines sichtbaren Responses (Becker 1a, 1b sowie Becker 2) festgestellt werden. Zusammenfassend konnte eine deutliche und signifikante Verbesserung der Gesamt- sowie rezidivfreien Übelebenszeit bei Respons nach neoadjuvanter Therapie beobachtet werden. Es bleibt aber weiterhin unklar, welche Patienten von der neoadjuvanten Therapie profitieren. Diesbezüglich sollen weitere Studie durchgeführt werden, da die toxische Wirkung der Neoadjuvanz bei den nicht respondierenden Patienten durch Selektion verhindert werden kann.Adenocarcinoma of the gastro-oesophageal junction is a distinct entity due to its anatomical, epidemiological and therapeutic characteristics. In contrast to gastric adenocarcinoma, the incidence of oesophageal junction carcinoma has been increasing steadily for decades. The cause is still unclear. However, several causes have been discussed, including the malignant potential of Barrett's mucosa and aetiological factors such as obesity, diet, alcohol, medication and tobacco. Due to early lymphatic metastasis, the overall prognosis for AEG adenocarcinoma is poor and depends on the depth of local tumour infiltration (T category) and the degree of lymphatic seeding (N category). Current guidelines therefore recommend neoadjuvant therapy (recommendation grade A) for suspected N1 situations in pre-therapeutic staging or suspected tumour growth beyond the wall. The multicentre MAGIC trial was particularly groundbreaking in this regard. However, this approach is not uncontroversial, as the tumour regression rate is low despite aggressive chemotherapy according to the FLOT regimen. On the other hand, the rate of side effects is high. These include changes in blood counts such as neutropenia, thrombocytopenia, anaemia, anorexia, sarcopenia, fatigue, nausea, vomiting and dehydration. A 1:1 implementation of the S3 and tumour board recommendations is not always possible in daily clinical practice because of contraindications in some patients, especially those over 70 years of age. A British study showed no relevant improvement in overall survival and recurrence-free survival in patients over 65 years of age who received neoadjuvant pretreatment compared with patients who underwent primary surgery. In addition, pre- treatment staging is often inaccurate, and a significant proportion of patients may be overstaged, so the indication for neoadjuvant therapy may be too generous. The data situation regarding the value of neoadjuvant therapy for AEG carcinomas is still inadequate. It remains unclear which patients really benefit from the therapy, whether the side effect profile of the therapy is in a meaningful relationship to the benefit, how high the tumour regression rates are under neoadjuvant therapy and whether there are certain subgroups of patients who benefit more from the therapy than others. Many of the published data are based on multi-centre studies in which the surgical therapy concept, in particular the extent of local radicality (lymphadenectomy), can hardly be compared with each other. In this study, clinical pathological parameters for patients with AEG carcinomas in the era of neoadjuvant therapy were evaluated retrospectively at a university institution. The target parameters are the tumour progression rate, long-term survival, and perioperative parameters such as treatment-specific morbidity and mortality. The clinical data set includes demographic data such as age and gender. The disease-related data includes the following parameters: preoperative staging as well as postoperative histological findings, pTNM, G, R, ypT, ypN, histological type, degree and grade of tumour regression according to Becker's classification, perineural invasion, lymph node ratio, number of lymph nodes removed, location of tumour, duration of surgery, type of gastrectomy or oesophagectomy, Localisation of the anastomosis (intra-abdominal or intrathoracic), multivisceral resection yes/no, length of stay in the intensive care unit, length of hospital stay, completion or discontinuation of treatment, recurrence rate, general and tumour-specific survival. Subgroup analyses were carried out to identify patients who particularly benefit from neoadjuvant treatment concepts. Similarly, conclusions were drawn about the patients for whom neoadjuvant therapy represents an avoidable burden, so that preference should be given to primary tumour resection. The results of this work provide the data based on which new studies could be initiated that could release new therapy methods and individualised treatment concepts could be developed for patients with AEG. Therefore, all patients treated at the University Hospital Düsseldorf with this clinical picture between 2010 and 2022 were analysed. In the centre, 74 patients with carcinomas in the oesophago-gastric junction were treated curatively. The mean age at diagnosis of AEG carcinoma in the entire cohort was 65.68 years (43-84 years) and 84.8% of the patients analysed were male. The total observation time in this study was 144 months (12 years). The median follow-up of the patients in this study was 73,95 months. The patient group with neoadjuvant therapy showed a median overall survival (OS) of 70 months (95% CI: 27-125), the patient group with surgery alone showed a median OS of 67 months (95% CI: 38-106). The difference between the treatment groups was not significant (long rank p=0.655). It was also shown that 5-year overall and recurrence-free survival in both treatment groups (surgery alone and neoadjuvant group) were comparable in both groups. Furthermore, the survival parameters were analysed in relation to the pathological remission. Patients who received neoadjuvant therapy but showed no response (in 56.6% of cases, or 30 patients) showed a 5- year overall and recurrence-free survival of 32% and 27% respectively. Again, the surgery- alone group showed 5-year overall and recurrence-free survival at 51% and 46%, respectively. An excellent 5-year overall and recurrence-free survival rate was observed in the response (Becker 1a, 1b and Becker 2) (82% and 76%). The difference between the response groups was significant with an advantage for the patients with response (long rank p=0.003). In summary, the improvement in overall and recurrence-free survival after neoadjuvant therapy can be shown in the response. However, it remains unclear which patients benefit from neoadjuvant therapy. Further studies should be conducted in this regard, as the toxic effect of neoadjuvant therapy on non-responders can be prevented by patient selection. | |||||||
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