{"id":{"repo_id":"freiburg-diss","oai_identifier":"oai:freidok.uni-freiburg.de:2134"},"canonical_url":"https://search.dev.ndltd.org/etd/freiburg-diss/oai:freidok.uni-freiburg.de:2134","repository":{"repo_id":"freiburg-diss","name":"University of Freiburg","base_url":"https://freidok.uni-freiburg.de/oai/oai2.php"},"display":{"title":"Course of clinical response during primary systemic therapy with a dose-dense 4 cycles regime of adriamycin and docetaxel in patients with operable cancer of the breast","abstract":"Background:
In contrast to adjuvant chemotherapy (AST), primary systemic therapy (PST) allows the observation of clinical response under treatment, serving as an in-vivo chemosensitivity test. One possibility to assess tumor response is the consideration and analysis of clinical parameters such as palpation of the tumor size.
Up to now, little is known about typical courses of tumor shrinkage or growth under PST.
The results of this dissertation support decision making in case of insufficient clinical response after a specific number of cycles of PST.
Methods:
Data on tumor palpation during PST based on n=436 patients with operable breast cancer (T2-3, N0-2, M0) in the dose-dense doxorubicin plus docetaxel (ADoc) therapy arm of the Geparduo trial (2005), a prospective randomized controlled phase III trial, has been investigated.
Primary aim was to assess the predictive value of clinical response for the primary endpoint, pathologic complete response (pCR). Secondary aim was to analyze the individual courses of clinical response by palpation in detail.
Results:
Half of the patients with a clinical complete response (cCR) after the last cycle of PST (31.19%) achieved the cCR only during the last cycle of PST. The negative predictive value (NPV) of a cCR in breast for a pCR in breast and axillary lymph nodes was constantly high throughout the course of PST. The positive predictive value (PPV) at any time-point during PST for a pCR in breast and axillary lymph nodes was low. The comparatively highest PPV was reached after the 3rd cycle of PST (23.8%). It cannot be deduced from a cCR early during PST that there is no chance of the tumor size increasing again during the further course of PST. The majority of patients (68.12%) experienced a monotonous decrease in tumor size during PST.
Conclusions:
In case the clinical response by palpation is used as a guide for further treatment, the hypothesis can be generated that it is advisable to decide not until after the 3rd cycle of PST whether a patient is categorized as a responder or non-responder to PST.","abstract_html":"Background: <br>In contrast to adjuvant chemotherapy (AST), primary systemic therapy (PST) allows the observation of clinical response under treatment, serving as an in-vivo chemosensitivity test. One possibility to assess tumor response is the consideration and analysis of clinical parameters such as palpation of the tumor size. <br>Up to now, little is known about typical courses of tumor shrinkage or growth under PST. <br>The results of this dissertation support decision making in case of insufficient clinical response after a specific number of cycles of PST. <br>Methods: <br>Data on tumor palpation during PST based on n=436 patients with operable breast cancer (T2-3, N0-2, M0) in the dose-dense doxorubicin plus docetaxel (ADoc) therapy arm of the Geparduo trial (2005), a prospective randomized controlled phase III trial, has been investigated. <br>Primary aim was to assess the predictive value of clinical response for the primary endpoint, pathologic complete response (pCR). Secondary aim was to analyze the individual courses of clinical response by palpation in detail. <br>Results: <br>Half of the patients with a clinical complete response (cCR) after the last cycle of PST (31.19%) achieved the cCR only during the last cycle of PST. The negative predictive value (NPV) of a cCR in breast for a pCR in breast and axillary lymph nodes was constantly high throughout the course of PST. The positive predictive value (PPV) at any time-point during PST for a pCR in breast and axillary lymph nodes was low. The comparatively highest PPV was reached after the 3rd cycle of PST (23.8%). It cannot be deduced from a cCR early during PST that there is no chance of the tumor size increasing again during the further course of PST. The majority of patients (68.12%) experienced a monotonous decrease in tumor size during PST. <br>Conclusions: <br>In case the clinical response by palpation is used as a guide for further treatment, the hypothesis can be generated that it is advisable to decide not until after the 3rd cycle of PST whether a patient is categorized as a responder or non-responder to PST.","abstract_has_math":false,"creators":["Müller, Christine-Susanne"],"institution":null,"degree_name":null,"degree_level":null,"degree_discipline":null,"degree_department":null,"school":null,"contributors":["Schumacher, Martin"],"advisors":[],"committee_chairs":[],"committee_members":[],"year":null,"date_issued":"","date_published":null,"updated_at":"2026-07-24T02:22:40Z","subjects":["Mammakarzinom","primär systemische Therapie","neoadjuvante Therapie","klinische Response","Palpation","breast cancer","chemotherapy","primary systemic therapy","neoadjuvant therapy","clinical response"],"languages":[],"rights":[],"rights_urls":[],"identifier_entries":[]},"links":{"outbound_url":"https://freidok.uni-freiburg.de/data/2134","outbound_label":"Repository record","outbound_source":"source_url"},"metadata_groups":[{"id":"people","label":"People","entries":[{"key":"dc:contributor","label":"Contributor","values":["Schumacher, Martin"]},{"key":"dc:creator","label":"Author","values":["Müller, Christine-Susanne"]}]},{"id":"academic_context","label":"Academic Context","entries":[{"key":"dc:type","label":"Dc Type","values":["DoctoralThesis"]}]},{"id":"subjects_keywords","label":"Subjects and Keywords","entries":[{"key":"dc:subject","label":"Dc Subject","values":["Mammakarzinom","primär systemische Therapie","neoadjuvante Therapie","klinische Response","Palpation","breast cancer","chemotherapy","primary systemic therapy","neoadjuvant therapy","clinical response"]}]},{"id":"additional","label":"Additional Metadata","entries":[{"key":"dc:description.abstract","label":"Abstract","values":["Background:
In contrast to adjuvant chemotherapy (AST), primary systemic therapy (PST) allows the observation of clinical response under treatment, serving as an in-vivo chemosensitivity test. One possibility to assess tumor response is the consideration and analysis of clinical parameters such as palpation of the tumor size.
Up to now, little is known about typical courses of tumor shrinkage or growth under PST.
The results of this dissertation support decision making in case of insufficient clinical response after a specific number of cycles of PST.
Methods:
Data on tumor palpation during PST based on n=436 patients with operable breast cancer (T2-3, N0-2, M0) in the dose-dense doxorubicin plus docetaxel (ADoc) therapy arm of the Geparduo trial (2005), a prospective randomized controlled phase III trial, has been investigated.
Primary aim was to assess the predictive value of clinical response for the primary endpoint, pathologic complete response (pCR). Secondary aim was to analyze the individual courses of clinical response by palpation in detail.
Results:
Half of the patients with a clinical complete response (cCR) after the last cycle of PST (31.19%) achieved the cCR only during the last cycle of PST. The negative predictive value (NPV) of a cCR in breast for a pCR in breast and axillary lymph nodes was constantly high throughout the course of PST. The positive predictive value (PPV) at any time-point during PST for a pCR in breast and axillary lymph nodes was low. The comparatively highest PPV was reached after the 3rd cycle of PST (23.8%). It cannot be deduced from a cCR early during PST that there is no chance of the tumor size increasing again during the further course of PST. The majority of patients (68.12%) experienced a monotonous decrease in tumor size during PST.
Conclusions:
In case the clinical response by palpation is used as a guide for further treatment, the hypothesis can be generated that it is advisable to decide not until after the 3rd cycle of PST whether a patient is categorized as a responder or non-responder to PST.","Hintergrund:
Im Gegensatz zu adjuvanten Chemotherapie (AST) ermöglicht die primäre systemische Chemotherapie (PST) eine Verlaufsbeobachtung der klinischen Response. Damit dient die PST als In-Vivo-Chemo-Sensitivitätstest. Die Erhebung und Analyse des Parameters Palpation zur Messung der Tumorgröße ist eine Möglichkeit die klinische Tumorresponse zu beurteilen.
Die Ergebnisse dieser Arbeit beeinflussen die therapeutische Entscheidungsfindung im Falle einer unvollständigen klinischen Response nach einer bestimmten Zahl von PST Zyklen.
Methoden:
Diese Arbeit untersucht die palpatorische Tumorgröße während einer PST, basierend auf Daten von n=436 Patientinnen mit operablem Mammakarzinom (T2-3, N0-2, M0) aus dem dosis-dichten Doxorubicin plus Docetaxel (ADoc) Therapiearm der Geparduo Studie (2005), einer prospektiven, kontrollierten, randomisierten klinischen Phase III Studie.
Primäres Ziel dieser Dissertation war die Ermittlung des prädiktiven Wertes der klinischen Response für den primären Endpunkt, die vollständige pathologische Response (pCR). Sekundäres Ziel war die detaillierte Analyse der zeitlichen Verläufe der individuellen palpatorischen Tumorresponse.
Ergebnisse:
Die vollständige klinische Response (cCR) nach dem letzten PST Zyklus (31.19%) wurde von der Hälfte der Patientinnen erst während des letzten Zyklus erreicht. Der negative prädiktive Wert (NPV) einer cCR des Primärtumors für eine pCR des Primärtumors und der axillären Lymphknoten war im Verlauf der PST durchgehend hoch. Der positive prädiktive Wert (PPV) einer cCR des Primärtumors für eine pCR des Primärtumors und der axillären Lymphknoten war im Verlauf der PST durchgehend niedrig. Der vergleichsweise höchste PPV wurde nach dem 3. Zyklus PST erreicht (23.8%). Die Mehrzahl der Patientinnen (68.12%) zeigte eine monotone Abnahme der Tumorgröße unter PST.
Schlussfolgerungen:
Sofern die mit Hilfe des klinische Parameters Palpation erhobene Tumorresponse zur Entscheidungsfindung bezüglich der weiteren Therapie im Falle einer unvollständigen klinischen Response herangezogen wird, ist es empfehlenswert, nicht vor Abschluss des 3. Zyklus PST über eine Einstufung als Responder oder Non-Responder zu entscheiden."]},{"key":"dc:format.medium","label":"Dc Format Medium","values":["application/pdf"]},{"key":"dc:title","label":"Title","values":["Course of clinical response during primary systemic therapy with a dose-dense 4 cycles regime of adriamycin and docetaxel in patients with operable cancer of the breast","Zeitlicher Verlauf der klinischen Response während der Primären Systemischen Therapie des operablen Mamma-Karzinoms mit einem Dosis Dichten Therapieregime aus 4 Zyklen Adriamycin und Docetaxel"]}]}],"canonical_facts":{"dc:contributor":["Schumacher, Martin"],"dc:creator":["Müller, Christine-Susanne"],"dc:description.abstract":["Background:
In contrast to adjuvant chemotherapy (AST), primary systemic therapy (PST) allows the observation of clinical response under treatment, serving as an in-vivo chemosensitivity test. One possibility to assess tumor response is the consideration and analysis of clinical parameters such as palpation of the tumor size.
Up to now, little is known about typical courses of tumor shrinkage or growth under PST.
The results of this dissertation support decision making in case of insufficient clinical response after a specific number of cycles of PST.
Methods:
Data on tumor palpation during PST based on n=436 patients with operable breast cancer (T2-3, N0-2, M0) in the dose-dense doxorubicin plus docetaxel (ADoc) therapy arm of the Geparduo trial (2005), a prospective randomized controlled phase III trial, has been investigated.
Primary aim was to assess the predictive value of clinical response for the primary endpoint, pathologic complete response (pCR). Secondary aim was to analyze the individual courses of clinical response by palpation in detail.
Results:
Half of the patients with a clinical complete response (cCR) after the last cycle of PST (31.19%) achieved the cCR only during the last cycle of PST. The negative predictive value (NPV) of a cCR in breast for a pCR in breast and axillary lymph nodes was constantly high throughout the course of PST. The positive predictive value (PPV) at any time-point during PST for a pCR in breast and axillary lymph nodes was low. The comparatively highest PPV was reached after the 3rd cycle of PST (23.8%). It cannot be deduced from a cCR early during PST that there is no chance of the tumor size increasing again during the further course of PST. The majority of patients (68.12%) experienced a monotonous decrease in tumor size during PST.
Conclusions:
In case the clinical response by palpation is used as a guide for further treatment, the hypothesis can be generated that it is advisable to decide not until after the 3rd cycle of PST whether a patient is categorized as a responder or non-responder to PST.","Hintergrund:
Im Gegensatz zu adjuvanten Chemotherapie (AST) ermöglicht die primäre systemische Chemotherapie (PST) eine Verlaufsbeobachtung der klinischen Response. Damit dient die PST als In-Vivo-Chemo-Sensitivitätstest. Die Erhebung und Analyse des Parameters Palpation zur Messung der Tumorgröße ist eine Möglichkeit die klinische Tumorresponse zu beurteilen.
Die Ergebnisse dieser Arbeit beeinflussen die therapeutische Entscheidungsfindung im Falle einer unvollständigen klinischen Response nach einer bestimmten Zahl von PST Zyklen.
Methoden:
Diese Arbeit untersucht die palpatorische Tumorgröße während einer PST, basierend auf Daten von n=436 Patientinnen mit operablem Mammakarzinom (T2-3, N0-2, M0) aus dem dosis-dichten Doxorubicin plus Docetaxel (ADoc) Therapiearm der Geparduo Studie (2005), einer prospektiven, kontrollierten, randomisierten klinischen Phase III Studie.
Primäres Ziel dieser Dissertation war die Ermittlung des prädiktiven Wertes der klinischen Response für den primären Endpunkt, die vollständige pathologische Response (pCR). Sekundäres Ziel war die detaillierte Analyse der zeitlichen Verläufe der individuellen palpatorischen Tumorresponse.
Ergebnisse:
Die vollständige klinische Response (cCR) nach dem letzten PST Zyklus (31.19%) wurde von der Hälfte der Patientinnen erst während des letzten Zyklus erreicht. Der negative prädiktive Wert (NPV) einer cCR des Primärtumors für eine pCR des Primärtumors und der axillären Lymphknoten war im Verlauf der PST durchgehend hoch. Der positive prädiktive Wert (PPV) einer cCR des Primärtumors für eine pCR des Primärtumors und der axillären Lymphknoten war im Verlauf der PST durchgehend niedrig. Der vergleichsweise höchste PPV wurde nach dem 3. Zyklus PST erreicht (23.8%). Die Mehrzahl der Patientinnen (68.12%) zeigte eine monotone Abnahme der Tumorgröße unter PST.
Schlussfolgerungen:
Sofern die mit Hilfe des klinische Parameters Palpation erhobene Tumorresponse zur Entscheidungsfindung bezüglich der weiteren Therapie im Falle einer unvollständigen klinischen Response herangezogen wird, ist es empfehlenswert, nicht vor Abschluss des 3. Zyklus PST über eine Einstufung als Responder oder Non-Responder zu entscheiden."],"dc:format.medium":["application/pdf"],"dc:subject":["Mammakarzinom","primär systemische Therapie","neoadjuvante Therapie","klinische Response","Palpation","breast cancer","chemotherapy","primary systemic therapy","neoadjuvant therapy","clinical response"],"dc:title":["Course of clinical response during primary systemic therapy with a dose-dense 4 cycles regime of adriamycin and docetaxel in patients with operable cancer of the breast","Zeitlicher Verlauf der klinischen Response während der Primären Systemischen Therapie des operablen Mamma-Karzinoms mit einem Dosis Dichten Therapieregime aus 4 Zyklen Adriamycin und Docetaxel"],"dc:type":["DoctoralThesis"]},"updated_at":"2026-07-24T02:22:40Z"}