title: Clinical response by palpation during primary systemic therapy with four dose-dense cycles doxorubicin and docetaxel in patients with operable breast cancer: further results from a randomised controlled trial.
abstract: Primary systemic therapy (PST) allows the observation of tumour response under treatment, but little is known regarding the typical course of clinical response during such therapy. The aim of this study is to support decision making in case of insufficient clinical response. Tumour response was assessed by palpation at different times in 436 patients with operable breast cancer from the dose-dense biweekly therapy arm of the GEPARDUO phase III trial. The predictive value of clinical response for pathologic complete response (pCR), prognostic models to assess the prognosis and individual courses of clinical response were investigated. Sensitivity and positive predictive value were low, but comparatively highest after the 3rd cycle. The predictive value of clinical response by palpation for pCR was subsequently limited. The majority of patients (68.1%) experienced a consistent decrease in tumour size during PST. The results indicate that decisions about further treatment should take place at the earliest after the 3rd cycle or 6 weeks of dose-dense PST.
authors.affiliation: Center of Clinical Trials, University Medical Center Freiburg, Elsaesser Strasse 2, 79110 Freiburg, Germany. christine.mueller@uniklinik-freiburg.de
authors.forename: Christine
authors.initials: C
authors.lastname: Müller
authors.forename: Angelika
authors.initials: A
authors.lastname: Caputo
authors.forename: Martin
authors.initials: M
authors.lastname: Schumacher
authors.forename: Günter
authors.initials: G
authors.lastname: Raab
authors.forename: Martin
authors.initials: M
authors.lastname: Schütte
authors.forename: Jörn
authors.initials: J
authors.lastname: Hilfrich
authors.forename: Manfred
authors.initials: M
authors.lastname: Kaufmann
authors.forename: Gunter
authors.initials: G
authors.lastname: von Minckwitz
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D010173:Palpation; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin