title: Impact of the first tumor response at eight weeks on overall survival in metastatic breast cancer patients treated with first-line combination chemotherapy.
abstract: The aim of this was to determine whether the change of size observed at the first response evaluation after initiation of first-line combination chemotherapy correlates with overall survival (OS) in patients with metastatic breast cancer (MBC). The change in size of tumors derived from measurements according to Response Evaluation Criteria In Solid Tumors (RECIST) at the first evaluation on computed tomography (CT) was obtained from a multicenter, randomized phase III trial ("TEX trial," n = 287) comparing treatment with a combination of epirubicin and paclitaxel alone or with capecitabine (TEX). Cox regression and Kaplan-Meier analyses were performed to evaluate the correlations between the first change in tumor size, response according to RECIST and OS. Data from CT evaluations of 233 patients were available. Appearance of new lesions or progression of non-target lesions (new/non-target) indicated short OS by univariable regression analysis (HR 3.76, 95 % CI 1.90-7.42, p < 0.001). A decrease by >30 % at this early time point was prognostic favorable (HR 0.69, 95 % CI 0.49-0.98, p = 0.04) and not significantly less than the best overall response according to RECIST. After adjustment for previous adjuvant treatment and the treatment given within the frame of the randomized trial, OS was still significantly shorter in patients with new/non-target lesions after a median 8 weeks of treatment (HR 4.41, 95 % CI 2.74-7.11, p < 0.001). Disease progression at the first evaluation correlates with OS in patients with MBC treated with first-line combination chemotherapy. The main reason for early disease progression was the appearance of new lesions or progression of non-target lesions. These patients had poor OS even though more lines of treatment were available. Thus, these factors should be focused on in the response evaluations besides tumor size changes.
authors: Department of Diagnostic Radiology, Karolinska University Hospital and Karolinska Institutet, 171-76 Stockholm, Sweden. Chikako.Suzuki@ki.se
authors: Chikako
authors: C
authors: Suzuki
authors: Lennart
authors: L
authors: Blomqvist
authors: Thomas
authors: T
authors: Hatschek
authors: Lena
authors: L
authors: Carlsson
authors: Zakaria
authors: Z
authors: Einbeigi
authors: Barbro
authors: B
authors: Linderholm
authors: Birgitta
authors: B
authors: Lindh
authors: Niklas
authors: N
authors: Loman
authors: Martin
authors: M
authors: Malmberg
authors: Samuel
authors: S
authors: Rotstein
authors: Martin
authors: M
authors: Söderberg
authors: Marie
authors: M
authors: Sundqvist
authors: Thomas M
authors: TM
authors: Walz
authors: Gunnar
authors: G
authors: Aström
authors: Hirofumi
authors: H
authors: Fujii
authors: Hans
authors: H
authors: Jacobsson
authors: Bengt
authors: B
authors: Glimelius
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D016016:Proportional Hazards Models; D016896:Treatment Outcome
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil