Universität zu Köln

Schmalenberg, Harald, Al-Batran, Salah-Eddin, Pauligk, Claudia, Zander, Thomas, Reichart, Alexander, Lindig, Udo, Kleiss, Mathias, Mueller, Lothar, Bolling, Claus, Seufferlein, Thomas, Reichardt, Peter, Kullmann, Frank, Eschenburg, Henning, Schmittel, Alexander, Egger, Matthias, Block, Andreas and Goetze, Thorsten Oliver (2018). CabaGast: multicentre, Phase II study with cabazitaxel in previously treated patients with advanced or metastatic adenocarcinoma of the esophagogastric junction and stomach. J. Cancer Res. Clin. Oncol., 144 (3). S. 559 - 570. NEW YORK: SPRINGER. ISSN 1432-1335

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Abstract

This is a single-arm study (NCT01956149) to determine the prolonged (4 months) disease control rate with cabazitaxel administered in second-(or later) setting for patients with advanced or metastatic adenocarcinoma of the esophagogastric junction (EGJ) and stomach. 65 patients with advanced EGJ and stomach cancer were treated with 20 mg/m(2) cabazitaxel every 3 weeks for a maximum of six cycles. The main objective of the study is a prolonged disease control rate (pDCR: CR, PR or SD lasting at least 4 months). Secondary outcome measures were overall survival, progression-free survival, response rate by subgroup (with vs without previous treatment with a taxane) and toxicity. Patients were assessed for tumor response every 6 weeks during therapy and during the follow-up (up to 12 months). 65 patients (median age: 63, range 31-86 years) were assigned to treatment. Median no. of prior therapies that had received prior taxane therapy was 2. 80%. Patients received a median of two cycles of cabazitaxel. Efficacy results are for the ITT population. The mDCR in n = 65 patients was 10.8% (95% CI 4.4-20.9%). There was a control of disease (CR + PR + SD) in n = 26 patients of n = 65, corresponding to a DCR of 40.0% (95% CI 28.0-52.9%). In patients without prior taxane use, it was 46.2% (95% CI 25.1-80.8%) and in patients with only one prior therapy, DCR was 50.0% (95% CI 31.3-68.7%). The median overall survival was 4.6 months (95% CI 3.16, 5.59) in the whole ITT population. In patients with only one prior therapy, median OS was 5.4 months (95% CI 2.60, 7.43) and in patients without taxane pretreatment, it was 6.4 months (95% CI 1.38, 14.17). The median progression-free survival time was 1.5 months (95% CI 1.32, 2.27) in the whole ITT population, 2.9 months (95% CI 0.72, 4.67) without prior taxane therapy and was 1.7 (95% CI 1.28, 3.35) months in patients with only one prior therapy median. Cabazitaxel is active in heavily pretreated patients with metastatic and advanced esophagogastric junction and gastric adenocarcinoma. Efficacy results in a classic second-line population are comparable to other second-line studies, therefore, under the limitations of this trial, (single arm, Phase II design) cabazitaxel might be an option especially in patients without prior taxane therapy, in second line and even further line therapy of metastatic and advanced esophagogastric junction and gastric adenocarcinoma.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Schmalenberg, Harald UNSPECIFIED UNSPECIFIED UNSPECIFIED Al-Batran, Salah-Eddin UNSPECIFIED UNSPECIFIED UNSPECIFIED Pauligk, Claudia UNSPECIFIED UNSPECIFIED UNSPECIFIED Zander, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Reichart, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindig, Udo UNSPECIFIED UNSPECIFIED UNSPECIFIED Kleiss, Mathias UNSPECIFIED UNSPECIFIED UNSPECIFIED Mueller, Lothar UNSPECIFIED UNSPECIFIED UNSPECIFIED Bolling, Claus UNSPECIFIED UNSPECIFIED UNSPECIFIED Seufferlein, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Reichardt, Peter UNSPECIFIED UNSPECIFIED UNSPECIFIED Kullmann, Frank UNSPECIFIED UNSPECIFIED UNSPECIFIED Eschenburg, Henning UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmittel, Alexander UNSPECIFIED UNSPECIFIED UNSPECIFIED Egger, Matthias UNSPECIFIED UNSPECIFIED UNSPECIFIED Block, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Goetze, Thorsten Oliver UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-195113
DOI:	10.1007/s00432-017-2565-5
Journal or Publication Title:	J. Cancer Res. Clin. Oncol.
Volume:	144
Number:	3
Page Range:	S. 559 - 570
Date:	2018
Publisher:	SPRINGER
Place of Publication:	NEW YORK
ISSN:	1432-1335
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ADVANCED GASTRIC-CANCER; ARBEITSGEMEINSCHAFT INTERNISTISCHE ONKOLOGIE; OPEN-LABEL; SALVAGE CHEMOTHERAPY; SUPPORTIVE CARE; COMBINATION CHEMOTHERAPY; 2ND-LINE TREATMENT; DOCETAXEL; TRIAL; PLUS Multiple languages Oncology Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/19511