Universität zu Köln

Arians, Nathalie ORCID: 0000-0002-2389-5404, Kieser, Meinhard, Benner, Laura, Rochet, Nathalie, Katayama, Sonja, Sterzing, Florian, Herfarth, Klaus, Schubert, Kai, Schroeder, Lars, Leitzen, Christina, Schneeweiss, Andreas, Sohn, Christof, Debus, Juergen and Lindel, Katja (2017). Adjuvant Intensity Modulated Whole-Abdominal Radiation Therapy for High-Risk Patients With Ovarian Cancer (International Federation of Gynecology and Obstetrics Stage III): First Results of a Prospective Phase 2 Study. Int. J. Radiat. Oncol. Biol. Phys., 99 (4). S. 912 - 921. NEW YORK: ELSEVIER SCIENCE INC. ISSN 1879-355X

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Abstract

Purpose: To assess treatment tolerance and toxicity rates of consolidative whole-abdominal radiation therapy (WART) following cytoreductive surgery and carboplatin/ paclitaxel chemotherapy in high-risk patients with advanced ovarian cancer (International Federation of Gynecology and Obstetrics stage III) using intensity modulated radiation therapy. Methods and Materials: The OVAR-IMRT-02 study is a multicenter, single-arm, phase 2 trial. Twenty patients with optimally debulked ovarian cancer (International Federation of Gynecology and Obstetrics stage III) with complete remission after chemotherapy were treated with intensity modulated WART as a consolidation therapy. A total dose of 30 Gy in 20 fractions of 1.5 Gy was applied to the entire peritoneal cavity. The primary endpoint was treatment tolerability, defined as lack of any Common Terminology Criteria for Adverse Events grade 4 toxicity within 10 weeks after start of treatment; secondary objectives were acute and chronic toxicity, quality of life, rates of therapy disruption and abortion, and progression-free and overall survival. Results: Intensity modulatedWART resulted in excellent coverage of the whole peritoneal cavity, with effective sparing of all organs at risk. The primary analysis included all 20 enrolled patients, of whom 19 did not experience Common Terminology Criteria for Adverse Events grade 4 toxicity. Only 1 patient experienced acute grade 4 hematologic toxicity. Thus, the tolerability rate of intensity modulated WART was significantly higher than 70%. No gastrointestinal acute toxicities higher than grade 2 have been observed. During WART, mean global health status decreased by 18.1 points (95% confidence interval 7.1, 29.0). Six weeks afterWART, global health status had already increased, with a mean score difference of 4.6 (95% confidence interval - 11.1, 20.4) compared with baseline. Similar characteristics were observed for all function scale scores. Conclusion: Intensity modulated WART after aggressive surgery and carboplatin/paclitaxel chemotherapy is associated with an acceptable risk of acute toxicity and a treatment tolerability rate significantly higher than 70%. Together with our knowledge about clinical feasibility, meaning excellent coverage of the planning target volume and effective sparing of organs at risk, intensity modulatedWART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer. (C) 2017 Elsevier Inc. All rights reserved.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Arians, Nathalie UNSPECIFIED orcid.org/0000-0002-2389-5404 UNSPECIFIED Kieser, Meinhard UNSPECIFIED UNSPECIFIED UNSPECIFIED Benner, Laura UNSPECIFIED UNSPECIFIED UNSPECIFIED Rochet, Nathalie UNSPECIFIED UNSPECIFIED UNSPECIFIED Katayama, Sonja UNSPECIFIED UNSPECIFIED UNSPECIFIED Sterzing, Florian UNSPECIFIED UNSPECIFIED UNSPECIFIED Herfarth, Klaus UNSPECIFIED UNSPECIFIED UNSPECIFIED Schubert, Kai UNSPECIFIED UNSPECIFIED UNSPECIFIED Schroeder, Lars UNSPECIFIED UNSPECIFIED UNSPECIFIED Leitzen, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Schneeweiss, Andreas UNSPECIFIED UNSPECIFIED UNSPECIFIED Sohn, Christof UNSPECIFIED UNSPECIFIED UNSPECIFIED Debus, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Lindel, Katja UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-211203
DOI:	10.1016/j.ijrobp.2017.06.2465
Journal or Publication Title:	Int. J. Radiat. Oncol. Biol. Phys.
Volume:	99
Number:	4
Page Range:	S. 912 - 921
Date:	2017
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	1879-355X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language LONG-TERM SURVIVAL; ABDOMINOPELVIC RADIOTHERAPY; CONSOLIDATION RADIOTHERAPY; NEOADJUVANT CHEMOTHERAPY; CONCURRENT CHEMOTHERAPY; PELVIC RADIOTHERAPY; PRIMARY SURGERY; CLINICAL-TRIAL; ONCOLOGY-GROUP; PACLITAXEL Multiple languages Oncology; Radiology, Nuclear Medicine & Medical Imaging Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/21120