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Title: 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

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 modulated WART 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,more » 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 after WART, 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 modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.« less

Authors:
 [1];  [2]; ;  [3]; ; ; ; ;  [1];  [2];  [4];  [5]; ;  [6]; ;  [1];  [2]
  1. National Center for Radiation Oncology, Heidelberg Institute for Radiation Oncology, Heidelberg (Germany)
  2. (Germany)
  3. Institute for Medical Biometry and Informatics, University of Heidelberg, Heidelberg (Germany)
  4. Department of Gynecology and Obstetrics, Center for Integrated Oncology (CIO) Köln/Bonn, Bonn (Germany)
  5. Department of Radiation Oncology, University Hospital Bonn, Bonn (Germany)
  6. Department of Gynecology and Obstetrics, University Hospital Heidelberg, Heidelberg (Germany)
Publication Date:
OSTI Identifier:
22723044
Resource Type:
Journal Article
Journal Name:
International Journal of Radiation Oncology, Biology and Physics
Additional Journal Information:
Journal Volume: 99; Journal Issue: 4; Other Information: Copyright (c) 2017 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); Journal ID: ISSN 0360-3016
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CHEMOTHERAPY; GY RANGE; GYNECOLOGY; NEOPLASMS; PATIENTS; RADIATION DOSES; RADIATION HAZARDS; RADIOTHERAPY; TOXICITY

Citation Formats

Arians, Nathalie, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Kieser, Meinhard, Benner, Laura, Rochet, Nathalie, Katayama, Sonja, Sterzing, Florian, Herfarth, Klaus, Schubert, Kai, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Schröder, Lars, Leitzen, Christina, Schneeweiss, Andreas, Sohn, Christof, Debus, Jürgen, Lindel, Katja, and Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg. 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. United States: N. p., 2017. Web. doi:10.1016/J.IJROBP.2017.06.2465.
Arians, Nathalie, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Kieser, Meinhard, Benner, Laura, Rochet, Nathalie, Katayama, Sonja, Sterzing, Florian, Herfarth, Klaus, Schubert, Kai, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Schröder, Lars, Leitzen, Christina, Schneeweiss, Andreas, Sohn, Christof, Debus, Jürgen, Lindel, Katja, & Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg. 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. United States. doi:10.1016/J.IJROBP.2017.06.2465.
Arians, Nathalie, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Kieser, Meinhard, Benner, Laura, Rochet, Nathalie, Katayama, Sonja, Sterzing, Florian, Herfarth, Klaus, Schubert, Kai, Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg, Schröder, Lars, Leitzen, Christina, Schneeweiss, Andreas, Sohn, Christof, Debus, Jürgen, Lindel, Katja, and Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg. Wed . "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". United States. doi:10.1016/J.IJROBP.2017.06.2465.
@article{osti_22723044,
title = {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},
author = {Arians, Nathalie and Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg and Kieser, Meinhard and Benner, Laura and Rochet, Nathalie and Katayama, Sonja and Sterzing, Florian and Herfarth, Klaus and Schubert, Kai and Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg and Schröder, Lars and Leitzen, Christina and Schneeweiss, Andreas and Sohn, Christof and Debus, Jürgen and Lindel, Katja and Department of Radiation Oncology, University Hospital Heidelberg, Heidelberg},
abstractNote = {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 modulated WART 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 after WART, 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 modulated WART could offer a new therapeutic option for consolidation treatment of patients with advanced ovarian cancer.},
doi = {10.1016/J.IJROBP.2017.06.2465},
journal = {International Journal of Radiation Oncology, Biology and Physics},
issn = {0360-3016},
number = 4,
volume = 99,
place = {United States},
year = {2017},
month = {11}
}