Abstract | PURPOSE: PATIENTS AND METHODS: RESULTS: Fifty-nine patients treated with concomitant radiochemotherapy with cisplatin were included in this study. Thirty-one patients received the aprepitant regimen and 29 the control regimen. The overall complete response rates for cycles 1 and 2 were 75.9% and 64.5% for the aprepitant group and 60.7% and 54.2% for the control group, respectively. Although a 15.2% absolute difference was reached in cycle 1, a statistical significance was not detected (P=.22). Furthermore maximum nausea was 1.58 ± 1.91 in the control group and 0.73 ± 1.79 in the aprepitant group (P=.084); for the head-and-neck subset, 2.23 ± 2.13 in the control group and 0.64 ± 1.77 in the aprepitant group, respectively (P=.03). CONCLUSION: This is the first study of an NK1-RA-containing antiemetic prophylaxis regimen in patients receiving concomitant radiochemotherapy. Although the primary endpoint was not obtained, the absolute difference of 10% in efficacy was reached, which is defined as clinically meaningful for patients by international guidelines groups. Randomized phase 3 studies are necessary to further define the potential role of an NK1-RA in this setting.
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Authors | Franziska Jahn, Anica Riesner, Patrick Jahn, Frank Sieker, Dirk Vordermark, Karin Jordan |
Journal | International journal of radiation oncology, biology, physics
(Int J Radiat Oncol Biol Phys)
Vol. 92
Issue 5
Pg. 1101-1107
(Aug 01 2015)
ISSN: 1879-355X [Electronic] United States |
PMID | 26059352
(Publication Type: Clinical Trial, Journal Article, Observational Study)
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Copyright | Copyright © 2015 Elsevier Inc. All rights reserved. |
Chemical References |
- Antiemetics
- Antineoplastic Agents
- Indoles
- Morpholines
- Neurokinin-1 Receptor Antagonists
- Serotonin Antagonists
- Aprepitant
- Ondansetron
- Tropisetron
- Dexamethasone
- Cisplatin
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Topics |
- Antiemetics
(therapeutic use)
- Antineoplastic Agents
(administration & dosage, adverse effects)
- Aprepitant
- Chemoradiotherapy
(adverse effects)
- Cisplatin
(administration & dosage, adverse effects)
- Dexamethasone
(therapeutic use)
- Drug Therapy, Combination
(methods)
- Esophageal Neoplasms
(therapy)
- Female
- Head and Neck Neoplasms
(therapy)
- Humans
- Indoles
(therapeutic use)
- Lung Neoplasms
(therapy)
- Male
- Middle Aged
- Morpholines
(therapeutic use)
- Nausea
(etiology, prevention & control)
- Neurokinin-1 Receptor Antagonists
(therapeutic use)
- Ondansetron
(therapeutic use)
- Prospective Studies
- Serotonin Antagonists
(therapeutic use)
- Tropisetron
- Uterine Cervical Neoplasms
(therapy)
- Vomiting
(etiology, prevention & control)
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