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01-12-2015 | Original Article

Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: a multicenter randomized phase II study (APOLLO)

Authors: Taishi Hata, Michitaka Honda, Michiya Kobayashi, Akihiro Toyokawa, Masahiro Tsuda, Yukihiko Tokunaga, Kozo Takase, Masakazu Miyake, Satoshi Morita, Naoki Nagata, Junichi Sakamoto, Masahiko Gosho, Hideyuki Mishima

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2015

Abstract

Purpose

The aim of this phase II clinical trial was to evaluate the preventive effect of dexamethasone mixing injection for venous pain in patients with colorectal cancer during chemotherapy.

Materials and methods

Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² (or S-1 40–60 mg/m²) twice daily on days 1 through 14 of every 3 weeks with or without dexamethasone 1.65 mg at the infusion on day 1.

Results

A total of 53 patients were enrolled. The analysis population consisted of 49 patients (arm A, with dexamethasone N = 24; arm B, without dexamethasone N = 25). The incidence of venous pain ≥grade 2 based on the CTCAE version 4.0 was 33.3 % in arm A and 56.0 % in arm B (relative risk 0.60; 95 % CI 0.31–1.16). The incidences based on the verbal rating scale for arms A and B were 50.0 and 64.0 %, respectively (relative risk 0.78; 95 % CI 0.48–1.28).

Conclusion

The primary endpoint was not met in this preliminary study.

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Title: Effect of pH adjustment by mixing steroid for venous pain in colorectal cancer patients receiving oxaliplatin through peripheral vein: a multicenter randomized phase II study (APOLLO)
Authors: Taishi Hata
Michitaka Honda
Michiya Kobayashi
Akihiro Toyokawa
Masahiro Tsuda
Yukihiko Tokunaga
Kozo Takase
Masakazu Miyake
Satoshi Morita
Naoki Nagata
Junichi Sakamoto
Masahiko Gosho
Hideyuki Mishima
Publication date: 01-12-2015
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 6/2015
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-015-2888-3

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Abstract

Purpose

Materials and methods

Results

Conclusion

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