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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.

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MATERIALS AND METHODS: Patients were randomized to receive a 2-h intravenous infusion of oxaliplatin 130 mg/m(2) on day 1 followed by capecitabine 1000 mg/m(2) (or S-1 40-60 mg/m(2)) 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.

Reference:

Hata, T., Honda, M., Kobayashi, M., Toyokawa, A., Tsuda, M., Tokunaga, Y., Takase, K., Miyake, M., Morita, S., Nagata, N., Sakamoto, J., Gosho, M. and Mishima, H. (2015) 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). Cancer Chemotherapy and Pharmacology. 76(6), p.1209-15.

DOI: 10.1007/s00280-015-2888-3.

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