Abstract 1064
Background
OIPN is a common adverse event leading to early discontinuation of oxaliplatin. This was the first exploratory trial for proof of concept of whether ART-123 prevented OIPN.
Methods
Patients with pStage II or III colon cancer who planned adjuvant chemotherapy with mFOLFOX6 were randomly allocated to the following 3 groups in a double-blind manner; placebo group (placebo saline on day 1-3), 1-day ART-123 group (ART-123 380U/kg on day 1 and placebo on day 2-3), and 3-day ART-123 group (ART-123 on day 1-3). Study drug was given intravenously for 30 min immediately before oxaliplatin. The severity of OIPN was evaluated using NCI-CTCAE by physicians and FACT/GOG-NTX-12 (score range 0-48, lower values more severe) by patients. NCI-CTCAE was assessed at baseline, day 1-3 of every cycle, and 14 and 42 days after the last treatment with oxaliplatin. FACT/GOG-NTX-12 was assessed at baseline, day 1 and 8 of every cycle, and 14 and 42 days after the last treatment with oxaliplatin.
Results
Eighty patients were randomized, and 79 (28 placebo, 27 1-day ART-123, and 24 3-day ART-123) patients were analyzed. Both 1-day and 3-day ART-123 tended to reduce the cumulative incidence of NCI-CTCAE grade 2 or higher OIPN and prevent worsening of FACT/GOG-NTX-12 scores, compared to placebo (Table). No substantial differences in other adverse events were noted.Table: 599P
| Placebo (n = 28) | 1-day ART-123 (n = 27) | 3-day ART-123 (n = 24) | ||
|---|---|---|---|---|
| Sensory neuropathy NCI-CTCAE (% grade 2 or higher) | Baseline | 0% | 0% | 0% |
| at 6th cycle | 39% | 19% | 17% | |
| at 12th cycle | 64% | 41% | 46% | |
| Overall scores in FACT/GOG-NTX-12 (the least square mean (SE)) | Baseline | 46 (0.4) | 47 (0.5) | 46 (0.5) |
| at 6th cycle | 35 (1.6) | 39 (1.6) | 38 (1.6) | |
| at 12th cycle | 29 (1.9) | 36 (1.9) | 32 (2.0) | |
| Median total dose of oxaliplatin (mg/m2)(range) | 819 (84-1000) | 849 (331-1037) | 921 (255-1012) |
Conclusions
ART-123 showed promising efficacy in delaying and reducing OIPN without serious safety concerns.
Clinical trial identification
NCT02792842.
Legal entity responsible for the study
Asahi Kasei Pharma Corporation.
Funding
Asahi Kasei Pharma Corporation.
Editorial Acknowledgement
Disclosure
G. Kusakawa: Employee, Stockholder: Asahi Kasei Pharma;. T. Sakai, Y. Uchida, M. Takamoto, S. Asami: Employee: Asahi Kasei Pharma. M. Ando, Y. Saito, I. Hyodo: Advisory board: Asahi Kasei Pharma. All other authors have declared no conflicts of interest.
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