In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 4_suppl ( 2012-02-01), p. 567-567
Abstract:
567 Background: Oxaliplatin-induced peripheral neuropathy (OPN) continues to be a substantial problem for many cancer patients. In light of the promising data on TJ-107 from a previous pilot study (ASCO-GI, 2009), the present clinical trial was conducted to evaluate its efficacy for the prevention of OPN. To determine whether TJ-107 given as an adjuvant therapy effectively prevents oxaliplatin-induced peripheral neuropathy Methods: A phase II, randomized, double-blind, placebo-controlled trial was conducted in colorectal cancer patients undergoing therapy with infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX). TJ-107 (7.5g) or matching placebo was orally administered three times daily. The primary endpoint was the incidence of grade 2 or greater OPN according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; version 3) criteria after 8 cycles of chemotherapy. Patient-reported neurotoxicity symptoms were also assessed using the neurotoxicity subscale of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group–Neurotoxicity (FACT/GOG-Ntx, version 4). Secondary endpoints included the incidence of all grades of OPN after each cycle and chemotherapy response rates. Results: A total of 93 patients were enrolled from May 1, 2009 to March 31, 2010 at 37 participating GONE trial institutions in Japan. Eighty-nine evaluable patients were randomized to either the TJ-107 group (n = 44) or the placebo group (n = 45). Placebo patients showed a significantly higher rate of neurotoxicity than that of TJ-107 patients (p 〈 0.001), with the median difference in NTX-12 score of 3 and 3.5 at the 8th week and 26th week, respectively. There were no significant between-group differences in response to chemotherapy (55.5% in TJ-107, 39.1% in placebo). In addition, TJ-107 treatment was well tolerated overall. Conclusions: TJ-107 shows promise in reducing the incidence of OPN. Further investigation in a larger phase III trial is necessary before any conclusions can be drawn. [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.4_suppl.567
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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