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Found 1 Presentation For Request "460P"
460P - Update analysis of phase II study of oxaliplatin based regimen in relapsed colorectal cancer patients treated with oxaliplatin based adjuvant chemotherapy: INSPIRE study
- Hironaga Satake (Hirakata, Hyogo, Japan)
Abstract
Background
INSPIRE study is a multicenter prospective phase II trial to evaluate the efficacy and safety of 1st line chemotherapy with re-introduction of oxaliplatin (Ox) more than 6 months after adjuvant chemotherapy including Ox. The initial report on progression free survival (PFS) has already been reported [Kotaka et al., 2020 WCGC], but this time we will report an update analysis on efficacy and allergic reactions due to Ox re-introduction.
Methods
This study was designed to evaluate efficacy and safety of treatment of physician choice for patients (pts) with stage II / III colorectal cancer (CRC) with neuropathies less than grade 1 who relapsed more than 6 months after adjuvant chemotherapy including Ox. Eligible pts were treated with Ox-containing regimens (FOLFOX, CAPOX, SOX) plus molecular targeted drugs. Primary endpoint was PFS and secondary endpoints were overall survival (OS), response rate (RR) and toxicity.
Results
From Sep 2013 to May 2019, a total of 50 pts with relapsed CRC were enrolled. Number of pts whose subgroup of Ox-free interval (6-12 month/ 12-24 month/ ≥24 months) was 15 pts, 14 pts and 21 pts, respectively. Median Ox-free interval was 20.8 months (range, 6.71 to 56.3). Of those 50 pts, 44 pts received low-dose dexamethasone (DEX) (≤ 8mg) and 6 pts received high-dose DEX (> 8mg) as supportive therapy at the time of the first re-introduction of Ox. With this update analysis, RR was 56.0% (95% CI, 42.3% – 68.8%), median PFS was 11.5 months (95% CI, 8.3-16.0) and median OS was 45.4 months (95% CI, 37.4-NA), respectively. The reasons for discontinuation of treatment was mainly due to disease progression (n=26, 54.2%). Allergic reactions to Ox were observed in grade 0 (n=39), grade 1 (n=1), grade 2 (n= 7), grade 3 (n=3) and grade 4 (n=0), respectively. Patients who received high-dose DEX as supportive therapy upon re-introduction of Ox had no allergic reaction.
Conclusions
First line chemotherapy with re-introduction of Ox more than 6 months after adjuvant chemotherapy including Ox could be expected survival for relapsed CRC pts. High-dose DEX may be considered for allergy prevention as supportive therapy during Ox re-introduction.
Clinical trial identification
jRCTs041180118, UMIN000011348.
Legal entity responsible for the study
Epidemiological and Clinical research Information Network (ECRIN).
Funding
Yakult Honsha Co., Ltd.
Disclosure
H. Satake: Honoraria (self): Yakult Honsha; Honoraria (self), Research grant/Funding (self): Taiho pharmaceutical; Honoraria (self): Chugai pharmaceutical; Honoraria (self): Merck biopharma; Honoraria (self), Research grant/Funding (self): Takeda pharmaceutical. M. Kotaka: Honoraria (self): Yakult Honsha. J. Sakamoto: Honoraria (self): Chugai pharmaceutical; Honoraria (self): Nihon Kayaku Co.Ltd.; Advisory/Consultancy: Takeda. K. Oba: Honoraria (self): Chugai Pharmaceutical Co, Ltd.; Honoraria (self): Daiichi Sankyo Co., Ltd.; Honoraria (self): Eisai Co., Ltd; Honoraria (self): Takeda Pharmaceutical Co., Ltd.; Honoraria (self): Ono pharmaceutical Co., Ltd.. All other authors have declared no conflicts of interest.