Randomized phase II trial of TEGAFIRI (tegafur/uracil, oral leucovorin, irinotecan) compared with FOLFIRI (folinic acid, 5‐fluorouracil, irinotecan) in patients with unresectable/recurrent colorectal cancer

Irinotecan‐based chemotherapy with bevacizumab is one of the first‐line standard therapies for metastatic colorectal cancer (mCRC). TEGAFIRI (UFT/LV + irinotecan) is an irinotecan‐based chemotherapy regimen. Currently, few clinical data regarding TEGAFIRI are available. This study evaluated the effi...

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Bibliographic Details
Published in:International journal of cancer 2016-08, Vol.139 (4), p.946-954
Main Authors: Shigeta, Kohei, Hasegawa, Hirotoshi, Okabayashi, Koji, Tsuruta, Masashi, Ishii, Yoshiyuki, Endo, Takashi, Ochiai, Hiroki, Kondo, Takayuki, Kitagawa, Yuko
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Camptothecin - adverse effects
Camptothecin - analogs & derivatives
Camptothecin - therapeutic use
Cancer
Chemotherapy
Clinical trials
Colorectal cancer
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - mortality
Colorectal Neoplasms - pathology
Disease Progression
Female
Fluorouracil - administration & dosage
Fluorouracil - adverse effects
Fluorouracil - therapeutic use
Humans
Irinotecan
Kaplan-Meier Estimate
Leucovorin - administration & dosage
Leucovorin - adverse effects
Leucovorin - therapeutic use
Male
Medical research
Middle Aged
Neoplasm Metastasis
Neoplasm Staging
Odds Ratio
Oncology
Oral 5‐FU
Proportional Hazards Models
randomized phase II trial
Recurrence
Tegafur - administration & dosage
Treatment Failure
Treatment Outcome
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Summary:Irinotecan‐based chemotherapy with bevacizumab is one of the first‐line standard therapies for metastatic colorectal cancer (mCRC). TEGAFIRI (UFT/LV + irinotecan) is an irinotecan‐based chemotherapy regimen. Currently, few clinical data regarding TEGAFIRI are available. This study evaluated the efficacy and safety of TEGAFIRI in Japanese patients with mCRC. This is a multicenter, randomized, phase II study. The major inclusion criteria were previously untreated patients with mCRC (age: 20–75 years, Eastern Cooperative Oncology Group performance status: 0–1). Eligible patients were randomly assigned (1:1) to receive either FOLFIRI ± bevacizumab or TEGAFIRI ± bevacizumab. The primary endpoint was progression‐free survival (PFS). The secondary endpoints were response rate, overall survival, dose intensity and toxicity. From November 2007 to October 2011, 36 and 35 patients assigned to the FOLFIRI and TEGAFIRI groups were included in the primary analysis. No significant difference in PFS was observed between the groups {median PFS: TEGAFIRI 9.9 months [95% confidence interval (CI), 6.5–14.7], FOLFIRI 10.6 months [95% CI, 7.7–16.5]; Hazard ratio, 0.98, 95% CI, 0.57–1.66, p = 0.930}. The response rates in the FOLFIRI and TEGAFIRI groups were 56% and 66%, respectively. Relative dose intensity was similar between the groups. The most common Grade 3/4 adverse event was diarrhea (26%) in TEGAFIRI group and neutropenia (39%) in the FOLFIRI group. The results of the present study indicate that TEGAFIRI ± bevacizumab is an effective and tolerable first‐line treatment regimen for mCRC. What's new? This study was the first to evaluate the safety and efficacy of a new combination therapy called TEGAFIRI. This therapy combines one of the most common chemotherapy agents in Europe and Japan, the oral fluoropyramidine UFT/LV, and combines it with irinotecan. They compared TEGAFIRI with the combination of 5‐FU/LV and irinotecan, called FOLFIRI, in patients with metastatic colorectal cancer who had not been treated before. They found no difference in progression‐free survival between patients treated with either therapy. Further, they showed that the side effects of TEGAFIRI were no worse than those from FOLFIRI.
ISSN:0020-7136
1097-0215
DOI:10.1002/ijc.30127