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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
Author(s) -
Shigeta Kohei,
Hasegawa Hirotoshi,
Okabayashi Koji,
Tsuruta Masashi,
Ishii Yoshiyuki,
Endo Takashi,
Ochiai Hiroki,
Kondo Takayuki,
Kitagawa Yuko
Publication year - 2016
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.30127
Subject(s) - irinotecan , medicine , folfiri , bevacizumab , folinic acid , clinical endpoint , hazard ratio , regimen , colorectal cancer , neutropenia , oncology , fluorouracil , progression free survival , gastroenterology , surgery , randomized controlled trial , chemotherapy , confidence interval , 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 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.