Raltitrexed (Tomudex®) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1)

被引：40

作者：

Popov, Ivan ^{[1
]}

Carrato, Alfredo ^{[2
]}

Sobrero, Alberto ^{[3
]}

Vincent, Mark ^{[4
]}

Kerr, David ^{[5
]}

Labianca, Roberto ^{[6
]}

Bianco, Angelo Raffaele ^{[7
]}

El-Serafi, Mostafa ^{[8
]}

Bedenne, Laurent ^{[9
]}

Paillot, Bernard ^{[10
]}

Mini, Enrico ^{[11
]}

Sanches, Evaristo ^{[12
]}

Welch, John ^{[13
]}

Collette, Laurence ^{[13
]}

Praet, Michel ^{[13
,14
]}

Wils, Jacques ^{[15
]}

机构：

[1] Inst Oncol & Radiol, Clin Med Oncol, Belgrade 11000, Serbia

[2] Hosp Univ Elche, Elche, Spain

[3] Osped San Martino Genova, Clin Univ Convenz, Genoa, Italy

[4] London Reg Canc Ctr, London, ON N6A 4L6, Canada

[5] Radcliffe Infirm, Oxford OX2 6HE, England

[6] Osped Riuniti Bergamo, Dept Med Oncol, I-24100 Bergamo, Italy

[7] Univ Fed Ii Med Sch, Naples, Italy

[8] Natl Canc Inst, Dept Med Oncol, Cairo, Egypt

[9] Federat Francophone Cancerol Digest, Dijon, France

[10] Hop Charles Nicolle, Rouen, France

[11] Univ Florence, Policlin Careggi, Dipartimento Farmacol, Florence, Italy

[12] Ctr Porto, Inst Portugues Oncol, Oporto, Portugal

[13] EORTC Headquarters, Brussels, Belgium

[14] PETACC Coordinating Unit, Brussels, Belgium

[15] Laurentius Zienkenhuis Roermond, Roermond, Netherlands

来源：

EUROPEAN JOURNAL OF CANCER | 2008年 / 44卷 / 15期

关键词：

Adjuvant treatment; Colon cancer; Raltitrexed; PETACC-1; Randomised clinical trial;

D O I：

10.1016/j.ejca.2008.07.002

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Objectives: PETACC-1 assessed if raltitrexed is non-inferior to 5-fluorouracil and leucovorin for relapse-free survival (RFS) and overall survival (OS) in adjuvant stage III colon cancer. Methods: Non-inferiority required both HR for RFS and OS < 1.25 at 1-sided alpha = 0.05. Patients (1921) were randomised to six cycles of 5-FU/LV (n = 969) or eight cycles of raltitrexed (n = 952). We report the final results in 993 eligible patients who started and completed the allocated treatment (489 5-FU/LV and n = 504 Raltitrexed) of whom respectively 146 and 148 died, respectively. Results: The trial closed prematurely when 17 (1.9%) raltitrexed-related deaths were reported. Haematological and gastrointestinal toxicities were more frequent with 5-FU/LV, liver toxicities with raltitrexed. Raltitrexed was stopped for toxicity in 13.2% and 5-FU/LV in 8.5%. Sixty-day mortality was 9% versus 7%. With 4.1 years median follow-up, the HR for RFS was 1.16 (90% CI 0.99-1.37) and that for OS was 1.01 (90% CI 0.84-1.23). Conclusion: The trial failed to demonstrate non-inferiority of raltitrexed.

引用

页码：2204 / 2211

页数：8

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