A randomized phase II study to compare oxaliplatin plus 5-fluorouracil and leucovorin (FOLFOX4) versus oxaliplatin plus raltitrexed (TOMOX) as first-line chemotherapy for advanced colorectal cancer

Clinical and Translational Oncology

Volumn 14, Issue 8, 2012, Pages 606-612

  Gravalos, Cristina ^a   Salut, Antonieta ^b   García Girón, Carlos ^c   García Carbonero, Rocío ^d   León, Ana Isabel ^e   Sevilla, Isabel ^f   Maurel, Joan ^g   Esteban, Beatriz ^h   García Rico, Eduardo ⁱ   Murias, Adolfo ^j   Cortés Funes, Hernán ^a  

^a HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^b Hospital Arnau de Villanova   (Spain)

^c HOSPITAL UNIVERSITARIO DE BURGOS   (Spain)

^d HOSPITAL SEVERO OCHOA   (Spain)

^e Hospital UniversitarioFundación Jiménez Díaz   (Spain)

^f HOSPITAL UNIVERSITARIO VIRGEN DE LA VICTORIA   (Spain)

^g HOSPITAL CLÍNIC   (Spain)

^h HOSPITAL GENERAL DE SEGOVIA   (Spain)

ⁱ Hospital de Monteprincipe   (Spain)

^j HOSPITAL UNIVERSITARIO INSULAR DE GRAN CANARIA   (Spain)

more..

Author keywords

Colorectal cancer; Fluorouracil; Oxaliplatin; Raltitrexed

Indexed keywords

FLUOROURACIL; FOLINIC ACID; OXALIPLATIN; RALTITREXED;

ADULT; ADVANCED CANCER; AGED; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; COLORECTAL CANCER; CONTINUOUS INFUSION; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG TOLERABILITY; FEMALE; HUMAN; LEUKOPENIA; LIVER DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PARESTHESIA; PHASE 2 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA;

EID: 84865719682     PISSN: 1699048X     EISSN: 16993055     Source Type: Journal    
DOI: 10.1007/s12094-012-0843-x     Document Type: Article

References (34)

1. International Agency for Research on Cancer (2008) World Cancer Report 2008. http://www.iarc.fr/en/publications/pdfs-online/wcr/2008/index.php
2. Boyle P, Ferlay P (2005) Cancer incidence and mortality in Europe 2004. Ann Oncol 16:481-488 (Pubitemid 40458328)
3. Grothey A, Sargent D, Goldberg RM et al (2004) Survival of patients with advanced colorectal cancer improves with the availability of fluorouracil-leucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol 22(7):1209-1214 (Pubitemid 41079833)
4. Chan RTT, Au GKH, Yau CC (2002) Chemotherapy for advanced colorectal carcinoma: fact and fable. Coll Radiol 5:143-154
5. Pessino A, Sobrero A (2006) Optimal treatment of metastatic colorectal cancer. Expert Rev Anticancer Ther 6(5):801-812 (Pubitemid 44192895)
6. Machover D (1997) A comprehensive review of 5-fluorouracil and leucovorin in patients with metastatic colorectal carcinoma. Cancer 80(7):1179-1187 (Pubitemid 27407218)
7. De Gramont A, Bosset JF, Milan C et al (1997) Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus with bimonthly high-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: A French Intergroup Study. J Clin Oncol 15:808-815 (Pubitemid 27074252)
8. De Gramont A, Figer A, Seymour M et al (2002) Leucovorin and fluorouracil with or without oxaliplatin as first line treatment in advanced colorectal cancer. J Clin Oncol 18:2938-2947
9. Engstrom PF, Arnoletti JP, Benson AB et al (2009) NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. JNCCN 7(8):778-831
10. Engstrom PF, Arnoletti JP, Benson AB et al (2009) NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer. JNCCN 7(8):838-881
11. Zalcberg JR, Cunningham D, Van Custsem E et al (1996) ZD1694: a novel thymidylate synthase inhibitor with substantial activity in the treatment of patients with advanced colorectal cancer. J Clin Oncol 14:716-721 (Pubitemid 26085514)
12. Farrugia DC, Ford HE, Cunningham D et al (2003) Thymidylate synthase expression in advanced colorectal cancer predicts for response to raltitrexed. Clin Cancer Res 9:792-801 (Pubitemid 36182617)
13. Beale P, Judson I, Hanwell J et al (1996) Metabolism, excretion and pharmacokinetics of a single dose of (14C)-raltitrexed in cancer patient. Cancer Chemother Pharmacol 42:71-76
14. Cunningham D, Zalcberg JR, Rath U et al (1996) Final results of a randomised trial comparing Tomudex (raltitrexed) with 5-fluorouracil plus leucovorin in advanced colorectal cancer. Ann Oncol 7:961-965
15. Cocconi G, Cunningham D, Van Cutsem E et al (1998) Open randomized, multicenter trial of raltitrexed versus fluorouracil plus high-dose leucovorin in patients with advanced colorectal cancer. J Clin Oncol 16:2943-2952 (Pubitemid 28417413)
16. Maughan TS, James RD, Kerr DJ et al (2002) Comparison of survival, palliation, and quality of life with three chemotherapy regimens in metastatic colorectal cancer: a multicentre randomized trial. Lancet 359:1555-1563 (Pubitemid 34621120)
17. Pazdur R, Vicent M (1997) Raltitrexed (Tomudex) vs 5-fluorouracil and leucovorin (5FU + LV) in patients with advanced colorectal cancer (ACC): results of a randomized, multicenter North American trial. Proc Am Clin Oncol 16:228 (abstract 801)
18. Young A, Topham C, Moore J et al (1999) A patient preference study comparing raltitrexed ('Tomudex') and bolus or infusional 5-fluorouracil regimens in advanced colorectal cancer: influence of side-effects and administration attributes. Eur J Cancer Care 8:154-161
19. Fizazi K, Ducreux M, Ruffie P et al (2000) Phase I dose-finding, and pharmacokinetic study of raltitrexed combined with oxaliplatin in patients with advanced cancer. J Clin Oncol 18:2293-2300 (Pubitemid 30350222)
20. Fizazi K, Caliandro R, Soulié P et al (2000) Combination raltitrexed (Tomudex(R))-oxaliplatin: a step forward in the struggle against mesothelioma? The Institut Gustave Roussy experience with chemotherapy and chemo-immunotherapy in mesothelioma. Eur J Cancer 36:1514-1521 (Pubitemid 30619004)
21. Seitz JF, Bennouna J, Paillot B et al (2002) Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol 13:1072-1079
22. Scheithauer W, Kornek GV, Ulrich-Pur H et al (2001) Oxaliplatin plus raltitrexed in patients with advanced colorectal carcinoma. Cancer 91:1264-1271 (Pubitemid 32267036)
23. Scheithauer W, Kornek GV, Schuell B et al (2001) Second-line treatment with oxaliplatin + raltitrexed in patients with advanced colorectal cancer failing fluoropyrimidine/leucovorin-based chemotherapy. Ann Oncol 12:709-714 (Pubitemid 32519926)
24. Neri B, Doni L, Fulignati C et al (2002) Raltitrexed plus oxaliplatin as first-line chemotherapy in metastatic colorectal carcinoma: a multicentric phase II trial. Anti Cancer Drugs 13:719-724
25. Cascinu S, Graziano F, Ferrau F et al (2002) Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol 13:716-720 (Pubitemid 34567377)
26. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observation. J Am Stat Assoc 53:457-481
27. Cox DR (1972) Regression models and life tables. J R Stat Soc B 34:187-220
28. Santini D, Massacesi C, D'Angelillo RM et al (2004) Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer. Med Oncol 21:59-66 (Pubitemid 38491331)
29. Cortinovis D, Bajetta E, Di Bartolomeo M et al (2004) Raltitrexed plus oxaliplatin in the treatment of metastatic colorectal cancer. Tumori 90(2):186-191 (Pubitemid 38745606)
30. Feliu J, Castañón C, Salud A et al (2005) Phase II randomized trial of raltitrexed oxaliplatin vs raltitrexed irinotecan as first-line treatment in advanced colorectal cancer. Br J Cancer 93:1230-1235 (Pubitemid 41679408)
31. Wang J, Li J, Qin S et al (2007) Randomized multicenter phase III trial of oxaliplatin plus raltitrexed compared to oxaliplatin plus fluorouracil and leucovorin treatment in recurrent and metastatic colorectal cancer. Nonparametric estimation from incomplete observation. J Clin Oncol 25:18S (Suppl). Abstract 4102
32. Popov I, Carrato A, Sobrero A et al (2008) 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). Eur J Cancer 44:2204-2211
33. Volk J, Reinke F, Van Kuilenburg AB et al (2001) Safe administration of irinotecan, oxaliplatin and raltitrexed in a DPD-deficient patient with metastatic colon cancer. Ann Oncol 12:569-571 (Pubitemid 32472116)
34. Luján J, García de Burgos F, Jordán A et al (2002) Angina en relación con 5-fluorouracilo. Rev Esp Cardiol 55(7):764-767