European Journal of Cancer
Volume 45, Issue 1 , Pages 65-73 , January 2009

Incidence and clinical implications of venous thromboembolism in advanced colorectal cancer patients: The ‘GISCAD-alternating schedule’ study findings

  • Mario Mandalà

      Affiliations

    • Unit of Medical Oncology, Ospedali Riuniti, 24100 Bergamo, Italy
    • Corresponding Author InformationCorresponding author: Tel.: +39 35269858; fax: +39 35266849.
  • ,
  • Sandro Barni

      Affiliations

    • Division of Medical Oncology, Treviglio Hospital, Treviglio Division of Medical Oncology, Italy
  • ,
  • Irene Floriani

      Affiliations

    • Department of Oncology, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy
  • ,
  • Luciano Isa

      Affiliations

    • Department of Medical Oncology, Ospedale Serbelloni, Gorgonzola (MI), Italy
  • ,
  • Giuseppe Fornarini

      Affiliations

    • Department of Medical Oncology, San Martino Hospital, Genova, Italy
  • ,
  • Maurizio Marangolo

      Affiliations

    • Istituto Oncologico Romagnolo, Department of Oncology, Santa Maria delle Croci Hospital, Ravenna, Italy
  • ,
  • Stefania Mosconi

      Affiliations

    • Unit of Medical Oncology, Ospedali Riuniti, 24100 Bergamo, Italy
  • ,
  • Domenico Corsi

      Affiliations

    • Department of Oncology, Fatebenefratelli Hospital, Roma, Italy
  • ,
  • Eliana Rulli

      Affiliations

    • Department of Oncology, Istituto di Ricerche Farmacologiche ‘Mario Negri’, Milan, Italy
  • ,
  • Luciano Frontini

      Affiliations

    • Division of Medical Oncology, San Gerardo Hospital, Monza, Italy
  • ,
  • Enrico Cortesi

      Affiliations

    • Medical Oncology B, Policlinico Umberto I Hospital, ‘La Sapienza’ University, Rome, Italy
  • ,
  • Alberto Zaniboni

      Affiliations

    • Fondazione poliambulanza, Brescia, Italy
  • ,
  • Massimo Aglietta

      Affiliations

    • U.O. Oncologia Medica IRCCS, Candiolo, Italy
  • ,
  • Roberto Labianca

      Affiliations

    • Unit of Medical Oncology, Ospedali Riuniti, 24100 Bergamo, Italy
    • On Behalf of GISCAD (Italian Group for the Study of Gastrointestinal Cancer).

Received 21 August 2008 ,Accepted 5 September 2008.

References 

  1. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet. 2008;371:387–394
  2. Otten HM, Mathijssen J, ten Cate H, et al. Symptomatic venous thromboembolism in cancer patients treated with chemotherapy, an underestimated phenomenon. Arch Intern Med. 2004;164:190–194
  3. Labianca R, Floriani I, Isa L, et al. Alternating versus continuous “FOLFIRI” in advanced colorectal cancer (ACC): a randomized “GISCAD” trial. Proceedings ASCO; 2006 [abstract 3505].
  4. Chew HK, Wun T, Harvey D, Zhou H, White RH. Incidence of venous thromboembolism and its effect on survival among patients with common cancers. Arch Intern Med. 2006;166:458–464
  5. Feliu J, Castañón C, Salud A, Mel JR, et al. Phase II randomised trial of raltitrexed-oxaliplatin vs raltitrexed-irinotecan as first-line treatment in advanced colorectal cancer. Brit J Cancer. 2005;93:1230–1235
  6. Van Cutsem E, Dirix L, Van Laethem JL, et al. Optimisation of irinotecan dose in the treatment of patients with metastatic colorectal cancer after 5-FU failure: results from a multinational, randomised phase II study. Brit J Cancer. 2005;92:1055–1062
  7. Van Cutsem E, Hoff PM, Harper P, et al. Oral capecitabine vs intravenous 5-fluorouracil and leucovorin: integrated efficacy data and novel analyses from two large, randomised, phase III trials. Brit J Cancer. 2004;90:1190–1197
  8. Bajetta E, Di Bartolomeo M, Buzzoni R, et al. Uracil/ftorafur/leucovorin combined with irinotecan (TEGAFIRI) or oxaliplatin (TEGAFOX) as first-line treatment for metastatic colorectal cancer patients: results of randomised phase II study. Brit J Cancer. 2007;96:439–444
  9. Souglakos J, Androulakis N, Syrigos K, et al. FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG). Brit J Cancer. 2006;798–805
  10. Martoni AA, Pinto C, Di Fabio F, et al. Capecitabine plus oxaliplatin (xelox) versus protracted 5-fluorouracil venous infusion plus oxaliplatin (pvifox) as first-line treatment in advanced colorectal cancer: a GOAM phase II randomised study (FOCA trial). Eur J Cancer. 2006;42:3161–3168
  11. Garufi C, Vanni B, Aschelter AM, et al. Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients. Eur J Cancer. 2006;42:608–616
  12. Nogué M, Salud A, Batiste-Alentorn E, et al. Randomised study of tegafur and oral leucovorin versus intravenous 5-fluorouracil and leucovorin in patients with advanced colorectal cancer. Eur J Cancer. 2005;41:2241–2249
  13. Hospers GAP, Schaapveld M, Nortier JWR, et al. Randomised phase III study of biweekly 24-h infusion of high-dose 5FU with folinic acid and oxaliplatin versus monthly plus 5-FU/folinic acid in first-line treatment of advanced colorectal cancer. Ann Oncol. 2006;17:443–449
  14. Goldberg RM, Sargent DJ, Morton RF, et al. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol. 2006;24:3347–3353
  15. Colucci G, Gebbia V, Paoletti G, et al. Phase III randomized trial of FOLFIRI versus FOLFOX4 in the treatment of advanced colorectal cancer: a multicenter study of the Gruppo Oncologico Dell’Italia Meridionale. J Clin Oncol. 2005;23:4866–4875
  16. Tournigand C, André T, Achille E, et al. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004;22:229–237
  17. Köhne CH, van Cutsem E, Wils J, et al. Phase III study of weekly high-dose infusional fluorouracil plus folinic acid with or without irinotecan in patients with metastatic colorectal cancer: European Organisation for Research and Treatment of Cancer Gastrointestinal Group Study 40986. J Clin Oncol. 2005;23:4856–4865
  18. Fuchs CS, Marshall J, Mitchell E, et al. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: results from the BICC-C Study. J Clin Oncol. 2007;25:4779–4786
  19. Falcone A, Ricci S, Brunetti I, et al. Phase III trial of infusional fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI) compared with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI) as first-line treatment for metastatic colorectal cancer: the Gruppo Oncologico Nord Ovest. J Clin Oncol. 2007;25:1670–1676
  20. Goldberg RM, Sargent DJ, Morton RF, et al. Randomized controlled trial of reduced-dose bolus fluorouracil plus leucovorin and irinotecan or infused fluorouracil plus leucovorin and oxaliplatin in patients with previously untreated metastatic colorectal cancer: a North American Intergroup Trial. J Clin Oncol. 2006;24:3347–3353
  21. Bécouarn Y, Senesse P, Thézenas S, et al. A randomized phase II trial evaluating safety and efficacy of an experimental chemotherapy regimen (irinotecan+oxaliplatin, IRINOX) and two standard arms (LV5 FU2+irinotecan or LV5 FU2+oxaliplatin) in first-line metastatic colorectal cancer: a study of the Digestive Group of the Fédération Nationale des Centres de Lutte Contre le Cancer. Ann Oncol. 2007;18:2000–2005
  22. Comella P, Massidda B, Filippelli G, et al. Oxaliplatin plus high-dose folinic acid and 5-fluorouracil i.v. bolus (OXAFAFU) versus irinotecan plus high-dose folinic acid and 5-fluorouracil i.v. bolus (IRIFAFU) in patients with metastatic colorectal carcinoma: a Southern Italy Cooperative Oncology Group phase III trial. Ann Oncol. 2005;16:878–886
  23. Kalofonos HP, Aravantinos G, Kosmidis P, et al. Irinotecan or oxaliplatin combined with leucovorin and 5-fluorouracil as first-line treatment in advanced colorectal cancer: a multicenter, randomized, phase II study. Ann Oncol. 2005;16:869–877
  24. Delaunoit T, Goldberg RM, Sargent DJ, et al. Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741. Cancer. 2004;101:2170–2176
  25. Koopman M, Antonini NF, Douma J, et al. Sequential versus combination chemotherapy with capecitabine, irinotecan, and oxaliplatin in advanced colorectal cancer (CAIRO): a phase III randomised controlled trial. Lancet. 2007;370:135–142
  26. Seymour MT, Maughan TS, Ledermann JA, et al. FOCUS Trial Investigators; National Cancer Research Institute Colorectal Clinical Studies Group Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet. 2007;370:143–152
  27. Schoemaker NE, Kuppens IE, Moiseyenko V, et al. Randomised phase II multicentre trial of irinotecan (CPT-11) using four different schedules in patients with metastatic colorectal cancer. Brit J Cancer. 2004;91:1434–1441
  28. Porschen R, Arkenau HT, Kubicka S, et al. Phase III study of capecitabine plus oxaliplatin compared with fluorouracil and leucovorin plus oxaliplatin in metastatic colorectal cancer: a final report of the AIO Colorectal Study Group. J Clin oncol. 2007;25:4217–4223
  29. Giacchetti S, Bjarnason G, Garufi C, et al. Phase III trial comparing 4-day chronomodulated therapy versus 2-day conventional delivery of fluorouracil, leucovorin, and oxaliplatin as first-line chemotherapy of metastatic colorectal cancer: the European Organisation for Research and Treatment of Cancer Chronotherapy Group. J Clin Oncol. 2006;24:3562–3569
  30. Ashley AC, Sargent DJ, Alberts SR, et al. Updated efficacy and toxicity analysis of irinotecan and oxaliplatin (IROX): intergroup trial N9741 in first-line treatment of metastatic colorectal cancer. Cancer. 2007;110:670–677
  31. Díaz-Rubio E, Tabernero J, Gómez-España A, et al. Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as first-line therapy in metastatic colorectal cancer: final report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial. J Clin Oncol. 2007;25:4224–4230
  32. Tournigand C, Cervantes A, Figer A, et al. OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-go fashion in advanced colorectal cancer – a GERCOR study. J Clin Oncol. 2006;20:394–400
  33. Saltz LB, Cox JV, Blanke C, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. New Engl J Med. 2000;343:905–914
  34. Khorana AA, Francis CW, Culakova E, et al. Risk factors for chemotherapy associated venous thromboembolism in a prospective observational study. Cancer. 2005;104:2822–2829
  35. Lyman GH, Khorana AA, Falanga A, et al. American Society of Clinical Oncology guideline: recommendations for venous thromboembolism prophylaxis and treatment in patients with cancer. J Clin Oncol. 2007;25:5490–5505
  36. Mandala M, Falanga A, Piccioli A, et al. Working Group AIOM Venous thromboembolism and cancer: guidelines of the Italian Association of Medical Oncology (AIOM). Crit Rev Oncol Hematol. 2006;59:194–204
  37. Alcalay A, Wun T, Khatri V, et al. Venous thromboembolism in patients with colorectal cancer: incidence and effect on survival. J Clin Oncol. 2006;24:1112–1118
  38. Levine MN, Gent M, Hirsh J, et al. The thrombogenic effect of anticancer drug therapy in women with stage II breast cancer. New Engl J Med. 1988;318:404–407

PII: S0959-8049(08)00704-1

doi: 10.1016/j.ejca.2008.09.005

European Journal of Cancer
Volume 45, Issue 1 , Pages 65-73 , January 2009