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Journal of Clinical Oncology, Vol 18, Issue 1 (January), 2000: 136
© 2000 American Society for Clinical Oncology

Phase III Multicenter Randomized Trial of Oxaliplatin Added to Chronomodulated Fluorouracil–Leucovorin as First-Line Treatment of Metastatic Colorectal Cancer

By S. Giacchetti, B. Perpoint{dagger}, R. Zidani, N. Le Bail, R. Faggiuolo, C. Focan, P. Chollet, J. F. Llory, Y. Letourneau, B. Coudert, F. Bertheaut-Cvitkovic, D. Larregain-Fournier, A. Le Rol, S. Walter, R. Adam, J. L. Misset, F. Lévi

From the International Organization of Cancer Chronotherapy, Centre de Chronothérapie, Hôpital Paul Brousse, Villejuif, France; and Debiopharm S.A., Lausanne, Switzerland.

Address reprint requests to Sylvie Giacchetti, MD, Centre de Chronothérapie, Hôpital Paul Brousse, 14 avenue Paul-Vaillant-Couturier, 94807 Villejuif Cédex, France; email sylvie.giacchetti@ pbr.ap_hop_paris.fr.

PURPOSE: To study how adding oxaliplatin (l-OHP) to chronomodulated fluorouracil (5-FU)–leucovorin (LV) affected the objective response rate, as first-line treatment of metastatic colorectal cancer.

PATIENTS AND METHODS: Two hundred patients from 15 institutions in four countries were randomly assigned to receive a 5-day course of chronomodulated 5-FU and LV (700 and 300 mg/m2/d, respectively; peak delivery rate at 0400 hours) with or without l-OHP on the first day of each course (125 mg/m2, as a 6-hour infusion). Each course was repeated every 21 days. Response was assessed by extramural review of computed tomography scans.

RESULTS: Grade 3 to 4 toxicity from 5-FU–LV occurred in <= 5% of the patients (<= 1% of the courses). Grade 3 to 4 diarrhea occurred in 43% of the patients given l-OHP (10% of the courses), and less than 2% of the patients had severe hematotoxicity. Thirteen percent of the patients had moderate functional impairment from peripheral sensory neuropathy. Sixteen percent of the patients receiving 5-FU–LV had an objective response (95% confidence interval [CI], 9% to 24%), compared with 53% of those receiving additional l-OHP (95% CI, 42% to 63%) (P < .001). The median progression-free survival time was 6.1 months with 5-FU–LV (range, 4.1 to 7.4 months) and 8.7 months (7.4 to 9.2 months) with l-OHP and 5-FU–LV (P = .048). Median survival times were 19.9 and 19.4 months, respectively.

CONCLUSION: By chronomodulating 5-FU–LV, we were able to add l-OHP without compromising dose-intensities. l-OHP significantly improved the antitumor efficacy of this regimen.

{dagger}Deceased.

Presented in part at the Thirty-Third Annual Meeting of the American Society of Clinical Oncology, Denver, CO, May 17-20, 1997 (abstr 805).


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Combined Therapy with Weekly Irinotecan, Infusional 5-Fluorouracil and the Selective COX-2 Inhibitor Rofecoxib Is a Safe and Effective Second-Line Treatment in Metastatic Colorectal Cancer
Oncologist, October 1, 2005; 10(9): 710 - 717.
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N Andre and W Schmiegel
CHEMORADIOTHERAPY FOR COLORECTAL CANCER
Gut, August 1, 2005; 54(8): 1194 - 1202.
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G. Folprecht, A. Grothey, S. Alberts, H.-R. Raab, and C.-H. Kohne
Neoadjuvant treatment of unresectable colorectal liver metastases: correlation between tumour response and resection rates
Ann. Onc., August 1, 2005; 16(8): 1311 - 1319.
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W. L. Allen and P. G. Johnston
Role of Genomic Markers in Colorectal Cancer Treatment
J. Clin. Oncol., July 10, 2005; 23(20): 4545 - 4552.
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H. Kelly and R. M. Goldberg
Systemic Therapy for Metastatic Colorectal Cancer: Current Options, Current Evidence
J. Clin. Oncol., July 10, 2005; 23(20): 4553 - 4560.
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C. Aschele, M. L. Friso, S. Pucciarelli, S. Lonardi, L. Sartor, G. Fabris, E. D. L. Urso, P. Del Bianco, G. Sotti, M. Lise, et al.
A phase I-II study of weekly oxaliplatin, 5-fluorouracil continuous infusion and preoperative radiotherapy in locally advanced rectal cancer
Ann. Onc., July 1, 2005; 16(7): 1140 - 1146.
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P. Comella, B. Massidda, G. Filippelli, S. Palmeri, D. Natale, A. Farris, F. De Vita, F. Buzzi, S. Tafuto, L. Maiorino, 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. Onc., June 1, 2005; 16(6): 878 - 886.
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J. Feliu, P. Escudero, F. Llosa, M. Bolanos, J.-M. Vicent, A. Yubero, J.-J. Sanz-Lacalle, R. Lopez, L. Lopez-Gomez, E. Casado, et al.
Capecitabine As First-Line Treatment for Patients Older Than 70 Years With Metastatic Colorectal Cancer: An Oncopaz Cooperative Group Study
J. Clin. Oncol., May 1, 2005; 23(13): 3104 - 3111.
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G. D. Leonard, B. Brenner, and N. E. Kemeny
Neoadjuvant Chemotherapy Before Liver Resection for Patients With Unresectable Liver Metastases From Colorectal Carcinoma
J. Clin. Oncol., March 20, 2005; 23(9): 2038 - 2048.
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T. Delaunoit, S. R. Alberts, D. J. Sargent, E. Green, R. M. Goldberg, J. Krook, C. Fuchs, R. K. Ramanathan, S. K. Williamson, R. F. Morton, et al.
Chemotherapy permits resection of metastatic colorectal cancer: experience from Intergroup N9741
Ann. Onc., March 1, 2005; 16(3): 425 - 429.
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J. A. Meyerhardt and R. J. Mayer
Systemic Therapy for Colorectal Cancer
N. Engl. J. Med., February 3, 2005; 352(5): 476 - 487.
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 The Annals of PharmacotherapyHome page
R. J Cersosimo
Oxaliplatin-Associated Neuropathy: A Review
Ann. Pharmacother., January 1, 2005; 39(1): 128 - 135.
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S. R. Grobmyer, Y. Fong, M. D'Angelica, R. P. DeMatteo, L. H. Blumgart, and W. R. Jarnagin
Diagnostic Laparoscopy Prior to Planned Hepatic Resection for Colorectal Metastases
Arch Surg, December 1, 2004; 139(12): 1326 - 1330.
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D. Elias, T. Matsuhisa, L. Sideris, G. Liberale, L. Drouard-Troalen, B. Raynard, M. Pocard, J. M. Puizillou, V. Billard, P. Bourget, et al.
Heated intra-operative intraperitoneal oxaliplatin plus irinotecan after complete resection of peritoneal carcinomatosis: pharmacokinetics, tissue distribution and tolerance
Ann. Onc., October 1, 2004; 15(10): 1558 - 1565.
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C. Aschele, D. Debernardis, S. Lonardi, R. Bandelloni, S. Casazza, S. Monfardini, and L. Gallo
Deleted in Colon Cancer Protein Expression in Colorectal Cancer Metastases: A Major Predictor of Survival in Patients With Unresectable Metastatic Disease Receiving Palliative Fluorouracil-Based Chemotherapy
J. Clin. Oncol., September 15, 2004; 22(18): 3758 - 3765.
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G. Folprecht, D. Cunningham, P. Ross, B. Glimelius, F. Di Costanzo, J. Wils, W. Scheithauer, P. Rougier, E. Aranda, H. Hecker, et al.
Efficacy of 5-fluorouracil-based chemotherapy in elderly patients with metastatic colorectal cancer: a pooled analysis of clinical trials
Ann. Onc., September 1, 2004; 15(9): 1330 - 1338.
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A R Gillams
Liver ablation therapy
Br. J. Radiol., September 1, 2004; 77(921): 713 - 723.
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D. Cunningham, Y. Humblet, S. Siena, D. Khayat, H. Bleiberg, A. Santoro, D. Bets, M. Mueser, A. Harstrick, C. Verslype, et al.
Cetuximab Monotherapy and Cetuximab plus Irinotecan in Irinotecan-Refractory Metastatic Colorectal Cancer
N. Engl. J. Med., July 22, 2004; 351(4): 337 - 345.
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M. Slevin and S. Payne
New treatments for colon cancer
BMJ, July 17, 2004; 329(7458): 124 - 126.
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L. Cals, O. Rixe, E. Francois, R. Favre, L. Merad, G. Deplanque, A. Laadem, P. Juin, J. M. Bereder, D. Bernardini, et al.
Dose-finding study of weekly 24-h continuous infusion of 5-fluorouracil associated with alternating oxaliplatin or irinotecan in advanced colorectal cancer patients
Ann. Onc., July 1, 2004; 15(7): 1018 - 1024.
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P. Noordhuis, U. Holwerda, C. L. Van der Wilt, C. J. Van Groeningen, K. Smid, S. Meijer, H. M. Pinedo, and G. J. Peters
5-Fluorouracil incorporation into RNA and DNA in relation to thymidylate synthase inhibition of human colorectal cancers
Ann. Onc., July 1, 2004; 15(7): 1025 - 1032.
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T. Andre, C. Boni, L. Mounedji-Boudiaf, M. Navarro, J. Tabernero, T. Hickish, C. Topham, M. Zaninelli, P. Clingan, J. Bridgewater, et al.
Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer
N. Engl. J. Med., June 3, 2004; 350(23): 2343 - 2351.
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C. Pozzo, M. Basso, A. Cassano, M. Quirino, G. Schinzari, N. Trigila, M. Vellone, F. Giuliante, G. Nuzzo, and C. Barone
Neoadjuvant treatment of unresectable liver disease with irinotecan and 5-fluorouracil plus folinic acid in colorectal cancer patients
Ann. Onc., June 1, 2004; 15(6): 933 - 939.
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J. Cassidy, J. Tabernero, C. Twelves, R. Brunet, C. Butts, T. Conroy, F. Debraud, A. Figer, J. Grossmann, N. Sawada, et al.
XELOX (Capecitabine Plus Oxaliplatin): Active First-Line Therapy for Patients With Metastatic Colorectal Cancer
J. Clin. Oncol., June 1, 2004; 22(11): 2084 - 2091.
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T. A. Rich, R. C. Shepard, and S. T. Mosley
Four Decades of Continuing Innovation With Fluorouracil: Current and Future Approaches to Fluorouracil Chemoradiation Therapy
J. Clin. Oncol., June 1, 2004; 22(11): 2214 - 2232.
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 The OncologistHome page
E. Diaz-Rubio
New Chemotherapeutic Advances in Pancreatic, Colorectal, and Gastric Cancers
Oncologist, June 1, 2004; 9(3): 282 - 294.
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D. Elias, L. Sideris, M. Pocard, C. Ede, D. Ben Hassouna, M. Ducreux, V. Boige, J. F. Cote, and P. Lasser
Efficacy of intraperitoneal chemohyperthermia with oxaliplatin in colorectal peritoneal carcinomatosis. Preliminary results in 24 patients
Ann. Onc., May 1, 2004; 15(5): 781 - 785.
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F. Innocenti, S. D. Undevia, L. Iyer, P. Xian Chen, S. Das, M. Kocherginsky, T. Karrison, L. Janisch, J. Ramirez, C. M. Rudin, et al.
Genetic Variants in the UDP-glucuronosyltransferase 1A1 Gene Predict the Risk of Severe Neutropenia of Irinotecan
J. Clin. Oncol., April 15, 2004; 22(8): 1382 - 1388.
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A. Di Leo, M. Buyse, and H. Bleiberg
Is overall survival a realistic primary end point in advanced colorectal cancer studies? A critical assessment based on four clinical trials comparing fluorouracil plus leucovorin with the same treatment combined either with oxaliplatin or with CPT-11
Ann. Onc., April 1, 2004; 15(4): 545 - 549.
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L. van Zuylen, J. Bridgewater, A. Sparreboom, F. A. L. M. Eskens, P. de Bruijn, I. Sklenar, A. S. T. Planting, L. Choi, D. Bootle, C. Mueller, et al.
Phase I and Pharmacokinetic Study of the Polyamine Synthesis Inhibitor SAM486A in Combination with 5-Fluorouracil/ Leucovorin in Metastatic Colorectal Cancer
Clin. Cancer Res., March 15, 2004; 10(6): 1949 - 1955.
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J. Boyer, E. G. McLean, S. Aroori, P. Wilson, A. McCulla, P. D. Carey, D. B. Longley, and P. G. Johnston
Characterization of p53 Wild-Type and Null Isogenic Colorectal Cancer Cell Lines Resistant to 5-Fluorouracil, Oxaliplatin, and Irinotecan
Clin. Cancer Res., March 15, 2004; 10(6): 2158 - 2167.
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T.-L. Wang, L. A. Diaz Jr., K. Romans, A. Bardelli, S. Saha, G. Galizia, M. Choti, R. Donehower, G. Parmigiani, I.-M. Shih, et al.
Digital karyotyping identifies thymidylate synthase amplification as a mechanism of resistance to 5-fluorouracil in metastatic colorectal cancer patients
PNAS, March 2, 2004; 101(9): 3089 - 3094.
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L. Rubbia-Brandt, V. Audard, P. Sartoretti, A. D. Roth, C. Brezault, M. Le Charpentier, B. Dousset, P. Morel, O. Soubrane, S. Chaussade, et al.
Severe hepatic sinusoidal obstruction associated with oxaliplatin-based chemotherapy in patients with metastatic colorectal cancer
Ann. Onc., March 1, 2004; 15(3): 460 - 466.
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S.-E. Al-Batran, A. Atmaca, S. Hegewisch-Becker, D. Jaeger, S. Hahnfeld, M. J Rummel, G. Seipelt, A. Rost, J. Orth, A. Knuth, et al.
Phase II Trial of Biweekly Infusional Fluorouracil, Folinic Acid, and Oxaliplatin in Patients With Advanced Gastric Cancer
J. Clin. Oncol., February 15, 2004; 22(4): 658 - 663.
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M. Fakih
First-line hepatic infusion of pirarubicin in patients with isolated liver metastases: is it really promising?
Ann. Onc., February 1, 2004; 15(2): 359 - 359.
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H. Sorbye, B. Glimelius, A. Berglund, T. Fokstuen, K. M. Tveit, M. Braendengen, D. Ogreid, and O. Dahl
Multicenter Phase II Study of Nordic Fluorouracil and Folinic Acid Bolus Schedule Combined With Oxaliplatin As First-Line Treatment of Metastatic Colorectal Cancer
J. Clin. Oncol., January 1, 2004; 22(1): 31 - 38.
[Abstract] [Full Text] [PDF]

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 JCOHome page
R. M. Goldberg, D. J. Sargent, R. F. Morton, C. S. Fuchs, R. K. Ramanathan, S. K. Williamson, B. P. Findlay, H. C. Pitot, and S. R. Alberts
A Randomized Controlled Trial of Fluorouracil Plus Leucovorin, Irinotecan, and Oxaliplatin Combinations in Patients With Previously Untreated Metastatic Colorectal Cancer
J. Clin. Oncol., January 1, 2004; 22(1): 23 - 30.
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 The Annals of PharmacotherapyHome page
E. H. Lim, R. S. C. Lim, T. S. Wu, and H. L. Kong
Oxaliplatin/Fluorouracil/Leucovorin in Advanced Colorectal Carcinoma: an Asian Experience
Ann. Pharmacother., December 1, 2003; 37(12): 1909 - 1912.
[Abstract] [Full Text] [PDF]

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M. P. Goetz, C. Erlichman, A. J. Windebank, J. M. Reid, J. A. Sloan, P. Atherton, A. A. Adjei, J. Rubin, H. Pitot, E. Galanis, et al.
Phase I and Pharmacokinetic Study of Two Different Schedules of Oxaliplatin, Irinotecan, Fluorouracil, and Leucovorin in Patients With Solid Tumors
J. Clin. Oncol., October 15, 2003; 21(20): 3761 - 3769.
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 JCOHome page
M. L. Rothenberg and J. D. Berlin
Therapeutic Strategies for Metastatic Colorectal Cancer: Simultaneous, Sequential, or Specific?
J. Clin. Oncol., October 15, 2003; 21(20): 3716 - 3717.
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