This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Borner, M. M. Articles by Roth, A. D. Search for Related Content PubMed PubMed Citation Articles by Borner, M. M. Articles by Roth, A. D. Social Bookmarking                            What's this?

Phase II Study of Capecitabine and Oxaliplatin in First- and Second-Line Treatment of Advanced or Metastatic Colorectal Cancer

From the Institute of Medical Oncology, Inselspital, and Swiss Institute for Applied Cancer Research Coordinating Center, Bern; Centre Hospitalier Universitaire Vaudois, Lausanne; Kantonsspital, St Gallen; Triemlispital and Universitätsspital, Zürich; Kantonsspital, Basel; Ospedale Civico, Lugano; and Hôpital Universitaire, Geneva, Switzerland.

Address reprint requests to Markus M. Borner, MD, Institute of Medical Oncology, Inselspital, 3010 Bern, Switzerland; email: markus.borner@ insel.ch.

PURPOSE: To determine the efficacy and tolerability of combining oxaliplatin with capecitabine in the treatment of advanced nonpretreated and pretreated colorectal cancer.

PATIENTS AND METHODS: Forty-three nonpretreated patients and 26 patients who had experienced one fluoropyrimidine-containing regimen for advanced colorectal cancer were treated with oxaliplatin 130 mg/m² on day 1 and capecitabine 1,250 mg/m² bid on days 1 to 14 every 3 weeks. Patients with good performance status (World Health Organization grade 0 to 1) were accrued onto two nonrandomized parallel arms of a phase II study.

RESULTS: The objective response rate was 49% (95% confidence interval [CI], 33% to 65%) for nonpretreated and 15% (95% CI, 4% to 35%) for pretreated patients. The main toxicity of this combination was diarrhea, which occurred at grade 3 or 4 in 35% of the nonpretreated and 50% of the pretreated patients. Grade 3 or 4 sensory neuropathy, including laryngopharyngeal dysesthesia, occurred in 16% of patients on both cohorts. Capecitabine dose reductions were necessary in 26% of the nonpretreated and 45% of the pretreated patients in the second treatment cycle. The median overall survival was 17.1 months and 11.5 months, respectively.

CONCLUSION: Combining capecitabine and oxaliplatin yields promising activity in advanced colorectal cancer. The main toxicity is diarrhea, which is manageable with appropriate dose reductions. On the basis of our toxicity experience, we recommend use of capecitabine in combination with oxaliplatin 130 mg/m² at an initial dose of 1,250 mg/m² bid in nonpretreated patients and at a dose of 1,000 mg/m² bid in pretreated patients.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				A. Molassiotis, S. Brearley, M. Saunders, O. Craven, A. Wardley, C. Farrell, R. Swindell, C. Todd, and K. Luker Effectiveness of a Home Care Nursing Program in the Symptom Management of Patients With Colorectal and Breast Cancer Receiving Oral Chemotherapy: A Randomized, Controlled Trial J. Clin. Oncol., December 20, 2009; 27(36): 6191 - 6198. [Abstract] [Full Text] [PDF]

				M. L. Rothenberg, J. V. Cox, C. Butts, M. Navarro, Y.-J. Bang, R. Goel, S. Gollins, L. L. Siu, S. Laguerre, and D. Cunningham Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: a randomized phase III noninferiority study Ann. Onc., October 1, 2008; 19(10): 1720 - 1726. [Abstract] [Full Text] [PDF]

				M. Borner, D. Koeberle, R. Von Moos, P. Saletti, D. Rauch, V. Hess, A. Trojan, D. Helbling, B. Pestalozzi, C. Caspar, et al. Adding cetuximab to capecitabine plus oxaliplatin (XELOX) in first-line treatment of metastatic colorectal cancer: a randomized phase II trial of the Swiss Group for Clinical Cancer Research SAKK Ann. Onc., July 1, 2008; 19(7): 1288 - 1292. [Abstract] [Full Text] [PDF]

				C.-H. Kohne, G. Folprecht, R. M. Goldberg, E. Mitry, and P. Rougier Chemotherapy in Elderly Patients with Colorectal Cancer Oncologist, April 1, 2008; 13(4): 390 - 402. [Abstract] [Full Text] [PDF]

				A. J. Gelibter, S. Lonardi, S. Di Segni, A. Fontana, F. Loupakis, F. Cognetti, and R. Labianca Are Dose-Finding Studies Still Necessary When Targeted Therapy Is Associated With Chemotherapy? J. Clin. Oncol., October 1, 2006; 24(28): 4668 - 4669. [Full Text] [PDF]

				J. A. Meyerhardt and C. S. Fuchs In Reply J. Clin. Oncol., October 1, 2006; 24(28): 4669 - 4669. [Full Text] [PDF]

				J. A. Meyerhardt, A. X. Zhu, P. C. Enzinger, D. P. Ryan, J. W. Clark, M. H. Kulke, C. C. Earle, M. Vincitore, A. Michelini, S. Sheehan, et al. Phase II Study of Capecitabine, Oxaliplatin, and Erlotinib in Previously Treated Patients With Metastastic Colorectal Cancer J. Clin. Oncol., April 20, 2006; 24(12): 1892 - 1897. [Abstract] [Full Text] [PDF]

				P. Pfeiffer, H. Sorbye, H. Ehrsson, T. Fokstuen, J. P. Mortensen, L. Baltesgard, K. M. Tveit, D. Ogreid, H. Starkhammar, I. Wallin, et al. Short-time infusion of oxaliplatin in combination with capecitabine (XELOX30) as second-line therapy in patients with advanced colorectal cancer after failure to irinotecan and 5-fluorouracil Ann. Onc., February 1, 2006; 17(2): 252 - 258. [Abstract] [Full Text] [PDF]

				A. Jatoi, B. R. Murphy, N. R. Foster, D. A. Nikcevich, S. R. Alberts, J. A. Knost, T. R. Fitch, and K. M. Rowland Jr Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group Ann. Onc., January 1, 2006; 17(1): 29 - 34. [Abstract] [Full Text] [PDF]

				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. [Abstract] [Full Text] [PDF]

				C. J. A. Punt New options and old dilemmas in the treatment of patients with advanced colorectal cancer Ann. Onc., October 1, 2004; 15(10): 1453 - 1459. [Abstract] [Full Text] [PDF]

				P. M. Hoff, R. Pazdur, Y. Lassere, S. Carter, D. Samid, D. Polito, and J. L. Abbruzzese Phase II Study of Capecitabine in Patients With Fluorouracil-Resistant Metastatic Colorectal Carcinoma J. Clin. Oncol., June 1, 2004; 22(11): 2078 - 2083. [Abstract] [Full Text] [PDF]

				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. [Abstract] [Full Text] [PDF]

				N. H. Fernando and H. I. Hurwitz Targeted Therapy of Colorectal Cancer: Clinical Experience with Bevacizumab Oncologist, June 1, 2004; 9(suppl_1): 11 - 18. [Abstract] [Full Text] [PDF]

				W. Scheithauer, J. McKendrick, S. Begbie, M. Borner, W. I. Burns, H. A. Burris, J. Cassidy, D. Jodrell, P. Koralewski, E. L. Levine, et al. Oral capecitabine as an alternative to i.v. 5-fluorouracil-based adjuvant therapy for colon cancer: safety results of a randomized, phase III trial Ann. Onc., December 1, 2003; 14(12): 1735 - 1743. [Abstract] [Full Text] [PDF]

				N. Magne, J.-L. Fischel, A. Dubreuil, P. Formento, J. Ciccolini, J.-L. Formento, C. Tiffon, N. Renee, S. Marchetti, M.-C. Etienne, et al. ZD1839 (Iressa) Modifies the Activity of Key Enzymes Linked to Fluoropyrimidine Activity: Rational Basis for a New Combination Therapy with Capecitabine Clin. Cancer Res., October 15, 2003; 9(13): 4735 - 4742. [Abstract] [Full Text] [PDF]

				M. Zeuli, C. Nardoni, M. S. Pino, T. Gamucci, A. Gabriele, V. Ferraresi, D. Giannarelli, and F. Cognetti Phase II study of capecitabine and oxaliplatin as first-line treatment in advanced colorectal cancer Ann. Onc., September 1, 2003; 14(9): 1378 - 1382. [Abstract] [Full Text] [PDF]

				M. Tewes, N. Schleucher, W. Achterrath, H. J. Wilke, S. Frings, S. Seeber, A. Harstrick, Y. M. Rustum, and U. Vanhoefer Capecitabine and irinotecan as first-line chemotherapy in patients with metastatic colorectal cancer: results of an extended phase I study{dagger} Ann. Onc., September 1, 2003; 14(9): 1442 - 1448. [Abstract] [Full Text] [PDF]

				C. Rodel, Gerhard. G. Grabenbauer, T. Papadopoulos, W. Hohenberger, H.-J. Schmoll, and R. Sauer Phase I/II Trial of Capecitabine, Oxaliplatin, and Radiation for Rectal Cancer J. Clin. Oncol., August 15, 2003; 21(16): 3098 - 3104. [Abstract] [Full Text] [PDF]

				R. K. Ramanathan, J. W. Clark, N. E. Kemeny, H.-J. Lenz, K. O. Gococo, D. G. Haller, E. P. Mitchell, and C. G. Kardinal Safety and Toxicity Analysis of Oxaliplatin Combined With Fluorouracil or as a Single Agent in Patients With Previously Treated Advanced Colorectal Cancer J. Clin. Oncol., August 1, 2003; 21(15): 2904 - 2911. [Abstract] [Full Text] [PDF]

				I. Chau and D. Cunningham Oxaliplatin for Colorectal Cancer in the United States: Better Late Than Never J. Clin. Oncol., June 1, 2003; 21(11): 2049 - 2051. [Full Text] [PDF]

				M. L. Rothenberg, A. M. Oza, R. H. Bigelow, J. D. Berlin, J. L. Marshall, R. K. Ramanathan, L. L. Hart, S. Gupta, C. A. Garay, B. G. Burger, et al. Superiority of Oxaliplatin and Fluorouracil-Leucovorin Compared With Either Therapy Alone in Patients With Progressive Colorectal Cancer After Irinotecan and Fluorouracil-Leucovorin: Interim Results of a Phase III Trial J. Clin. Oncol., June 1, 2003; 21(11): 2059 - 2069. [Abstract] [Full Text] [PDF]

				W. Scheithauer, G. V. Kornek, M. Raderer, B. Schull, K. Schmid, E. Kovats, B. Schneeweiss, F. Lang, A. Lenauer, and D. Depisch Randomized Multicenter Phase II Trial of Two Different Schedules of Capecitabine Plus Oxaliplatin as First-Line Treatment in Advanced Colorectal Cancer J. Clin. Oncol., April 1, 2003; 21(7): 1307 - 1312. [Abstract] [Full Text] [PDF]

				I. Chau and D. Cunningham Chemotherapy in colorectal cancer: new options and new challenges Br. Med. Bull., December 1, 2002; 64(1): 159 - 180. [Abstract] [Full Text] [PDF]

				R. Schmelz, C. Lersch, J. L. Grem, T. Lehky, R. Thomas, M. Quinn, and M. K. Floeter Acute Oxaliplatin-Induced Peripheral-Nerve Hyperexcitability J. Clin. Oncol., August 15, 2002; 20(16): 3561 - 3562. [Full Text] [PDF]