|
Advertisement |
|
|
||
 |
|
|||||
|
|||||
|
 |
||||||
|
||||||
|
||||||
|
Journal of Clinical Oncology, Vol 26, No 8 (March 10), 2008: pp. 1386-1387 © 2008 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.15.4492
Role of Palifermin in Fluorouracil-Based Therapy for Metastatic Colorectal CancerPeter MacCallum Cancer Centre, Melbourne, Australia University of Melbourne, Victoria, Australia
Premiere Oncology, John Wayne Cancer Institute, St John’s Health Centre, Santa Monica, CA
Medical Oncology, The Tweed Hospital, Tweed Heads, New South Wales, Australia
Department of Medical Oncology, Austin Health, Heidelberg, Victoria, Australia
Proacta Inc, San Diego, CA
Central Georgia Hematology and Oncology, Macon, GA
Biogen Idec, San Diego, CA
Amgen Inc, Thousand Oaks, CA
Department of Medicine, Concord Hospital, Camperdown, New South Wales, Australia To the Editor: We would like to address questions raised in Dr Haines’ Letter to the Editor published July 1, 2007,1 regarding the study, "Palifermin reduces the incidence of mucositis in patients with metastatic colorectal cancer treated with fluorouracil-based chemotherapy."2 With respect to the choice of treatment regimen used, the particular fluorouracil / leucovorin (FU/ LV, Mayo) regimen used in this study was widely used both in the United States and Australia at the time the study was designed and conducted. The study commenced in the mid 1990s, with the final patient enrolled onto the treatment phase of the trial in May 2000. Dr Haines cites a study by Wang et al,3 however this was not published until after our study had completed accrual. On the other hand, a much larger study involving 372 patients published in 1994 in this journal,4 suggested that the Mayo schedule as used in this study2 was preferable to the original, weekly Roswell Park regimen of FU and folinic acid, on the basis of similar effectiveness with reduced toxicity. A second FU regimen5 suggested by Dr Haines involves the use of infusional FU and folinic acid (the de Gramont regimen). Although this therapy has become the backbone for the administration of combination therapies with oxaliplatin or irinotecan, a survey of 50 Australian hospitals, coincidentally conducted in 1999, revealed that the vast majority of centers were using bolus FU rather than an infusional regimen.6 In addition, 73% of these same centers were not using cryotherapy routinely with bolus administration of FU. Hence, the study design mirrored current practice at the time, which is why it was considered acceptable to the multiple institutional review boards that approved the study in Australia and the United States. In addition, the Multinational Association of Supportive Care in Cancer (MASCC) Guidelines that include a recommendation for the use of cryotherapy with bolus FU-containing regimens were not published until 2004.7 With respect to the issue of irinotecan, the pivotal studies of irinotecan and FU/LV in the first-line treatment of advanced colorectal cancer were both published after the last patient was recruited.8,9 This United States trial involved a comparison of two irinotecan-containing regimens (one was irinotecan, fluorouracil, and leucovorin [IFL]) with the Mayo regimen and did not use cryotherapy.9 However, the publication did make mention of a 22.7% incidence of grade 3/4 diarrhea with IFL compared to 13.2% in patients receiving the Mayo regimen. The incidence of mucositis was much less with the IFL regimen but in the original design of the palifermin study,2 it was thought that this drug might also reduce the incidence of diarrhea as well as mucositis. Alternative schedules of irinotecan involving concurrent infusions were also published in the year 20008 (when our study population had been largely recruited), given that irinotecan was only registered in Australia for the first-line treatment of advanced colorectal cancer in March 2001 and reimbursed from December 2004, few patients were receiving such therapy at the time. Hence, at the time the study was initiated, irinotecan was not considered a standard of care to which a novel agent such as palifermin should be added. In this study, palifermin was tested against current standards of care both in terms of the choice of regimen and the supportive care provided to patients under the direction of experienced clinical investigators, all of whom were required to provide advice about potential conflicts of interest according to the Journal’s guidelines. Collaboration between such investigators and pharmaceutical companies, as occurred in this study, is an effective model for defining more effective and less toxic therapies for patients, and we look forward to Dr Haines’ involvement in such studies in the future to help define current standards of care against which new approaches can be compared. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO’s conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors. Employment or Leadership Position: Urte Gayko, Amgen (C); Mon-Gy Chen, Amgen (C) Consultant or Advisory Role: John R. Zalcberg, Amgen (C); Frederick M. Schnell, Roche (C), Amgen (C); Mon-Gy Chen, Amgen (C); Stephen Clarke, Amgen (C) Stock Ownership: Alessandra Cesano, Amgen; Urte Gayko, Amgen; Mon-Gy Chen, Amgen Honoraria: John R. Zalcberg, Amgen; Frederick M. Schnell, Roche, Amgen; Stephen Clarke, Amgen Research Funding: John R. Zalcberg, Amgen; Stephen Clarke, Amgen Expert Testimony: None Other Remuneration: John R. Zalcberg, Amgen REFERENCES
1. Haines IE: Questions about the role of palifermin in fluorouracil-based therapy for metastatic colorectal cancer. J Clin Oncol 25:e24-e25, 2007 2. Rosen LS, Abdi E, Davis ID, et al: Palifermin reduces the incidence of oral mucositis in patients with metastatic colorectal cancer treated with fluorouracil based chemotherapy. J Clin Oncol 24:5194-5200, 2006 3. Wang WS, Lin JK, Chiou TJ, et al: Randomised trial comparing weekly bolus 5-fluorouracil plus leucovorin versus monthly 5-day 5-fluorouracil plus leucovorin in metastatic colorectal cancer. Hepatogastroenterology 47:1599-1603, 2000[Medline] 4. Buroker TR, O’Connell MJ, Wieand S, et al: Randomized comparison of two schedules of fluorouracil and leucovorin in the treatment of advanced colorectal cancer. J Clin Oncol 12:14-20, 1994[Abstract] 5. de Gramont A, Bosset JF, Milan C, et al: Randomized trial comparing monthly low-dose leucovorin and fluorouracil bolus plus continuous infusion for advanced colorectal cancer: A French Intergroup Study. J Clin Oncol 15:808-815, 1997 6. Dooley MJ, Harsley SR, Zalcberg J et al: Response rates and administration of FU in Australian hospitals. Poster and conference proceedings at COSA, 1999 7. Rubenstein EB, Peterson DE, Schubert M, et al: Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer 100:2026-2046, 2004 (Suppl 1)[CrossRef][Medline] 8. Douillard JY, Cunningham D, Roth AD, et al: Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: A multicentre randomised trial. Lancet 355:1041-1047, 2000[CrossRef][Medline] 9. Saltz LB, Cox JV, Blanke C, et al: Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. N Engl J Med 343:905-914, 2000
Related Article
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||||||||||
|
|||||||||||
|
|
Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
|
