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 Leong, S. S. Articles by Ang, P. T. Search for Related Content PubMed PubMed Citation Articles by Leong, S. S. Articles by Ang, P. T. Social Bookmarking                            What's this?

Randomized Double-Blind Trial of Combined Modality Treatment With or Without Amifostine in Unresectable Stage III Non–Small-Cell Lung Cancer

Swan Swan Leong, Eng Huat Tan, Kam Weng Fong, Einar Wilder-Smith, Yew Kwang Ong, Bee Choo Tai, Lita Chew, Shih Hui Lim, Joseph Wee, Khai Mun Lee, Kian Fong Foo, Peter Ang, Peng Tiam Ang

From the National Cancer Centre, Singapore.

Address reprint requests to Swan Swan Leong, MD, Department of Medical Oncology, National Cancer Centre, 11 Hospital Dr, Singapore 169610; email: dmolss{at}nccs.com.sg.

Purpose: Greater toxicities have been recognized to be a consequence of combined chemotherapy and radiotherapy in the treatment of locally advanced non–small-cell lung cancer (NSCLC). This study was designed to determine if the use of amifostine could reduce treatment-related toxicities associated with the use of paclitaxel plus carboplatin and thoracic radiotherapy.

Patients and Methods: Sixty patients with unresectable stage III NSCLC were treated with two cycles of paclitaxel 175 mg/m² and carboplatin (area under the time-concentration curve = 6), followed by thoracic radiotherapy (64 Gy) with concurrent weekly paclitaxel 60 mg/m². Patients were randomly assigned to receive 740 mg/m² of amifostine (arm A) or placebo (arm B) before each dose of paclitaxel and carboplatin. Treatment-related toxicities were evaluated at each visit and nerve conduction tests were performed before and after treatment for the objective assessment of neurotoxicity.

Results: There was no significant difference between arms A and B in grade 3 to 4 neutropenia. In all 72 neurophysiological parameters measured, there was no significant difference between the two treatment arms, although there was a trend toward fewer patients showing deterioration in arm A for six of the parameters. Grade 2 to 3 esophagitis occurred in 43% of patients in arm A and in 70% of patients in arm B. The difference of -27% (95% confidence limit = -50%, 0.4%) was not statistically significant. Response rates and survival were also not significantly different between the two arms.

Conclusion: Pretreatment with amifostine showed a trend toward reducing the severity of esophagitis associated with concurrent chemoradiotherapy, but it did not reach statistical significance. There was no significant protective effect on hematologic or neurologic toxicities induced by paclitaxel and carboplatin.

Supported in part by Schering Plough, which also provided the amifostine.

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

This article has been cited by other articles:

				M. L. Hensley, K. L. Hagerty, T. Kewalramani, D. M. Green, N. J. Meropol, T. H. Wasserman, G. I. Cohen, B. Emami, W. J. Gradishar, R. B. Mitchell, et al. American Society of Clinical Oncology 2008 Clinical Practice Guideline Update: Use of Chemotherapy and Radiation Therapy Protectants J. Clin. Oncol., January 1, 2009; 27(1): 127 - 145. [Abstract] [Full Text] [PDF]

				B. D. Lawenda, K. M. Kelly, E. J. Ladas, S. M. Sagar, A. Vickers, and J. B. Blumberg Should Supplemental Antioxidant Administration Be Avoided During Chemotherapy and Radiation Therapy? J Natl Cancer Inst, June 4, 2008; 100(11): 773 - 783. [Abstract] [Full Text] [PDF]

				T. E. Stinchcombe, D. Fried, D. E. Morris, and M. A. Socinski Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer Oncologist, July 1, 2006; 11(7): 809 - 823. [Abstract] [Full Text] [PDF]

				J. J. Lee and S. M. Swain Peripheral Neuropathy Induced by Microtubule-Stabilizing Agents J. Clin. Oncol., April 1, 2006; 24(10): 1633 - 1642. [Abstract] [Full Text] [PDF]

				R. Komaki What Should the Optimal Timing Be for Amifostine Administration Relative to Radiation and Chemotherapy? J. Clin. Oncol., October 1, 2005; 23(28): 7232 - 7233. [Full Text] [PDF]

				P. Fournel, G. Robinet, P. Thomas, P.-J. Souquet, H. Lena, A. Vergnenegre, J.-Y. Delhoume, J. Le Treut, J.-A. Silvani, E. Dansin, et al. Randomized Phase III Trial of Sequential Chemoradiotherapy Compared With Concurrent Chemoradiotherapy in Locally Advanced Non-Small-Cell Lung Cancer: Groupe Lyon-Saint-Etienne d'Oncologie Thoracique-Groupe Francais de Pneumo-Cancerologie NPC 95-01 Study J. Clin. Oncol., September 1, 2005; 23(25): 5910 - 5917. [Abstract] [Full Text] [PDF]

				S. W. Redding Cancer Therapy-Related Oral Mucositis J Dent Educ., August 1, 2005; 69(8): 919 - 929. [Abstract] [Full Text] [PDF]

				B. Movsas, C. Scott, C. Langer, M. Werner-Wasik, N. Nicolaou, R. Komaki, M. Machtay, C. Smith, R. Axelrod, L. Sarna, et al. Randomized Trial of Amifostine in Locally Advanced Non-Small-Cell Lung Cancer Patients Receiving Chemotherapy and Hyperfractionated Radiation: Radiation Therapy Oncology Group Trial 98-01 J. Clin. Oncol., April 1, 2005; 23(10): 2145 - 2154. [Abstract] [Full Text] [PDF]

				V. C. Archie and C. R. Thomas Jr. Superior Sulcus Tumors: A Mini-Review Oncologist, September 1, 2004; 9(5): 550 - 555. [Abstract] [Full Text] [PDF]