Journal of Clinical Oncology, Vol 12, 2648-2653, Copyright © 1994 by American Society of Clinical Oncology
Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer
GP Browman, C Cripps, DI Hodson, L Eapen, J Sathya and MN Levine
Hamilton Regional Cancer Centre, McMaster University, Ontario, Canada.
PURPOSE: To determine whether the addition of infusional fluorouracil
(I-FU) to standard radiotherapy improves survival at acceptable toxicity in
patients with locally advanced squamous cell head and neck cancer (SCHNC).
PATIENTS AND METHODS: Consenting patients with an Eastern Cooperative
Oncology Group (ECOG) performance status < or = 2; with stage III or IV
SCHNC of the oral cavity, oropharynx, hypopharynx, or larynx; and who were
recommended for radiotherapy with curative intent received 66 Gy of
radiation therapy delivered in 2-Gy fractions once daily 5 days per week
for 6 1/2 weeks. Those in the experimental arm received I-FU 1.2 g/m2/d, as
a 72-hour infusion in the first and third weeks of radiation. Saline
infusions were used in the placebo arm. RESULTS: One hundred seventy-five
patients were randomized (88 to I-FU and 87 to placebo), and the treatment
arms were well balanced. The complete response rate was 68% for I-FU and
56% for placebo (P = .04). The overall median survival duration was 33
months for I-FU and 25 months for placebo (P = .08). Progression-free
survival also favored I- FU (P = .06). Toxicity was greater in I-FU
patients, but did not interfere with the scheduled delivery or completion
of radiation. CONCLUSION: The addition of I-FU to standard radiation in
SCHNC improved the complete response rate and was associated with
beneficial trends in progression-free and overall survival compared with
radiation alone. I-FU patients also experienced greater morbidity, but this
did not compromise delivery of radiotherapy.
 CiteULike  Complore  Connotea  Del.icio.us  Digg  Facebook  Reddit  Technorati  Twitter What's this?
This article has been cited by other articles:
|
|
|
|
 
M. Rastogi, M. Srivastava, K. S. Chufal, M. C. Pant, K. Srivastava, and M. B. Bhatt
Mitomycin and Fluorouracil in Combination with Concomitant Radiotherapy: A Potentially Curable Approach for Locally Advanced Head and Neck Squamous Cell Carcinoma
Jpn. J. Clin. Oncol.,
October 1, 2005;
35(10):
572 - 579.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
K. T. Robbins, P. Kumar, J. Harris, T. McCulloch, A. Cmelak, R. Sofferman, P. Levine, R. Weisman, W. Wilson, E. Weymuller, et al.
Supradose Intra-Arterial Cisplatin and Concurrent Radiation Therapy for the Treatment of Stage IV Head and Neck Squamous Cell Carcinoma Is Feasible and Efficacious in a Multi-Institutional Setting: Results of Radiation Therapy Oncology Group Trial 9615
J. Clin. Oncol.,
March 1, 2005;
23(7):
1447 - 1454.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Jeremic, B. Milicic, A. Dagovic, Z. Vaskovic, and L. Tadic
Radiation Therapy With or Without Concurrent Low-Dose Daily Chemotherapy in Locally Advanced, Nonmetastatic Squamous Cell Carcinoma of the Head and Neck
J. Clin. Oncol.,
September 1, 2004;
22(17):
3540 - 3548.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
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.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. E.W. Cohen, M. W. Lingen, and E. E. Vokes
The Expanding Role of Systemic Therapy in Head and Neck Cancer
J. Clin. Oncol.,
May 1, 2004;
22(9):
1743 - 1752.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Trotti and S. M. Bentzen
The Need for Adverse Effects Reporting Standards in Oncology Clinical Trials
J. Clin. Oncol.,
January 1, 2004;
22(1):
19 - 22.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A. Argiris, D. J. Haraf, M. S. Kies, and E. E. Vokes
Intensive Concurrent Chemoradiotherapy for Head and Neck Cancer with 5-Fluorouracil- and Hydroxyurea-Based Regimens: Reversing a Pattern of Failure
Oncologist,
August 1, 2003;
8(4):
350 - 360.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. A. Bonner, K. P. Raisch, H. Q. Trummell, F. Robert, R. F. Meredith, S. A. Spencer, D. J. Buchsbaum, M. N. Saleh, M. A. Stackhouse, A. F. LoBuglio, et al.
Enhanced Apoptosis With Combination C225/Radiation Treatment Serves as the Impetus for Clinical Investigation in Head and Neck Cancers
J. Clin. Oncol.,
November 1, 2000;
18(90001):
47s - 53.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Jeremic, Y. Shibamoto, B. Milicic, N. Nikolic, A. Dagovic, J. Aleksandrovic, Z. Vaskovic, and L. Tadic
Hyperfractionated Radiation Therapy With or Without Concurrent Low-Dose Daily Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Prospective Randomized Trial
J. Clin. Oncol.,
April 7, 2000;
18(7):
1458 - 1464.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. E. Vokes, M. S. Kies, D. J. Haraf, K. Stenson, M. List, R. Humerickhouse, M. E. Dolan, H. Pelzer, L. Sulzen, M. E. Witt, et al.
Concomitant Chemoradiotherapy as Primary Therapy for Locoregionally Advanced Head and Neck Cancer
J. Clin. Oncol.,
April 1, 2000;
18(8):
1652 - 1661.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. Calais, M. Alfonsi, E. Bardet, C. Sire, T. Germain, P. Bergerot, B. Rhein, J. Tortochaux, P. Oudinot, and P. Bertrand
Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and Radiation Therapy for Advanced-Stage Oropharynx Carcinoma
J Natl Cancer Inst,
December 15, 1999;
91(24):
2081 - 2086.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. R. Posner, P. G. Johnston, R. B. Tishler, J. Andersen, M. Fiorentino, P. M. Busse, L. A. Cavacini, A. D. Colevas, J. Clark, and C. M. Norris
The Prognostic Value of Thymidylate Synthase and p53 Expression in Patients Treated with Induction Chemotherapy for Squamous Cell Carcinoma of the Head and Neck
Oncologist,
December 1, 1998;
3(6):
424 - 431.
[Abstract]
[Full Text]
|
|
|
|
