© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 24, 2081-2086,
December 15, 1999
© 1999 Oxford University Press
Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and Radiation Therapy for Advanced-Stage Oropharynx Carcinoma
Affiliations of authors: G. Calais, Centre Hospitalier
Universitaire Tours, France; M. Alfonsi, Clinique Sainte Catherine
Avignon, France; E. Bardet, Centre René Gauducheau, Nantes,
France; C. Sire, Centre Hospitalier, Lorient, France; T. Germain,
Centre Hospitalier Universitaire, Poitiers, France; P. Bergerot, Centre
Etienne Dolet, Saint Nazaire, France; B. Rhein, Centre Hospitalier
Universitaire, Limoges, France; J. Tortochaux, Centre Jean Perrin,
Clermont-Ferrand, France; P. Oudinot, Centre Guillaume Le
Conquérant, Le Havre, France; P. Bertrand, Département de
Biostatistiques, Université de Tours, France.
Correspondence to: Gilles Calais, M.D., Clinique d'Oncologie et
Radiothérapie, Hopital Bretonneau, 2 Boulevard Tonnellé, 37044 Tours, France
(e-mail: calais{at}med.univ-tours.fr).
Other authors included the following: P. Maillard (Centre Paul
Papin, Angers, France); A. Favre (Centre Hospitalier Régional,
Orléans, France); P. Desprez (Centre Saint Yves, Vannes, France);
J. M. Ardiet (Centre Hospitalier Universitaire, Lyon Sud, France); S.
Chaib-Rassou (Centre Hospitalier, Metz, France); C. Alavena (Centre C.
de Sienne, Nantes, France); A. Delpon (Centre J Bernard, Le Mans,
France); P. Gesta (Centre Hospitalier, Niort, France); J. J. Auregan
(Centre G de Varye, Saint Doulchard, France); P. E. Cailleux (Clinique
Fleming, Tours, France); Y. Raoul (Centre de Radiothérapie, Saint
Gregoire, France)
BACKGROUND: We designed a randomized clinical trial to test whether the addition of three cycles of chemotherapy during standard radiation therapy would improve disease-free survival in patients with stages III and IV (i.e., advanced oropharynx carcinoma). METHODS: A total of 226 patients have been entered in a phase III multicenter, randomized trial comparing radiotherapy alone (arm A) with radiotherapy with concomitant chemotherapy (arm B). Radiotherapy was identical in the two arms, delivering, with conventional fractionation, 70 Gy in 35 fractions. In arm B, patients received during the period of radiotherapy three cycles of a 4-day regimen containing carboplatin (70 mg/m2 per day) and 5-fluorouracil (600 mg/m2 per day) by continuous infusion. The two arms were equally balanced with regard to age, sex, stage, performance status, histology, and primary tumor site. RESULTS: Radiotherapy compliance was similar in the two arms with respect to total dose, treatment duration, and treatment interruption. The rate of grades 3 and 4 mucositis was statistically significantly higher in arm B (71%; 95% confidence interval [CI] = 54%-85%) than in arm A (39%; 95% CI = 29%-56%). Skin toxicity was not different between the two arms. Hematologic toxicity was higher in arm B as measured by neutrophil count and hemoglobin level. Three-year overall actuarial survival and disease-free survival rates were, respectively, 51% (95% CI = 39%-68%) versus 31% (95% CI = 18%-49%) and 42% (95% CI = 30%-57%) versus 20% (95% CI = 10%-33%) for patients treated with combined modality versus radiation therapy alone (P = .02 and .04, respectively). The locoregional control rate was improved in arm B (66%; 95% CI = 51%-78%) versus arm A (42%; 95% CI = 31%-56%). CONCLUSION: The statistically significant improvement in overall survival that was obtained supports the use of concomitant chemotherapy as an adjunct to radiotherapy in the management of carcinoma of the oropharynx.
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F. R. Rosen, D. J. Haraf, M. S. Kies, K. Stenson, L. Portugal, M. A. List, B. E. Brockstein, B. B. Mittal, A. W. Rademaker, M. E. Witt, et al. Multicenter Randomized Phase II Study of Paclitaxel (1-Hour Infusion), Fluorouracil, Hydroxyurea, and Concomitant Twice Daily Radiation with or without Erythropoietin for Advanced Head and Neck Cancer Clin. Cancer Res., May 1, 2003; 9(5): 1689 - 1697. [Abstract] [Full Text] [PDF]
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R. Haddad, R. B. Tishler, C. M. Norris, A. Mahadevan, P. Busse, L. Wirth, L. A. Goguen, C. A. Sullivan, R. Costello, M. A. Case, et al. Docetaxel, Cisplatin, 5-Fluorouracil (TPF)-Based Induction Chemotherapy for Head and Neck Cancer and the Case for Sequential, Combined-Modality Treatment Oncologist, February 1, 2003; 8(1): 35 - 44. [Abstract] [Full Text] [PDF]
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E. E. Vokes, K. Stenson, F. R. Rosen, M. S. Kies, A. W. Rademaker, M. E. Witt, B. E. Brockstein, M. A. List, B. B. Fung, L. Portugal, et al. Weekly Carboplatin and Paclitaxel Followed by Concomitant Paclitaxel, Fluorouracil, and Hydroxyurea Chemoradiotherapy: Curative and Organ-Preserving Therapy for Advanced Head and Neck Cancer J. Clin. Oncol., January 15, 2003; 21(2): 320 - 326. [Abstract] [Full Text] [PDF]
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D. J. Adelstein, Y. Li, G. L. Adams, H. Wagner Jr, J. A. Kish, J. F. Ensley, D. E. Schuller, and A. A. Forastiere An Intergroup Phase III Comparison of Standard Radiation Therapy and Two Schedules of Concurrent Chemoradiotherapy in Patients With Unresectable Squamous Cell Head and Neck Cancer J. Clin. Oncol., January 1, 2003; 21(1): 92 - 98. [Abstract] [Full Text] [PDF]
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G. H. Yoo, M. P. Piechocki, J. F. Ensley, T. Nguyen, J. Oliver, H. Meng, D. Kewson, T. Y. Shibuya, F. Lonardo, and M. A. Tainsky Docetaxel Induced Gene Expression Patterns in Head and Neck Squamous Cell Carcinoma Using cDNA Microarray and PowerBlot Clin. Cancer Res., December 1, 2002; 8(12): 3910 - 3921. [Abstract] [Full Text] [PDF]
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S. El-Sayed, A. Nabid, W. Shelley, J. Hay, J. Balogh, M. Gelinas, R. MacKenzie, N. Read, E. Berthelet, H. Lau, et al. Prophylaxis of Radiation-Associated Mucositis in Conventionally Treated Patients With Head and Neck Cancer: A Double-Blind, Phase III, Randomized, Controlled Trial Evaluating the Clinical Efficacy of an Antimicrobial Lozenge Using a Validated Mucositis Scoring System J. Clin. Oncol., October 1, 2002; 20(19): 3956 - 3963. [Abstract] [Full Text] [PDF]
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M. Machtay, D. I. Rosenthal, D. Hershock, H. Jones, S. Williamson, M. J. Greenberg, G. S. Weinstein, V. M. Aviles, A. A. Chalian, and R. S. Weber Organ Preservation Therapy Using Induction Plus Concurrent Chemoradiation for Advanced Resectable Oropharyngeal Carcinoma: A University of Pennsylvania Phase II Trial J. Clin. Oncol., October 1, 2002; 20(19): 3964 - 3971. [Abstract] [Full Text] [PDF]
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C. Monnerat, S. Faivre, S. Temam, J. Bourhis, and E. Raymond End points for new agents in induction chemotherapy for locally advanced head and neck cancers Ann. Onc., July 1, 2002; 13(7): 995 - 1006. [Abstract] [Full Text] [PDF]
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B. W. Neville and T. A. Day Oral Cancer and Precancerous Lesions CA Cancer J Clin, July 1, 2002; 52(4): 195 - 215. [Abstract] [Full Text] [PDF]
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W. M. Mendenhall, C. G. Morris, S. P. Stringer, R. J. Amdur, R. W. Hinerman, D. B. Villaret, and K. T. Robbins Voice Rehabilitation After Total Laryngectomy and Postoperative Radiation Therapy J. Clin. Oncol., May 15, 2002; 20(10): 2500 - 2505. [Abstract] [Full Text] [PDF]
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C. Taneja, H. Allen, R. J. Koness, K. Radie-Keane, and H. J. Wanebo Changing Patterns of Failure of Head and Neck Cancer Arch Otolaryngol Head Neck Surg, March 1, 2002; 128(3): 324 - 327. [Abstract] [Full Text] [PDF]
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A. Forastiere, W. Koch, A. Trotti, and D. Sidransky Head and Neck Cancer N. Engl. J. Med., December 27, 2001; 345(26): 1890 - 1900. [Full Text] [PDF]
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G. T. Wolf Commentary: Phase III Trial to Preserve the Larynx: Induction Chemotherapy and Radiotherapy Versus Concurrent Chemotherapy and Radiotherapy Versus Radiotherapy--Intergroup Trial R91-11 J. Clin. Oncol., September 15, 2001; 19(90001): 28s - 31. [Full Text] [PDF]
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M. S. Kies, D. J. Haraf, F. Rosen, K. Stenson, M. List, B. Brockstein, T. Chung, B. B. Mittal, H. Pelzer, L. Portugal, et al. Concomitant Infusional Paclitaxel and Fluorouracil, Oral Hydroxyurea, and Hyperfractionated Radiation for Locally Advanced Squamous Head and Neck Cancer J. Clin. Oncol., April 1, 2001; 19(7): 1961 - 1969. [Abstract] [Full Text] [PDF]
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D. I. Rosenthal, J. H. Lee, R. Sinard, D. A. Yardley, M. Machtay, D. M. Rosen, M. J. Egorin, R. S. Weber, G. S. Weinstein, A. A. Chalian, et al. Phase I Study of Paclitaxel Given by Seven-Week Continuous Infusion Concurrent With Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck J. Clin. Oncol., March 1, 2001; 19(5): 1363 - 1373. [Abstract] [Full Text] [PDF]
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M. R. Posner, B. Glisson, G. Frenette, M. Al-Sarraf, A. D. Colevas, C. M. Norris, J. D. Seroskie, D. M. Shin, R. Olivares, and C. A. Garay Multicenter Phase I-II Trial of Docetaxel, Cisplatin, and Fluorouracil Induction Chemotherapy for Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck J. Clin. Oncol., February 15, 2001; 19(4): 1096 - 1104. [Abstract] [Full Text] [PDF]
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A. Eisbruch, D. S. Shewach, C. R. Bradford, J. F. Littles, T. N. Teknos, D. B. Chepeha, L. J. Marentette, J. E. Terrell, N. D. Hogikyan, L. A. Dawson, et al. Radiation Concurrent With Gemcitabine for Locally Advanced Head and Neck Cancer: A Phase I Trial and Intracellular Drug Incorporation Study J. Clin. Oncol., February 1, 2001; 19(3): 792 - 799. [Abstract] [Full Text] [PDF]
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D. Rischin, L. Peters, R. Hicks, P. Hughes, R. Fisher, R. Hart, M. Sexton, I. D'Costa, and R. von Roemeling Phase I Trial of Concurrent Tirapazamine, Cisplatin, and Radiotherapy in Patients With Advanced Head and Neck Cancer J. Clin. Oncol., January 15, 2001; 19(2): 535 - 542. [Abstract] [Full Text] [PDF]
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B. Vikram Re: Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and Radiation Therapy for Advanced-Stage Oropharynx Carcinoma J Natl Cancer Inst, April 19, 2000; 92(8): 657 - 657. [Full Text] [PDF]
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A. A. Forastiere and A. Trotti Radiotherapy and Concurrent Chemotherapy: a Strategy That Improves Locoregional Control and Survival in Oropharyngeal Cancer J Natl Cancer Inst, December 15, 1999; 91(24): 2065 - 2066. [Full Text] [PDF]
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