© 1996 by Oxford University Press
Journal of the National Cancer Institute, Vol. 88, No. 13, 890-899,
July 3, 1996
© 1996 Oxford University Press
Larynx Preservation in Pyriform Sinus Cancer: Preliminary Results of a European Organization for Research and Treatment of Cancer Phase III Trial
Centre Oscar Lambret Lille, France
Hospital Claude Huriez Lille, France
Institut Gustave-Roussy Villejuif, France
EORTC Data Centre Brussels, Belgium
Jean-Louis Lefebvre, M.D., Centre Oscar Lambret-BP 307, 59020 Lille (Cedex), France.
Background: As a general rule, surgery whenever possible, followed by irradiation is considered to be the standard treatment for cancer of the hypopharynx, thus sacrificing natural speech. In most patients, surgery includes removal of the larynx. Purpose: A prospective, randomized phase III study was conducted by the European Organization for Research and Treatment of Cancer (EORTC) starting in 1990 to compare a larynx-preserving treatment (induction chemotherapy plus definitive, radiation therapy in patients who showed a complete response or surgery in those who did not respond) with conventional treatment (total laryngectomy with partial pharyngectomy, radical neck dissection, and postoperative irradiation) in previously untreated and operable patients with histologically proven squamous cell carcinomas of the pyriform sinus or aryepiglottic fold, but free of other cancers. Methods: Patients were randomly assigned to one of two treatment arms: 1) immediate surgery with postoperative radiotherapy (50–70 Gy) or 2) induction chemotherapy (cisplatin [100 mg/m2] given as a bolus intravenous injection on day 1, followed by infusion of fluorouracil [1000 mg/m2 per day] on days 1–5). An endoscopic evaluation was performed after each cycle of chemotherapy. After two cycles, only partial and complete responders received a third cycle. Patients with a complete response after two or three cycles of chemotherapy were treated thereafter by irradiation (70 Gy); nonresponding patients underwent conventional surgery with postoperative radiation (50–70 Gy). Salvage surgery was also performed when patients relapsed after chemotherapy and irradiation. The trial was designed to test the equivalence of the two treatment arms; i.e., the induction chemotherapy treatment would be judged equivalent to immediate surgery if the relative risk of death for induction chemotherapy compared with immediate surgery was significantly less than 1.43 using a one-sided hypothesis test at the.05 level of significance. Results: Two hundred two patients entered the trial and were randomly assigned; only 194 were eligible for treatment (94 in the immediate-surgery arm and 100 in the induction-chemotherapy arm). In the induction-chemotherapy arm, complete response was seen in 52 (54%) of 97 patients with local disease (primary tumor) and in 31 (51%) of 61 patients with regional disease (involvement of the neck). Treatment failures at local, regional, and second primary sites occurred at approximately the same frequencies in the immediate-surgery arm (12%, 19%, and 16%, respectively) and in the induction-chemotherapy arm (17%, 23%, and 13%, respectively). In contrast, there were fewer failures at distant sites in the induction-chemotherapy arm than in the immediate-surgery arm (25% versus 36%, respectively; P =.041). The median duration of survival was 25 months in the immediate-surgery arm and 44 months in the induction-chemotherapy arm and, since the observed hazard ratio was 0.86 (logrank test, P =.006), which was significantly less than 1.43, the two treatments were judged to be equivalent. The 3- and 5-year estimates of retaining a functional larynx in patients treated in the induction chemotherapy arm were 42% (95% confidence interval = 31%-53%) and 35% (95% confidence interval = 22%-48%), respectively. Conclusions and Implications: Larynx preservation without jeopardizing survival appears feasible in patients with cancer of the hypopharynx. On the basis of these observations, the EORTC has now accepted the use of induction chemotherapy followed by radiation as the new standard treatment in its future phase III larynx preservation trials. [J Natl Cancer Inst 1996; 88: 890–9]
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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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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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J.-M. Prades, T. M. Schmitt, A. P. Timoshenko, P.-G. Simon, J. de Cornulier, M. Durand, A. Guillot, and C. Martin Concomitant Chemoradiotherapy in Pyriform Sinus Carcinoma Arch Otolaryngol Head Neck Surg, April 1, 2002; 128(4): 384 - 388. [Abstract] [Full Text] [PDF]
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D. J. Adelstein, J. P. Saxton, P. Lavertu, L. A. Rybicki, R. M. Esclamado, B. G. Wood, M. Strome, and M. A. Carroll Maximizing Local Control and Organ Preservation in Stage IV Squamous Cell Head and Neck Cancer With Hyperfractionated Radiation and Concurrent Chemotherapy J. Clin. Oncol., March 1, 2002; 20(5): 1405 - 1410. [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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A. Fortin, C. Couture, R. Doucet, M. Albert, J. Allard, and B. Tetu Does Histologic Grade Have a Role in the Management of Head and Neck Cancers? J. Clin. Oncol., November 1, 2001; 19(21): 4107 - 4116. [Abstract] [Full Text] [PDF]
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I. Doweck, K. T. Robbins, and F. Vieira Analysis of Risk Factors Predictive of Distant Failure After Targeted Chemoradiation for Advanced Head and Neck Cancer Arch Otolaryngol Head Neck Surg, November 1, 2001; 127(11): 1315 - 1318. [Abstract] [Full Text] [PDF]
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 R. A. ORD and R. H. BLANCHAERT JR Current management of oral cancer: A multidisciplinary approach J Am Dent Assoc, November 1, 2001; 132(suppl_1): 19S - 23S. [Abstract] [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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S. Schwartz, D. L. Patrick, and B. Yueh Quality-of-Life Outcomes in the Evaluation of Head and Neck Cancer Treatments Arch Otolaryngol Head Neck Surg, June 1, 2001; 127(6): 673 - 678. [Abstract] [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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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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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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 W. L. Greene, J. Concato, and A. R. Feinstein Claims of Equivalence in Medical Research: Are They Supported by the Evidence? Ann Intern Med, May 2, 2000; 132(9): 715 - 722. [Abstract] [Full Text] [PDF]
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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]
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K. T. Robbins The Evolving Role of Combined Modality Therapy in Head and Neck Cancer Arch Otolaryngol Head Neck Surg, March 1, 2000; 126(3): 265 - 269. [Full Text] [PDF]
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S. Temam, A. Flahault, S. Perie, G. Monceaux, F. Coulet, P. Callard, J.-F. Bernaudin, J. L. St Guily, and P. Fouret p53 Gene Status as a Predictor of Tumor Response to Induction Chemotherapy of Patients With Locoregionally Advanced Squamous Cell Carcinomas of the Head and Neck J. Clin. Oncol., January 14, 2000; 18(2): 385 - 385. [Abstract] [Full Text] [PDF]
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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]
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A. D. Colevas, C. M. Norris, R. B. Tishler, M. P. Fried, H. I. Gomolin, P. Amrein, A. Nixon, C. Lamb, R. Costello, J. Barton, et al. Phase II Trial of Docetaxel, Cisplatin, Fluorouracil, and Leucovorin as Induction for Squamous Cell Carcinoma of the Head and Neck J. Clin. Oncol., November 1, 1999; 17(11): 3503 - 3511. [Abstract] [Full Text] [PDF]
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A. S. Garden, B. S. Glisson, K. K. Ang, W. H. Morrison, S. M. Lippman, R. M. Byers, F. Geara, G. L. Clayman, D. M. Shin, D. L. Callender, et al. Phase I/II Trial of Radiation With Chemotherapy ""Boost"" for Advanced Squamous Cell Carcinomas of the Head and Neck: Toxicities and Responses J. Clin. Oncol., August 1, 1999; 17(8): 2390 - 2390. [Abstract] [Full Text] [PDF]
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M. R. Posner, L. A. Cavacini, M. P. Upton, K. C. Tillman, E. R. Gornstein, and C. M. Norris Jr. Surface Membrane-expressed CD40 Is Present on Tumor Cells from Squamous Cell Cancer of the Head and Neck in Vitro and in Vivo and Regulates Cell Growth in Tumor Cell Lines Clin. Cancer Res., August 1, 1999; 5(8): 2261 - 2270. [Abstract] [Full Text] [PDF]
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B. J. Davidson, K. A. Newkirk, K. W. Harter, C. A. Picken, K. J. Cullen, and R. B. Sessions Complications From Planned, Posttreatment Neck Dissections Arch Otolaryngol Head Neck Surg, April 1, 1999; 125(4): 401 - 405. [Abstract] [Full Text] [PDF]
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A. A. Mancuso, S. K. Mukherji, I. Schmalfuss, W. Mendenhall, J. Parsons, F. Pameijer, R. Hermans, and P. Kubilis Preradiotherapy Computed Tomography as a Predictor of Local Control in Supraglottic Carcinoma J. Clin. Oncol., February 1, 1999; 17(2): 631 - 631. [Abstract] [Full Text] [PDF]
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D. J. Haraf, M. Kies, A. W. Rademaker, K. Stenson, B. Mittal, H. Pelzer, B. Wenig, M. E. Witt, L. Sulzen, R. R. Weichselbaum, et al. Radiation Therapy With Concomitant Hydroxyurea and Fluorouracil in Stage II and III Head and Neck Cancer J. Clin. Oncol., February 1, 1999; 17(2): 638 - 638. [Abstract] [Full Text] [PDF]
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P. Lavertu, D. J. Adelstein, J. P. Saxton, M. Secic, I. Eliachar, M. Strome, M. A. Larto, and B. G. Wood Aggressive Concurrent Chemoradiotherapy for Squamous Cell Head and Neck Cancer: An 8-Year Single-Institution Experience Arch Otolaryngol Head Neck Surg, February 1, 1999; 125(2): 142 - 148. [Abstract] [Full Text] [PDF]
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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]
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H. T. Hoffman, L. H. Karnell, G. F. Funk, R. A. Robinson, and H. R. Menck The National Cancer Data Base Report on Cancer of the Head and Neck Arch Otolaryngol Head Neck Surg, September 1, 1998; 124(9): 951 - 962. [Abstract] [Full Text] [PDF]
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D. M. Brizel, M. E. Albers, S. R. Fisher, R. L. Scher, W. J. Richtsmeier, V. Hars, S. L. George, A. T. Huang, and L. R. Prosnitz Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer N. Engl. J. Med., June 18, 1998; 338(25): 1798 - 1804. [Abstract] [Full Text] [PDF]
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