Larynx preservation clinical trial design: Key issues and recommendations - A consensus panel summary

Head and Neck

Volumn 31, Issue 4, 2009, Pages 429-441

  Lefebvre, Jean Louis ^a   Ang, K Kian ^b  

^a CENTRE OSCAR LAMBRET   (France)

^b UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Carcinoma; Guidelines; Head and neck; Hypopharyngeal; Laryngeal; Larynx preservation

Indexed keywords

AMPHIREGULIN; BETA CATENIN; CARBOPLATIN; CISPLATIN; DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIREGULIN; EXCISION REPAIR CROSS COMPLEMENTING PROTEIN 1; FLUOROURACIL; PROTEIN P53; UVOMORULIN;

CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER SURGERY; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; CLINICAL TRIAL; CONFERENCE PAPER; DISEASE SEVERITY; ESOPHAGUS DISEASE; FEEDING APPARATUS; FUNCTIONAL ASSESSMENT; GENE MUTATION; HEAD AND NECK CANCER; HUMAN; HYPOPHARYNX CANCER; LARYNGECTOMY; LARYNX CANCER; LARYNX DISORDER; ORGAN PRESERVATION; OUTCOME ASSESSMENT; PATIENT SELECTION; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; SELF REPORT; SPEECH; SQUAMOUS CELL CARCINOMA; SWALLOWING; TRACHEOTOMY; VOICE;

CARCINOMA, SQUAMOUS CELL; CLINICAL TRIALS, PHASE III AS TOPIC; COMBINED MODALITY THERAPY; DEGLUTITION; DISEASE-FREE SURVIVAL; GUIDELINES AS TOPIC; HUMANS; HYPOPHARYNGEAL NEOPLASMS; LARYNGEAL NEOPLASMS; LARYNGECTOMY; LARYNX; SPEECH; SURVIVAL RATE;

EID: 65649124927     PISSN: 10433074     EISSN: 10970347     Source Type: Journal    
DOI: 10.1002/hed.21081     Document Type: Conference Paper

References (47)

1. VALCSG (The Department of Veterans Affairs Laryngeal Cancer Study Group). Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med 1991;324:1685-1690.
2. Lefebvre J-L, Chevalier D, Luboinski B, et al. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. J Natl Cancer Inst 1996;88:890-899.
3. Forastiere AA, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med 2003;349:2091-2098.
4. Forastiere AA, Maor M, Weber RS, et al. Long-term results of Intergroup RTOG 91-11: a phase III trial to preserve the larynx-induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. J Clin Oncol (2006 ASCO Annual Meeting Proc Part I) 2006;24(Suppl):5517. Abstract.
5. Marur S, Forastiere AA. Head and neck cancer: changing epidemiology, diagnosis, and treatment. Mayo Clin Proc 2008;83:489-501.
6. Posner MR, Hershock DM, Blajman CR, et al. Cisplatin and fluorouracil alone or with docetaxel in head and neck cancer. N Engl J Med 2007;357:1705-1715.
7. Bonner JA, Harari PM, Giralt J, et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med 2006;354:567-578.
8. Urba S, Wolf G, Eisbruch A, et al. Single-cycle induction chemotherapy selects patients with advanced laryngeal cancer for combined chemoradiation: a new treatment paradigm. J Clin Oncol 2006;24:593-598. (Pubitemid 46630421)
9. Weber RS, Berkey BA, Forastiere A, et al. Outcome of salvage total laryngectomy following organ preservation therapy: the Radiation Therapy Oncology Group trial 91-11. Arch Otolaryngol Head Neck Surg 2003;129:44-49.
10. Spaulding MB, Fischer SG, Wolf GT, et al. Tumor response, toxicity, and survival after neoadjuvant organ-preserving chemotherapy for advanced laryngeal carcinoma. J Clin Oncol 1994;12:1592-1599.
11. Bradford CR, Wolf GT, Carey TE, et al. Predictive markers for response to chemotherapy, organ preservation, and survival in patients with advanced laryngeal carcinoma. Otolaryngol Head Neck Surg 1999;121:534-538.
12. Lefebvre J-L, Chevalier D, Luboinski B, et al. Is laryngeal preservation (LP) with induction chemotherapy (ICT) safe in the treatment of hypopharyngeal SCC? Final results of the EORTC 24891 trial. J Clin Oncol (2004 ASCO Annual Meeting Proc ([(Post(-(Meeting Edition]) 2004;22(Suppl):5531. Abstract.
13. Richard JM, Sancho-Garnier H, Pessey JJ, et al. Randomized trial of induction chemotherapy in larynx carcinoma. Oral Oncol 1998;34:224-228.
14. Calais G, Pointreau Y, Alfonsi M, et al. Induction chemotherapy for larynx preservation. Updated results of the GORTEC 2000-2001 randomized trial comparing docetaxel + cisplatinum + fluorouracil (TPF) versus cisplatinum + fluorouracil (PF). Eur J Cancer Suppl 2007;5:324. Abstract.
15. Lefebvre J, Horiot J, Rolland F, et al. Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers. EORTC protocol 24954-122950 J Clin Oncol (2007 ASCO Annual Meeting Proc Part I) 2007;25(Suppl):LBA6016. Abstract.
16. Bernier J, Cooper JS, Pajak TF, et al. Defining risk levels in locally advanced head and neck cancers: a comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501). Head Neck 2005;27:843-850.
17. Brockstein B, Haraf DJ, Rademaker AW, et al. Patterns of failure, prognostic factors and survival in locoregionally advanced head and neck cancer treated with concomitant chemoradiotherapy: a 9-year, 337-patient, multi-institutional experience. Ann Oncol 2004;15:1179-1186.
18. Li XM, Wei WI, Guo XF, et al. Cervical lymph node metastatic patterns of squamous carcinomas of the upper aerodigestive tract. J Laryngol Otol 1996;110:937-941.
19. Mendenhall WM, Parsons JT, Stringer SP, et al. Stage T3 squamous cell carcinoma of the glottic larynx: a comparison of laryngectomy and irradiation. Int J Radiat Oncol Biol Phys 1992;23:725-732.
20. MacKenzie R, Franssen E, Balogh J, et al. The prognostic significance of tracheostomy in carcinoma of the larynx treated with radiotherapy and surgery for salvage. Int J Radiat Oncol Biol Phys 1998;41:43-51.
21. Pignon JP, Bourhis J, Domenge C, et al. Chemotherapy added to locoregional treatment for head and neck squamous- cell carcinoma: three meta-analyses of updated individual data. Lancet 2000;355:949-955.
22. Lefebvre J-L, Buisett E, Coche-Dequeant B, et al. Epilarynx: pharynx or larynx? Head Neck 1995;17:377-781.
23. Eisbruch A, Thornton AF, Urba S, et al. Chemotherapy followed by accelerated fractionated radiation for larynx preservation in patients with advanced laryngeal cancer. J Clin Oncol 1996;14:2322-2330.
24. Machtay M, Moughan J, Trotti A, et al. Pre-treatment and treatment related risk factors for severe late toxicity after chemo-RT for head and neck cancer: an RTOG analysis. J Clin Oncol (2006 ASCO Annual Meeting Proc Part I) 2006;24(Suppl):5500 Abstract.
25. Rosen CA, Lee AS, Osborne J, et al. Development and validation of the voice handicap index-10. Laryngoscope 2004;114:1549-1556.
26. Hogikyan ND, Sethuraman G. Validation of an instrument to measure voice-related quality of life (V-RQOL). J Voice 1999;13:557-569. (Pubitemid 30007814)
27. Fung K, Lyden TH, Lee J, et al. Voice and swallowing outcomes of an organ-preservation trial for advanced laryngeal cancer. Int J Radiat Oncol Biol Phys 2005;63:1395-1399.
28. List MA, Rutherford JL, Stracks J, et al. Prioritizing treatment outcomes: head and neck cancer patients versus nonpatients. Head Neck 2004;26:163-170.
29. Ronis DL, Duffy SA, Fowler KE, et al. Changes in quality of life over 1 year in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg 2008;134:241-248.
30. Terrell JE, Ronis DL, Fowler KE, et al. Clinical predictors of quality of life in patients with head and neck cancer. Arch Otolaryngol Head Neck Surg 2004;130:401-408.
31. Hoffman HT, Porter K, Karnell LH, et al. Laryngeal cancer in the United States: changes in demographics, patterns of care, and survival. Laryngoscope 2006;116(Suppl 111):1-13.
32. Grandis JR, Melhem MF, Gooding WE, et al. Levels of TGF-alpha and EGFR protein in head and neck squamous cell carcinoma and patient survival. J Natl Cancer Inst 1998;90:824-832.
33. Ang KK, Berkey BA, Tu X, et al. Impact of epidermal growth factor receptor expression on survival and pattern of relapse in patients with advanced head and neck carcinoma. Cancer Res 2002;62:7350-7356.
34. Sok JC, Coppelli FM, Thomas SM, et al. Mutant epidermal growth factor receptor (EGFRvIII) contributes to head and neck cancer growth and resistance to EGFR targeting. Clin Cancer Res 2006;12:5064-5073.
35. Mountzios G, Handra-Luca A, Hernandez J, et al. ERCC1 immunohistochemical expression and cancer-specific survival in patients with locally advanced squamous- cell carcinoma of the head and neck treated by cisplatin-based induction chemotherapy. J Clin Oncol (2007 ASCO Annual Meeting Proc Part I) 2007;25(Suppl):6011. Abstract.
36. El-Naggar AK, Lippman SM, Johnson FM, et al. Correlation of Src activation with epithelial-mesenchymal transformation and aggressive features of head and neck squamous carcinoma. J Clin Oncol (2007 ASCO Annual Meeting Proc Part I) 2007;25(Suppl):6026.Abstract.
37. Khambata-Ford S, Garrett CR, Meropol NJ, et al. Expression of epiregulin and amphiregulin and K-ras mutation status predict disease control in metastatic colorectal cancer patients treated with cetuximab. J Clin Oncol 2007;25:3230-3237.
38. Poeta ML, Manola J, Goldwasser MA, et al. TP53 mutations and survival in squamous-cell carcinoma of the head and neck. N Engl J Med 2007;357:2552-2561.
39. Rosenbek JC, Robbins JA, Roecker EB, et al. A penetration- aspiration scale. Dysphagia 1996;11:93-98.
40. Rademaker AW, Pauloski BF. Oropharyngeal swallow efficiency as a representative measure of swallowing function. J Speech Hearing Res 1994;37:314-325. (Pubitemid 24116494)
41. Ludlow CL, Sonies BC, Humbert IA, et al. Validity and reliability of the swallowing safety scale. Poster presentation at The Fifteenth Annual Dysphagia Research Society Meeting, March 8-10, 2007. Poster # 59; Conference book p. 362.
42. List MA, Ritter-Sterr C, Lansky SB. A performance status scale for head and neck cancer patients. Cancer 1990;66:564-569. (Pubitemid 20233457)
43. Chen AY, Frankowski R, Bishop-Leone J, et al. The development and validation of a dysphagia-specific quality-of-life questionnaire for patients with head and neck cancer: the M.D. Anderson Dysphagia Inventory. Arch Otolaryngol Head Neck Surg 2001;127:870-876.
44. Karnell M, Melton J, Childes T, et al. Reliability of clinician- based (GRBAS and CAPE-V) and patient-based (VRQOL and IPVI) documentation of voice disorders. J Voice 2007;21:576-590.
45. Rosenthal DI, Mendoza TR, Chambers MS, et al. Measuring head and neck cancer symptom burden: the development and validation of the M. D. Anderson symptom inventory, head and neck module. Head Neck 2007;29:923-931.
46. Bjordal K, Hammerlid E, Ahlnder-Elmqvist M, et al. Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35. J Clin Oncol 1999;17:1008-1019.
47. Op de Coul BM, Ackerstaff AH, van As CJ, et al. Quality of life assessment in laryngectomized individuals: do we need additions to standard questionnaires in specific clinical research projects? Clin Otolaryngol 2005;30:169-175.