Development of targeted therapy for squamous cell carcinomas of the head and neck

References

• Jemal A, Siegel R, Ward E et al. Cancer statistics, 2009. CA Cancer J. Clin.59, 225–249 (2009).
   PubMed Web of Science ®Google Scholar
• Mendelsohn J, Baselga J. Status of epidermal growth factor receptor antagonists in the biology and treatment of cancer. J. Clin. Oncol.21(14), 2787–2799 (2003).
   PubMed Web of Science ®Google Scholar
• Salomon DS, Brandt R, Ciardiello F, Normanno N. Epidermal growth factor-related peptides and their receptors in human malignancies. Crit. Rev. Oncol. Hematol.19(3), 183–232 (1995).
   PubMed Web of Science ®Google Scholar
• Citri A, Yarden Y. EGF–ErbB signaling: towards the systems level. Nat. Rev. Mol. Biol.7(7), 505–516 (2006).
   PubMed Web of Science ®Google Scholar
• Hynes NE, Lane HA. ErbB receptors and cancer: the complexity of targeted inhibitors. Nat. Rev. Cancer5(5), 341–354 (2005).
   PubMed Web of Science ®Google Scholar
• Normanno N, Bianco C, De Luca A, Maiello MR, Salomon DS. Target-based agents against ErbB receptors and their ligands: a novel approach to cancer treatment. Endocr. Relat. Cancer10(1), 1–21 (2003).
   PubMed Web of Science ®Google Scholar
• Li S, Schmitz KR, Jeffrey PD, Wiltzius JJ, Kussie P, Ferguson KM. Structural basis for inhibition of the epidermal growth factor receptor by cetuximab. Cancer Cell7(4), 301–311 (2005).
   PubMed Web of Science ®Google Scholar
• Fan Z, Lu Y, Wu X, Mendelsohn J. Antibody-induced epidermal growth factor receptor dimerization mediates inhibition of autocrine proliferation of A431 squamous carcinoma cells. J. Biol. Chem.269(44), 27595–27602 (1994).
   PubMed Web of Science ®Google Scholar
• Goldstein NI, Prewett M, Zuklys K, Rockwell P, Mendelsohn J. Biological efficacy of a chimeric antibody to the epidermal growth factor in a human tumor xenograft model. Clin. Cancer Res.1, 1311–1318 (1995).
   PubMed Web of Science ®Google Scholar
• Prewett M, Rockwell P, Rockwell RF et al. The biologic effects of C225, a chimeric monoclonal antibody to the EGFR, on human prostate carcinoma. J. Immunother. Emphasis Tumor Immunol.19(6), 419–427 (1996).
   PubMed Web of Science ®Google Scholar
• Mendelsohn J, Fan Z. Epidermal growth factor receptor family and chemosensitization. J. Natl Cancer Inst.89(5), 341–343 (1997).
   PubMed Web of Science ®Google Scholar
• Saleh MN, Raisch KP, Stackhouse MA et al. Combined modality therapy of A431 human epidermal cancer using anti-EGFR antibody C225 and radiation. Cancer Biother. Radiopharm.14(6), 451–463 (1999).
   PubMed Web of Science ®Google Scholar
• Baselga J, Pfister D, Cooper MR et al. Phase I studies of anti-epidermal growth factor receptor chimeric antibody C225 alone and in combination with cisplatin. J. Clin. Oncol.18(4), 904–914 (2000).
   PubMed Web of Science ®Google Scholar
• Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for squamous cell carcinoma of the head and neck. N. Engl. J. Med.354(6), 567–578 (2006).
   PubMed Web of Science ®Google Scholar
• Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J. Clin. Oncol.23(34), 8646–8654 (2005).
   PubMed Web of Science ®Google Scholar
• Vermorken JB, Trigo J, Hitt R et al. Open-label, uncontrolled, multicenter Phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J. Clin. Oncol.25(16), 2171–2177 (2007).
   PubMed Web of Science ®Google Scholar
• Vermorken JB, Mesia R, Rivera F et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N. Engl. J. Med.359, 1116–1127 (2008).
   PubMed Web of Science ®Google Scholar
• Milas L, Fan Z, Andratschke N et al. Epidermal growth factor receptor and tumor response to radiation: in vivo preclinical studies. Int. J. Radiat. Oncol. Biol. Phys.58, 966–971 (2004).
   PubMed Web of Science ®Google Scholar
• Bonner J, Harari P, Giralt J et al. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a Phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol.11, 21–27 (2010).
   PubMed Web of Science ®Google Scholar
• Kies MS, Harris J, Rotman MZ et al. Phase II randomized trial of postoperative chemoradiation plus cetuximab for high-risk squamous cell carcinoma of the head and neck (RTOG 0234). Int. J. Radiat. Oncol. Biol. Phys.75(3), S15 (2009).
   Google Scholar
• Lefebvre JL. Surgery for laryngopharyngeal SCC in the era of organ preservation. Clin. Exp. Otorhinolaryngol.2(4), 159–163 (2009).
   PubMedGoogle Scholar
• Lefebvre JL, Pointreau Y, Rolland F et al. Groupe Oncologie Radiotherapie Tete Et Cou (GORTEC). Sequential chemoradiotherapy (SCRT) for larynx preservation (LP), preliminary results of the randomized Phase II TREMPLIN study. Presented at: American Society of Clinical Oncology. Orlando, FL, USA, 29 May–2 June 2009.
   Google Scholar
• Baselga J, Trigo JM, Bourhis J et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J. Clin. Oncol.23(24), 5568–5577 (2005).
   PubMed Web of Science ®Google Scholar
• Cohen EE, Kane MA, List MA et al. Phase II trial of gefitinib 250 mg daily in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck. Clin. Cancer Res.11(23), 8418–8424 (2005).
   PubMed Web of Science ®Google Scholar
• Stewart JS, Cohen E, Licitra L et al. A Phase III randomized parallel-group study of gefitinib (IRESSA) versus methotrexate (IMEX) in patients with recurrent squamous cell carcinoma of the head and neck. Presented at: 98th Annual Meeting of the American Association for Cancer Research. Los Angeles, CA, USA, 14–18 April 2007.
   Google Scholar
• Wheeler RH, Jones D, Sharma P et al. Clinical and molecular Phase II study of gefitinib in patients (pts) with recurrent squamous cell cancer of the head and neck (H&N Ca). J. Clin. Oncol.23(16S), 507s (2005) (Abstract 5531).
   Google Scholar
• Soulieres D, Senzer NN, Vokes EE, Hidalgo M, Agarwala SS, Siu LL. Multicenter Phase II study of erlotinib, an oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent or metastatic squamous cell cancer of the head and neck. J. Clin. Oncol.22(1), 77–85 (2004).
   PubMed Web of Science ®Google Scholar
• Ezra E, Cohen W, Rosen F et al. Phase II trial of ZD1839 in recurrent or metastatic squamous cell carcinoma of the head and neck. J. Clin. Oncol.21(10), 1980–1987 (2003).
   PubMedGoogle Scholar
• Argiris, Ghebremichael M, Gilbert J, Burtness B, Forastiere A. A Phase III randomized, placebo-controlled trial of docetaxel (D) with or without gefitinib (G) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN), a trial of the Eastern Cooperative Oncology Group (ECOG). J. Clin. Oncol.27(15S), 6011 (2009).
   Google Scholar
• Simon J, Stewart W, Vokes E et al. Phase III study of gefitinib compared with intravenous methotrexate for recurrent squamous cell carcinoma of the head and neck. J. Clin. Oncol.27, 1864–1871 (2009).
   PubMedGoogle Scholar
• Pollack VA, Savage DM, Baker DA et al. Inhibition of epidermal growth factor receptor-associated tyrosine phosphorylation in human carcinomas with CP-358, 774: dynamics of receptor inhibition in situ and antitumor effects in athymic mice. J. Pharmacol. Exp. Ther.291, 739–748 (1999).
   PubMed Web of Science ®Google Scholar
• Hidalgo M, Siu LL, Nemunaitis J et al. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J. Clin. Oncol.19, 3267–3279 (2001).
   PubMed Web of Science ®Google Scholar
• Harrington K, El-Hariry I, Bourhis J et al. Phase I study of lapatinib in combination with chemoradiation in patients with locally advanced squamous cell carcinoma of the head and neck. J. Clin. Oncol.27(7), 1100–1107 (2009).
   PubMed Web of Science ®Google Scholar
• Ferrara N, Gerber HP. The role of vascular endothelial growth factor in angiogenesis. Acta Haematol.106(4), 148–156 (2001).
   PubMed Web of Science ®Google Scholar
• Kies M, Gibson M, Kim S et al. Cetuximab (C) and bevacizumab (B) in patients with recurrent or metastatic head and neck squamous cell carcinoma (SCCHN). An interim analysis. J. Clin. Oncol.26(15S), 6072 (2008).
   Web of Science ®Google Scholar
• Feinstein T, Raez L, Rajasenan K et al. Pemetrexed (P) and bevacizumab (B) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), updated results of a Phase II trial. J. Clin. Oncol.26(15S), 6069 (2008).
   Google Scholar
• Choong W, Cohen E, Kozloff M et al. Phase II trial of sunitinib in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). J. Clin. Oncol.26(15S), 6064 (2008).
   Google Scholar
• Loncaster JA, Cooper RA, Logue JP et al. Vascular endothelial growth factor (VEGF) expression is a prognostic factor for radiotherapy outcome in advanced carcinoma of the cervix. Br. J. Cancer83(5), 620–625 (2000).
   PubMed Web of Science ®Google Scholar
• Hockel M, Vaupel P. Biological consequences of tumor hypoxia. Semin. Oncol.28(2 Suppl. 8), 36–41 (2001).
   PubMed Web of Science ®Google Scholar
• Gorski DH, Beckett MA, Jaskowiak NT et al. Blockage of the vascular endothelial growth factor stress response increases the antitumor effects of ionizing radiation. Cancer Res.59(14), 3374–3378 (1999).
   PubMed Web of Science ®Google Scholar
• Shemirani B, Crowe DL. Head and neck squamous cell carcinoma lines produce biologically active angiogenic factors. Oral Oncol.36(1), 61–66 (2000).
   PubMed Web of Science ®Google Scholar
• Riedel F, Gotte K, Schwalb J, Wirtz H, Bergler W, Hormann K. Serum levels of vascular endothelial growth factor in patients with head and neck cancer. Eur. Arch. Otorhinolaryngol.257(6), 332–336 (2000).
   PubMed Web of Science ®Google Scholar
• Smith BD, Smith GL, Carter D, Sasaki CT, Haffty BG. Prognostic significance of vascular endothelial growth factor protein levels in oral and oropharyngeal squamous cell carcinoma. J. Clin. Oncol.18(10), 2046–2052 (2000).
   PubMed Web of Science ®Google Scholar
• Folkman J. What is the evidence that tumors are angiogenesis dependent? J. Natl Cancer Inst.82(1), 4–6 (1990).
   PubMed Web of Science ®Google Scholar
• Wachsberger P, Burd R, Dicker AP. Tumor response to ionizing radiation combined with antiangiogenesis or vascular targeting agents: exploring mechanisms of interaction. Clin. Cancer Res.9(6), 1957–1971 (2003).
   PubMed Web of Science ®Google Scholar
• Lothaire P, de Azambuja E, Dequanter D et al. Molecular markers of head and neck squamous cell carcinoma: promising signs in need of prospective evaluation. Head Neck28(3), 256–269 (2006).
   PubMed Web of Science ®Google Scholar
• O-Charoenrat P, Rhys-Evans P, Modjtahedi H, Eccles SA. Vascular endothelial growth factor family members aredifferentially regulated by c-ErbB signaling in head and neck squamous carcinoma cells. Clin. Exp. Metastasis18(2), 155–161 (2000).
   PubMed Web of Science ®Google Scholar
• Vokes EE, Cohen EE, Mauer AM et al. A Phase I study of erlotinib and bevacizumab for recurrent or metastatic squamous cell carcinoma of the head and neck (HNC). J. Clin. Oncol.23(16S), 501s (2005) (Abstract 5504).
   Web of Science ®Google Scholar
• Cohen EE, Davis DW, Karrison TG et al. Erlotinib and bevacizumab in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck: a Phase I/II study. Lancet Oncol.10(3), 204–205 (2009).
   PubMedGoogle Scholar
• Feinstein T, Raez L, Rajasenan K et al. Pemetrexed (P) and bevacizumab (B) in patients (pts) with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), updated results of a Phase II trial. J. Clin. Oncol.26(15S), 6069 (2008).
   Google Scholar
• Ceppi P, Volante M, Saviozzi S et al. Squamous cell carcinoma of the lung compared with other histotypes shows higher messenger RNA and protein levels for thymidylate synthase. Cancer107, 1589–1596 (2006).
   PubMed Web of Science ®Google Scholar
• Savvides P, Greskovich J, Bokar J et al. Phase II study of bevacizumab in combination with docetaxel and radiation in locally advanced squamous cell cancer of the head and neck (SCCHN). J. Clin. Oncol.25(18S), 302s (2007) (Abstract 6068).
   Google Scholar
• Choong NW, Haraf DJ, Cohen EE et al. Randomized Phase II study of concomitant chemoradiotherapy with 5-fluorouracil–hydroxyurea (FHX) compared to FHX and bevacizumab (FHXB) in intermediate stage head and neck cancer (HNC). J. Clin. Oncol.25(18S), 302s (2007) (Abstract 6034).
   Google Scholar
• Seiwert TY, Haraf DJ, Cohen E et al. Phase I study of bevacizumab added to fluorouracil and hydroxyurea-based concomitant chemoradiotherapy for poor-prognosis head and neck cancer. J. Clin. Oncol.26(10), 1732–1741 (2008).
   PubMed Web of Science ®Google Scholar
• Choong NW, Cohen EE, Kozloff MF et al. Phase II trial of sunitinib in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). J. Clin. Oncol.26(15S), 332s (2008) (Abstract 6064).
   PubMed Web of Science ®Google Scholar
• Machiels H, Henry S, Zanetta S et al. Phase II Study of sunitinib in recurrent or metastatic squamous cell carcinoma of the head and neck: GORTEC 2006-01. J. Clin. Oncol.27(15S), 6024 (2009).
   Google Scholar
• Saura C, Baselga J, Herbst R et al. Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC). An open-label exploratory study. J. Clin. Oncol.27(15S), 6023 (2009).
   Google Scholar
• Roccaro AM, Hideshima T, Richardson PG et al. Bortezomib as an antitumor agent. Curr. Pharm. Biotechnol.7(6), 441–448 (2006).
   PubMed Web of Science ®Google Scholar
• Milano A, Iaffaioli RV, Caponigro F. The proteasome: a worthwhile target for the treatment of solid tumours? Eur. J. Cancer43(7), 1125–1133 (2007).
   PubMed Web of Science ®Google Scholar
• Scagliotti G. Proteasome inhibitors in the lung cancer. Crit. Rev. Oncol. Hematol.58(3), 177–189 (2006).
   PubMed Web of Science ®Google Scholar
• Adams J. Development of the proteasome inhibitor PS-341. Oncologist7, 9–16 (2002).
   PubMed Web of Science ®Google Scholar
• Lun M, Zhang PL, Pellitteri PK, Law A. Kennedy TL, Brown RE. Nuclear factor-κB pathway as a therapeutic target in head and neck squamous cell carcinoma: pharmaceutical and molecular validation in human cell lines using Velcade and siRNA/NFκB. Ann. Clin. Lab. Sci.35, 251–258 (2005).
   PubMed Web of Science ®Google Scholar
• Van Waes C, Chang AA, Lebowitz PF et al. Inhibition of nuclear factor-κB and target genes during combined therapy with proteasome inhibitor bortezomib and reirradiation in patients with recurrent head-and-neck squamous cell carcinoma. Int. J. Rad. Oncol. Biol. Phys.63(5), 1400–1412 (2005).
   PubMed Web of Science ®Google Scholar
• Hayslip J, Chaudhary U, Green M et al. Bortezomib in combination with celecoxib in patients with advanced solid tumors: a Phase I trial. BMC Cancer7(221), 1–6 (2007).
   PubMedGoogle Scholar
• Davies AM, Ho C, Metzger AS et al. Phase I study of two different schedules of bortezomib and pemetrexed in advanced solid tumors with emphasis on non-small cell lung cancer. J. Thorac. Oncol.2, 1112–1116 (2007).
   PubMed Web of Science ®Google Scholar
• Cohen SJ, Engstrom PF, Lewis NL et al. Phase I study of capecitabine and oxaliplatin in combination with the proteasome inhibitor bortezomib in patients with advanced solid tumors. Am. J. Clin. Oncol.31, 1–5 (2008).
   PubMedGoogle Scholar
• Kubicek GJ, Machtay M, Axelrod RA et al. Phase I trial of bortezomib (VELCADE), cisplatin and radiotherapy for advanced head and neck cancer. J. Clin. Oncol.26(15 Suppl.), S323 (2008).
   Google Scholar
• Lorch JH, Thomas TO, Schmoll HJ. Bortezomib inhibits cell–cell adhesion and cell migration and enhances epidermal growth factor receptor inhibitor-induced cell death in squamous cell cancer. Cancer Res.67, 727–734 (2007).
   PubMedGoogle Scholar
• Dudek AZ, Lesniewski-Kmak K, Shehadeh NJ et al. Phase I study of bortezomib and cetuximab in patients with solid tumours expressing epidermal growth factor receptor. Br. J. Cancer100, 1379–1384 (2009).
   PubMed Web of Science ®Google Scholar
• Chung CH, Aulino J, Muldowney NJ et al. Nuclear factor-κB pathway and response in a Phase II trial of bortezomib and docetaxel in patients with recurrent and/or metastatic head and neck squamous cell carcinoma. Ann. Oncol.21, 864–870 (2010).
   PubMed Web of Science ®Google Scholar
• Barnes CJ, Ohshiro K, Rayala SK, El-Naggar AK, Kumar R. Insulin-like growth factor receptor as a therapeutic target in head and neck cancer. Clin. Cancer Res.13(14), 4291–4299 (2007).
   PubMed Web of Science ®Google Scholar
• Slomainy MG, Black LA, Kibbey MM, Tingler MA, Day TA, Rosenzweig SA. Insulin-like growth factor-1 receptor and ligand targeting in head and neck squamous cell carcinoma. Cancer Lett.248(2), 269–279 (2007).
   PubMedGoogle Scholar
• Abe S, Funato T, Takahashi S et al. Increased expression of insulin-like growth factor 1 is associated with Ara-C resistance in leukemia. Tohoku J. Exp. Med.209(3), 217–228 (2006).
   PubMed Web of Science ®Google Scholar
• Allen GW, Saba C, Armstrong EA et al. Insulin-like growth factor-1 receptor signaling blockade combined with radiation. Cancer Res.67(3), 1155–1162 (2007).
   PubMed Web of Science ®Google Scholar
• Desbois-Mouthon C, Cacheux W, Blivet-Van Eggelpoel MJ et al. Impact of IGF-1R/EGFR cross-talks on hepatoma cell sensitivity of gefitinib. Int. J. Cancer119(11), 2557–2566 (2006).
   PubMed Web of Science ®Google Scholar
• Knowlden JM, Hutchenson IR, Barrow et al. Insulin-like growth factor-1 receptor signaling in tamoxifen-resistant breast cancer: a supporting role of the epidermal growth factor receptor. Endocrinology146(11), 4609–4618 (2005).
   PubMed Web of Science ®Google Scholar
• Wan X, Helman LJ. Effect of insulin-like growth factor II on protecting myoblast cells against cisplatin-induced apoptosis through p70 S6 kinase pathway. Neoplasia4(5), 400–408 (2002).
   PubMedGoogle Scholar
• Yin D, Tamaki N, Parent AD et al. Insulin-like growth factor-1 decreased etoposide-induced apoptosis in glioma cells by increasing bcl-2 expression and decreasing CPP32 activity. Neurol. Res.27(1), 27–35 (2005).
   PubMed Web of Science ®Google Scholar
• Lacy MQ, Alsina M, Fonseca R et al. Phase I, pharmacokinetic and pharmacodynamic study of the anti-insulin like growth factor type 1 receptor monoclonal antibody CP-751871 in patients with multiple myeloma. J. Clin. Oncol.26(19), 3196–3203 (2008).
   PubMed Web of Science ®Google Scholar
• Haluska P, Shaw HM, Batzel GN et al. Phase I dose escalation study of the anti insulin-like growth factor-1 receptor monoclonal antibody CP-751, 871 in patients with refractory solid tumors. Clin. Cancer Res.13(19), 5834–5840 (2007).
   PubMed Web of Science ®Google Scholar
• Karp DD, Paz-Ares LG, Blakely LJ et al. Efficacy of the anti-insulin like growth factor 1 receptor antibody CP-751871 in combination with paclitaxel and carboplatin as first line treatment for advanced non-small cell lung cancer (NSCLC). J. Clin. Oncol.25(18S), 7506 (2007).
   Google Scholar
• Karp DD, Novello S, Cardenal F et al. Continued high activity of figitumumab (CP-751, 871) combination therapy in squamous lung cancer. J. Clin. Oncol.27(15S), (2009).
   Google Scholar
• Postel-Vinay S, Okuno S, Schuetze S et al. Safety, pharmacokinetics and preliminary activity of the anti-IGF-1R antibody CP-751, 871 in patients with sarcoma. Proc. Eur. J. Cancer6(12), 388 (2008).
   Google Scholar
• Higano CS, Yu EY, Whiting SH et al. A Phase I, first in man study of weekly IMC-A12, a fully human insulin like growth factor-1 receptor IgG1 monoclonal antibody, in patients with advanced solid tumors. J. Clin. Oncol.25(18S), 3505 (2007).
   Google Scholar
• Rothenberg ML. Phase I dose-escalation study of the anti-IGF-1R recombinant human IgG1 monoclonal antibody (Mab) IMC-A12, administered every other week to patients with advanced solid tumors. Mol. Target Cancer Ther.12, 84 (2007).
   Google Scholar
• Tolcher AW, Rothenberg ML, Rodon J et al. A Phase I pharmacokinetic and pharmacodynamic study of AMG-479, a fully human monoclonal antibody against insulin-like growth factor type 1 receptor (IGF-1R), in advanced solid tumors. J. Clin. Oncol.25(18S), 3002 (2007).
   Google Scholar
• Sarantopoulus J, Mita AC, Mulay M et al. A Phase IB study of AMG-479, a type 1 insulin-like growth factor receptor (IGF-1R) antibody, in combination with panitumumab (P) or gemcitabine (G). J. Clin. Oncol.26(15S), 3583 (2008).
   Google Scholar
• Clayman GL, Frank DK, Bruso PA, Goepfert H. Adenovirus-mediated wild-type p53 gene transfer as a surgicaladjuvant in head and neck cancers. Clin. Cancer Res.5, 1715–1722 (1999).
   PubMed Web of Science ®Google Scholar
• Clayman GL, El-Naggar AK, Lippman SM et al. Adenovirus-mediated p53 gene transfer in patients with advanced recurrent head and neck squamous cell carcinoma. J. Clin. Oncol.16, 2221–2232 (1998).
   PubMed Web of Science ®Google Scholar
• Nemunaitis J, Hamm J, Clayman GL et al. Tumor response and biomarkers associated with increased survival following adenoviral p53 gene therapy (ADVEXIN) in patients with recurrent squamous cell carcinoma of the head and neck. J. Clin. Oncol.25(18S), 313 (2007) (Abstract 6057).
   PubMedGoogle Scholar
• Goodwin WJ, Esser D, Clayman GL, Nemunaitis J, Yver A. Dreiling L. Randomized Phase II study of intratumoral injections of two dosing schedules using a replication-deficient adenovirus carrying p53 gene (Ad5CMV–p53) in patients with recurrent/refractory head and neck cancer. Proc. Am. Soc. Clin. Oncol.18, 445a (1999) (Abstract 1717).
   Google Scholar
• Bier-Laning CM, VanEcho D, Yver A. A Phase II multi-center study of AdCMV–p53 administered intratumorally to patients with recurrent head and neck cancer. Proc. Am. Soc. Clin. Oncol.18, 431a (1999) (Abstract 1712).
   Google Scholar
• Yoo GH, Moon J, LeBlanc M et al. A Phase II trail of surgery with perioperative INGN 201 (Ad5CMV–p53) gene therapy followed by chemoradiotherapy for advanced, resectable squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx. Report of the Southwest oncology group. Arch. Otolaryngol. Head Neck Surg.135(9), 869–874 (2009).
   PubMedGoogle Scholar
• Ganly I, Kirn D, Eckhardt SG et al. A Phase I study of Onyx-015, an E1B attenuated adenovirus, administered intratumorally to patients with recurrent head and neck cancer. Clin. Cancer Res.6, 798–806 (2000).
   PubMed Web of Science ®Google Scholar
• Nemunaitis J, Ganly I, Khuri F et al. Selective replication and oncolysis in p53 mutant tumors with Onyx-015, an E1B55Kd gene-deleted adenovirus, in patients with advanced head and neck cancer: a Phase II trial. Cancer Res.60, 6359–6366 (2000).
   PubMed Web of Science ®Google Scholar
• Bischoff JR. An adenovirus mutant that replicates selectively in p53-deficient tumor cells. Science274, 373–376 (1996).
   PubMed Web of Science ®Google Scholar
• Khuri FR, Nemunaitis J, Ganly I et al. A controlled trial of intratumoral Onyx-015, a selectively-replicating adenovirus, in combination with cisplatin and 5-FU in patients with recurrent head and neck cancer. Nat. Med.6(8), 879–885 (2000).
   PubMed Web of Science ®Google Scholar
• Gillison ML, Harris J, Westra W et al. Survival outcomes by tumor human papillomavirus (HPV) status in stage III-IV oropharyngeal cancer (OPC) in RTOG 0129. J. Clin. Oncol.27(15 Suppl.), (2009) (Abstract 6003).
   PubMedGoogle Scholar
• Perrone F, Bossi P, Cortelazzi B et al. TP53 mutations and pathologic complete response to neoadjuvant cisplatin and fluorouracil chemotherapy in resected oral cavity squamous cell carcinoma. J. Clin. Oncol.28(5), 761–766 (2010).
   PubMed Web of Science ®Google Scholar
• Holgersson G, Ekman S, Reizenstein J et al. Molecular profiling using tissue microarrays as a tool to identify predictive biomarkers in laryngeal cancer treated with radiotherapy. Cancer Genomics Proteomics7(1), 1–7 (2010).
   PubMedGoogle Scholar
• Silva P, Slevin NJ, Sloan P et al. Use of multiple biological markers in radiotherapy-treated head and neck cancer. J. Laryngol. Otol.14, 1–9 (2010).
   Google Scholar
• Lajer CB, von Buchwald C. The role of human papillomavirus in head and neck cancer. APMIS118(6–7), 510–519 (2010).
   PubMed Web of Science ®Google Scholar