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Review

Recent advances in the management of squamous cell carcinoma of the head and neck

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Pages 99-110 | Published online: 10 Jan 2014

References

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  • ••A comprhensive review of head and neckcancer in general.
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  • •The study compared combination of cisplatin and 5-fluorouracil with single agents in recurrent head and neck cancer. The response rate of the combination was higher than single agents, but the median survival rates were not different between the combination and single agents.
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  • •The SWOG study compared cisplatin plus fluorouracil versus carboplatin plus 5-fluorouracil versus single-agent methotrexate in recurrent and metastatic head and neck cancer. The combination chemotherapy resulted in improved response rates, but was associated with an increased toxicity and no improvement in overall survival.
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  • •The study compared cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The study showed that the CABO regimen has no advantage over the CF regimen. Both combinations showed improved response rates, but also more toxicity and no improvement in overall survival in comparison with cisplatin alone.
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  • •The ECOG study evaluated paclitaxel in patients with advanced head and neck cancer in a Phase II setting. The response rate was 40% and the median duration of response was 4.5 months with a median survival of 9.2 months and a 1-year survival rate of 33%. The study concluded that paclitaxel is an active agent for the treatment of HNSCC.
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  • •The study assessed the activity and toxicity profile of combined paclitaxel, ifosfamide, and cisplatin (TIP) in patients with recurrent or metastatic HNSCC. TIP had major activity, with a 58% objective response rate, 17% complete response rate, durable complete responses (six of nine persisting) and relatively well-tolerated toxicity, with no toxic deaths.
  • Forastiere AA, Leong T, Rowinsky E et al. Phase III comparison of high-dose paclitaxel + cisplatin + granulocyte colony-stimulating factor versus low-dose paclitaxel + cisplatin in advanced head and neck cancer: Eastern Cooperative Oncology Group Study E1393. j Clin. 0=1 19(4), 1088–1095 (2001).
  • •The ECOG study examined dose-response effects and the activity of pacfitaxel combined with cisplatin in patients with incurable HNSCC. Two aims of treatments were compared: Arm A, paclitaxel 200 mg/m2 (24 h infusion) + cisplatin 75 mg/m2 + granulocyte colony-stimulating factor or Arm B, paclitaxel 135 mg/m2 (24-hour infusion) + cisplatin 75 mg/m2. This phase III multicenter trial showed no advantage for high-dose paclitaxel and excessive hematologic toxicity associated with both regimens.
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  • •The study evaluated the antitumor activity and toxicity profile of a combination of paclitaxel, ifosfamide and carboplatin (TIC) in patients with recurrent or metastatic HNSCC. The TIC regimen had high antitumor activity in patients with recurrent or metastatic HNSCC, with a 59% major response rate (17% complete response rate with relatively durable complete responses). Neutropenic fever developed in 30% of the patients, the incidence of which might have been decreased by prophylactic antibiotics or hematopoietic growth factor support.
  • Papadimitrakopoulou VA, Glisson BS, Khuri FR et al. Phase II study of induction chemotherapy with paclitaxel, ifosfamide and carboplatin in patients with locally advanced squamous cell carcinoma of the head and neck. Proc. Am. Soc. Clin. Oncol New Orleans, USA abstract 1659 (2000).
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  • •Phase II study designed to evaluate the activity, safety and tolerability of docetaxel in patients with advanced, incurable or recurrent HNSCC who had not received prior palliative chemotherapy. Docetaxel has major activity against HNSCC.
  • Schoffski P, Catimel G, Planting AS et al. Docetaxel and cisplatin: an active regimen in patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck. Results of a Phase II study of the EORTC Early Clinical Studies Group. Ann. 0=1 10(1), 119–122 (1999).
  • •Multicenter Phase II study in patients with locally advanced, recurrent or metastatic HNSCC to evaluate the antitumor efficacy and toxicity of the combination docetaxel and cisplatin. This combination is feasible and active in locally advanced, recurrent and metastatic HNSCC.
  • Forastiere A, Glisson BS, Murphy B, O'Connell B. A Phase II study of docetaxel and cisplatin in patients with locally advanced, recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), not curable by standard therapy. Proc. Am. Soc. Gun. awl, Los Angeles, USA abstract 1540 (1998).
  • Janinis J, Papadakou M, Xidakis E et al. Combination chemotherapy with docetaxel, cisplatin and 5-fluorouracil in previously treated patients with advanced/ recurrent head and neck cancer: a Phase II feasibility study. Am j Gun. Oncol 23(2), 128–131 (2000).
  • Colevas AD, Norris CM, Tishler RB et al. Phase II trial of docetaxel, cisplatin, fluorouracil and leucovorin as induction for squamous cell carcinoma of the head and neck [See Comments]. j Clin. 17(11), 3503–3511 (1999).
  • •The study evaluated the toxicity and efficacy of a 4-day regimen of docetaxel, cisplatin, fluorouracil and leucovorin (TPFL4). The overall clinical response rate to TPFL4 was 93%, with 63% complete responses and 30% partial responses. TPFL4 has an acceptable toxicity profile in good performance-status patients. Modification of the 5-day TPFL regimen (TPFL5: shorter chemotherapy infusion time, earlier intervention with growth factors and antibiotics) led to fewer episodes of febrile neutropenia and hospitalization.
  • Posner MR, Glisson B, Frenette G et al. 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 19(4), 1096–1104 (2001).
  • •The Phase I-111, multi-institutional trial determined the maximum tolerated dose (MTD) of cisplatin in an induction chemotherapy regimen of docetaxel, cisplatin and fluorouracil (TPF) for HNSCC and evaluated the safety, tolerability and efficacy of the regimen at MTD. TPF induction chemotherapy can be delivered safely with a cisplatin dose of 100 mg/m2 in previously untreated patients with HNSCC. The regimen is associated with a high rate of primary site clinical and pathologic complete responses.
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  • •The study examined the presence of EGFR in normal and neoplastic human urotheliurn. The findings suggest that the presence of a high intensity of staining for the EGFR in human bladder tumors is associated with poor differentiation and invasion.
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  • •This study showed that elements of the signal transduction pathway activated by EGF determined cellular sensitivity to cisplatin and that a cisplatin-resistant phenotype is associated with a defect in this signal transduction pathway.
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  • 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 [See Comments]. Natl Cancer Inst. 90(11), 824–832 (1998).
  • •This study revealed that disease-free survival and cal Ise-specific survival were reduced among patients with higher levels of EGFR or TGF-a. Quantitation of EGFR and TGF-a protein levels in primary HNSCC may be useful in identifying subgroups of patients at high risk of tumor recurrence and in guiding therapy
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  • ••This study indicated that EGFR dysregulation occurs in two steps, the moderate up-regulation of EGFR expression in normal epithelium adjacent to tumor and the further up-regulation of EGFR expression in the change from dysplasia to squamous cell carcinoma. Therefore, EGFR dysregulation might be a useful marker for identifying individuals at risk of tumor development and an intermediate end point in chemoprevention trials.
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  • •The study suggests that the profound in vivo antitumor activity identified in the xenograft setting when C225 is combined with radiation derives from more than simply the antiproliferative and cell cycle effects of EGFR system inhibition. In addition to antiproliferative growth inhibition, EGFR blockade with C225 appears to influence the capacity of human squamous cell cancer to effect DNA repair after exposure to radiation and to express classic markers of tumor angiogenesis.
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  • •The study evaluated the pharmacokinetics and toxicity of C225 in patients with advanced tumors overexpressing EGFR C225 has dose-dependent pharrnacoldnetics and doses that achieve saturation of systemic clearance are well-tolerated. C225 given in combination with cisplatin has biologic activity at pharmacologically relevant doses.
  • Shin DM, Donato NJ, Perez-Soler R et al. Epidermal growth factor receptor-targeted therapy with C225 and cisplatin in patients with head and neck cancer. Clin. Cancer Res. 7(5), 1204–1213 (2001).
  • ••The Phase lb study with C225 incombination with cisplatin in patients with recurrent HNSCC examined the tumor EGFR saturation dose with C225 and the fate of infused C225. Infused C225 binds and significantly saturates tumor EGFR, which may render a high degree of antitumor activity and provides a novel mechanism for targeting cancer therapy for patients who have EGFR expression in their tumors.
  • Hong WK, Arquette M, Nabell L, Needle MN, Waksal HW, Herbst RS. Efficacy and safety of the anti-epidermal growth factor antibody IMC- C225, in combination with cisplatin in patients with recurrent squamous cell carcinoma of the head and neck refractory to cisplatin comtaining chemotherapy. Proc. Am. Soc. Clin. Oncol, San Francisco, USA abstract 895 (2001).
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  • •The antiproliferative activity of ZD-1839 alone or in combination with cytotoxic drugs differing in mechanism(s) of action was evaluated in human ovarian, breast and colon cancer cells that coexpress EGFR and TGF-a. A dose-dependent supra-additive increase in growth inhibition was observed when cancer cells were treated with each cytotoxic drug and ZD-1839. These results demonstrate the antitumor effect of this EGFR-selective tyrosine kinase inhibitor.
  • Baselga J, Herbst R, LoRusso P et al Continuous administration of ZD1839 (Iressa), a novel oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), in patients with five selected tumor types: evidence of activity and good tolerablility. Proc. Am. Soc. Clin. Oncol, New Orleans, USA abstract 686 (2000).
  • Ferry D, Hammond L, Ranson M et al. Intermittent oral ZD1839 (Iressa), a novel epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI), shows evidence of good tolerablitiy and activity: final results from a Phase I study. Proc. Am. Soc. Clin. Oncol, New Orleans, USA abstract 5E (2000).
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  • ••The study reported that normal humancells were highly resistant to ONYX-015-mediated, replication-dependent cytolysis while a wide range of human tumor cells, including numerous carcinoma lines with either mutant or normal p53 gene sequences, were efficiently destroyed. Antitumoral efficacy was documented following intratumoral or iv. administration of ONYX-015 to nude mouse-human tumor xenografts; efficacy with ONYX-015 plus chemotherapy (cisplatin, 5- fluorouraci0 was significantly greater than with either agent alone.
  • Kim D, Hermiston T, McCormick E ONYX-015: clinical data are encouraging [Letter; Comment]. Nature Med. 4 (12), 1341–1342 (1998). A discussion of recent clinical trials of ONYX–015.
  • Kim D, Nemunaitis J, Ganly I et al. A Phase II trial of intratumoral injection with an E1B-deleted adenovius, ONYX-015, in patients with recurrent, refractory head and neck cancer. Proc. Am. Soc. Clin. Oncol, Los Angeles, USA abstract 1509 (1998).
  • Ganly I, Eckhardt SG, Rodriguez GI et al. A Phase I study of Onyx-015, an ElB attenuated adenovirus, administered intratumorally to patients with recurrent head and neck cancer [published erratum appears in Gun. Cancer Res. 6(5), 2120 (2000)1. Clin. Cancer Res. 6(3), 798–806 (2000).
  • 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-fluorouracil in patients with recurrent head and neck cancer [See Comments]. Nature Med. 6(8), 879–885 (2000).
  • ••The Phase 11 trial examined thecombination of intratumoral ONYX-015 injection with cisplatin and 5-fluorouracil in patients with recurrent HNSCC. This study reported substantial objective responses, including a high proportion of complete responses, and acceptable toxic effects of the combination.
  • Clayman GL, El-Naggar AK, Roth JA et al. In vivo molecular therapy with p53 adenovirus for microscopic residual head and neck squamous carcinoma. Cancer Res 55(1), 1–6 (1995).
  • •This study showed the prevention of the establishment of tumors in nude mice, in which tumor cells had been subcutaneouly implanted by transiently introducing exogenous wild-type p53 via an adenoviral vector. These effects were vector dose-dependent but independent on the endogenous wild type or mutated p53 status of the cells.
  • Hamada K, Alemany R, Zhang WW et al. Adenovirus-mediated transfer of a wild- type p53 gene and induction of apoptosis in cervical cancer. Cancer Res. 56(13), 3047–3054 (1996).
  • Liu TJ, el-Naggar AK, McDonnell TJ et al. Apoptosis induction mediated by wild-type p53 adenoviral gene transfer in squamous cell carcinoma of the head and neck. Cancer Res. 55(14), 3117–3122 (1995).
  • 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(6), 2221–2232 (1998).
  • •This study examined the safety and therapeutic potential of Ad-p53 in advanced head and neck cancer. Patients were safely injected intratumorally with Ad-p53. Objective antitumor activity was detected in several patients. The infectious Ad-p53 in body fluids was asymptomatic and suggests that systemic or regional treatment may be tolerable.
  • Beadling C, Guschin D, Witthuhn BA et al Activation of JAK kinases and STAT proteins by interleukin-2 and interferon alpha, but not the T cell antigen receptor, in human T lymphocytes. EMI3013(23), 5605–5615 (1994).

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