Phase III Study of Gefitinib Compared With Intravenous Methotrexate for Recurrent Squamous Cell Carcinoma of the Head and Neck

Stewart, J.S.W.; Cohen, Ezra E.W.; Licitra, Lisa; Herpen, Carla M.L. van; Khorprasert, Chonlakiet; Soulières, Denis; Vodvárka, P; Rischin, Danny; Garin, A.; Hirsch, Fred R.; Varella‐Garcia, Marileila; Ghiorghiu, Serban; Hargreaves, Laura; Armour, Alison; Speake, Georgina; Swaisland, Alan; Vokes, Everett E.

doi:10.1200/jco.2008.17.0530

Cited by 357 publications

(200 citation statements)

References 23 publications

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“…Although Gefitinib and Methotrexate plus 5-FU were not found to increase survival, significant improvement in QOL was observed in gefitinib arm. It was different as recorded in Stewart et al and Cohen et al 15,18 It could be because Cohen et al study documented QOL measurement with patients receiving 250 mg of Gefitinib and in Stewart et al study multiple QOL instrument were used which might have resulted in poor patients compliance rate.…”

Section: Discussionmentioning

confidence: 96%

Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma

Kushwaha

Gupta

Husain

et al. 2015

Cancer Biology & Therapy

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Section: Discussionmentioning

confidence: 96%

Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma

Kushwaha

Gupta

Husain

et al. 2015

Cancer Biology & Therapy

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“…Molecularly targeted agents show lower response rates, ranging from 10 to 13% for the monoclonal anti-EGFR antibody cetuximab 60 to 1 to 11% for the tyrosine kinase inhibitors erlotinib 61 and gefitinib. [62][63][64][65][66] For patients with excellent performance status, normal end-organ function, and no significant comorbidities, combination chemotherapy regimens are recommended. Most frequently used are two-drug combination regimens (cisplatin þ 5-FU, 67,68 cisplatin þ paclitaxel, 69,70 cisplatin þ docetaxel, [71][72][73][74] carboplatin þ taxane [75][76][77] ) and are associated with improved response rates compared with single agent, but they are also associated with increased toxicity and no statistically significant survival benefit.…”

Section: Chemotherapy In Metastatic Diseasementioning

confidence: 99%

The Role of Chemotherapy in the Management of Patients with Head and Neck Cancer

Savvides

2010

Seminars in Plastic Surgery

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Recent advances in the management of patients with head and neck cancer point to an expanding role of chemotherapy, resulting in an increased involvement of the medical oncologist in the multidisciplinary care of these patients. This review focuses on patients with squamous cell carcinoma of the oral cavity, pharynx, and larynx. A comprehensive review of the clinical trial data that have defined new standards of care and a detailed presentation of widely used chemotherapeutic regimens, including both cytotoxic and molecularly targeted agents, are presented. Information on human papilloma virusassociated squamous cell cancer of the head and neck is presented, and implications in the clinical management of this subgroup of patients based on the epidemiologic and pathologic characteristics are discussed.KEYWORDS: Cancer of the head and neck, chemotherapy, squamous cell carcinoma Approximately 48,000 new cases of head and neck cancer were expected in the United States in 2009 alone, 1 and more than 600,000 new cases will be diagnosed worldwide. Head and neck cancer accounts for 3 to 4% of all cancer diagnoses in Western countries, 2,3 and its incidence is higher in southeast Asia and in Africa where it accounts for 8 to 10% of all cancers. 4 Overall, head and neck cancer represents the eighth most common cause of cancer death.Historically, treatment of patients with squamous cell carcinoma of the head and neck (SSCHN) has primarily been driven by surgical interventions and continued advances in radiation therapy (RT) treatment planning and delivery. In this setting of complex treatment algorithms, recent advances in the management of patients with head and neck cancer point to an expanding role of chemotherapy and therefore an increased involvement of the medical oncologist in the multidisciplinary care of these patients.The scope of this review is to provide a comprehensive description of expanding chemotherapeutic options, including both cytotoxic and molecularly targeted agents, that are applicable to patients diagnosed with squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx. Data on patients diagnosed with cancer of the nasopharynx will be presented separately because of its distinct etiology, pathology, and response to treatment modalities.Chemotherapy alone does not have curative potential. As a result, it does not have a defined role

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“…However, 2 phase III randomized trials did not show survival benefit of single-agent gefitinib over standard methotrexate (Stewart et al, 2009) or of docetaxel plus gefitinib versus docetaxel plus placebo in patients with recurrent or metastatic HNSCC (Argiris et al, 2009). Multiple studies of the combination of gefitinib with RT or CRT in locally advanced HNSCC have been conducted.…”

Section: Gefitinibmentioning

confidence: 99%

Novel Chemoradiotherapy Regimens Incorporating Targeted Therapies in Locally Advanced Head and Neck Cancers

Rathore¹

2012

Head and Neck Cancer

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A forest plot analysis was done to assess whether certain patient groups benefitted with the addition of cetuximab to RT. In this analysis, factors which were associated with a potential increased benefit included presence of oropharyngeal tumors, concomitant boost RT, early T stage (T1-T3), high Karnofsky performance score (90%-100%), male sex, and age < 65 years. These results are provocative but given that the trial was not powered for this subgroup analysis, they should be interpreted with caution.Patients who received cetuximab commonly developed an acneiform rash (83.7%); the severity of the rash was grade 3-4 in 16.8% patients. Infusion-related reactions were also seen in 15.4% patients; in 3.9% patients these were of grade 3/4 severity. However, in-field toxicities, such as mucositis, dermatitis, and dysphagia did not significantly increase with the addition of cetuximab to RT. Quality-of-life parameters were not adversely affected by the addition of cetuximab. This study allowed different RT fractionation regimens which may have impacted results and survival outcomes.

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Phase III Study of Gefitinib Compared With Intravenous Methotrexate for Recurrent Squamous Cell Carcinoma of the Head and Neck

Cited by 357 publications

References 23 publications

Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma

Gefitinib, Methotrexate and Methotrexate plus 5-Fluorouracil as palliative treatment in recurrent head and neck squamous cell carcinoma

The Role of Chemotherapy in the Management of Patients with Head and Neck Cancer

Novel Chemoradiotherapy Regimens Incorporating Targeted Therapies in Locally Advanced Head and Neck Cancers

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