An open-label, randomized, study of h-R3mAb (nimotuzumab) in patients with advanced (stage III or IVa) squamous cell carcinoma of head and neck (SCCHN): Four-year survival results from a phase IIb study.

Babu, K Govind; Viswanath, Lokesh; Reddy, Balaswamy; Shenoy, Kalpana; Shenoy, Ashok M.; Naveen, Thota; Joseph, Bindhu; Vidyasagar, M S; Bonanthaya, Ravikiran; Pasha, C. T.; Bapsy, P P; Aravind, A S; Eswaraiah, Anand; Nk, Gupta

doi:10.1200/jco.2010.28.15_suppl.5530

Cited by 26 publications

(17 citation statements)

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“…The results of this study were comparable with other studies conducted in the past with similar combination [8]. On the other hand, even though cetuximab was found to improve overall survival at 5 years in a study [13], it was also found to induce moderate to severe rash in almost 87% patients in another study [14].…”

Section: Discussionsupporting

confidence: 80%

“…As compared to other monoclonal antibodies, nimotuzumab has been proved to be remarkably safe repeatedly [8] [21] [22]. In total, nimotuzumab has been administered to more than 4000 patients and notably no evidence of severe skin rash has been reported.…”

Section: Discussionmentioning

confidence: 99%

“…It has also demonstrated good safety profile in combination with chemo-radiotherapy (CRT) as compared to other monoclonal antibodies [8] [9].…”

Section: Introductionmentioning

confidence: 99%

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Nimotuzumab with Concurrent Chemo-Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN)

Somani¹

2015

JCT

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Background: Head and neck cancers (HNCs) constitute 5% of all cancers globally and are the most common cancers in India. Chemotherapy and radiotherapy have not been proved to be effective in advanced cases and the prognosis remains dismal. This underscores the need for newer treatment options in these cases. Nimotuzumab, an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, was safer when combined with chemo-or radio-therapy. Aim: To evaluate the safety and efficacy of concurrently administered nimotuzumab with chemo-radiotherapy in patients with advanced inoperable squamous cell carcinomas of head and neck (LASCCHN).

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Section: Discussionsupporting

confidence: 80%

Section: Discussionmentioning

confidence: 99%

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Nimotuzumab with Concurrent Chemo-Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN)

Somani¹

2015

JCT

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“…A retrospective study of 835 patients with advanced carcinomas of diverse tissue types suggested that nimotuzumab was well tolerated in combination with CRT, without potentiating the toxicities of concurrent therapy [42]. Randomized phase II data demonstrated that nimotuzumab plus CRT improved median OS compared with RT alone [25,28]. Similarly, sequential lapatinib and RT yielded improvements in ORR compared with placebo/ RT (70% vs. 53%) in the definitive setting [26].…”

Section: Definitive Therapy For Unresectable Diseasementioning

confidence: 99%

Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck

Iberri

Colevas

2015

The Oncologist

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The epidermal growth factor receptor (EGFR) is overexpressed in more than 80% of squamous cell cancers of the head and neck (SCCHN). An evolving understanding of the role of EGFR in tumorigenesis has made the receptor an important therapeutic target in SCCHN. Several EGFR inhibitors (EGFRIs) are active in SCCHN, and their use is associated with improvement in progression-free survival and overall survival in various treatment settings. Nevertheless, EGFR inhibition is associated with significant mucocutaneous toxicity that must be balanced against its anticipated efficacy. This review summarizes the relevant clinical trial experience with EGFRIs, with attention to efficacy, toxicity, and methods of selecting patients most likely to benefit from therapy.

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“…In an open-label, phase IIb randomized study from India, Babu et al evaluated nimotuzumab in patients with locally advanced, inoperative HNSCC (Babu et al, 2010). Of 113 screened patients, 92 were randomized to receive a) RT alone, b) RT plus nimotuzumab, c) RT plus cisplatin, and d) RT plus cisplatin plus nimotuzumab.…”

Section: Nimotuzumab and Chemoradiotherapymentioning

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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An open-label, randomized, study of h-R3mAb (nimotuzumab) in patients with advanced (stage III or IVa) squamous cell carcinoma of head and neck (SCCHN): Four-year survival results from a phase IIb study.

Cited by 26 publications

References 0 publications

Nimotuzumab with Concurrent Chemo-Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN)

Nimotuzumab with Concurrent Chemo-Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN)

Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck

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

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