Results of a randomized phase III study of nimotuzumab in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in locally advanced squamous cell carcinoma of the head and neck.

Patil, Vijay; Noronha, Vanita; Joshi, Amit; Agarwal, Jitendra; Laskar, Sarbani Ghosh; Budrukkar, Ashwini; Murthy, Vedang; Kannan, Sadhana; Bhattacharjee, Atanu; Chaturvedi, Pankaj; Pai, Prathamesh; Chaukar, Devendra; D’Cruz, Anil; Juvekar, Shashikant; Manjrekar, Aparna; Mathrudev, Vijayalakshmi; Nawale, Kavita Prakash; Bhelekar, Arti; Banavali, Shripad; Prabhash, Kumar

doi:10.1200/jco.2018.36.15_suppl.6000

Cited by 11 publications

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“…Moreover, concurrent chemoradiotherapy constitutes an absolute 6.5% increment in five-year survival compared with radiotherapy alone, which may be attributed to the radio-sensitizing effect of platinum-based chemotherapy [53]. The addition of Cetuximab, an anti-EGFR monoclonal antibody, may help improve patients' prognosis in different settings, including first-line chemotherapy in metastatic or refractory settings and curative settings [54,55]. Robotic surgery for oropharyngeal cancer was approved by the FDA in 2009 and shows comparable survival outcomes with radiotherapy [56,57].…”

Section: Discussionmentioning

confidence: 99%

Epidemiological Trends of Head and Neck Cancer: A Population-Based Study

Guo

Xiao

Chen

et al. 2021

BioMed Research International

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Background. Over the past decades, lots of advance have occurred in the prevention, diagnosis, and treatment of head and neck cancer (HNC). However, the contemporaneous incidence and survival trends, on the basis of population-based registry, have not been reported. Methods. The HNC cancer cases were accessed from the Surveillance, Epidemiology, and End Results (SEER) database. The incidence trend was analyzed by joinpoint analysis, with the survival trend being analyzed by period analysis of relative survival rate (RSR) and Kaplan-Meier analyses. Cox regression analysis was performed to identify the prognostic factors for overall survival. Results. The general incidence trend of HNC increases slightly, with an average annual percentage change of 0.6%, along with five fluctuating segments. The improvement of net survival over the past decades was showed by increasing 60-month RSR, from 54.1% to 56.0% to 60.9% to 66.8%, which was further confirmed by Kaplan-Meier analyses. Moreover, disparities in incidence and survival patterns can be observed in different subgroups. Conclusion. A fluctuating incidence pattern and an ever-improving survival were observed in HNC over time.

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Section: Discussionmentioning

confidence: 99%

Epidemiological Trends of Head and Neck Cancer: A Population-Based Study

Guo

Xiao

Chen

et al. 2021

BioMed Research International

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“…Nimotuzumab also increased response rates when combined with CRT, as reported by Ramakrishnan et al With 20 patients in each group, when combining with nimotuzumab, total response (including complete response and partial response) rose to 100%, compared with 70% in the group treated with radiotherapy alone (p = 0.02) [5]. Similarly, Patil et al demonstrated that nimotuzumab in combination with cisplatin and radiotherapy was superior to cisplatin and radiotherapy in improving the PFS, duration of locoregional control and disease-free survival in locally advanced squamous head and neck cancer [13].…”

Section: Discussionmentioning

confidence: 97%

Combined Nimotuzumab with Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Hoa

Huy

2020

Cureus

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Background Most head and neck cancers (HNCs), specifically squamous cell carcinoma, express epidermal growth factor and are associated with an inadequate response to radiotherapy and chemotherapy. Anti-epidermal growth factor receptor (EGFR) monoclonal antibodies (mAb) increase response rates and survival when combined with radiotherapy or chemoradiotherapy (CRT). This study evaluates the outcome and toxicity of the nimotuzumab-CRT combination for stage III, IVa, and IVb squamous cell carcinoma of the head and neck. Methods Eighty-seven patients with squamous cell carcinoma of the head and neck, stage III, IVa, or IVb were enrolled in a prospective comparative study. The nimotuzumab plus CRT group consisted of patients who received nimotuzumab 200 mg every week for six consecutive weeks chemoradiation therapy; cisplatin 30 mg/m 2 every week for six weeks; radiotherapy of 2-Gy/fraction, five fractions/week for a total dose of 70 Gy; and neck lymph node invasion prophylaxis at 50 Gy. The CRT alone arm was treated with CRT (without nimotuzumab). Results Tumor response rate of 90.6% was achieved in nimotuzumab plus CRT group (complete response: 58.1%), and 70.4% in CRT alone arm (complete response: 38.6%; p=0.029). The lymph node response rate was 83.4% in nimotuzumab plus CRT group (complete response: 46.7%), and 73.0% in CRT group (complete response: 23.0%). The general response rate in nimotuzumab plus CRT group was 86.0% (complete response: 48.8%), and 68.0% in CRT alone arm (complete response: 36.0%). Twelve-month overall survival (OS) was 75.1% for the nimotuzumab plus CRT group and 54.4% for the CRT group. The 24-month survival was 48.0% (nimotuzumab plus CRT group) and 29.0% (CRT alone arm). The median OS was 20 months and 13 months for nimotuzumab plus CRT group and CRT alone arm, respectively. Progression-free survival (PFS) in the nimotuzumab plus CRT group at 12 months and 24 months was 64.2% and 37.4%, respectively. PFS in the CRT group at 12 months and 24 months was 39.5% and 21.3%, respectively. Infusion reaction presented mildly in two of 43 patients in the nimotuzumab plus CRT group, and no shock occurred. Other toxicity occurrences were similar between the two groups, mainly in grade I, II. Skin rash (grade I only) occurred at a rate of 4.7% in the nimotuzumab plus CRT group. Conclusion 1 2

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“…e landmark TAX 323 trial established the role of induction TPF regimen in locally advanced HNSCC; however, the survival rates for the above group continued to be poor [9]. As nimotuzumab has shown promising activity with minimal added toxicity when combined with chemoradiation in locally advanced HNSCC, our study was designed to establish an effective safe and tolerable regimen using TPF + N as induction treatment for locally advanced HNSCC [14].…”

Section: Discussionmentioning

confidence: 99%

“…However, they excluded patients with primary of the oral cavity [19]. Similarly, the study by Patil VM et al only included three patients with oral cavity cancer [14].…”

Section: Discussionmentioning

confidence: 99%

“…However, the addition of cetuximab was associated with significantly increased toxicities such as dermatitis, hypomagnesemia, skin rash, and sepsis [12,13]. Nimotuzumab is yet another anti-EGFR agent which has shown tremendous benefit with minimal added toxicity when used along with CRT in locally advanced HNSCC [14]. Nimotuzumab has also shown greater response rates with no added toxicity when used as an induction agent long with platinum and 5-FU in locally advanced nasopharyngeal cancer [15].…”

Section: Introductionmentioning

confidence: 99%

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Addition of Nimotuzumab to Standard TPF Regimen in Locally Advanced Head and Neck Cancer: A Single Institutional Study

Koramati

Sarathy

Varayathu

et al. 2021

Journal of Oncology

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Background. Induction docetaxel, cisplatin, and 5-fluorouracil (TPF) chemotherapy followed by definitive concurrent chemoradiation remains the standard of care in locally advanced squamous cell carcinoma of head and neck cancers despite which the survival remains low. So, we analyzed the efficacy and adverse effect profile of the addition of nimotuzumab to standard TPF induction chemotherapy. Methods. We included 20 patients with locally advanced squamous cell carcinoma of the head and neck. Patients were administered with induction chemotherapy with nimotuzumab plus docetaxel, cisplatin, and 5-fluorouracil (TPF + N) followed by definitive concurrent chemoradiation with carboplatin. Treatment responses were assessed by PET-CT following induction chemotherapy and concurrent chemoradiation. Response rates, survival, and adverse effects data were tabulated and analyzed using the Kaplan Meier method. Results. At a minimum follow-up of two years, the median progression-free survival (PFS) and median overall survival (OS) were 16 months and 38 months, respectively. PFS and OS were not reached (NR) in patients who showed a complete radiological response (CR). Median PFS and OS in patients who had partial response were 17.6 and 34.5 months, respectively. All subsites of primary including oral cavity, hypopharynx, and oropharynx showed similar response rates and survival. Overall the treatment was well tolerated with predominantly grade 1/2 toxicities. Conclusions. Patients with locally advanced head and neck cancer could possibly have a better response and survival with nimotuzumab added to the standard TPF regimen. A complete response may serve as a good surrogate for survival irrespective of the primary site of head and neck cancer.

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Results of a randomized phase III study of nimotuzumab in combination with concurrent radiotherapy and cisplatin versus radiotherapy and cisplatin alone, in locally advanced squamous cell carcinoma of the head and neck.

Cited by 11 publications

References 0 publications

Epidemiological Trends of Head and Neck Cancer: A Population-Based Study

Epidemiological Trends of Head and Neck Cancer: A Population-Based Study

Combined Nimotuzumab with Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Addition of Nimotuzumab to Standard TPF Regimen in Locally Advanced Head and Neck Cancer: A Single Institutional Study

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