Effectiveness and tolerability of nimotuzumab in unresectable, locally advanced/metastatic esophageal cancer: Indian hospital-based retrospective evidence

Sundaram Subramanian; Nithya Sridharan; V. Balasundaram; Sameer Chaudhari

doi:10.4103/sajc.sajc_89_18

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ORIGINAL ARTICLE: Head and Neck Cancers

08 (

); 112-115

doi:

10.4103/sajc.sajc_89_18

Effectiveness and tolerability of nimotuzumab in unresectable, locally advanced/metastatic esophageal cancer: Indian hospital-based retrospective evidence

Sundaram Subramanian¹, Nithya Sridharan¹, V. Balasundaram^1,, Sameer Chaudhari²

1 V. S Hospital and Cancer Center, Chennai, Tamil Nadu

2 Medical advisor, Biocon Ltd, Bengaluru, Karnataka

*Corresponding author: Dr. Nithya Sridharan. nithya.hhk@gmail.com

Published: 2020-12-21

MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/.)

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This article was originally published by Thieme Medical and Scientific Publishers Pvt. Ltd. and was migrated to Scientific Scholar after the change of Publisher.

Abstract

Context: Epidermal growth factor receptor (EGFR) is overly expressed in esophageal squamous cell carcinoma (ESCC) and is important prognostic and predictive biomarker. Nimotuzumab is a humanized anti-EGFR monoclonal antibody and has documented promising clinical outcomes and survival rates in various solid tumors with high EGFR expression. Aims: Attempt to fill gap on paucity of data in India on the efficacy of Nimotuzumab in the treatment of locally advanced/metastatic ESCC. Settings and Design: Hospital records of 15 patients with unresectable, locally advanced/metastatic esophageal cancers, histologically confirmed squamous cell carcinoma being treated with Nimotuzumab along with standard treatments from October 2006 to November 2016 were retrospectively analyzed. Subjects and Methods: The tumor response rate and overall survival (OS) were analyzed. All patients were assessed for toxicity and adverse events (AEs) as per Common Terminology Criteria for Adverse Events (CTCAE) v4. Results: Majority had lower thoracic esophageal cancer. Tumor response rate observed was as follows 33% had a complete response, 67% had a partial response, and objective response rate was 100%. Survival rate at 1-, 3-, and 5-year was 58.33%, 29.17%, and 29.17%, respectively. Median OS was 26.8 months (95% confidence interval, 2.63–not reached). No Grade III or Grade IV AEs were observed. No added toxicity was observed due to nimotuzumab.Conclusions: Nimotuzumab combined with standard treatment in locally advanced/metastatic ESCC improved the survival rate and achieved a better tumor response rate without accumulation of toxicity and was well tolerated.

Keywords

Acknowledgment

We would like to thank Ramez Ahmed, Medical Affairs- Biocon, for his valuable inputs and transcribing the manuscript.

References

Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the human development index (2008-2030): A population-based study. Lancet Oncol 2012;13:790-801.
Samarasam I. Esophageal cancer in India: Current status and future perspectives. Int J Adv Med Health Res 2017;4:5-10.
Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet 2013;381:400-12.
Cherian JV, Sivaraman R, Muthusamy AK, Jayanthi V. Carcinoma of the esophagus in Tamil Nadu (South India): 16-year trends from a tertiary center. J Gastrointestin Liver Dis 2007;16:245-9.
Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med 2003;349:2241-52.
Zingg U, Divalentino D, McQuinn A, Mardzuki A, Thompson SK, Karapetis CS, et al. Outcome for esophageal cancer following treatment with chemotherapy and radiotherapy but not esophagectomy: Nonsurgical treatment of esophageal cancer. Clin Exp Gastroenterol 2009;2:75-83.
Zhu LL, Yuan L, Wang H, Ye L, Yao GY, Liu C, et al. A meta-analysis of concurrent chemoradiotherapy for advanced esophageal cancer. PLoS One 2015;10:e0128616.
Harari PM. Epidermal growth factor receptor inhibition strategies in oncology. Endocr Relat Cancer 2004;11:689-708.
Hanawa M, Suzuki S, Dobashi Y, Yamane T, Kono K, Enomoto N, et al. EGFR protein overexpression and gene amplification in squamous cell carcinomas of the esophagus. Int J Cancer 2006;118:1173-80.
Yu WW, Guo YM, Zhu M, Cai XW, Zhu ZF, Zhao WX, et al. Clinicopathological and prognostic significance of EGFR over-expression in esophageal squamous cell carcinoma: A meta-analysis. Hepatogastroenterology 2011;58:426-31.
Wykosky J, Fenton T, Furnari F, Cavenee WK. Therapeutic targeting of epidermal growth factor receptor in human cancer: Successes and limitations. Chin J Cancer 2011;30:5-12.
Joseph B, Sruthi K, Vishwanath L. EGFR Targeting in oesophageal squamous cell carcinoma: Potential role and rationale. Clin Oncol 2017;2:1247.
Ramakrishnan MS, Eswaraiah A, Crombet T, Piedra P, Saurez G, Iyer H, et al. Nimotuzumab, a promising therapeutic monoclonal for treatment of tumors of epithelial origin. MAbs 2009;1:41-8.
Saurez-Martínez G, Bencomo-Yanes A. Nimotuzumab effective immunotherapy for the treatment of malignant epithelial tumors. Biotecnol Apl 2014;31:159-67.
Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, et al. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: A randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol 2014;50:498-505.
Xu S, Ramos-Suzarte M, Bai X, Xu B. Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: A single institute experience. Oncotarget 2016;7:33391-407.
Liang J, Mingyan E, Wu G, Zhao L, Li X, Xiu X, et al. Nimotuzumab combined with radiotherapy for esophageal cancer: Preliminary study of a phase II clinical trial. Onco Targets Ther 2013;6:1589-96.
Lu M, Wang X, Shen L, Jia J, Gong J, Li J, et al. Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial. Cancer Sci 2016;107:486-90.
Han X, Lu N, Pan Y, Xu J. Nimotuzumab combined with chemotherapy is a promising treatment for locally advanced and metastatic esophageal cancer. Med Sci Monit 2017;23:412-8.
Lai X, Gu Q, Zheng X, Liu G, Feng W, Lin X, et al. Combined nimotuzumab with chemoradiotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma: A retrospective study. J Cancer Res Ther 2016;12:89-95.
Wang C, Fu X, Cai X, Wu X, Hu X, Fan M, et al. High-dose nimotuzumab improves the survival rate of esophageal cancer patients who underwent radiotherapy. Onco Targets Ther 2016;9:117-22.
Perez R, Moreno E, Garrido G, Crombet T. EGFR-targeting as a biological therapy: Understanding nimotuzumab's clinical effects. Cancers (Basel) 2011;3:2014-31.
Liu H, Yang W, Gao H, Jiang T, Gu B, Dong Q, et al. Nimotuzumab abrogates acquired radio resistance of KYSESE-150R esophageal cancer cells by inhibiting EGFR signaling and cellular DNA repair. Onco Targets Ther 2015;8:509-18.
Garrido G, Tikhomirov IA, Rabasa A, Yang E, Gracia E, Iznaga N, et al. Bivalent binding by intermediate affinity of nimotuzumab: A contribution to explain antibody clinical profile. Cancer Biol Ther 2011;11:373-82.
Guo JH, Chen MQ, Chen C, Lu HJ, Xu BH. Efficacy and toxicity of nimotuzumab combined with radiotherapy in elderly patients with esophageal squamous cell carcinoma. Mol Clin Oncol 2015;3:1135-8.
Sharma JP. Nimotuzumab in combination with chemo-radiotherapy in a case of locally advanced oesophageal malignancy. J Case Rep 2016;6:313-6.

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[1] Bray F, Jemal A, Grey N, Ferlay J, Forman D. Global cancer transitions according to the human development index (2008-2030): A population-based study. Lancet Oncol 2012;13:790-801.

[2] Samarasam I. Esophageal cancer in India: Current status and future perspectives. Int J Adv Med Health Res 2017;4:5-10.

[3] Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet 2013;381:400-12.

[4] Cherian JV, Sivaraman R, Muthusamy AK, Jayanthi V. Carcinoma of the esophagus in Tamil Nadu (South India): 16-year trends from a tertiary center. J Gastrointestin Liver Dis 2007;16:245-9.

[5] Enzinger PC, Mayer RJ. Esophageal cancer. N Engl J Med 2003;349:2241-52.

[6] Zingg U, Divalentino D, McQuinn A, Mardzuki A, Thompson SK, Karapetis CS, et al. Outcome for esophageal cancer following treatment with chemotherapy and radiotherapy but not esophagectomy: Nonsurgical treatment of esophageal cancer. Clin Exp Gastroenterol 2009;2:75-83.

[7] Zhu LL, Yuan L, Wang H, Ye L, Yao GY, Liu C, et al. A meta-analysis of concurrent chemoradiotherapy for advanced esophageal cancer. PLoS One 2015;10:e0128616.

[8] Harari PM. Epidermal growth factor receptor inhibition strategies in oncology. Endocr Relat Cancer 2004;11:689-708.

[9] Hanawa M, Suzuki S, Dobashi Y, Yamane T, Kono K, Enomoto N, et al. EGFR protein overexpression and gene amplification in squamous cell carcinomas of the esophagus. Int J Cancer 2006;118:1173-80.

[10] Yu WW, Guo YM, Zhu M, Cai XW, Zhu ZF, Zhao WX, et al. Clinicopathological and prognostic significance of EGFR over-expression in esophageal squamous cell carcinoma: A meta-analysis. Hepatogastroenterology 2011;58:426-31.

[11] Wykosky J, Fenton T, Furnari F, Cavenee WK. Therapeutic targeting of epidermal growth factor receptor in human cancer: Successes and limitations. Chin J Cancer 2011;30:5-12.

[12] Joseph B, Sruthi K, Vishwanath L. EGFR Targeting in oesophageal squamous cell carcinoma: Potential role and rationale. Clin Oncol 2017;2:1247.

[13] Ramakrishnan MS, Eswaraiah A, Crombet T, Piedra P, Saurez G, Iyer H, et al. Nimotuzumab, a promising therapeutic monoclonal for treatment of tumors of epithelial origin. MAbs 2009;1:41-8.

[14] Saurez-Martínez G, Bencomo-Yanes A. Nimotuzumab effective immunotherapy for the treatment of malignant epithelial tumors. Biotecnol Apl 2014;31:159-67.

[15] Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, et al. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: A randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol 2014;50:498-505.

[16] Xu S, Ramos-Suzarte M, Bai X, Xu B. Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: A single institute experience. Oncotarget 2016;7:33391-407.

[17] Liang J, Mingyan E, Wu G, Zhao L, Li X, Xiu X, et al. Nimotuzumab combined with radiotherapy for esophageal cancer: Preliminary study of a phase II clinical trial. Onco Targets Ther 2013;6:1589-96.

[18] Lu M, Wang X, Shen L, Jia J, Gong J, Li J, et al. Nimotuzumab plus paclitaxel and cisplatin as the first line treatment for advanced esophageal squamous cell cancer: A single centre prospective phase II trial. Cancer Sci 2016;107:486-90.

[19] Han X, Lu N, Pan Y, Xu J. Nimotuzumab combined with chemotherapy is a promising treatment for locally advanced and metastatic esophageal cancer. Med Sci Monit 2017;23:412-8.

[20] Lai X, Gu Q, Zheng X, Liu G, Feng W, Lin X, et al. Combined nimotuzumab with chemoradiotherapy in patients with locally advanced or metastatic esophageal squamous cell carcinoma: A retrospective study. J Cancer Res Ther 2016;12:89-95.

[21] Wang C, Fu X, Cai X, Wu X, Hu X, Fan M, et al. High-dose nimotuzumab improves the survival rate of esophageal cancer patients who underwent radiotherapy. Onco Targets Ther 2016;9:117-22.

[22] Perez R, Moreno E, Garrido G, Crombet T. EGFR-targeting as a biological therapy: Understanding nimotuzumab's clinical effects. Cancers (Basel) 2011;3:2014-31.

[23] Liu H, Yang W, Gao H, Jiang T, Gu B, Dong Q, et al. Nimotuzumab abrogates acquired radio resistance of KYSESE-150R esophageal cancer cells by inhibiting EGFR signaling and cellular DNA repair. Onco Targets Ther 2015;8:509-18.

[24] Garrido G, Tikhomirov IA, Rabasa A, Yang E, Gracia E, Iznaga N, et al. Bivalent binding by intermediate affinity of nimotuzumab: A contribution to explain antibody clinical profile. Cancer Biol Ther 2011;11:373-82.

[25] Guo JH, Chen MQ, Chen C, Lu HJ, Xu BH. Efficacy and toxicity of nimotuzumab combined with radiotherapy in elderly patients with esophageal squamous cell carcinoma. Mol Clin Oncol 2015;3:1135-8.

[26] Sharma JP. Nimotuzumab in combination with chemo-radiotherapy in a case of locally advanced oesophageal malignancy. J Case Rep 2016;6:313-6.

Effectiveness and tolerability of nimotuzumab in unresectable, locally advanced/metastatic esophageal cancer: Indian hospital-based retrospective evidence

Abstract

Abstract

Keywords

Acknowledgment

References

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