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

B. K.M. Reddy, V. Lokesh, M. S. Vidyasagar, K. Shenoy, K. G. Babu, A. Shenoy, T. Naveen, Bindhu Joseph, R. Bonanthaya, Nanjundappa, P. P. Bapsy, Loknatha, Jayarama Shetty, Krishna Prasad, C. R. Tanvir Pasha

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Abstract

Objective Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). Methods This open-label study randomized 92 treatment-naïve patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator's discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60-66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60. Results Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100% with CRT + nimotuzumab, 70% with CRT, 76% with RT + nimotuzumab, and 37% with RT. At Month 60, overall survival was 57% with CRT + nimotuzumab, 26% with CRT (P = 0.03), 39% with RT + nimotuzumab, and 26% with RT (P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT (P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT (P = 0.45). Risk of death was 64% lower with CRT + nimotuzumab than with CRT (95%CI: 0.37, 1.56), and 24% lower with RT + nimotuzumab than with RT (95%CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events. Conclusion Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.

Original languageEnglish
Pages (from-to)498-505
Number of pages8
JournalOral Oncology
Volume50
Issue number5
DOIs
Publication statusPublished - 01-01-2014

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Chemoradiotherapy
Radiotherapy
Survival
Carcinoma, squamous cell of head and neck
nimotuzumab
Epidermal Growth Factor Receptor
Radiation
Therapeutics
Cisplatin
Neoplasms
Research Personnel

All Science Journal Classification (ASJC) codes

  • Oral Surgery
  • Oncology
  • Cancer Research

Cite this

Reddy, B. K.M. ; Lokesh, V. ; Vidyasagar, M. S. ; Shenoy, K. ; Babu, K. G. ; Shenoy, A. ; Naveen, T. ; Joseph, Bindhu ; Bonanthaya, R. ; Nanjundappa ; Bapsy, P. P. ; Loknatha ; Shetty, Jayarama ; Prasad, Krishna ; Tanvir Pasha, C. R. / 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. In: Oral Oncology. 2014 ; Vol. 50, No. 5. pp. 498-505.
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title = "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",
abstract = "Objective Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). Methods This open-label study randomized 92 treatment-na{\"i}ve patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator's discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60-66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60. Results Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100{\%} with CRT + nimotuzumab, 70{\%} with CRT, 76{\%} with RT + nimotuzumab, and 37{\%} with RT. At Month 60, overall survival was 57{\%} with CRT + nimotuzumab, 26{\%} with CRT (P = 0.03), 39{\%} with RT + nimotuzumab, and 26{\%} with RT (P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT (P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT (P = 0.45). Risk of death was 64{\%} lower with CRT + nimotuzumab than with CRT (95{\%}CI: 0.37, 1.56), and 24{\%} lower with RT + nimotuzumab than with RT (95{\%}CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events. Conclusion Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.",
author = "Reddy, {B. K.M.} and V. Lokesh and Vidyasagar, {M. S.} and K. Shenoy and Babu, {K. G.} and A. Shenoy and T. Naveen and Bindhu Joseph and R. Bonanthaya and Nanjundappa and Bapsy, {P. P.} and Loknatha and Jayarama Shetty and Krishna Prasad and {Tanvir Pasha}, {C. R.}",
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language = "English",
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pages = "498--505",
journal = "Oral Oncology",
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Reddy, BKM, Lokesh, V, Vidyasagar, MS, Shenoy, K, Babu, KG, Shenoy, A, Naveen, T, Joseph, B, Bonanthaya, R, Nanjundappa, Bapsy, PP, Loknatha, Shetty, J, Prasad, K & Tanvir Pasha, CR 2014, '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 Oncology, vol. 50, no. 5, pp. 498-505. https://doi.org/10.1016/j.oraloncology.2013.11.008

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. / Reddy, B. K.M.; Lokesh, V.; Vidyasagar, M. S.; Shenoy, K.; Babu, K. G.; Shenoy, A.; Naveen, T.; Joseph, Bindhu; Bonanthaya, R.; Nanjundappa; Bapsy, P. P.; Loknatha; Shetty, Jayarama; Prasad, Krishna; Tanvir Pasha, C. R.

In: Oral Oncology, Vol. 50, No. 5, 01.01.2014, p. 498-505.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck

T2 - A randomized, open-label, phase IIb, 5-year study in Indian patients

AU - Reddy, B. K.M.

AU - Lokesh, V.

AU - Vidyasagar, M. S.

AU - Shenoy, K.

AU - Babu, K. G.

AU - Shenoy, A.

AU - Naveen, T.

AU - Joseph, Bindhu

AU - Bonanthaya, R.

AU - Nanjundappa,

AU - Bapsy, P. P.

AU - Loknatha,

AU - Shetty, Jayarama

AU - Prasad, Krishna

AU - Tanvir Pasha, C. R.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - Objective Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). Methods This open-label study randomized 92 treatment-naïve patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator's discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60-66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60. Results Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100% with CRT + nimotuzumab, 70% with CRT, 76% with RT + nimotuzumab, and 37% with RT. At Month 60, overall survival was 57% with CRT + nimotuzumab, 26% with CRT (P = 0.03), 39% with RT + nimotuzumab, and 26% with RT (P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT (P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT (P = 0.45). Risk of death was 64% lower with CRT + nimotuzumab than with CRT (95%CI: 0.37, 1.56), and 24% lower with RT + nimotuzumab than with RT (95%CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events. Conclusion Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.

AB - Objective Overexpression of epidermal growth factor receptor (EGFR) in many cancers makes it an attractive therapeutic target. This study evaluated the clinical utility of nimotuzumab, a monoclonal anti-EGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). Methods This open-label study randomized 92 treatment-naïve patients (1:1) with advanced SCCHN into chemoradiation (CRT ± nimotuzumab) or radiation (RT ± nimotuzumab) group by investigator's discretion; these were further randomized into CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups, respectively. Treatment included 6 cycles each of cisplatin (50 mg/week), nimotuzumab (200 mg/week), and RT (total dose, 60-66 Gy). Response (tumor size reduction) was assessed at Month 6 post-treatment and survival, at Month 60. Results Forty and 36 patients in the chemoradiation and radiation groups, respectively (intent-to-treat population) were evaluated. Overall response at Month 6 post-treatment was 100% with CRT + nimotuzumab, 70% with CRT, 76% with RT + nimotuzumab, and 37% with RT. At Month 60, overall survival was 57% with CRT + nimotuzumab, 26% with CRT (P = 0.03), 39% with RT + nimotuzumab, and 26% with RT (P > 0.05). Median overall survival was not reached for CRT + nimotuzumab; it was 21.94 months for CRT (P = 0.0078), 14.36 months for RT + nimotuzumab, and 12.78 months for RT (P = 0.45). Risk of death was 64% lower with CRT + nimotuzumab than with CRT (95%CI: 0.37, 1.56), and 24% lower with RT + nimotuzumab than with RT (95%CI: 0.16, 0.79). Thus nimotuzumab was safe and well tolerated with few mild to moderate self-limiting adverse events. Conclusion Concurrent use of nimotuzumab with CRT/RT is safe and provides long-term survival benefit.

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