| General information |
| Database: | DB00377 |
| 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 antiEGFR antibody, used concurrently with radiotherapy (RT) and chemoradiotherapy (CRT) in squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | Reddy BK, et al |
| Title: | Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, openlabel, phase IIb, 5year study in Indian patients. |
| Journal: | Oral Oncol. |
| Year: | 2014 |
| PMID: | 24613543 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | nimotuzumab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups |
| Study Type: | randomized, openlabel, phase IIb, 5year study |
| Key Patients Feature: | Patients aged 18-70 years with histologically proven stage III orIVA (T1T4a, N0N2) SCCHN who were suitable for concurrent CRT/RT, had a Karnofsky performance status of P60% with a life expectancy of >6 months, and adequate hematological function (whiteblood cell [WBC] count, >4000/lL; absolute neutrophil count[ANC], P1500/lL; platelets, P100, 000/lL; total bilirubin, 61.2 mg/dL; aspartate aminotransferase [AST] and alanine aminotransferase [ALT], 62.5 times the normal limit [37 and 40 U/L, respectively]; serum creatinine, <1.4 mg/dL) were included. Patients for whom surgery was contraindicated owing to prohibitivemorbidity or compromised quality of life were also included. |
| Biomarker: | EGFR expression |
| Biomark Analysis: | No correlation was found between EGFR expression and response atMonth 6 posttreatment or survival at Month 60 posttreatment, although the numbers were too small to draw conclusions. |
| Control Group Info: | CRT + nimotuzumab or CRT and RT + nimotuzumab or RT groups |
| Treatment Info: | Treatmentna ve patients (1:1) with advanced SCCHN into chemoradiation (CRT ¡À nimotuzumab) or radiation (RT ¡À 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, 6066 Gy). Response (tumor size reduction) was assessed at Month 6 posttreatment and survival, at Month 60. |
| Primary End Point: | response rates for outcomes at Month 6; |
| Secondary End Point: | assessment of progression free survival (PFS) and overall survival. |
| Patients Number: | 92 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Overall response at Month 6 posttreatment 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) |
| Disease Control Rate: | CRT + nimotuzumab:100%. CRT:70%. RT + nimotuzumab:76.47%. RT:36.27%. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 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). |
| Adverse Event(agent arm): | There were no significant differences in the hematological, biochemical, and urine analysis findings of patients in all study arms, except for the platelet count that was significantly increased in the CRT + nimotuzumab arm as compared to the CRT arm (P = 0.001), and the mean corpuscular volume that was significantly higher in the RT + nimotuzumab arm as compared to the RT arm (P = 0.022); these findings, however, did not have any clinical relevance. |
| Conclusions: | Concurrent use of nimotuzumab with CRTRT is safe and provides longterm survival benefit. |