941PD - An Investigator Initiated, Open Label, Randomized, Controlled, Multicentric Study, to assess the Safety and Efficacy of Nimotuzumab (BIOMAb-...

Date 09 September 2017
Event ESMO 2017 Congress
Session Gynaecological cancers
Topics Anti-Cancer Agents & Biologic Therapy
Cervical Cancer
Gynaecologic Malignancies
Surgery and/or Radiotherapy of Cancer
Presenter Basavalingaiah Ajaikumar
Citation Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372
Authors B.S. Ajaikumar1, K. Swamy2, N. Radheshyam1, S. Patil1, H.P. Shashidhara3, M.S.A. Vishweshwara4, N.K. Rao2, Y. Madhavi4, N. Ravi5, R. Bilimagga2, R. Rao6, D. Pawar7
  • 1Medical Oncology, Healthcare Global Enterprises ltd., 560027 - BANGALORE/IN
  • 2Radiation Oncology, Healthcare Global Enterprises ltd., 560027 - BANGALORE/IN
  • 3Medical Oncology, HCG Bangalore Institute of Oncology Speciality Centre, 560027 - Bangalore/IN
  • 4Radiation Oncology, Bharath Hospital and Institute of Oncology, 570017 - Mysore/IN
  • 5Radiation Oncology, HCG Malnad Hospital Institute of Oncology, Shimoga/IN
  • 6Healthcare Global Enterprises Ltd., CARE, HCG Foundation, 560027 - BANGALORE/IN
  • 7Medical Affairs, Biocon Limited, 560100 - Bangalore/IN

Abstract

Background

EGFR inhibitors have proven to improve the efficacy of anticancer treatments in lung, colon, pancreas, or HNC. Results from studies show EGFR expression in cervical Ca to improve survival outcomes in the same. This study was designed to assess safety and efficacy of Nimotuzumab with concurrent cisplatin and RT in patients with Ca Cervix.

Methods

In this open-label randomized controlled multicentric study 100 patients with histologically confirmed Ca Cervix were recruited over a 4 year period with an equal allocation of 1:1 for intervention (Standard arm- concurrent CTRT (Cisplatin 40mg/m2 weekly IV +RT) plus 200mg weekly BIOMAB IV (n = 50) on same day of cisplatin infusion) vs. standard arm only (n = 50). At 2 years data were available for 39 patients in the intervention arm and 35 patients in standard arm. The size of the lesion was documented using CT/PETCT at baseline. The response was analyzed using RECIST criteria at the following treatment every 3 months for subsequent 2 years. Toxicity was assessed using CTCAE v4 toxicity criteria.

Results

There were 74 evaluable patients at end of 2 years. The mean age was 49.6± 10.2 years. The complete response following treatment was seen in 37.8% (BIOMAB arm) of patients at two years following treatment compared to 38.2% in standard arm. However, progressive disease was seen more in standard arm (52.9%) compared to BIOMAB arm (35.1%). Best overall response was seen in 64.9% patients in the intervention arm compared to 47.1% patients in the standard arm at two years following treatment which is significant. At 2 years 60% progressed on standard arm compared to 37.5% in the intervention arm. The mean estimate of progression-free survival being 36 months vs. 56.5 months (BioMab arm) (Log rank Mantel-Cox χ2= 3.9, p = 0.05). Except for one patient with Biomab sensitivity, there was no additional toxicity compared to the standard arm.

Conclusions

Nimotuzumab appears to be safe and effective targeted therapy in cervical cancer patients with long-term benefits.

Clinical trial identification

TS-01-2009

Legal entity responsible for the study

Healthcare Global Enterprises Ltd.

Funding

BIOCON

Disclosure

All authors have declared no conflicts of interest.