title: Nimotuzumab plus chemotherapy versus chemotherapy alone in advanced non-small-cell lung cancer: a multicenter, randomized, open-label Phase II study.
abstract: BACKGROUND
  The purpose of this study was to evaluate the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin) versus chemotherapy alone in patients with stage IIIB/IV non-small-cell lung cancer.
  
  
  METHODS
  This multicenter, open-label, Phase II study randomized 110 patients to receive nimotuzumab plus chemotherapy (nimotuzumab group) or chemotherapy alone (control group), and comprised concomitant, maintenance, and follow-up phases. Nimotuzumab 200 mg was administered once weekly for 13 weeks during the first two phases with four cycles of chemotherapy and docetaxel 75 mg/m(2) and carboplatin (area under the curve 5 mg/mL*min) every 3 weeks for a maximum of four cycles during the concomitant phase. The primary endpoint was objective response rate (sum of complete response and partial response). Secondary endpoints, ie, overall survival and progression-free survival, were estimated using the Kaplan-Meier method. Efficacy was evaluated on the intent-to-treat and efficacy-evaluable sets. Safety was assessed from adverse event and serious adverse event data.
  
  
  RESULTS
  The objective response rate was significantly higher in the nimotuzumab group than in the control group in the intent-to-treat population (54% versus 34.5%; P=0.04). A complete response and partial response were achieved in 3.6% and 50% of patients, respectively, in the nimotuzumab group, and in 4% and 30.9% of patients, respectively, in the control group. No significant differences in median progression-free survival and overall survival were observed. Safety profiles were comparable between the two groups.
  
  
  CONCLUSIONS
  Nimotuzumab plus chemotherapy significantly improved the objective response rate as compared with chemotherapy alone. The combination was safe and well tolerated in patients with stage IIIB/IV non-small-cell lung cancer.
authors: Kidwai Memorial Institute of Oncology, Bangalore, India.
authors: K Govind
authors: KG
authors: Babu
authors: Tata Memorial Hospital, Mumbai, India.
authors: Kumar
authors: K
authors: Prabhash
authors: Artemis Health Institute, Delhi, India.
authors: Ashok K
authors: AK
authors: Vaid
authors: Artemis Health Institute, Delhi, India.
authors: Bhawna
authors: B
authors: Sirohi
authors: Bangalore Institute of Oncology, Bangalore, India.
authors: Ravi B
authors: RB
authors: Diwakar
authors: Nizam Institute of Medical Sciences, Hyderabad, India.
authors: Raghunadha
authors: R
authors: Rao
authors: B R Singh Hospital, Kolkata, India.
authors: Madhuchanda
authors: M
authors: Kar
authors: Birla Cancer Centre, Jaipur, India.
authors: Hemant
authors: H
authors: Malhotra
authors: Jehangir Hospital, Pune, India.
authors: Shona
authors: S
authors: Nag
authors: B P Poddar Hospital and Medical Research Ltd, Kolkata, India.
authors: Chanchal
authors: C
authors: Goswami
authors: Institute Rotary Cancer Hospital, New Delhi, India.
authors: Vinod
authors: V
authors: Raina
authors: King George Hospital, Visakhapatnam, India, India.
authors: Ravi
authors: R
authors: Mohan
keywords: carboplatin; docetaxel; epidermal growth factor receptor; nimotuzumab; non-small cell lung cancer