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G. Babu
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-073 - Nimotuzumab in Advanced Squamous Cell Lung Cancer: A 2 Year Comparative Indian Clinical Experience (ID 1162)
09:30 - 09:30 | Author(s): G. Babu
- Abstract
Background:
Lung cancer is mainly a disease of modern era and probably one of the most important health problems today. Approximately 63,000 new lung cancer cases are reported each year (Ganesh et al., 2011) in India. In the series from west as well as from India, it is reported that 30% of lung cancers are of squamous cell histology (SQCLC) and 50-70% cases usually present in advanced stage (Becket, 1993; Govindan et al., 2006; Grivaux et al., 2011; Malik et al., 2013). The median overall survival observed with the current standard of care is 9-11 months and highlights the need for targeted agents that will add to the survival and quality of life of these patients. EGFR is the most evaluated target in lung cancer. EGFR overexpression is recorded in about 75-80% of the patients and associated with a worser clinical outcome. Nimotuzumab is humanized EGFR antagonist and is being actively evaluated in the management of advanced lung cancer. This study is done to observe the safety and efficacy of nimotuzumab in combination with chemotherapy (docetaxel and carboplatin) versus chemotherapy alone in patients with stage IIIB/IV SQCLC with recorded EGFR overexpression.
Methods:
This single-center, open-label, study evaluating 20 patients to receive nimotuzumab plus chemotherapy (nimo group, n=10) or chemotherapy alone (control group, n=10), 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/m2 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 (66% versus 34.5%; P=0.04). A complete response and partial response were achieved in 15% and 50% of patients, respectively, in the nimotuzumab group, and in 4% and 30.9% of patients, respectively, in the control group. Median progression-free survival and median overall survival in nimo group and control groups were 5.9 vs 3.7 months and 12.2 vs 9.8 months respectively, both being significant for Nimotuzumab. Safety profiles were comparable between the two groups.
Conclusion:
Nimotuzumab plus chemotherapy significantly improved the tumor response, PFS and mOS as compared with chemotherapy alone. The combination was safe and well tolerated in patients with stage IIIB/IV lung cancer.
