131O - Combination of chemotherapy and gefitinib as first-line treatment of patients with advanced lung adenocarcinoma and sensitive EGFR mutations: A ran...

Date 14 April 2016
Event European Lung Cancer Conference 2016 (ELCC) 2016
Session New strategies for EGFR addicted NSCLC
Topics Cytotoxic agents
Non-small-cell lung cancer
Therapy
Biological therapy
Presenter Baohui Han
Citation Journal of Thoracic Oncology (2016) 11 (supplement 4): S57-S166. S1556-0864(16)X0004-4
Authors B. Han1, Y. Zhang2, B. Jin3, T. Chu2, A. Gu2, J. Xu2
  • 1Dept. Of Pulmonary, Shanghai Chest Hospital, 230030 - Shanghai/CN
  • 2Dept. Of Pulmonary, Shanghai Chest Hospital, Shanghai/CN
  • 3Department Of Pulmonary, Shanghai Chest Hospital, Shanghai/CN

Abstract

Background

To explore the optimal treatment strategy for patients who harbored a sensitive EGFR mutation. We did a head-to-head study to compare chemotherapy and gefitinib in combination with either agent alone in terms of efficacy and safety as first-line therapy in those population.

Methods

121 untreated patients with advanced lung adenocarcinoma who harbored sensitive EGFR mutations, were randomly assigned to 3 groups. Combination therapy group (group A), received pemetrexed (500 mg/m2 on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5–21) and repeated every 4 weeks for up to six cycles, then continued to receive pemetrexed combined with gefitinib every 4 weeks. Chemotherapy group (group B), received the same chemotherapy regimen alone every 4 weeks for up to six cycles, then continued to receive pemetrexed alone every 4 weeks. Gefitinib group (group C), received gefitinib alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death. The primary endpoint was Median PFS. Analyses were done on an ITT basis.

Results

Median PFS for patients in group A was 18.83 months, 95% CI (16.82, 20.83), Median PFS for patients in group B was 5.75 months, 95% CI (5.19, 6.31), Median PFS for patients in group C was 12.00 months, 95% CI (9.90, 14.09). 6-month PFS was 92.5% (37 of 40) in the group A, 42.5% (17 of 40) in the group B, and 80.5% (33 of 41) in the group C. ORR was 82.5% in the group A, 32.5% in the group B, and 65.9% in the group C. The most common grade 3–4 adverse events were neutropenia (4 [10.0%] of patients in the group A vs 5 [12.5%] in the group B vs 0 [0.0%] in the group C), fatigue (3 [7.5%] of patients in the group A vs 2 [5.0%] in the group B vs 0 [0.0%] in the group C), and liver dysfunction (4 [10.0%] of patients in the group A vs 0 [0.0%] in the group B vs 1 [2.5%] in the group C), skin allergy (4 [10.0%] of patients in the group A vs 4 [10.0%] in the group B vs 0 [0.0%] in the group C).

Conclusions

Patients with lung adenocarcinoma who harbored a sensitive EGFR mutation have longer PFS if they are treated with pemetrexed plus carboplatin combined with gefitinib.

Clinical trial identification

NCT02148380

Legal entity responsible for the study

Baohui Han; Bo Jin; Yanwei Zhang; Tianqing Chu; Jianlin Xu; Aiqin Gu

Funding

Key Projects of the Biomedicine Department, Science and Technology Commission of Shanghai Municipality (Project No. 11411951200)

Disclosure

All authors have declared no conflicts of interest.