81O - Erlotinib as neoadjuvant treatment in endobronchial ultrasound confirmed stage IIIA-N2 non-small cell lung cancer (NSCLC) patients with epidermal gr...

Date 16 April 2015
Event ELCC 2015
Session New treatment avenues
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Locally Advanced
Presenter Baohui Han
Citation Annals of Oncology (2015) 26 (suppl_1): 24-28. 10.1093/annonc/mdv049
Authors B. Han1, L. Xiong1, J. Sun1, R. Li1, Y. Lou1, Y. Zhang1, A. Gu1, L. Jiang1, J. Shi2
  • 1Department Of Pulmonary, Shanghai Chest Hospital, 200030 - Shanghai/CN
  • 2Department Of Thoracic Surgery, Shanghai Chest Hospital, 200030 - Shanghai/CN

Abstract

Aim/Background

The objective of this trial is to explore the efficacy and safety of erlotinib (Tarceva ®) as neoadjuvant treatment in stage IIIA-N2 NSCLC patients with activating EGFR mutation.

Methods

Previously untreated patients with endobronchial ultrasound confirmed stage IIIA-N2 NSCLC with activating EGFR mutation in exon 19 or 21 were recruited into the study. All enrolled patients were treated with erlotinib 150mg orally per day for 56 days for neoadjuvant period. Only patients who got benefits from erlotinib treatment and were resectable would receive surgery. The primary endpoint is radical resection rate. The secondary endpoints included pathological complete response rate, objective response rate, disease free survival, overall survival, safety profile, and explorative biomarkers. This study was registered in clinicaltrials.gov (NCT01217619).

Results

From 10 Oct 2010 to 30 Jun 2014, total 155 patients were screened, 44 patients with IIIA N2, 25 patients (with IIIA N2 EGFR Mutations) were finally enrolled into the study (Table 1). After erlotinib treatment, RR32%, DCR76%. Sixteen patients underwent resection surgery. Fifteen patients (93.8%) had R0 resection and the radical resection rate was 60% (15/25). pCR6.3%; pRR93.7%. The median DFS were 10.4 months. OS data are not mature. All patients were consistent on EGFR mutation before and after the surgery except three patients with exon 19 deletion turn to EGFR wild type after the surgery. Seven patients (28%,7/25) had rash(grade I-II) and one patient had diarrhea(grade I) after erlotinib treatment. Table 1.

Patient and disease characteristics

Items Total enrolled (n = 25) No surgery (n = 9) Surgery (n = 16)
Age, median (range), year 59 (33,74) 59 (33,74) 60 (38,73)
Sex,male/female 13/12 7/2 6/10
ECOG, n (%)
1 25 (100%) 9 (100%) 16 (100%)
Current or former smoker/never-smoker 12/13 7/2 5/11
EGFR mutation type before erlotinib, n(%)
exon 19 deletion 16 (64%) 6 (66.7%) 10 (62.5%)
exon 21 L858R mutation 10 (40%) 4 (44.4%)* 6 (37.5%)
Carcinoembryonic antigen, µg/L, mean (S.D.)
Before treatment 78.2 (140.6) 120.8 (185.9) 54.2 (99.2)
4 weeks after erlotinib 41.7 (86.7) 89.7 (124.0) 12.2 (19.9)
7 weeks after erlotinib 33.2 (61.9) 106.8 (92.4) 10.6 (14.5)
after surgery NA NA 3.2 (2.2)
AE during erlotinib treatment, n(%)
Rash 7 (28%) 2 (22.2%) 5, (31.3%)
Diarrhea 1 (4%) 0 1 (6.3%)
Abnormal liver function 1 (4%) 1 (11.1%) 0
Leukocytopenia 1 (4%) 1 (11.1%) 0
Cerebral infarction 1 (4%) 1 (11.1%) 0
Reason for no surgery
Progress of disease 6 NA
Serious AE (cerebral infarction) 1 NA
Not suitable for surgery 2 NA

*: one patient had both exon 19 deletion and exon 21 L858R point mutation.

Conclusions

Erlotinibas neoadjuvant therapyis a promising treatment for EGFR mutant IIIA-N2 NSCLC patients with tolerable toxicity.

Clinical trial identification (NCT01217619, ESTERN) 10-2010

Disclosure

All authors have declared no conflicts of interest.