Cancer Res Treat.  2017 Oct;49(4):981-989. 10.4143/crt.2016.522.

Incorporating Erlotinib or Irinotecan Plus Cisplatin into Chemoradiotherapy for Stage III Non-small Cell Lung Cancer According to EGFR Mutation Status

• Lee Y
• Han JY
• Moon SH
• Nam BH
• Lim KY
• Lee GK
• Kim HT
• Yun T
• An HJ
• Lee JS

• KMID: 2394817
• DOI: http://doi.org/10.4143/crt.2016.522

Abstract

PURPOSE
Concurrent chemoradiotherapy (CCRT) is the standard care for stage III non-small cell lung cancer (NSCLC) patients; however, a more effective regimen is needed to improve the outcome by better controlling occult metastases. We conducted two parallel randomized phase II studies to incorporate erlotinib or irinotecan-cisplatin (IP) into CCRT for stage III NSCLC depending on epidermal growth factor receptor (EGFR) mutation status.
MATERIALS AND METHODS
Patients with EGFR-mutant tumors were randomized to receive three cycles of erlotinib first and then either CCRT with erlotinib followed by erlotinib (arm A) or CCRT with IP only (arm B). Patients with EGFR unknown or wild-type tumors were randomized to receive either three cycles of IP before (arm C) or after CCRT with IP (arm D).
RESULTS
Seventy-three patients were screened and the study was closed early because of slow accrual after 59 patients were randomized. Overall, there were seven patients in arm A, five in arm B, 22 in arm C, and 25 in arm D. The response rate was 71.4% and 80.0% for arm A and B, and 70.0% and 73.9% for arm C and D. The median overall survival (OS) was 39.3 months versus 31.2 months for arm A and B (p=0.442), and 16.3 months versus 25.3 months for arm C and D (p=0.050). Patients with sensitive EGFR mutations had significantly longer OS than EGFR-wild patients (74.8 months vs. 25.3 months, p=0.034). There were no unexpected toxicities.
CONCLUSION
Combined-modality treatment by molecular diagnostics is feasible in stage III NSCLC. EGFR-mutant patients appear to be a distinct subset with longer survival.

Keyword

Chemoradiotherapy; EGFR tyrosine kinase inhibitor; EGFR mutation; Non-small-cell lung carcinoma

MeSH Terms

Arm
Carcinoma, Non-Small-Cell Lung*
Chemoradiotherapy*
Cisplatin*
Erlotinib Hydrochloride*
Humans
Neoplasm Metastasis
Pathology, Molecular
Receptor, Epidermal Growth Factor
Cisplatin
Erlotinib Hydrochloride
Receptor, Epidermal Growth Factor

Figure

• 

  Fig. 1. Study design. EGFR, epidermal growth factor receptor; WT, wild type; IP, irinotecan plus cisplatin; TRT, thoracic radiotherapy; PD, disease progression.

• 

  Fig. 2. Survival outcomes by treatment arm. (A) Progression-free survival (PFS). (B) Overall survival (OS).

Reference

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