Concurrent EGFR-TKI and Thoracic Radiotherapy as First-Line Treatment for Stage IV Non-Small Cell Lung Cancer Harboring EGFR Active Mutations

Autor: Bo Zhu, Yuzhong Duan, Zihan Xu, Qiao Yang, Yanmei Wang, Linpeng Zheng, Jianguo Sun, Guangkuo Zhu, Xing-Yun Liao, Xiewan Chen
Rok vydání: 2019
Předmět:
Male
0301 basic medicine
Oncology
Cancer Research
Lung Neoplasms
medicine.medical_treatment
Phases of clinical research
0302 clinical medicine
Carcinoma
Non-Small-Cell Lung

Medicine
Prospective cohort study
Gefitinib
Chemoradiotherapy
Middle Aged
Progression-Free Survival
ErbB Receptors
030220 oncology & carcinogenesis
Female
Erlotinib
medicine.drug
Adult
medicine.medical_specialty
Erlotinib Hydrochloride
03 medical and health sciences
Internal medicine
Humans
Progression-free survival
Radiation Injuries
Lung cancer
Glucocorticoids
Protein Kinase Inhibitors
Aged
Neoplasm Staging
Pneumonitis
business.industry
Clinical Trial Results
Dose fractionation
Pneumonia
Exanthema
medicine.disease
respiratory tract diseases
Radiation therapy
030104 developmental biology
Dose Fractionation
Radiation

Neoplasm Recurrence
Local

business
Follow-Up Studies
Zdroj: The Oncologist
ISSN: 1549-490X
1083-7159
DOI: 10.1634/theoncologist.2019-0285
Popis: Lessons Learned This single-arm, phase II study shows that concurrent EGFR-tyrosine kinase inhibitor plus thoracic radiotherapy as the first-line treatment for stage IV non-small cell lung cancer harboring EGFR active mutations provides long-term control for the primary lung lesion, and 1-year progression-free survival (PFS) rate and median PFS are numerically higher than those of the erlotinib monotherapy. Serious adverse events are acceptable, although grade >3 radiation pneumonitis occurred in 20% of patients. Background Studies show effective local control by EGFR-tyrosine kinase inhibitor (TKI) combined with radiotherapy at metastatic sites in advanced lung cancer harboring EGFR active mutations. Salvage local radiotherapy is associated with prolonged progression-free survival (PFS) in local disease during EGFR-TKI treatment. However, no prospective study has been reported on concurrent EGFR-TKI and radiotherapy for primary lung lesions. This study investigated the efficacy and safety of first-line EGFR-TKI combined with thoracic radiotherapy in treating stage IV non-small cell lung cancer (NSCLC) harboring EGFR active mutations. Methods We conducted a single-arm, phase II clinical trial. Each patient received EGFR-TKI (erlotinib 150 mg or gefitinib 250 mg per day) plus thoracic radiotherapy (54–60 Gy/27–30 F/5.5–6 w) within 2 weeks of beginning EGFR-TKI therapy until either disease progression or intolerable adverse events (AEs) appeared. Results From January 2015 to March 2018, 401 patients were screened, and 10 patients (5 male and 5 female) were eligible. These patients had a median age of 55 years (40–75) and median follow-up of 19.8 months (5.8–34). The 1-year PFS rate was 57.1%, median PFS was 13 months, and median time to progression of irradiated lesion (iTTP) was 20.5 months. Objective response rate (ORR), was 50% and disease control rate (DCR) was 100%. The most common grade ≥3 AEs were radiation pneumonitis (20%) and rash (10%). One patient died after rejecting treatment for pneumonitis. The others received a full, systematic course of glucocorticoid therapy. Pneumonitis was all well controlled and did not relapse. Conclusion Concurrent EGFR-TKI plus thoracic radiotherapy as the first-line treatment for stage IV NSCLC harboring EGFR active mutations shows a long-term control of primary lung lesion. The 1-year PFS rate and median PFS of this combined therapy are numerically higher than those of the erlotinib monotherapy. The risk of serious adverse events is acceptable.
Databáze: OpenAIRE