A Phase II Trial on Osimertinib as a First-Line Treatment for EGFR Mutation-Positive Advanced NSCLC in Elderly Patients: The SPIRAL-0 Study

Author:

Chihara Yusuke1ORCID,Takeda Takayuki2,Goto Yasuhiro3,Nakamura Yoichi4,Tsuchiya-Kawano Yuko5,Nakao Akira6,Onoi Keisuke7,Hibino Makoto8,Fukuda Minoru9,Honda Ryoichi10,Yamada Takahiro11,Taniguchi Ryusuke12,Sakamoto Sinjiro13,Date Koji14,Nagashima Seiji15,Tanzawa Shigeru16,Minato Koichi17,Nakatani Koichi18,Izumi Miiru19,Shimose Takayuki20,Kishimoto Junji21,Uchino Junji7,Takayama Koichi7

Affiliation:

1. Department of Respiratory Medicine, Uji-Tokushukai Medical Center , Uji , Japan

2. Department of Respiratory Medicine, Japanese Red Cross Kyoto Daini Hospital , Kyoto , Japan

3. Department of Respiratory Medicine, Fujita Health University School of Medicine , Toyoake , Japan

4. Division of Thoracic Oncology, Tochigi Cancer Center , Utsunomiya , Japan

5. Department of Respiratory Medicine, Kitakyushu Municipal Medical Center , Kitakyushu , Japan

6. Department of Respiratory Medicine, Fukuoka University Hospital , Fukuoka , Japan

7. Department of Pulmonary Medicine, Kyoto Prefectural University of Medicine , Kyoto , Japan

8. Department of Respiratory Medicine, Shonan Fujisawa Tokushukai Hospital , Fujisawa , Japan

9. Department of Respiratory Medicine, Nagasaki University Hospital , Nagasaki , Japan

10. Department of Respiratory Medicine, Asahi General Hospital , Asahi , Japan

11. Department of Pulmonary Medicine, Matsushita Memorial Hospital , Moriguchi , Japan

12. Department of Respiratory Medicine, Otsu City Hospital , Otsu , Japan

13. Department of Respiratory Medicine, Hiroshima University Hospital , Hiroshima , Japan

14. Department of Pulmonary Medicine, Kyoto Chubu Medical Center , Nantan , Japan

15. Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center , Omura , Japan

16. Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine , Tokyo , Japan

17. Division of Respiratory Medicine, Gunma Prefectural Cancer Center , Ota , Japan

18. Division of Respiratory Medicine, National Hospital Organization Kyoto Medical Center , Kyoto , Japan

19. Department of Respiratory Medicine, National Hospital Organization Omuta National Hospital , Omuta , Japan

20. Department of Statistics and Data Center, Clinical Research Support Center Kyushu , Fukuoka , Japan

21. Center for Clinical and Translational Research, Kyushu University Hospital , Fukuoka , Japan

Abstract

Abstract Background Osimertinib is one of the standard first-line treatments for advanced non-small cell lung cancer in patients with epidermal growth factor receptor (EGFR) mutations, because it achieves significantly longer progression-free survival (PFS) than conventional first-line treatments (hazard ratio: 0.46). However, the efficacy and safety of osimertinib as a first-line treatment for patients aged ≥75 years remain unclear. Methods This phase II study was performed to prospectively investigate the efficacy and safety of osimertinib for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. The primary endpoint was 1-year PFS rate; secondary endpoints were overall response rate (ORR), PFS, overall survival (OS), and safety. Results Thirty-eight patients were included in the analysis. The 1-year PFS rate was 59.4% (95% confidence interval [CI], 46.1%-72.7%), which did not meet the primary endpoint (the threshold 1-year PFS rate of 50% predicted using data from the NEJ003 study). The most common grade 3/4 adverse events were rash/dermatitis acneiform/ALT increased/hypokalemia (2 patients, 5%). Seven patients developed pneumonitis (17.5%). There were no other cases of treatment discontinuation due to adverse events other than pneumonitis. Conclusion Although this study did not meet the primary endpoint, osimertinib was tolerable for elderly patients with EGFR mutation-positive advanced non-small cell lung cancer. (Japan Registry of Clinical Trials [JRCT] ID number: jRCTs071180007).

Funder

AstraZeneca

Publisher

Oxford University Press (OUP)

Subject

Cancer Research,Oncology

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