A phase II trial of erlotinib monotherapy for pretreated elderly patients with advanced EGFR wild-type non-small cell lung cancer

BMC Research Notes

Mitsuru Munakata³  Takashi Ishida⁴  Akio Oishi¹  Yutaka Katsuura²  Taeko Ishii²  Yayoi Inokoshi²  Yoshinori Tanino³  Kenya Kanazawa³  Kengo Oshima³  Satoko Sekine³  Ken-ichiro Hirai³  Keisuke Azuma³  Hiroshi Yokouchi³  Hiroyuki Minemura³ 

[1] Department of Thoracic Surgery, Fukushima Red Cross Hospital, 11-31 Irie-cho, Fukushima 960-8530, Japan;Department of Pulmonary Medicine, Saiseikai Fukushima General Hospital, 25 Omori Aza Shimo-harada, Fukushima 960-1101, Japan;Department of Pulmonary Medicine, Fukushima Medical University, 1 Hikariga-oka, Fukushima 960-1295, Japan;Clinical Oncology Center, Fukushima Medical University Hospital, 1 Hikariga-oka, Fukushima 960-1295, Japan

关键词: PCR-invader;    EGFR wild-type;    Elderly;    Erlotinib;    Non-small cell lung cancer;   

Others  :  1232414
DOI  :  10.1186/s13104-015-1214-9

 received in 2015-05-09, accepted in 2015-05-29,  发布年份 2015

【 摘 要 】

Background

Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which is an effective treatment for patients with non-small cell lung cancer (NSCLC), especially those harboring activating EGFR mutations. A previous phase III trial suggested that patients with EGFR wild-type (EGFR-wt) NSCLC or elderly patients with disease progression after cytotoxic chemotherapy might benefit from erlotinib monotherapy. However, few studies have prospectively evaluated the efficacy and safety of second- or third-line erlotinib monotherapy for elderly patients with EGFR-wt advanced or recurrent NSCLC.

Methods

Pretreated patients aged ≥70 years with EGFR-wt stage IIIB/IV NSCLC or those with postoperative recurrence were enrolled and received oral erlotinib at a dose of 150 mg/day until disease progression. Primary outcome was the objective response rate (ORR). Secondary end points included the disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and toxicity profile.

Results

This study was terminated early because of the results from a Japanese phase III trial (DELTA trial). Sixteen patients were enrolled between April 2010 and May 2013. The median age was 78 years (range 70–84 years). Six patients were female. Five patients had an Eastern Cooperative Oncology Group performance status of 0. Eleven (69%) patients had adenocarcinoma. Fifteen (94%) patients were treated with erlotinib as a second-line therapy. The ORR was 0% [95% confidence interval (CI) 0–17.1]. DCR was 56.3% (95% CI 33.2–76.9). The median PFS and OS were 1.7 months (95% CI 1.3–2.2) and 7.2 months (95% CI 5.6–8.7), respectively. The most commonly occurring adverse events included acneiform eruption (31.3%) and skin rash (25.0%). One patient developed grade 3 interstitial lung disease, which improved following steroid therapy.

Conclusions

In pretreated elderly patients with advanced or recurrent EGFR-wt NSCLC, daily oral erlotinib was well tolerated; however, administration of the drug should not be considered as a second line therapy.

Trial registration: University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000004561 (Date of registration: November 15th, 2010)

【 授权许可】

   
2015 Minemura et al.

【 图 表 】

Figure1.

Figure2.

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