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T. Ishida
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-074 - Phase II Trial of Erlotinib Monotherapy for Pretreated Elderly Patients with Advanced EGFR Wild-Type Non-Small-Cell Lung Cancer (ID 188)
09:30 - 09:30 | Author(s): T. Ishida
- Abstract
Background:
In industrialized countries, the age of approximately 50% of patients at diagnosis of non-small cell lung cancer (NSCLC) is >70 years old. Exploration of an optimal treatment strategy for elderly patients with NSCLC as either a first-line or second-line therapy is required. Erlotinib is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that is an effective treatment for patients with 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 in elderly patients with EGFR-wt advanced or recurrent NSCLC.
Methods:
Eligibility criteria included: patients aged ≥70 years with pathologically or cytologically proven NSCLC; measurable tumor sites according to the Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1; an Eastern Cooperative Oncology Group performance status of 0–2; no activating EGFR gene mutations (exon 18, 19, 20 and 21); history of 1–2 regimens of systemic chemotherapy; stage IIIB or IV NSCLC, or postoperative recurrence; treatment naïve to EGFR-TKI; and appropriate organ function. EGFR gene mutation analysis was performed by using invasive signal amplification reaction with a structure-specific 5’ nuclease and a polymerase chain reaction (PCR) product (PCR-invader). Patients 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), and six patients were female. Five patients had an Eastern Cooperative Oncology Group performance status of 0, and 11 (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) and 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 was improved by following steroid therapy.
Conclusion:
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.
