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T. Morimoto
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-014 - A Phase I Study of Afatinib for Patients Aged 75 or Older with Advanced NSCLC Harboring EGFR Mutations (ID 8246)
09:30 - 09:30 | Author(s): T. Morimoto
- Abstract
Background:
The efficacy and safety of afatinib therapy among elderly (aged 75 or older) populations diagnosed with EGFR-mutated non-small cell lung cancer (NSCLC) has not been evaluated yet. This phase I trial was conducted to determine the maximum tolerated dose (MTD), recommended phase II dose of afatinib in elderly patients with advanced NSCLC harboring EGFR mutations.
Method:
The study used a standard 3 + 3 dose escalation design. Patients aged 75 years or older advanced NSCLC harboring EGFR mutations were enrolled. Patients were required to have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1 and adequate organ function. The doses of afatinib, which was given once daily, were planned as follows: level 1, 20 mg/body; level 2, 30 mg/body; level 3, 40 mg/body. Dose-limiting toxicity (DLT) was defined as grade 4 hematologic or grade 3 non-hematologic toxicity. DLT was evaluated during day1-28.
Result:
From February 2015 to October 2016, 15 patients were enrolled from 3 participating institutions. Patient characteristics were: male/female 3/12; median age 79 (range 75-87); Performance status 0/1 2/13. Six patients have been treated at level 1, 3 and three patients have been treated at level 2, respectively. At level 1, 1 of 6 patients showed DLTs. The patient grade 3 rush, grade 3 anorexia, and grade 3 infection was observed. At level 2, none of 3 patients experienced a DLT. At level 3, 2 to 6 patients were observed DLTs. One patient developed grade 3 diarrhea, another patient developed grade 3 diarrhea and grade 3 anorexia. Most frequent adverse events (AEs, any grade) were diarrhea, paronychia, rush, and nausea. Most patients at level 3 required dose reduction in three months. No treatment-related deaths were observed at either level. An objective response was 73.3%.
Conclusion:
We considered level 3 was the MTD and recommended phase II dose level was 3. Clinical trial information: UMIN000016441.
