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Atsushi Nakamura
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OA03 - Promising Antibody-Drug Conjugate and Cytotoxic Therapy in NSCLC (ID 100)
- Event: WCLC 2020
- Type: Oral
- Track: Antibody Drug Conjugates, Novel Therapeutics and Cytotoxics
- Presentations: 1
- Moderators:
- Coordinates: 1/29/2021, 10:30 - 11:30, Scientific Program Auditorium
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OA03.05 - Phase III Study Comparing Nab-Paclitaxel With Docetaxel in Patients With Previously Treated Advanced Non-Small-Cell Lung Cancer (ID 3117)
10:30 - 11:30 | Presenting Author(s): Atsushi Nakamura
- Abstract
- Presentation
Introduction
Nanoparticle albumin-bound (nab-) paclitaxel showed promising efficacy for treatment of advanced non–small cell lung cancer (NSCLC) in a phase 2 study. We aimed to assess the efficacy and safety of nab-paclitaxel for previously treated patients with advanced NSCLC.
Methods
In this multicenter, randomized, open-label, noninferiority phase 3 trial, we enrolled patients with advanced NSCLC previously treated with cytotoxic chemotherapy. Patients were randomly allocated (1:1) to receive docetaxel (60 mg/m²) on day 1 or nab-paclitaxel (100 mg/m²) on days 1, 8, and 15 of a 21-day cycle. The primary end point was overall survival analyzed on an intention-to-treat basis. Adverse events were assessed according to treatment received.
Results
Between 22 May 2015 and 12 March 2018, 503 patients were randomly allocated to treatment. Median overall survival was 13.6 months (95% CI, 10.9–16.5) for the 251 patients allocated to docetaxel and 16.2 months (95% CI, 14.4–19.0) for the 252 patients allocated to nab-paclitaxel (hazard ratio, 0.85; 95.2% CI, 0.68–1.07). Median progression-free survival was 4.2 months (95% CI, 3.9–5.0) for the nab-paclitaxel group versus 3.4 months (95% CI, 2.9–4.1) for the docetaxel group (hazard ratio, 0.76; 95% CI, 0.63–0.92; p=0.0042). The objective response rate was 29.9% (95% CI, 24.0–36.2) for the nab-paclitaxel group and 15.4% (95% CI, 10.9–20.7) for the docetaxel group (p=0.0002), and it showed a significant improvement for nab-paclitaxel versus docetaxel regardless of tumor histology. Adverse events of grade ≥3 included febrile neutropenia (55 [22%] of 249 patients in the docetaxel group versus 5 [2%] of 245 patients in the nab-paclitaxel group) and peripheral sensory neuropathy (2 [1%] versus 24 [10%], respectively).
Conclusion
The trial showed that nab-paclitaxel was noninferior to docetaxel in terms of overall survival. Nab-paclitaxel should thus be considered a standard treatment option for previously treated patients with advanced NSCLC.
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P76 - Targeted Therapy - Clinically Focused - EGFR (ID 253)
- Event: WCLC 2020
- Type: Posters
- Track: Targeted Therapy - Clinically Focused
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P76.79 - Osimertinib in Poor PS Patients with T790M-Positive Advanced NSCLC after Progression of EGFR TKI Treatments (NEJ032B) (ID 3492)
00:00 - 00:00 | Author(s): Atsushi Nakamura
- Abstract
Introduction
Osimertinib has already been reported to be highly effective in epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) -resistant patients with T790M mutation-positive advanced non-small-cell lung cancer (NSCLC). However, its effectiveness and safety in those patients with poor performance status (PS) are unknown.
Methods
After progression by a treatment of gefitinib, elrotinib and/or afatinib patients who had T790M mutation, a Stage IIIB, IV or recurrence disease, and PS 2-4 were enrolled in this study. Osimertinib at a dose of 80 mg/day was orally administered. The primary endpoint of this phase II study was response rate (RR), and the secondary endpoints were progression free survival (PFS), overall survival (OS) and safety.
Results
Thirty-three patients were enrolled from February 2017 to May 2019. All patients met the eligibility criteria. Their median age was 72 years (range: 47–89). Women accounted for 81.8% of the patients, and 69.7% and 24.2% of the patients had a PS of 2 and 3, respectively. For 32 patients except for a patient with a protocol violation, the RR was 53.1% (95% confidence interval: 34.7-70.9%), and the disease control rate was 75.0%. The PFS was 4.8 months, and the OS was 11.1 months. Interstitial lung disease (ILD) at all grades and grade 3-5 were observed in 15.1% (5/33) and 6.1% (2/33), respectively, and treatment-related death by ILD occurred in one patient.
Conclusion
As the primary endpoint, we verified that osimertinib was sufficiently effective in EGFR TKI-resistant, poor PS patients with T790M mutation-positive advanced NSCLC. However, physicians should pay attention to relatively short PFS and adverse events such as ILD.
Clinical trial information: jRCTs061180018.
