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Yusuke Okuma
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EP1.01 - Advanced NSCLC (ID 150)
- Event: WCLC 2019
- Type: E-Poster Viewing in the Exhibit Hall
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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EP1.01-20 - A Single-Arm Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel Monotherapy After Standard Therapy for Advanced NSCLC (Now Available) (ID 370)
08:00 - 18:00 | Author(s): Yusuke Okuma
- Abstract
Background
Few studies have investigated the clinical efficacy of later-line treatments after standard therapy for advanced non-small cell lung cancer (NSCLC). Nanoparticle albumin-bound paclitaxel was one of the useful option for treatment of NSCLC. We conducted PII trial for evaluating the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard therapy for advanced NSCLC.
Method
The eligible patients having adequate organ functions with performance status 0−2 were enrolled after completing standard therapy. Standarad therapy defined as chemotherapy including docetaxel and pemetrexed in patients with non-squamous cell lung cancer or docetaxel in patients with squamous cell lung cancer. After the ICI nivolumab was approved by the Ministry of Health, Labor and Welfare of Japan in December 2015, standard therapy was defined as including ICIs treatment. They received weekly nab-paclitaxel 100 mg/m2 intravenously on days 1, 8, and 15 every 3 weeks. The primary end point was objective response rate (ORR). Median progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as secondary end points.
Result
This trial was discontinued because of late accrual. Twenty-two patients were enrolled from April 2013 and February 2019. All patients recieved chemotherapy including docetaxel and Six patients recieved ICIs tretment. Median follow-up interval was 6.7 months. The total ORR was 22.7% [95% CI: 7.8−45.4] and disease control rate (DCR) was 81.8% [95% CI: 59.7−94.8]. Median PFS was 3.4 months [95% CI: 2.3−4.1] and median OS was 7.4 months [95% CI: 4.2−10.7]. Hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), and the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient.
Conclusion
Although all patients recieved chemotherapy including docetaxel before protocol tretment, our tral suggested nab-paclitaxel may be a safe and effective later-line chemotherapeutic option for previously treated advanced NSCLC after standard of chemotherapies based on other trials.
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P1.14 - Targeted Therapy (ID 182)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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P1.14-28 - Correlation Between the Qualification for the Bevacizumab Use and the Survival of NSCLC Patients with EGFR Mutations (ID 1174)
09:45 - 18:00 | Author(s): Yusuke Okuma
- Abstract
Background
Previously, the combination of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) and bevacizumab (BEV) has been investigated. A subgroup analysis of a phase III trial investigating the combination of atezolizumab, carboplatin, paclitaxel, and bevacizumab (ABCP) demonstrated the benefit of ABCP in patients harboring EGFR mutations. This study aims to assess the prognostic significance of the qualification for the BEV use on the survival and proportion of patients who potentially benefit from BEV before and after first-line EGFR-TKIs.
Method
We retrospectively analyzed the data of 283 patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) harboring EGFR mutations who had received EGFR-TKIs. We performed statistical analyzes using the Kaplan–Meier method and Cox regression adjusted for risk factors.
Result
Of 283 patients, 196 (69%) were eligible to administer BEV (“BEV fit”) at the time of EGFR-TKIs initiation. Among “BEV unfit” patients at the baseline (n = 67), 14 (21%) became “BEV fit” at the time of EGFR-TKIs failure. The median overall survival (OS) time of “BEV fit” and “BEV unfit” patients were 25.0 [95% confidence interval (CI): 23.0–29.4] and 18.8 (95% CI: 14.4–22.0) months, respectively (P = 0.0001). The multivariate analysis revealed a marked correlation between survival and the qualification for the BEV use.
Conclusion
The qualification for the BEV use at the baseline is independently related to the OS. Some patients harboring EGFR mutations, including “BEV unfit” at the baseline, could be eligible for the ABCP regimen after the first-line EGFR-TKIs failure.
