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yasuhiro Kato
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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 | Presenting Author(s): yasuhiro Kato
- 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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P2.04 - Immuno-oncology (ID 167)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Immuno-oncology
- Presentations: 1
- Now Available
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.04-39 - Clinical Characteristics of Long-Term Survivors with Nivolumab in Previously Treated Advanced NSCLC from Real World Data (Now Available) (ID 518)
10:15 - 18:15 | Author(s): yasuhiro Kato
- Abstract
Background
Nivolumab, a programmed death-1 immune checkpoint inhibitor antibody, has become one of the new standard therapies for previously treated advanced non-small cell lung cancer (NSCLC). However, there is limited information about the long-term survival of real-world patients treated with nivolumab in Japan.
Method
We performed a retrospective study of previously treated patients with advanced NSCLC who received nivolumab at 3 mg/kg every 2 weeks outside clinical trials from our institution in Saitama (Japan) between January 2016 and February 2017. We used real-world data (RWD) to analyze the clinical characteristics of patients who were alive 2 years after initiating nivolumab treatment.
Result
A total of 129 patients fulfilled the inclusion criteria. Thirty-eight patients (30%) were alive 2 years after receiving the first dose of nivolumab. The median age at initial nivolumab treatment was 65 years (38–79). Twenty-nine (76%) patients were male, 12 (32%) were never-smokers, 37 (97%) had performance status (PS) 0 and 1, and 30 (79%) had adenocarcinoma histology. Twenty-five (66%) patients received nivolumab as second-line therapy, and 9 (24%) had genetic abnormalities including 7 with epidermal growth factor receptor (EGFR) mutations. Thirty-four cases of programmed death-ligand 1 expression in tumor samples were not quantifiable. The best responses to nivolumab per the Response Evaluation Criteria in Solid Tumors version 1.1 included 12 partial responses (32%) and 6 complete responses (16%). Eleven 2-year survivors (29%) received nivolumab for more than two years, three (8%) discontinued nivolumab because of immune-related adverse effects, and four (11%) were retreated. Fourteen 2-year survivors (37%) received only nivolumab without subsequent therapy and did not display evidence of progressive disease at the last follow-up. These survivors exhibited significantly good PS, were male, had a history of smoking, and did not harbour somatic genetic abnormalities. Multivariate analysis identified only good PS as an independent positive predictor of survival of two years or more.
Conclusion
In our RWD experience, nivolumab resulted in a 2-year survival rate of 30% in previously treated patients with advanced NSCLC. The 2-year survival rate in a real-world clinical setting was slightly lower than that in a Japanese phase II study (ONO4538-05/06 study). Clinical characteristics associated with a positive treatment response were comparable to those observed in previous studies.
