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Sakiko Otani



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    MA21 - Non EGFR/MET Targeted Therapies (ID 153)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Now Available
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      MA21.11 - A Multicenter Phase II Study of Low-Dose Erlotinib in Frail Patients with EGFR Mutation-Positive, Non-Small Cell Lung Cancer: TORG1425 (Now Available) (ID 633)

      14:30 - 16:00  |  Presenting Author(s): Sakiko Otani

      • Abstract
      • Presentation
      • Slides

      Background

      We conducted a multicenter phase II trial evaluating the efficacy of low-dose erlotinib (ERL) in frail patients with EGFR-mt non-small cell lung cancer (NSCLC). The primary endpoint was met, with the objective response rate (ORR) of 60%. Here we present the final overall survival (OS) results. Furthermore, we investigated the effect of ABCB1 genetic polymorphisms on the ERL plasma concentration pharmacokinetics (PK) and pharmacodynamics (PD).

      Method

      Chemotherapy-naïve NSCLC patients with EGFR mt who had frailty were enrolled and received ERL 50 mg/d. Patient’s frailty was defined as follows: (Group 1) 20 to 74 years of age with Eastern Cooperative Oncology Group performance status (PS) ≥2 or Charlson Comorbidity Index (CCI) ≥6 points; (Group 2) 75 to 80 years of age with PS ≥1 or CCI ≥6 points; (Group 3) ≥81 years of age with any PS and CCI. ABCB1 gene polymorphism analysis were using the i-densyTM genetic testing platform, and blood samples for the ABCB1 genetic testing were collected prior to treatment. Steady-state trough plasma ERL concentration was measured with a high-performance liquid chromatograph-tandem mass spectrometry at 15 days (±7 days) after initiating ERL administration.

      Result

      From December 2014 and April 2017, 80 patients were enrolled: males/females 26/54; median age 80 (range 49-90); Group 1/2/3 15/28/37; Ad/Sq/Others 76/1/3. EGFR mt types were: exon 19/21 42/38. All 80 patients were included in efficacy and safety analysis. Median progression-free survival and OS were 9.3 (95%CI: 7.2-11.4), 26.1 (95%CI: 21.9-30.4) months respectively. The trough of ERL could be measured in 48 patients, and 45 of these patients were analyzed for ABCB1 genetic polymorphism. The ORR for the 48 patients was 62.5%, and their median trough of ERL was 685 ng/ml (range 153-1950) , which surpassed the reported “effective” level (500ng/ml). Nine (60%) of 15 the patients who failed to achieve the level responded. Genetic polymorphisms were not correlated with ERL PK, nor were they associated with efficacy and adverse events.

      Conclusion

      This is the first prospective study evaluating low-dose ERL for frail patients with EGFR mt NSCLC. This treatment was safe and effective, and the ABCB1 genetic polymorphisms did not affect ERL PK/PD. Clinical trial information: UMIN 000015949.

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    P1.01 - Advanced NSCLC (ID 158)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Advanced NSCLC
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 09:45 - 18:00, Exhibit Hall
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      P1.01-15 - Multicenter, Single-Arm Phase II Study of Nab-Paclitaxel/Carboplatin in Untreated PS2 Patients with Advanced NSCLC: TORG1426 (Now Available) (ID 519)

      09:45 - 18:00  |  Author(s): Sakiko Otani

      • Abstract
      • Slides

      Background

      Performance Status (PS) has been shown to predict survival in patients with advanced non-small cell lung cancer (NSCLC). To date, PS2 patients have been underrepresented in clinical trials due to concerns about tolerability. Consequently, no standard of care exists for these patients. In CA031 trial, nab-paclitaxel/carboplatin (nab-PTX/CBDCA) demonstrated significantly higher response rate (RR) compared with PTX/CBDCA in PS0-1 patients with advanced NSCLC. Furthermore, in elderly subgroup, nab-PTX/CBDCA tended to show superior progression-free survival (PFS) and overall survival (OS) based on better tolerability compared with PTX/CBDCA. Therefore, this phase II trial was designed to characterize the efficacy, safety, and tolerability of nab-PTX/CBDCA in untreated PS2 patients with advanced NSCLC.

      Method

      Chemotherapy-naive PS2 patients with stage IIIB/IV NSCLC were treated with nab-PTX (70 mg/m2 on day1, 8, and15, q4w) and CBDCA (AUC 5 on day1, q4w) up to 6 cycles if they did not have uncontrolled brain metastasis or pleural effusion. The primary endpoint was PFS rate at 6 months. Its achievement of more than 50% was considered worthy of further development of this regimen, whereas that of less than 30% was considered insufficient for further investigation. The estimated power was 80% with type I error of 0.05, resulting in 35 patients needed. Concurrently, Symptom Score and Charlson Comorbidity Index (CCI) were evaluated.

      Result

      This trial was terminated due to slow accrual. Between September 2015 and August 2018, 17 patients (median age, 68 years [range, 50-73]) were enrolled and received a median of 3 cycles. The reasons for PS2 were tumor progression (71%), comorbidities (12%), or both (17%). The PFS rate at 6 months was 20.8% (95% confidence interval, 0%-41.6%). The median PFS, OS, RR, and disease control rate (DCR) were 3.0 months, 9.5 months, 17.4%, and 70.6%, respectively. Grade 3-5 adverse events (AE) included fatigue (24%), lung infection (24%, including 6% of grade 5), neutropenia (18%), and anemia (18%), resulting in trial withdrawal rate of 24%. The median PFSs of 11 patients with and 6 patients without 2nd line chemotherapy were 5 months and 1.7 months, respectively (p = 0.009). Symptom Score was improved by chemotherapy (p = 0.004), whereas comparison between lower and higher CCI values demonstrated no difference regarding chemotherapy cycles administered (p = 0.5) and regarding chemotherapy efficacy (p = 0.268).

      Conclusion

      Nab-PTX/CBDCA did not meet its primary endpoint, but could be a feasible treatment option for untreated PS2 patients with advanced NSCLC. Clinical trial information: UMIN000019458

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