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Hiroaki Okamoto
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MA13 - Going Back to the Roots! (ID 139)
- Event: WCLC 2019
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Now Available
- Moderators:Maurice Perol, Kaoru Kubota
- Coordinates: 9/09/2019, 14:00 - 15:30, Vancouver (2003)
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MA13.07 - Phase I/II Study of Carboplatin Plus Weekly Nab-Paclitaxel in Aged ≥75 Patients with Squamous-Cell Lung Cancer: TORG1322 (Now Available) (ID 1369)
14:00 - 15:30 | Author(s): Hiroaki Okamoto
- Abstract
- Presentation
Background
Combination chemotherapy of carboplatin (CBDCA) plus weekly nab-paclitaxel (nab-PTX) showed a favorable efficacy for elderly (70 year or older) patients with squamous non-small cell lung cancer (Sq-NSCLC) in a subgroup analysis of the CA031 study. We conducted a phase I/II study of CBDCA plus nab-PTX in chemo-naïve elderly patients with advanced Sq-NSCLC.
Method
Patients aged ≥75 years with untreated, measurable lesion, advanced Sq-NSCLC, performance status (PS) 0-1, and adequate organ function were eligible. In a phase I study, doses of carboplatin at an area under the curve (AUC) of 5 or 6 mg/mL min on day 1 (levels 1 and 2, respectively) were administered along with weekly nab-PTX (100 mg/m2) on days 1, 8, and 15 every 4 weeks up to 6 cycles using a modified 3 + 3 design. The primary endpoint for the phase II study was the 6-month progression-free survival (6m PFS) rate and hypothesis required 36 patients to be enrolled with expecting and threshold values for the primary endpoints of 40% and 25% (one-sided alpha = 0.05; beta = 0.2).
Result
A total of 46 patients were enrolled in this study. The median age was 78 (range 75-85 years); male (n = 41); PS 0/1, (n = 15/31). Ten patients were enrolled in the phase I part. At dose level 1, 2/7 patients showed dose-limiting toxicities (DLTs) of grade 3 diarrhea and febrile neutropenia, and at dose level 2, 1/3 patient showed DLT of grade 3 anorexia. The recommended dose was determined to be level 2. Additional 36 patients were enrolled, and a total of 39 patients were evaluated in the phase II study. The median number of cycles was 4 (range 1-6), and the median follow-up time was 17.5 months (range 5.6-28.9). The 6m PFS rate was 59% (90% CI, 44.8-71.4), and the primary endpoint was met. The median overall survival time was 23.5 months (95% CI, 11.6-35.4), and the median PFS was 6.8 months (95% CI, 5.4-9.1). The response rate was 54% and disease control rate was 92%. Nineteen patients (49%) received post-study treatment and 14 out of 19 patients (74%) received immunotherapy. Common toxicities of grade 3 or 4 were neutropenia (61.5%), anemia (46.2%), thrombocytopenia (17.9%), and febrile neutropenia (15.4%). There was no treatment-related death.
Conclusion
Combination chemotherapy of CBDCA plus weekly nab-PTX had a promising efficacy and acceptable toxicities in elderly (aged ≥75) patients with advanced Sq-NSCLC. Clinical trial information: UMIN000011216.
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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
- Moderators:Benjamin Besse, Michael Thomas
- Coordinates: 9/10/2019, 14:30 - 16:00, Vienna (2016)
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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 | Author(s): Hiroaki Okamoto
- Abstract
- Presentation
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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OA12 - Profiling the Multidisciplinary Management of Stage III NSCLC (ID 144)
- Event: WCLC 2019
- Type: Oral Session
- Track: Treatment of Locoregional Disease - NSCLC
- Presentations: 1
- Now Available
- Moderators:Dirk De Ruysscher, Bartomeu Massuti
- Coordinates: 9/09/2019, 15:45 - 17:15, Seoul (2007)
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OA12.02 - Randomized Phase II Study of CDDP+S-1 vs CDDP+PEM Combined with Thoracic RT for Locally Advanced Non-Sq NSCLC: SPECTRA Study (Now Available) (ID 428)
15:45 - 17:15 | Author(s): Hiroaki Okamoto
- Abstract
- Presentation
Background
SPECTRA, a multicenter, randomized phase II study of CDDP+S-1 versus CDDP+pemetrexed (PEM) combined with thoracic radiotherapy (TRT) for locally advanced non-squamous non-small cell lung cancer (NSCLC), previously reported that toxicities were tolerable and manageable in both arms; however, febrile neutropenia was more frequently observed in the CDDP+S-1 arm (9.6%/2%). Completion rate of TRT (60Gy) and chemotherapy (4 cycles) was 92%/98% and 73%/86%, respectively. Response rate was 60%/64% (WCLC 2017, MA17.06). Here, we present primary analysis of 2-year survival data.
Method
Patients were randomly assigned to receive CDDP+S-1 (CDDP 60mg/m2, d1, and S-1 80mg/m2, d1-14, q4w, up to 4 cycles) or CDDP+PEM (CDDP 75mg/m2, d1, and PEM 500mg/m2, d1, q3w, up to 4 cycles) combined with TRT 60Gy in 30 fractions. The primary endpoint was 2-year progression-free survival (PFS) rate. The sample size was set at 100 patients.
Result
Between Jan 2013 and Oct 2016, 102 patients were enrolled in this study from 9 institutions in Japan. All 102 patients were eligible and assessable, of whom 52 were assigned to CDDP+S-1 and 50 to CDDP+PEM. Baseline characteristics were similar (CDDP+S-1/CDDP+PEM): median age (range) 64.5 (39-73)/63.5 (32-74) years; women, n=17 (33%)/n=17 (34%); stage IIIB, n=21 (40%)/n=20 (40%); ECOG PS of 1, n=14 (27%)/n=14 (28%); never smoker, n=12 (23%)/n=12 (24%); and adenocarcinoma, n=47(90%)/n=45(90%); activating EGFR mutation, n=9 (17%)/n=4 (8%); ALK fusion, n=2 (4%)/n=3 (6%). A total of 72 PFS events were observed at the data cut-off (28 November 2018). After a median follow-up of 32.1 months, median PFS was 12.7/13.8 months (HR=1.16, 95% CI, 0.73-1.84, p=0.538), and 2-year PFS rate was 36.5% (95% CI, 23.5-49.6)/32.1% (95%CI, 18.9-45.4). Disease progression was observed in 33 and 36 patients. Distant metastases were the first site of failure in 24 and 31 patients. Local relapse as the first site of failure was observed in 14 and 13 patients. After a median follow-up of 34.6 months, 44 OS events were observed. Median OS was 48.3/59.1 months (HR=1.05, 95%CI, 0.58-1.90, p=0.883), and 2-year OS rate was 69.2% (95%CI, 56.7-81.8)/66.4% (95%CI, 53.0-79.9). 27 patients in each arm received post-study chemotherapy including EGFR-TKIs (n=7/n=5), ALK-TKIs (n=0/n=3), and immune checkpoint inhibitors (n=6/n=10).
Conclusion
2-year PFS rate in the CDDP+S-1 arm was better than that in the CDDP+PEM arm. We will select the CDDP+S-1 arm as the investigational arm in a future phase III study. UMIN000009914 (release date: 31/Jan/2013)
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