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S. Murakami
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-028 - Phase I/II Trial of Carboplatin, nab-Paclitaxel and Bevacizumab for Advanced Non-Squamous Non-Small Cell Lung Cancer: Results of Phase I Part (ID 4205)
14:30 - 14:30 | Author(s): S. Murakami
- Abstract
Background:
Nanoparticle albumin-bound paclitaxel (nab-PTX) is a new formulation of paclitaxel and has demonstrated efficacy when combined with carboplatin (Cb), resulting in one of the standard platinum-containing chemotherapy regimens for patients (pts) with chemo-naïve advanced non-small cell lung cancer (NSCLC). The addition of anti-vascular endothelial growth factor antibody bevacizumab (BEV) to chemotherapy has been known an effective treatment option for non-squamous NSCLC. The efficacy and safety of the new triplet regimen: Cb + nab-PTX + BEV has not yet been assessed.
Methods:
We planned multicenter, open-label, phase I/II trial of Cb + nab-PTX + BEV (CARNAVAL study; TORG1424 / OLCSG1402). Eligible pts were chemo-naïve, aged ≥20 years, ECOG PS 0/1 with advanced non-squamous NSCLC. Pts received 4 to 6 cycles of Cb (AUC = 6, day1) + nab-PTX (dose level 1; 100mg/m[2] on days 1, 8 or dose level 2; 100mg/m[2] on days 1, 8, and 15) + BEV (15mg/kg, day1) followed by maintenance nab-PTX + BEV every 3 weeks until disease progression. The phase I part of the study used a 6+6 dose-escalation design to determine the maximum tolerated dose. Major dose-limiting toxicity (DLT) was defined as grade 4 neutropenia for at least 4 consecutive days, febrile neutropenia, grade 4 thrombocytopenia, grade ≥3 non-hematologic toxicity (excluding nausea, vomiting, loss of appetite, fatigue, diarrhea, constipation, disorder of electrolyte, hypertension and hypersensitivity, if they are manageable), and grade 4 hypertension. DLT was assessed during 1st cycle. This study was registered at UMIN (ID: 000014560).
Results:
From October 2014 to July 2015, 4 and 12 pts were enrolled at dose level 1 and 2 cohorts respectively. No DLT was observed at either level and recommended phase II dose (RP2D) was determined at dose level 2. Grade ≥3 adverse events (AEs) during the overall treatment period were as follows; neutropenia (13 pts), thrombocytopenia (4 pts), nausea, vomiting, anorexia (3 pts each), anemia, fatigue, hypertension (2 pts each), pneumonitis, liver disorder, hyponatremia, febrile neutropenia, skin ulcer, esophageal perforation (1 pt each). All AEs were manageable.
Conclusion:
RP2D of Cb + nab-PTX + BEV was determined at dose level 2 (nab-PTX; 100mg/m[2] on days 1, 8 and 15 every 3 weeks). We have started phase 2 part of the trial at dose level 2 since November 2015.
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-039 - Analysis of Prognostic Factor for Afatinib Treated Patients with EGFR Mutation Positive NSCLC (ID 6360)
14:30 - 14:30 | Author(s): S. Murakami
- Abstract
Background:
Afatinib, known as irreversible EGFR-TKI, significantly improved PFS and OS versus cisplatin-based chemotherapy, in combined analysis of LUX-Lung 3 and 6 despite this was not proved in treatment with former reversible agents. We have tried to examine the factors correlated to improvement of survival in patients treated with afatinib compared to gefitinib or erlotinib.
Methods:
Patients who are enrolled in clinical trials from 2008 to 2014, and treated with EGFR-TKI as first line treatment were eligible. To explore the prognostic factors, we analyzed correlation of candidate factors including age, sex, clinical stage, mutation type and subsequent systemic treatments on medical record in afatinib treated group and reversible agents treated group including gefitinib or erlotinib.
Results:
Nineteen patients (5 men, 14 women) with a median age of 62 years (range, 46-88 ) were treated with EGFR-TKI as first line treatment. Twelve patients were treated with reversible TKIs, 8 with gefitinib, 4 with erlotinib. Seven patients were treated with afatinib. Median PFS for reversible TKI group versus afatinib group was 397 vs 422 days (P = 0.810). Median OS for reversible TKI group versus afatinib group was 741 vs 1380 days (P = 0.501). There is no difference between the two groups, age(P=0.147), sex(P=0.211), stage(P=0.891), and mutation type(P=0.581). Eleven patients received subsequent EGFR-TKI after first line EGFR-TKI failed as “re-challenge”, 7 patients in reversible TKI group, and 4 patients in afatinib group. There is no difference of tumor response of “re-challenge” EGFR-TKI, and duration of treatment with EGFR-TKI, in two groups.
Conclusion:
The patient treated with afatinib tends to live longer in terms of overall survival. But there were no significant correlated factor between clinical characteristics and duration of survival.
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P3.02b-124 - Efficacy of Osimertinib in Patients with Non-Small-Cell Lung Cancer (NSCLC) and Pleural Effusion (ID 5653)
14:30 - 14:30 | Author(s): S. Murakami
- Abstract
Background:
Although epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are effective in patients with mutated non-small-cell lung cancer (NSCLC), pleural or pericardial effusion is a known negative factor in EGFR-TKI monotherapy. Osimertinib, a 3rd-generation EGFR-TKI is an active agent for treating EGFR T790M-positive NSCLC. We analyzed the efficacy of osimertinib in EGFR T790M-positive patients with pleural effusion.
Methods:Patients treated with osimertinib were evaluated in clinical practice following approval of the drug in Japan. Treatment responses of tumor and effusion were measured and analyzed in patients with and without pleural effusion.
Results:Twenty-five patients (7 men, 18 women) with a median age of 70 years (range, 38 – 86 years) were treated with osimertinib between 28 March and 30 June, 2016. Thirteen of the patients had no pleural effusion, of which twelve were evaluable for tumor response and all of these experienced efficacies in terms of response and stable disease. Twelve out of 25 patients had pleural effusion, of which ten patients were evaluable; of these, nine patients had no progression and one patient had progression during a short period of treatment with osimertinib. Regarding the pleural effusion in these ten patients, the effusion decreased in two patients and, was stable in three patients; in five patients, these was a slight or moderate increase despite daily administration of osimertinib. The long-term effects of treatment with osimertinib will be presented in detail at the meeting. Figure 1
Conclusion:Although an active agent in clinical practice, osimertinib might not provide an early response for pleural effusion.
