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Ajeet Gajra
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-014 - ABOUND.PS2: Safety and Efficacy of Nab-Paclitaxel–Based Therapy in Patients with NSCLC and ECOG PS 2 (ID 8186)
09:00 - 16:00 | Presenting Author(s): Ajeet Gajra
- Abstract
Background:
Patients with advanced NSCLC with poor ECOG PS can benefit from platinum-based doublet chemotherapy, although limited data exist from recent, randomized prospective trials. ABOUND.PS2 evaluated the safety and efficacy of nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with advanced NSCLC and ECOG PS 2.
Method:
Chemotherapy-naive patients with histologically/cytologically confirmed stage IIIB/IV NSCLC and ECOG PS 2 received 4 cycles of nab-paclitaxel 100 mg/m[2] on days 1 and 8 plus carboplatin AUC 5 on day 1 q3w. Patients not progressing could receive monotherapy with nab-paclitaxel 100 mg/m[2] on days 1 and 8 q3w until progression or unacceptable toxicity. Primary endpoint: percentage of patients discontinuing within the first 4 cycles due to treatment-emergent adverse events (TEAEs). Other endpoints: progression-free survival (PFS), disease control rate (DCR), overall survival (OS), overall response rate (ORR), and quality of life (QoL) by Lung Cancer Symptom Score (LCSS).
Result:
Forty patients were treated. Median age was 67.5 years, 60.0% were male, 92.5% were white, and 62.5% had nonsquamous histology. During induction, 11 of 40 patients (28%) discontinued due to TEAEs (primary endpoint). In total, 16 of 40 patients (40.0%) received nab-paclitaxel as monotherapy. In all treated patients, the median percentage of per-protocol dose of nab-paclitaxel was 78.3% and the median nab-paclitaxel dose intensity was 52.2 mg/m[2]/week (planned, 66.7 mg/m[2]/week). See table for additional safety, efficacy, and QoL results.
Conclusion:
These results support the role of this nab-paclitaxel–based regimen in patients with NSCLC and ECOG PS 2. The regimen was well tolerated and appears to have resulted in a clinically meaningful improvement in QoL. Compared with historical data, this regimen is active in patients with stage IIIB/IV NSCLC and ECOG PS 2. NCT02289456
[a] A ≥ 10-mm improvement was considered clinically meaningful.All Treated Patients N = 40 Safety Grade ≥ 3 TEAEs of special interest, n (%) Neutropenia Anemia Thrombocytopenia Peripheral neuropathy 9 (22.5) 7 (17.5) 2 (5.0) 1 (2.5) Efficacy PFS, median (95% CI), months 4.4 (2.99-7.00) OS, median (95% CI), months 7.66 (4.93-13.17) ORR (RECIST v1.1), n (%) 12 (30.0) DCR, % Complete response Partial response Stable disease Progressive disease, % Patients with no postbaseline tumor assessment 30 (75.0) 0 12 (30.0) 18 (45.0) 2 (5.0) 8 (20.0) QoL Mean maximum improvement from baseline LCSS Global QoL item, mm[a] 16.91
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P2.01-015 - Longitudinal Assessment of Performance Status (PS) in Patients with NSCLC and ECOG PS 2 on Nab-Paclitaxel–Based Therapy (ID 8187)
09:00 - 16:00 | Author(s): Ajeet Gajra
- Abstract
Background:
ABOUND.PS2 evaluated nab-paclitaxel/carboplatin induction followed by nab-paclitaxel monotherapy in patients with advanced NSCLC and ECOG PS 2. Concordance between patient- and physician-reported PS as well as change in PS with chemotherapy were assessed longitudinally.
Method:
Chemotherapy-naive patients with histologically/cytologically confirmed stage IIIB/IV NSCLC and ECOG PS 2 received 4 cycles of nab-paclitaxel 100 mg/m[2] on days 1 and 8 plus carboplatin AUC 5 on day 1 q3w. Patients not progressing could receive monotherapy with nab-paclitaxel 100 mg/m[2] on days 1 and 8 q3w until progression or unacceptable toxicity. Primary endpoint was the percentage of patients discontinuing within the first 4 cycles due to treatment-emergent adverse events. ECOG PS was assessed by patients on day 1 of each cycle and at treatment discontinuation, and ECOG PS and spirometry were assessed by physicians at screening, on day 1 of each cycle, and at treatment discontinuation.
Result:
Forty patients were treated. Baseline ECOG PS was reported as 2 by 48% and 95% of patients and physicians, respectively. Only 53% of patients rated their ECOG PS the same as the physician at cycle 1 day 1. For patients with both pre- and post-treatment ECOG assessments, 14 of 33 patients (42%) and 12 of 38 physicians (32%) reported an improvement from baseline at least once during treatment (Figure). At baseline, physicians believed that ECOG PS would be reversible with treatment in the majority of patients (80%). Mean FEV1 was 1.29 L and mean PEF was 2.66 L/s at baseline; exploratory investigations of spirometry data indicate that lung function (FEV1 and PEF) remained stable over the course of treatment.
Conclusion:
These results from the ABOUND.PS2 study suggest that patient-reported PS assessments may differ from physician assessments. Improvements in ECOG PS were reported by both patients and physicians during treatment. NCT02289456Figure 1
