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K.I. Amiri
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P2.01 - Advanced NSCLC (ID 618)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 4
- Moderators:
- Coordinates: 10/17/2017, 09:00 - 16:00, Exhibit Hall (Hall B + C)
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P2.01-004 - Safety and Efficacy of Nab-Paclitaxel plus Carboplatin in Elderly Patients with NSCLC (ABOUND.70+) (ID 7561)
09:00 - 09:00 | Author(s): K.I. Amiri
- Abstract
Background:
A subanalysis of a phase III registrational trial demonstrated a 9.5-month survival benefit with nab-paclitaxel/carboplatin vs paclitaxel/carboplatin for patients ≥70 years with advanced NSCLC. ABOUND.70+ evaluated 2 schedules of nab-paclitaxel/carboplatin to determine whether a 1-week break could improve tolerability.
Method:
Patients ≥70 years with locally advanced/metastatic NSCLC were randomized to receive first-line nab-paclitaxel 100mg/m[2] on days 1, 8, 15 and carboplatin AUC 6 on day 1 of a 21-d cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: the percentage of patients with grade ≥2 peripheral neuropathy or grade ≥3 myelosuppression; key secondary endpoints: progression-free survival (PFS), overall survival (OS), and overall response rate (ORR), for which statistical analyses did not control for type I error (P values unadjusted).
Result:
At interim evaluation, the primary endpoint was similar across treatment arms leading to early closure of enrollment. Baseline characteristics were well balanced between arms (Arm A, n = 71; Arm B, n = 72). Primary endpoint results are presented in the table. Overall, confirmed ORR was 23.9% vs 40.3% (P = 0.038), median PFS was 3.6 vs 7.0 months (HR 0.48 [95% CI, 0.30-0.76]; P = 0.002), and median OS was 15.2 vs 16.2 months (HR 0.72 [95% CI, 0.44-1.19]; P = 0.197). Among patients who received second-line therapy across treatment arms (n = 61), median OS from start of first-line treatment was 22.7 months (95% CI, 11.79-not estimable [NE]) and 16.4 months (95% CI, 12.12-NE) in patients receiving chemotherapy and immunotherapy, respectively.
Conclusion:
nab-Paclitaxel/carboplatin was well tolerated and efficacious in elderly patients with advanced NSCLC. Incidence of grade ≥2 peripheral neuropathy or grade ≥3 myelosuppression (primary endpoint) was similar in both treatment arms. A signal of improvement was observed in PFS and ORR in Arm B. NCT02151149Primary Endpoint Event, n (%) Arm A n = 68 Arm B n = 70 Patients with either grade ≥ 2 peripheral neuropathy or grade ≥ 3 myelosuppression 52 (76.5) 54 (77.1) Grade ≥ 2 peripheral neuropathy 25 (36.8) 25 (35.7) Grade ≥ 3 myelosuppression 48 (70.6) 45 (64.3) Neutropenia 39 (57.4) 39 (55.7) Anemia 14 (20.6) 17 (24.3) Thrombocytopenia 17 (25.0) 12 (17.1)
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P2.01-013 - Nab-Paclitaxel/Carboplatin in Elderly Patients with NSCLC (ABOUND.70+): Analysis of Safety and Quality of Life (QoL) by Cycle (ID 8185)
09:00 - 09:00 | Author(s): K.I. Amiri
- Abstract
Background:
ABOUND.70+ evaluated 2 schedules of first-line nab-paclitaxel/carboplatin in patients ≥70 years with advanced NSCLC to determine whether a 1-week break can improve tolerability. Safety and QoL by cycle are reported.
Method:
Patients ≥70 years with locally advanced/metastatic NSCLC were randomized to first-line nab-paclitaxel 100mg/m[2] on d1, 8, 15 and carboplatin AUC 6 on d1 of a 21-d cycle (Arm A) or the same regimen with a 1-week break between cycles (Arm B). Primary endpoint: percentage of patients with grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression (laboratory values). QoL (exploratory endpoint) was assessed using Lung Cancer Symptom Scale (LCSS) on d1 of each cycle. Safety analyses included patients receiving ≥1 dose of study medication. AEs/QoL were analyzed at each of the first 6 cycles.
Result:
At interim evaluation, primary endpoint was similar across arms, resulting in early closure of enrollment. Of 143 randomized patients, 68 and 70 in Arms A and B received ≥1 dose of study drug. Table lists primary endpoint and key safety results by cycle. Grade ≥2 PN occurred earlier in Arm A. Incidence of grade ≥3 myelosuppression was highest in the first 2 cycles, progressively declining after cycle 3 (both arms). Dose reductions occurred in earlier cycles for Arm A; at the start of cycle 4, 36% vs 47% of patients received the maximum dose (100mg/m[2]) of nab-paclitaxel in Arms A and B. Generally, QoL was maintained throughout treatment. LCSS item of cough improved with each cycle; mean change from baseline at the end of cycle 6 was 25.4 and 13.8mm (visual analog scale).
Conclusion:
Although the overall rate of grade ≥2 PN and grade ≥3 myelosuppression was similar between arms, analysis by cycle showed that grade ≥2 PN and dose reductions occurred earlier in Arm A. QoL was maintained in both arms. NCT02151149
.Arm A n = 68 Arm B n = 70 Safety Primary endpoint, % 76 77 P value 0.9258 Peripheral neuropathy, % Grade ≥ 2[a] Grade ≥ 3[a] Grade ≥ 2[a] Grade ≥ 3[a] All cycles 37 13 36 17 Cycle 1 6 0 0 0 Cycle 2 6 4 1 0 Cycle 3 7 4 9 1 Cycle 4 4 0 7 1 Cycle 5 6 3 4 1 Cycle 6 4 1 4 9 Myelosuppression, % Grade ≥ 3 Grade ≥ 3 All cycles 71 64 Cycle 1 35 37 Cycle 2 22 10 Cycle 3 3 10 Cycle 4 6 1 Cycle 5 1 3 Cycle 6 3 3 [a ]Calculated by first occurrence of adverse event of respective grade.
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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 - 09:00 | Author(s): K.I. Amiri
- 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 - 09:00 | Author(s): K.I. Amiri
- 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
