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J. Weiss
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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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P2.01-004 - Safety and Efficacy of Nab-Paclitaxel plus Carboplatin in Elderly Patients with NSCLC (ABOUND.70+) (ID 7561)
09:00 - 09:00 | Author(s): J. Weiss
- 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): J. Weiss
- 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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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-036 - Appropriate Use of Immune Checkpoint Inhibitors in Advanced NSCLC: Effectiveness of Unique Case-Based Education on Clinical Decision-Making (ID 9441)
09:30 - 09:30 | Author(s): J. Weiss
- Abstract
Background:
The past several years have witnessed unparalleled changes in treatment for patients with advanced NSCLC. Although these changes present significant hope, it remains unclear if oncologists have been able to stay current on the breadth of practice changes, and effectively incorporate evidence-base into practice. The objective of this study was to evaluate oncologists’ competence regarding the use of immune checkpoint inhibitors (ICI) in the management of advanced NSCLC and the impact of education on narrowing gaps in clinical practices.
Method:
An online education environment that employed video vignettes to simulate practice, presented 3 CME-certified case activities, each illustrating a clinical challenge. Questions regarding point-of-care decisions were posed as a means of testing the oncologist’s ability to make treatment decisions and to communicate effectively with patients who have NSCLC. These case activities included patients with non-squamous and squamous NSCLC and who exhibited adverse events. For each activity, an assessment instrument using case-based, multiple-choice questions was administered to compare each oncologist’a responses to questions posed before and after the education was presented. Confidentiality of respondents was maintained, responses were de-identified, and aggregated prior to analyses. McNemar's χ[2] test compared learners' responses from pre- to post-assessment. The activities were launched between October 21, 2016, and December 6, 2016, and data were collected through April 26, 2017.
Result:
2,399 oncologists participated in at least one of the 3 activities. Responses of 325 participants who answered all questions during the study period were included. Upon completion of the activities, an improvement was observed in oncologists’ ability to: Identify the correct evidence-based regimen including when to use ICIs for a patient that has progressed on first line therapy (76% vs 98%, P <0.001) Counsel patients on the expected effectiveness of ICI in patients (69% vs 89%, P <0.001) Select the most appropriate monitoring strategy to detect immune-related adverse events in patients receiving an ICI (52% vs 78%, P <0.001) Order appropriate tests to identify the etiology of symptoms that appear during treatment (60% vs 92%, P <0.001) Properly manage immune-related adverse events due to treatment with ICI (67% at baseline to 88% post education, P =0.001) In addition, comfort with prescribing ICIs also increased.
Conclusion:
Use of online, case-based CME utilizing video vignettes to simulate practice improved competence among participating oncologists, demonstrating that online CME can be an effective tool to improve clinical decision-making in the rapidly changing environment of advanced NSCLC disease management.
