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N. Trunova
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 3
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-088 - <em>nab</em>-Paclitaxel + Carboplatin for Elderly Patients with Advanced NSCLC (ABOUND.70+) (ID 1084)
09:30 - 09:30 | Author(s): N. Trunova
- Abstract
Background:
Treatment of elderly patients with non-small cell lung cancer (NSCLC) is challenging due to comorbidities and reduced tolerability; as a result, these patients often receive suboptimal treatment. In addition, 5-year survival rates are lower in elderly than in younger patients with NSCLC. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) significantly increased median overall survival (OS) vs solvent-based paclitaxel plus C in a subset of patients ≥ 70 years of age with advanced NSCLC (19.9 vs 10.4 months; HR 0.583; P = 0.009; Socinski et al. Ann Oncol. 2013;24:314-321). However, 55% of elderly patients treated with nab-P/C required dose reductions and 84% had dose delays, primarily due to adverse events, including myelosuppression. In the open-label, multicenter phase IV ABOUND.70+ trial, the safety and efficacy of 2 different schedules of first-line nab-P/C treatment will be evaluated prospectively in elderly patients with advanced NSCLC.
Methods:
Approximately 284 patients with NSCLC ≥ 70 years of age who are not candidates for curative surgery or radiation therapy will be randomized 1:1 to nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus C AUC 6 on day 1 every 21 days or the same nab-P/C dose every 21 days followed by a 1-week break. Key eligibility criteria include histologically/cytologically confirmed locally advanced or metastatic NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and absence of preexisting peripheral neuropathy (PN) grade > 2. Patients will be stratified by ECOG performance status (0 vs 1) and histology (squamous vs nonsquamous). ClinicalTrials.gov identifier NCT02151149.
[a] Additional exploratory endpoints may be defined in the statistical analysis plan if applicable.Key Endpoints Primary Percentage of patients developing either PN grade ≥ 2 or myelosuppression grade ≥ 3 Secondary Safety Progression-free survival OS Overall response rate Exploratory[a] Healthcare resource utilization throughout the study Changes in quality of life
Results:
TPS Abstract Section NA
Conclusion:
TPS Abstract Section NA
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P2.01-095 - <em>nab</em>-Paclitaxel/Carboplatin Followed By <em>nab</em>-Paclitaxel for NSCLC PS 2 (ABOUND.PS2) (ID 955)
09:30 - 09:30 | Author(s): N. Trunova
- Abstract
Background:
Many patients with advanced non-small cell lung cancer (NSCLC) often present with poor performance status (PS), and there is no clear consensus on how best to treat these patients. Despite an increased risk of toxicity resulting from standard chemotherapy, patients with NSCLC and a poor PS can clinically benefit from platinum-doublet therapy. In a multicenter phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) in patients with NSCLC and an ECOG PS 0-1 significantly improved the overall response rate (ORR) compared with solvent-based paclitaxel plus C (33% vs 25%; P = 0.005; Socinski et al. J Clin Oncol. 2012;30:2055-2062). In the single-arm, open-label, multicenter phase II ABOUND.PS2 study, the safety and efficacy of first-line nab-P/C followed by nab-P monotherapy will be evaluated in patients with locally advanced/metastatic NSCLC and an ECOG PS of 2.
Methods:
During the induction part of the study, approximately 50 patients will be treated with 4 cycles of nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1 and 8 plus C AUC 5 IV on day 1 every 21 days. Patients without disease progression may proceed to the monotherapy part of the study in which they will continue to receive nab-P 100 mg/m[2] IV (30-minute infusion) on days 1 and 8 every 21 days until progression or unacceptable toxicity. Key eligibility criteria include histologically/cytologically confirmed stage IIIB/IV NSCLC, no prior chemotherapy for metastatic disease, ECOG PS of 2, adequate organ function, no active brain metastases, and preexisting peripheral neuropathy grade < 2. ClinicalTrials.gov number NCT02289456.Key Endpoints Primary The percentage of patients who discontinue treatment during the induction part due to treatment-emergent adverse events Secondary Safety Progression-free survival Disease control rate Overall survival ORR Exploratory Healthcare resource utilization throughout the study Changes in physician-reported ECOG PS and patient-reported quality of life Summary of Charlson Co-Morbidity Index at baseline Correlation between patient- and physician-reported ECOG PS during treatment Correlation between patient- and physician-reported Karnofsky PS at baseline
Results:
This is a TPS abstract Results = NA
Conclusion:
This is a TPS abstract Results = NA
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P2.01-099 - nab-Paclitaxel as Maintenance Therapy in Patients with Squamous Cell NSCLC (ABOUND.sqm) (ID 3122)
09:30 - 09:30 | Author(s): N. Trunova
- Abstract
Background:
Patients with squamous cell (SCC) non-small cell lung cancer (NSCLC) may be at risk of poorer outcomes and have fewer treatment options than those with other histologies. Furthermore, no randomized studies have demonstrated the benefit of maintenance therapy in these patients. In a phase III trial, first-line treatment with nab-paclitaxel plus carboplatin (nab-P/C) demonstrated a 68% improvement in the overall response rate (ORR; 41% vs 24%; P < 0.001) and a trend toward improved overall survival (OS; median, 10.7 vs 9.5 months; HR 0.890; P = 0.310) compared with solvent-based paclitaxel plus C in a subset of patients with advanced SCC NSCLC (Socinski et al. Ann Oncol. 2013;24:2390-2396). An exploratory analysis of the phase III trial demonstrated that therapy with nab-P/C beyond 4 cycles of first-line treatment was effective in the subset of patients with SCC NSCLC who did not progress (from the time of randomization, median progression-free survival [PFS] and OS were 6.8 and 13.8 months, respectively), and no new safety signals were noted (Socinski et al. IASLC 2013 [abstract 3438]). In the open-label, multicenter phase III ABOUND.sqm trial, the efficacy and safety of nab-P maintenance therapy after nab-P/C induction therapy will be evaluated in patients with advanced SCC NSCLC.
Methods:
During the induction part of the study, approximately 540 patients will be treated with 4 cycles of nab-P 100 mg/m[2] intravenously (IV; 30-minute infusion) on days 1, 8, and 15 plus IV C AUC 6 on day 1 every 21 days. Patients with a complete response (CR), a partial response (PR), or stable disease (SD) will be eligible for maintenance. In the maintenance part of the study, approximately 260 patients will be randomized 2:1 to nab-P 100 mg/m[2] on days 1 and 8 every 21 days plus best supportive care (BSC) or BSC alone until disease progression. Patients will be stratified by disease stage (IIIB vs IV), response to induction therapy (CR/PR vs SD), and ECOG performance status at the end of induction (0 vs 1). Key eligibility criteria include histologically or cytologically confirmed stage IIIB/IV SCC NSCLC, no prior chemotherapy for metastatic disease, ECOG performance status ≤ 1, adequate organ function, no active brain metastases, and preexisting peripheral neuropathy grade < 2. ClinicalTrials.gov identifier NCT02027428.Key Endpoints Primary PFS from randomization into the maintenance part of the study Secondary Safety OS from randomization into the maintenance part of the study ORR during the induction and maintenance parts of the study Exploratory Correlation between pretreatment tumor characteristics and response to treatment Association between changes in tumor characteristics and acquisition of resistance to therapy at the time of treatment failure during maintenance Correlation between genetic polymorphisms and treatment efficacy and/or toxicity Healthcare resource utilization during the maintenance part of the study Changes in quality of life
Results:
Not applicable.
Conclusion:
Not applicable.
