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D. Haggstrom
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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: 1
- 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): D. Haggstrom
- 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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P2.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 234)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.04-043 - A Successful Case in Which Electromagnetic Navigation Bronchoscopy Identified an EGFR Mutation in Small Peripheral Lung Lesions (ID 2447)
09:30 - 09:30 | Author(s): D. Haggstrom
- Abstract
Background:
Our institution participated in a Phase I National Trial that treats patients with advanced NSCLC. Clinical enrollment not only required repeat biopsy of tissue for histopathological analysis and molecular testing, but the target lesions were technically challenging due to size, number of lesions, risk, and and time constraints. Utilization of electromagnetic navigation bronchoscopy (ENB) was used to enroll a patient in a clinical trial in which multiple target lesions were identified, but the only viable target lesion was a mere 6mm in diameter in the periphery of the lung.
Methods:
A 54 year old Asian male showed disease progression in a follow-up chest CT after 9 months of treatment with Erlotinib, suggesting that an acquired resistance to Erlotinib had developed after an initial successful response. Additional tissue specimens were needed to determine if the patient was eligible to participate in a Phase I National Clinical Trial that is attempting to prevent EGFR mutations from acquiring resistance mechanisms. An electromagnetic navigational bronchoscopy (ENB™) guided forceps biopsy tool was utilized to obtain tissue samples from 3 separately identified lesions. Figure 1
Results:
All 3 lesions were successfully navigated and tissue samples were all adequate for molecular testing. NSCLC favoring adenocarcinoma was diagnosed for all 3 sites. However, the admixture of cell types (bronchial epithelial, inflammatory cells, etc) meant that only the smallest 6mm peripheral right middle lobe lesion tissue sample biopsy could be used for this specific trial. Based on these pathology results this patient was enrolled.
Conclusion:
Newer minimally invasive biopsy technologies such as ENB™ guidance can facilitate biopsies of multiple pulmonary sites in one procedure; such procedures are safe and feasible in a community based setting. Moreover, these procedures are increasingly important to meet the expanding needs for advanced histological and molecular testing in oncology. This procedure enabled us to enroll this patient in a Phase I National Trial that may potentially address his acquired resistance to Erlotinib treatment.
