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K. Hirano
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P1.07 - Immunology and Immunotherapy (ID 693)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.07-004 - Predictive Biomarkers of Response to Nivolumab in Non–Small Cell Lung Cancer: A Multicenter Retrospective Cohort Study (ID 7441)
09:30 - 09:30 | Author(s): K. Hirano
- Abstract
Background:
It is important to seek predictive factors for the efficient use of immune check point inhibitors in non-small-cell lung cancer (NSCLC), because of the lack of a definitive predictive biomarker.
Method:
Study design for the analysis: A multicenter retrospective cohort study. Patient eligibility criteria: Consecutive patients treated with nivolumab between January 2016 and October 2016 after the second line systemic chemotherapy outside of a clinical trial. Definition of exposures: Variables were retrieved from the medical records before the administration of nivolumab. All variables were dichotomized based on previous study or median. Definition of study endpoint: Progression free survival (PFS) defined by response evaluation criteria in solid tumours (RECIST) 1.1. Two researchers evaluated the endpoint independently. Any disagreements were resolved by discussion. Statistical methods: Cox proportional hazards models were used to assess the impact of pretreatment markers on PFS. Missing values were imputed by multiple imputation.
Result:
A total of 189 patients were included in the study. Median follow-up time was 5.5 months. Fourty six (24%) patients were censored. Median age was 69 (range, 38–88); 26% were female. 64% had received ≧2 prior systemic therapies. In multivariate analyses, worse performance status, higher lactate dehydrogenase, and higher carcinoembryonic antigen,were independently associated with inferior PFS (Table 1). Figure 1
Conclusion:
Our study indicated that patients with NSCLC treated with nivolumab in routine practice, pretreatment performance status ≧2, carcinoembryonic antigen ≦13.8, and Lactate Dehydrogenase ≧217 were associated with inferior PFS. Another study is warranted to determine the precise utility of each marker take account of the programmed death-ligand 1.
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P1.08 - Locally Advanced NSCLC (ID 694)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Locally Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.08-006 - Phase I/II Study of Carboplatin, nab-paclitaxel, and Concurrent Radiation Therapy for Patients with Locally Advanced NSCLC. (ID 8356)
09:30 - 09:30 | Author(s): K. Hirano
- Abstract
Background:
A regimen of weekly paclitaxel plus carboplatin (CBDCA) with concurrent thoracic radiotherapy is recognized as standard for patients with unresectable stage III lung cancer. Nanoparticle albumin-bound paclitaxel (nab-PTX) is a cremophor-free formulation of paclitaxel to increase solubility and intratumor drug delivery and is effective for patients with advanced NSCLC. The purpose of this study is to determine recommended dose and investigate the efficacy and safety profile of a regimen of nab-PTX plus CBDCA with concurrent thoracic radiotherapy for patients with unresectable non-small cell lung cancer (NSCLC).
Method:
Patients with unresectable stage IIIA or IIIB NSCLC, good performance status, age between 20 and 74 years, and adequate organ function, a relative volume of normal lung receiving a dose of ≥ 20 Gy (V20) ≤35% were eligible. In a phase I study (standard 3+3 design), weekly nab-PTX plus CBDCA was administered intraveneously for six weeks. Doses of each drug were planned as follows: level 1, 40/2; level 2, 50/2 (nab-PTX [mg/m[2]] / CBDCA [area under the plasma concentration time curve (AUC) mg/ml/min]). Concurrent thoracic radiotherapy was administered in 2 Gy fractions to a total dose of 60 Gy. Dose-limiting toxicity (DLT) was observed during concurrent chemotherapy and thoracic radiation and up to 28 days following the end of radiotherapy. After the evaluation of DLT, patients received an additional two cycles of consolidation chemotherapy that consisted of 3-week cycles of nab-PTX (100 mg/m[2] on Days 1, 8 and 15) plus CBDCA (AUC 6 mg/ml/min on Day 1). In a phase II study, we planned to enroll 50 patients treated with recommended dose.
Result:
In a Phase I study, 11 patients were enrolled and received treatment per protocol, with 9 evaluable for efficacy and toxicity. At nab-PTX dose level 1 (40mg/m[2]), none of 3 patients experienced DLT. At nab-PTX dose level 2 (50mg/m[2]), 1 of 6 patients experienced DLT: grade 3 leukopenia requiring a second consecutive skip in the administration of weekly nab-PTX plus CBDCA. The recommended doses (RDs) for the phase II study were nab-paclitaxel 50 mg/m[2] and CBDCA (AUC=2). From October 2015 to November 2016, a total of 52 patients were entered in the phase II portion ( median age, 66 years; age range, 48–74 years; male/female 44/8) .
Conclusion:
Concurrent chemoradiotherapy with nab-PTX 50 mg/m[2] and CBDCA AUC 2 was the recommended dose. We will report the latest efficacy and safety profile of the present therapy. Trial registration: UMIN000012719.
