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Journal Thoracic Oncology

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Abstracts <strong>Journal</strong> of <strong>Thoracic</strong> <strong>Oncology</strong> • Volume 12 Issue S1 January 2017<br />

Background: Scc accounts for about 30-40% of lung cancer cases, and the<br />

majority presents with locally advanced or metastatic disease. Vinorelbine/<br />

carboplatin (VC) and gemcitabine/carboplatin (GC) are both third-generation<br />

combinations used in the treatment of NSCLC. VC and GC were similar with<br />

respect to efficacy, healthrelated quality of life (HRQOL) and toxicity in<br />

stage IIIB/IV NSCLC patients.The aim is to compare VC and GC with respect to<br />

efficacy, DFS, hematologic toxicity in stage IIIB/IV Scc lung cancer patients.<br />

Methods: Chemonaive patients with SCC lung cancer stage IIIB/IV and<br />

WHO performance status 0–2 were eligible. No upper age limit was defined.<br />

Patients received vinorelbine 25 mg m 2 or gemcitabine 1000 mg m 2 on days<br />

1 and 8 and carboplatin AUC 4 on day 1 and six courses with 3-week cycles.<br />

During 13 months, 103 patients were included (VC, n=53; GC, n=50). Results:<br />

median DFS was 22 vs 24.5 weeks (p=0.42 ), ORR (3cycle) 49.05% vs 58%<br />

and ORR(6cycle) % 16.89 vs %16 in the VC and GC arm, respectively (P=0.48).<br />

nausea/vomiting showed no significant differences. More grade 3–4 anemia<br />

(P=0.009), thrombocytopenia (P = 0.004) in GC arm . There was more grade 3–4<br />

leucopoenia (P=0.28) in the VC arm, but the rate of neutropenic infections was<br />

the same (P=0.87). Conclusion: VC and GC are similar in treating advanced SCC<br />

lung cancer when regarding ORR and DFS, while grade 3–4 toxicity requiring<br />

interventions were less frequent when VC is compared to GC in advanced<br />

squamous cell lung cancer.<br />

Keywords: GC, VC, First Line, Advanced squamous lung cancer<br />

POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />

IMMUNOTHERAPY<br />

CLINICAL TRIALS –<br />

TUESDAY, DECEMBER 6, 2016<br />

P2.03A-022 QOL AND FEBRILE NEUTROPENIA: JAPANESE PHASE 2<br />

TRIAL OF DOCETAXEL WITH/OUT ANTIANGIOGENIC AGENT IN 2ND<br />

LINE NSCLC<br />

Yukie Omori 1 , Alan Brnabic 2 , Narayan Rajan 2 , Jangchul Park 1 , Sotaro Enatsu 1 ,<br />

Akira Inoue 3<br />

1 Eli Lilly Japan K.K., Kobe/Japan, 2 Eli Lilly Australia Pty. Limited, West Ryde/NSW/<br />

Australia, 3 Tohoku University, Sendai/Japan<br />

Background: Febrile neutropenia (FN) is one of the serious complications<br />

associated with cancer chemotherapy and often leads to dose reduction and<br />

change of administration schedule which may affect treatment outcomes.<br />

This post hoc analysis explored the association between FN and patient<br />

reported outcomes (PRO). Methods: PROs were collected in the trial JVCG with<br />

Lung Cancer Symptom Scale (LCSS) and EQ-5D-3L. LCSS includes 6 symptom<br />

questions (loss of appetite, fatigue, cough, dyspnea, hemoptysis, pain)<br />

and 3 global QOL items (symptom distress, difficulties with daily activities,<br />

QOL) measured on a 0-100 mm scale, with higher scores representing greater<br />

symptom burden. PROs were collected at baseline (BL, during 14days till<br />

randomization), around Day 21 in every cycle, at the timing of discontinuation<br />

and at 30-day follow up (FU). LCSS total score, global QOL total score, each<br />

global QOL item score, EQ-5D utility index and VAS score were calculated.<br />

Time to deterioration (TtD) of the LCSS and EQ-5D defined as increase from<br />

BL by ≥15 mm for LCSS and ≥15% drop for EQ-5D, respectively, was analysed<br />

using the Kaplan-Meier method stratified by treatment-emergent FN status.<br />

Results: Of 192 patients randomized to receive ramucirumab+docetaxel<br />

or placebo+docetaxel, 80.0% were male, median age was 64.6 and 54.0%<br />

had performance status1 at BL. FN occurred in 26.0% (50/192). Patients<br />

compliance with LCSS and EQ-5D were approximately 97.4% and 97.9%,<br />

respectively. Patients without FN showed longer TtD than patients with FN<br />

in LCSS total score and EQ-5D VAS score. Hazard ratio (HR) (95% CI) for LCSS<br />

total score were 0.731 (0.469, 1.141), p=0.0945 (stratified) with censoring<br />

rate of 44.0% (with FN) and 54.9% (without FN). For EQ-5D VAS score, HR<br />

were 0.802 (0.537, 1.199), p=0.5956 with censoring rate of 32.0% (with FN)<br />

and 43.0% (without FN). No significant difference was found. Conclusion:<br />

Prevailing clinical opinion suggests that FN negatively impacts QOL. In trial<br />

JVCG, a tendency was shown that QOL of patients with FN deteriorates<br />

more rapidly than in patients without FN, consistent with current beliefs.<br />

Additional investigation is needed but prevention and management of FN<br />

may contribute to maintaining QOL.<br />

Keywords: Targeted therapy, antiangiogenesis, advanced NSCLC, Patient<br />

reported outcomes (PRO)<br />

POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />

IMMUNOTHERAPY<br />

CLINICAL TRIALS –<br />

TUESDAY, DECEMBER 6, 2016<br />

P2.03A-023 INDUCTION-MAINTENANCE TREATMENT SEQUENCE<br />

IN NON-SQUAMOUS NON-SMALL CELL LUNG CANCER (NENSCLC):<br />

PEMETREXED VS VINORELBINE-BASED INDUCTION<br />

Xabier Mielgo Rubio 1 , Ruth Martínez-Cabañes 2 , Clara Olier-Garate 1 , Jorge<br />

Silva-Ruiz 1 , María García-Ferrón 1 , Susana Hernando 1 , Juan Carlos Cámara-<br />

Vicario 1 , Alicia Hurtado-Nuño 1 , Cristina Aguayo-Zamora 1 , Diana Moreno-<br />

Muñoz 1 , Elia Pérez-Fernández 3 , Carlos Jara-Sánchez 1<br />

1 Medical <strong>Oncology</strong>, Hospital Universitario Fundación Alcorcón, Alcorcón/Spain,<br />

2 <strong>Oncology</strong> Department, Hospital Universitario Fundación Alcorcón, Alcorcón/<br />

Spain, 3 Statistics Department, Hospital Universitario Fundación Alcorcón,<br />

Alcorcón/Spain<br />

Background: Non-squamous non-small cell lung cancer (neNSCLC) is the most<br />

frequent lung cancer subtype. Prognosis of advanced disease is poor, but in<br />

recent years, the treat-to-progression strategy has emerged, demonstrating<br />

significant improvement in overall survival (OS) of maintenance regimen with<br />

pemetrexed (Pem). There are limited head-to-head clinical trial data of various<br />

treat-to-progression strategies, and a Pem-based platin doublet induction<br />

strategy has never been directly compared to vinorelbine (VNR)-based one.<br />

Methods: We reviewed retrospectively patients diagnosed of advanced<br />

neNSCLC from 2006 to 2015 who were treated with Pem-based and VNR-based<br />

platinum doublet as induction chemotherapy, followed by Pem maintenance<br />

if they had not progressed. We evaluated clinicopathological features and<br />

clinical outcomes. The main objective was to assess if there were survival<br />

differences between both induction strategies in terms of progression free<br />

survival (PFS) and OS. Results: 51 patients were reviewed, 74.5% men and<br />

25.5% women. Mean diagnosis age was 64 (range 37-78). 15.7% never smoked<br />

and 84.3% had ever smoked. 70.6% received Pem-platin doublet and 29.4%<br />

VNR-platin doublet. Initial PS was 0 in 35%, 1 in 63%, 2 in 2%. In Pem group<br />

69.4%. did not progress during induction and in VNR group 46.7%. 55,6%<br />

received maintenance Pem in Pem group and 33,3% in VNR group (p=0,08).<br />

More treatment delays were done in VNR doublet (53,3% vs 30,6%, p=0,047).<br />

Objective response rate (ORR) and disease control rate (DCR) were better<br />

with Pem-doublet. Pem: partial response (PR) 35.3%; stable disease (SD)<br />

44.1%, disease progression (DP) 20.6%; VNR: PR 38.5%, SD 23.1%, DP 38.5%.<br />

Median PFS was slightly better in Pem group than in VNR one (6,2 vs 4,5<br />

months; p=0,28) and median OS was also better with Pem (16,1 vs 11,2 months;<br />

p=0,39), but there were no significant statistical differences. More patients<br />

in VNR group needed hospitalization during induction (42,9 vs 25%; p=0,06).<br />

Most frequent adverse effects (AEs) were asthenia, anemia and neutropenia.<br />

Grade 3-4 asthenia, anemia and neutropenia were more frequent in VNR<br />

group. Conclusion: No big differences were found between both inductionmaintenance<br />

strategies. Os and PFS were similar in both groups but Pem<br />

group presented a trend to better OS and PFS. More patients presented DP<br />

during induction treatment in VNR group. Pem group had better toxicity<br />

profile and less hospitalizations during treatment.<br />

Keywords: vinorelbine, NSCLC, pemetrexed, induction<br />

POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />

IMMUNOTHERAPY<br />

CLINICAL TRIALS –<br />

TUESDAY, DECEMBER 6, 2016<br />

P2.03A-024 THE CLINICAL EFFICACY AND SAFETY OF PACLITAXEL<br />

LIPOSOME ON THE PATIENTS WITH NON-SMALL CELL LUNG<br />

CANCER: A META-ANALYSIS<br />

Xingsheng Hu 1 , Lin Lin 2 , Puyuan Xing 2 , Changgong Zhang 2 , Lin Wang 2 , Yiqun<br />

Li 2<br />

1 Department of Medical <strong>Oncology</strong>, Cancer Hospital,chinese Academy of Medical<br />

Sciences & Peking Union Medical College, Beijing/China, 2 Cancer Hospital,chinese<br />

Academy of Medical Sciences & Peking Union Medical College, Beijing/China<br />

Background: This study was conducted to extract a specific conclusion<br />

about the clinical efficacy of paclitaxel liposome in non-small cell lung cancer<br />

(NSCLC). Methods: Pubmed, Embase and Chinese National Knowledge<br />

Infrastructure (CNKI) databases were searched for potential relevant<br />

articles. Relative risks (RRs) with 95% confidence intervals (CIs) represented<br />

the influences of paclitaxel liposome on the objective response rate (ORR),<br />

disease control rate (DCR) and adverse events. I2>50% and P

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