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P.J. Souquet
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OA11 - Angiogenesis in Advanced Lung Cancer (ID 387)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:L.M. Montuenga, J. Heymach
- Coordinates: 12/06/2016, 11:00 - 12:30, Stolz 2
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OA11.01 - Prolonged OS of Patients Exposed to Weekly Paclitaxel and Bevacizumab: Impact of the Cross-Over in the IFCT-1103 ULTIMATE Study (ID 4988)
11:00 - 12:30 | Author(s): P.J. Souquet
- Abstract
- Presentation
Background:
Overall survival (OS) is considered as the gold standard for evaluating efficacy of antineoplastic treatments, including chemotherapy and targeted therapies. In randomized trials, allowing patients to cross-over to the other arm usually prevents demonstration of a survival benefit. However, it may provide important information with clinical relevance.
Methods:
The phase III IFCT-1503 ULTIMATE study compared weekly paclitaxel and bevacizumab (wPB) vs. docetaxel (DOC) as second- or third-line therapy in non-squamous NSCLC. At progression, patients were allowed to cross over to the other arm. Date of progression was collected for patients who crossed over to the other arm and for those who did not cross over but received a post-discontinuation treatment within 60 days following progression. Post-discontinuation progression-free survival (PFS2) and OS2 were calculated from day 1 of post-discontinuation treatment.
Results:
The study met its primary endpoint, PFS, which was significantly improved in the wPB arm (medians 5.4 vs. 3.9 mo, hazard ratio (HR) 0.62, p=0.006). No overall survival was observed (medians 9.9 vs. 11.4 mo, HR 1.18, p=0.4). Out of patients treated with DOC (n=55), those who crossed over to wPB (n=21, 38.2%) had a median PFS2 of 4.9 mo [3.1-6.2] and a median OS2 of 12.5 mo (7.0-NR), whereas those who did not cross over but received a post-discontinuation treatment (n=13, 23.7%) had a median PFS2 of 1.7 mo [1.1-2.2] and a median OS2 of 4.1 mo [2.1-5.9]. Out of patients treated with wPB (n=111), median PFS2 was 1.9 mo [1.2-2.2] for those who crossed over to DOC (n=9, 8.3%) and median PFS2 and OS2 were 1.9 mo [1.7-2.6] and 5.0 m [3.4-9.0] for those who did not cross over but received a post-discontinuation treatment (n=57, 52.3%).
Conclusion:
Allowing patients to cross over to the other arm demonstrated benefit of wPB following progression on docetaxel and explains the absence of OS benefit.
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OA16 - Improving the Quality of Lung Cancer Care - Patients Perspective (ID 399)
- Event: WCLC 2016
- Type: Oral Session
- Track: Patient Support and Advocacy Groups
- Presentations: 1
- Moderators:G. Kreye, D. Tan
- Coordinates: 12/06/2016, 16:00 - 17:30, Schubert 6
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OA16.05 - Socioeconomic Determinants of Late Diagnosis of Lung Cancer in France: A Nationwide Study (the TERRITOIRE Study) (ID 4840)
16:00 - 17:30 | Author(s): P.J. Souquet
- Abstract
- Presentation
Background:
Socioeconomic disparities in survival of patients with lung cancer have been identified in many countries. The aim of this study was to examine determinants of late diagnosis of lung cancer in France.
Methods:
All patients with a first diagnosis of lung cancer in 2011 in the National hospitals databases were included. Information on gender, age, presence of metastasis at diagnosis and any significant chronic comorbidities (hypertension, diabetes mellitus, renal insufficiency, and other chronic lung diseases) was retrieved. Based on municipality of residence, patients were classified by population density, social deprivation, access to general practitioners and pulmonologists.
Results:
We identified 41,015 patients newly diagnosed for lung cancer in French hospitals. Mean age at diagnosis was 66.4 (±11.9) years and 72% patients were men. 53% (N=21,613) patients were metastatic at the time of diagnosis. This rate was higher for patients in public compared to private hospitals (56.1% vs 42.9%, p<0.0001) and in community compared to university hospitals (60.2% vs 49.6%, p<0.0001). Multivariate analysis found that metastases at the time of diagnosis were significantly associated with a younger age (55 years or less, OR: 1.22 [95%CI:1.16–1.29]; p<0.0001), a low access to pulmonologists (OR: 1.13 [95%CI:1.04–1.23]; p=0.004), a rural or semi-rural dwelling (OR: 1.07 [95%CI:1.02–1.13]; p=0.004) and deprived areas (OR: 1.06 [95%CI:1.01–1.11]; p=0.01). Of the 8,413 patients (20%) who were initially admitted through emergency room (ER) 68.1% had metastatic tumors. Multivariate analysis showed significantly higher rate of admission through ER at diagnosis in patients from most deprived areas (OR: 1.44 [95%CI:1.37–1.52]; p0.0001), rural or semi-rural (OR: 1.25 [95%CI:1.19–1.32]; p<0.0001), with a low access to pulmonologists and general practitioners (OR: 1.24 [95%CI:1.17–1.30]; p<0.0001 and 1.15 [95%CI:1.08–1.23]; p<0.0001, respectively). Gender (male) and presence of comorbidities were also significant determinants of metastatic disease and admission through ER at diagnosis.
Conclusion:
A majority of French patients with lung cancer were initially metastatic at the time of diagnosis and 1 out of 5 were diagnosed following admission through ER. Residential socioeconomic indicators and access to general practitioners and pulmonologists were significantly associated with these indicators of poor outcome.
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P3.02a - Poster Session with Presenters Present (ID 470)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02a-034 - Vemurafenib in Patients with Non-Small Cell Lung Cancer (NSCLC) Harboring BRAF Mutation. Preliminary Results of the AcSé Trial (ID 4924)
14:30 - 15:45 | Author(s): P.J. Souquet
- Abstract
Background:
BRAF is found mutated in 2-3% of stage IV NSCLC. BRAF inhibitors have been reported to have antitumor activity. A nationwide access to vemurafenib for cancer patients with tumors presenting with BRAF mutations was launched by the French National Cancer Institute (INCa) providing free access to tumor molecular diagnosis. The AcSé-Vemurafenib study is the 2[nd] exploratory multi-tumor 2-stage design phase II trial of AcSé program. We report the preliminary results of the NSCLC cohort in this nationwide program.
Methods:
BRAF mutational status was assessed on INCa molecular genetic platforms by either direct sequencing or NGS. Patients with BRAF mutation (including BRAF V600E and others less common mutations), progressing after at least one standard treatment (including a platinum-based doublet, unless pts were considered as unfit for chemotherapy) were proposed to receive vemurafenib 960 mg BID. Responses were centrally assessed using RECIST v1.1 every 8 weeks.
Results:
From Oct. 13, 2014 to June 15, 2016, 65 patients were enrolled including 55 NSCLC harboring BRAF V600E and 10 pts with other activating mutations (2 G466, 3 G469, 1 G596, 3 K601 and 1 N581). 55 patients received vemurafenib and had at least one post-baseline assessment. Median age: 67 years (range 40–84), 51% females and 100% non-squamous histology. Median number of prior chemotherapy lines: 1 (0 –5). Most frequent grade ≥3 adverse events (AEs) were skin (18% of patients) and gastrointestinal toxicities (16%). Among the 39 BRAF V600E NSCLC patients evaluable for the best overall response (BOR) with a minimum follow-up of 4 months, 15 PR, 8 SD, 10 PD, 5 deaths before assessment and 1 missing were observed. The objective response rate was 38.5% [95% CI:23.4-55.4], and the disease control rate 59% [42.1-74.4]. Median duration of response was 5.1 months [1.8-9.2]. Progression-free survival (PFS) at 4 months was 48.2% [31.8-62.8]. No response was reported among the 7 evaluable patients with other BRAF mutations with 5 PD, 1 death before assessment and 1 missing as BOR ; PFS at 4 months was 14.3% [0.7-46.5]. 18 patients were still on treatment at the cut-off date, 47 have stopped vemurafenib (25 PD, 15 AEs, 1 death, 1 doctor’s decision, 5 patient’s decisions).
Conclusion:
Vemurafenib provided response rate and DCR in BRAF V600E pretreated NSCLC but was not found efficient in NSCLC with other BRAF mutations. These results underline the interest of integrating BRAF V600E in biomarkers routine screening.
