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F. Blanchon
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MINI 17 - WT EGFR, Angiogenesis and OMD (ID 131)
- Event: WCLC 2015
- Type: Mini Oral
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:R. Feld, R. Dziadziuszko
- Coordinates: 9/08/2015, 16:45 - 18:15, Mile High Ballroom 4a-4f
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MINI17.04 - Erlotinib in 2nd Line in Advanced Squamous NSCLC: Final Results of the Pepita Cohort (ID 822)
16:45 - 18:15 | Author(s): F. Blanchon
- Abstract
Background:
Erlotinib in 2[nd] line improves survival in patients with recurrent/progressive NSCLC, is also active in squamous cell NSCLC, as reported in a BR.21 study subgroup. So far, no prospective non interventional study has specifically evaluated patients with this histological subtype treated with erlotinib. We present the final results of PEPITA cohort.
Methods:
PEPITA is a French multicenter, prospective cohort study assessing erlotinib modalities of use in daily practice in squamous NSCLC. The primary endpoint was progression-free survival (PFS); secondary endpoints included patients’ characteristics, overall survival (OS), safety and quality of life. EGFR mutation was tested in 41 patients (28.5%) reason why exploratory analyses assessing EGFR genotyping and smoking status were also performed.
Results:
Between June 2012 - May 2013, 152 patients were included and 146 patients were analyzed for efficacy; median follow-up was 5.31 months (0.03-17.65).
* 2 patients without EGFR mutation status Efficacy and genotyping results were:Patients characteristics at baseline Efficacy population (n=146) EGFR tested (n=41) EGFR not tested* (n=103) p-value Mean age (±SD), years Men 67.7 (±8.6) 90.4% 67.4 (±8.9) 87.8% 67.8 (±8.6) 92.2% 0.79 0.52 ECOG PS 0/1 ECOG PS 2/3 17.5% / 43.8% 33.6% / 5.1% n=39 20.5% / 56.4% 23.1% / 0 n=96 16.7% / 38.5% 38.5% / 6.3% 0.09 Current smoker Former smoker Never smoker 28.8% 63.7% 7.5% 24.4% 63.4% 12.2% 31.1% 63.1% 5.8% 0.39 Comorbitities : Cardiovascular Endocrinological Pulmonary 63.0% 23.3% 19.9% 65.9% 22.0% 19.5% 62.1% 23.3% 20.4% 0.68 0.86 0.91
*[95% CI] In the safety population (n=152 patients), 158 adverse events (AEs) were reported in 70 patients (46.1%), including 48 grade ≥ 3 AEs in 31 patients (20.4%). The most frequent AEs related to erlotinib were skin rash (all grades [23,7%], grade ≥ 3 [5,2%]) and diarrhea (all grades [11,8%], grade ≥ 3 [2.0%]); 19 serious adverse events (SAEs) were reported in 12 patients (7.9%), including 16 grade ≥ 3 SAEs in 10 patients (6.6%). There were 6 SAEs leading to death (3.9% patients), but none SAE was related to erlotinib.EGFR mutation not tested n=103 EGFR mutation tested n=41 Non-smoker n=11 Smoker/Ex-smoker n=135 Efficacy population n=146 PFS Event (progression or death) 95 (92.2%) 34 (82.9%) 8 (72.7%) 123 (91.1%) 131 (89.7%) Median (months) 2.8 [2.3;3.2]* 4.4 [2.9;5.8]* 3.3 [0.7;ND]* 3.0 [2.7;3.5]* 3.0 [2.7;3.5]* Survival rates at 12 months 7.0% [3.1;13.1]* 10.7% [3.1;23.6]* 27.3% [6.5;53.9]* 6.3% [2.9;11.6]* 8.0% [4.2;13.4]* OS Event (progression or death) 79 (76.7%) 22 (53.7%) 6 (54.5%) 96 (71.1%) 102 (69.9%) Median (months) 5.5 [4.0;6.4]* 9.1 [4.4;ND]* 8.0 [1.6;ND]* 5.8 [4.5;7.1]* 5.8 [4.7;7.1]* Survival rates at 12 months 22.4% [14.5;31.3]* 37.1% [20.9;53.5]* 43.6% [14.7;69.9]* 24.8% [17.2;33.0]* 26.3% [18.9;34.3]*
Conclusion:
PEPITA is the first non-interventional study assessing modalities of use in daily practice of patients with stade IIIb/IV squamous NSCLC treated in 2[nd] line with erlotinib. This final analysis show similar efficacy and safety results to those observed in clinical trials. Clinical profile may drive EGFR genotyping.
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P1.07 - Poster Session/ Small Cell Lung Cancer (ID 221)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.07-013 - Real-Life 2-Year Therapeutic Strategies in the Management of 525 Small-Cell Lung Cancers: The ESCAP Study Preliminary Results (ID 1657)
09:30 - 17:00 | Author(s): F. Blanchon
- Abstract
Background:
In the last years, new drugs and strategies have emerged in the management of lung cancer (LC). The French College of General Hospital Respiratory Physicians therefore promoted a prospective multicenter epidemiological study: the ESCAP study. This study was aimed to describe the therapeutic strategies implemented during the first 2-year after diagnosis in patients with LC followed in French General Hospital chest departments. We report below descriptive results for small-cell lung cancer (SCLC).
Methods:
For each patient with a LC diagnosed in 2010, a standardized form was completed at diagnosis and following each change in treatment strategy up to at least 2 years after diagnosis.
Results:
53 centers participated in the ESCAP study, and included 3,943 LC patients. Of these, 525 patients had a SCLC. Characteristics of SCLC patients at diagnosis were: mean age +/- standard deviation (SD), 65.6 +/- 10.8 years; male, 77%; never-smokers, 4.8%. The mean follow-up in SCLC patients was 10.5 months (SD: 8.8) and median number of strategies was 2 (Interquartile range: 1-3). Main strategy characteristics are summarized in the following table.
As regards first strategy, cisplatin (46%) and carboplatin (42%) were the most frequent used drugs associated with etoposide. As regards second strategy, the most frequently used drugs were topotecan (22%), etoposide (21%), or carboplatin (20%). Few patients received targeted therapy (< 1% in strategies 1 and 2).First strategy (N=525) Second strategy (N=309) Third strategy (N=153) Duration (months): mean+/-SD 5.4 +/- 4.5 3.6 +/- 3.5 2.7 +/- 2.4 Curative surgery 2% 1% - Radiotherapy 10% 47% 20% Radiochemotherapy 15% - - Chemotherapy 75% 55% 61% Exclusive supportive care 8% 14% 27% Patients died during the strategy 195 (37%) 134 (43%) 90 (59%) Patients with a new strategy 309 (59%) 153 (50%) 54 (35%)
Conclusion:
The ESCAP study describes the 2-year management of SCLC on real-life settings in France. Its preliminary results showed that 3 or 4 strategies were not uncommon in the management of SCLC patients.
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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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P2.01-048 - Real-Life 2-Year Therapeutic Strategies in the Management of Metastatic Non-Small-Cell Lung Cancers: The ESCAP Study (ID 1515)
09:30 - 17:00 | Author(s): F. Blanchon
- Abstract
Background:
In the last years, new drugs and strategies have emerged in the management of lung cancer (LC). The French College of General Hospital Respiratory Physicians therefore promoted a prospective multicenter epidemiological study: the ESCAP study. This study was aimed to describe the therapeutic strategies implemented during the first 2-year after diagnosis in patients with LC followed in French General Hospital chest departments. We report below descriptive results for metastatic non-small-cell lung cancer (mNSCLC).
Methods:
For each patient with a LC diagnosed in 2010, a standardized form was completed at diagnosis and following each change in treatment strategy up to at least 2 years after diagnosis.
Results:
53 centers participated in the ESCAP study and included 3,943 patients. Among them, 3,418 patients had a NSCLC. NSCLC was metastatic in 2,003 patients. In patients with mNSCLC, the first therapeutic strategy was chemotherapy alone (56%) followed by palliative chemotherapy plus incidental radiotherapy (35%); 4% of patients died without any implemented therapeutic strategy (see figure). 29% of patients with chemotherapy alone as first strategy died without undergoing any other strategy and 70% had a second strategy (72% chemotherapy alone). 35% of patients with radiochemotherapy died without undergoing any other strategy and 64% had a 2[nd] strategy (73% chemotherapy alone). Figure 1 The most frequent chemotherapy during the first strategy was platinum salts doublet with pemetrexed (39%), followed by platinum salts doublet with paclitaxel (15%). Chemotherapy during the second strategy was second line chemotherapy (67%) or maintenance therapy (25%). EGFR-TKi (34%) and docetaxel (26%) alone were the most frequently prescribed drugs for second line chemotherapy, and pemetrexed (44%) and EGFR-TKi (26%) alone for maintenance therapy.
Conclusion:
The ESCAP study describes the 2-year management of metastatic NSCLC on real-life settings in France. Its preliminary results are consistent with the guidelines of the French National Cancer Institute.
