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Libor Havel
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P2.14 - Targeted Therapy (ID 183)
- Event: WCLC 2019
- Type: Poster Viewing in the Exhibit Hall
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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P2.14-34 - Tyrosine-Kinase Inhibitors (TKI) in First-Line Treatment of 470 Patients with Non-Small Cell Lung Cancer (NSCLC) from the Czech Republic (ID 422)
10:15 - 18:15 | Author(s): Libor Havel
- Abstract
Background
From October 2013 there is a possibility to treat patients with NSCLC and with activated epidermal growth factor receptor (EGFR) mutations with three TKI in the Czech Republic. We have tried to find differences among patient groups treated with single TKI in 1st line of treatment.
Method
The TULUNG registry was used as a data source for this analysis. This clinical registry is focused on the collection of epidemiological and clinical data of patients with NSCLC treated with target therapy in the Czech Republic. A total of 959 patients treated with TKI inhibitors was enrolled in registry until December 31, 2018. Only patients with EGFR mutation and in which 1st line treatment started in October 2013 and later were included in analysis. With respect to defined inclusion criteria we analysed 470 patients. With gefitinib were treated 234, with afatinib 180 and with erlotinib 56 patients.
Descriptive statistics and frequency tables were used to characterize the sample data set. Statistical significance of differences among three TKI inhibitors subgroups was assessed using the Fisher’s exact test or Kruskal-Wallis test for continuous variables.
OS and PFS were estimated using Kaplan-Meier method and all point estimates include 95% confidence intervals (95% CI). Statistical significance of differences in survival between subgroups was assessed using the log-rank test. All statistical tests were performed at a significance level of α=0.05.
Result
There was statistically significant difference according to age (< 0.001) and PS (< 0.001), patients treated with gefitinib were statistically significant older and had significantly significant higher PS than patients treated with afatinib and erlotinib There was statistically significant difference in the occurrence of adverse events (p<0.001). Patients treated with gefitinib had a significantly lower incidence of adverse events than patients treated with afatinib and erlotinib.
Between these three groups of patients there was no statistically significant difference in sex (p=0.863), in smoking habits (p=0.463, in type of EGFR mutation (p=0.103), in adenocarcinoma proportion (p=0.183). There was no statistically significant difference according to disease control (p=0.183), in response to treatment (p = 0.804), in OS and (p=0.053, in PFS (p=0.06).
Conclusion
Between these three groups of patients we found a statistically significant difference in age, PS segmentation and in occurrence of adverse events. We have not found any important statistically difference in sex, smoking, in histology type of EGFR mutation, difference in response to treatment, in disease control and OS.
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PL02 - Presidential Symposium including Top 7 Rated Abstracts (ID 89)
- Event: WCLC 2019
- Type: Plenary Session
- Track:
- Presentations: 1
- Now Available
- Moderators:Giorgio Vittorio Scagliotti, Ramon Rami-Porta
- Coordinates: 9/09/2019, 08:00 - 10:15, Barcelona (2005)
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PL02.11 - Overall Survival with Durvalumab Plus Etoposide-Platinum in First-Line Extensive-Stage SCLC: Results from the CASPIAN Study (Now Available) (ID 2265)
08:00 - 10:15 | Author(s): Libor Havel
- Abstract
- Presentation
Background
Extensive-stage (ES)-SCLC is a recalcitrant disease associated with a median OS of ~10 months following etoposide-platinum (EP); new treatments that prolong survival are needed. CASPIAN (NCT03043872) is an open-label, phase 3 study of durvalumab (anti-PD-L1), ± tremelimumab (anti-CTLA-4), combined with EP as first-line treatment for patients with ES-SCLC. Here we report results for durvalumab + EP (D+EP) versus EP from a planned interim analysis.
Method
Patients with previously untreated ES-SCLC (ECOG PS 0/1) were randomised (1:1:1) to durvalumab 1500 mg + EP q3w; durvalumab 1500 mg + tremelimumab 75 mg + EP q3w; or EP q3w. Patients in immunotherapy arms received up to 4 cycles of EP followed by maintenance durvalumab until progression. Patients in the EP arm received up to 6 cycles of EP and prophylactic cranial irradiation (PCI), at the investigator’s discretion. Investigator’s choice of cisplatin or carboplatin was allowed across all arms and was a stratification factor at randomisation. The primary endpoint was OS. Data cutoff: 11 March 2019.
Result
268 patients were randomised to D+EP and 269 to EP. Baseline characteristics were well balanced between arms. In the EP arm, 56.8% of patients received 6 cycles of EP. At the interim analysis, D+EP significantly improved OS compared to EP with a HR of 0.73 (95% CI, 0.591-0.909; p=0.0047); mOS 13.0 versus 10.3 months, respectively. 33.9% of patients were alive at 18 months with D+EP versus 24.7% with EP. Secondary endpoints of PFS and ORR were also improved with D+EP compared to EP: PFS HR 0.78 (95% CI, 0.645-0.936); mPFS 5.1 versus 5.4 months; 12-month PFS rate 17.5% versus 4.7%; investigator-assessed ORR (RECIST v1.1; unconfirmed) 79.5% versus 70.3% (odds ratio, 1.64 [95% CI, 1.106-2.443]). The incidences of grade 3/4 AEs (61.5% versus 62.4%) and AEs leading to discontinuation (9.4% each) were similar between arms; the incidence of haematological toxicities was numerically higher in the EP arm. The durvalumab + tremelimumab + EP arm continues blinded to final analysis.
Conclusion
The addition of durvalumab to EP as first-line treatment for ES-SCLC significantly improved OS (27% reduction in risk of death) versus a robust control arm that permitted up to 6 cycles of EP and PCI. Of note, this chemo-immunotherapy regimen offers flexibility in platinum choice (carboplatin or cisplatin), reflecting current clinical practice for this challenging disease. No new safety signals were identified.
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