Op verzoek van de producent hebben we dit artikel opgeslagen. Hun persbericht was alleen voor medici bestemd en wij mogen dit persbericht niet vermelden.

9 februari 2020: Hier het persbericht dat we juli 2019 niet mochten plaatsen:
Het gaat om deze studie: Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study (abstract onderaan artikel)

Overall survival

After a median follow-up of 30.3 months (interquartile range: 24.0–36.8), median OS was 41.3 months (90% CI: 36.8–46.3; Figure 2A). The 2-year OS rate was 80%. Median OS was 45.7 months (90% CI: 45.3–51.5; Figure 2B) in patients with Del19-positive tumors (2-year OS rate of 82%).

(A) All patients; (B) patients with Del19-positive tumors.

Alkmaar, 25 juli 2019 – Boehringer Ingelheim heeft de tussentijdse analyseresultaten van de GioTag-studie bekend gemaakt. Deze resultaten tonen aan dat het starten van de behandeling met afatinib, gevolgd door osimertinib, een algehele overleving van bijna vier jaar (45,7 maanden) oplevert bij EGFR M+ NSCLC-patiënten met Del19-positieve tumoren.1

De GioTag-studie is een real world restrospectieve, observationele en niet-geblindeerde studie die de impact onderzoekt van behandeling met Giotrif® (afatinib), gevolgd door osimertinib, bij patiënten met epidermale groeifactor receptor mutatiepositieve (EGFR M+)* niet-kleincellig longcarcinoom (NSCLC) met de T790M-mutatie. Deze mutatie is het meest voorkomende mechanisme van resistentie tegen EGFR-tyrosinekinaseremmers (TKI’s) van de eerste en tweede generatie.

Uit eerder gepubliceerde resultaten bleek de mediane algehele overleving bijna drieënhalf jaar (41,3 maanden) na een follow-up van 30,3 maanden, bij patiënten met EGFR T790M-positieve NSCLC. Het algehele overlevingspercentage na twee jaar was 80%.i De algehele overleving is met name veelbelovend bij EGFR M+ NSCLC-patiënten met Del19-positieve tumoren aan het begin van de behandeling met afatinib. Bij deze patiënten bleek de mediane algehele overleving 45,7 maanden en het algehele overlevingspercentage na twee jaar bedroeg 82%.

De definitieve analyse staat gepland voor begin 2020 met gegevens van Aziatische en Europese landen.

Voetnoot

*73,5% van de patiënten had een Del19-mutatie en 26,5% had een L858R-mutatiei

Referentie

MJ Hochmair et al. Overall survival in patients with EGFR mutation-positive NSCLC receiving sequential afatinib and osimertinib: updated analysis of the observational GioTag study. Future Oncol. (2019)

9 februari 2020: wellicht is ook deze meta-analyse interessant eens te raadplegen: Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Hier het abstract van deze meta analyse:

Int J Cancer. 2019 Jul 1; 145(1): 284–294.

Published online 2019 Jan 20. doi: 10.1002/ijc.32097

PMCID: PMC6590181

PMID: 30613959

Efficacy and safety of osimertinib in treating EGFR‐mutated advanced NSCLC: A meta‐analysis

Lilan Yi, 1 , † Junsheng Fan, 1 , 2 , † Ruolan Qian, 1 , † Peng Luo, corresponding author

1 and Jian Zhang corresponding author

Author information Article notes Copyright and License information Disclaimer

This article has been cited by other articles in PMC.

Associated Data

Supplementary Materials

Go to:

Abstract

Osimertinib is the only Food and Drug Administration‐approved third‐generation epidermal growth factor receptor (EGFR) tyrosine‐kinase inhibitor (TKI). A meta‐analysis was performed to aggregate the mixed results of published clinical trials to assess the efficacy and safety of osimertinib. A systematic search of the PubMed, Web of Science, and Cochrane Library electronic databases was performed to identify eligible literature. The primary endpoints were overall response rate (ORR), disease control rate (DCR), progression‐free survival (PFS), and adverse events (AEs). A total of 3,086 advanced nonsmall cell lung cancer (NSCLC) patients from 11 studies have been identified. The aggregate efficacy parameters for treatment‐naïve patients with EGFR‐TKI‐sensitizing mutations are as follows: ORR 79% (95% CI 75–84%), DCR 97% (95% CI 95–99%), 6‐month PFS 83% (95% CI 80–87%), and 12‐month PFS 64% (95% CI 59–69%). The aggregate efficacy parameters for advanced NSCLC harboring T790M mutations after earlier‐generation EGFR‐TKI therapy are as follows: ORR 58% (95% CI 46–71%), DCR 80% (95% CI 63–98%), 6‐month PFS 63% (95% CI 58–69%), and 12‐month PFS 32% (95% CI 17–47%). EGFR‐TKI‐naïve patients with EGFR‐positive mutations tend to have longer median PFS than EGFR‐TKI‐pretreated counterparts (19.17 vs

Sequential afatinib/osimertinib was associated with encouraging OS/TTF in patients with EGFR T790M-positive non-small-cell lung cancer, especially in patients with Del19-positive tumors.

SHORT COMMUNICATIONOpen Access

Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study

Maximilian J Hochmair

Published Online:2 Aug 2019https://doi.org/10.2217/fon-2019-0346

Aims: Overall survival (OS) and updated time to treatment failure (TTF) analysis of patients with EGFR mutation-positive (Del19, L858R) non-small-cell lung cancer who received sequential afatinib/osimertinib in the real-world GioTag study. Patients & methods: Patients had T790M-positive disease following first-line afatinib and received osimertinib treatment (n = 203). Primary outcome was TTF. The OS analysis was exploratory. Results: Median OS was 41.3 months (90% CI: 36.8–46.3) overall and 45.7 months (90% CI: 45.3–51.5) in patients with Del19-positive tumors (n = 149); 2-year survival was 80 and 82%, respectively. Updated median TTF with afatinib and osimertinib was 28.1 months (90% CI: 26.8–30.3). Conclusion: Sequential afatinib/osimertinib was associated with encouraging OS/TTF in patients with EGFR T790M-positive non-small-cell lung cancer, especially in patients with Del19-positive tumors.

Trial registration number: NCT03370770

niet-kleincellige longkanker, NLCLC, EGFR T790M-positieve niet-kleincellige longkanker, Del19 mutatie, HER2 expressie, overall overleving, Fase III studie