KESINTASAN HIDUP DAN KESINTASAN BEBAS PROGRESI PASIEN ADENOKARSINOMA PARU YANG MENDAPAT TERAPI TYROSINE KINASE INHIBITOR LINI PERTAMA DI RSUP DR.SARDJITO

DWI WAHYUNI, dr. Eko Budiono Sp.PD-KP.; dr.Ika Trisnawati, Msc, Sp.PD KP

2020 | Tesis-Spesialis | ILMU PENYAKIT DALAM

Latar Belakang : Terapi Tyrosine Kinase inhibitor (TKI) merupakan terapi yang memperbaiki transduksi sinyal pertumbuhan sel kanker sehingga proliferasi sel menurun sehingga terjadi perbaikan kesintasan bebas progresi/progression-free survival (PFS) dan kualitas hidup serta meningkatkan kesintasan hidup/ overall survival (OS) dibandingkan dengan kemoterapi secara umum. Uji klinik fase II telah dilakukan pada pasien adenokarsinoma paru denganmutasi gen EGFR menggunakan gefitinib 250mg atau 500mg pada 400 pasien dengan metode randomized controlled trial, double blind. Pada penelitian tersebut didapatkan median overall survival 6-8 bulan dengan penurunan gejala kanker paru. Pada dosis 500 mg terdapat peningkatan efek samping (Kris et al., 2003). Tujuan Penelitian : Untuk mengetahui kesintasan hidup dan kesintasan bebas progresi pasien addenokarsinoma paru yang mendapat terapi TKI lini pertama di RSUP Dr.Sardjito. Metode penelitian: Penelitian ini merupakan penelitian observasional dengan desain khusus analisis kesintasan data diambil secara retrospektif dengan subyek penelitian adalah pasien yang terdiagnosis adenokarsinoma paru yang mendapatkan terapi TKI lini pertama di RSUP Dr.Sardjito pada tahun 2016-2018. Analisa statistik: Kesintasan dianalisis dengan metode Kaplan-Meier mengunakan log-rank. Analisis cox regression untuk mengidentifikasi faktor yang mempengaruhi kesintasan hidup dan kesintasan bebas progresi. Hasil Penelitian: Didapatkan nilai median kesintasan hidup sebesar 11 bulan (IK95% 9,006-12,994), kesintasan hidup 1 tahun sebesar 41,5% , median kesintasan bebas progresi 8 bulan (IK95% 6,112-9,888) dan kesintasan bebas progresi 1 tahun sebesar 22,3%. Faktor yang mepengaruhi kesintasan hidup memiliki hazard ratio terhadap kejadian mortalitas adalah variabel ECOG 2 (B 0,803; HR 2,23; IK95% 1,212-4,108; p=0,010) dan Infeksi aktif (B 1,226; HR 3,41; IK95% 1,469-7,905; p=0,004). Variabel dengan kemaknaan statistik memiliki hazard ratio terhadap progresi penyakit adalah variabel Infeksi aktif (HR 3,41; IK95% 1,469-7,905; p=0,004). Kesimpulan : Kesintasan hidup 1 tahun sebesar 41,5% serta kesintasan bebas progresi 1 tahun sebesar 22,3%.

Background: Tyrosine Kinase inhibitor (TKI) therapy improves signal transduction of cancer cell growth, which resulted in decrease cell proliferation. This therapy leads to improvement in progression-free survival(PFS), quality of life, and overall survival (OS) compared to chemotherapy in general. Double blind randomized controlled phase II clinical trial had been conducted in patients with adenocarcinoma of the lung with EGFR mutations using gefitinib 250 mg or 500 mg in 400 patient. It was concluded that the median overall survival was 6-8 months with reduction in lung cancer symptoms. However, there was a noticeable increase of side effects with 500 mg dose. Objective: To examine the overall survival and progression-free survival of patients with adenocarcinoma of the lung treated with first- TKI therapy at Dr.Sardjito General Hospital. Methods: This was an observational study with a survival analysis. Data was taken retrospectively, from which the subjects were patients diagnosed with adenocarcinoma of the lungs treated with first-line TKI in Dr. Sardjito General Hospital from 2016 to 2018. Statistical analysis: Years of survival was analyzed with the Kaplan-Meier method using log-rank. Cox regression analysis was conducted to identify factors influencing overall survival and progression-free survival. Results: Median overall survival was 11 months (CI 95% 9,006 -12,994), 1-year survival was 41,5%, while median progression-free survival was 8 months (CI95%; 6,112 -9,888) and 1-year progression-free survival was 22,3%. Factors influencing survival rate which had hazard ratioto mortality rate was ECOG 2 (B 0,803; HR 2,23; CI95% 1,212-4,108; p = 0,010) and active infection (B 1,226; HR 3.41; CI95% 1,469 -7,905; p = 0,004). Statistically significance variable, which had hazard ratio against disease progression, was active infection (HR 3.41; CI95% 1,469 - 7,905; p = 0,004). Conclusion: 1-year survival rate was 41.5% and 1-year progression-free survival was 22,3%.

Kata Kunci : Kesintasan, adenokarsinoma paru, EGFR-TKI lini pertama, Survival, adenocarcinoma of the lungs, first line TKI, EGFR