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"ABSTRACTLung cancer is a devastating disease with a high incidence, mortality and morbidity rate, especially in developing countries. Conventional treatment with cytotoxic chemotherapy has some limitations attributed to chemoresistance and toxicity. Recent advances have shown that first generation Tyrosine Kinase Inhibitor (TKI), Gefitinib and Erlotinib, and the newest available second generation Tyrosine Kinase Inhibitor (TKI), Afatinib, have the potential to be an option in the management of patients with epidermal growth factor receptor/ EGFR mutation positive advanced/ metastatic non-small cell lung cancer. Afatinib works by binding to EGFR irreversibly, thus inactivating the tyrosine kinase receptor. Some studies demostrated that Afatinib first-line may result in longer progression free survival (PFS) and better disease control, and as an alternative for patients who intolerance to Gefitinib or Erlotinib. In Indonesia, the era of National Health Insurance has been implemented and National Health Insurance has covered treatment for cancer, including first generation TKIs, Gefitinib dan erlotinib, for patients with EGFR mutation positive advanced/ metastatic non-small cell lung cancer at Cipto Mangunkusumo National Hospital. Afatinib, as one of the newest available second generation TKI, may be given free of charge too as an alternative if the National Health Insurance will be covered in the future. Further research is needed to know the efficacy and adverse effects that may occur in patients from developing countries."

"Pendahuluan: Tyrosine Kinase Inhibitors (TKIs) sangat efektif terhadap KankerParu jenis Karsinoma Bukan Sel Kecil (KPKBSK) dengan mutasi EpidermalGrowth Factor Receptor (EGFR). Gefitinib dan Erlotinib adalah generasi pertamaEGFR-TKI untuk pengobatan KPKBSK dengan mutasi EGFR. Obat-obat ini telahtersedia melalui asuransi kesehatan di Indonesia untuk pasien Adenokarsinomaparu dengan mutasi EGFR. Data mengenai efikasi dan toksisitas EGFR-TKI saatini belum tersedia di Indonesia.Metode: Kami melakukan analisis observasional kohort retrospektif pada pasienAdenokarsinoma paru dengan mutasi EGFR di RSUP Persahabatan, JakartaIndonesia dari Januari 2015 sampai dengan Desember 2017. Kami meninjaurekam medis 331 pasien dengan diagnosis Adenokarsinoma paru dengan mutasiEGFR stage lanjut yang diobati dengan EGFR-TKI generasi pertama. Sebanyak192 subjek yang memenuhi kriteria inklusi.Hasil: Subjek yang mendapatkan Gefitinib (n=132) dan Erlotinib (n=60). Medianprogression free survival (PFS) sebanding antara Gefitinib dan Erlotinib (9,0 dan7,0 bulan, interval kepercayaan 95% [IK] 0,57-1,07, p=0,126). Median Overallsurvival (OS) dan angka tahan hidup 1 tahun masing-masing kelompok adalah44,5 vs 39,5 bulan (95% IK 0,35-1,29, p=0,670) dan 92% berbanding 92%(p=0,228). Terdapat toksisitas termasuk diare, paronikia, skin rash dan stomatitisyang diamati tetapi tidak ada perbedaan yang bermakna pada toksisitas derajat 3atau 4 antara kedua kelompok (p=0,713).Kesimpulan: Kedua EGFR-TKIs generasi pertama sebanding dalam PFS dan OS,meskipun Gefitinib terlihat lebih tinggi, tetapi secara statistik tidak bermakna dankeduanya memiliki toksisitas yang sebanding dan dapat ditoleransi.

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Introductions: Tyrosine kinase inhibitors (TKIs) are effective against non-smallcell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)mutation. Gefitinib and erlotinib are the first-generation EGFR-TKIsrecommended as first-line treatments for NSCLC with EGFR mutations and areavailable through Universal Health Coverage in Indonesia for lungadenocarcinoma patients with EGFR mutations. However, the efficacy and safetydata of EGFR-TKIs are unavailable in Indonesia.Methods: We did a retrospective cohort analysis of the patients of lungadenocarcinoma with EGFR mutations treated in Persahabatan Hospital Jakarta,Indonesia, between January 2015 and December 2017. We reviewed the recordsof 331 patients with advanced stage lung adenocarcinoma with EGFR mutationtreated with the first-generation EGFR-TKIs. The subjects were 192 patients whomet the inclusion criteria.Results: Subjects were receiving gefitinib (n=132) and erlotinib (n=60). Medianprogression-free survival (PFS) was comparable between gefitinib and erlotinib(9.0 vs 7.0 months, 95% confidence interval [CI] 0.57-1.07, p=0.126). Themedian overall survival (OS) and 1-year survival were 44.5 vs 39.5 months(95%CI 0.35-1.29, p=0.228; and 92% vs 92%, p=0.228, respectively). Reportedtoxicities were diarrhea, paronychia, rash, and stomatitis but not of significantdifference between grade 3 or 4 toxicities (p=0.713).Conclusions: The PFS and OS of the first-generation EGFR-TKIs werecomparable, although gefitinib PFS and OS was shown to be better, but withoutsignificance. Both gefitinib and erlotinib had comparable and tolerable adverseeffects"

"Latar Belakang: Kanker paru menjadi penyebab kematian utama akibat keganasan pada laki-laki sebesar 31% dan perempuan sebesar 27%. Pada pasien adenokarsinoma paru dengan mutasi pada exon 20 T790M memberikan respons yang buruk terhadap terapi EGFR-TKI generasi pertama maupun generasi kedua. Tujuan: Mengetahui profil serta angka tahan hidup 1 tahun pasien kanker paru jenis Adenokarsinoma dengan mutasi exon 20 T790M primer. Metode: Penelitian menggunakan desain kohort terhadap pasien-pasien adenokarsinoma paru stadium IV dengan mutasi exon 20 T790M primer dari bulan September 2015 sampai Desember 2017 di RSUP Persahabatan. Variabel yang diteliti adalah karakteristik klinis dan angka kesintasanberdasarkan kurva Kaplan Meier. Hasil analisis dinyatakan berbeda bermakna apabila nilai p<0,05. Hasil: Didapatkan 27 subjek penelitian dengan rerata usia 58,5 tahun dan berjenis kelamin laki-laki (70,6%). Keluhan utama berupa sesak napas (73,5%) dan nyeri dada (55,9%). Mutasi genetik tunggal pada Exon 20 T790M (64,7%), sedangkan mutasi Exon 20 T790M dengan Exon 21 L858R (11,8%) dan mutasi Exon 20 T790M dengan 21 L861Q (8,8%). Organ target metastasis adalah efusi pleura (73,5%), tulang (26,5%) dan otak (20,6%). Angka kesintasan 360 dan 990 hari sebesar 35% dan 20% dengan median kesintasan sebesar 213 hari. Kesimpulan: Mutasi exon 20 T790M pada adenokarsinoma paru memegang peranan penting terhadap kesintasan dan prediktor responsterhadap terapi yang diberikan.

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Background: Lung cancer causes mortality in men (31%) and in women (27%). Lung adenocarcinoma patients with exon 20 T790Mepidermal growth factor receptor(EGFR) mutation showed poor response to the first generation and second generation of EGFR tyrosine kinase inhibitor (TKI) therapy.

Purpose: This study aims to reveal the characteristics and one year survival rate of lung adenocarcinoma patients with primary exon 20 T790M EGFR mutations treated at Persahabatan Hospital Jakarta, Indonesia.

Methods: The cohort study involved patients with primary exon 20 T790M EGFR mutation between September 2015 to December 2017 in Persahabatan Hospital Jakarta, Indonesia. The survival rate was observed from Kaplan Meier estimator curve and was statistically analyzed.

Results: There were 27 subjects with mean age of 58.5 years and were predominated male (70.6%). The most common chief complaints were shortness of breath (73.5%) and chest pain (55.9%). The EGFR mutations detected were exon 20 T790M (64.7%), exon 20 T790M with exon 21 L858R (11.8%) and exon 20 T790M with exon 21 L861Q (8.8%). Metastatic target organs were pleural effusions (73.5%), bone (26.5%) and brain (20.6%). Survival rate of 360 and 990 days was 35% and 20% respectively with median survival rate was 213 days.

Conclusion: Exon 20 T790M EGFR mutation in lung adenocarcinoma was revealed to be an important factor in survival and in predicting response to EGFR TKI chemotherapy."