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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."

"Pasien kanker paru mengalami kualitas tidur yang buruk sehingga dapat memengaruhi kualitas hidup pasien secara negatif dan bahkan dapat memperparah perkembangan kanker. Peranan gejala psikologis terhadap kualitas tidur pasien kanker paru tidak bisa diabaikan. Penelitian ini bertujuan untuk mengetahui hubungan gejala psikologis dengan kualitas tidur pada pasien kanker paru. Penelitian ini dilakukan secara kuantitatif observasional dengan pendekatan cross sectional. Penelitian ini melibatkan 92 pasien kanker paru dengan teknik convenience sampling. Data dianalisis menggunakan uji korelatif Pearson. Hasil penelitian ini menemukan adanya hubungan positif antara gejala psikologis dengan kualitas tidur pada pasien kanker paru (p<0,001, α=0,05). Dengan demikian, hasil penelitian ini diharapkan dapat menjadi acuan agar perawat mengkaji gejala psikologis dan kualitas tidur pasien agar dapat memberikan intervensi yang spesifik seperti edukasi terkait manajemen gejala psikologis dan kualitas tidur yang buruk.

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Patients with lung cancer experience poor sleep quality, which can negatively affect their quality of life and potentially worsen the progression of cancer. The role of psychological symptoms in the sleep quality of lung cancer patients cannot be overlooked. This study aims to determine the relationship between psychological symptoms and sleep quality in lung cancer patients. It employed a quantitative observational approach with a cross-sectional design, involving 92 lung cancer patients selected through convenience sampling. The collected data is analyzed using Pearson Correlation test. The results indicate a positive correlation between psychological symptoms and sleep quality in lung cancer patients (p<0.001, α=0.05). Therefore, this research highlights the importance for nurses to assess psychological symptoms and quality of sleep in patients to provide specific intervention like education regarding the management of psychological symptoms and poor quality of sleep."

"[ABSTRAKPendahuluan. Kanker paru jenis karsinoma bukan sel kecil (KPKBSK) terdiri dari nonskuamosa dan skuamosa. Kanker paru jenis karsinoma bukan sel kecil nonskuamosa adalah adenokarsinoma dan karsinoma sel besar. Saat ini terapi kanker paru sangat berkembang dari agen kemoterapi sampai terapi target terutama EGFR-TKI. Penelitian ini bertujuan untuk menilai angka tahan hidup pasien KPKSBK nonskuamosa yang mendapat kemoterapi lini pertama dibandingkan terapi EGFR-TKI di RSUP Persahabatan.Metode. Penelitian ini adalah penelitian retrospektif antara tahun 2010 sampai 2013 dari rekam medis pasien KPKBSK non skumosa yang mendapatkan kemoterapi lini pertama dan EGFR-TKI. Pasien dikemoterapi dengan platinum baseddan EGFR-TKI diterapi gefitinib 1x250 mg/hari atau erlotinib 1x150 mg/hari. Angka tahan hidup dinilai dari mulai tegak diagnosis sampai pasien meninggal atau saat penelitian dihentikan.Hasil. Dari 96 sampel KPKBSK non skuamosa terdiri dari 48 pasien yang mendapat kemoterapi lini pertama dan 48 pasien yang diterapi EGFR-TKI. Berdasarkan karakteristik pasien, usia terbanyak adalah 40-60 tahun (kemoterapi 32 (66,7%) dan EGFR-TKI 31 (64,6%) dengan jenis kelamin laki-laki yang mendominasi (kemoterapi 25(52,1%), EGFR-TKI 27 (56,2%). Pasien merokok yang mendapat kemoterapi lini pertama 41,7% dan EGFR-TKI 56,3% dengan IB terbanyak untuk kemoterapi (IB ringan 27,1%) dan untuk EGFR-TKI (IB sedang 22,9%). Jenis histologi adenokarsinoma 95,8% dengan dominasi stage IV 89,6% (kemoterapi 91,7% dan EGFR-TKI 87,5%) disertai tampilan status 2 59,4%. Angka tahan hidup pasien (ATH) 6 bulan 74%, ATH 1 tahun 22,90% dan ATH 2 tahun 6,20%. Masa tengah tahan hidup (MTTH) pasien yang mendapat EGFR-TKI lebih lama sedikit dibandingkan yang mendapat kemoterapi lini pertama (263 hari versus 260 hari.Kesimpulan. Masa tahan hidup 1 tahun pasien KPKBSK non skuamosa yang diterapi EGFR-TKI sedikit lebih lama dibandingkan kemoterapi lini pertama (263 hari vs 260 hari). Sedangkan ATH 1 tahun pasien kemoterapi lini pertama lebih besar dibandingkan EGFR-TKI (25% vs 20,8%). Faktor yang paling mempengaruhi angka tahan hidup adalah stage dengan nilai p<0,05.

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ABSTRACT Introduction. Lung cancer is the type of non-small cell carcinoma (NSCLC) consists of non-squamous and squamous. Non-small cell lung cancer of non squamous types consist of adenocarcinoma and large cell carcinoma. Currently, lung cancer therapy is highly developed of chemotherapeutic agents to targeted therapy especially EGFR-TKI. This study aims to assess the survival rate of NSCLC patients of non-squamous type who receive first line chemotherapy and those who recieve EGFR-TKI therapy at Persahabatan hospital.Methods. This study is a retrospective study between 2010 to 2013 from the medical records of NSCLC patients of non-squmous type who receive first-line chemotherapy and thise who recieve EGFR-TKI.Patients with platinum-based chemotherapy and EGFR-TKI with gefitinib therapy 1x250 mg/day or erlotinib 1x150mg/day. Survival rate assessed from start to erect the diagnosis until the patient dies or when the study is discontinued.Result. From 96 subject of NSCLC patients with non-squamous type consisted of 48 patients who receive first-line chemotherapy, and 48 patients are treate with EGFR-TKI. Based on the characteristics of the patients, most are 40-60 years old (chemotherapy 32 (66.7%) and EGFR-TKI 31 (64.6%) with the male gender that dominates (chemotherapy 25 (52.1%), EGFR-TKI 27 (56.2%). Smoking patients who received first-line chemotherapy are 41.7% and 56.3% of EGFR-TKIs with chemotherapy highest IB (mild IB 27.1%) and for EGFR-TKI (moderate IB are 22.9%). 95.8% of adenocarcinoma histology type with a predominance of stage IV 89.6% (91.7% for chemotherapy and EGFR-TKI 87.5%) with performance status 2 59.4% . Survival rate of patients are 74% for 6 months survival, 1 year survival rate is 22.90% and 2 years survival rate of 6.20%. Median period of survival rate in patients who receiving EGFR-TKI longer than they received first-line chemotherapy (263 days versus 260 days).Conclusion. Median survival rate of non-squamous NSCLC that treated by EGFR-TKI is longer than first-line chemotherapy (263 days vs 260 days). Although 1 year survival rate first-line chemotherapy in patients is greater than EGFR-TKI (25% vs 20.8%). The factors that most influence the survival rate is stages with p value<0.05.;Introduction. Lung cancer is the type of non-small cell carcinoma (NSCLC) consists of non-squamous and squamous. Non-small cell lung cancer of non squamous types consist of adenocarcinoma and large cell carcinoma. Currently, lung cancer therapy is highly developed of chemotherapeutic agents to targeted therapy especially EGFR-TKI. This study aims to assess the survival rate of NSCLC patients of non-squamous type who receive first line chemotherapy and those who recieve EGFR-TKI therapy at Persahabatan hospital.Methods. This study is a retrospective study between 2010 to 2013 from the medical records of NSCLC patients of non-squmous type who receive first-line chemotherapy and thise who recieve EGFR-TKI.Patients with platinum-based chemotherapy and EGFR-TKI with gefitinib therapy 1x250 mg/day or erlotinib 1x150mg/day. Survival rate assessed from start to erect the diagnosis until the patient dies or when the study is discontinued.Result. From 96 subject of NSCLC patients with non-squamous type consisted of 48 patients who receive first-line chemotherapy, and 48 patients are treate with EGFR-TKI. Based on the characteristics of the patients, most are 40-60 years old (chemotherapy 32 (66.7%) and EGFR-TKI 31 (64.6%) with the male gender that dominates (chemotherapy 25 (52.1%), EGFR-TKI 27 (56.2%). Smoking patients who received first-line chemotherapy are 41.7% and 56.3% of EGFR-TKIs with chemotherapy highest IB (mild IB 27.1%) and for EGFR-TKI (moderate IB are 22.9%). 95.8% of adenocarcinoma histology type with a predominance of stage IV 89.6% (91.7% for chemotherapy and EGFR-TKI 87.5%) with performance status 2 59.4% . Survival rate of patients are 74% for 6 months survival, 1 year survival rate is 22.90% and 2 years survival rate of 6.20%. Median period of survival rate in patients who receiving EGFR-TKI longer than they received first-line chemotherapy (263 days versus 260 days).Conclusion. Median survival rate of non-squamous NSCLC that treated by EGFR-TKI is longer than first-line chemotherapy (263 days vs 260 days). Although 1 year survival rate first-line chemotherapy in patients is greater than EGFR-TKI (25% vs 20.8%). The factors that most influence the survival rate is stages with p value<0.05.;Introduction. Lung cancer is the type of non-small cell carcinoma (NSCLC) consists of non-squamous and squamous. Non-small cell lung cancer of non squamous types consist of adenocarcinoma and large cell carcinoma. Currently, lung cancer therapy is highly developed of chemotherapeutic agents to targeted therapy especially EGFR-TKI. This study aims to assess the survival rate of NSCLC patients of non-squamous type who receive first line chemotherapy and those who recieve EGFR-TKI therapy at Persahabatan hospital.Methods. This study is a retrospective study between 2010 to 2013 from the medical records of NSCLC patients of non-squmous type who receive first-line chemotherapy and thise who recieve EGFR-TKI.Patients with platinum-based chemotherapy and EGFR-TKI with gefitinib therapy 1x250 mg/day or erlotinib 1x150mg/day. Survival rate assessed from start to erect the diagnosis until the patient dies or when the study is discontinued.Result. From 96 subject of NSCLC patients with non-squamous type consisted of 48 patients who receive first-line chemotherapy, and 48 patients are treate with EGFR-TKI. Based on the characteristics of the patients, most are 40-60 years old (chemotherapy 32 (66.7%) and EGFR-TKI 31 (64.6%) with the male gender that dominates (chemotherapy 25 (52.1%), EGFR-TKI 27 (56.2%). Smoking patients who received first-line chemotherapy are 41.7% and 56.3% of EGFR-TKIs with chemotherapy highest IB (mild IB 27.1%) and for EGFR-TKI (moderate IB are 22.9%). 95.8% of adenocarcinoma histology type with a predominance of stage IV 89.6% (91.7% for chemotherapy and EGFR-TKI 87.5%) with performance status 2 59.4% . Survival rate of patients are 74% for 6 months survival, 1 year survival rate is 22.90% and 2 years survival rate of 6.20%. Median period of survival rate in patients who receiving EGFR-TKI longer than they received first-line chemotherapy (263 days versus 260 days).Conclusion. Median survival rate of non-squamous NSCLC that treated by EGFR-TKI is longer than first-line chemotherapy (263 days vs 260 days). Although 1 year survival rate first-line chemotherapy in patients is greater than EGFR-TKI (25% vs 20.8%). The factors that most influence the survival rate is stages with p value<0.05.;Introduction. Lung cancer is the type of non-small cell carcinoma (NSCLC) consists of non-squamous and squamous. Non-small cell lung cancer of non squamous types consist of adenocarcinoma and large cell carcinoma. Currently, lung cancer therapy is highly developed of chemotherapeutic agents to targeted therapy especially EGFR-TKI. This study aims to assess the survival rate of NSCLC patients of non-squamous type who receive first line chemotherapy and those who recieve EGFR-TKI therapy at Persahabatan hospital.Methods. This study is a retrospective study between 2010 to 2013 from the medical records of NSCLC patients of non-squmous type who receive first-line chemotherapy and thise who recieve EGFR-TKI.Patients with platinum-based chemotherapy and EGFR-TKI with gefitinib therapy 1x250 mg/day or erlotinib 1x150mg/day. Survival rate assessed from start to erect the diagnosis until the patient dies or when the study is discontinued.Result. From 96 subject of NSCLC patients with non-squamous type consisted of 48 patients who receive first-line chemotherapy, and 48 patients are treate with EGFR-TKI. Based on the characteristics of the patients, most are 40-60 years old (chemotherapy 32 (66.7%) and EGFR-TKI 31 (64.6%) with the male gender that dominates (chemotherapy 25 (52.1%), EGFR-TKI 27 (56.2%). Smoking patients who received first-line chemotherapy are 41.7% and 56.3% of EGFR-TKIs with chemotherapy highest IB (mild IB 27.1%) and for EGFR-TKI (moderate IB are 22.9%). 95.8% of adenocarcinoma histology type with a predominance of stage IV 89.6% (91.7% for chemotherapy and EGFR-TKI 87.5%) with performance status 2 59.4% . Survival rate of patients are 74% for 6 months survival, 1 year survival rate is 22.90% and 2 years survival rate of 6.20%. Median period of survival rate in patients who receiving EGFR-TKI longer than they received first-line chemotherapy (263 days versus 260 days).Conclusion. Median survival rate of non-squamous NSCLC that treated by EGFR-TKI is longer than first-line chemotherapy (263 days vs 260 days). Although 1 year survival rate first-line chemotherapy in patients is greater than EGFR-TKI (25% vs 20.8%). The factors that most influence the survival rate is stages with p value<0.05., Introduction. Lung cancer is the type of non-small cell carcinoma (NSCLC) consists of non-squamous and squamous. Non-small cell lung cancer of non squamous types consist of adenocarcinoma and large cell carcinoma. Currently, lung cancer therapy is highly developed of chemotherapeutic agents to targeted therapy especially EGFR-TKI. This study aims to assess the survival rate of NSCLC patients of non-squamous type who receive first line chemotherapy and those who recieve EGFR-TKI therapy at Persahabatan hospital.Methods. This study is a retrospective study between 2010 to 2013 from the medical records of NSCLC patients of non-squmous type who receive first-line chemotherapy and thise who recieve EGFR-TKI.Patients with platinum-based chemotherapy and EGFR-TKI with gefitinib therapy 1x250 mg/day or erlotinib 1x150mg/day. Survival rate assessed from start to erect the diagnosis until the patient dies or when the study is discontinued.Result. From 96 subject of NSCLC patients with non-squamous type consisted of 48 patients who receive first-line chemotherapy, and 48 patients are treate with EGFR-TKI. Based on the characteristics of the patients, most are 40-60 years old (chemotherapy 32 (66.7%) and EGFR-TKI 31 (64.6%) with the male gender that dominates (chemotherapy 25 (52.1%), EGFR-TKI 27 (56.2%). Smoking patients who received first-line chemotherapy are 41.7% and 56.3% of EGFR-TKIs with chemotherapy highest IB (mild IB 27.1%) and for EGFR-TKI (moderate IB are 22.9%). 95.8% of adenocarcinoma histology type with a predominance of stage IV 89.6% (91.7% for chemotherapy and EGFR-TKI 87.5%) with performance status 2 59.4% . Survival rate of patients are 74% for 6 months survival, 1 year survival rate is 22.90% and 2 years survival rate of 6.20%. Median period of survival rate in patients who receiving EGFR-TKI longer than they received first-line chemotherapy (263 days versus 260 days).Conclusion. Median survival rate of non-squamous NSCLC that treated by EGFR-TKI is longer than first-line chemotherapy (263 days vs 260 days). Although 1 year survival rate first-line chemotherapy in patients is greater than EGFR-TKI (25% vs 20.8%). The factors that most influence the survival rate is stages with p value<0.05.]"

"Latar Belakang: Tingginya angka kejadian kanker paru menyebabkan diperlukan pemanfaatan suatu penanda biologis spesifik kanker paru untuk menilai progresifitas penyakit. Transforming growth factor-β adalah protein yang disekresi untuk meregulasi proliferasi, diferensiasi dan kematian dari berbagai jenis sel. Semua jenis sel kekebalan termasuk sel B, sel T, sel dendritik dan makrofag mensekresi TGF-β. Jenis TGF-β yang terbanyak adalah TGF-β1. Diperlukan pengukuran kadar TGF-β1 serum darah tepi sebagai faktor prognostik pada kanker paru khususnya KPKBSK stage lanjutMetode: Penelitian ini merupakan studi perbandingan dengan disain potong lintang pada pasien kanker paru yang telah tegak diagnosis dan bersedia diambil serum darah tepi untuk pemeriksaan kadar TGF-β1 serum menggunakan Human TGF-β1 Quantikine ELISA kit dari R D. Kadar TGF-β1 serum diukur pada 68 subjek yang terdiri dari 30 subjek kelompok kanker paru dan 38 subjek kelompok bukan kanker paru.Hasil: Kadar TGF-β1 serum pada kelompok kanker paru meningkat signifikan lebih tinggi dibandingkan kelompok bukan kanker paru (median; min-max) (3601.85; 2006.87-14995.25 pg/mL vs 2510.11; 646.31-5584.07 pg/mL) (P = 0.000). Tidak ditemukan hubungan antara kadar TGF-β1 serum dengan jenis kelamin, umur, riwayat merokok, gejala klinis, gambaran bronkoskopi, jenis sitologi/histopatologi, KPKBSK stage lanjut, dan status tampilan umum. Median Survival Time (95% CI) TGF-β1 < 3601.85 pg/mL adalah 9.7 (2.4-16.9) bulan sedangkan TGF-β1 ≥ 3601.85 pg/mL adalah 16.7 (7.7-25.7) bulan. Over all survival TGF-β1 13.3 (5.8-20.8) bulanKesimpulan: Kadar TGF-β1 serum meningkat pada kelompok kanker paru dibandingkan kelompok bukan kanker paru. Kadar TGF-β1 serum belum dapat digunakan sebagai marker prognostik kanker paru.

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Beckground: The high incidence rate of lung cancer leads to the utilization of a specific biological marker of lung cancer to assess disease progression. Transforming growth factor-β is a secreted protein to regulate the proliferation, differentiation and death of different cell types. Types of immune cells are B cells, T cells, dendritic cells and macrophages secreting TGF-β. The most common type of TGF-β is TGF-β1. Therefore, measurement of serum level of TGF-β1 as a prognostic factors in lung cancer, especially advanced stage NSCLC, to assess progressivity of lung cancer is needed. Method: This study is a comparative study with cross-sectional design in lung cancer patients who had been diagnosed and were willing to be taken for examination of peripheral blood serum levels of TGF-β1 using the Quantikine Human TGF-β1 ELISA kit from R&D system. TGF-β1 serum levels were measured in 68 subjects consisted of 30 subjects with lung cancer group and 38 subjects controlled group. Result: Serum level of TGF-β1 in lung cancer group increased significantly higher than control group (median; min-max) (3601.85; 2006.87-14995.25 pg/mL vs. 2510.11; 646.31-5584.07 pg/mL) (P = 0.000). There was no association between serum level of TGF-β1 with gender, age, smoking history, clinical symptoms, bronchoscopy, cytology/histopathology, advanced stage of NSCLC, and performance status. Median Survival Time (95% CI) TGF-β1 <3601.85 pg/mL was 9.7 (2.4-16.9) months while TGF-β1 ≥ 3601.85 pg/mL was 16.7 (7.7-25.7) months. Over all survival TGF-β1 13.3 (5.8-20.8) months. Conclusion: Serum level of TGF-β1 is higher in the lung cancer group compared to controlled group. Serum TGF-β1 levels can not be used as a prognostic markers of lung cancer."

"Latar belakang : Terapi target baru golongan EGFR-TKi telah direkomendasikan sebagai terapi lini pertama untuk pasien KPKBSK non skuamosa dengan mutasi EGFR positif. Belum tersedia data di Indonesia tentang efikasi dan toksisitas terapi target baru EGFR-TKi pada pasien KPKBSK dengan mutasi EGFR positif dibandingkan dengan kemoradioterapi pada EGFR wild type di RSUP Persahabatan Jakarta.Metode : Disain penelitian ini kohort retrospektif melalui resume medis pasien KPKBSK non skuamosa di RSUP Persahabatan periode Januari 2010 sampai Juli 2014. Teknik pengambilan sampel adalah consequtive sampling. Jumlah sampel 61 pasien yang terdiri dari 31 pasien KPKBSK non skuamosa dengan mutasi EGFR positif yang diberikan terapi target baru EGFR-TKi dan 30 pasien dengan EGFR wild type yang diberikan kemoradioterapi.Hasil : Karakteristik pasien KPKBSK non skuamosa dengan mutasi EGFR yang positif adalah laki-laki sebanding dengan perempuan, bukan perokok, mutasi delesi di ekson 19 sebanding dengan mutasi L858R di ekson 21, angka tahan hidup 1 tahun 48,37%, rata-rata time to progression 284 hari sedangkan pasien EGFR wild type adalah laki-laki lebih dominan, perokok, angka tahan hidup 1 tahun 33,3% dan rata-rata time to progression 210 hari dan overall survival 293 hari. Uji T independen menunjukan terdapat hubungan yang bermakna antara terapi target baru EGFR-TKi dengan lama time to progression (p=0,028). Toksisitas yang sering ditemukan pada terapi target baru EGFR-TKi adalah mual- muntah (6,8%) diare (16,2%), alopesia (3,2%) dan kelainan kulit kemerahan (12,9%) sedangkan pada kelompok kemoradioterapi toksisitas yang ditemukan adalah anemia (13,3%), leukopenia (6,7%) dan trombositopenia (3,3%).Kesimpulan : Pasien KPKBSK non skuamosa dengan mutasi EGFR yang positif dan diberikan terapi target baru EGFR-TKi memiliki time to progression yang lebih lama dan toksisitas yang dapat ditoleransi.

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Background: The new targeted therapy of EGFR-TKi has been recommended as first-line therapy for patients with NSCLCC non-squamous with mutated EGFR. There are no data about the efficacy and toxicity of the new targeted therapy of EGFR-TKi in NSCLC non-squamous with mutated EGFR compared with chemotradiotherapy in wild type at Persahabatan Hospital, Jakarta.

Methods: The design of study are retrospective cohort through medical records of NSCLC non-squamous patients in the Department of Pulmonology and Respiratory Persahabatan Hospital in January 2010 to July 2014. The sampling technique is consequtive sampling. The number of samples are 61 patients consisted of 31 patients with NSCLC non-squamous with mutated EGFR treated the new targeted therapy of EGFR-TKi and 30 patients with EGFR wild type treated chemoradiotherapy.

Results: The characteristics of NSCLC non-squamous patients with positive mutated EGFR are male compared to women, non-smokers, a deletion mutation in exon 19 L858R mutation comparable with in exon 21, 1-year survival 41,9%, mean time to progression is 284 days and patients of wild-type mutation are more dominant in males, smokers, 1-year survival 33,3% and mean time to progression is 210 days and overall survival is 293 days . The independent t test showed a significant relationship between the new targeted therapy with EGFR-TKi and TTP (p = 0.028). The most common adverse events in the EGFR-TKi group are nausea and vomitus 96,8%), diarrhea (16,2%), alopecia (3,2%) and rash (12,9%) and in the chemotherapy group, anemia (13,3%), leucopenia (6,7%) and thrombocytopenia (3,3%).

Conclusions: The EFGR-TKi for patients with advanced non small cell lung cancer who are selected on the basis of EGFR mutations improve time to progression with acceptable toxicity."

"Latar Belakang: Mutasi Epidermal Growth Factor Receptor (EGFR) merupakan prediktor keberhasilan terapi TKI pada non-small cell lung cancer (NSCLC). Ras Asia, perempuan, bukan perokok, tipe histologis adenokarsinoma adalah karakteristik klinikopatologis yang diketahui memiliki asosiasi dengan mutasi EGFR pada NSCLC. Di Indonesia belum pernah dilakukan penelitian yang membuktikan asosiasi tersebut di tengah keterbatasan sumber daya dan fasilitas pemeriksaan biomolekuler untuk medeteksi mutasi EGFR.Metode: Desain studi adalah potong lintang. Subjek dikumpulkan secara konsekutif dari pasien adenokarsinoma paru stadium lanjut Rumah Sakit Umum Pusat Nasional Cipto Mangunkusumo dan Rumah Sakit Dharmais Pusat Kanker Nasional yang memeriksakan status mutasi EGFR di Laboratorium Kalbe Genomics dalam kurun waktu Januari 2010 hingga Desember 2013. Dari rekam medis pasien ditelusuri data umur, jenis kelamin, status merokok, diagnosis dan status mutasi EGFR. Uji chi-square dilanjutkan regresi logistik digunakan untuk menilai asosiasi jenis kelamin dan status merokok terhadap status mutasi EGFR.Hasil: Studi melibatkan 51 subjek dan didapatkan proporsi mutasi EGFR sebesar 47,1% (IK 95% = 33,4% – 60,8%). Uji bivariat menunjukkan perempuan (RO=4,80; IK 95%=1,12-20,61) dan bukan perokok (RO=4,00; IK 95%=1,23-13,06) memiliki asosiasi dengan mutasi EGFR, namun pada uji multivariat hanya status bukan perokok yang masih bermakna (RO=4,00; IK 95%=1,22-13,06).Simpulan: Proporsi mutasi EGFR pada kelompok pasien adenokarsinoma paru stadium lanjut 47,1%. Hanya status bukan perokok yang memiliki asosiasi independen dengan mutasi EGFR.

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Background: Epidermal Growth Factor Receptor (EGFR) mutation is predictor for successful TKI therapy in non-small cell lung cancer (NSCLC) patient. Asian, women, non-smoker, and histology of adenocarcinoma are the clinicopathological characteristics associated with EGFR mutation in NSCLC patient. In Indonesia, no research has been performed to confirm association between those characteristics while the resources and facilities to detect EGFR mutation are lacking.

Method: A cross sectional study was performed in Cipto Mangunkusumo National Referral Hospital and Dharmais Hospital National Cancer Center from January 2010 to December 2013. Subjects were collected consecutively from advanced lung adenocarcinoma patients who underwent examination for EGFR mutation in Kalbe Genomics Laboratory during study period. From medical records, information about age, gender, smoking status, diagnosis, and EGFR mutation status were collected. Chi square and logistic regression analysis were performed to assess association between variables.

Results: From 51 subjects participated in this study, proportion of EGFR mutation was 47.1% (CI 95% = 33,4% – 60,8%). Bivariate analysis revealed that women (OR=4,80; CI 95%=1,12-20,61) and non-smoker (OR=4,00; CI 95%=1,23-13,06) were associated with EGFR mutation. While in multivariate analysis, non-smoker status was the only significant clinical factor associated with EGFR mutation (OR=4.00; CI 95%=1.22-13.06).

Conclusion: Proportion of EGFR mutation in advanced lung adenocarcinoma patients is 47,1%. Non-smoker status is the only clinical factor associated with EGFR mutation."

"Latar Belakang : Penelitian perbandingan kesintasan pasien karsinoma paru bukan sel kecil usia lanjut stadium IIIB/IV yang menjalani kemoterapi dan non-kemoterapi sudah pernah diteliti di negara lain sebelumnya, namun penelitian tersebut di Indonesia belum pernah dilakukan. Penelitian-penelitian terdahulu belum banyak yang memperhitungkan faktor perancu seperti komorbiditas, jenis histopatologi, indeks massa tubuh, stadium, usia dan status fungsional dalam meneliti pengaruh kemoterapi terhadap kesintasan karsinoma paru bukan sel kecil usia lanjut.Tujuan : Mengetahui adakah perbedaan kesintasan satu tahun antara pasien kanker paru karsinoma bukan sel kecil usia lanjut stadium IIIB/IV yang menjalani kemoterapi dan non-kemoterapi.Metode : Kohort retrospektif dengan analisis kesintasan terhadap 232 pasien kanker paru karsinoma bukan sel kecil stadium IIIB/IV dan status fungsional ECOG 0-2 yang berobat jalan maupun rawat inap di RS Cipto Mangunkusumo dan RS Kanker Dharmais Januari 2007-April 2013, terbagi menjadi dua kelompok yaitu yang menjalani kemoterapi dan non-kemoterapi. Kurva Kaplan-Meier digunakan untuk mengetahui kesintasan satu tahun masing-masing kelompok. Analisis bivariat menggunakan uji log-rank, analisis multivariat menggunakan cox proportional hazard regression. Besarnya hubungan variabel kemoterapi dengan kesintasan dinyatakan dengan crude HR dan IK 95% serta adjusted HR dan IK 95% setelah dimasukkan variabel perancu.Hasil : Terdapat 232 pasien kanker paru karsinoma bukan sel kecil yang dibagi menjadi dua kelompok yaitu kemoterapi (118 subyek) dan non-kemoterapi (114 subyek). Persentase mortalitas satu tahun adalah 93,9% pada kelompok non-kemoterapi dan 57,6% pada kelompok kemoterapi. Median kesintasan kelompok non-kemoterapi adalah 2 bulan, sedangkan kelompok kemoterapi 9,73 bulan, p<0,001, HR 3,447(IK 95% 2,522-4,711). Analisis bivariat menunjukkan hubungan bermakna antara kemoterapi dengan kesintasan satu tahun. Analisis multivariat menunjukkan stadium adalah perancu kemoterapi terhadap kesintasan.Simpulan : Kesintasan satu tahun pasien kanker paru bukan sel kecil usia lanjut stadium IIIB/IV yang menjalani kemoterapi lebih baik dibandingkan dengan non-kemoterapi.

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Background : The effects of chemotherapy on survival in elderly with advanced non-small cell lung cancer has been studied in other country before, but in Indonesia this topic hasn?t been studied. The influence of confounding factors such as comorbidity, histopathology, body mass index, functional status, age and stage of cancer were seldom considered in the earlier studies.Objective : To determine whether there?s a difference in one year survival between elderly with advanced non-small cell lung cancer who received chemotherapy and those who received non-chemoterapeutic approaches.Methods : Retrospective cohort design and survival analysis were used to 232 elderly with advanced non-small cell lung cancer (IIIB/IV) and performance status of ECOG 0-2 who visited Cipto Mangunkusumo Hospital and Dharmais Cancer Hospital between January 2007 and April 2013 that divided into 2 groups according to therapy that they received (chemotherapy and non-chemotherapy). Kaplan-Meier curve was used to evaluate the one year survival of each group. Bivariate analysis was conducted using log-rank test, multivariate analysis was conducted using Cox proportional hazard regression. The extend of relation between advancing age and survival was expressed with crude HR with 95% CI and adjusted HR with 95%CI after adjusting for confounders.Results : There were 232 elderly advanced non-small cell lung cancer that divided into two groups ; chemotherapy (118 subjects) and non-chemotherapy (114 subjects). One year mortality percentage were 93,9% and 57,6% to non-chemotherapy and chemotherapy group. The survival median were 2 months in non-chemotherapy group and 9,73 months in chemotherapy group, with p< 0,001 and HR 3,447 (95% CI : 2,522-4,711). Bivariate analysis showed statistically significant relation between chemotherapy and one year survival. Multivariate analysis showed that stage of cancer was a confounder to chemotherapy relation to survival.Conclusion : One year survival in elderly with advanced non-small cell lung cancer who received chemotherapy were better compared to those who received non-chemotherapeutic approaches."

"ABSTRAK Tesis ini menilai efikasi dan toksisiti Erlotinib/Gefitinib sebagai terapi lini kedua pada pasien KPKBSK yang mengalami progresifitas. Ini adalah sebuah penelitiankohor retrospektif antara tahun 2009 sampai 2013 dari rekam medis pasienKPKBSK yang mengalami progresifitas. Respons (subjektif, semisubjektif danobjektif) dievaluasi setiap bulan. Toksisiti dinilai setiap minggu sejak pemberianErlotinib/Gefitinib berdasarkan kriteria WHO. Hasil evaluasi respons objektif,tidak ada pasien yang memberikan respons komplit. Best overall response ratedari 31 pasien, 48,8% menetap, 22,6% perburukan,12,9% respons sebagian dan6,5% tidak dinilai/inevaluable. Pada penilaian respons semisubjektif didapatkan19.4% peningkatan berat badan, 51,6% penurunan berat badan dan 29,0%menetap. Waktu tengah tahan hidup mencapai 18 bulan, rerata masa tahan hidup1 tahunan 80,6% dan masa tahan hidup keseluruhan 6,50%. Data menunjukkantidak ada timbul toksisiti hematologi berat (grade ¾) dan data penilaian toksisitinon hematologi sangat jarang timbul toksisiti berat (grade ¾). Efikasi monoterapiEGFR-TKI (Erlotinib/Gefitinib) cukup tinggi dengan toksisiti yang ditimbulkantidak berat. Dengan demikian Erlotinib/Gefitinib sebagai terapi lini kedua cukupbaik.ABSTRACT This thesis assesses the efficacy and toxicity of Erlotinib/Gefitinib as a second

line therapy in NSCLC patients. This is a retrospective cohort study between 2009

and 2013 from the medical records of patients who experienced progression

NSCLC. Therapeutic response was evaluated every month. Toxicity assessed

every month since giving Erlotinib/Gefitinib according to WHO?s criteria. Results

of objective response evaluation none of the patients complete response. Best

overall response rate of 31 patients with the most stable response are 48.8%. Most

semisubjective response obtained are 51.6% weight loss. The middle survival time

reached 18 month, the mean 1 year survival time are 80.6% and a 6.50% overall

survival. The data showed no hematologic toxicity arise severe (grade ¾) and

non-hematological toxicity very rarely arise severe toxicity. The efficacy of EGFR

TKI monotherapy (Erlotinib/Gefitinib) is high enough with toxicity cause not

severe. Thus Erlotinib/Gefitinib as second-line therapy is quite good. ;This thesis assesses the efficacy and toxicity of Erlotinib/Gefitinib as a second

line therapy in NSCLC patients. This is a retrospective cohort study between 2009

and 2013 from the medical records of patients who experienced progression

NSCLC. Therapeutic response was evaluated every month. Toxicity assessed

every month since giving Erlotinib/Gefitinib according to WHO?s criteria. Results

of objective response evaluation none of the patients complete response. Best

overall response rate of 31 patients with the most stable response are 48.8%. Most

semisubjective response obtained are 51.6% weight loss. The middle survival time

reached 18 month, the mean 1 year survival time are 80.6% and a 6.50% overall

survival. The data showed no hematologic toxicity arise severe (grade ¾) and

non-hematological toxicity very rarely arise severe toxicity. The efficacy of EGFR

TKI monotherapy (Erlotinib/Gefitinib) is high enough with toxicity cause not

severe. Thus Erlotinib/Gefitinib as second-line therapy is quite good. "