Edward Pandu Wiriansya (2017) PERBANDINGAN RESPONS KEMOTERAPI DAN EFEK SAMPING PENGGUNAAN PLATINUM DOUBLET KOMBINASI EGFR TKI DENGAN PLATINUM DOUBLET TUNGGAL PADA PENDERITA NSCLC MUTASI GEN EGFR PROGRESSIVE DISEASE. Thesis thesis, Universitas Airlangga.

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Abstract

EGFR-TKI is the first-line therapy for EGFR-mutant patients. Nevertheless, patients will have disease progression (median PFS 10 – 12 months) due to resistance. The treatment options are still limited in developing countries for such cases, thus double-platinum chemotherapy is the next option. Although IMPRESS study reported no difference in terms of PFS and OS between double-platinum and double-platinum plus EGFR-TKI, several local studies reported benefit of continuing EGFR-TKI in combination with double-platinum chemotherapy (treatment beyond progression). Aim: The Aims is to Compare chemotherapy effects of Double-Platinum Plus EGFR-TKI Versus Double-Platinum alone on patients with NSCLC progression following EGFR-TKI treatment. Methods: This is an analytical descriptive study using prospective cohort design, involving 30 patients with disease progression following EGFR-TKI treatment that meet inclusion criteria in Dr. Soetomo General Hospital. Subjects divided into two groups: arm A (double-platinum plus EGFR-TKI) and arm B (double-platinum alone). Subjects then observed until 4 cycles of double-platinum chemotherapy. Subjective response (body weight and EQ5D questionnaire) were analyzed, chest CT scans were evaluated using Recist criteria, and adverse effects were monitored. This study was conducted in accordance with GCP principles and has received ethics certificate from Dr. Soetomo General Hospital ethics committee (No.08/Panke.KKE/I/ 2017). Results: Subject characteristics between two arms are insignificantly different (p ≥ 0.05). The most common EGFR mutation is exon 21 (50% on arm A and 60% on arm B). Chi square test on subjective response parameter (EQ5D (p=0.483)). T2 free sample test on semi-subjective parameter (body weight (p=1.00)). Comparison test on both groups after cycle 2 and 4 showed p value ≥ 0.05. Statistical test on adverse effect between both groups showed p value = 0.526. Conclusion: This study showed no significant difference between double-platinum and double-platinum plus EGFR-TKI on patients who had disease progression following EGFR-TKI treatment.

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