Purpose Selective internal radiation therapy or radioembolization (RE) shows efficacy in unresectable hepatocellular carcinoma (HCC) limited to the liver. This study compared the safety and efficacy of RE and sorafenib in patients with locally advanced HCC. Patients and Methods SIRveNIB (selective internal radiation therapy v sorafenib), an open-label, investigator-initiated, phase III trial, compared yttrium-90 (Y) resin microspheres RE with sorafenib 800 mg/d in patients with locally advanced HCC in a two-tailed study designed for superiority/detriment. Patients were randomly assigned 1:1 and stratified by center and presence of portal vein thrombosis. Primary end point was overall survival (OS). Efficacy analyses were performed in the intention-to-treat population and safety analyses in the treated population. Results A total of 360 patients were randomly assigned (RE, 182; sorafenib, 178) from 11 countries in the Asia-Pacific region. In the RE and sorafenib groups, 28.6% and 9.0%, respectively, failed to receive assigned therapy without significant cross-over to either group. Median OS was 8.8 and 10.0 months with RE and sorafenib, respectively (hazard ratio, 1.1; 95% CI, 0.9 to 1.4; P = .36). A total of 1,468 treatment-emergent adverse events (AEs) were reported (RE, 437; sorafenib, 1,031). Significantly fewer patients in the RE than sorafenib group had grade ≥ 3 AEs (36 of 130 [27.7%]) v 82 of 162 [50.6%]; P < .001). The most common grade ≥ 3 AEs were ascites (five of 130 [3.8%] v four of 162 [2.5%] patients), abdominal pain (three [2.3%] v two [1.2%] patients), anemia (zero v four [2.5%] patients), and radiation hepatitis (two [1.5%] v zero [0%] patients). Fewer patients in the RE group (27 of 130 [20.8%]) than in the sorafenib group (57 of 162 [35.2%]) had serious AEs. Conclusion In patients with locally advanced HCC, OS did not differ significantly between RE and sorafenib. The improved toxicity profile of RE may inform treatment choice in selected patients.
An anti-cancer agent containing benzene-poly-carboxylic acids complex with cis-diammineplatinum (II) dichloride (BP-C1) was developed to establish a low toxic and cost effective treatment of breast cancer. The study was aimed to investigate if BP-C1 could be given continuously without rest periods and to estimate Maximum Tolerated (MTD) and Minimum Efficient Dose (MED) in metastatic breast cancer (MBC) treatment. A non-randomized, multicentre trial with 3-level Response Surface Pathway design was performed. Five MBC patients were included at each of the three design levels. BP-C1 was daily administrated intramuscularly during 32 days. The first five patients were given a cumulative dose of 0.64 mg/kg bodyweight. Based on the obtained results, the dose was increased /decreased for the next five patients in the next design level. The main variable was the National Cancer Institute Common Toxicity Criteria (NCI-CTC). Cumulative doses of 0.96 mg/kg or higher were defined as high-dose. One moderate and one mild increase in maximum NCI-CTC were found on 0.64 mg/kg, one mild increase occurred on 0.96 mg/kg and no changes were detected on 1.12 mg/kg. The Sum NCI-CTC increased (p=0.07) in the low-dose group, but reduced (p=0.09) in the high-dose group. In the high-dose group, 62.5% of the patients were classified as responders including one complete responder compared to 28.6% in the low-dose group. In conclusion, BP-C1 can safely be administrated continuously during 32 days. The MTD is larger than 1.12 mg/kg and MED estimated to 0.96 mg/kg.
Specific mutations in BRCA1 and BRCA2 genes have been identified in specific populations and ethnic groups. However, little is known about the contribution of BRCA1 and BRCA2 mutations to breast cancers in the Indonesian population. One hundredtwenty moderate to high risk breast cancer patients were tested using PCR-DGGE, and any aberrant band was sequenced. Multiplex ligation-dependent probe amplification (MLPA) was performed on all samples to detect large deletions in the two genes. Twenty-three different mutations were detected in 30 individuals, ten were deleterious mutations and 20 were ''unclassified variants'' with uncertain clinical consequences. Three of seven (c.2784_2875insT, p.Leu1415X and del exon 13-15) and two of four (p.Glu2183X and p.Gln2894X) deleterious mutations that were found in BRCA1 and BRCA2 respectively, are novel. Several novel, pathogenic BRCA1 and BRCA2 germline mutations are found in early onset Indonesian breast cancer patients, these may therefore be specific for the Indonesian population.
Salah satu pemeriksaan dini untuk mengetahui kanker payudara adalah dengan sadari (periksa payudara sendiri). Dengan melakukan sadari, pasien akan dapat mengetahui jika terdapat benjolan atau sesuatu yang tidak normal. Sadari dapat di lakukan sendiri setelah selesai mandi dengan berdiri di depan cermin.Penelitian di lakukan di 2 rumah sakit di kota Denpasar untuk mendapatkan deskripsi mengenai pengetahuan pasien kanker payudara tentang sadari. Hasil yang di dapatkan dari 30 sampel kanker payudara adalah 4 pasien (13,3%) kanker payudara tahu tentang sadari. Kemudian dari 4 pasien kanker payudara yang tahu tentang sadari, 2 pasien (50%) pernah melakukan sadari. Sisa sampel yang berjumlah 26 pasien (86,7%) tidak tahu tentang sadari. Informasi tentang sadari di sendiri dapat dari keluarga atau teman yang pernah mengidap kanker payudara. Pasien-pasien yang mendapatkan kelainan dari pemeriksaan sadari biasanya tidak langsung datang kerumah sakit, melainkan di biarkan sehingga datang dalam keadaan yang buruk. Kata Kunci : sadari, kanker, payudara Knowledge about SADARI in Breast Cancer (Ca Mammae)Patient in Sanglah Hospital ABSTRACT One of theearly inspectionto determinebreastcanceris sadari (periksa payudara sendiri). By doing sadari,patients will beable to knowifthere is alumporsomething that isabnormal. Sadarican be donealoneafter showerby standing infront of the mirror. Researchconducted in2 hospitalsin Denpasartogeta description of thepatient's knowledgeaboutbreastcancer.Resultsin gettingfrom 30breast cancer sampleswere4 patients(13.3%) breast cancer knowaboutsadari. Thenfrom 4breastcancerpatientsknowaboutsadari, 2 patients(50%) didsadari.The remainingsample of26 patients(86.7%) did not know aboutsadari. They got information aboutsadarifromfamily orfriends who'vehad breast cancer. Patientswho foundabnormalities from the examinationare usually notcameto the hospital, butthey didn't care about it,socomein a bad state.
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