title: Influence of the sorafenib patients assistance program on treatment compliance and overall survival  of unresectable hepatocellular carcinoma patients.
abstract: OBJECTIVE
  to evaluate treatment compliance and survival of patients receiving oral sorafenib in Indonesia.
  
  
  METHODS
  a prospective cohort trial. Unresectable Hepatocelullar carcinoma patients receiving Sorafenib in NexPAP program were recruited between October 2008 and September 2011. A historical cohort from Cipto Mangunkusumo Hospital, between 1998 and 2000 was selected to serve as control group. Patients in the control group received symptomatic treatment. Survival analysis was done by the Kaplan-Meier survival curve analysis and the log-rank test. Median survival difference between the NexPAP and control group was tested using the Cox-regression hazard analysis.
  
  
  RESULTS
  There were 48 patients in the NexPAP group and 40 patients in the control group. Treatment compliance was very good; no patient with drew from the study. Sorafenib generally could be tolerated by the patients. The most common adverse events are mild or moderate hand and foot skin reaction and diarrhea. The median survival was 49 weeks in NexPAP group (95% CI 37.9-60.1) vs. 20 weeks in the control group (95% CI 9.0-31.0). Cox-regression analysis showed that sorafenib significantly prolonged overall survival with a hazard ratio (HR) of 0.339 (95% CI: 0.196-0.584). There was no survival difference between patients with Child-Pugh class A and class B in both NexPAP (median 49 vs. 52 weeks; HR 1.1; 95% CI 0.5-2.3; p=0.855) and control groups (27 vs. 20 weeks; HR 1.1; 95% CI 0.5-2.4; p=0.822).
  
  
  CONCLUSIONS
  Sorafenib patient assistant program in unresectable hepatocellular carcinoma ensured compliance treatment and significantly prolonged overall survival over the historical cohort receiving palliative treatment.
authors.affiliation: Department of Internal Medicine, Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital, Jakarta Pusat, Indonesia. llesmana.id@gmail.com
authors.forename: Laurentius A
authors.initials: LA
authors.lastname: Lesmana
authors.forename: Rino A
authors.initials: RA
authors.lastname: Gani
authors.forename: Irsan
authors.initials: I
authors.lastname: Hasan
authors.forename: Agus
authors.initials: A
authors.lastname: Waspodo
authors.forename: Poernomo
authors.initials: P
authors.lastname: Boedi
authors.forename: Melissa S
authors.initials: MS
authors.lastname: Luwia
authors.forename: Adityawati
authors.initials: A
authors.lastname: Ganggaiswari
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D005260:Female; D005378:Financial Support; D006801:Humans; D007214:Indonesia; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D015397:Program Evaluation; D016016:Proportional Hazards Models; D011446:Prospective Studies; D000077157:Sorafenib; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib