REAL WORLD EXPERIENCE OF SUNITINIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA; RESULTS FROM COMPASSIONATE USE PROGRAM IN MALAYSIA
Author(s)
Lee YY1, Lim TO2, Hong LW1
1Pfizer Malaysia, Kuala Lumpur, Malaysia, 2StatsConsulting, Petaling Jaya, Malaysia
OBJECTIVES: Sunitinib is an oral targeted small molecule inhibitor of vascular endothelial growth factor receptors indicated for treatment of advanced renal cell carcinoma (RCC). Robust data on efficacy and effectiveness for Sunitinib from global clinical trials and real world studies are available. However, local real world experience is rare. METHODS: A global access program (SPAP) was commenced to provide sunitinib treatment on the basis of compassionate use to patients with advanced RCC. Program recruitment was done between 2008 and 2012. Sunitinib was administered in repeated 6-week cycles (4 weeks on and 2 weeks off) until occurrence of disease progression or unacceptable toxicity. All patient vital status was matched against the national death registration database on January 2016 using unique national identification number. Survival analysis was performed. RESULTS: A total of 196 patients were enrolled from both private and government hospitals. Patient with incomplete date of diagnosis and national identifier were excluded. Forty one (41%) of the cohort was aged 60 years and below. 31% of the patients were female and over half of the patients were of Chinese ethnicity (68%). One third of patients underwent radiotherapy and 22% had chemotherapy. At baseline, 73%, 70% and 69% reported inadequate liver, renal and thyroid function, respectively. We found SPAP patients had greater overall median survival compare to the trial results, a difference of 6 months. This preliminary finding warrant further verification. CONCLUSIONS: Malaysia sunitinib overall survival data corresponds to clinical trial data. This implied that benefit of sunitinib extends beyond stringent criteria of clinical trial setting.
Conference/Value in Health Info
2016-09, ISPOR Asia Pacific 2016, Singapore
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PCN10
Topic
Clinical Outcomes
Topic Subcategory
Relating Intermediate to Long-term Outcomes
Disease
Oncology