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Clinical outcomes of patients with advanced hepatocellular carcinoma treated with sorafenib: a retrospective study of routine clinical practice in multi-institutions.

Lee SH, Song IH, Noh R, Kang HY, Kim SB, Ko SY, Lee ES, Kim SH, Lee BS, Kim AN, Chae HB, Kim HS, Lee TH, Kang YW, Lee JD, Lee HY - BMC Cancer (2015)

Bottom Line: Overall median survival, but not the median time to progression, was significantly shorter for patients with Child-Pugh B cirrhosis compared with those with Child-Pugh A cirrhosis (64 days vs 168 days, P = 0.004).Child-Pugh B cirrhosis (P = 0.024) and a high level of serum alpha-fetoprotein (P = 0.039) were independent risk factors for poor overall survival.Thirty-nine (34%) patients experienced grade 3/4 adverse events such as hand-foot skin reactions and diarrhea that required dose adjustment.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Republic of Korea. stevesh@sch.ac.kr.

ABSTRACT

Background: Sorafenib is an orally administered multikinase inhibitor with antiangiogenic and antiproliferative properties. The results of large clinical trials demonstrate that sorafenib prolongs survival and the time to progression of patients with advanced hepatocellular carcinoma (HCC). The aim of the present study was to determine the outcomes of such patients who were routinely treated with sorafenib at multi-institutions in Korea, in contrast to formal clinical trials.

Methods: Between August 2007 and March 2012, patients with advanced HCC in seven referral medical centers in Daejeon-Chungcheong Province of Korea were retrospectively enrolled to evaluate treatment response, survival, and tolerability following administration of sorafenib. The treatment response was assessed in accordance with the Response Evaluation Criteria in Solid Tumor 1.1 guidelines.

Results: Among 116 patients, 66 (57%) had undergone treatment for HCC, and 77 (66%) were accompanied with Child-Pugh A cirrhosis. The median duration of sorafenib treatment was 67 days (range 14-452 days). Median overall survival and median time to progression were 141 days and 90 days, respectively. Complete response, partial response, and stable disease were achieved for 0%, 2%, and 29% of patients, respectively. Overall median survival, but not the median time to progression, was significantly shorter for patients with Child-Pugh B cirrhosis compared with those with Child-Pugh A cirrhosis (64 days vs 168 days, P = 0.004). Child-Pugh B cirrhosis (P = 0.024) and a high level of serum alpha-fetoprotein (P = 0.039) were independent risk factors for poor overall survival. Thirty-nine (34%) patients experienced grade 3/4 adverse events such as hand-foot skin reactions and diarrhea that required dose adjustment.

Conclusions: The clinical outcomes of sorafenib-treated patients with advanced HCC were comparable to those reported by formal clinical trial conducted in the Asia-Pacific region. Underlying hepatic dysfunction was the most important risk factor for shorter survival.

No MeSH data available.


Related in: MedlinePlus

Probability of overall survival (A) and the time to progression (B) according to Child-Pugh classification of cirrhosis. The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of the HCC patients with Child-Pugh B cirrhosis (186 days vs 64 days, P = 0.004), although the median time to tumor progression did not differ between the two groups (104 days vs 63 days, P = 0.154).
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Fig2: Probability of overall survival (A) and the time to progression (B) according to Child-Pugh classification of cirrhosis. The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of the HCC patients with Child-Pugh B cirrhosis (186 days vs 64 days, P = 0.004), although the median time to tumor progression did not differ between the two groups (104 days vs 63 days, P = 0.154).

Mentions: Eighty-three (72%) patients died by the end of the follow-up period. Median overall survival was 141 (14–1581) days, and survival rates at 6, 12, and 18 months were 47%, 21%, and 11%, respectively (Figure 1A). The median follow-up period was 118 (28–1,581) days for 94 patients treated with sorafenib for at least 4 weeks who were administered a follow-up radiological evaluation and were available for assessment of their radiological response. The radiological responses of these patients were as follows (Table 3): 0 with a complete response; 2 (2%) with a partial response; 28 (29%) with stable disease; and 64 (69%) with progressive disease. The disease control rate was 21.9%. The median time to radiological progression of 64 patients with progressive disease was 90 (28–1,574) days (Figure 1B). The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of HCC patients with Child-Pugh B cirrhosis (186 vs 64 days, P = 0.004) (Figure 2A), although the median time to tumor progression did not differ between the groups (104 vs 63 days, P = 0.154) (Figure 2B).Figure 1


Clinical outcomes of patients with advanced hepatocellular carcinoma treated with sorafenib: a retrospective study of routine clinical practice in multi-institutions.

Lee SH, Song IH, Noh R, Kang HY, Kim SB, Ko SY, Lee ES, Kim SH, Lee BS, Kim AN, Chae HB, Kim HS, Lee TH, Kang YW, Lee JD, Lee HY - BMC Cancer (2015)

Probability of overall survival (A) and the time to progression (B) according to Child-Pugh classification of cirrhosis. The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of the HCC patients with Child-Pugh B cirrhosis (186 days vs 64 days, P = 0.004), although the median time to tumor progression did not differ between the two groups (104 days vs 63 days, P = 0.154).
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4403976&req=5

Fig2: Probability of overall survival (A) and the time to progression (B) according to Child-Pugh classification of cirrhosis. The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of the HCC patients with Child-Pugh B cirrhosis (186 days vs 64 days, P = 0.004), although the median time to tumor progression did not differ between the two groups (104 days vs 63 days, P = 0.154).
Mentions: Eighty-three (72%) patients died by the end of the follow-up period. Median overall survival was 141 (14–1581) days, and survival rates at 6, 12, and 18 months were 47%, 21%, and 11%, respectively (Figure 1A). The median follow-up period was 118 (28–1,581) days for 94 patients treated with sorafenib for at least 4 weeks who were administered a follow-up radiological evaluation and were available for assessment of their radiological response. The radiological responses of these patients were as follows (Table 3): 0 with a complete response; 2 (2%) with a partial response; 28 (29%) with stable disease; and 64 (69%) with progressive disease. The disease control rate was 21.9%. The median time to radiological progression of 64 patients with progressive disease was 90 (28–1,574) days (Figure 1B). The median overall survival of the HCC patients with Child-Pugh A cirrhosis was significantly longer compared with that of HCC patients with Child-Pugh B cirrhosis (186 vs 64 days, P = 0.004) (Figure 2A), although the median time to tumor progression did not differ between the groups (104 vs 63 days, P = 0.154) (Figure 2B).Figure 1

Bottom Line: Overall median survival, but not the median time to progression, was significantly shorter for patients with Child-Pugh B cirrhosis compared with those with Child-Pugh A cirrhosis (64 days vs 168 days, P = 0.004).Child-Pugh B cirrhosis (P = 0.024) and a high level of serum alpha-fetoprotein (P = 0.039) were independent risk factors for poor overall survival.Thirty-nine (34%) patients experienced grade 3/4 adverse events such as hand-foot skin reactions and diarrhea that required dose adjustment.

View Article: PubMed Central - PubMed

Affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan, Republic of Korea. stevesh@sch.ac.kr.

ABSTRACT

Background: Sorafenib is an orally administered multikinase inhibitor with antiangiogenic and antiproliferative properties. The results of large clinical trials demonstrate that sorafenib prolongs survival and the time to progression of patients with advanced hepatocellular carcinoma (HCC). The aim of the present study was to determine the outcomes of such patients who were routinely treated with sorafenib at multi-institutions in Korea, in contrast to formal clinical trials.

Methods: Between August 2007 and March 2012, patients with advanced HCC in seven referral medical centers in Daejeon-Chungcheong Province of Korea were retrospectively enrolled to evaluate treatment response, survival, and tolerability following administration of sorafenib. The treatment response was assessed in accordance with the Response Evaluation Criteria in Solid Tumor 1.1 guidelines.

Results: Among 116 patients, 66 (57%) had undergone treatment for HCC, and 77 (66%) were accompanied with Child-Pugh A cirrhosis. The median duration of sorafenib treatment was 67 days (range 14-452 days). Median overall survival and median time to progression were 141 days and 90 days, respectively. Complete response, partial response, and stable disease were achieved for 0%, 2%, and 29% of patients, respectively. Overall median survival, but not the median time to progression, was significantly shorter for patients with Child-Pugh B cirrhosis compared with those with Child-Pugh A cirrhosis (64 days vs 168 days, P = 0.004). Child-Pugh B cirrhosis (P = 0.024) and a high level of serum alpha-fetoprotein (P = 0.039) were independent risk factors for poor overall survival. Thirty-nine (34%) patients experienced grade 3/4 adverse events such as hand-foot skin reactions and diarrhea that required dose adjustment.

Conclusions: The clinical outcomes of sorafenib-treated patients with advanced HCC were comparable to those reported by formal clinical trial conducted in the Asia-Pacific region. Underlying hepatic dysfunction was the most important risk factor for shorter survival.

No MeSH data available.


Related in: MedlinePlus