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Gemcitabine Plus Carboplatin in Patients with Advanced Hepatocellular Carcinoma: Results of a Phase II Study.

Azmy AM, Nasr KE, Gobran NS, Yassin M - ISRN Oncol (2012)

Bottom Line: Results.Conclusion.The gemcitabine/carboplatin regimen seems to be effective, well tolerated, and active in advanced HCC.

View Article: PubMed Central - PubMed

Affiliation: Clinical Oncology Departement, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

ABSTRACT
Objectives. Assessment of gemcitabine/carboplatin combination in patients with advanced-stage hepatocellular carcinoma (HCC) in a phase II trial for safety and efficacy. Methods. Forty patients with previously untreated advanced-stage HCC were prospectively enrolled and subjected to gemcitabine/carboplatin regimen which consisted of gemcitabine 1000 mg/m(2) on days 1 and 8, and carboplatin AUC 6 on day 1. The treatment was repeated every 3 weeks until disease progression or limiting toxicity. Results. Forty patients were assessable for efficacy and toxicity. In all, 276 treatment cycles were administered. No toxic deaths occurred. Hematological grade 3-4 toxicity consisted of thrombocytopenia (27% of patients) and neutropenia (24%), including 2 febrile neutropenia and anemia (9%). Grade 3 carboplatin-induced neurotoxicity was observed in 3 (9%) patients. ORR was 23% (95% CI, 0.10-0.29) with 9 partial responses and disease stabilization was observed in 46% (95% CI, 0.22-0.42) of patients, giving a disease control rate of 69%. Median progression-free and overall survival times were, respectively, 5 months (95% CI: 3-8 months) and 8 months (95% CI: 6-18 months). Conclusion. The gemcitabine/carboplatin regimen seems to be effective, well tolerated, and active in advanced HCC.

No MeSH data available.


Related in: MedlinePlus

Overall survival (OS) (solid line) in the intent-to-treat population (n = 40).
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fig2: Overall survival (OS) (solid line) in the intent-to-treat population (n = 40).

Mentions: ORR was 23% (95% CI, 0.10–0.29); pattern of response is shown in Table 2. The responses lasted from 3 to 12 months. Stable disease was observed in 46% (95% CI, 0.22–0.42) of patients, in assessable patients who had at least 1 postbaseline tumor assessment (n = 40) the disease control rate was 69% (PR, 23% and SD, 46%). In the ITT population, the median PFS was 5 months (95% CI, 3–8 months) (Figure 1), and the median OS was 8 months (95% CI, 6–18 months) (Figure 2). The 1-year survival rate was 35.4%. The AFP level fell by >50% during therapy in 12 (38%) of the 31 patients with elevated AFP levels at baseline (>400 ng/mL), of which 5 patients had partial response and 7 patients had SD.


Gemcitabine Plus Carboplatin in Patients with Advanced Hepatocellular Carcinoma: Results of a Phase II Study.

Azmy AM, Nasr KE, Gobran NS, Yassin M - ISRN Oncol (2012)

Overall survival (OS) (solid line) in the intent-to-treat population (n = 40).
© Copyright Policy - open-access
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3405685&req=5

fig2: Overall survival (OS) (solid line) in the intent-to-treat population (n = 40).
Mentions: ORR was 23% (95% CI, 0.10–0.29); pattern of response is shown in Table 2. The responses lasted from 3 to 12 months. Stable disease was observed in 46% (95% CI, 0.22–0.42) of patients, in assessable patients who had at least 1 postbaseline tumor assessment (n = 40) the disease control rate was 69% (PR, 23% and SD, 46%). In the ITT population, the median PFS was 5 months (95% CI, 3–8 months) (Figure 1), and the median OS was 8 months (95% CI, 6–18 months) (Figure 2). The 1-year survival rate was 35.4%. The AFP level fell by >50% during therapy in 12 (38%) of the 31 patients with elevated AFP levels at baseline (>400 ng/mL), of which 5 patients had partial response and 7 patients had SD.

Bottom Line: Results.Conclusion.The gemcitabine/carboplatin regimen seems to be effective, well tolerated, and active in advanced HCC.

View Article: PubMed Central - PubMed

Affiliation: Clinical Oncology Departement, Faculty of Medicine, Ain Shams University, Cairo, Egypt.

ABSTRACT
Objectives. Assessment of gemcitabine/carboplatin combination in patients with advanced-stage hepatocellular carcinoma (HCC) in a phase II trial for safety and efficacy. Methods. Forty patients with previously untreated advanced-stage HCC were prospectively enrolled and subjected to gemcitabine/carboplatin regimen which consisted of gemcitabine 1000 mg/m(2) on days 1 and 8, and carboplatin AUC 6 on day 1. The treatment was repeated every 3 weeks until disease progression or limiting toxicity. Results. Forty patients were assessable for efficacy and toxicity. In all, 276 treatment cycles were administered. No toxic deaths occurred. Hematological grade 3-4 toxicity consisted of thrombocytopenia (27% of patients) and neutropenia (24%), including 2 febrile neutropenia and anemia (9%). Grade 3 carboplatin-induced neurotoxicity was observed in 3 (9%) patients. ORR was 23% (95% CI, 0.10-0.29) with 9 partial responses and disease stabilization was observed in 46% (95% CI, 0.22-0.42) of patients, giving a disease control rate of 69%. Median progression-free and overall survival times were, respectively, 5 months (95% CI: 3-8 months) and 8 months (95% CI: 6-18 months). Conclusion. The gemcitabine/carboplatin regimen seems to be effective, well tolerated, and active in advanced HCC.

No MeSH data available.


Related in: MedlinePlus