A Randomized Controlled Study Comparing the Impact of Prophylactic Versus Deferred Lamivudine on the Delivery of Cytotoxic Chemotherapy in Hepatitis B Surface-antigen Positive Patients With Malignant Solid Tumor
Inclusion Criteria:
1. Patient with histology-proven malignant solid tumor other than malignant lymphoma
2. Patients with age between 18 and 75
3. Patients with Karnofsky performance score (KPS) of at least 60
4. Patients planned for at least 4 cycles of intensive cytotoxic chemotherapy (either as
part of curative therapy or as palliative therapy), except for those receiving single
agent cisplatin chemotherapy alone concurrently with radiation for radiosensitization
5. Patients with at least 6 months' life expectany from date of recruitment
6. Patients with normal liver function tests including alanine aminpotransferase (ALT),
alkaline phosphatase (ALP), gamma glutamyl-transpeptidase (GGT), and bilirubin
7. Patients with no known history of radiological &/or histological diagnosis of chronic
active hepatitis or cirrhosis of any cuase, or history of prior hepatitis B
reactivation, or prior chronic therapy for HBV within 6 months
8. Patients with no evidence of autoimmune hepatitis, hepatitis C or delta virus
infection, HIV infection or radiological evidence of liver metastasis
9. Patients with negative pregnancy test for female gender of child-bearing age
Exclusion Criteria:
1. Patients with age < 18 and > 75
2. Patients with Karnofsky performance score (KPS) of < 60
3. Patients planned for single agent cisplatin chemotherapy alone concurrently with
radiation for radiosensitization
4. Patients with < 6 months' life expectancy from date of recruitment
5. Patients with abnormal liver function tests including alanine aminotransferase (ALT),
alkaline phosphatase (ALP), gamma glutamyl- transpeptidase (GGT), and bilirubin
6. Patients with known history or radiological and/or histological diagnosis of chronic
active hepatitis or cirrhosis of any cause, or history of prior hepatitis B
reactivation, or prior chronic therapy for HBV within 6 months
7. Patients with autoimmune hepatitis, hepatitis C or delta virus infection, HIV
infection or radiological evidence of liver metastasis
8. pregnant female patients