RESUMEN
Background: Biliary tract carcinoma is highly fatal and one of the commonest cancers in Bangladesh. Chemotherapy is the mainstay of treatment as it is present in an advanced stage. Gemcitabine-Cisplatin association has been a standard of care for first-line regimens in advanced biliary tract cancer. Nevertheless, the Gemcitabine-Oxaliplatin regimen is frequently preferred. There has been no nationwide study to compare the effectiveness of these two platinum groups. Therefore, this study compared the efficacy and toxicities of Gemcitabine-Cisplatin (Gem-Cis) with Gemcitabine-Oxaliplatin (GEMOX) combination chemotherapy for the treatment of ABTC.Material & Methods:In this quasi-experimental study, a total number of eighty patients (40 patients in arm A and 40 patients in arm B), who had histopathologically or cytopathological proven ABTC with no history of previous treatment were included. The study has done between the periods of January 2019 to June 2020. The patients received Gemcitabine (1000 mg/m2 i.v. on day 1 and day 8) plus Cisplatin (25 mg/m2 i.v. on day 1 and 8) every 3 weeks for 6 cycles in Arm A. In another group, Gemcitabine (1000 mg/m2 i.v. on day 1) plus Oxaliplatin (100 mg/m2 i.v. on day 2) every 2 weeks for 6 cycles in Arm B was given. All the patients were followed up according to the set follow-up criteria up to 6 weeks after completion of treatment.Results:At the end of the treatment, Response rates (CR+PR+SD) were analyzed. No patient from both the arms showed Complete Response (CR). 37.5% and 45% of patients of the Arm A and Arm B groups showed Partial Response (PR) respectively. Meanwhile, 45% and 40% of patients from Arm A and B showed Stable Disease (SD) respectively. P-value was 0.410 (>0.05). Seven patients (17%) in Arm A and six patients (15%) in Arm B developed Progressive disease (PD). The most common treatment-related grade 3 toxicities were more experienced in the Arm A group. For Arm A versus Arm B that were as follows: neutropenia (15% versus 5%), anemia (15% versus 8%), thrombocytopenia (10% versus 2.5%), nausea (10% versus 5%), vomiting (5%versus 2.5%), peripheral neuropathy (0% versus 15%) and renal toxicity (7.5% versus 0%). For none of them, the p-value was <0.05 except for neutropenia, anemia, thrombocytopenia, renal toxicity, and peripheral neuropathy in which the p-value was 0.042, 0.001, 0.014, 0.0001, and 0.00001 respectively. For both Arms, there were no treatment-related Grade 4 toxicities.Conclusion:The study exhibited that treatment with the Gemcitabine-Oxaliplatin regimen was well tolerated, less toxic, and convenient with similar effectiveness compared to the Gemcitabine-Cisplatin regimen in loco regional control of advanced biliary tract cancer.
RESUMEN
Background: Biliary tract carcinoma is highly fatal and one of the commonest cancers in Bangladesh. Chemotherapy is the mainstay of treatment as it is present in an advanced stage. Gemcitabine-Cisplatin association has been a standard of care for first-line regimens in advanced biliary tract cancer. Nevertheless, the Gemcitabine-Oxaliplatin regimen is frequently preferred. There has been no nationwide study to compare the effectiveness of these two platinum groups. Therefore, this study compared the efficacy and toxicities of Gemcitabine-Cisplatin (Gem-Cis) with Gemcitabine-Oxaliplatin (GEMOX) combination chemotherapy for the treatment of ABTC.Material & Methods:In this quasi-experimental study, a total number of eighty patients (40 patients in arm A and 40 patients in arm B), who had histopathologically or cytopathologically proven ABTC with no history of previous treatment were included. The study has done between the periods of January 2019 to June 2020. The patients received Gemcitabine (1000 mg/m2 i.v. on day 1 and day 8) plus Cisplatin (25 mg/m2i.v. on day 1 and 8) every 3 weeks for 6 cycles in Arm A. In another group, Gemcitabine (1000 mg/m2 i.v. on day 1) plus Oxaliplatin (100 mg/m2 i.v. on day 2) every 2 weeks for 6 cycles in Arm B was given. All the patients were followed up according to the set follow-up criteria up to 6 weeks after completion of treatment.Results:At the end of the treatment, Response rates (CR+PR+SD) were analyzed. No patient from both the arms showed Complete Response (CR). 37.5% and 45% of patients of the Arm A and Arm B groups showed Partial Response (PR) respectively. Meanwhile, 45% and 40% of patients from Arm A and B showed Stable Disease (SD) respectively. P-value was 0.410 (>0.05). Seven patients (17%) in Arm A and six patients (15%) in Arm B developed Progressive disease (PD). The most common treatment-related grade 3 toxicities were more experienced in the Arm A group. For Arm A versus Arm B that were as follows: neutropenia (15% versus 5%), anemia (15% versus 8%), thrombocytopenia (10% versus 2.5%), nausea (10% versus 5%), vomiting (5%versus 2.5%), peripheral neuropathy (0% versus 15%) and renal toxicity (7.5% versus 0%). For none of them, the p-value was <0.05 except for neutropenia, anemia, thrombocytopenia, renal toxicity, and peripheral neuropathy in which the p-value was 0.042, 0.001, 0.014, 0.0001, and 0.00001 respectively. For both Arms, there were no treatment-related Grade 4 toxicities.Conclusion:The study exhibited that treatment with Gemcitabine-Oxaliplatin regimen was well tolerated, less toxic, and convenient with similar effectiveness compared to Gemcitabine-Cisplatin regimen in loco regional control of advanced biliary tract cancer.