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Objective:To evaluate the efficacy and safety of quadruple therapy involving radiotherapy (RT), lenvatinib, anti-PD-1 antibody and GEMOX (oxaliplatin and gemcitabine) chemotherapy (quadruple therapy) in treatment cohort of patients with unresectable intrahepatic cholangiocarcinoma (ICC).Methods:The patients with recurrent, metastatic, or unresectable ICC underwent quadruple therapy at Zhongshan Hospital, Fudan University between September 2018 and May 2022 were selected. The data about efficacy and safety of quadruple therapy were collected in the hospital electronic medical record system. All patients were followed up regularly to obtain the long-term prognostic data until December 31, 2022. The efficacy, prognosis, and toxicity data were collected and analyzed.Results:A total of 41 patients were included in the analysis. After a median follow-up period of 15 months, disease progression was diagnosed in 36 patients (18 patients died), while 3 patients were lost to follow-up. The causes of death included liver failure induced by intrahepatic tumor progression ( n=6), distant metastases (lungs or brain, n=6), abdominal lymph node metastases ( n=3), cancer cachexia ( n=2), and unknown cause ( n=1). The median progression-free survival (PFS) was 11 months (95% CI: 9.2-12.8), and the median overall survival (OS) was 35 months (95% CI: 17.0-52.0). All patients experienced treatment-related adverse events (AEs) during the study treatment period. Of the 41 patients, 13 patients experienced at least once grade 3 or worse treatment-related AE, but all were manageable with symptomatic treatment. No treatment-related deaths were reported during the follow-up period. Conclusions:Radiotherapy (RT), lenvatinib, anti-PD-1 antibody and GEMOX in the treatment of unresectable ICC shows significant efficacy and good safety, which is worthy of clinical application.
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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.
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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.
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Objective To study the efficacy, safety and tolerance of the therapeutic schedule of GemOx±R regimen suitable for elderly patients with B-cell lymphoma. Methods 11 elderly patients with B-cell lymphoma were enrolled in this study, which were diagnosed by biopsy. All the patients were treated according the GemOx ± R therapeutic schedule as described: rituximab (375 mg/m2 on day 0),gemcitabine (1000 mg/m2 on day 1),oxaliplatin (100 mg/m2 on day 1).Treatment response,therapy related toxic and sideeffect were assessed after inductive and consolidated treatment. Results The median age of 11 patients were 72.18 years(range 55-83 years).The overall response rate(ORR) after inductive treatment was 90 ％(9/10).The ORR of 4 DLBCL patients using GemOx+R as initial treatment was 100 ％. GemOx regimen were used for 4 refractory/relapse patients,and 3/4 patients got PR after inductive treatment.No patient got dose adjustment.The hematological toxicity was controllable and nobody got renal function impairment. Conclusions The GemOx ± R regimen is feasible,tolerable,effective for elderly patients with B-cell lymphoma.