| RicKinianenub | Дата: Среда, 04.12.2013, 14:08 | Сообщение # 1 |
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A total of 1538 patients between the ages of 15 and 70 years were enrolled in the trial. All had untreated clinical stage I or II supradiaphragmatic Hodgkin's disease and were being treated at any of 91 centers in Belgium, France, Italy, the Netherlands, Poland, Portugal, Slovenia, and Spain. Of the total patient population, 542 (35%) were categorized as having a favorable prognostic factors and 996 (65%) were categorized as having an unfavorable prognostic factors. Patients in the favourable prognosic factor arm were randomly assigned to receive either subtotal nodal radiotherapy or combination therapy consisting of three cycles of chemotherapy plus involved-field radiotherapy. Patients in the unfavourable prognostic factor arm were randomly assigned to one of three regimens: six or four cycles of chemotherapy plus involved-field radiotherapy or four cycles of drugs plus subtotal nodal radiotherapy.
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The chemotherapy regimen used for all the groups was mechlorethamine, vincristine, procarbazine, and prednisone in combination with doxorubicin, bleomycin, and vinblastine. Taking event-free survival as a primary endpoint, the researchers found that, in the group with favourable prognostic features, response rates to the two treatment regimens were similar. However, among the 446 patients from both groups who had a complete remission there was a significant different in rates between the combination group and the radiotherapy alone group: five had a relapse after combination therapy and 61 after subtotal nodal radiotherapy. This equated to a difference in the estimated 5-year event-free survival rate of 24%, favouring the combination-therapy group. For patients with unfavourable prognostic factors, complete-remission rates were 83% in the group receiving six cycles of chemotherapy plus involved-field radiotherapy, 85% in the group receiving four cycles plus involved-field radiotherapy, and 86% in the group receiving four cycles plus subtotal nodal radiotherapy. However, there were no significant differences in the 5-year event-free survival estimates or in estimated overall survival. The researchers conclude from their findings that four courses of a doxorubicin-containing regimen and involved-field radiotherapy should be the standard treatment for this tumour type. Furthermore, they note, in patients with risk factors, four cycles of a doxorubicin-containing regimen are as effective as six cycles and involved-field radiotherapy yields a disease-control rate similar to that with subtotal nodal radiotherapy. Our study showed that a combination of chemotherapy and radiotherapy should now be considered the standard treatment for all patients with localized stage supradiaphragmatic Hodgkin's disease and that subtotal nodal radiotherapy alone can no longer be recommended, summarise the authors.
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