Fermé Christophe, Eghbali Houchingue, Meerwaldt Jacobus H, Rieux Chantal, Bosq Jacques, Berger Françoise, Girinsky Théodore, Brice Pauline, van't Veer Mars B, Walewski Jan A, Lederlin Pierre, Tirelli Umberto, Carde Patrice, Van den Neste Eric, Gyan Emmanuel, Monconduit Mathieu, Diviné Marine, Raemaekers John M M, Salles Gilles, Noordijk Evert M, Creemers Geert-Jan, Gabarre Jean, Hagenbeek Anton, Reman Oumédaly, Blanc Michel, Thomas José, Vié Brigitte, Kluin-Nelemans Johanna C, Viseu Fernando, Baars Joke W, Poortmans Philip, Lugtenburg Pieternella J, Carrie Christian, Jaubert Jérôme, Henry-Amar Michel
Department of Medicine, Institut de Cancérologie Gustave Roussy, Villejuif, France.
N Engl J Med. 2007 Nov 8;357(19):1916-27. doi: 10.1056/NEJMoa064601.
Treatment of early-stage Hodgkin's disease is usually tailored in line with prognostic factors that allow for reductions in the amount of chemotherapy and extent of radiotherapy required for a possible cure.
From 1993 to 1999, we identified 1538 patients (age, 15 to 70 years) who had untreated stage I or II supradiaphragmatic Hodgkin's disease with favorable prognostic features (the H8-F trial) or unfavorable features (the H8-U trial). In the H8-F trial, we compared three cycles of mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) combined with doxorubicin, bleomycin, and vinblastine (ABV) plus involved-field radiotherapy with subtotal nodal radiotherapy alone (reference group). In the H8-U trial, we compared three regimens: six cycles of MOPP-ABV plus involved-field radiotherapy (reference group), four cycles of MOPP-ABV plus involved-field radiotherapy, and four cycles of MOPP-ABV plus subtotal nodal radiotherapy.
The median follow-up was 92 months. In the H8-F trial, the estimated 5-year event-free survival rate was significantly higher after three cycles of MOPP-ABV plus involved-field radiotherapy than after subtotal nodal radiotherapy alone (98% vs. 74%, P<0.001). The 10-year overall survival estimates were 97% and 92%, respectively (P=0.001). In the H8-U trial, the estimated 5-year event-free survival rates were similar in the three treatment groups: 84% after six cycles of MOPP-ABV plus involved-field radiotherapy, 88% after four cycles of MOPP-ABV plus involved-field radiotherapy, and 87% after four cycles of MOPP-ABV plus subtotal nodal radiotherapy. The 10-year overall survival estimates were 88%, 85%, and 84%, respectively.
Chemotherapy plus involved-field radiotherapy should be the standard treatment for Hodgkin's disease with favorable prognostic features. In patients with unfavorable features, four courses of chemotherapy plus involved-field radiotherapy should be the standard treatment. (ClinicalTrials.gov number, NCT00379041 [ClinicalTrials.gov].).
早期霍奇金淋巴瘤的治疗通常根据预后因素进行调整,以便减少可能治愈所需的化疗剂量和放疗范围。
1993年至1999年,我们确定了1538例年龄在15至70岁之间、未经治疗的具有良好预后特征(H8-F试验)或不良预后特征(H8-U试验)的I期或II期膈上霍奇金淋巴瘤患者。在H8-F试验中,我们比较了三个周期的氮芥、长春新碱、丙卡巴肼和泼尼松(MOPP)联合多柔比星、博来霉素和长春花碱(ABV)加受累野放疗与单纯次全淋巴结放疗(参照组)。在H8-U试验中,我们比较了三种方案:六个周期的MOPP-ABV加受累野放疗(参照组)、四个周期的MOPP-ABV加受累野放疗以及四个周期的MOPP-ABV加次全淋巴结放疗。
中位随访时间为92个月。在H8-F试验中,三个周期的MOPP-ABV加受累野放疗后的估计5年无事件生存率显著高于单纯次全淋巴结放疗(98%对74%,P<0.001)。10年总生存率估计分别为97%和92%(P=0.001)。在H8-U试验中,三个治疗组的估计5年无事件生存率相似:六个周期的MOPP-ABV加受累野放疗后为84%,四个周期的MOPP-ABV加受累野放疗后为88%,四个周期的MOPP-ABV加次全淋巴结放疗后为87%。10年总生存率估计分别为88%、85%和84%。
化疗加受累野放疗应作为具有良好预后特征的霍奇金淋巴瘤的标准治疗方法。对于具有不良预后特征的患者,四个疗程的化疗加受累野放疗应作为标准治疗方法。(ClinicalTrials.gov编号,NCT00379041 [ClinicalTrials.gov]。)