Kuoppala Tapio, Mäenpää Johanna, Tomas Eija, Puistola Ulla, Salmi Tuula, Grenman Seija, Lehtovirta Pentti, Fors Matti, Luukkaala Tiina, Sipilä Pirkko
Tampere University Hospital, Finland.
Gynecol Oncol. 2008 Aug;110(2):190-5. doi: 10.1016/j.ygyno.2008.03.020. Epub 2008 Jun 4.
Our purpose was to establish whether platinum-based chemotherapy combined with standard surgery and radiotherapy will improve overall and disease-free survival and lower the recurrence rate in patients with high-risk endometrial cancer.
A total of 156 patients with Stage IA-B Grade 3 (n=28), or Stage IC-IIIA Grade 1-3 (n=128) were postoperatively randomized to receive radiotherapy (56 Gy) only (Group A, n=72) or radiotherapy combined with three courses of cisplatin (50 mg/m(2)), epirubicin (60 mg/m(2)) and cyclophosphamide (500 mg/m(2)) (Group B, n=84).
The disease-specific overall five-year survival was in Group A 84.7% vs. 82.1% in Group B (p=0.148). The median disease-free survival in A was 18 (range 9-36) months and 25 (range 12-49) months in B (p=0.134), respectively. During a five-year follow-up 32 patients relapsed. Of the recurrences 5 were local and 20 distant, while 7 were combined. As calculated from the operation, the median time to recurrence was 15 (range 6-37) months in Group A, and 20 (range 8-60) months in Group B, respectively (p=0.170). Twenty-six patients died of the disease during the five-year follow-up, 11 in A and 15 in B. The patients succumbing in A lived a median 23 (range 15-44) months as compared to 37 (range 13-50) months in B (p=0.148). Chemotherapy was associated with an acceptable rate of acute toxicity. Less than 8% of the patients complained of Grade 3/4 nausea. The rate of Grade 3/4 leucopenia was at the highest at 16.6% during the third cycle but only 6.2% of the patients had Grade 3 infection. A total of 10 patients developed intestinal complications demanding surgery, 2 in Group A (2.7%) and 8 (9.5%) in Group B, respectively.
Adjuvant chemotherapy with cisplatin, epirubicin and cyclophosphamide failed to improve overall survival or lower the recurrence rate in patients operated on and radiated for high-risk endometrial carcinoma. Chemotherapy was associated with a low rate of acute toxicity but appeared to increase the risk of bowel complications.
我们的目的是确定铂类化疗联合标准手术及放疗是否能提高高危子宫内膜癌患者的总生存率和无病生存率，并降低复发率。
总共156例IA - B期3级（n = 28）或IC - IIIA期1 - 3级（n = 128）的患者术后被随机分为两组，仅接受放疗（56 Gy）（A组，n = 72）或放疗联合三个疗程的顺铂（50 mg/m²）、表柔比星（60 mg/m²）和环磷酰胺（500 mg/m²）（B组，n = 84）。
A组疾病特异性总五年生存率为84.7%，B组为82.1%（p = 0.148）。A组的无病生存期中位数为18（9 - 36）个月，B组为25（12 - 49）个月（p = 0.134）。在五年随访期间，32例患者复发。复发患者中5例为局部复发，20例为远处复发，7例为联合复发。从手术时算起，A组复发的中位时间为15（6 - 37）个月，B组为20（8 - 60）个月（p = 0.170）。在五年随访期间，26例患者死于该疾病，A组11例，B组15例。A组死亡患者的中位生存时间为23（15 - 44）个月相比之下，B组为37（13 - 50）个月（p = 0.148）。化疗的急性毒性发生率可接受。不到8%的患者抱怨有3/4级恶心。3/4级白细胞减少率在第三个周期时最高，为16.6%，但只有6.2%的患者有3级感染。共有10例患者出现需要手术的肠道并发症，A组2例（2.7%），B组8例（9.5%）。
对于接受手术和放疗的高危子宫内膜癌患者，顺铂、表柔比星和环磷酰胺辅助化疗未能提高总生存率或降低复发率。化疗的急性毒性发生率较低，但似乎增加了肠道并发症的风险。
