Hernberg Micaela, Virkkunen Pekka, Maasilta Paula, Keyriläinen Jani, Blomqvist Carl, Bergh Jonas, Wiklund Tom
Department of Oncology, Helsinki University Central Hospital, Helsinki, Finland.
Int J Radiat Oncol Biol Phys. 2002 Jan 1;52(1):128-36. doi: 10.1016/s0360-3016(01)01760-6.
Pulmonary toxicity was prospectively evaluated within a randomized trial for breast cancer patients at high risk for relapse, who postoperatively received as adjuvant therapy either 9 cycles of tailored chemotherapy (20 patients) (cyclophosphamide, epirubicin, 5-fluorouracil [FEC]) or standard FEC x 3 followed by high-dose chemotherapy (cyclophosphamide, thiotepa, carboplatin [CTCb]) supported by peripheral blood stem cell transplantation (14 patients). After high-dose chemotherapy or tailored FEC, all patients received locoregional radiotherapy (50 Gy/5 weeks), plus tamoxifen for 5 years.
Lung function tests (FVC, FEV1, and DL(CO)) were performed before chemotherapy and 9 months after radiotherapy. Computed tomography of the lungs was performed before radiotherapy and 6 weeks, 3 months, and 9 months after radiotherapy.
Clinical signs of suspected pneumonitis were noted in 29% of patients, but only 1 patient needed symptomatic therapy. Radiologic changes were detected in 68% of patients, and they were most frequent at 3 months after radiotherapy. FVC decreased in both groups (tailored FEC: mean difference, -6.5%, p = 0.0005; CTCb: -2.0%, p = 0.21; tailored FEC vs. CTCb: -4.5%, p = 0.05). DL(CO) decreased significantly in both groups (tailored FEC: mean difference, -11.2%, p < 0.0001; CTCb: -5.6%, p = 0.02; tailored FEC vs. CTCb: -5.6%, p = 0.07). FEV1 decreased by 7.3% in patients treated with tailored FEC (p < 0.0001) and by 2.5% in patients treated with CTCb (p = 0.03) (tailored FEC vs. CTCb: 3.7%, p = 0.08).
Changes in pulmonary function were thus detected in both groups, although to a greater extent in the tailored FEC group. The clinical significance of these findings should be balanced carefully against the improved, statistically significant relapse-free survival achieved with the tailored FEC regimen compared to high-dose CTCb + peripheral blood stem cell transplantation (PSCT).
在一项针对复发高危乳腺癌患者的随机试验中，对肺毒性进行前瞻性评估。这些患者术后接受辅助治疗，其中20例患者接受9个周期的个体化化疗（环磷酰胺、表柔比星、5-氟尿嘧啶[FEC]），14例患者接受标准FEC×3周期，随后接受外周血干细胞移植支持的大剂量化疗（环磷酰胺、噻替派、卡铂[CTCb]）。在大剂量化疗或个体化FEC治疗后，所有患者均接受局部区域放疗（50 Gy/5周），并加用他莫昔芬治疗5年。
在化疗前及放疗后9个月进行肺功能测试（用力肺活量[FVC]、第一秒用力呼气量[FEV1]和一氧化碳弥散量[DL(CO)]）。在放疗前及放疗后6周、3个月和9个月进行肺部计算机断层扫描。
29%的患者出现疑似肺炎的临床症状，但只有1例患者需要对症治疗。68%的患者检测到放射学改变，且在放疗后3个月最为常见。两组患者的FVC均下降（个体化FEC组：平均差异为-6.5%，p = 0.0005；CTCb组：-2.0%，p = 0.21；个体化FEC组与CTCb组比较：-4.5%，p = 0.05）。两组患者的DL(CO)均显著下降（个体化FEC组：平均差异为-11.2%，p < 0.0001；CTCb组：-5.6%，p = 0.02；个体化FEC组与CTCb组比较：-5.6%，p = 0.07）。接受个体化FEC治疗的患者FEV1下降7.3%（p < 0.0001），接受CTCb治疗的患者FEV1下降2.5%（p = 0.03）（个体化FEC组与CTCb组比较：3.7%，p = 0.08）。
两组患者均检测到肺功能变化，不过个体化FEC组变化程度更大。与大剂量CTCb加外周血干细胞移植（PSCT）相比，个体化FEC方案实现了无复发生存率的提高且具有统计学意义，应仔细权衡这些发现的临床意义。
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