Late toxicity results of the Gortec 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: Comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems
Late toxicity results of the Gortec 94-01 randomized trial comparing radiotherapy with concomitant radiochemotherapy for advanced-stage oropharynx carcinoma: Comparison of LENT/SOMA, RTOG/EORTC, and NCI-CTC scoring systems
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DOI：
10.1016/s0360-3016(02)03819-1
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发表时间：
2003-01-01
影响因子：
7
通讯作者：
Calais, G
中科院分区：
文献类型：
--
作者：
Denis, F;Garaud, P;Calais, G
目的：使用三种不同的毒性量表前瞻性评估局部晚期口咽癌联合放化疗患者的 5 年晚期毒性。方法和材料：共有 226 名患者参加了一项 III 期多中心、随机试验，比较单独放疗（35 次分次 70 Gy：A 组）与联合放化疗（35 次分次 70 Gy，三个周期的 4 天治疗方案，其中包含卡铂和 5-氟尿嘧啶：B 组）。五名活着的患者，没有局部或远处复发，无法评估晚期毒性。 44 名患者符合晚期毒性的条件，中位随访时间为 5 年。放射肿瘤学家使用包含三个量表（NCI-CTC、LENT/SOMA 和 RTOG）120 个混合项目的大型调查问卷来评估晚期毒性。然后使用相应的等级将数据转置到不同的量表上。结果：B 组的 5 年总体生存率为 22%，A 组为 16%（p = 0.05）。 B 组的 5 年局部控制率为 48%，A 组为 25%（p = 0.002）。脊髓未受到伴随化疗的影响，并且没有因晚期毒性导致死亡。使用三种晚期毒性量表，接受联合疗法（B 组）治疗的患者中 100% 出现一种或多种晚期并发症，而单独放疗组（A 组）中这一比例为 94%。差异无统计学意义。最常受损的器官（均为 1-4 级）是唾液腺（B 组为 100%，A 组为 82%，p
Purpose: To prospectively assess 5-year late toxicity in patients treated by concomitant radiochemotherapy for locally advanced oropharynx carcinoma using three different toxicity scales.Methods and Materials: A total of 226 patients were entered in a Phase III multicenter, randomized trial comparing radiotherapy alone (70 Gy in 35 fractions: Arm A) with concomitant radiochemotherapy (70 Gy in 35 fractions with three cycles of a 4-day regimen containing carboplatin and 5-fluorouracil: Arm B). Five living patients, free of local or distant recurrences, could not be evaluated for late toxicity. Forty-four patients were eligible for late toxicity with a median follow-up of 5 years. Late toxicity was evaluated by the radiation oncologist using a large questionnaire containing 120 mixed items of three scales (NCI-CTC, LENT/SOMA, and RTOG). The data were then transposed on separate scales using corresponding grades.Results: The 5-year overall survival rate was 22% in Arm B and 16% in Arm A (p = 0.05). The 5-year locoregional control rate was 48% in Arm B and 25% in Arm A (p = 0.002). The spinal cord was not affected by the concomitant adjunct of chemotherapy, and no deaths were caused by late toxicity. Using the three late toxicity scales, 100% of the patients treated with the combined modality (Arm B) developed one or more late complications vs. 94% in the radiotherapy-alone arm (Arm A). The difference was not statistically significant. The most commonly damaged organs (all Grade 1-4) were the salivary glands (100% in Arm B vs. 82% in Arm A, p