前列腺腺癌的剂量递增：一项 3 期单机构随机临床试验结果的长期更新。
Dose Escalation for Prostate Adenocarcinoma: A Long-Term Update on the Outcomes of a Phase 3, Single Institution Randomized Clinical Trial.
机构信息
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Radiation Oncology, The University of Miami, Miami, Florida.
出版信息
Int J Radiat Oncol Biol Phys. 2019 Jul 15;104(4):790-797. doi: 10.1016/j.ijrobp.2019.02.045. Epub 2019 Mar 2.
PURPOSE
To determine the long-term outcomes for prostate adenocarcinoma when escalating radiation dose from 70 Gy to 78 Gy.
METHODS AND MATERIALS
Between 1993 and 1998, 301 patients with biopsy-proven clinical stage T1b-T3 prostate adenocarcinoma, any prostate-specific antigen level, and any Gleason score were randomized to 70 Gy in 35 fractions versus 78 Gy in 39 fractions of photon radiation therapy using a 4-field box technique without hormone deprivation therapy. The primary outcome was powered to detect a 15% difference in biochemical or clinical failure. Secondary outcomes included survival, prostate cancer mortality, biochemical failure, local failure, nodal failure, distant failure, and secondary malignancy rates.
RESULTS
With a median follow-up of 14.3 years, the cumulative incidence of 15-year biochemical or clinical failure was 18.9% versus 12.0% in the 70 Gy versus 78 Gy arms, respectively (subhazard ratio [sHR], 0.61; 95% confidence interval [CI], 0.38-0.98; Fine-Gray P = .042). The 15-year cumulative incidence of distant metastasis was 3.4% versus 1.1%, respectively (sHR, 0.33; 95% CI, 0.13-0.82; Fine-Gray P = .018). The 15-year cumulative incidence of prostate cancer-specific mortality was 6.2% versus 3.2%, respectively, (sHR, 0.52; 95% CI, 0.27-0.98; Fine-Gray P = .045). There were no differences in overall survival (HR, 1.10; 95% CI, 0.84-1.45; log rank P = .469) or other-cause survival (sHR, 1.33; 95% CI, 0.99-1.79; Fine-Gray P = .061). Salvage therapy was more common in the 70 Gy arm, at 38.7% versus 21.9% in the 78 Gy arm (P = .002). There was a 2.3% secondary solid malignancy rate (1 bladder, 6 rectal) within the radiation treatment field, which was not significantly different between treatment arms.
CONCLUSIONS
Dose escalation by 8 Gy (78 Gy vs 70 Gy) provided a sustained improvement in biochemical and clinical failure, which translated into lower salvage rates and improved prostate cancer-specific mortality, but not overall survival. Long-term follow-up demonstrated a low incidence of potential solid tumor secondary malignancies.
目的
确定前列腺腺癌的长期结果，当从 70Gy 增加到 78Gy 时。
方法和材料
1993 年至 1998 年，301 名经活检证实的临床 T1b-T3 前列腺腺癌患者，任何前列腺特异性抗原水平和任何 Gleason 评分，均随机分为 70Gy 组（70Gy 组）和 78Gy 组（78Gy 组），每组 35 个剂量的光子放射治疗，采用 4 野箱式技术，无激素剥夺治疗。主要结果是检测生物化学或临床失败率 15%差异的能力。次要结果包括生存、前列腺癌死亡率、生化失败、局部失败、淋巴结失败、远处失败和继发性恶性肿瘤发生率。
结果
中位随访 14.3 年后，15 年生化或临床失败的累积发生率分别为 70Gy 组 18.9%和 78Gy 组 12.0%（亚危险比[sHR]，0.61；95%置信区间[CI]，0.38-0.98；Fine-Gray P = 0.042）。远处转移的 15 年累积发生率分别为 3.4%和 1.1%（sHR，0.33；95%CI，0.13-0.82；Fine-Gray P = 0.018）。15 年前列腺癌特异性死亡率分别为 6.2%和 3.2%（sHR，0.52；95%CI，0.27-0.98；Fine-Gray P = 0.045）。总生存率（HR，1.10；95%CI，0.84-1.45；对数秩 P = 0.469）或其他原因生存率（sHR，1.33；95%CI，0.99-1.79；Fine-Gray P = 0.061）无差异。70Gy 组挽救性治疗更常见，为 38.7%，78Gy 组为 21.9%（P = 0.002）。在放射治疗野内有 2.3%的继发性实体恶性肿瘤发生率（1 例膀胱癌，6 例直肠癌），两组之间无显著差异。
结论
8Gy （78Gy 与 70Gy）的剂量递增为生化和临床失败提供了持续的改善，这转化为较低的挽救率和改善的前列腺癌特异性死亡率，但没有整体生存率。长期随访显示潜在的实体瘤继发性恶性肿瘤发生率较低。
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