Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Radiation Oncology, The University of Miami, Miami, Florida.
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.
To determine the long-term outcomes for prostate adenocarcinoma when escalating radiation dose from 70 Gy to 78 Gy.
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.
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.
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.
确定前列腺腺癌的长期结果，当从 70Gy 增加到 78Gy 时。
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。
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。
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。
