Long-term outcomes of the first prospective study of active surveillance for prostate cancer in Japan.

IF 2.4 3区 医学 Q3 ONCOLOGY International Journal of Clinical Oncology Pub Date : 2024-10-01 Epub Date: 2024-08-01 DOI:10.1007/s10147-024-02590-4
Takuma Kato, Hiromi Hirama, Toshiyuki Kamoto, Takayuki Goto, Hiroyuki Fujimoto, Shinichi Sakamoto, Nobuo Shinohara, Shin Egawa, Dai Kouguchi, Masashi Nakayama, Katsuyoshi Hashine, Nobuaki Shimizu, Koji Inoue, Tomonori Habuchi, Takaya Hioka, Taizou Shiraishi, Mikio Sugimoto, Yoshiyuki Kakehi
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Abstract

Background: Active surveillance for prostate cancer was initiated in the early 2000s. We assessed the long-term outcomes of active surveillance in Japan.

Methods: This multicenter prospective observational cohort study enrolled men aged 50-80 years with stage cT1cN0M0 prostate cancer in 2002 and 2003. The eligibility criteria included serum prostate-specific antigen level ≤ 20 ng/mL, ≤ 2 positive cores per 6-12 biopsy samples, Gleason score ≤ 6, and cancer involvement < 50% in the positive core. Patients were encouraged to undergo active surveillance. Prostate-specific antigen levels were measured bimonthly for 6 months and every 3 months thereafter. Triggers for recommending treatment were prostate-specific antigen doubling time of < 2 years and pathological progression on repeat biopsy.

Results: Among 134 patients, 118 underwent active surveillance. The median age, prostate-specific antigen level at diagnosis, and maximum cancer occupancy were 70 years, 6.5 ng/mL, and 11.2%, respectively. Ninety-one patients had only one positive cancer core. The median observation period was 10.7 years. At 1 year, 65.7% underwent a repeat biopsy, and 37% of patients experienced pathological progression. The active surveillance continuation rates at 5, 10, and 15 years were 28%, 9%, and 4%, respectively. One prostate cancer-related death occurred in a patient who refused treatment despite pathological progression at the one-year repeat biopsy.

Conclusion: Active surveillance according to this study protocol was associated with conversion to the next treatment without delay, when indicated, despite the selection criteria and follow-up protocols being less rigorous than those recommended in current international guidelines.

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日本首个前列腺癌主动监测前瞻性研究的长期结果。
背景:前列腺癌的主动监测始于本世纪初。我们评估了日本主动监测的长期结果:这项多中心前瞻性观察队列研究在 2002 年和 2003 年招募了 50-80 岁的 cT1cN0M0 期前列腺癌男性患者。资格标准包括血清前列腺特异性抗原水平≤ 20 ng/mL、每 6-12 份活检样本中≤ 2 个阳性核、格雷森评分≤ 6 分以及癌症受累:134 名患者中,118 人接受了主动监测。中位年龄、诊断时的前列腺特异性抗原水平和最大癌变率分别为 70 岁、6.5 纳克/毫升和 11.2%。91名患者只有一个阳性癌芯。中位观察期为 10.7 年。1年后,65.7%的患者接受了重复活检,37%的患者出现病理进展。5年、10年和15年后继续接受主动监测的比例分别为28%、9%和4%。有一名前列腺癌相关死亡患者在一年的重复活检中出现病理进展,但拒绝接受治疗:结论:尽管选择标准和随访方案不如当前国际指南所建议的那么严格,但根据本研究方案进行的积极监测与在有指征的情况下毫不拖延地转入下一步治疗有关。
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来源期刊
CiteScore
6.80
自引率
3.00%
发文量
175
审稿时长
2 months
期刊介绍: The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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