Feasibility study of neoadjuvant chemotherapy followed by interval debulking surgery for stage III/IV ovarian, tubal, and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206
Feasibility study of neoadjuvant chemotherapy followed by interval debulking surgery for stage III/IV ovarian, tubal, and peritoneal cancers: Japan Clinical Oncology Group Study JCOG0206
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DOI：
10.1016/j.ygyno.2008.12.027
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发表时间：
2009-04-01
影响因子：
4.7
通讯作者：
Yoshikawa, Hiroyuki
中科院分区：
文献类型：
--
作者：
Onda, Takashi;Kobayashi, Hiroaki;Yoshikawa, Hiroyuki
背景为了评估苗勒管癌（如卵巢癌、输卵管癌和腹膜癌）新辅助化疗（NAC）后间隔减积手术（IDS）的安全性和有效性，并确定我们是否可以在治疗开始前省略诊断性腹腔镜检查，进行了一项可行性研究。符合条件的患者具有通过影像学研究、细胞学和肿瘤市场临床诊断的假定III/IV期苗勒管癌。所有患者均接受诊断性腹腔镜检查以确认临床诊断。给予四个周期的紫杉醇和卡铂作为NAC，然后进行间隔减瘤手术和另外4个周期的化疗。主要终点是诊断性腹腔镜检查证实的所有III/IV期苗勒管癌中达到临床完全缓解（cCR）的患者比例。主要次要终点为临床诊断的阳性预测值（PPV）。五十六例患者入组研究。肿瘤起源、组织学和分期的总体临床诊断PPV为95%（53156）。53例患者接受了从NAC开始的方案治疗。89%（47/53）的患者进行了IDS。55%（29/53）的患者完全切除，无肿瘤残留，
Background. To assess the safety and efficacy of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) for mullerian carcinomas, such as ovarian, tubal, and peritoneal cancers, and to determine whether we can omit diagnostic laparoscopy before treatment initiation, a feasibility study was performed.Methods. Eligible patients had presumed stage III/IV mullerian carcinomas clinically diagnosed by imaging studies, cytology, and tumor markets. All patients underwent diagnostic laparoscopy to confirm the clinical diagnosis. Four cycles of paclitaxel and carboplatin were administered as NAC, followed by interval debulking surgery and an additional 4 cycles of chemotherapy. The primary end point was the proportion of patients achieving clinical complete remission (cCR) among all stage III/IV mullerian carcinomas confirmed by diagnostic laparoscopy. The major secondary end point was the positive predictive value (PPV) of clinical diagnosis.Results. Fifty-six patients were enrolled into the study. The PPV of overall clinical diagnosis for the tumor origin, histology, and stage was 95% (53156). Fifty-three patients received the protocol treatment starting with NAC. IDS was performed in 89% (47/53) of patients. Complete resection without residual tumors was achieved in 55% (29/53) and residual tumors became