Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy in High-Grade Epithelial Ovarian Cancer A LANCE Randomized Clinical Trial

被引:1
|
作者
Rauh-Hain, J. Alejandro [1 ,2 ]
Melamed, Alexander [3 ]
Pareja, Rene [4 ]
May, Taymaa [5 ,6 ,7 ]
Sinno, Abdulrahman [8 ]
Mcnally, Leah [9 ]
Horowitz, Neil S. [6 ]
De Iaco, Pierandrea [10 ]
Michener, Chad M. [11 ]
Van Lonkhuijzen, Luc [12 ]
Iniesta, Maria D. [1 ]
Yuan, Ying [13 ]
Ramirez, Pedro T. [14 ]
Fagotti, Anna [15 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Dept Gynecol Oncol & Reprod Med, 155 Pressler St,Unit 1362, Houston, TX 77030 USA
[2] Univ Texas MD Anderson Canc Ctr, Dept Hlth Serv Res, Houston, TX USA
[3] Harvard Med Sch, Massachusetts Gen Hosp, Div Gynecol Oncol Vincent Obstet & Gynecol, Boston, MA USA
[4] Inst Nacl Cancerol, Dept Gynecol Oncol, Bogota, Colombia
[5] Princess Margaret Hosp, Canc Ctr, Toronto, ON, Canada
[6] Dana Farber Canc Inst, Dept Med Oncol, Div Gynecol Oncol, Boston, MA USA
[7] Univ Toronto, Dept Obstet & Gynaecol, Toronto, ON, Canada
[8] Univ Miami, Miller Sch Med, Dept Obstet & Gynecol, Div Gynecol Oncol, Miami, FL USA
[9] Duke Univ, Durham, NC USA
[10] Azienda Osped Univ Bologna, Ist Ricovero & Cura Carattere Sci, Div Oncol Gynecol, Bologna, Italy
[11] Cleveland Clin, Obstet & Gynecol Inst, Cleveland, OH USA
[12] Univ Amsterdam, Ctr Gynecol Oncol Amsterdam, Dept Gynecol Oncol, Med Ctr, Amsterdam, Netherlands
[13] Univ Texas MD Anderson Canc Ctr, Dept Biostat, Houston, TX USA
[14] Houston Methodist Hosp, Neal Canc Ctr, Dept Obstet & Gynecol, Houston, TX USA
[15] Policlin A Gemelli, Dept Womens & Childrens Hlth, Rome, Italy
基金
美国国家卫生研究院;
关键词
INTERVAL DEBULKING SURGERY; LAPAROTOMY; SURVIVAL;
D O I
10.1001/jamanetworkopen.2024.46325
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
IMPORTANCE Despite the absence of high-quality evidence of its safety and effectiveness, minimally invasive surgery (MIS) is increasingly used to treat advanced epithelial ovarian cancer (EOC). OBJECTIVE To assess the feasibility of conducting a full-scale randomized clinical trial (RCT) designed to compare the efficacy of MIS vs laparotomy in patients with advanced-stage EOC and a complete or partial response to neoadjuvant chemotherapy (NACT). DESIGN, SETTING, AND PARTICIPANTS This lead-in pilot phase of LANCE (Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy), an international, open-label, noninferiority RCT, opened to enrollment in September 2020 and enrolled the 100th eligible patient in February 2023. It was conducted at 11 academic cancer centers in North America and Europe. Participants were adults with stage IIIC or IV epithelial ovarian, fallopian, or primary peritoneal carcinoma who had normal cancer antigen 125 levels and at least a partial radiologic response after 3 to 4 cycles of NACT. Patients were randomly assigned to receive either interval cytoreductive surgery performed using MIS or laparotomy. Data analysis was based on the evaluable population. INTERVENTIONS The MIS arm underwent laparoscopic or robotic surgery, vs laparotomy for the control arm. Resection of all visible tumor was attempted, and conversion from MIS to laparotomy was performed when necessary to attain complete resection. MAIN OUTCOMES AND MEASURES Trial feasibility was defined by 3 primary end points: patient accrual rate of at least 5.6 patients per month by the last month of the lead-in pilot phase, conversion from MIS to laparotomy in less than 25% of patients, and a difference in complete gross resection rates of fewer than 20 percentage points between study arms. RESULTS One hundred women (median [IQR] age, 63 [39-82] years) were included, of whom 49 were randomly assigned to MIS and 51 to laparotomy; 95 were evaluable for surgical outcomes. Most patients (34 [67%] in the laparotomy arm, and 33 [67%] in the MIS arm) had stage IIIC cancer. The monthly accrual rate reached 5.9 patients per month in the final month of the study. Six of 48 evaluable patients (12.5%; 95% CI, 4.7%-25.2%) assigned to MIS underwent conversion to laparotomy. Surgeons achieved a complete gross resection rate in 42 of 48 evaluable patients (88%) assigned to MIS and in 39 of 47 patients (83%) assigned to laparotomy (difference, 4.5 [95% CI, -9.7 to 18.8] percentage points). CONCLUSIONS AND RELEVANCE Results of this lead-in pilot study indicated the feasibility of the LANCE RCT to compare the oncological outcomes of MIS vs laparotomy.
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页数:11
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