Treatment invasiveness of neoadjuvant chemotherapy for stage III/IV ovarian, tubal, and peritoneal cancers.
演題番号 : IS2-5
1:Obstetrics and Gynecology, School of Medicine, Kitasato University
We conducted a phase III trial comparing upfront primary debulking surgery (PDS) and NAC for stage III/IV ovarian, tubal and peritoneal cancers (JCOG0602) (UMIN-CTR: UMIN000000523). Two preceding studies, EORTC55971 and CHORUS, successfully demonstrated non-inferior survival of patients treated with NAC. However, invasiveness of treatment (Tx) has not yet fully been analyzed. To prove efficacy of NAC compared to standard Tx, it is necessary to demonstrate apparently reduced invasiveness of Tx.
JCOG0602 is now on-going and the primary analysis of OS is planned in 2016. Patients were randomized to standard arm (PDS followed by 8 cycles of paclitaxel and carboplatin, i.e. TC regimen) and NAC arm (4 cycles of TC, interval debulking surgery [IDS], 4 cycles of TC). In standard arm, IDS was optional for patients who underwent suboptimal or incomplete PDS. Surgical invasiveness and incidence of adverse events related to Tx were compared between two arms.
Results: From Nov 2006 to Oct 2011, 301 patients (149 standard arm and 152 NAC arm) were randomized. In standard arm 147/149 underwent PDS and 46 of them underwent IDS. In NAC arm 131/152 underwent IDS. Average number of times of surgeries was smaller in NAC arm (0.86 vs. 1.30, P<0.001). Though pelvic and paraaortic lymphadenectomy (PLA/PALA) were more frequently performed in NAC arm (P<0.001), frequency of bowel or organ resection was lower in NAC arm (P=0.012 and 0.027, respectively). In a comparison between PDS in standard arm and IDS in NAC arm, blood/ascites loss (<0.001), albumin transfusion (<0.001), and G3/4 adverse events after surgery in total (P=0.005) were fewer in IDS.
Tx with NAC is less invasive than standard Tx. When non-inferior survival will be confirmed in this trial and new staging system is established, Tx with NAC can become a new standard Tx for advanced ovarian cancer.