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.
BACKGROUND
To assess the safety and efficacy of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS) for müllerian 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 müllerian carcinomas clinically diagnosed by imaging studies, cytology, and tumor markers. 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 müllerian 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% (53/56). 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 <1 cm in 17% (9/53) of patients. Twenty-two patients (42%) achieved cCR after completion of the treatment. The median overall and progression-free survival was 45 and 14 months, respectively.


CONCLUSIONS
NAC without diagnostic laparoscopy for advanced müllerian carcinomas holds sufficient promise to be compared with direct surgery in a phase III trial.
Onda
Takashi
T
Division of Gynecologic Oncology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan. taonda@ncc.go.jp
Kobayashi
Hiroaki
H
Nakanishi
Toru
T
Hatae
Masayuki
M
Iwasaka
Tsuyoshi
T
Konishi
Ikuo
I
Shibata
Taro
T
Fukuda
Haruhiko
H
Kamura
Toshiharu
T
Yoshikawa
Hiroyuki
H
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008875:Middle Aged; D018200:Mixed Tumor, Mullerian / Q000188:drug therapy / Q000601:surgery; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*
D016190:Carboplatin; D017239:Paclitaxel