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Clinical Trial
. 2020 May:130:114-125.
doi: 10.1016/j.ejca.2020.02.020. Epub 2020 Mar 13.

Comparison of survival between primary debulking surgery and neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers in phase III randomised trial

Takashi Onda  1 , Toyomi Satoh  2 , Gakuto Ogawa  3 , Toshiaki Saito  4 , Takahiro Kasamatsu  5 , Toru Nakanishi  6 , Tomonori Mizutani  3 , Kazuhiro Takehara  7 , Aikou Okamoto  8 , Kimio Ushijima  9 , Hiroaki Kobayashi  10 , Kei Kawana  11 , Harushige Yokota  12 , Masashi Takano  13 , Hiroyuki Kanao  14 , Yoh Watanabe  15 , Kaichiro Yamamoto  16 , Nobuo Yaegashi  17 , Toshiharu Kamura  18 , Hiroyuki Yoshikawa  19 ; Japan Clinical Oncology Group
Affiliations
Clinical Trial

Comparison of survival between primary debulking surgery and neoadjuvant chemotherapy for stage III/IV ovarian, tubal and peritoneal cancers in phase III randomised trial

Takashi Onda et al. Eur J Cancer. 2020 May.

Abstract

Background: Regarding the comparison between primary debulking surgery (PDS) and neoadjuvant chemotherapy (NACT) for stage III/IV ovarian, tubal and peritoneal cancers, EORTC55971 and CHORUS studies demonstrated noninferiority of NACT. Previously, we reported reduced invasiveness of NACT in JCOG0602. This is a final analysis including the primary endpoint of overall survival (OS).

Methods: Patients were randomised to PDS (PDS followed by 8x paclitaxel and carboplatin, i.e. TC regimen) or NACT (4x TC, interval debulking surgery [IDS], 4x TC). The primary endpoint was OS. The noninferiority hazard ratio (HR) margin for NACT compared with PDS was 1·161. The planned sample size was 300.

Findings: Between 2006 and 2011, 301 patients were randomised, 149 to PDS and 152 to NACT. The median OS was 49·0 and 44·3 months in the PDS and NACT. HR for NACT was 1·052 [90·8% confidence interval (CI) 0·835-1·326], and one-sided noninferiority p-value was 0·24. Median progression-free survival was 15·1 and 16·4 months in the PDS and NACT (HR: 0·96 [95%CI 0·75-1·23]). In the PDS arm, 147/149 underwent PDS and 49/147 underwent IDS. In the NACT arm 130/152 underwent IDS. Complete resection was achieved in 12% (17/147) of PDS and 31% (45/147) of PDS ± IDS in the PDS arm and in 64% (83/130) of IDS in the NACT arm. Optimal surgery (residual tumour <1 cm) was achieved in 37% (55/147), 63% (92/147), and 82% (107/130 respectively. In the NACT, PS 2/3, serum albumin ≤2·5, CA125 > 2000 an institution with low study activity was advantageous, whereas clear/mucinous histology was disadvantageous for OS.

Interpretation: The noninferiority of NACT was not confirmed. NACT may not always be a substitute for PDS. However, as our study had smaller numbers, the noninferiority of the previous studies cannot be denied.

Funding: Ministry of Health, Labour and Welfare, Japan and the National Cancer Center, Japan.

Clinical trial information: UMIN000000523.

Keywords: Interval debulking surgery; Neoadjuvant chemotherapy; Ovarian neoplasms; Primary debulking surgery.

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Conflict of interest statement

Conflict of interest statement TO(1) received grant and personal fee from Chugai, grants from Kaken, Taiho, Daiichi-Sankyo, Mochida, and Meiji Yasuda Health Development Foundation, and personal fees from AstraZeneca and Ono outside the submitted work. TS(2) reported personal fees from Mochida, Nippon Kayaku, Chugai, Daiichi-Sankyo, Kyowa Kirin, AstraZeneca, Kaken, Eisai, Tsumura, Beyer, and Aska outside the submitted work. TS(4) reported grants and personal fees from Chugai and Nippon Kayaku, and grants from Taiho and Yakult outside the submitted work. KT(7) reported other financial activities from AstraZeneca, Daiichi Sankyo, Chugai, and Eisai outside the submitted work. AO(8) reported other financial activities from Taiho, Meiji, Fuji, Nippon Shinyaku, Novartis, Mochida, Chugai, Tsumura, Pfizer, Kissei, Shionogi, Daiichi Sankyo, Kaken, GenoDive, CMIC, and Shinnihonseiyaku, and personal fee from AstraZeneca outside the submitted work. KU(9) received grants and personal fees from AstraZeneca, MSD, Chugai, Kaken, Takeda, Nippon Kayaku, Mochida, and Tsumura, and grants from Abbvie, Ono, and Eisai, and personal fees from Taiho, Yakult, Kyowa Kirin, Bayer, and Aska outside the submitted work. HY(12) received grants from MSD and Zeria, and personal fees from Kaken, Ono, AstraZeneca and Chugai, and Pfizer outside the submitted work. TK(18) reported a personal fee from BrightPath Biotherapeutics outside the submitted work. HY(19) reported personal fees from Ono, Taiho, MSD, and GSK outside the submitted work. GO(3), TK(5), TM(3), TN(6), HK(10), KK(11), MT(13), HK(14), YW(15), KY(16), NY(17) reported no competing interests.

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