Spread of tumor and adverse events after modified radical hysterectomy for FIGO Stage IB1 cervical cancer patients with tumor diameter preoperative...

Date 29 September 2019
Event ESMO 2019 Congress
Session Poster Display session 2
Topics Cervical Cancer
Presenter Takahide Arimoto
Citation Annals of Oncology (2019) 30 (suppl_5): v403-v434. 10.1093/annonc/mdz250
Authors T. Arimoto1, K. Takahiro2, T. Toita3, H. Kobayashi4, R. Machida5, T. Mizutani5, T. Onda6, M. Mizuno7, H. Yokota8, S. Kamiura9, K. Takehara10, H. Takano11, T. Saito12, M. Mandai13, T. Satoh14, S. Yamaguchi15, T. Nakamura16, K. Ushijima17, D. Aoki18, N. Yaegashi19
  • 1Obstetrics And Gynaecology, Toranomon Hospital, 105-8470 - Minato-ku, Tokyo/JP
  • 2Obstetrics & Gynecology, Tokyo Metropolitan Bokutoh Hospital, 130-8575 - Tokyo/JP
  • 3Radiology, Okinawa Chubu Hospital, 904-2293 - Uruma, Okinawa/JP
  • 4Obstetrics & Gynecology, Kagoshima University Hospital, 890-8544 - Kagoshima/JP
  • 5Clinical Research Support Office, National Cancer Center Hospital, 104-0045 - Chuo-ku, Tokyo/JP
  • 6Obstetrics & Gynecology, Kitasato University Hospital, 252-0375 - Sagamihara, Kanagawa/JP
  • 7Gynaecology, Aichi Cancer Center hospital, Aichi/JP
  • 8Gynaecology, Saitama Cancer Center Hospital, Saitama/JP
  • 9Gynaecology, Osaka International Cancer Institute, Osaka/JP
  • 10Gynaecology, Shikoku Cancer Center, Ehime/JP
  • 11Obstetrics And Gynaecology, The Jikei University Kashiwa Hospital, Kashiwa, Chiba/JP
  • 12Gynaecology, Kyushu Cancer Center, Fukuoka/JP
  • 13Obstetrics And Gynaecology, Kyoto University Hospital, Kyoto/JP
  • 14Obstetrics And Gynaecology, University of Tsukuba Hospital, Tsukuba, Ibaraki/JP
  • 15Gynaecology, Hyogo Cancer Center, Akashi, Hyogo/JP
  • 16Obstetrics And Gynaecology, Kagoshima City Hospital, Kagoshima/JP
  • 17Obstetrics And Gynaecology, Kurume University Hospital, Kurume, Fukuoka/JP
  • 18Obstetrics And Gynaecology, Keio University Hospital, Shinjuku-ku, Tokyo/JP
  • 19Obstetrics And Gynaecology, Tohoku University Hospital, Sendai, Miyagi/JP

Abstract

Background

A single-arm confirmatory trial (JCOG1101) is now on follow-up, which is to evaluate the efficacy of modified radical hysterectomy for FIGO Stage IB1 uterine cervical cancer patients (pts) with clinical maximal tumor diameter (MTD) estimated 2 cm or less (UMIN-CTR: UMIN000009726). It is needed to evaluate whether application of modified radical hysterectomy is feasible or not.

Methods

From Jan 2013 to Aug 2017, 240 pts were enrolled. We analyzed the data of 224 eligible pts who underwent modified radical hysterectomy to elucidate the relationship between clinical maximal tumor diameter (cMTD) and pathological MTD (pMTD), degree of tumor extension and adverse events (AEs).

Results

In 224 eligible pts, median pMTD was 1.5 cm (range, 0-4.5), and. pMTD were < = 2cm in 184 pts (82.1%). Parametrial involvement and lymph node metastasis were observed in 3 pts (1.3%) and 16 pts (7.1%). cMTD (MTD) 2 cm or less were determined prior to surgery by clinical diagnosis with MRI in 164 pts (clinical group), and by conization in 60 pts (cone group). Of clinical group, 128 (78.0%) had < =2cm tumor pathologically. There was no remarkable difference of the proportion of lymph node metastasis between clinical group and cone group (10/164 (6.1%) vs. 6/60 (10.0%)). No intraoperative Grade 3/4 complication was observed. Grade 2 intraoperative urinary tract injury was found in one (0.4%). Grade 3/4 acute nonhematological AEs were observed in 18 pts (8.0%), including infection in 8 pts and hemorrhage in 4 pts.

Conclusions

Though cMTD does not always correspond to pMTD on stage IB1 cervical cancer, low incidence of parametrial involvement and lymph node metastasis indicate that cMTD is useful as presurgical diagnosis. In addition, there was low frequency of AEs by modified radical hysterectomy, which was presumed to be less invasive than radical hysterectomy. Modified radical hysterectomy will be a standard surgery if the efficacy of modified radical hysterectomy in overall survival is confirmed by the primary analysis planned in 2022.

Clinical trial identification

UMIN-CTR: UMIN000009726, 08/Jan/2013.

Editorial acknowledgement

Legal entity responsible for the study

JCOG (Japan Clinical Oncology Group).

Funding

National Cancer Center Research and Development Funds.

Disclosure

All authors have declared no conflicts of interest.