1346 - Spread of tumor and adverse events after modified radical hysterectomy for FIGO Stage IB1 cervical cancer patients with tumor diameter preoperatively estimated 2 cm or less: Japan Clinical Oncology Group trial (JCOG1101); exploratory analysis before primary analysis.

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.