Abstract 1346
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.
Resources from the same session
3875 - Correlation of radiotherapy with the prognosis of elderly patients with hormone receptor-positive breast cancer according to immunohistochemical subtyping
Presenter: Jin Zhang
Session: Poster Display session 2
Resources:
Abstract
5793 - Real world treatment sequencing patterns in secondary breast cancer (SBC): Pathway visualisation using national datasets.
Presenter: Ashley Horne
Session: Poster Display session 2
Resources:
Abstract
3185 - Utilization Pattern of Bone Targeting Agents in Patients with Solid Tumor in Taiwan, Hong Kong and Korea
Presenter: Shi Jie Lai
Session: Poster Display session 2
Resources:
Abstract
3705 - Clinico-pathological Features and Prognosis of Patients with Pregnancy Associated Breast Cancer – A Matched Case Control Study
Presenter: Ruyan Zhang
Session: Poster Display session 2
Resources:
Abstract
1421 - TRYbeCA-2: A Randomized Phase 2/3 Study of Eryaspase in Combination with Gemcitabine and Carboplatin Chemotherapy versus Chemotherapy Alone As First-Line Treatment in Patients with Metastatic or Locally Recurrent Triple-Negative Breast Cancer
Presenter: Ahmad Awada
Session: Poster Display session 2
Resources:
Abstract
4119 - CONTESSA TRIO: A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus 3 Different PD-(L)1 Inhibitors in Patients with Metastatic Triple-Negative Breast Cancer (TNBC) and Tesetaxel Monotherapy in Elderly Patients with HER2- Metastatic Breast Cancer (MBC)
Presenter: Sara Tolaney
Session: Poster Display session 2
Resources:
Abstract
4545 - Bintrafusp alfa (M7824) and Eribulin Mesylate in Treating Patients With Metastatic Triple Negative Breast Cancer (TNBC)(NCT03579472)
Presenter: Jennifer Litton
Session: Poster Display session 2
Resources:
Abstract
3340 - Effectiveness of Olaparib Plus Trastuzumab in HER2[+], BRCA–mutated (BRCAm) or Homologous Recombination Deficient (HRD) Advanced Breast Cancer (ABC) patients (pts). The OPHELIA Study
Presenter: José Enrique Alés-Martínez
Session: Poster Display session 2
Resources:
Abstract
1113 - RIBOB : A Study on the efficacy and safety of Ribociclib in combination with letrozole in Older women (≥70 years) with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced Breast cancer (aBC) with no prior systemic therapy for advanced disease
Presenter: Cindy Kenis
Session: Poster Display session 2
Resources:
Abstract
4025 - RIbociclib plus Goserelin with Hormonal Therapy versus physician Choice chemotherapy in premenopausal or perimenopausal patients with HR+, HER2– inoperable locally advanced or metastatic breast cancer – RIGHT Choice study
Presenter: Nagi El Saghir
Session: Poster Display session 2
Resources:
Abstract