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
3139 - Efficacy and safety of FOLFIRI/Aflibercept (FA) in elderly population with mCRC after failure of oxaliplatin-based chemotherapy.
Presenter: Nieves Martinez Lago
Session: Poster Display session 2
Resources:
Abstract
3446 - Fluoropyrimidine-induced cardiotoxicity in colorectal cancer patients: preliminary data from the prospective observational CHECKPOINT trial (NCT02665312)
Presenter: Pasquale Lombardi
Session: Poster Display session 2
Resources:
Abstract
3969 - Comparable survival outcome between Thai patients with sporadic young adult and adult onset colorectal cancer
Presenter: Kanjana Sukhokanjanachusak
Session: Poster Display session 2
Resources:
Abstract
4455 - Impact of primary tumor side on 3-year survival outcomes of first-line (1L) FOLFOX-4 ± cetuximab in patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) in the phase 3 TAILOR trial
Presenter: Shukui Qin
Session: Poster Display session 2
Resources:
Abstract
4481 - Undetectable RAS mutant clones in plasma: possible implication for therapy and prognosis in the patient with RAS mutant metastatic colorectal cancer?
Presenter: Mohamed Bouchahda
Session: Poster Display session 2
Resources:
Abstract
5074 - Dihydropyrimidine dehydrogenase (DPD) determination prior the administration of medicines containing fluorouracil: a single Spanish hospital experience.
Presenter: Maria Dolores Mediano Rambla
Session: Poster Display session 2
Resources:
Abstract
5242 - Differences in survival between right and left-sided colorrectal cancer (CRC) in every stage, a CARESS-CCR Group Study.
Presenter: Julia Alcaide-Garcia
Session: Poster Display session 2
Resources:
Abstract
1123 - Quality of Life (QoL) in patients with aflibercept (AFL) and FOLFIRI for metastatic colorectal cancer (mCRC) – Interim analysis with focus on mutational status of the non-interventional study QoLiTrap (AIO-LQ-0113)
Presenter: Roger von Moos
Session: Poster Display session 2
Resources:
Abstract
1212 - The cost of adverse event management in patients with RAS wild-type metastatic colorectal cancer treated with first-line cetuximab and panitumumab: an Italian healthcare payer perspective
Presenter: Karl Patterson
Session: Poster Display session 2
Resources:
Abstract
1619 - Meta-analysis of KRAS Mutation as prognostic factor in patients (pts.) with resection of colorectal (CRC) liver metastases: Tumor burden and Sideness analysis.
Presenter: Maria Romina Luca
Session: Poster Display session 2
Resources:
Abstract