Abstract 1948P
Background
JCOG1306 was a multicenter randomized phase II/III trial comparing perioperative chemotherapy with adriamycin plus ifosfamide (AI) and gemcitabine plus docetaxel (GD) for high-grade non-round-cell sarcomas of FNCLCC classification ≥G2. After the histopathological diagnosis was confirmed by each local institution, specialized sarcoma pathologists reviewed each pathological diagnosis. In this study, we examined the concordance proportion of pathological diagnoses between the local institutional judgment (LIJ) and central judgment (CJ) and its impact on the study.
Methods
A total of 142 patients with proven high-grade non-round-cell sarcoma based on an incisional biopsy were included. We evaluated the concordance between the LIJ and CJ for pathological types and FNCLCC classification.
Results
The concordance proportion for pathological types between the LIJ and CJ was 63.4%. Compared to the LIJ (G1: 0%, G2: 59.9%, G3: 40.1%), the CJ (G1: 15.5%, G2: 61.3%, G3: 23.2%) showed more patients diagnosed with G1, and the concordance proportion for the FNCLCC classification was 62.7%. Histological types diagnosed as G1 were myxofibrosarcoma in 15 patients, myxoid liposarcoma in 6 patients, and fibrosarcoma in 1 patient. The proportion of patients in which the LIJ agreed with the CJ for each histological type was higher for synovial sarcoma (100%) and myxofibrosarcoma (88.2%) and lower for undifferentiated/unclassifiable sarcoma (17.6%). The 3-year survival proportions for 120 patients excluding G1 cases (AI: 59, GD: 61) were 89.8% and 74.9%, respectively, and those for all 143 patients (AI: 70, GD: 73) were 91.4% and 79.2%, respectively.
Conclusions
The present analysis included 15% of G1 patients who were not originally eligible for this trial. However, this did not significantly affect the results, as the AI and GD groups contained similar numbers of G1 patients. Patients with a background of myxoid components tended to be judged as G1 by the CJ. Although the limitations of assigning a grade using an incisional biopsy should be considered, the CJ is still useful for ensuring the accuracy of the clinical trial for such rare cancers.
Clinical trial identification
JCOG1306S1.
Editorial acknowledgement
This abstract was edited by Japan Medical Communication.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1830P - CBP-1018, a bi-ligand-drug conjugate treated in patients with advanced solid tumors: A phase I, multi-center, open-label, dose-escalation and dose expansion study
Presenter: Kaiwen Li
Session: Poster session 15
1831P - Dissecting the meaning of obesity in metastatic castration resistant prostate cancer: Size or metabolism?
Presenter: Lisa Horvath
Session: Poster session 15
1832P - Centralized screening for homologous recombination repair (HRR) genes in metastatic castration-resistant prostate cancer (mCRPC): A feasibility study from a multicenter Spanish cohort
Presenter: Javier Freire
Session: Poster session 15
1833P - Concurrent high-dose IV Vitamin C (IVC) and docetaxel for metastatic castrate-resistant prostate cancer (mCRPC): A randomized, placebo-controlled, double-blind phase II trial
Presenter: Channing Paller
Session: Poster session 15
1834P - Exposure-efficacy analyses of talazoparib in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) in the TALAPRO-2 trial
Presenter: Arun Azad
Session: Poster session 15
1835P - A prospective study to determine the prevalence of DNA repair defects in patients (pts) with advanced prostate cancer (PC)
Presenter: Shahneen Sandhu
Session: Poster session 15
1836P - Blood based biomarkers identify metastatic castration-resistant prostate cancer (mCRPC) with the greatest benefit from continuing enzalutamide (ENZ) beyond progression in combination with docetaxel (Doc): A pre-specified biomarker study of the phase IIIb PRESIDE trial
Presenter: Maria Ruiz Vico
Session: Poster session 15
1837P - Assessing PSA
Presenter: Susan Halabi
Session: Poster session 15
1839P - Circulating tumor DNA (ctDNA) low pass whole genome sequencing (lpWGS) studies identify genomic alterations associating with taxane outcomes in prospective phase III taxane trials for metastatic castration resistant prostate cancer (mCRPC) sufferers
Presenter: George Seed
Session: Poster session 15