19 results on '"Byoung-Gie Kim"'
Search Results
2. Interim analysis from a phase II study of olaparib maintenance with pembrolizumab and bevacizumab in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer: APGOT-ov4/ OPEB-01
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Jung-Yun LEE, Jae-Weon Kim, Byoung-Gie Kim, Sang Wun Kim, Hee Seung Kim, Se Ik Kim, Myong Cheol Lim, Chel Hun Choi, Natalie Ngoi, David Shao Peng Tan, and Yoo Na Kim
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Cancer Research ,Oncology - Abstract
e17579 Background: The optimal treatment of BRCA wild-type patients with platinum-sensitive recurrent (PSR) ovarian cancer remains controversial. This single arm phase 2 study (OPEB-01) evaluated a triple combination regimen with olaparib, bevacizumab, and pembrolizumab as 2nd-line maintenance treatment in BRCA non-mutated, PSR ovarian cancer. Methods: Women with PSR ovarian cancer who had a partial or complete response to their most recent platinum-based regimen were eligible. Patients received olaparib 300mg PO bid daily, bevacizumab 15mg/kg IV q3w, and pembrolizumab 200mg IV q3w until progressive disease or unacceptable toxicity. The primary endpoint of the study was 6-month PFS rate. A simon 2-stage design was utilized. Target accrual was 22 patients in the first stage; 13 or more patients with non-progressive disease at 6 months was required to proceed to second stage. Results: 22 patients were enrolled at the first stage. Median age was 60 years old and most of the patients (90.9%) had high-grade serous carcinoma. Secondary cytoreductive surgery was performed in 6 (27.3%) patients. The objective response rate (ORR) was 68.2% and the disease control rate (DCR) was 90.9%. At the time of data analysis (data cutoff Jan 19 2022), 20 (90.9%) had non-progressive disease at 6 months. No grade 4 adverse events were reported and no treatment related adverse events leading to treatment discontinuation was observed. Additional correlative data regarding homologous recombination deficiency and PD-L1 will be presented at the meeting. Conclusions: OPEB-01 is the first trial to suggest the potential benefit of triple combination maintenance in BRCA wild-type patients. These combinations showed a manageable safety profile. Accrual is ongoing in the second stage. Clinical trial information: NCT4361370.
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- 2022
3. An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer (KGOG 3045, AMBITION)
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Chel Hun Choi, Byoung-Gie Kim, Jae Weon Kim, Hee Seung Kim, Jung Bok Lee, Eunhyang Park, Jung Yun Lee, and Sung Hoon Kim
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,medicine.disease ,Targeted therapy ,Recurrent Ovarian Cancer ,Internal medicine ,medicine ,Single agent chemotherapy ,Biomarker (medicine) ,In patient ,Ovarian cancer ,business ,Standard therapy ,Platinum resistant - Abstract
5520 Background: Heavily treated platinum-resistant ovarian cancer remains a therapeutic challenge. Although standard therapy includes non-platinum single agent chemotherapy (CT), prognoses are very poor in this setting. Anticancer therapies based on molecular biomarkers have improved dramatically. We report data from an umbrella study of biomarker-driven targeted therapy (olaparib, O; cediranib, C; durvalumab, D; tremelimumab, T) in platinum-resistant recurrent ovarian cancer (NCT03699449). Methods: Patients with platinum-resistant ovarian cancer with ≥ two lines of prior chemotherapy and ECOG 0/1 were eligible for this study. In the screening phase, archival tumor samples were tested for HRD and PD-L1 status. Treatment arms were allocated according to the test results. For HRD+ patients, we tested the synergistic effects of O with other agents: patients were randomly allocated to arm 1, O+C (O 200mg bid + C 30mg qd); or arm 2, O+D (O 300mg bid + D 1500mg q4w). For HRD- patients, we tested the role of biomarker-driven immunotherapy according to PD-L1 expression: arm 3, D+CT (D 1500mg q4w + PLD or topotecan or weekly paclitaxel [6 cycles]) in patients with high PD-L1 expression; arm 4, D+T75+CT (D 1500mg q4w + T 75mg q4w [4 doses] + PLD or topotecan or weekly paclitaxel [4 cycles]) in patients with low PD-L1 expression; or arm 5, D+T300+CT (D 1500mg q4w + T 300mg [1 dose] + weekly paclitaxel [60mg/m2 D1,8,15 q4w for 4 cycles]) in patients with low PD-L1 expression. Recruitment to arm 5 was initiated after completion in arm 4. The primary endpoint was objective response rates (ORR) according to RECIST 1.1. Results: Between Dec 2018 and Oct 2020, 70 patients were allocated to treatment as follows: arm 1 (n = 16), arm 2 (n = 14), arm 3 (n = 5), arm 4 (n = 18), and arm 5 (n = 17). Median age was 57 years (range 34-77) and median prior lines of treatment was 3 (range: 2-10). Among all patients, the ORR was 35.7% (25/70, 95% CI: 24.6%-48.0%); complete response was observed in two patients. The ORRs (95% CI) for each treatment arm were shown (Table). Treatment-related grade 3/4 adverse events were reported in 37.5%, 35.7%, 20%, 66.7%, and 35.3% of patients in each treatment arm, respectively. No treatment-related adverse events (TRAEs) leading to discontinuation of treatment and no grade 5 TRAEs were observed. Conclusions: This is the first biomarker-driven umbrella study conducted in patients with platinum-resistant recurrent ovarian cancer. This umbrella study provides preliminary evidence on the clinical benefit of biomarker-driven targeted therapy. All regimens were manageable, without unexpected toxicities. Clinical trial information: NCT03699449. [Table: see text]
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- 2021
4. Phase IIa study of BVAC-C in HPV type 16 or 18 positive recurrent cervical carcinoma
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Kidong Kim, Yong-Man Kim, Taegwon Oh, Duck Cho, Myong Cheol Lim, Chel Hun Choi, Jae Weon Kim, Chang-Yuil Kang, Eun-Suk Kang, Jung Yun Lee, Duk-Soo Bae, Jeong-Won Lee, Hee Seung Kim, Young Tae Kim, and Byoung-Gie Kim
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Cancer Research ,Hpv types ,business.industry ,HPV Positive ,Transfection ,Recurrent Cervical Carcinoma ,law.invention ,medicine.anatomical_structure ,Oncology ,law ,medicine ,Cancer research ,Recombinant DNA ,business ,B cell - Abstract
5512 Background: BVAC-C is a B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7, which was well tolerated in HPV positive recurrent cervical carcinoma in phase I study (J Clin Med. 2020 Jan 5;9(1):147). This phase IIa study sought to determine the antitumor activity of BVAC-C. Methods: Twenty-one patients with HPV 16 or 18 positive recurrent cervical cancer who had experienced recurrence after one prior platinum-based combination chemotherapy were enrolled. They were allocated to 3 arms; Arm 1, BVAC-C injection at 0, 4, 8 weeks (1x108 cells/dose); Arm 2, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose); Arm 3, BVAC-C injection at 0, 4, 8, 12 weeks (5x107 cells/dose) with topotecan at 2, 6, 10, 14 weeks (0.75 mg/m2 for 3 days). Results: The overall response rate was 21% (Arm 1: 29% (2/7), Arm 2: 25% (1/4), Arm 3 : 0 % (0/3)) among the evaluable patients (N = 14), and the median duration of response was 18 months (range, 9 – 26 months). The disease control rate was 43% (Arm 1: 29% (2/7), Arm 2: 50% (2/4), Arm 3 : 67 % (2/3)) and the median duration of stable disease were 12 months (range, 6 - 26 months). The median progression-free survival in all patients was 4 months (95% CI, 2 to Infinite months). Immune responses of patients after vaccination were shown to be correlated with clinical responses of them. Consistent with Phase I study, all evaluated patients showed not only inflammatory cytokine responses (IFN-γ or TNF-α), which might be mediated by the activation of natural killer cells and natural killer T cells, but also potent E6/E7-specific T cell responses upon vaccinations. Conclusions: BVAC-C demonstrated a durable antitumor activity with an immune response in HPV 16- or 18-positive recurrent cervical carcinoma patients who failed 1st line platinum based chemotherapy. Clinical trial information: NCT02866006.
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- 2021
5. Efficacy and safety results of GX-188E, a therapeutic DNA vaccine, combined with pembrolizumab administration in patients with HPV 16- and/or 18- positive advanced cervical cancer: Phase II interim analysis results (KEYNOTE-567)
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Jung Won Woo, Soo Young Hur, Myong Cheol Lim, Yong Man Kim, Kyungun Kim, Jong Sup Park, Yoon-Jeong Choi, Young Chul Sung, Jae Hong No, Jae Kwan Lee, Dae Hoon Jeong, You Suk Suh, Chi Heum Cho, Sung Hoon Kim, and Byoung-Gie Kim
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Cervical cancer ,Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Pembrolizumab ,Interim analysis ,medicine.disease ,DNA vaccination ,Internal medicine ,medicine ,In patient ,business ,Objective response ,Metastatic cervical cancer - Abstract
5511 Background: Pembrolizumab was approved for the treatment of recurrent or metastatic cervical cancer, based on 14.3% of objective response rate (ORR) in patients with PD-L1 expression (CPS≥1). GX-188E vaccination has been shown to induce human papillomavirus (HPV) E6- and E7-specific T-cell responses. We aimed to investigate whether a combination of GX-188E (Tirvalimogene teraplasmid) therapeutic DNA vaccine plus pembrolizumab showed antitumor activity against recurrent or advanced cervical cancer. Methods: In this open-label, single-arm, phase 2 trial, patients with recurrent or advanced cervical cancer, who were aged over 18 years with ECOG PS of 0 or 1, HPV-16 or HPV-18 and histologically confirmed positive cervical cancer, and who had progressed after standard-of-care therapy were recruited from nine hospitals in South Korea. Patients received intramuscular 2 mg GX-188E at weeks 1, 2, 4, 7, 13, 19, and optional dose at week 46, and intravenous pembrolizumab 200 mg every 3 weeks for up to 2 years or until disease progression. The primary endpoint was the Best Overall Response Rate assessed by the investigator using RECIST version 1.1. Results: To date, a total of 52 patients have been enrolled and received at least one study treatment, and this interim analysis was performed after obtaining at least one post-baseline tumor assessment data from 48 patients. Median age was 52 (range, 27-79) years and 46.2% had ECOG PS 1. At the data cutoff date on January 11, 2021, median follow-up duration was 6.2 months (range; 1.7- 24.2 months). According to investigator evaluation, 15 (31.3%) of 48 patients achieved best overall response; 5 (10.4 %) patients had a complete response (CR) and 10 (20.8 %) had a partial response (PR). Especially, this combination treatment showed higher response rate, 48.0 %, in patients with PD-L1 positive, HPV-16 and squamous cell carcinoma. Median PFS was 4.1 months (range; 1.3-24.2) and median OS was 16.7 months (range; 1.7-24.2). In this clinical trial with cervical cancer patients, GX-188E in combination with pembrolizumab has shown an improved median PFS and OS than the monotherapy of pembrolizumab (KEYNOTE-158). 17 (32.7%) of 52 patients had treatment-related adverse events of any grade and two (3.8%) had grade 3 or 4 treatment-related adverse events; increased aspartate aminotransferase or alanine aminotransferase. No treatment-related deaths were reported. Conclusions: GX-188E vaccine combined with pembrolizumab in recurrent/advanced cervical cancer was safe and tolerable, and showed an enhanced clinical response rate compared with pembrolizumab alone in particular in patients with PD-L1 positive, HPV-16 and squamous cell carcinoma. The combination therapy could represent a new potential treatment option for this patient population. Clinical trial information: NCT03444376.
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- 2021
6. Randomized Phase III Trial of Irinotecan Plus Cisplatin Compared With Paclitaxel Plus Carboplatin As First-Line Chemotherapy for Ovarian Clear Cell Carcinoma: JGOG3017/GCIG Trial
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Mikio Mikami, Jae Weon Kim, Hiroshi Tanabe, Aikou Okamoto, Seiji Isonishi, Daisuke Aoki, Yoshihito Yokoyama, Hiroyuki Yoshikawa, Koji Nishino, Fumitoshi Terauchi, Takayuki Enomoto, John Green, Tetsutaro Hamano, Eriko Aotani, Nobuo Yaegashi, Jérôme Alexandre, Sandro Pignata, Hiroyuki Nomura, Nao Suzuki, Kiyoko Kato, Toru Sugiyama, Yasuhisa Terao, Byoung-Gie Kim, and Keiichi Fujiwara
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Adult ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Paclitaxel ,Urology ,Gynecologic oncology ,Irinotecan ,Disease-Free Survival ,Carboplatin ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Survival rate ,Aged ,Aged, 80 and over ,Ovarian Neoplasms ,Cisplatin ,business.industry ,Middle Aged ,Survival Rate ,030104 developmental biology ,chemistry ,030220 oncology & carcinogenesis ,Clear cell carcinoma ,Camptothecin ,Female ,business ,Adenocarcinoma, Clear Cell ,medicine.drug - Abstract
Purpose Clear cell carcinoma (CCC) is a rare histologic subtype that demonstrates poor outcomes in epithelial ovarian cancer. The Japanese Gynecologic Oncology Group conducted the first randomized phase III, CCC-specific clinical trial that compared irinotecan and cisplatin (CPT-P) with paclitaxel plus carboplatin (TC) in patients with CCC. Patients and Methods Six hundred sixty-seven patients with stage I to IV CCC of the ovary were randomly assigned to receive irinotecan 60 mg/m2 on days 1, 8, and 15 plus cisplatin 60 mg/m2 on day 1 (CPT-P group) every 4 weeks for six cycles or paclitaxel 175 mg/m2 plus carboplatin area under the curve 6.0 mg/mL/min on day 1 every 3 weeks for six cycles (TC group). The primary end point was progression-free survival. Secondary end points were overall survival, overall response rate, and adverse events. Results Six hundred nineteen patients were clinically and pathologically eligible for evaluation. With a median follow-up of 44.3 months, 2-year progression-free survival rates were 73.0% in the CPT-P group and 77.6% in TC group (hazard ratio, 1.17; 95% CI, 0.87 to 1.58; P = .85). Two-year overall survival rates were 85.5% with CPT-P and 87.4% with TC (hazard ratio, 1.13; 95% CI, 0.80 to 1.61; one-sided P = .76). Grade 3/4 anorexia, diarrhea, nausea, vomiting, and febrile neutropenia occurred more frequently with CPT-P, whereas grade 3/4 leukopenia, neutropenia, thrombocytopenia, peripheral sensory neuropathy, and joint pain occurred more frequently with TC. Conclusion No significant survival benefit was found for CPT-P. Both regimens were well tolerated, but the toxicity profiles differed significantly. Treatment with existing anticancer agents has limitations to improving the prognosis of CCC.
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- 2016
7. Maintenance olaparib after platinum-based chemotherapy in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Efficacy by surgical and tumor status in the Phase III SOLO1 trial
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Paul DiSilvestro, Carol Aghajanian, Michael Friedlander, Elizabeth S. Lowe, Gabe S. Sonke, Charlie Gourley, Giovanni Scambia, Alexandra Leary, Nicoletta Colombo, Antonio González-Martín, Byoung-Gie Kim, Kathleen N. Moore, Susana Banerjee, William H. Bradley, Amit M. Oza, Alla Sergeevna Lisyanskaya, Cara Mathews, Ana Oaknin, Anne Floquet, and Ralph Bloomfield
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Oncology ,Cancer Research ,medicine.medical_specialty ,Advanced ovarian cancer ,Chemotherapy ,business.industry ,medicine.medical_treatment ,BRCA mutation ,Newly diagnosed ,Placebo ,Olaparib ,03 medical and health sciences ,chemistry.chemical_compound ,Tumor Status ,0302 clinical medicine ,chemistry ,030220 oncology & carcinogenesis ,Internal medicine ,medicine ,In patient ,business ,030215 immunology - Abstract
5541 Background: In SOLO1 (NCT01844986), maintenance olaparib significantly improved progression-free survival (PFS) vs placebo (HR 0.30; 95% CI 0.23–0.41; Moore et al. N Engl J Med 2018) in pts with newly diagnosed advanced OC and a BRCAm. This analysis evaluates olaparib efficacy by timing of surgery, presence of residual tumor following surgery and response status after completion of chemotherapy in SOLO1. Methods: Pts underwent cytoreductive surgery and were in clinical complete response (CR) or partial response (PR) after platinum-based chemotherapy. Pts were stratified by response and received olaparib tablets 300 mg twice daily or placebo. Investigator-assessed PFS and objective response were assessed using modified RECIST v1.1. Results: 260 pts were randomized to olaparib and 131 to placebo; one pt did not receive placebo. Median follow-up was 41 months in both arms. 63% and 35% of pts underwent upfront and interval surgery, 21% and 76% had residual and no residual macroscopic disease after surgery, and 74% and 26% entered the study in clinical CR and PR (based on electronic case report form [eCRF] data). PFS was significantly improved regardless of the timing of surgery, residual disease status after surgery or response after platinum-based chemotherapy (Table). In pts with baseline radiologic evidence of disease (n=80; eCRF), the objective response rate was 43% for olaparib (CR, 28%) and 23% for placebo (CR, 12%). Conclusions: Maintenance olaparib improved outcomes compared with placebo in pts with newly diagnosed advanced OC and a BRCAm, regardless of surgical or tumor status. Clinical trial information: NCT01844986. [Table: see text]
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- 2019
8. Efficacy of maintenance olaparib for newly diagnosed, advanced ovarian cancer patients (pts) by BRCA1 or BRCA2 mutation in the phase III SOLO1 trial
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Nicoletta Colombo, Giovanni Scambia, Elizabeth S. Lowe, William H. Bradley, Alla Sergeevna Lisyanskaya, Gabe S. Sonke, Ralph Bloomfield, Paul DiSilvestro, Kathleen N. Moore, Amit M. Oza, Anne Floquet, Carol Aghajanian, Michael Friedlander, Byoung-Gie Kim, Ana Oaknin, Charlie Gourley, Antonio González-Martín, Alexandra Leary, and Susana Banerjee
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Oncology ,Cancer Research ,medicine.medical_specialty ,Advanced ovarian cancer ,business.industry ,Newly diagnosed ,Olaparib ,chemistry.chemical_compound ,BRCA2 Mutation ,chemistry ,Internal medicine ,medicine ,business - Abstract
5551 Background: In SOLO1 (NCT01844986), maintenance olaparib resulted in a significant improvement in progression-free survival (PFS) for newly diagnosed, BRCA1- and/or BRCA2-mutated, advanced ovarian cancer pts compared with placebo (HR 0.30, 95% CI 0.23–0.41; median not reached vs 13.8 months; Moore et al. N Engl J Med 2018). We investigated PFS in SOLO1 for the subgroups of pts with BRCA1 mutations ( BRCA1m) or BRCA2 mutations ( BRCA2m). Methods: All pts were in clinical complete or partial response to platinum-based chemotherapy and were randomized to maintenance olaparib (300 mg twice daily; tablets) or placebo. After 2 years, pts with no evidence of disease discontinued study treatment, but pts with evidence of disease could continue study treatment. PFS by BRCAm was a predefined analysis. BRCAm were identified by central germline (Myriad or BGI) or local testing; Foundation Medicine testing confirmed tumor BRCAm. Results: Median follow-up for PFS was ~41 months in the olaparib and placebo arms. Of 391 randomized pts, 282 had BRCA1m (72%), 106 had BRCA2m (27%) and three (1%) had both (Table). Two pts in the olaparib arm had somatic BRCAm (one BRCA1m, one BRCA2m); all others had germline BRCAm. At the primary data cut-off, 155 pts in the BRCA1-mutated group (55%), 43 in the BRCA2-mutated group (41%) and none in the BRCA1/2 -mutated group had disease progression. The percentage of BRCA1-mutated pts who received olaparib and were progression-free at 1, 2 and 3 years was 86%, 69% and 53% (vs 52%, 36% and 26% receiving placebo) and for BRCA2-mutated pts was 92%, 85% and 80% (vs 50%, 32% and 29%, respectively). Conclusions: Significant PFS benefit with olaparib versus placebo was demonstrated for all pts, regardless of whether they had BRCA1m or BRCA2m. Statistical tests were not used to compare BRCA1- and BRCA2-mutated pts, but those with BRCA2m appeared to receive greater benefit from maintenance olaparib than those with BRCA1m. Clinical trial information: NCT01844986. [Table: see text]
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- 2019
9. ENGOT-OV43/KEYLYNK-001: A phase III, randomized, double-blind, active- and placebo-controlled study of pembrolizumab plus chemotherapy with olaparib maintenance for first-line treatment of BRCA-nonmutated advanced epithelial ovarian cancer
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M Puglisi, Ignace Vergote, Qi Liu, Vanda Salutari, Robert M. Wenham, Stephanie Lheureux, Chyong-Huey Lai, Patricia Pautier, Stephen Michael Keefe, Antonio González-Martín, Radoslaw Madry, Paolo Zola, David Cibula, Jacob Korach, Samet Topuz, Jalid Sehouli, Kosei Hasegawa, and Byoung-Gie Kim
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,Placebo-controlled study ,Pembrolizumab ,Olaparib ,Double blind ,First line treatment ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,chemistry ,030220 oncology & carcinogenesis ,Internal medicine ,PARP inhibitor ,medicine ,Epithelial ovarian cancer ,business ,030215 immunology - Abstract
TPS5603 Background: There is a significant unmet need to develop new regimens for BRCA1/2-nonmutated advanced ovarian cancer (OC). The PARP inhibitor olaparib is approved for women with platinum-sensitive, recurrent OC regardless of BRCA1/2 status and, more recently, for newly diagnosed women with BRCA-mutated OC. In the TOPACIO/KEYNOTE-162 study, the combination of the PD-1–blocking antibody pembrolizumab (pembro) and niraparib demonstrated efficacy in platinum-resistant relapsed OCirrespective of BRCA1/2 status. ENGOT-OV43/KEYLYNK-001 (ClinicalTrials.gov, NCT03740165) is a phase 3, randomized, double-blind, active- and placebo-controlled study of pembro plus paclitaxel-carboplatin chemotherapy (CT) followed by olaparib maintenance for first-line treatment of patients with BRCA1/2-nonmutated advanced epithelial OC (EOC). Methods: Patients with stage III or IV BRCA-nonmutated EOC, primary peritoneal cancer, or fallopian tube cancer will be stratified by surgery status (no residual tumor after primary debulking surgery [PDS], residual tumor after PDS, or planned interval debulking), bevacizumab use, and PD-L1 status (combined positive score < 10 or ≥10). After one lead-in cycle of CT, patients will be randomized 1:1:1 to receive: CT + pembro followed by olaparib maintenance; CT + pembro followed by placebo; or CT + placebo followed by placebo. The CT regimen will be administered for 5 cycles, and pembro 200 mg Q3W will be administered for 35 infusions. Olaparib 300 mg BID maintenance therapy will start after the end of CT as concomitant treatment with pembro until discontinuation or for 2 years if the patient has a complete response. Bevacizumab use is permitted at investigator’s discretion and determined prerandomization. Primary endpoints are investigator-assessed progression-free survival (PFS) per RECIST 1.1 criteria and overall survival. Key secondary endpoints are PFS per RECIST 1.1 assessed by blinded independent central review, PFS after next-line treatment, and safety. Enrollment is currently ongoing. Clinical trial information: NCT03740165.
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- 2019
10. Quality of life (QoL) in a phase III trial of pelvic external beam radiation therapy (PXRT) versus vaginal cuff brachytherapy followed by paclitaxel/carboplatin chemotherapy (VCB/C) in patients with high risk, early stage endometrial carcinoma: An NRG Oncology/Gynecologic Oncology Group study
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David Cella, Katina Robison, James J. Burke, Robert S. Mannel, Thomas J. Rutherford, Vivian Vongruenigen, Ritu Salani, Helen Q. Huang, Lari Wenzel, Nick M. Spirtos, Marcus E. Randall, and Byoung-Gie Kim
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,Brachytherapy ,Gynecologic oncology ,medicine.disease ,Quality of life ,Internal medicine ,Carcinoma ,Medicine ,In patient ,Paclitaxel carboplatin ,Stage (cooking) ,business - Abstract
5593Background: In GOG Study 249, VCB/C was not superior to PXRT in overall survival or treatment failure rate (Randall et al, ASTRO, 2017). Here we compare QoL, fatigue, neurotoxicity, and gastroi...
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- 2018
11. Prognostic model for disease-free survival, lymphatic and/or hematogenous recurrence, in patients with early stage cervical cancer treated with radical hysterectomy: A Korean Gynecologic Oncology Group Study
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Yoo-Young Lee, Byoung-Gie Kim, Tae-Joong Kim, Min Kyu Kim, Jeong-Won Lee, Duk-Soo Bae, and Chel Hun Choi
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Cervical cancer ,Oncology ,Cancer Research ,medicine.medical_specialty ,Group study ,business.industry ,Gynecologic oncology ,medicine.disease ,Lymphatic system ,Internal medicine ,medicine ,Prognostic model ,In patient ,Stage (cooking) ,Radical Hysterectomy ,business - Abstract
e17000Background: To develop a model to predict 5 year disease-free survival (DFS), lymphatic and/or hematogenous recurrence, in early stage cervical cancer treated with radical hysterectomy, which...
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- 2016
12. Randomized phase III trial of carboplatin/paclitaxel alone (CP) or in combination with bevacizumab followed by bevacizumab (CPB) and secondary cytoreduction surgery in platinum-sensitive recurrent ovarian cancer: GOG0213, an NRG Oncology/GOG Study—Analysis of patient reported outcomes (PRO) on chemotherapy randomization
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Paul Sabbatini, Keiichi Fujiwara, Robert L. Coleman, Karen Basen-Engquist, Helen Q. Huang, David M. O'Malley, Byoung-Gie Kim, Deborah K. Armstrong, Thomas J. Herzog, Krishnansu S. Tewari, and Joan L. Walker
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,Randomization ,Bevacizumab ,business.industry ,medicine.medical_treatment ,Carboplatin/paclitaxel ,law.invention ,Surgery ,Tolerability ,Randomized controlled trial ,law ,Recurrent Ovarian Cancer ,Internal medicine ,medicine ,Platinum sensitive ,business ,medicine.drug - Abstract
5525 Purpose: GOG 213 is a bifactorial, phase III, randomized trial studying the efficacy and tolerability of the incorporation of B and secondary cytoreduction in women with platinum sensitive rec...
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- 2015
13. Propensity-score analysis of neoadjuvant chemotherapy vs. primary surgery in advanced ovarian cancer: Does surgical quality matter?
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Hyo Sook Bae, Joo-Hyun Nam, Jae Weon Kim, Byoung-Gie Kim, Sang Young Ryu, Sokbom Kang, and Seok Ju Seong
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Selection bias ,Cancer Research ,Advanced ovarian cancer ,Chemotherapy ,medicine.medical_specialty ,Multivariate statistics ,business.industry ,medicine.medical_treatment ,media_common.quotation_subject ,Histology ,Surgery ,Acs nsqip ,Oncology ,Propensity score matching ,medicine ,Stage (cooking) ,business ,media_common - Abstract
5568 Background: Although there are many studies that compared the outcome of neoadjuvant chemotherapy (NAC) and primary surgery in advanced ovarian cancer, most of them showed some limitations such as selection bias and the quality control of surgical procedure. Methods: Data of 1124 patients with advanced epithelial ovarian cancer (stage III-IV) were reviewed retrospectively. To mitigate the possible biases from the retrospective nature of the study, we performed a propensity score analysis. Progression-free survival was assessed using a multivariate Cox-proportional hazards regression model with inverse probability weights to adjust for propensity score. Results: Among the 1124 patients, 198 patients (17.6%) underwent NAC. The factors associated with the use of NAC were old age, non-serous histology, poor histologic grade, stage IV and higher serum CA 125 levels (P-value 0.211, 0.050, < 0.001, < 0.001 and < 0.001, respectively). After a propensity score adjustment using those factors, the progression-f...
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- 2015
14. Efficacy and safety comparison between belotecan and topotecan in patients with recurrent or refractory ovarian cancer: A multi-center, randomized, open-labelled, parallel-group phase IIb trial
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Yong Sang Song, Chi-Heum Cho, Yong Jung Song, Jong-Hyeok Kim, Byoung-Gie Kim, Hee Seung Kim, Beob-Jong Kim, Young Tae Kim, Sang Yoon Park, Chan Yong Park, and Yong Beom Kim
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Oncology ,Cancer Research ,medicine.medical_specialty ,Chemotherapy ,business.industry ,medicine.medical_treatment ,medicine.disease ,Surgery ,Refractory ,Internal medicine ,medicine ,Clinical endpoint ,Topotecan ,In patient ,Ovarian cancer ,business ,Adverse effect ,Camptothecin ,medicine.drug - Abstract
5527 Background: Belotecan is a camptothecin derivative with anti-tumor properties. Previous studies suggested the feasibility of belotecan-based chemotherapy for patients with primary or recurrent ovarian cancer. Thus, we conducted a phase IIb trial to compare the efficacy and safety between belotecan and another derivative of camptothecin, topotecan, in patients with recurrent or refractory ovarian cancer. Methods: Patients with recurrent or refractory ovarian cancer were randomized to receive belotecan 0.5 mg/m2 (B-arm) or topotecan 1.5 mg/m2(T-arm) intravenously for 5 consecutive days every 3 weeks till 6 cycles or disease progression. The primary endpoint was overall response rate based on RECIST or GCIG criteria, and secondary endpoints were progression-free survival (PFS), overall survival (OS) and adverse events according to NCI-CTCAE version 4.0. Results: One hundred and forty one patients were randomized from January 2011 to June 2014. Among all patients, 140 were eligible in full analysis (FA) ...
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- 2015
15. Randomized phase III trial of paclitaxel/carboplatin (PC) versus cisplatin/irinotecan (CPT-P) as first-line chemotherapy in patients with clear cell carcinoma (CCC) of the ovary: A Japanese Gynecologic Oncology Group (JGOG)/GCIG study
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Aikou Okamoto, Mikio Mikami, Nao Suzuki, Kiyoko Kato, Daisuke Aoki, John Green, Tetsutaro Hamano, Kazunori Ochiai, Hiroyuki Yoshikawa, Seiji Isonishi, Takayuki Enomoto, Jae Weon Kim, Keiichi Fujiwara, Nobuo Yaegashi, Fumitoshi Terauchi, Byoung Gie Kim, Sandro Pignata, Toru Sugiyama, Jérôme Alexandre, and Yasuhisa Terao
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,Cisplatin/irinotecan ,Ovary ,Gynecologic oncology ,medicine.anatomical_structure ,Internal medicine ,Clear cell carcinoma ,Medicine ,Epithelial ovarian cancer ,In patient ,Paclitaxel carboplatin ,First line chemotherapy ,business - Abstract
5507 Background: CCC is a histologic subtype of epithelial ovarian cancer showing different clinical and biological characteristics. CCC has become well known for its resistance to current standard...
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- 2014
16. Frequent use of complex surgeries and survival outcomes in ovarian cancer patients: A propensity score analysis from the Korean Gynecologic Oncology Group
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Jae Weon Kim, Sang Young Ryu, Seung Cheol Kim, Seok Ju Seong, Joo-Hyun Nam, Sokbom Kang, Byoung-Gie Kim, and Dae Chul Jung
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Cancer Research ,medicine.medical_specialty ,business.industry ,Proportional hazards model ,Gynecologic oncology ,Disease ,Logistic regression ,medicine.disease ,Frequent use ,Surgery ,Oncology ,Internal medicine ,Propensity score matching ,Prognostic model ,Medicine ,business ,Ovarian cancer - Abstract
5537 Background: To develop an indicator representing the quality of ovarian cancer surgery and to determine its predictive role in a prognostic model. Methods: From January 2002 to December 2008, the clinical records and computed tomography (CT) data of epithelial ovarian cancer patients were reviewed from the KGOG-3022 dataset. A propensity score was developed from a multivariable logistic model and used as a stratification factor or co-variable in Cox models to balance the differences between the high- and low/intermediate-complexity surgery group. Results: Data for 331 patients from six specialized teaching hospitals were reviewed. Complex surgery, defined as a surgery with a surgical complexity score > 7, was more frequently performed in patients with an ‘upper abdominal extension’ pattern, ‘diffuse peritoneal spread’ pattern, and grade III disease (P < 0.001, 0.017, and 0.001, respectively). To balance the differences, a propensity score for complex surgery was developed. The use of complex surgery ...
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- 2014
17. Randomized Phase III Trial of Irinotecan Plus Cisplatin Compared With Paclitaxel Plus Carboplatin As First-Line Chemotherapy for Ovarian Clear Cell Carcinoma: JGOG3017/GCIG Trial.
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Toru Sugiyama, Aikou Okamoto, Takayuki Enomoto, Tetsutaro Hamano, Eriko Aotani, Yasuhisa Terao, Nao Suzuki, Mikio Mikami, Nobuo Yaegashi, Kiyoko Kato, Hiroyuki Yoshikawa, Yoshihito Yokoyama, Hiroshi Tanabe, Koji Nishino, Hiroyuki Nomura, Jae-Weon Kim, Byoung-Gie Kim, Pignata, Sandro, Alexandre, Jerome, and Green, John
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- 2016
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18. An open label, randomized, parallel, phase II trial to evaluate the efficacy and safety of cremophor-free, polymeric micelle formulation of paclitaxel compared to paclitaxel in subjects with ovarian cancer
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Seung Cheol Kim, Hee-Sug Ryu, Seok-Mo Kim, Jae Hoon Kim, Soo Young Hur, Soon-Beom Kang, Yong-Man Kim, Young Tae Kim, Shin-Wha Lee, Chi Heum Cho, and Byoung-Gie Kim
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Oncology ,Cancer Research ,medicine.medical_specialty ,endocrine system diseases ,business.industry ,Combination chemotherapy ,medicine.disease ,Debulking ,female genital diseases and pregnancy complications ,Carboplatin ,chemistry.chemical_compound ,Paclitaxel ,chemistry ,Tolerability ,Response Evaluation Criteria in Solid Tumors ,Internal medicine ,medicine ,Clinical endpoint ,Ovarian cancer ,business - Abstract
5568 Background: Cremorphor EL, used to enhance drug solubility, may add to paclitaxel’s toxicities such as hypersensitivity reactions or peripheral neuropathy. This multi-institutional phase II trial is to evaluate the efficacy and safety of Cremophor-Free, Polymeric Micelle Formulation of Paclitaxel (Genexol-PM) compared to Paclitaxel (Genexol) as a combined chemotherapy with carboplatin in patients with advanced epithelial ovarian cancer. Methods: In this phase II, randomized, parallel study, patients with FIGO stage IC-IV epithelial ovarian cancer after debulking surgery received intravenously Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 combined with carboplatin iv (AUC 5) on day 1 of every 3-week cycle for a maximum of six cycles. The primary endpoint was composite response by GCIG CA-125 Response and Response Evaluation Criteria In Solid Tumors (RECIST). Secondary and exploratory endpoints included overall survival, progression-free survival, time to tumor progression, and safety and tolerability. Results: A total of 102 patients were randomized to Genexol-PM plus carboplatin (n = 51) or Genexol plus carboplatin (n = 51). Composite response rate in patients with or without measurable disease was 88.0% in the Genexol-PM plus carboplatin group and 77.1% in the Genexol plus carboplatin group. Noninferiority of Genexol-PM plus carboplatin compared with Genexol plus carboplatin was confirmed for composite response rate by CA-125/RECIST criteria. There were no differences in progression-free survival and overall tumor progression between the groups. Although there was a higher rate of grade 3 neutropenia in the Genexol-PM plus carboplatin group, the overall rate of hemodynamic adverse events was comparable between the 2 groups. There was no difference in peripheral neuropathy and hypersensitivity. No unexpected safety concerns were identified in this study. Conclusions: High-dose of Genexol-PM in combination with carboplatin was well tolerated, and its response rate was noninferior to that of Genexol plus carboplatin in patients with advanced epithelial ovarian cancer. Clinical trial information: NCT01276548.
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- 2013
19. Pazopanib (Paz) monotherapy in Asian women who have not progressed after first-line chemotherapy for advanced ovarian, Fallopian tube, or primary peritoneal carcinoma
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Beihua Kong, Jianqing Zhu, Yuanquing Yao, Qiong Wang, Lingying Wu, Qiang Wu, Lihui Wei, Xing Xie, Jihong Liu, Xiuqin Li, Kung-Liahng Wang, Rongyu Zang, Christopher L. Carpenter, Hextan Y.S. Ngan, Rutie Yin, Pingkuan Zhang, Ming-Shyen Yen, Ionel Mitrica, and Byoung-Gie Kim
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Oncology ,Gynecology ,Cancer Research ,medicine.medical_specialty ,Advanced ovarian cancer ,biology ,business.industry ,medicine.disease ,Pazopanib ,Multikinase inhibitor ,medicine.anatomical_structure ,Primary peritoneal carcinoma ,Maintenance therapy ,Internal medicine ,medicine ,biology.protein ,First line chemotherapy ,business ,Platelet-derived growth factor receptor ,medicine.drug ,Fallopian tube - Abstract
5512 Background: Paz, an oral multikinase inhibitor of VEGF, PDGF and c-Kit has showed activity in advanced ovarian cancer. This study evaluated paz as maintenance therapy in Asian women with advanced ovarian cancer. Methods: Subjects with FIGO stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer whose disease had not progressed after debulking surgery and followed by chemotherapy were randomized 1:1 to paz 800 mg once daily or placebo for up to 24 months. Primary endpoint was PFS by RECIST v1.0 based on visit date. If a progression occurred between the 2 scheduled visits (6 mos apart), progression was considered to have occurred at the next scheduled scan date. This minimized potential bias due to any imbalance of visit frequency between the arms. Results: 145 Asian subjects were randomized; 144 were treated. Mean age was 52.9 years. At diagnosis 17% were FIGO stage II, 73% stage III and 10% stage IV. After debulking surgery, 30% (n = 44) had no residual disease and 41% (n = 59) had. 47% (28/59) had residual disease ≤1cm. Prior to randomization, all subjects received median 8 cycles of chemotherapy; all subjects received platinum and taxane. At randomization 81% had ECOG status 0, 97% were disease free and all had normal CA-125. At clinical data cut-off median PFS was 18.1 months in both arms. Because of the small sample size a HR was not calculated but the KM curves indicated a trend in favor of paz from 6 to 18 mos; the curves crossed after 18 mos. The adverse event (AE) profile for paz was similar to previous reports except rates of hypertension and neutropenia were higher. The most frequent AEs (≥ 20%) on the paz arm were hypertension (76%), neutropenia (64%), leucopenia (53%), diarrhea (47%), hair color changes (40%), palm-plantar erythrodysaethesia syndrome (29%), ALT increase (28%), thrombocytopenia (24%), AST increase (22%) and TSH increase (21%). Most of these AEs were Grade 1-2. Conclusions: The results of this study alone cannot confirm the efficacy of paz maintenance treatment in Asian women with ovarian cancer, but should be interpreted in conjunction of AGO-OVAR16 study. Clinical trial information: NCT01227928.
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- 2013
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