An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021)

Shin Wha Lee; Yong Man Kim; Chi Heum Cho; Young Tae Kim; Seok Mo Kim; Soo Young Hur; Jae Hoon Kim; Byoung Gie Kim; Seung Cheol Kim; Hee Sug Ryu; Soon Beom Kang

doi:10.4143/crt.2016.376

An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021)

Shin Wha Lee, Yong Man Kim, Chi Heum Cho, Young Tae Kim, Seok Mo Kim, Soo Young Hur, Jae Hoon Kim, Byoung Gie Kim, Seung Cheol Kim, Hee Sug Ryu, Soon Beom Kang

Department of Obstetrics and Gynecology

Research output: Contribution to journal › Article › peer-review

65 Scopus citations

Abstract

Purpose Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here, we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment. Materials and Methods In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² with 5 area under the curve carboplatin every 3 weeks (6 cycles). The primary endpoint was the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR). Results Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m² Genexol-PM or 174.24±3.81 mg/m² Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ! grade 3 occurred in one patient receiving Genexol. All toxicities were manageable. Conclusion Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.

Original language	English
Pages (from-to)	195-203
Number of pages	9
Journal	Cancer Research and Treatment
Volume	50
Issue number	1
DOIs	https://doi.org/10.4143/crt.2016.376
State	Published - 1 Jan 2018

Bibliographical note

Publisher Copyright:
© 2018 by the Korean Cancer Association.

Keywords

Carboplatin
Genexol
Genexol-PM
Ovarian neoplasms
Phase II trial

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Lee, S. W., Kim, Y. M., Cho, C. H., Kim, Y. T., Kim, S. M., Hur, S. Y., Kim, J. H., Kim, B. G., Kim, S. C., Ryu, H. S., & Kang, S. B. (2018). An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021). Cancer Research and Treatment, 50(1), 195-203. https://doi.org/10.4143/crt.2016.376

Lee, Shin Wha ; Kim, Yong Man ; Cho, Chi Heum et al. / An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer : A Korean Gynecologic Oncology Group Study (KGOG-3021). In: Cancer Research and Treatment. 2018 ; Vol. 50, No. 1. pp. 195-203.

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title = "An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021)",

abstract = "Purpose Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here, we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment. Materials and Methods In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 with 5 area under the curve carboplatin every 3 weeks (6 cycles). The primary endpoint was the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR). Results Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m2 Genexol-PM or 174.24±3.81 mg/m2 Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ! grade 3 occurred in one patient receiving Genexol. All toxicities were manageable. Conclusion Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.",

keywords = "Carboplatin, Genexol, Genexol-PM, Ovarian neoplasms, Phase II trial",

author = "Lee, {Shin Wha} and Kim, {Yong Man} and Cho, {Chi Heum} and Kim, {Young Tae} and Kim, {Seok Mo} and Hur, {Soo Young} and Kim, {Jae Hoon} and Kim, {Byoung Gie} and Kim, {Seung Cheol} and Ryu, {Hee Sug} and Kang, {Soon Beom}",

note = "Publisher Copyright: {\textcopyright} 2018 by the Korean Cancer Association.",

year = "2018",

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doi = "10.4143/crt.2016.376",

language = "English",

volume = "50",

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Lee, SW, Kim, YM, Cho, CH, Kim, YT, Kim, SM, Hur, SY, Kim, JH, Kim, BG, Kim, SC, Ryu, HS & Kang, SB 2018, 'An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021)', Cancer Research and Treatment, vol. 50, no. 1, pp. 195-203. https://doi.org/10.4143/crt.2016.376

An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021). / Lee, Shin Wha; Kim, Yong Man; Cho, Chi Heum et al.
In: Cancer Research and Treatment, Vol. 50, No. 1, 01.01.2018, p. 195-203.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer

T2 - A Korean Gynecologic Oncology Group Study (KGOG-3021)

AU - Lee, Shin Wha

AU - Kim, Yong Man

AU - Cho, Chi Heum

AU - Kim, Young Tae

AU - Kim, Seok Mo

AU - Hur, Soo Young

AU - Kim, Jae Hoon

AU - Kim, Byoung Gie

AU - Kim, Seung Cheol

AU - Ryu, Hee Sug

AU - Kang, Soon Beom

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Purpose Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here, we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment. Materials and Methods In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 with 5 area under the curve carboplatin every 3 weeks (6 cycles). The primary endpoint was the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR). Results Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m2 Genexol-PM or 174.24±3.81 mg/m2 Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ! grade 3 occurred in one patient receiving Genexol. All toxicities were manageable. Conclusion Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.

AB - Purpose Genexol-PM is a biodegradable cremophor EL-free polymeric micelle formulation of paclitaxel. Here, we compared efficacy and safety of Genexol-PM plus carboplatin versus Genexol plus carboplatin for ovarian cancer treatment. Materials and Methods In this multicenter, randomized, phase II study, patients with International Federation of Gynecology and Obstetrics IC-IV epithelial ovarian cancer were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 with 5 area under the curve carboplatin every 3 weeks (6 cycles). The primary endpoint was the carbohydrate antigen 125 and Response Evaluation Criteria In Solid Tumor composite overall response rate (ORR). Results Of 131 enrolled patients, 98 were included in intention-to-treat analysis. Mean dosages were 260.00±0.00 mg/m2 Genexol-PM or 174.24±3.81 mg/m2 Genexol. Median followup was 18.0 months (range, 6.1 to 33.8 months). ORR was 88.0% (95% confidence interval [CI], 80.4 to 95.6) with Genexol-PM, and 77.1% (95% CI, 67.1 to 87.1) with Genexol (noninferiority threshold, 16.3%). Median time to progression was 14.8 months (95% CI, 11.3 to 20.2) with Genexol-PM and 15.4 months (95% CI, 13.2 to 29.6) with Genexol (p=0.550). Overall, six patients died. Neutropenia was the most common toxicity (incidences of 86.0% vs. 77.1%, p=0.120). Peripheral neuropathy incidences were 84.0% versus 64.6% (p= 0.148). Peripheral neuropathy of ! grade 3 occurred in one patient receiving Genexol. All toxicities were manageable. Conclusion Genexol-PM plus carboplatin as first-line treatment in patients with epithelial ovarian cancer demonstrated non-inferior efficacy and well-tolerated toxicities compared with the standard paclitaxel regimen. Further studies are warranted to optimize the dose and schedule, and to investigate long-term outcomes.

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KW - Genexol

KW - Genexol-PM

KW - Ovarian neoplasms

KW - Phase II trial

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Lee SW, Kim YM, Cho CH, Kim YT, Kim SM, Hur SY et al. An open-label, randomized, parallel, phase ii trial to evaluate the efficacy and safety of a cremophor-free polymeric micelle formulation of paclitaxel as first-line treatment for ovarian cancer: A Korean Gynecologic Oncology Group Study (KGOG-3021). Cancer Research and Treatment. 2018 Jan 1;50(1):195-203. doi: 10.4143/crt.2016.376