Cancer Research and Treatment

Original Articles

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; Cancer Res Treat. 2018;50(1):195-203. Published online March 21, 2017; DOI: https://doi.org/10.4143/crt.2016.376

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 3weeks (6 cycles). The primary endpointwas 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.

Citations

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Uterine Leiomyosarcoma : 14-year Two-center Experience of 31 Cases: Woo Young Kim, Suk-Joon Chang, Ki-Hong Chang, Jong-Hyuck Yoon, Jang Hee Kim, Byoung-Gie Kim, Duk-Soo Bae, Hee-Sug Ryu; Cancer Res Treat. 2009;41(1):24-28. Published online March 31, 2009; DOI: https://doi.org/10.4143/crt.2009.41.1.24

Abstract PDF PubReader ePub

Purpose

The aim of this study was to evaluate the clinicopathological characteristics of uterine leiomyosarcoma (LMS) and possible prognostic factors.

Materials and Methods

This study included 31 patients with histologically proven LMS at Samsung Medical Center and Ajou University Hospital between 1994 and 2007. The medical records and available histological slides were reviewed retrospectively.

Results

The median age was 46 years (range, 32~63). The most common symptom was vaginal bleeding (11 patients, 35.5%). There were 23 patients with stage I, one patient with stage III, seven patients with stage IV disease. The median follow up time was 29 months (range, 1~94). The most common recurrence site was lung (5 case), followed by pelvis and upper abdomen (2 case). Nine patients died of disease with a 5-year overall survival rate of 63%. Early tumor stage and mitotic count were the prognostic factor in univariate analysis (p<0.0001 and p=0.0031, respectively), but early tumor stage only was associated with prognosis in multivariate analysis (p=0.010 vs p=0.143). Adjuvant treatment for early stage disease did not decrease the recurrence rate (p=0.1075), but high mitotic count (15>10HPF) had a trend for disease recurrence in early stage LMS (p=0.0859).

Conclusion

Mitotic count less than 15/HPF in early stage may be related with longer progression-free interval, but we could not reach the conclusion that adjuvant therapy in early stage LMS be effective.

Citations

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Relationship between Pre-treatment Serum SCC (squamous cell carcinoma) Antigen, Cyfra 21-1 Levels, and Survival in Squamous Cell Carcinoma of the Uterine Cervix: Ki-Hong Chang, Hee-Sug Ryu, Suk-Joon Chang, Young-Ji Byun, Jung-Pil Lee; Cancer Res Treat. 2005;37(5):302-306. Published online October 31, 2005; DOI: https://doi.org/10.4143/crt.2005.37.5.302

Abstract PDF PubReader ePub: Purpose
To determine the relationship between pretreatment serum squamous cell carcinoma (SCC) antigen and Cyfra 21-1 levels, and survival in patients with invasive squamous cell carcinoma of the cervix.
Materials and Methods
One hundred and one cervical squamous cell carcinoma patients were included. Pre-treatment levels of serum SCC antigen and Cyfra 21-1 were measured, with a 5 year minimum follow up. Thirty two recurrent disease (RD) patients were compared to 99 non-recurrent disease (NRD) patients with respect to tumor markers, FIGO stage, lesion size, lymph node status, and parametrial involvement.
Results
Pre-treatment serum SCC antigen and Cyfra 21-1 levels were significantly higher in the RD group (p<0.001). Combined serum SCC antigen and Cyfra 21-1 levels showed higher sensitivity for prediction of recurrence (90.6%). Pre-treatment SCC antigen and Cyfra 21-1 levels showed correlation with high FIGO stage, large lesion size, lymph node status, and parametrial involvement (p<0.001). Normal pre-treatment levels of SCC antigen and Cyfra 21-1 showed a 5-year survival rate of 93% and 90% respectively, while elevated levels showed significantly decreased survival rate of 63% and 59%, respectively (p<0.001). Odd ratio for cumulative survival rates were 6.87 for SCC antigen, and 5.07 for Cyfra 21-1 (p<0.001).
Conclusion
Initial pre-treatment levels of serum SCC antigen and Cyfra 21-1 are closely related to FIGO stage, lesion size, lymph node and parametrial involvement in patients with squamous cell carcinoma of the cervix. Also, these markers may be of help to predicting recurrent disease and survival rates.

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