Cancer Research and Treatment

Original Articles

Development and Validation of Ovarian Symptom Index-18 and Neurotoxicity-4 for Korean Patients with Ovarian, Fallopian Tube, or Primary Peritoneal Cancer: Maria Lee, Yumi Lee, Kidong Kim, Eun Young Park, Myong Cheol Lim, Jung-Sup Kim, Hee Seung Kim, Yong-Beom Kim, Yong-Man Kim, Jungnam Joo, Sang Yoon Park, Chel Hun Choi, Jae-Hoon Kim; Cancer Res Treat. 2019;51(1):112-118. Published online March 7, 2018; DOI: https://doi.org/10.4143/crt.2017.361

Abstract PDF Supplementary Material PubReader ePub

Purpose
The purpose of this study was to develop Korean versions of the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (NCCN-FACT) Ovarian Symptom Index-18 (NFOSI-18) and FACT/Gynecologic Oncology Group (FACT-GOG) Neurotoxicity 4-item (NTX-4), evaluating their reliability and reproducibility.
Materials and Methods
In converting NFOSI-18 and NTX-4, the following steps were performed: forward translation, backward translation, expert review, pretest of preliminary format, and finalization of Korean versions (K-NFOSI-18 and K-NTX-4). Patients were enrolled from six institutions where each had completed chemotherapy for ovarian, tubal, or peritoneal cancer at least 1 month earlier. In addition to demographics obtained by questionnaire, all subjects were assessed via K-NFOSI-18, K-NTX-4, and a Korean version of the EuroQoL-5 Dimension. Internal structural validity and reliability were evaluated using item internal consistency, item discriminant validity, and Cronbach's α. To evaluate test-retest reliability, K-NFOSI-18 and K-NTX-4 were readministered after 7-21 days, and intraclass correlation coefficients (ICCs) were calculated.
Results
Of the 250 women enrolled during the 3-month recruitment period, 13 withdrew or did not respond, leaving 237 (94.8%) for the analyses. Mean patient age was 54.3±10.8 years. Re-testing was performed in 190 patients (80.2%). The total K-NFOSI-18 and K-NTX-4 scores were 49 (range, 20 to 72) and 9 (range, 0 to 16), respectively, with high reliability (Cronbach's α=0.84 and 0.89, respectively) and reproducibility (ICC=0.77 and 0.84, respectively) achieved in retesting.
Conclusion
Both NFOSI-18 and NTX-4 were successfully developed in Korean with minimal modification. Each Korean version showed high internal consistency and reproducibility.

Citations

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Peripheral Neuropathy Instruments for Individuals with Cancer: A COSMIN-Based Systematic Review of Measurement Properties
Silvia Belloni, Arianna Magon, Chiara Giacon, Francesca Savioni, Gianluca Conte, Rosario Caruso, Cristina Arrigoni
Current Oncology.2024; 31(12): 7828. CrossRef
Assessing the quality of patient-reported outcome measurements for gynecological cancers: a systematic review
Charlotte L Moss, Teresa Guerrero-Urbano, Ingrid White, Benjamin Taylor, Rebecca Kristeleit, Ana Montes, Louis Fox, Katharina Beyer, Monika Sztankay, Maria M Ratti, Elena S Sisca, Alexandra Derevianko, Steven MacLennan, Nicholas Wood, Lisa M Wintner, Miek
Future Oncology.2023; 19(9): 663. CrossRef
Validity and Reliability of the Turkish Version of National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18) and Neurotoxicity-4 (NTX-4) for Patients with Advanced Ovarian Cancer
Husnu Tore Yavuzsen, Sukriye Cansu Gulteki̇n, Karya Polat, Murat Keser, Zeynep Gulsum Guc, Merve Keskinkilic, Tugba Yavuzsen, Didem Karadibak, Sourav Panja
European Journal of Cancer Care.2023; 2023: 1. CrossRef
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Tiffany Li, Susanna B. Park, Eva Battaglini, Madeleine T. King, Matthew C. Kiernan, David Goldstein, Claudia Rutherford
Quality of Life Research.2022; 31(11): 3091. CrossRef
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Aline Reinmann, Anne-Violette Bruyneel, Joseph Gligorov, Serge Mesure, Christophe Combescure, Thibaud Koessler, Alexandre Bodmer
BMJ Open.2022; 12(9): e061664. CrossRef

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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

Abstract PDF PubReader ePub

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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