1.Efficacy of palonosetron plus dexamethasone in preventing chemotherapy-induced nausea and emesis in patients receiving carboplatin-based chemotherapy for gynecologic cancers: a phase II study by the West Japan Gynecologic Oncology Group (WJGOG 131).
Shin NISHIO ; Satomi AIHARA ; Mototsugu SHIMOKAWA ; Akira FUJISHITA ; Shuichi TANIGUCHI ; Toru HACHISUGA ; Shintaro YANAZUME ; Hiroaki KOBAYASHI ; Fumihiro MURAKAMI ; Fumitaka NUMA ; Kohei KOTERA ; Naofumi OKURA ; Naoyuki TOKI ; Masatoshi YOKOYAMA ; Kimio USHIJIMA
Journal of Gynecologic Oncology 2018;29(5):e77-
OBJECTIVE: Palonosetron is effective for the management of acute and delayed chemotherapy-induced nausea and vomiting (CINV). While emetogenic carboplatin-based chemotherapy is widely used to treat gynecologic cancers, few studies have evaluated the antiemetic effectiveness of palonosetron in this setting. METHODS: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer. Chemotherapy-naïve patients received intravenous palonosetron (0.75 mg/body) and dexamethasone before the infusion of carboplatin-based chemotherapy on day 1. Dexamethasone was administered (orally or intravenously) on days 2–3. The incidence and severity of CINV were evaluated using the patient-completed Multinational Association of Supportive Care in Cancer Antiemesis Tool and treatment diaries. The primary endpoint was the proportion of patients experiencing complete control (CC) of vomiting, with “no rescue antiemetic medication” and “no clinically significant nausea” or “only mild nausea” in the delayed phase (24–120 hours post-chemotherapy). Secondary endpoints were the proportion of patients with a complete response (CR: “no vomiting” and “no rescue antiemetic medication”) in the acute (0–24 hours), delayed (24–120 hours), and overall (0–120 hours) phases, and CC in the acute and overall phases. RESULTS: Efficacy was assessable in 77 of 80 patients recruited. In the acute and delayed phases, the CR rates the primary endpoint, were 71.4% and 59.7% and the CC rates, the secondary endpoint, were 97.4% and 96.1%, respectively. CONCLUSION: While palonosetron effectively controls acute CINV, additional antiemetic management is warranted in the delayed phase after carboplatin-based chemotherapy in gynecologic cancer patients (Trial registry at UMIN Clinical Trials Registry, UMIN000012806).
Antiemetics
;
Carboplatin
;
Dexamethasone*
;
Drug Therapy*
;
Female
;
Genital Neoplasms, Female
;
Humans
;
Incidence
;
Japan*
;
Nausea*
;
Vomiting*
2.Clinical statistics of gynecologic cancers in Japan.
Wataru YAMAGAMI ; Satoru NAGASE ; Fumiaki TAKAHASHI ; Kazuhiko INO ; Toru HACHISUGA ; Daisuke AOKI ; Hidetaka KATABUCHI
Journal of Gynecologic Oncology 2017;28(2):e32-
Cervical, endometrial, and ovarian cancers, have both high morbidity and mortality among the gynecologic malignant tumors in Japan. The present study was conducted using both the population-based cancer registry and the gynecologic cancer registry to elucidate the characteristics of gynecologic malignant tumors in Japan. Based on nationwide estimates from the population-based cancer registry in Japan, the morbidities and mortality of cervical, endometrial, and ovarian cancers were obtained and used for analysis. Clinicopathologic factors for cervical cancer, endometrial cancer, ovarian cancer, including age, clinical stage, postsurgical stage, histological type, therapeutic strategy, and prognosis were retrieved from the gynecologic cancer registry published by the Japan Society of Obstetrics and Gynecology and used for analysis. The morbidities of cervical, endometrial, and ovarian cancers were 10,908, 13,606, and 9,384 women in 2012, respectively. The prevalence of endometrial cancer has significantly and consistently been increasing and represents the most common gynecologic malignant tumor in Japan. The mortalities of cervical, endometrial, and ovarian cancers were 2.1, 1.3, and 3.2 per 100,000 in 2012, respectively. In 2014, 52.2% of cervical cancer patients were classified as stage I, 22.5% as stage II, 10.2% as stage III, and 11.2% as stage IV. In addition, 71.9% of endometrial cancer patients were classified as stage I, 6.0% as stage II, 13.3% as stage III, and 7.5% as stage IV. Finally, 43.2% of ovarian cancer patients were classified as stage I, 9.1% as stage II, 27.6% as stage III, and 7.2% as stage IV. Twelve point five percent of ovarian cancer patients received neoadjuvant chemotherapy.
Drug Therapy
;
Endometrial Neoplasms
;
Female
;
Genital Neoplasms, Female
;
Gynecology
;
Humans
;
Japan*
;
Mortality
;
Obstetrics
;
Ovarian Neoplasms
;
Prevalence
;
Prognosis
;
Registries
;
Uterine Cervical Neoplasms
3.The Relationships among Chemotherapy-Induced Nausea and Vomiting (CINV), Non-Pharmacological Coping Methods, and Nutritional Status in Patients with Gynecologic Cancer.
Journal of Korean Academy of Nursing 2017;47(6):731-743
PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) can cause severe malnutrition. However, relationships between CINV levels, non-pharmacological coping methods, and nutritional status of female cancer patients have rarely been investigated. Therefore, this study aimed to analyze their relationships in gynecologic cancer patients. METHODS: Participants receiving a highly and moderately emetogenic chemotherapy were recruited. The level of CINV was assessed using a numeric rating scale. Coping methods were determined using multiple-choice self-report questionnaires and categorized into seven types for statistical analysis. Nutritional status was evaluated using biochemical and anthropometric parameters. RESULTS: Among all the 485 patients, 200 eligible inpatients were included. Despite the administration of prophylactic antiemetics, 157 patients (78.5%) still experienced CINV, and several used nonmedically recommended coping methods, such as just enduring the symptom or rejecting food intake. A total of 181 patients (90.5%) had nutritional disorders. Although the level of CINV was indirectly related to the occurrence of nutritional disorders, patients who rejected food (β=1.57, p=.023) and did not use physical measures (β= −1.23, p=.041) as coping methods were under the high risk of nutritional disorders. CONCLUSION: Korean gynecologic cancer patients had high levels of CINV and were at high risk of nutritional disorders, which may be related to the use of nonscientific coping methods, possibly due to cultural backgrounds and lack of proper nutritional program. Therefore, developing a culturally appropriate educational program for the cancer patients with CINV is urgently needed.
Antiemetics
;
Child
;
Drug Therapy
;
Eating
;
Female
;
Genital Neoplasms, Female
;
Humans
;
Inpatients
;
Malnutrition
;
Methods*
;
Nausea*
;
Nutrition Disorders
;
Nutritional Status*
;
Vomiting*
4.The impact of malnutrition on survival in patients with gynecologic cancer undergoing chemotherapy.
Ju Hee NHO ; Yong Soon KWON ; Seongil JO
Journal of Nutrition and Health 2017;50(6):595-602
PURPOSE: Malnutrition is a major concern in patients with gynecologic cancer receiving chemotherapy. The aim of this study was to evaluate the prognostic significance of malnutrition in patients with gynecologic cancer undergoing chemotherapy. METHODS: A prospective, observational study was conducted on a total of 99 subjects who were treated at a tertiary hospital in Korea. Data regarding demographic, clinical, nutritional, and psychological characteristics at baseline and survival were obtained. RESULTS: Performance status, nutritional status, depression, and annual income were significantly different between survivors and non-survivors. Multivariate Cox modeling after adjusting for other factors showed that a malnourished status in patients with gynecologic cancer undergoing chemotherapy was a significant and independent negative influencing factor for survival. CONCLUSION: These findings provide evidence that adequate nutritional assessment and intervention may assist in improving survival in patients with gynecologic cancer undergoing chemotherapy.
Depression
;
Drug Therapy*
;
Female
;
Genital Neoplasms, Female
;
Humans
;
Korea
;
Malnutrition*
;
Nutrition Assessment
;
Nutritional Status
;
Observational Study
;
Prospective Studies
;
Survivors
;
Tertiary Care Centers
5.Major clinical research advances in gynecologic cancer in 2016: 10-year special edition.
Dong Hoon SUH ; Miseon KIM ; Kidong KIM ; Hak Jae KIM ; Kyung Hun LEE ; Jae Weon KIM
Journal of Gynecologic Oncology 2017;28(3):e45-
In 2016, 13 topics were selected as major research advances in gynecologic oncology. For ovarian cancer, study results supporting previous ones regarding surgical preventive strategies were reported. There were several targeted agents that showed comparable responses in phase III trials, including niraparib, cediranib, and nintedanib. On the contrary to our expectations, dose-dense weekly chemotherapy regimen failed to prove superior survival outcomes compared with conventional triweekly regimen. Single-agent non-platinum treatment to prolong platinum-free-interval in patients with recurrent, partially platinum-sensitive ovarian cancer did not improve and even worsened overall survival (OS). For cervical cancer, we reviewed robust evidences of larger-scaled population-based study and cost-effectiveness of nonavalent vaccine for expanding human papillomavirus (HPV) vaccine coverage. Standard of care treatment of locally advanced cervical cancer (LACC) was briefly reviewed. For uterine corpus cancer, new findings about appropriate surgical wait time from diagnosis to surgery were reported. Advantages of minimally invasive surgery over conventional laparotomy were reconfirmed. There were 5 new gene regions that increase the risk of developing endometrial cancer. Regarding radiation therapy, Post-Operative Radiation Therapy in Endometrial Cancer (PORTEC)-3 quality of life (QOL) data were released and higher local control rate of image-guided adaptive brachytherapy was reported in LACC. In addition, 4 general oncology topics followed: chemotherapy at the end-of-life, immunotherapy with reengineering T-cells, actualization of precision medicine, and artificial intelligence (AI) to make personalized cancer therapy real. For breast cancer, adaptively randomized trials, extending aromatase inhibitor therapy, and ribociclib and palbociclib were introduced.
Aromatase
;
Artificial Intelligence
;
Brachytherapy
;
Breast Neoplasms
;
Diagnosis
;
Drug Therapy
;
Endometrial Neoplasms
;
Female
;
Genital Neoplasms, Female
;
Humans
;
Immunotherapy
;
Laparotomy
;
Minimally Invasive Surgical Procedures
;
Ovarian Neoplasms
;
Precision Medicine
;
Quality of Life
;
Standard of Care
;
T-Lymphocytes
;
Uterine Cervical Neoplasms
7.Effects of Lifestyle Intervention on Fatigue, Nutritional Status and Quality of Life in Patients with Gynecologic Cancer.
Hyunjin AN ; Ju Hee NHO ; Sunyoung YOO ; Hyunmin KIM ; Minji NHO ; Hojeong YOO
Journal of Korean Academy of Nursing 2015;45(6):812-822
PURPOSE: The purpose of this study was to examine the effect of lifestyle intervention on the development of fatigue, nutritional status and quality of life of patients with gynecologic cancer. METHODS: A nonequivalent control group quasi-experimental design was used. Participants were 49 patients with gynecologic cancer. They were assigned to the experiment group (n=24) or the control group (n=25). The lifestyle intervention for this study consisted of physical activity, nutritional education, telephone call counseling, health counseling, monitoring for lifestyle, and affective support based on Cox's Interaction Model of Client Health Behavior and was implemented for six weeks. RESULTS: Significant group differences were found for fatigue (p =.037), nutritional status (p =.034) and social/family well-being (p =.035) in these patients with gynecologic cancer. CONCLUSION: Results indicate that this lifestyle intervention is effective in lessening fatigue, and improving nutritional status and social/family well-being. Therefore, nurses in hospitals should develop strategies to expand and provide lifestyle interventions for patients with cancer.
Adult
;
Aged
;
Antineoplastic Agents/therapeutic use
;
*Fatigue
;
Female
;
Genital Neoplasms, Female/drug therapy/*psychology
;
Health Behavior
;
Health Education
;
Humans
;
*Life Style
;
Middle Aged
;
*Nutritional Status
;
Proportional Hazards Models
;
*Quality of Life
;
Surveys and Questionnaires
8.Major clinical research advances in gynecologic cancer in 2014.
Dong Hoon SUH ; Kyung Hun LEE ; Kidong KIM ; Sokbom KANG ; Jae Weon KIM
Journal of Gynecologic Oncology 2015;26(2):156-167
In 2014, 9 topics were selected as major advances in clinical research for gynecologic oncology: 2 each in cervical and corpus cancer, 4 in ovarian cancer, and 1 in breast cancer. For cervical cancer, several therapeutic agents showed viable antitumor clinical response in recurrent and metastatic disease: bevacizumab, cediranib, and immunotherapies including human papillomavirus (HPV)-tumor infiltrating lymphocytes and Z-100. The HPV test received FDA approval as the primary screening tool of cervical cancer in women aged 25 and older, based on the results of the ATHENA trial, which suggested that the HPV test was a more sensitive and efficient strategy for cervical cancer screening than methods based solely on cytology. For corpus cancers, results of a phase III Gynecologic Oncology Group (GOG) 249 study of early-stage endometrial cancer with high-intermediate risk factors are followed by the controversial topic of uterine power morcellation in minimally invasive gynecologic surgery. Promising results of phase II studies regarding the effectiveness of olaparib in various ovarian cancer settings are summarized. After a brief review of results from a phase III study on pazopanib maintenance therapy in advanced ovarian cancer, 2 outstanding 2014 ASCO presentations cover the topic of using molecular subtypes in predicting response to bevacizumab. A review of the use of opportunistic bilateral salpingectomy as an ovarian cancer preventive strategy in the general population is presented. Two remarkable studies that discussed the effectiveness of adjuvant ovarian suppression in premenopausal early breast cancer have been selected as the last topics covered in this review.
Biomedical Research/*trends
;
Endometrial Neoplasms/drug therapy/pathology/surgery
;
Female
;
Genital Neoplasms, Female/diagnosis/*therapy
;
Humans
;
Ovarian Neoplasms/drug therapy/pathology/surgery
;
Uterine Cervical Neoplasms/drug therapy/pathology/surgery
9.Palonosetron versus granisetron in combination with aprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients with gynecologic cancer.
Satoe FUJIWARA ; Yoshito TERAI ; Satoshi TSUNETOH ; Hiroshi SASAKI ; Masanori KANEMURA ; Masahide OHMICHI
Journal of Gynecologic Oncology 2015;26(4):311-319
OBJECTIVE: There is no research regarding the appropriate antiemetic agents for female patients, especially those receiving moderately emetogenic chemotherapy (MEC). We evaluated the antiemetic efficacy of a combination of 5-HT3 receptor with/without aprepitant in patients with gynecological cancer treated with the TC (paclitaxel and carboplatin) regimen of MEC. METHODS: We enrolled 38 patients diagnosed with gynecologic cancer and scheduled to receive the TC regimen. The patients were randomly assigned to receive a 5-HT3 receptor antagonist, either palonosetron in the first cycle followed by granisetron in the second cycle or vice versa. In the third cycle, all patients received a combination of the 5-HT3 receptor and dexamethasone with/without aprepitant. RESULTS: When three drugs were administered, palonosetron consistently produced an equivalent complete response (CR) rate to granisetron in the acute phase (89.5% vs. 86.8%, p=0.87) and delayed phase (60.5% vs. 65.8%, p=0.79). With regard to the change in dietary intake, palonosetron exhibited similar efficacy to granisetron in the acute phase (92.1% vs. 89.4%, p=0.19) and delayed phase (65.7% vs. 68.4%, p=0.14). However, in the delayed phase, the addition of aprepitant therapy with a 5-HT3 receptor antagonist and dexamethasone produced a higher CR rate than a 5-HT3 receptor antagonist with dexamethasone (93.3% vs. 47.8%, p<0.001) and allowed the patients to maintain a higher level of dietary intake (93.3% vs. 56.5%, p<0.001). CONCLUSION: The addition of aprepitant therapy was more effective than the control therapy of a 5-HT3 receptor antagonist, and dexamethasone in gynecological cancer patients treated with the TC regimen.
Adult
;
Aged
;
Antiemetics/*administration & dosage
;
Antineoplastic Combined Chemotherapy Protocols/adverse effects
;
Carboplatin/administration & dosage/adverse effects
;
Cross-Over Studies
;
Diet
;
Drug Administration Schedule
;
Female
;
Genital Neoplasms, Female/*drug therapy
;
Granisetron/administration & dosage
;
Humans
;
Isoquinolines/administration & dosage
;
Middle Aged
;
Morpholines/administration & dosage
;
Nausea/chemically induced/*prevention & control
;
Paclitaxel/administration & dosage/adverse effects
;
Quinuclidines/administration & dosage
;
Serotonin 5-HT3 Receptor Antagonists
;
Vomiting/chemically induced/*prevention & control

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