Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer / 부인종양

Objective@#To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. @*Methods@#This Phase 2 open-label, single-arm study enrolled Japanese women with homologous recombination deficiency-positive relapsed, high-grade serous ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-emergent adverse events (TEAEs), including serious TEAEs. @*Results@#Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS) was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to discontinuation of niraparib whereas reductions or interruptions were reported in 14 (70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily) corresponded to a relative dose intensity of 67.6%. @*Conclusion@#Efficacy and safety of niraparib in heavily pretreated Japanese women was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.

Clinical utility of CA-125 in the management of uterine carcinosarcoma / 부인종양

No abstract available.

Platinum sensitivity and non-cross-resistance of cisplatin analogue with cisplatin in recurrent cervical cancer / 부인종양

OBJECTIVE: The concept of platinum sensitivity and cross-resistance among platinum agents are widely known in the management of recurrent ovarian cancer. The aim of this study was to evaluate two hypotheses regarding the validity of the concept of platinum sensitivity and non-cross-resistance of cisplatin analogue with cisplatin in recurrent cervical cancer. METHODS: In this retrospective study, the clinical data of patients with recurrent cervical cancer, who had a history of receiving cisplatin based chemotherapy (including concurrent chemoradiotherapy [CCRT] with cisplatin) and who received second-line chemotherapy at the time of recurrence between April 2004 and July 2012 were reviewed. RESULTS: In total, 49 patients-34 squamous cell carcinomas (69.4%) and 15 non-squamous cell carcinomas (30.6%)-were enrolled. The median age was 53 years (range, 26 to 79 years). Univariate and multivariate analysis showed that a platinum free interval (PFI) of 12 months has a strong relationship with the response rate to second-line chemotherapy. Upon multivariate analysis of survival after second-line platinum-based chemotherapy, a PFI of 12 months significantly influenced both progression-free survival (hazard ratio [HR], 0.349; 95% confidence interval [CI], 0.140 to 0.871; p=0.024) and overall survival (HR, 0.322; 95% CI, 0.123 to 0.842; p=0.021). In patients with a PFI of less than 6 months, the difference of progression-free survival between patients with re-administration of cisplatin (3.0 months) and administration of cisplatin analogue (7.2 months) as second-line chemotherapy was statistically significant (p=0.049, log-rank test). CONCLUSION: The concept of platinum sensitivity could be applied to recurrent cervical cancer and there is a possibility of noncross-resistance of cisplatin analogue with cisplatin.

The relationship between positive peritoneal cytology and the prognosis of patients with FIGO stage I/II uterine cervical cancer / 부인종양

OBJECTIVE: The purpose of this study was to assess whether peritoneal cytology has prognostic significance in uterine cervical cancer. METHODS: Peritoneal cytology was obtained in 228 patients with carcinoma of the uterine cervix (International Federation of Gynecology and Obstetrics [FIGO] stages IB1-IIB) between October 2002 and August 2010. All patients were negative for intraperitoneal disease at the time of their radical hysterectomy. The pathological features and clinical prognosis of cases of positive peritoneal cytology were examined retrospectively. RESULTS: Peritoneal cytology was positive in 9 patients (3.9%). Of these patients, 3/139 (2.2%) had squamous cell carcinoma and 6/89 (6.7%) had adenocarcinoma or adenosquamous carcinoma. One of the 3 patients with squamous cell carcinoma who had positive cytology had a recurrence at the vaginal stump 21 months after radical hysterectomy. All of the 6 patients with adenocarcinoma or adenosquamous carcinoma had disease recurrence during the follow-up period: 3 with peritoneal dissemination and 2 with lymph node metastases. There were significant differences in recurrence-free survival and overall survival between the peritoneal cytology-negative and cytology-positive groups (log-rank p<0.001). Multivariate analysis of prognosis in cervical cancer revealed that peritoneal cytology (p=0.029) and histological type (p=0.004) were independent prognostic factors. CONCLUSION: Positive peritoneal cytology may be associated with a poor prognosis in adenocarcinoma or adenosquamous carcinoma of the uterine cervix. Therefore, the results of peritoneal cytology must be considered in postoperative treatment planning.

Clinical research of olanzapine for prevention of chemotherapy-induced nausea and vomiting resistant to standard antiemetic treatment for highly emetogenic chemotherapy

<b>Purpose</b>: Olanzapine has antiemetic activity for chemotherapy-induced nausea and vomiting (CINV). The purpose of this retrospective study is to evaluate the efficacy of olanzapine for prevention of CINV in patients with severe nausea resistant to standard antiemetic regimen for highly emetogenic chemotherapy (HEC). <b>Methods</b>: Olanzapine was administered in twenty gynecological cancer patients receiving HEC. They had grade 3 nausea (CTCAE ver.4.0) for the acute (24 hours postchemotherapy) and/or delayed (24-120 hours postchemotherapy) period despite the combined use of 5-HT3 receptor antagonist, NK-1 receptor antagonist, and dexamethasone. Oral olanzapine (5 mg/day) was administered on day -1 prior to chemotherapy and continued for 7 days in combination with standard antiemetic regimen. The nausea control rate (grade 0-1) with olanzapine were evaluated. <b>Results</b>: The nausea control rate improved from 30% to 95% for the acute period, 0% to 95% for the delayed period, and 0% to 90% for the overall period. In each period, the nausea control rate improved significantly (<i>p</i>≤0.001). Grade 0-1 sleepiness was observed but there were no grade 3 or 4 toxicities. Conclusion: In this study, olanzapine combined with the standard antiemetic regimen had good antiemetic activity at both acute and delayed period in most of chemotherapy-naive patients receiving HEC. The efficacy of olanzapine suggested additional improvement in the control of severe CINV resistant to standard antiemetic regimen for HEC.