Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer / 부인종양

Objective@#The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. @*Methods@#Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens.The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs). @*Results@#Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8–79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration.Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease). @*Conclusion@#The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib.

Should indications for laterally extended endopelvic resection (LEER) exclude patients with sciatica? / 부인종양

Objective@#Previously, indications for laterally extended endopelvic resection (LEER) have excluded patients with sciatica because R0 resection has not been deemed possible [1].Because laparoscopy optimizes visualization and thus provides for meticulous dissection, we hypothesized that R0 resection can be achieved by means of laparoscopic LEER in patients with sciatica. This video article aimed to clarify the technical feasibility of laparoscopic LEER performed for laterally recurrent previously irradiated cervical cancer with concomitant sciatica. @*Methods@#We investigated technical feasibility of laparoscopic LEER performed as a salvage therapy following abdominal radical hysterectomy and concurrent chemoradiotherapy in a patient suffering laterally recurrent cervical carcinoma with concomitant sciatica. The recurrent tumor involved the right external and internal iliac artery and vein, ileocecum, rectosigmoid colon, right ureter, right obturator nerve, and right sciatic nerve, with a resulting fistula between the tumor and the rectosigmoid colon, and severe sciatica.Resection of all these structures was essential for achievement of R0 status, and such resection means concomitant femoral bypass with prosthetic graft interposition and gastrointestinal/urinary tract resection. @*Results@#Laparoscopic LEER with femoral-femoral artery bypass could be conducted without any postoperative complications. Pathological R0 resection could be achieved, and local recurrence could have been controlled. However, the patient died from liver and lung metastasis at 1 year after this resection surgery. @*Conclusion@#Laparoscopic LEER for a laterally recurrent previously irradiated cervical cancer with concomitant sciatica was technically feasible, however, further study involving a greater number of patients and longer follow-up period is warranted to determine the stringent indications.

Should indications for laterally extended endopelvic resection (LEER) exclude patients with sciatica? / 부인종양

Objective@#Previously, indications for laterally extended endopelvic resection (LEER) have excluded patients with sciatica because R0 resection has not been deemed possible [1].Because laparoscopy optimizes visualization and thus provides for meticulous dissection, we hypothesized that R0 resection can be achieved by means of laparoscopic LEER in patients with sciatica. This video article aimed to clarify the technical feasibility of laparoscopic LEER performed for laterally recurrent previously irradiated cervical cancer with concomitant sciatica. @*Methods@#We investigated technical feasibility of laparoscopic LEER performed as a salvage therapy following abdominal radical hysterectomy and concurrent chemoradiotherapy in a patient suffering laterally recurrent cervical carcinoma with concomitant sciatica. The recurrent tumor involved the right external and internal iliac artery and vein, ileocecum, rectosigmoid colon, right ureter, right obturator nerve, and right sciatic nerve, with a resulting fistula between the tumor and the rectosigmoid colon, and severe sciatica.Resection of all these structures was essential for achievement of R0 status, and such resection means concomitant femoral bypass with prosthetic graft interposition and gastrointestinal/urinary tract resection. @*Results@#Laparoscopic LEER with femoral-femoral artery bypass could be conducted without any postoperative complications. Pathological R0 resection could be achieved, and local recurrence could have been controlled. However, the patient died from liver and lung metastasis at 1 year after this resection surgery. @*Conclusion@#Laparoscopic LEER for a laterally recurrent previously irradiated cervical cancer with concomitant sciatica was technically feasible, however, further study involving a greater number of patients and longer follow-up period is warranted to determine the stringent indications.

Feasibility and outcome of total laparoscopic radical hysterectomy with no-look no-touch technique for FIGO IB1 cervical cancer / 부인종양

OBJECTIVES: Intraoperative tumor manipulation and dissemination may possibly compromise survival of women with early-stage cervical cancer who undergo minimally-invasive radical hysterectomy (RH). The objective of the study was to examine survival related to minimally-invasive RH with a “no-look no-touch” technique for clinical stage IB1 cervical cancer. METHODS: This retrospective study compared patients who underwent total laparoscopic radical hysterectomy (TLRH) with no-look no-touch technique (n=80) to those who underwent an abdominal radical hysterectomy (ARH; n=83) for stage IB1 (≤4 cm) cervical cancer. TLRH with no-look no-touch technique incorporates 4 specific measures to prevent tumor spillage: 1) creation of a vaginal cuff, 2) avoidance of a uterine manipulator, 3) minimal handling of the uterine cervix, and 4) bagging of the specimen. RESULTS: Surgical outcomes of TLRH were significantly superior to ARH for operative time (294 vs. 376 minutes), estimated blood loss (185 vs. 500 mL), and length of hospital stay (14 vs. 18 days) (all, p < 0.001). Oncologic outcomes were similar between the 2 groups, including disease-free survival (DFS) (p=0.591) and overall survival (p=0.188). When stratified by tumor size (<2 vs. ≥2 cm), DFS was similar between the 2 groups (p=0.897 and p=0.602, respectively). The loco-regional recurrence rate following TLRH was similar to the rate after ARH (6.3% vs. 9.6%, p=0.566). Multiple-pelvic recurrence was observed in only 1 patient in the TLRH group. CONCLUSION: Our study suggests that the no-look no-touch technique may be a useful surgical procedure to reduce recurrence risk via preventing intraoperative tumor spillage during TLRH for early-stage cervical cancer.

Unexpected result of minimally invasive surgery for cervical cancer / 부인종양

No abstract available.

Practice patterns of adjuvant therapy for intermediate/high recurrence risk cervical cancer patients in Japan / 부인종양

OBJECTIVE: Although radiation therapy (RT) and concurrent chemoradiotherapy (CCRT) are the global standards for adjuvant therapy treatment in cervical cancer, many Japanese institutions choose chemotherapy (CT) because of the low frequency of irreversible adverse events. In this study, we aimed to clarify the trends of adjuvant therapy for intermediate/high-risk cervical cancer after radical surgery in Japan. METHODS: A questionnaire survey was conducted by the Japanese Gynecologic Oncology Group to 186 authorized institutions active in the treatment of gynecologic cancer. RESULTS: Responses were obtained from 129 facilities. Adjuvant RT/CCRT and intensity-modulated RT were performed in 98 (76%) and 23 (18%) institutions, respectively. On the other hand, CT was chosen as an alternative in 93 institutions (72%). The most common regimen of CT, which was used in 66 institutions (51%), was a combination of cisplatin/carboplatin with paclitaxel. CT was considered an appropriate alternative option to RT/CCRT in patients with risk factors such as bulky tumors, lymph node metastasis, lymphovascular invasion, parametrial invasion, and stromal invasion. The risk of severe adverse events was considered to be lower for CT than for RT/CCRT in 109 institutions (84%). CONCLUSION: This survey revealed a variety of policies regarding adjuvant therapy among institutions. A clinical study to assess the efficacy or non-inferiority of adjuvant CT is warranted.