Nobuhiro Takeshima

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

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. 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. 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. 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.

Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study

This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer. This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms "thrombocytopenia" and "platelet count decreased") occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival. Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56-1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6-26.7) months. Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients. ClinicalTrials.gov Identifier: NCT03759587.