Tolerability of the niraparib individualized starting dose in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy.

PURPOSE: To explore safety and tolerability parameters for the niraparib individualized starting dose (ISD) in patients with newly diagnosed advanced ovarian cancer that responded to platinum-based chemotherapy who participated in the phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016). METHODS: The PRIMA protocol was amended so newly enrolled patients received an ISD based on baseline body weight/platelet count. In this ad hoc analysis, the timing, duration, and resolution of the first occurrence of common any-grade hematologic (thrombocytopenia, anemia, neutropenia) and nonhematologic (nausea, asthenia/fatigue, constipation, insomnia, hypertension) treatment-emergent adverse events (TEAEs) were evaluated by treatment arm in the ISD safety population (data cutoff, November 17, 2021; median follow-up, 3.5 years). RESULTS: Of 733 randomized patients, 255 were enrolled after the ISD protocol amendment and received ≥ 1 dose of study treatment (niraparib, 169; placebo, 86). In the niraparib arm, median times to first events were 22.0-35.0 days for hematologic TEAEs and 7.0-56.0 days for nonhematologic TEAEs. First events resolved in ≥ 89.8% of patients for hematologic TEAEs; for nonhematologic TEAEs, resolution rates ranged from 55.3% (insomnia) to 86.0% (nausea). Median durations of first hematologic TEAEs were ≤ 16.0 days, but for first nonhematologic TEAEs ranged from 18.0 days (nausea) to 134.0 days (insomnia). CONCLUSION: The niraparib ISD was generally well tolerated and TEAEs were manageable. Common hematologic and nonhematologic TEAEs occurred early and first events of hematologic TEAEs had a short duration (≈ 2 weeks) and a high resolution rate. These findings support close monitoring immediately following niraparib initiation and may help inform patient expectations for niraparib safety.

Comparison of robotic, laparoscopic, and abdominal myomectomy in a community hospital.

BACKGROUND AND OBJECTIVES: To evaluate the operative outcomes between robotic, laparoscopic, and abdominal myomectomies performed by a private gynecologic oncology practice in a suburban community hospital. METHODS: The medical records of 322 consecutive robotic, laparoscopic, and abdominal myomectomies performed from January 2007 through December 2009 were reviewed. The outcomes were collected from a retrospective review of patient medical records. RESULTS: Records for 14/322 (4.3%) patients were incomplete. Complete data were available for 308 patients, including 169 (54.9%) abdominal, 73 (23.7%) laparoscopic, and 66 (21.4%) robotic-assisted laparoscopic myomectomies. Patients were similar in age, body mass index, parity, and previous abdominopelvic surgery. Median operative time for robotic surgery (140 min) was significantly longer (P<.005) compared to laparoscopic (70 min) and abdominal (72 min) myomectomies. Robotic and laparoscopic myomectomies had significantly less estimated blood loss and hospital stay compared to abdominal myomectomies. There was no significant difference in complications or in the median size of the largest myoma removed between the different modalities. However, the median aggregate weight of myomas removed abdominally (200g; range, 1.4 to 2682) was significantly larger than that seen laparoscopically (115g; range, 1 to 602) and robotically (129g; range 9.4 to 935). Postoperative transfusion was significantly less frequent in robotic myomectomies compared to laparoscopic and abdominal myomectomies. CONCLUSION: While robotic-assisted laparoscopic myomectomies had longer operative times, laparoscopic and robotic assisted laparoscopic myomectomies demonstrated shorter hospital stays, less blood loss, and fewer transfusions than abdominal myomectomies. Robotic myomectomy offers a minimally invasive alternative for management of symptomatic myoma in a community hospital setting.

Asymptomatic postmenopausal simple ovarian cyst.

UNLABELLED: High-resolution transvaginal ultrasound frequently reveals incidental, simple ovarian cysts in asymptomatic postmenopausal women. Traditionally oophorectomy has been recommended for these women. However, evidence is emerging that most postmenopausal simple ovarian cysts are benign, allowing conservative management. Furthermore, many of these cysts will resolve spontaneously. Cancer antigen 125 (CA-125) and color Doppler may help differentiate benign from malignant cysts. When oophorectomy is favored, the laparoscopic approach may be considered, depending on the clinical situation. Nonoperative management of simple ovarian cysts in asymptomatic women is reasonable; regular follow-up with sonography should be performed. Because sonography is an operator-dependent test, it is imperative that the sonographer have expertise in ovarian imaging. Monitoring of CA-125 levels may be useful. Indications for removal during follow-up are increasing size, development of solid components, abnormal Doppler flow, CA-125 elevation, patient desire for removal of the cyst, and noncompliance with sonographic follow-up. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians LEARNING OBJECTIVES: After completion of this article, the reader will be able to estimate the prevalence of benign simple ovarian cysts in a postmenopausal population of women, to describe the natural history of a simple ovarian cyst, and outline the features consistent with a benign ovarian cyst on ultrasound.