Kathryn F. McGonigle

Combined Weekly Topotecan and Biweekly Bevacizumab in Women With Platinum- Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer

A phase 2 trial was conducted to determine the toxicity and efficacy of combined weekly topotecan and biweekly bevacizumab in patients with primary or secondary platinum‐resistant ovarian, peritoneal, or fallopian tube cancer (OC).

A phase II evaluation of nintedanib (BIBF-1120) in the treatment of recurrent or persistent endometrial cancer: an NRG Oncology/Gynecologic Oncology Group Study.

INTRODUCTIONnPatients presenting with advanced, recurrent, or metastatic endometrial cancer have limited treatment options. On behalf of the Gynecologic Oncology Group, we conducted this phase II trial of nintedanib (BIBF 1120), a potent small molecule triple receptor tyrosine kinase inhibitor of PDGFR α and β, FGFR 1/3, and VEGFR 1-3, in this population.nnnOBJECTIVESnThe primary objectives were to estimate event-free survival (EFS) at 6 months and the proportion of patients who have an objective tumor response. In addition, we sought to determine the nature and degree of toxicity. Secondary objectives were to estimate progression-free and overall survival.nnnMETHODSnThis was a two-stage, single-arm phase II study. Eligible patients were treated with single-agent nintedanib at a dose of 200mg twice daily.nnnRESULTSnOf 37 patients enrolled, 32 were eligible. There were zero complete and three partial responses for an overall response rate of 9.4% (90% 2-sided CI=2.6-22.5%). Seven patients (21.9%; 90% 2-sided CI=10.7-37.2%) were EFS at 6 months, with one patient continuing on study at the time of this writing. Serious toxicity included the following grade 3 events: gastrointestinal toxicity (5), neutropenia (1), edema (1), hypertension (1), and liver function abnormalities (5).nnnCONCLUSIONSnNintedanib lacked sufficient activity as a single agent to warrant enrollment to second stage. However, preclinical data indicate it may be synergistic with paclitaxel in a population of patients enriched for specific p53 mutations that result in loss of function. Subsequent studies may evaluate this agent in combination with paclitaxel.

Robot-assisted total laparoscopic hysterectomy in obese and morbidly obese women

Total laparoscopic hysterectomy (TLH) in obese patients is challenging. We sought to evaluate whether total laparoscopic hysterectomies using the da Vinci robotic system in obese patients, in comparison with non-obese patients, is a reasonable surgical approach. One-hundred consecutive robot-assisted TLHs were performed over a 17-month period. Obesity was not a contraindication to robotic surgery, assuming adequate respiratory function to tolerate Trendelenburg position and, for cancer cases, a small enough uterus to allow vaginal extraction without morcellation. Data were prospectively collected on patient characteristics, total operative time, hysterectomy time, estimated blood loss, length of stay, and complications. Outcomes with non-obese and obese women were compared. The median age, weight, and BMI of the 100 patients who underwent robot-assisted TLH was 57.6xa0years (30.0–90.6), 82.1xa0kg (51.9–159.6), and 30.2xa0kg/m2 (19.3–60.2), respectively. Fifty (50%) patients were obese (BMIxa0≥xa030); 22 patients were morbidly obese (BMIxa0≥xa040). There was no increase in complications (pxa0=xa00.56) or blood loss (pxa0=xa00.44) with increasing BMI. While increased BMI was associated with longer operative times (pxa0=xa00.05), median time increased by only 36xa0min when comparing non-obese and morbidly obese patients. Median length of stay was one day for all weight categories (pxa0=xa00.42). Robot-assisted TLH is feasible and can be safely performed in obese patients. More data are needed to compare robot-assisted TLH with other hysterectomy techniques in obese patients. Nonetheless, our results are encouraging. Robot-assisted total laparoscopic hysterectomy may be the preferred technique for appropriately selected obese patients.

Phase 2 study of intraperitoneal topotecan as consolidation chemotherapy in ovarian and primary peritoneal carcinoma

Intravenous topotecan is approved for the treatment of ovarian cancer (OC). In intraperitoneal (i.p.) topotecan studies, 20 mg/m2 dosing was tolerable. This study evaluated the feasibility, safety, and preliminary efficacy of i.p. topotecan as consolidation chemotherapy in patients with OC or primary peritoneal cancers (PPCs).

Robotic-Assisted Gynecologic Surgery and Perioperative Morbidity in Elderly Women

STUDY OBJECTIVEnTo assess perioperative complications, conversions, and operative times in patients age ≥75xa0years undergoing robotic-assisted gynecologic surgery.nnnDESIGNnRetrospective cohort study (Canadian Task Force classification II-2).nnnSETTINGnHigh-volume, 2-physician gynecologic oncology practice.nnnPATIENTSnA total of 705 women who underwent any robot-assisted gynecologic procedure for benign (nxa0=xa0380) or malignant (nxa0=xa0325) conditions between July 2008 and May 2014. Fifty patients age ≥75xa0years (elderly group) were compared with 655 patients age <75xa0years (younger group).nnnINTERVENTIONSnOperative data were gathered prospectively for all robotic-assisted procedures. Demographic and perioperative outcomes were analyzed retrospectively for this study.nnnMEASUREMENTS AND MAIN RESULTSnThe mean age was 81.3xa0±xa04.2xa0years (range, 75.0-90.5xa0years) in the elderly group and 52.8xa0±xa011.5xa0years (range, 22.9-74.6xa0years) in the younger group. The elderly group had higher rates of surgery for malignancy (90.0% vs 43.2%; pxa0<xa0.01) and lymphadenectomy (44.0% vs 23.4%; pxa0<xa0.01), and was more likely to have cardiovascular disease (88.0% vs 37.6%; pxa0<xa0.01). There were no between-group differences in body mass index or history of chronic obstructive pulmonary disease, diabetes mellitus, or more than 1 previous abdominal surgical procedure. The elderly group was more likely to have a length of stay greater than postoperative day one (30.0% vs 14.8%; pxa0=xa0.01) and had a higher incidence of postoperative cardiac arrhythmia (8.0% vs 1.2%; pxa0<xa0.01). The elderly group also had a smaller median uterine size (83.0xa0±xa049.1xa0g vs 126.0xa0±xa0189.5xa0g; pxa0<xa0.01), but total operative time, rate of conversion (6.0% vs 1.8%) and rate of blood transfusion (2.0% vs 1.5%) were not significantly different between the 2 groups. Rates of bowel and genitourinary injury were <1% in both groups, and there was no between-group difference in postoperative infectious morbidity, vaginal cuff complications, or reoperation.nnnCONCLUSIONnThe perioperative complication rates of robotic-assisted surgery are comparable in elderly women and younger women, despite a longer hospital length of stay and greater likelihood of postoperative arrhythmia in elderly women.

Leukocytosis after robotic hysterectomy: commonly observed but clinically insignificant

Laboratory studies are commonly performed after surgery, but with little evidence of clinical utility. We evaluated our experience with measuring a complete blood count (CBC) to determine peripheral blood leukocyte count (WBC) postoperatively following consecutive robotic hysterectomies. From January 2008 through November 2009, two surgeons (KM, HM) performed 204 robotic hysterectomies. Patient age, weight, height, indication for surgery, surgical procedure, operative time, estimated blood loss, hospital length of stay, postoperative fever, and complications were prospectively recorded and correlated with WBC measured on the day after surgery. The postoperative WBC was elevated (>11,000/μl) in 59/204 (29%) patients. Eight (4%) patients had marked leukocytosis (WBC >15,000/μl; maximum 16,600/μl). There was no correlation between postoperative leukocytosis and operative time, BMI, performance of lymphadenectomy, or length of hospitalization. The only factor significantly associated with elevated postoperative WBC was elevated preoperative WBC (Pxa0<xa0.001). Also, there was no correlation between postoperative leukocytosis with fever or infectious complications. The mean Tmax was 37.1ºC and Tmax over 38ºC was seen in nine patients. Of the five women who developed infectious complications, only one (diagnosed with pneumonia) had a minimally elevated postoperative WBC (11,600/μl); the other four (pneumonia and pelvic abscess, two each) had normal postoperative WBC. Routine measurement of WBC after robotic hysterectomy is not useful. In about 25% of cases there will be a slight leukocytosis, and rarely (about 4%) will the WBC exceed 15,000/μl. In no case was measurement of postoperative WBC clinically relevant.