As compared with intravenous paclitaxel plus cisplatin, intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel improves survival in patients with optimally debulked stage III ovarian cancer.
No abstract
Adding weekly infusions of cisplatin to pelvic radiotherapy followed by hysterectomy significantly reduced the risk of disease recurrence and death in women with bulky stage IB cervical cancers.
Laparoscopic surgical staging for uterine cancer is feasible and safe in terms of short-term outcomes and results in fewer complications and shorter hospital stay. Follow-up of these patients will determine whether surgical technique impacts pattern of recurrence or disease-free survival.
A B S T R A C T PurposeThe primary objective was to establish noninferiority of laparoscopy compared with laparotomy for recurrence after surgical staging of uterine cancer. Patients and MethodsPatients with clinical stages I to IIA disease were randomly allocated (two to one) to laparoscopy (n ϭ 1,696) versus laparotomy (n ϭ 920) for hysterectomy, salpingo-oophorectomy, pelvic cytology, and pelvic and para-aortic lymphadenectomy. The primary study end point was noninferiority of recurrence-free interval defined as no more than a 40% increase in the risk of recurrence with laparoscopy compared with laparotomy. ResultsWith a median follow-up time of 59 months for 2,181 patients still alive, there were 309 recurrences (210 laparoscopy; 99 laparotomy) and 350 deaths (229 laparoscopy; 121 laparotomy). The estimated hazard ratio for laparoscopy relative to laparotomy was 1.14 (90% lower bound, 0.92; 95% upper bound, 1.46), falling short of the protocol-specified definition of noninferiority. However, the actual recurrence rates were substantially lower than anticipated, resulting in an estimated 3-year recurrence rate of 11.4% with laparoscopy and 10.2% with laparotomy, or a difference of 1.14% (90% lower bound, Ϫ1.28; 95% upper bound, 4.0). The estimated 5-year overall survival was almost identical in both arms at 89.8%. ConclusionThis study previously reported that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay end points. The potential for increased risk of cancer recurrence with laparoscopy versus laparotomy was quantified and found to be small, providing accurate information for decision making for women with uterine cancer.
This study was conducted to identify the method of laparoscopic entry used by practicing gynecologists and learn whether they are following new recommendations for improvement of the safety of laparoscopic gynecologic surgery. Several international societies of endoscopy have endorsed new guidelines for safe laparoscopic entry techniques. Physicians are advised to place the primary incision in the base of the umbilicus when performing closed laparoscopy. If adhesions are suspected, the incision can be made in Palmer's point. Intraabdominal pressure should be 25 mm Hg for trocar insertion. In open laparoscopy, the incision should be made at the lower border of the umbilicus and care taken to elevate the deep fascia to separate the abdominal wall from its contents. Secondary trocars should be inserted under direct laparoscopic guidance.The authors mailed an anonymous questionnaire about laparoscopic techniques to all gynecologists in the United Kingdom and Ireland (n ϭ 1190). They received 764 (64%) responses.A large majority (90%) of responders used a closed entry technique with a Veress needle, 8% preferred a direct entry technique without a pneumoperitoneum, and 1% each used Hasson's method or a combination of open and closed laparoscopy. The patient positions used in performing laparoscopy were lithotomy with Trendelenburg tilt (61%), the flat position (29%), or a combination of positions (10%).Over half of respondents (54%) used a subumbilical entry point, 44% preferred an intraumbilical entry point, 2% used a suprapubic entry, and 2% used a combination of sites. Only 44% indicated that they performed a check test to assure correct positioning of the Veress needle; when used, Palmer's aspiration technique was used most often (90%).Sixty-two percent of responders used volume (range, less than 2.0-3.5) and 38% used the intraabdominal pressure technique (range, 15-25 mm Hg) to establish a satisfactory pneumoperitoneum before trocar insertion.Half of the responding gynecologists (53%) said that they would use their preferred techniques for all patients, regardless of a patient's history. Forty-seven percent would change their techniques for obese patients or those who had prior abdominal surgery. One third (34%) indicated that their techniques had changed in the past 5 years.Thirty-four percent of the responders had attended a laparoscopic or endoscopic surgery course in the past and 66% had not. Those who had attended a course were more likely to follow the new recommendations for safe laparoscopy (69%). Only 26% of responders were aware of the new guidelines, whereas 74% were not aware of these recommendations. GYNECOLOGY ABSTRACTTo identify the preoperative and intraoperative factors that might affect the outcome from a tension-free vaginal tape (TVT) procedure for the treatment of stress urinary incontinence (SUI), 809 participants were recruited from women scheduled to undergo TVT between March 2000 and September 2001. Patients with recurrent urinary tract infections, symptoms of urge incontinence greater tha...
Summary Background Platinum-based chemotherapy doublets are a standard of care for women with ovarian cancer recurring 6 months after completion of initial therapy. In this study, we aimed to explore the roles of secondary surgical cytoreduction and bevacizumab in this population, and report the results of the bevacizumab component here. Methods The multicentre, open-label, randomised phase 3 GOG-0213 trial was done in 67 predominantly academic centres in the USA (65 centres), Japan (one centre), and South Korea (one centre). Eligible patients were adult women (aged ≥18 years) with recurrent measurable or evaluable epithelial ovarian, primary peritoneal, or fallopian tube cancer, and a clinical complete response to primary platinum-based chemotherapy, who had been disease-free for at least 6 months following last infused cycle of platinum. Patients were randomly assigned (1:1) to standard chemotherapy (six 3-weekly cycles of paclitaxel [175 mg/m2 of body surface area] and carboplatin [area under the curve 5]) or the same chemotherapy regimen plus bevacizumab (15 mg/kg of bodyweight) every 3 weeks and continued as maintenance every 3 weeks until disease progression or unacceptable toxicity. Individuals who participated in both the bevacizumab objective and surgical objective (which is ongoing) were randomly assigned (1:1:1:1) to receive either of these two chemotherapy regimens with or without prior secondary cytoreductive surgery. Randomisation for the bevacizumab objective was stratified by treatment-free interval and participation in the surgical objective. The primary endpoint was overall survival, analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00565851. Findings Between Dec 10, 2007, and Aug 26, 2011, 674 women were enrolled and randomly assigned to standard chemotherapy (n=337) or chemotherapy plus bevacizumab (n=377). Median follow-up at the end of the trial on Nov 5, 2014, was 49·6 months in each treatment group (IQR 41·5–62·2 for chemotherapy plus bevacizumab; IQR 40·8–59·3 for chemotherapy), at which point 415 patients had died (214 in the chemotherapy group and 201 in the chemotherapy plus bevacizumab group). Based on pretreatment stratification data, median overall survival in the chemotherapy plus bevacizumab group was 42·2 months (95% CI 37·7–46·2) versus 37·3 months (32·6–39·7) in the chemotherapy group (hazard ratio [HR] 0·829; 95% CI 0·683–1·005; p=0·056). We identified incorrect treatment-free interval stratification data for 45 (7%) patients (equally balanced between treatment groups); a sensitivity analysis of overall survival based on the audited treatment-free interval stratification data gave an adjusted HR of 0·823 (95% CI 0·680–0·996; p=0·0447). In the safety population (all patients who initiated treatment), 317 (96%) of 325 patients in the chemotherapy plus bevacizumab group had at least one grade 3 or worse adverse event compared with 282 (86%) of 332 in the chemotherapy group; the most frequently reported of these in the chemotherapy p...
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