Plagiarism and data falsification are the most common reasons for retracted publications in obstetrics and gynaecology.

OBJECTIVE: To determine the number of retracted articles and to examine the reasons for retraction within the obstetrics and gynaecology literature. DESIGN: Retrospective review of the PubMed database. SETTING: N/A. POPULATION: Obstetrics and gynaecology articles published from indexation until June 2018. METHODS: Articles were identified using keywords for retracted articles in obstetrics and gynaecology. Descriptive statistics were performed. MAIN OUTCOME MEASURES: Incidence of article retraction, the reasons given for retraction, and article demographics. RESULTS: A total of 176 articles were identified with a median time to retraction of 2 years; over three-quarters were retracted within the last decade (n = 136; 77.3%). The median journal impact factor was 2.5 (range of 0.26-52.67). Subspecialties with the highest number of retractions were gynaecological oncology (n = 76; 43.2%), gynaecology (n = 36; 20.5%), and obstetrics (n = 31; 17.6%). Among 176 first authors, 18 authors (10.2%) had two or more retracted articles. Clinical research articles accounted for approximately one-half of the retracted articles (n = 87; 49.4%). Among the clinical studies, 10.2% (n = 18) were randomised control trials, 16.5% (n = 29) were prospective trials and 13.1% (n = 23) were retrospective studies. Plagiarism (n = 40; 22.7%) and data falsification (n = 37; 21.0%) were the most common reasons given for retraction. CONCLUSION: Article retraction within the obstetrics and gynaecology literature is increasing. The most frequently cited reasons for article retractions were plagiarism, errors in data, fabricated results, article duplication, and compromised peer review. Consequences of article retractions to patient care and the scientific community can be significant. The thorough screening of manuscripts prior to publication should be prioritised. TWEETABLE ABSTRACT: The rate of retraction in obstetrics and gynaecology is increasing; the most common reason for retraction is plagiarism.

Progression-free and overall survival in ovarian cancer patients treated with CVac, a mucin 1 dendritic cell therapy in a randomized phase 2 trial.

BACKGROUND: CAN-003 was a randomized, open-label, Phase 2 trial evaluating the safety, efficacy and immune outcomes of CVac, a mucin 1 targeted-dendritic cell (DC) treatment as a maintenance therapy to patients with epithelial ovarian cancer (EOC). METHODS: Patients (n = 56) in first (CR1) or second clinical remission (CR2) were randomized (1:1) to standard of care (SOC) observation or CVac maintenance treatment. Ten doses were administered over 56 weeks. Both groups were followed for progression-free survival (PFS) and overall survival (OS). RESULTS: Fifty-six patients were randomized: 27 to SOC and 29 to CVac. Therapy was safe with only seven patients with Grade 3-4 treatment-emergent adverse events. A variable but measurable mucin 1 T cell-specific response was induced in all CVac-treated and some standard of care (SOC) patients. Progression free survival (PFS) was not significantly longer in the treated group compared to SOC group (13 vs. 9 months, p = 0.36, hazard ratio [HR] = 0.73). Analysis by remission status showed in the CR1 subgroup a median PFS of 18 months (SOC) vs. 13 months (CVac); p = 0.69 (HR = 1.18; CI 0.52-2.71). However CR2 patients showed a longer median PFS in the CVac-treated group (median PFS not yet reached, >13 vs. 5 months; p = 0.04, HR = 0.32 CI). OS for CR2 patients at 42 months of follow-up showed a difference of 26 months for SOC vs. > 42 months for CVac-treated (as median OS had not been reached; HR = 0.17 (CI 0.02-1.4) with a p = 0.07). CONCLUSIONS: CVac, a mucin 1-dendritic cell maintenance treatment was safe and well tolerated in ovarian cancer patients. A variable but observed CVac-derived, mucin 1-specific T cell response was measured. Notably, CR2 patients showed an improved PFS and lengthened OS. Further studies in CR2 ovarian cancer patients are warranted (NCT01068509). TRIAL REGISTRATION: NCT01068509. Study Initiation Date (first patient screened): 20 July 2010. Study Completion Date (last patient observation): 20 August 2013, the last patient observation for progression-free survival; 29 April 2015, the last patient was documented regarding overall survival.

Total laparoscopic hysterectomy versus laparoscopic-assisted vaginal hysterectomy in endometrial cancer: surgical and survival outcomes.

STUDY OBJECTIVE: To compare surgical and survival outcomes of patients with early-stage endometrial cancer (EC) who underwent total laparoscopic hysterectomy (TLH) or laparoscopic-assisted vaginal hysterectomy (LAVH) +/- lymphadenectomy. DESIGN: Retrospective, nonrandomized clinical study (Canadian Task Force classification II-2). SETTING: Two tertiary care academic medical centers. PATIENTS: Patients with EC treated by TLH or LAVH from 1998 through 2006. INTERVENTIONS: TLH and LAVH were performed in 80 and 24 patients, respectively. Patient demographics and clinical variables were collected, and surgical and survival outcomes were determined. MEASUREMENTS AND MAIN RESULTS: Median operating time was significantly higher for patients undergoing LAVH than for those undergoing TLH (212.5 and 183.5 minutes, respectively; p = .039). EBL was also greater in patients undergoing LAVH (median 220 mL) compared with those undergoing TLH (median100 mL; p = .001). After a median follow-up time of 51.5 months, there was no difference in recurrence or survival rates between the groups. CONCLUSION: Early-stage EC can be treated effectively with either TLH or LAVH. TLH patients may experience shorter operating times and less blood loss. When performed by experienced laparoscopists, TLH may be more feasible than LAVH in this cohort of patients.

Phase II evaluation of capecitabine in refractory nonsquamous cell carcinoma of the cervix: a Gynecologic Oncology Group study.

We conducted a multi-institutional study to assess the activity and toxicity of capecitabine in patients with persistent or recurrent nonsquamous cancer of the cervix. Eligible patients were required to possess adequate renal, hepatic and bone marrow function and a Gynecologic Oncology Group performance status of 0-2. Histologic confirmation of the original primary cancer was mandated. Patients must have received one prior systemic chemotherapeutic regimen for cervical cancer that did not include the chemotherapy that may have been administered in conjunction with prior radiation therapy. The initial dose schedule was 2500 mg/m2 orally daily in two divided doses for 14 consecutive days, followed by a 7-day rest, such that each cycle was 21 days. Responses were assessed using response evaluation criteria in solid tumors. Twenty-one patients were entered into the trial. One patient was declared ineligible for wrong cell type; thus, 20 were evaluable for toxicity. A median of 2.5 cycles was administered (range 1-11). There was one septic death. Grade 4 neutropenia, renal, neurologic, and pulmonary toxicity was seen in 5%, 5%, 5%, and 10% patients, respectively. There were no responses. Nine patients (45%) each had stable disease and nine showed progression. The remaining two cases (10%) did not have subsequent disease assessment and response could not be assessed. Oral capecitabine at the dose and schedule tested has insignificant activity in nonsquamous cervical cancer patients previously treated with chemotherapy.

Primary gynecological neoplasms and clinical outcomes in patients diagnosed with breast carcinoma.

The purpose of this study was to quantify and describe nonmammary neoplasms (n-MN), particularly gynecological neoplasms, in a patient population previously diagnosed with breast cancer. Data were collected prospectively in our institutional review board-approved registry for patients diagnosed with infiltrating breast cancer or ductal carcinoma in situ. Patients who developed a second, n-MN were identified; neoplastic site, time to development after breast cancer, and clinical outcomes were recorded. FIGO stage was recorded for patients who developed a gynecological neoplasm. Synchronous bilateral breast cancer was defined as a second, contralateral diagnosis made within 12 months of the first and, similarly, synchronous n-MN were defined as those identified within 1 year of a breast cancer diagnosis. Outcome curves were generated using the method of Kaplan and Meier, and compared using the log-rank test. Of 4126 patients diagnosed with breast cancer, 3% developed a n-MN, the majority of which were nongynecological and asynchronous to the initial breast cancer diagnosis. Three percent of patients diagnosed with breast cancer were diagnosed with a second, n-MN. Among patients who developed a n-MN, most developed a nongynecological cancer more than 1 year after the initial breast cancer diagnosis, and their outcomes were significantly worse than those patients who did not develop a n-MN.

The Martius flap neovagina revisited.

The Martius bulbocavernosus flap has been used frequently in the repair of various vaginal fistulas. It can also be a useful source for the construction of a neovagina if used in the appropriate patient. We present a case of a patient who underwent a total pelvic exenteration for recurrent cervical cancer. For her neovagina, a novel variation of the Martius flap was constructed. In carefully selected patients, this can be a useful option for neovagina reconstruction.

Ovarian conservation in a woman of reproductive age with müllerian adenosarcoma.

BACKGROUND: Total abdominal hysterectomy with bilateral salpingo-oophorectomy is generally considered optimal therapy for patients with uterine sarcomas. Local resection of the tumor or hysterectomy with ovarian conservation has been used in only a small number of patients. Recurrence risk in women undergoing ovarian-sparing surgery for müllerian adenosarcomas can be difficult to evaluate due to the paucity of literature in this area. We present a reproductive-age woman with a müllerian adenosarcoma and review the literature on conservative surgical management of this class of tumors. CASE: A 25-year-old nulligravida was diagnosed with a uterine adenosarcoma and the question of conservative surgical therapy arose. Following a literature review, discussion with the patient led to the decision for ovarian preservation at the time of hysterectomy. The pelvis and abdomen were grossly free of metastatic disease at laparotomy and all tumor was confined to the uterus on pathologic examination. She is free of disease 36 months postoperatively and is now considering in vitro fertilization using a surrogate. CONCLUSION: Ovarian conservation can probably be offered safely in carefully selected women of reproductive age with müllerian adenosarcomas.