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Abstract
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<h5 class="title" id="d606809e219">Objective</h5>
<p id="P1">To estimate whether gastrointestinal-type chemotherapy was associated with
improved
survival compared to standard gynecologic regimens for women with ovarian mucinous
carcinoma.
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<h5 class="title" id="d606809e224">Methods</h5>
<p id="P2">We conducted a retrospective cohort study of patients with ovarian mucinous
carcinoma
who received postoperative adjuvant chemotherapy at two academic centers. Demographic
and clinical information was abstracted from the medical records. Gastrointestinal-type
chemotherapy contained 5-fluorouracil, capecitabine, irinotecan, or oxaliplatin. Gynecologic
regimens included standard carboplatin or cisplatin. Bevacizumab treatment was allowed
in both groups. Summary statistics were used to compare baseline characteristics;
Kaplan-Meier product-limit estimator was used to compare survival outcomes.
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<h5 class="title" id="d606809e229">Results</h5>
<p id="P3">Fifty-two patients received either gastrointestinal-type chemotherapy (n=26;
50%)
or a standard gynecologic regimen (n=26; 50%). Three-quarters of tumors were early-stage
(I or II), 68% grade 1 or 2 and 88% of patients had no gross residual disease after
surgery. Patients receiving gastrointestinal-type chemotherapy were more likely to
receive bevacizumab (50% vs. 4%;
<i>P</i> < .001), but there were no other differences in clinical or demographic
characteristics.
Unadjusted overall survival analyses showed that gastrointestinal-type chemotherapy
was associated with better overall survival (HR 0.2, 95% CI 0.1–0.8), as were early
stage tumors and having no gross residual disease.
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<h5 class="title" id="d606809e237">Conclusion</h5>
<p id="P4">Gastrointestinal-type chemotherapy with or without bevacizumab was associated
with
improved survival and should be considered in patients with ovarian mucinous carcinoma
requiring adjuvant therapy.
</p>
</div><p id="P5">Gastrointestinal-type chemotherapy is associated with improved survival
in ovarian
mucinous carcinoma when compared to standard gynecologic regimens.
</p>
Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
Vascular endothelial growth factor is a key promoter of angiogenesis and disease progression in epithelial ovarian cancer. Bevacizumab, a humanized anti-vascular endothelial growth factor monoclonal antibody, has shown single-agent activity in women with recurrent tumors. Thus, we aimed to evaluate the addition of bevacizumab to standard front-line therapy. In our double-blind, placebo-controlled, phase 3 trial, we randomly assigned eligible patients with newly diagnosed stage III (incompletely resectable) or stage IV epithelial ovarian cancer who had undergone debulking surgery to receive one of three treatments. All three included chemotherapy consisting of intravenous paclitaxel at a dose of 175 mg per square meter of body-surface area, plus carboplatin at an area under the curve of 6, for cycles 1 through 6, plus a study treatment for cycles 2 through 22, each cycle of 3 weeks' duration. The control treatment was chemotherapy with placebo added in cycles 2 through 22; bevacizumab-initiation treatment was chemotherapy with bevacizumab (15 mg per kilogram of body weight) added in cycles 2 through 6 and placebo added in cycles 7 through 22. Bevacizumab-throughout treatment was chemotherapy with bevacizumab added in cycles 2 through 22. The primary end point was progression-free survival. Overall, 1873 women were enrolled. The median progression-free survival was 10.3 months in the control group, 11.2 in the bevacizumab-initiation group, and 14.1 in the bevacizumab-throughout group. Relative to control treatment, the hazard ratio for progression or death was 0.908 (95% confidence interval [CI], 0.795 to 1.040; P=0.16) with bevacizumab initiation and 0.717 (95% CI, 0.625 to 0.824; P<0.001) with bevacizumab throughout. At the time of analysis, 76.3% of patients were alive, with no significant differences in overall survival among the three groups. The rate of hypertension requiring medical therapy was higher in the bevacizumab-initiation group (16.5%) and the bevacizumab-throughout group (22.9%) than in the control group (7.2%). Gastrointestinal-wall disruption requiring medical intervention occurred in 1.2%, 2.8%, and 2.6% of patients in the control group, the bevacizumab-initiation group, and the bevacizumab-throughout group, respectively. The use of bevacizumab during and up to 10 months after carboplatin and paclitaxel chemotherapy prolongs the median progression-free survival by about 4 months in patients with advanced epithelial ovarian cancer. (Funded by the National Cancer Institute and Genentech; ClinicalTrials.gov number, NCT00262847.).
Chemotherapy combinations that include an alkylating agent and a platinum coordination complex have high response rates in women with advanced ovarian cancer. Such combinations provide long-term control of disease in few patients, however. We compared two combinations, cisplatin and cyclophosphamide and cisplatin and paclitaxel, in women with ovarian cancer. We randomly assigned 410 women with advanced ovarian cancer and residual masses larger than 1 cm after initial surgery to receive cisplatin (75 mg per square meter of body-surface area) with either cyclophosphamide (750 mg per square meter) or paclitaxel (135 mg per square meter over 24 hours). Three hundred eighty-six women met all the eligibility criteria. Known prognostic factors were similar in the two treatment groups. Alopecia, neutropenia, fever, and allergic reactions were reported more frequently in the cisplatin-paclitaxel group. Among 216 women with measurable disease, 73 percent in the cisplatin-paclitaxel group responded to therapy, as compared with 60 percent in the cisplatin-cyclophosphamide group (P = 0.01). The frequency of surgically verified complete response was similar in the two groups. Progression-free survival was significantly longer (P < 0.001) in the cisplatin-paclitaxel group than in the cisplatin-cyclophosphamide group (median, 18 vs. 13 months). Survival was also significantly longer (P < 0.001) in the cisplatin-paclitaxel group (median, 38 vs. 24 months). Incorporating paclitaxel into first-line therapy improves the duration of progression-free survival and of overall survival in women with incompletely resected stage III and stage IV ovarian cancer.
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