-
Thomas J Herzog,
Giovanni Scambia,
Byoung-Gie Kim,
Catherine Lhommé,
Janina Markowska,
Isabelle Ray-Coquard,
Jalid Sehouli, Nicoletta Colombo,
Minghua Shan,
Oana Petrenciuc,
Amit Oza
[show abstract]
[hide abstract]
ABSTRACT: BACKGROUND: Sorafenib, an oral multikinase inhibitor of the VEGFR/PDGFR/ Raf/MEK/ERK pathway, has shown potential activity in patients with recurrent ovarian cancer (OC). One strategy to prolong disease control and survival in patients with OC is maintenance therapy after achieving a complete response. A double-blind, randomized, placebo-controlled, phase II study to assess the efficacy and safety of maintenance therapy with sorafenib in the treatment of OC is presented. METHODS: Patients with epithelial OC or primary peritoneal cancer in complete remission were randomized to sorafenib 400mg BID or matching placebo. The primary endpoint was progression-free survival (PFS). RESULTS: Of 246 randomized patients, 93% had OC; baseline characteristics were balanced between treatment arms. There was no significant difference between sorafenib and placebo arms for PFS (median 12.7 vs 15.7months; hazard ratio 1.09; 95% CI 0.72-1.63), although there was a notable imbalance in early censoring. The most common≥grade 3 adverse events (AEs) were hand-foot skin reaction (39.0% vs 0.8%) and rash (14.6% vs 0%). More patients receiving sorafenib versus placebo required dose reductions (67.5% vs 30.1%), resulting in a lower than planned median daily dose (median 584.6 vs 800.0mg). Treatment with sorafenib was of shorter duration (median 17.6 vs 51.9weeks) with more frequent discontinuations due to AEs (37.4% vs 6.5%). CONCLUSIONS: Sorafenib 400mg BID cannot be recommended as maintenance therapy for patients with OC in complete remission. Assessment of efficacy was limited by the high rate of dose reductions and early discontinuations.
Gynecologic Oncology 04/2013; · 3.89 Impact Factor
-
José María Del Campo,
Cristiana Sessa,
Carolyn N Krasner,
Jan B Vermorken, Nicoletta Colombo,
Stan Kaye,
Martin Gore,
Patrik Zintl,
Javier Gómez,
Trilok Parekh,
Youn Choi Park,
Scott McMeekin
[show abstract]
[hide abstract]
ABSTRACT: Three phase II studies evaluated trabectedin monotherapy as second-/third-line therapy in patients with refractory/recurrent ovarian cancer (ROC). Three different schedules were investigated: 3-h infusion every 3 weeks (3-h_q3w), 24-h infusion q3w (24-h_q3w), and 3-h weekly infusion for 3 weeks of a 4-week cycle. This retrospective pooled analysis evaluated the efficacy and the safety profile of trabectedin according to each administered regimen. Data from 295 patients were used to compare weekly versus q3w schedules, and 3-h versus 24-h infusion given q3w. Both q3w regimens showed higher overall response rate (36 vs. 16 %; p = 0.0001), disease control rate (66 vs. 46 %; p = 0.0007), and longer median progression-free survival (5.6 vs. 2.8 months; p < 0.0001) than the weekly schedule. Comparable activity was observed for the 3- and 24-h infusions q3w. Common adverse events were nausea, fatigue, vomiting, transient neutropenia, and transaminase increases. A better safety profile regarding neutropenia, fatigue, and vomiting was seen for the 3-h_q3w regimen as compared to the 24-h_q3w one. Trabectedin given as a single agent q3w as 3-h infusion is the schedule of choice for the treatment of ROC, and its efficacy and safety profile favorably compares with other active salvage treatments.
Medical Oncology 03/2013; 30(1):435. · 2.14 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: The aim of surgical approach in advanced ovarian cancer should be the complete removal of all visible disease. Our purpose was to compare perioperative features and postoperative complications, and secondarily oncological outcomes, between patients who underwent splenectomy and those who did not at the time of surgery.
Thirty-three subjects underwent splenectomy, and we selected 99 controls with similar surgical characteristics but who did not undergo splenectomy. Data collected included perioperative details and follow-up data.
Longer operating time (33 minutes longer; P = 0.02), larger estimated blood loss (812 mL more; P = 0.03), higher rate of intraoperative blood transfusions (78.8% vs 42.4%; P < 0.01), and intensive care unit stay (1.4 vs 0.5 days; P < 0.01) as well as higher pneumonia rate (2% vs 0%; P = 0.01) were observed in the splenectomy group. Disease-free and overall survival rates were 30.3% and 66.6%, respectively, in the splenectomy group, and 33.3% and 59.6%, respectively, in the control group.
Splenectomy at the time of primary cytoreductive surgery for advanced ovarian cancer may contribute to achieve complete cytoreduction with low perioperative complication rate. This procedure seems to be an acceptable and rational intervention to increase the survival rates of those patients.
International Journal of Gynecological Cancer 06/2012; 22(6):968-73. · 1.65 Impact Factor
-
Gabriella Parma,
Rosanna Mancari,
Gianluca Del Conte,
Giovanni Scambia,
Angiolo Gadducci,
Dagmar Hess,
Dionyssios Katsaros,
Cristiana Sessa,
Andrea Rinaldi,
Francesco Bertoni,
Andrea Vitali,
Carlo Vittorio Catapano,
Silvia Marsoni,
Helgi van de Velde, Nicoletta Colombo
[show abstract]
[hide abstract]
ABSTRACT: Pegylated liposomal doxorubicin (PLD) is an established treatment for relapsed ovarian cancer. Preclinical and clinical evidences in other tumor types suggest that the proteasome inhibitor bortezomib can act synergistically with PLD.
Patients with relapsed ovarian cancer (N = 58), previously treated with platinum (100%) and taxane (95%), received bortezomib, 1.3 mg/m intravenous (days 1, 4, 8, and 11), and PLD, 30 mg/m intravenous (day 1), every 3 weeks. Tumor responses were assessed using Response Evaluation Criteria In Solid Tumors and Gynecologic Cancer Intergroup criteria. An optimal 2-stage design was implemented. Gene expression profiling in peripheral blood was characterized before and during treatment in 10 platinum-sensitive patients enrolled in stage 2 of the study.
Median number of bortezomib-PLD cycles was 3.5. Of 38 patients in the platinum-sensitive group, 9 responses were observed (median duration, 4.8 months). The platinum-resistant group was closed at stage 1 owing to lack of response. Toxicity was moderate and mainly consisted of hematologic, gastrointestinal, and mucositis events. Of the total 58 patients, peripheral neuropathy was reported in 9 patients (none were grade 3). Transcription profiling identified the prevalence of genes associated with ribonucleoprotein complexes, RNA processing, and protein translation. The gene expression changes were more robust in patients who responded or had stable disease compared with patients who had progressive disease.
The combination of bortezomib and PLD was well tolerated, but the antitumor activity is insufficient to warrant further investigation in ovarian cancer.
International Journal of Gynecological Cancer 06/2012; 22(5):792-800. · 1.65 Impact Factor
-
Ate G J van der Zee, Nicoletta Colombo,
Gerald Gitsch,
Nicolas Reed,
Frederic Amant,
David Cibula,
Vesna I Kesic,
Rainer Kimmig,
Alberto D B Lopes,
Janina Markowska,
Christian Marth,
Alexander Radolakis,
Helga Salvesen,
Daiva Vaitkiene,
René H M Verheijen,
Paolo Zola
International Journal of Gynecological Cancer 01/2012; 22(1):175. · 1.65 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Standard approach for medically stable advanced ovarian cancer patients should be primary cytoreduction following platinum-based chemotherapy. The aim of surgical effort should be the complete removal of all visible disease. Our objective was to compare perioperative features, postoperative complications, and secondarily oncological outcomes of patients who underwent diaphragmatic stripping with those who underwent diaphragmatic resection for advanced ovarian cancer.
One hundred twelve cases were identified, among them 79 underwent diaphragmatic stripping and 33 underwent diaphragmatic full-thickness resection. Data collected included patients' age, all perioperative details and pathological findings, International Federation of Gynecology and Obstetrics stage, adjuvant therapy, and follow-up data.
Larger residual tumors (mean, 5.1 vs 1.6 mm, respectively; P < 0.01) but shorter operating time (25 minutes shorter operative time, P = 0.07) were observed in the stripping group. Higher postoperative pleural effusions rates (63.6% vs 37.9%, P = 0.01), but no differences in the remaining complications, were observed in the resection group. After a mean of 31 months of follow-up, disease-free survival rates were 27.8% in the stripping group and 39.4% in the resection group (P = 0.04). No significant differences were observed for overall survival.
Diaphragmatic surgery at the time of primary cytoreductive surgery for advanced ovarian cancer may contribute to the achievement of complete cytoreduction with low perioperative complication rate; full-thickness resection is preferable if peritoneum stripping will not achieve a complete removal of the disease.
International Journal of Gynecological Cancer 11/2011; 21(9):1698-703. · 1.65 Impact Factor
-
Silvia Zecchini,
Lorenzo Bombardelli,
Alessandra Decio,
Marco Bianchi,
Giovanni Mazzarol,
Fabio Sanguineti,
Giovanni Aletti,
Luigi Maddaluno,
Vladimir Berezin,
Elisabeth Bock,
Chiara Casadio,
Giuseppe Viale, Nicoletta Colombo,
Raffaella Giavazzi,
Ugo Cavallaro
[show abstract]
[hide abstract]
ABSTRACT: Epithelial ovarian carcinoma (EOC) is an aggressive neoplasm, which mainly disseminates to organs of the peritoneal cavity, an event mediated by molecular mechanisms that remain elusive. Here, we investigated the expression and functional role of neural cell adhesion molecule (NCAM), a cell surface glycoprotein involved in brain development and plasticity, in EOC. NCAM is absent from normal ovarian epithelium but becomes highly expressed in a subset of human EOC, in which NCAM expression is associated with high tumour grade, suggesting a causal role in cancer aggressiveness. We demonstrate that NCAM stimulates EOC cell migration and invasion in vitro and promotes metastatic dissemination in mice. This pro-malignant function of NCAM is mediated by its interaction with fibroblast growth factor receptor (FGFR). Indeed, not only FGFR signalling is required for NCAM-induced EOC cell motility, but targeting the NCAM/FGFR interplay with a monoclonal antibody abolishes the metastatic dissemination of EOC in mice. Our results point to NCAM-mediated stimulation of FGFR as a novel mechanism underlying EOC malignancy and indicate that this interplay may represent a valuable therapeutic target.
EMBO Molecular Medicine 08/2011; 3(8):480-94. · 10.33 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: In young patients with borderline ovarian tumor a conservative treatment approach does not seem to have a significant impact on survival, and the outcome regarding fertility is good in general. It can be considered even if noninvasive peritoneal implants are discovered at the time of the initial surgery. In contrast, in patients with epithelial ovarian cancer, conservative surgery should be considered only in adequately staged patients, with a stage IA grade 1 (and probably 2) serous, mucinous or an endometrioid tumor, including a careful follow-up. Such an approach could also probably be discussed in stage IC grade 1 disease.In patients with nonepithelial malignant ovarian tumors, conservative surgery is also feasible, particularly in patients with malignant germ cell tumors because of their high chemosensitivity leading to an excellent prognosis in general.
International Journal of Gynecological Cancer 07/2011; 21(5):951-63. · 1.65 Impact Factor
-
David Cibula,
Rene Verheijen,
Alberto Lopes,
Frederic Amant,
Uziel Beller, Nicoletta Colombo,
Gerald Gitsch,
Vesna Kesic,
Rainer Kimmig,
Janina Markowska,
Christian Marth,
Nicholas Reed,
Alexandros Rodolakis,
Helga Salvesen,
Daiva Vaitkiene,
Ate G J van der Zee,
Paolo Zola
International Journal of Gynecological Cancer 06/2011; 21(7):1264-5. · 1.65 Impact Factor
-
Nicoletta Colombo
[show abstract]
[hide abstract]
ABSTRACT: The results of the OVA-301 study show that trabectedin in combination with pegylated liposomal doxorubicin (PLD) results in improved progression-free survival and response rate in patients with advanced ovarian cancer. The trial has also demonstrated a trend toward improvement in overall survival. A subgroup analysis indicates that in the subset of patients with platinum-free interval (PFI) of 6 to 12 months, the combined treatment resulted in a 6-month improvement in overall survival. Furthermore, in the patients who have received third-line treatment with a platinum agent, it was found that the survival was better in those who had received trabectedin and PLD. These results suggest that prolonging the PFI by a nonplatinum-effective regimen improves the outcome with subsequent, third-line platinum treatment. This strategy may also have positive effects in treatment tolerability, as it allows extra time to recover from platinum-induced toxicities. This hypothesis is currently been tested in the INOVATYON (INternational OVArian Cancer Patients Trial With YONdelis) phase III study.
International Journal of Gynecological Cancer 05/2011; 21 Suppl 1:S12-6. · 1.65 Impact Factor
-
Tate Thigpen,
Andreas duBois,
Jessica McAlpine,
Philip DiSaia,
Keiichi Fujiwara,
William Hoskins,
Gunnar Kristensen,
Robert Mannel,
Maurie Markman,
Jacobus Pfisterer, [......],
Jonathan Berek, Nicoletta Colombo,
Gilles Freyer,
Dolores Gallardo,
Marie Plante,
Andres Poveda,
Lawrence Rubinstein,
Monica Bacon,
Henry Kitchener,
Gavin C E Stuart
[show abstract]
[hide abstract]
ABSTRACT: At the 4th Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG) held in Vancouver, Canada, in June 2010, representatives of 23 cooperative research groups studying gynecologic cancers gathered to establish international consensus on issues critical to the conduct of large randomized trials. The process focused on 13 predetermined questions. Group A, 1 of the 3 discussion groups, addressed the first 5 questions, examining first-line therapies in newly diagnosed ovarian cancer patients. A1: What are the appropriate end points for different trials (maintenance, upfront chemotherapy trials including molecular drugs)? A2: Are there any subgroups defined by tumor biology who need specific treatment options/trials? A3: Is the 2004 GCIG-recommended standard comparator arm still valid? A4: What is the role of modifying dose, schedule, and delivery of chemotherapy? A5: What role does surgery play today?
International Journal of Gynecological Cancer 05/2011; 21(4):756-62. · 1.65 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: This randomized, open label, phase III clinical trial (1988-1992) compared the efficacy and safety of a dose-dense regimen of single-agent cisplatin with a standard 3-weekly schedule in first-line chemotherapy for advanced epithelial ovarian cancer. Two hundred eighty-five patients were randomly assigned to the experimental dose-dense arm (cisplatin 50 mg/m(2) weekly × nine cycles) or to the control (standard treatment) arm (cisplatin 75 mg/m(2), administered on day 1 every 21 days × six cycles). The primary outcome was progression-free survival (PFS). Secondary outcomes were overall survival (OS), overall response to chemotherapy, and toxicity. Toxicity and response to treatment were compared with the χ(2) test using trend or exact correction. PFS and OS were estimated by Kaplan-Meier analyses and treatment hazard ratios (HRs) with the Cox proportional hazards model. All statistical tests were two-sided. After a median follow-up of 16.8 years, no differences were observed between the two treatments in PFS (experimental arm: 17.2 months; control arm: 18.1 months; HR = 1.08, 95% confidence interval [CI] = 0.83 to 1.40; P = .57) and in OS (experimental arm: 35 months; control arm: 32 months; HR = 0.97, 95% CI = 0.75 to 1.26; P = .97). Thus, increasing dose intensity of cisplatin does not improve PFS or OS compared with standard chemotherapy.
CancerSpectrum Knowledge Environment 02/2011; 103(4):347-51. · 14.07 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Borderline ovarian tumors (BOTs) are a histological category of epithelial ovarian tumors and 70% of them are early diagnosed (stage I). Since early stage is the most important prognostic factor, restaging procedure could be justified. This study aims to evaluate the role of restaging surgery in the management of patients with borderline ovarian tumors referred to our Institution after being incompletely surgically staged in other hospitals.
We retrospectively reviewed the charts of patients with BOT who were referred to our centre to undergo restaging procedure. From December 1995 to May 2008, 186 patients were treated for BOT and 70 patients met the inclusion criteria. Data collected included patients' age, primary and re-staging surgery details, FIGO stage after first and second procedure, pathological findings, and follow-up data.
FIGO stage after primary surgery was IA in 46 patients (68.6%), IB in 7 patients (10.4%), IC in 12 patients (17.9%, 6 due to ruptured cyst), IIA in 1 patient (1.4%), IIB in 1 patient (1.4%), III B in 2 patients (2.8%), and IIIC in 1 patient (1.4%). Among stage I patients (representing 97% of all patients), 12.3% (8 patients) were up-staged. The upstaging rate among serous tumors was 16.2%, and 4% among mucinous tumors. The mean follow-up time was 60.4 months from restaging surgery (SD 30.6 months). We observed 8 primary recurrences of the disease and 3 second recurrences.
There were no differences in terms of overall survival between patients who were upstaged and those who were not. Restaging procedure does not seem to have a significant impact on the management of patients diagnosed with borderline ovarian tumors, especially in mucinous subtype and apparent FIGO stage higher than I.
Gynecologic Oncology 11/2010; 119(2):274-7. · 3.89 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To determinate the impact of maximal cytoreductive surgery on progression free survival (PFS), overall survival (OS) rates and morbidity, in patients with advanced epithelial ovarian or fallopian tube cancer.
We reviewed all medical records of patients with stages IIIC-IV epithelial ovarian and fallopian tube cancer that were managed at our institution between January 2001 and December 2008. The following information was collected: demographics, tumor characteristics, operative information, surgical outcomes and peri-operative complication.
A total of 288 patients with advanced epithelial ovarian and fallopian tube cancer were referred to our institution between January 2001 and December 2008, 259 consecutive patients were enrolled in the study. After a median follow-up of 29.8 months, the PFS and OS were 19.9 and 57.6 months, respectively. At univariate analysis, factors significantly associated with decreased PFS included: age greater than median (>60 years), stage IV, presence of ascites >1000 cc, presence of diffuse peritoneal carcinomatosis and diameter of residual disease. This was confirmed also at multivariate analysis with age greater than 60 years (P=0.025), stage IV vs IIIC (P=0.037) and any residual disease (P=0.032) having an independent association with worse PFS.
Our study seems to demonstrate that a more extensive surgical approach is associated with prolonged disease-free interval and improved survival in patients with stages IIIC-IV epithelial ovarian and fallopian tube cancer. Moreover all patients with no residual tumor seem to have the best prognosis and in view of these results we believe that the goal of primary surgery should be considered as leaving no macroscopic disease.
Gynecologic Oncology 11/2010; 119(2):259-64. · 3.89 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Cervical cancer is the second most common cause of female cancer mortality worldwide. Concurrent chemoradiotherapy represents the standard of care for patients with stage IB2-IIIB cervical cancer. However, the lack of radiotherapy departments, especially in developing countries, the presumed high incidence of long-term complications, and the poor control of metastatic disease have brought about the development of different therapeutic approaches such as neoadjuvant chemotherapy followed by surgery. We reviewed the literature concerning the role of neoadjuvant chemotherapy for locally advanced cervical cancer.
International Journal of Gynecological Cancer 10/2010; 20(11 Suppl 2):S47-8. · 1.65 Impact Factor
-
Edward L Trimble,
Michael J Birrer,
William J Hoskins,
Christian Marth,
Ray Petryshyn,
Michael Quinn,
Gillian M Thomas,
Henry C Kitchener,
Carol Aghajanian,
David S Alberts, [......],
Iain A McNeish,
Lori Minasian,
Amit Oza,
Jim Paul,
Andres Poveda,
Eric Pujade-Lauraine,
Mason Schoenfeldt,
Ann Marie Swart,
Vivian von Gruenigen,
Lari Wenzel
[show abstract]
[hide abstract]
ABSTRACT: To review the current status of large phase academic clinical trials for women with ovarian cancer, address cross-cutting issues, and identify promising areas for future collaboration.
In May 2009, the Gynecologic Cancer Intergroup, which represents 19 Cooperative Groups conducting trials for women with gynecologic cancer, and the US National Cancer Institute convened a Clinical Trials Planning Meeting.
The topics covered included the impact of new developments in cancer biology upon molecular targets and novel agents, pharmacogenomics, advances in imaging, the potential benefit of diet and exercise to reduce the risk of recurrence, academic partnership with industry, statistical considerations for phases 2 and 3 trials, trial end points, and symptom benefit and health-related quality-of-life issues. The clinical trials discussed spanned the spectrum of ovarian cancer from initial diagnosis, staging, and cytoreductive surgery to consolidation chemotherapy, and treatment of recurrent disease.
Ongoing and effective collaboration with industry, government, and patients aims to ensure that the most important scientific questions can be answered rapidly. We encourage women with ovarian cancer and their oncologists to consider participation in the academic clinical trials conducted by the member groups of the Gynecologic Cancer Intergroup.
International Journal of Gynecological Cancer 10/2010; 20(7):1290-8. · 1.65 Impact Factor
-
Helen J Mackay,
Mark F Brady,
Amit M Oza,
Alexander Reuss,
Eric Pujade-Lauraine,
Ann M Swart,
Nadeem Siddiqui, Nicoletta Colombo,
Michael A Bookman,
Jacobus Pfisterer,
Andreas du Bois
[show abstract]
[hide abstract]
ABSTRACT: The prognostic relevance of uncommon epithelial ovarian cancer (EOC) histological subtypes remains controversial. The Gynecologic Cancer InterGroup (GCIG) initiated this meta-analysis to assess the relative prognosis of women with a diagnosis of rare EOC histologies from completed, prospectively randomized studies performed by cooperative GCIG study groups.
Studies eligible for analysis included first-line treatment of at least 150 patients with stage III/IV EOC treated with a platinum/taxane-based regimen. Collaborating groups were to provide patient-level data. Serous acted as the reference histology, and a proportional hazards model was used to estimate the relative rate of progression or death.
Data on 8704 women with stage III/IV EOC from 7 randomized trials were included in these analyses. Two hundred twenty-one patients (2.5%) had clear cell carcinoma; 264 (3.0%), mucinous; and 36 (0.4%), transitional cell. The mean age of patients with serous histology was greater than those with mucinous (4.1 years) and clear cell (2.6 years, P < 0.001). Mucinous, clear cell, and transitional cell tumors were more likely to be completely resected than serous (P < 0.05). When controlling for age and residual disease, mucinous and clear cell tumors had shorter times to progression (hazards ratio [HR], 2.1; 95% confidence interval [CI], 1.8-2.4 and HR, 1.6; 95% CI, 1.4-1.9, respectively) and death (HR, 2.7; 95% CI, 2.3-3.1 and HR, 2.2; 95% CI, 1.8-2.6, respectively) compared with serous. The median overall survival for serous, clear cell, mucinous, and endometrioid histologies were 40.8, 21.3, 14.6, and 50.9 months.
Mucinous and clear cell carcinomas are independent predictors of poor prognosis in stage III/IV EOC. Studies targeting these rare histological subtypes are warranted and will require significant intergroup collaboration.
International Journal of Gynecological Cancer 08/2010; 20(6):945-52. · 1.65 Impact Factor
-
Lucas Minig,
Roberto Biffi,
Vanna Zanagnolo,
Anna Attanasio,
Carmen Beltrami,
Luca Bocciolone,
Edoardo Botteri, Nicoletta Colombo,
Simona Iodice,
Fabio Landoni,
Michele Peiretti,
Giovanni Roviglione,
Angelo Maggioni
[show abstract]
[hide abstract]
ABSTRACT: A randomized controlled trial was performed to assess the outcome of early oral postoperative feeding (EOF) compared with traditional oral feeding (TOF) in gynecologic oncology patients undergoing a complex laparotomy, including upper abdominal surgery.
Patients aged 18-75 years, undergoing an elective laparotomy and with a preoperative suspicion of gynecologic malignancy, were eligible. Exclusion criteria included infectious conditions, intestinal obstruction, severe malnutrition, American Society of Anesthesiologists score C4, intestinal resection, and postoperative stay in the intensive care unit lasting 24 h. Patients allocated to EOF received liquid diet in the first postoperative day and then regular diet. Patients received traditional feeding scheme until resolution of postoperative ileus to start liquid diet. The primary end-point of the trial was length of hospital stay.
Between January 1, 2007, and November 17, 2007, a total of 143 patients were randomized to receive either EOF or TOF. Hospital stay for patients who received EOF (n=71) was 4.7 vs. 5.8 days for the TOF group (n=72) (P=0.006). The mean level of postoperative satisfaction was significantly higher in the EOF group (82.8 vs. 71.7 mm, P B 0.001). Patients who received the TOF scheme had significantly higher overall postoperative complications (39 vs. 17% in EOF group, P=0.003) and infective complications (14% in TOF group vs. 3% in EOF group, P=0.017). Variables such as nausea and vomiting, analgesic and antiemetic requirement as well as level of pain and quality of life were not different between groups.
On the basis of these findings, the policy of EOF should be used after a complex gynecologic oncologic laparotomy.
Annals of Surgical Oncology 09/2009; 16(11):3101-10. · 4.17 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: Ovarian carcinosarcoma (OCS) is a rare malignancy associated with a poor prognosis. Platinum, anthracyclines, and alkylating agents are the most effective antiblastic drugs for treatment of gynecologic epithelial and stromal tumors. The aim of this study was to determine response rate and overall survival (OS) of patients with OCS who were treated with a combination of these 3 drugs.
Forty-one women with OCS who were referred to the Department of Gynecologic Oncology of San Gerardo Hospital in Monza and European Institute of Oncology in Milan, between January 1995, and December 2006, and treated with a combination regimen of cisplatin, adriamycin, and cyclophosphamide or a combination regimen containing of cisplatin, epirubicin, and ifosfamide plus granulocyte colony-stimulating factor were considered for this study.
Four women had OCS stage I; 7, stage II; 23, stage III; and 7, stage IV. Heterologous, homologous, and mixed stromal components were described in 17, 14, and 10 patients, respectively. Thirteen women were treated with a combination of cisplatin, adriamycin, and cyclophosphamide and 28 with a combination of cisplatin, epirubicin, and ifosfamide plus granulocyte colony-stimulating factor. Two women did not complete their treatment because of the rapid progression of their disease and severe toxicity. Among 22 women considered evaluable for response, 10 (46%) achieved a complete response and 3 (13%) achieved a partial response (global response rate, 59%). Overall progression-free survival was 11.8 months (range, 0.9-96 months) and 13.8 and 10.1 months in stage I-II and III-IV, respectively (P = 0.13). Median OS was 20 months (range, 1-123 months), not reached in stage I-II, and 19.7 months in stage III-IV (P = 0.07). No significant difference between homologous and heterologous sarcomatous components was observed (P = 0.95), whereas no significant trend of improved OS was noticed for stage IIIC-IV with optimal debulking surgery (n = 9), compared with suboptimal cytoreduction (n = 19; 32.6 vs 14.5 months, P = 0.14).
The combination of anthracycline, alkylating agent, and cisplatin showed a good response rate but also a high toxicity. The prognosis of OCS remains poor. Optimal cytoreduction may improve survival, but new anticancer drugs or more effective regimens are awaited.
International Journal of Gynecological Cancer 08/2009; 19(6):1142-6. · 1.65 Impact Factor
-
[show abstract]
[hide abstract]
ABSTRACT: To compare the surgical outcome of robotic radical hysterectomy (RRH) versus abdominal radical hysterectomy (ARH) for the treatment of early stage cervical cancer.
A prospective collection of data of all RRH for stages IA2-IIA cervical cancer was done. The procedures were performed at the European Institute of Oncology, Milan, Italy, between November 1, 2006 and February 1, 2009.
A total of 40 RRH were analyzed, and compared with 40 historic ARH cases. The groups did not differ significantly in body mass index, stage, histology, or intraoperative complications, but in age (p=0.035). The mean (SD) operative time was significantly shorter for ARH than RRH, 199.6 (65.6) minutes and 272.27 (42.3) minutes respectively (p=0.0001). The mean (SD) estimated blood loss (EBL) was 78 ml (94.8) in RRH group and 221.8 ml (132.4) in ARH. This difference was statistically significant in favor of RRH group (p<0.0001). Statistically significantly higher number of pelvic lymph nodes was removed by ARH than by RRH, mean (SD) 26.2 (11.7) versus 20.4 (6.9), p<0.05. Mean length of stay was significantly shorter for the RRH group (3.7 versus 5.0 days, p<0.01). There was no significant difference in terms of postoperative complications between groups.
This study shows that RRH is safe and feasible. However, a comparison of oncologic outcomes and cost-benefit analysis is still needed and it has to be carefully evaluated in the future.
Gynecologic Oncology 07/2009; 115(1):60-4. · 3.89 Impact Factor
