Purpose of investigation: In this paper the authors have analyzed the long-term survival of women with Stage Ill ovarian cancer due to lymph node metastasis. Materials and Methods: This retrospective study included 27 patients with FIGO Stage IIIC epithelial ovarian carcinoma due to lymph node metastases observed consecutively at the Mangiagalli Clinic of Milan from 1982 to 2008. Results: Two cases had Fallopian tube carcinoma. A total of ten recurrences were observed. Median time to recurrence was 158 months. The five-year disease-free survival (DFS) was 57.7%. The ten-year corresponding value was 53.2%. Median survival time was 158 months, with median follow-up time of 169 months. The five-year (overall survival) OS rate was 77.1%; the ten-year rate was 55.4%. Conclusion: Women with ovarian cancer Stage IIIC due to nodal involvement have a five-year OS of about 80% and a ten-year OS of about 50%.
Aim: To evaluate safety, feasibility and oncological outcome of total laparoscopic radical hysterectomy (TLRH) in patients with early invasive cervical cancer.Methods: Data of patients with Ib1 cervical cancer who underwent TLRH were prospectively collected. Inclusion criteria were: good general condition, tumor size < 3 cm, and no evidence of lymph node metastases in imaging study (MRI and/or CT and/or PET). Radical hysterectomy was performed with a PlasmaKinetic tissue management system. Adjuvant therapy was administered according to surgical risk factors.Results: Between September 2001 and October 2007 107 patients underwent laparoscopic radical hysterectomy and pelvic lymphadenectomy. Conversion to laparotomy was necessary in 6 patients. Median number of resected pelvic lymph nodes was 26. Median blood loss was 200 ml and median duration of surgery was 305 min. Minor intraoperative complications were registered in two patients, while five patients needed a second surgery for postoperative complications. Thirteen patients had microscopic nodal metastasis. A total of 24 patients received adjuvant therapy. After a median follow-up of 30 months 11 patients had a recurrences survival rate is 95%.Conclusion: Total laparoscopic radical hysterectomy, in experienced hands, has to be considerate an adequate and feasible surgical technique. Considering historical data the oncological outcome can be considered comparable to patients treated with laparotomy, as the relapse c, c, rate in our population was 11% and the overall survival good. (c) 2008 Elsevier Ltd. All rights reserved.
PURPOSE:To analyze the effect of different doses of paclitaxel with fixed doses of carboplatin in the treatment of ovarian cancer.PATIENTS AND METHODS:Patients with histologically confirmed epithelial ovarian cancer, International Federation of Gynecology and Obstetrics stages IIB to IV, were eligible for this randomized, multicenter study. Women were randomly assigned to treatment with (1) carboplatin at the dose (in milligrams) corresponding to the following formula: target area under the free carboplatin plasma concentration versus time curve (AUC) = 6 x (glomerular filtration rate + 25) mg/m(2) (AUC6) plus paclitaxel 175 mg/m(2) for six cycles every 21 days or (2) carboplatin AUC6 plus paclitaxel 225 mg/m(2) for six cycles every 21 days. A total of 502 women entered the study.RESULTS:Pathologic complete response was documented in 132 patients (63.8%) in the 175 mg/m(2) group and in 127 cases (55.7%) in the 225 mg/m(2) group (chi(2) P =.090). The 4-year progression-free survival rate was 41.5% (SE = 3.5) in the 175-mg group and 39.2% (SE = 3.5) in the 225-mg group. The corresponding 4-year survival rates were 46.2% (based on 115 deaths) and 47.3% (based on 113 deaths), respectively.CONCLUSION:This randomized trial suggests that paclitaxel 175 mg/m(2) plus carboplatin AUC6 is the schedule with a more favorable profile than paclitaxel 225 mg/m(2) plus carboplatin AUC6.
Ifosfamide is one of the best-known alkylating agents. In advanced epithelial ovarian cancer, it has been tested in association with cisplatin, achieving results equal, if not better than cyclophosphamide, with acceptable toxicity. In second-line therapy, it shows remarkable activity, even in patients refractory to cisplatin already treated with cyclophosphamide, with more severe, but always manageable toxicity. In gynecological sarcomas, ifosfamide is, together with doxorubicin, the reference drug for chemotherapy. Copyright (C) 2003 S. Karger AG, Basel.
Purpose: The purpose of this study is to report the results of a systematic laparoscopic staging procedure in locally advanced cervical carcinomas Patients and methods: Between 1/97 and 11/02, 133 patients with IB2(41); IIA(7); IIB(29); IIIA(6); IIIB(44); IVA(2) or a recurrent (4) cervical carcinoma, underwent a pretherapeutic laparoscopic staging involving a diagnostic transperitoneal laparoscopy, followed, if normal, by an ilio-infrarenal extraperitoneal laparoscopic para-aortic lymphadenectomy Results: Age averaged 46 ( (cid:3) 9) years. BMI was 24 ( (cid:3) 5) kg/m2. Node count was 20 ( (cid:3) 11) with 29 (22 % ) pN1 patients. Operative time averaged 154 ( (cid:3) 46) min and postop stay was 2 days. Symptomatic lymphoceles (14 % ) were the main complication. 2 patients had to be re-operated (1 abcess, 1 bowel obstruction). If radiation therapy is usually limited to the pelvis in stage IB2, our staging revealed that 9pN1 patients (22 % ) would have been under-treated. In the other hand, in the subgroup of 89 stage IIB, III and IV, usually managed by extended field therapy, our 69 pN0 patients (77,5 % ) would have been over-treated. At a distance, pN1 patients tolerated well the extended chemoradiation treatment but prognosis was poor (median survival 27 months), the median survival of pN0 patients after pelvic radiation was not reached after 16.6-month follow up. Conclusions: Laparoscopic staging of locally advanced cervical carcinoma is a feasible and useful technique that combines the
From 1995 to December 2000 nulliparous patients with cervical tumor size :! 3 cm, aged less than or equal to40 years and without uterine and lymphnode involvement were evaluated for a conservative program. Three courses with cisplatin, paclitaxel and ifosphamide (epirubicin in adenocarcinoma) every 3 weeks were administered. Subsequently patients underwent cervical cold knife conization and pelvic lymphadenectomy. Ten (48%) of 21 eligible patients did not accepted the conservative approach, and 2 were deemed ineligible for conservative surgery after chemotherapy. In the remaining 9 patients pathological complete response was observed in 3 cases, in situ or microinvasive residual in 5 and stromal invasion >3 mm in 1. After a median follow-up of 30 months no relapses were observed. Five women attended to conceive: one is pregnant and two underwent cesarean delivery for obstetrical reasons.
Objective. The aim of the study was to analyze the benefit/ toxicity profile of a second-line treatment with carboplatin alone or carboplatin plus another non-cross-resistant drug (epidoxorubicin) in ovarian cancer patients sensitive to cisplatin-based chemotherapy at first-line treatment.Methods. We conducted a randomized clinical trial. Women with epithelial ovarian cancer FIGO Stage II-IV who had a complete or partial response to first-line treatment with cisplatin or carboplatin-based regiments and subsequently progressed or relapsed more than 6 months after discontinuation of first-line treatment were eligible for the study. A total of 190 subjects entered the study. They were randomly allocated to either 300 mg/m(2) of carboplatin every 28 days for five cycles (95 patients) or 120 mg/m(2) of epidoxorubicin and 300 mg/m(2) of carboplatin every 28 days for five cycles (95 patients).Results. A complete response was reported, respectively, in 32 (36%) women allocated to carboplatin alone and in 28 (31.8%) of those allocated to carboplatin plus epidoxorubicin, The corresponding figures for partial response were 18 (20.2%) and 26 (29.9%). Comparing the frequency of complete response, partial response, no change, and progression, the differences between the two groups were not significant (chi (2)(3) 5.10, P = 0,16). The median duration of response was 16 months in the carboplatin alone and 20 months in the carboplatin plus epidoxorubicin group (P = not significant). The 3-year percentage of survival was 29% in the carboplatin alone and 42% in the carboplatin plus epidoxorubicin group; this difference was not statistically significant, The frequency of leukopenia, anemia, and thrombocytopenia grade 3-4 was higher in the epidoxorubicin plus carboplatin than in the carboplatin alone group. Alopecia G3 was present in 88% of women treated with epidoxorubicin plus carboplatin.Conclusions. The general results of this study do not show any marked differences in response to second-line treatment among women treated with single-agent (carboplatin) or multiagent (carboplatin plus epidoxorubicin) schedules. Toxicity, particularly hematological, was more relevant in women treated with the multiagent schedule. (C) 2001 Academic Press.
OBJECTIVE:The objective of this open uncontrolled study was to evaluate the toxicity and efficacy of topotecan in ovarian cancer cases with microscopic small residual disease to a first-line treatment, given as sequential treatment, including carboplatinum and paclitaxel. METHODS:Inclusion criteria were laparotomically or laparoscopically documented microscopic or macroscopic (<2 cm) residual disease after first-line chemotherapy including carboplatinum plus paclitaxel in patients with histologically documented epithelial ovarian cancer FIGO stage III or IV at first diagnosis. All patients had a response >50% after first-line treatment. Eligible patients received 1.25 mg/m(2)/day of topotecan intravenously as a 30-min infusion for 5 consecutive days every 21 days for four cycles. A total of 38 women entered the study. Surgical "third-look" laparotomy or laparoscopy was performed in patients without clinical/instrumental evidence of progressive disease within 1 month from the last topotecan administration. RESULTS:A complete response was observed in 10 cases (28.6%, 95% confidence interval, based on the Poisson's approximation, 15.6-59. 5), a partial response in 1 (2.5%), progressive disease in 11 (31. 4%) and no change/stable disease in 13. The median duration of response was 8 months (range 5-20). The overall 1-year survival after treatment was 82.8% (SE 6.4). CONCLUSION:This study indicates that sequential therapy with carboplatin plus paclitaxel followed by topotecan, all given at standard doses, is feasible and provides favorable response rates.
AIMS AND BACKGROUND:To evaluate the toxicity of high-dose ifosfamide in ovarian cancer patients refractory or resistant to platinum and/or paclitaxel-containing chemotherapy.METHODS:This was an open, non-randomized phase I-II trial of high-dose ifosfamide. Eligibility criteria were: patients aged 18-75 years affected by ovarian cancer with refractory or resistant disease or early relapse after first-line treatment including platinum or paclitaxel. Three patients were given escalating ifosfamide doses; if no severe adverse events occurred, the ifosfamide dose was increased. The starting dose of ifosfamide was 10 g/m2 i.v. and the dose increase was 1 g/m2 every four weeks for a total of five courses; 12 g/m2 was the maximum ifosfamide dose to be administered. The trial then progressed to a phase II trial, in which ifosfamide was given at the maximum tolerated dose reached during the escalating dose phase.RESULTS:A total of 36 patients entered the trial. Nine patients were involved in phase I of the study; 3 received 10 g/m2 ifosfamide, 3 11 g/m2 and 3 12 g/m2. Of the 32 evaluable patients 6 (18.8%) achieved a complete response and three (9.4%) a partial response, giving an overall response rate of 28.1% (95% CI, 15-61% based on Poisson's approximation). The median number of ifosfamide courses was five. G1, G2 and G3 neurotoxicity was reported in 3 (8%), 2 (5%) and 2 (5%) patients, respectively.CONCLUSION:This phase I-II trial indicates that high-dose ifosfamide has some activity but also a relevant degree of toxicity in resistant or refractory platinum and paclitaxel-pretreated ovarian cancer.
We conducted a randomized clinical trial to compare the efficacy and safety of paclitaxel and a combination including paclitaxel and epidoxorubicin as second-line treatment in platinum-refractory or -resistant ovarian cancer. Patients who had progressive or stable disease during first-line therapy with regimens containing cisplatin or carboplatin (platinum-refractory patients) or who responded and subsequently relapsed within 6 months after discontinuation of first-line platinum-based regimen (platinum-resistant patients) were eligible for the study. They were randomly allocated to paclitaxel 175 mg/m2every 28 days (41 women) for five cycles or epidoxorubicin 120 mg/m2iv plus paclitaxel 150 mg/m2iv every 28 days (40 women). The overall response rates (complete plus partial response) were, respectively, 17.1% in the paclitaxel and 34.2% in the epidoxorubicin plus paclitaxel group (P= 0.10). The 2-year percentage survival was 18 in the paclitaxel group and 10 in the epidoxorubicin plus paclitaxel group. A higher frequency of leukopenia and thrombocytopenia was reported in women allocated to epidoxorubicin plus paclitaxel than in the paclitaxel alone group, but the frequency of neurotoxicity was higher in the paclitaxel alone group. An important limitation of the study is the small sample size. With this sample size we can exclude that multiagent therapy in comparison with single-agent therapy improves response in platinum-refractory and -resistant ovarian cancer of more than 25%.