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A du Bois

Publications and source records attributed to A du Bois.

At least 19 recordsLinked to original sources
PubMed2006

Feasibility, toxicity and quality of life of first-line chemotherapy with platinum/paclitaxel in elderly patients aged >or=70 years with advanced ovarian cancer--a study by the AGO OVAR Germany.

BACKGROUND: The purpose of the study was to evaluate first-line platinum/paclitaxel (Taxol) under phase III trial conditions in ovarian cancer (OC) patients aged >or=70 years. PATIENTS AND METHODS: Phase III results of 779 patients with OC International Federation of Gynecology and Obstetrics (FIGO) stage IIB/IV treated with cisplatin/paclitaxel versus carboplatin/paclitaxel were retrospectively analyzed according to feasibility, toxicity (National Cancer Institute Common Toxicity Criteria) and quality of life (QoL) [European Organization for Research and Treatment of Cancer QoL questionnaire (EORTC QLQ-C30)] in patients aged <70 or >or=70 years. RESULTS: One hundred and three (13%) patients were aged >or=70 years. Patient characteristics (<70 versus >or=70 years) showed significant differences with regard to Eastern Cooperative Oncology Group performance status, residual disease and constitutional factors but not to FIGO stage, histology or grading. Elderly patients received 98%, 100% and 96% of the recommended paclitaxel, carboplatin and cisplatin dose, respectively, per cycle. Early discontinuation was more frequent in elderly, although QoL, nonhematological and hematological toxicity were comparable between elderly and younger patients, except for febrile neutropenia (5% versus <1%, P = 0.005). There were no significant differences with regard to cycle delays, dose reductions or the use of granulocyte colony-stimulating factor and antibiotics. CONCLUSION: Platinum/paclitaxel appeared to be feasible and tolerable in elderly patients under clinical trial conditions, but there seems to be a different investigators' estimation of toxicity and less intention to maintain trial treatment in elderly.

Adult↗
PubMed2006

A phase I and pharmacokinetic study of novel taxane BMS-188797 and cisplatin in patients with advanced solid tumours.

This phase I study investigated the maximum tolerated dose and pharmacokinetics of a 3-weekly administration of BMS-188797, a paclitaxel derivate, at three dose levels (DLs) (80, 110 and 150 mg m(-2) DL), combined with cisplatin (standard dose 75 mg m(-2)). In 16 patients with advanced malignancies treated, one patient experienced dose-limiting febrile neutropenia, sepsis and severe colitis at the 150 mg m(-2) DL; at the 110 mg m(-2) DL one episode of dose-limiting grade 3 diarrhoea/nausea occurred. Grade 3/4 haematological toxicities were leucopenia/neutropenia; grade 3 nonhaematological toxicities were neuropathy, nausea, diarrhoea and stomatits. Objective response was seen in four patients, with three complete remissions in ovarian and cervical cancer patients. Pharmacokinetics of BMS-188797 appeared linear through the 110 mg m(-2), but not through the 150 mg m(-2) DL. The mean+/-SD values for clearance, distribution volume at steady state and terminal half-life during cycle 1 were 317+/-60 ml min(-1) m(-2), 258+/-96 l m(-2) and 30.8+/-7.7 h, respectively. The maximum tolerated and recommended phase II dose for BMS-188797 was 110 mg m(-2) (1-h infusion, every 3 weeks) combined with cisplatin 75 mg m(-2).

Adult↗
PubMed2006

Small cell of the ovary, hypercalcemic type -- analysis of combined experience and recommendation for management. A GCIG study.

UNLABELLED: Small cell carcinoma of the ovary, hypercalcemic type (SCCOHT) is a rare tumor typically affecting young women. It is an aggressive malignancy with a poor prognosis and few long-term survivors. OBJECTIVE: Investigate the outcome of patients with SCCOHT. METHOD: Data were collected for patients with SCCOHT treated in Australia, Canada and Europe. Information included stage, surgery, chemotherapy, radiotherapy, recurrence and survival. RESULTS: The median follow-up is 13 months for all patients and 35.5 months in surviving patients. Ten patients had FIGO stage I tumors, six stage III tumors and one stage unknown. All underwent surgical resection. Adjuvant platinum-based chemotherapy was given to all patients. Seven received adjuvant radiotherapy with either pelvic and para-aortic radiotherapy, average dose 46.5 Gy (40 Gy/25# - 50.4 Gy/23#), or pelvic and whole abdominal radiotherapy, average dose 45 Gy to pelvis and 25 Gy (22.5 Gy/22# - 30 Gy/25#) to abdomen. The median survival for stage I tumors was not reached and was 6 months for stage III tumors. For the ten patients with stage I tumors: six received adjuvant radiotherapy with five alive and disease-free; four received no adjuvant radiotherapy with one alive and disease-free, while three have relapsed with one alive and disease-free after resection. Of the seven patients with stage III or unknown stage tumors, all but one have died. Recurrences were most frequent in the pelvis and the abdomen. Patients receiving salvage treatment with chemotherapy and radiotherapy did poorly. CONCLUSION: We advocate a multi-modality treatment approach including surgery, chemotherapy with the addition of radiotherapy either sequentially or concurrently.

Adult↗
PubMed2006

[Diagnosis and treatment of malignant ovarian tumors 2005: recommendations of the Kommission Ovar of the AGO].

Recommendations for diagnosis and treatment of malignant ovarian tumors with regard to the most recent data were worked out in a consensus process and valued by level of evidence (LoE) and grade of recommendation (GoR) of the Canadian Task Force for Preventive Health Care by the members of the Kommission Ovar der Arbeitsgemeinschaft für Gynäkologische Onkologie (AGO) in June 2005. A short version of these guidelines is presented.

Aged↗
PubMed2006

[Ovarian cancer -- can peritoneal therapy be regarded as new standard?].

Recently, the publication of the GOG 172 trial led to intraperitoneal (i. p.) chemotherapy in patients with ovarian cancer being regarded as potential new standard. The AGO Kommission Ovar, AGO-OVAR and NOGGO disagree with this view. In the GOG 172 study, several variables were mixed, and i. p.-therapy was not compared to the current standard paclitaxel plus carboplatin. The analysis was not based on an intention-to-treat (ITT) population, while even the slightest changes of significant results could lead to the elimination of their significance. Furthermore, the GOG 172 trial did not provide any details on second-line treatment which could have an impact on overall survival. High toxicity and the low number of cycles in i. p.-therapy might call the significant effect into question. The low median time of survival of the GOG 172 trial in the control arm (49.7 months) diverges from comparable collectives of three AGO-OVAR trials and the GOG 158 study (56.5-59.5 months). If the result of the GOG 172 trial had been similar, there would not have been any significance in comparison to i. p.-therapy. In order to change the current standard, it would be necessary to base the analysis on an ITT-population, provide details about second-line therapy, rule out bias regarding second-line therapy and to develop less toxic regimens.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

The anti-idiotypic antibody abagovomab in patients with recurrent ovarian cancer. A phase I trial of the AGO-OVAR.

BACKGROUND: Abagovomab is a murine anti-idiotypic antibody against the antigen CA-125 which has been shown to elicit humoral and cellular immune responses against ovarian cancer (oc). PATIENTS AND METHODS: This phase I trial included 36 patients with recurrent oc comparing two subcutaneous (s.c.) vaccination schedules: nine (group L) versus six injections (group S), 18 patients in each group. Four injections of 2.0 mg abagovomab were administered every 2 weeks and then two or five additional doses monthly. Primary endpoint was drop-out rate due to toxicity, and the secondary endpoint was analysis of immunological response. RESULTS: Treatment was completed in eight (44%) and 16 (89%) patients in groups L and S, respectively. Premature termination occurred due to patient withdrawal or disease progression. No treatment-limiting toxicities occurred in either group. The most common toxicity related to the vaccine was grade 1/2 local injection site reaction. Induction of Ab3 was observed in all evaluable patients. There were no differences between the groups with regard to induction of human anti-mouse antibody (P = 0.1006). IFNgamma-expressing CA125-specific CD8+ T-cells were significantly more frequent in group L, while there was no significant difference between CD4+ T-cells in the two groups. CONCLUSIONS: Abagovomab s.c. vaccination is safe and well tolerated. The long vaccination schedule tended to be more effective with regard to AB3-induction and cellular cytotoxicity.

Adult↗
PubMed2005

Pegylated liposomal doxorubicin and carboplatin in advanced gynecologic tumors: a prospective phase I/II study of the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR).

BACKGROUND: Single-agent platinum and single-agent pegylated liposomal doxorubicin (PLD) are both effective in the treatment of gynecologic malignancies. Based on evidence that combination platinum-containing regimens offer superior efficacy versus single-agent regimens, we conducted this study to determine the maximum tolerated dose (MTD) of PLD in combination with carboplatin. PATIENTS AND METHODS: In this phase I/II dose-finding study, six courses of PLD (20, 30, 40 or 50 mg/m2) and carboplatin (AUC 6) were administered every 28 days to women with advanced gynecologic malignancies. Three to six patients were treated at each dose level; an additional 12 patients were treated at the MTD. RESULTS: PLD 40 mg/m2 was identified as the MTD when administered with carboplatin. Five of 18 patients experienced a dose-limiting toxicity at the MTD; two patients had grade 3/4 neutropenia, and one each had grade 3 emesis and grade 3 thrombocytopenia and thrombosis. No patient developed cardiotoxicity. In 11 patients evaluable for response, there were two complete responses, two partial responses and four patients with stable disease. CONCLUSIONS: The MTD for PLD when administered in combination with carboplatin is 40 mg/m2. This regimen is well tolerated and offers promising activity in women with advanced gynecologic malignancies.

Adult↗
PubMed2005

Non-enrolment of ovarian cancer patients in clinical trials: reasons and background.

BACKGROUND: Some retrospective analyses have suggested that participation in clinical trials is associated with better outcome. However, it is not clear to what extent selection bias contributes to this observation. PATIENTS AND METHODS: We evaluated the reasons for non-enrolment of ovarian cancer patients in clinical trials. All patients with ovarian cancer not enrolled in clinical studies and treated in 2001 in the participating centres were documented retrospectively and compared with patients enrolled in clinical trials at the same institutions during the same time period. RESULTS: Two hundred and seventy-four patients with advanced ovarian cancer (FIGO stage IIB-IV) were included, of whom 139 (51%) and 135 (49%) patients were enrolled in this study and in prospective clinical trials, respectively. Ninety-four of 274 patients (34%) did not meet the inclusion criteria for clinical trials. Of 180 eligible patients, 28 (16%) refused participation and a further 17 patients (9%) were not recruited although they met the inclusion criteria. The non-study patients were older (66.7 versus 57.2 years; P <0.0001), underwent less radical surgery (hysterectomy, oophorectomy and omentectomy performed: 61.2% versus 80.7%; P = 0.001; rate of lymphadenectomy 30.9% versus 45.2%; P = 0.015) and more frequently had bulky residual disease (residual disease >2 cm: 36.2% versus 20%; P = 0.016). However, 62% of the non-study patients were treated with the same chemotherapy as in the standard arm of the respective clinical studies. CONCLUSIONS: Study patients differ substantially from non-study patients, thus hampering generalisation of study results. Our results suggest that at least some inclusion criteria for clinical trials should be modified to increase study participation without compromising safety.

Adult↗
PubMed2005

Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy--a double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynäkologische Onkologoie (AGO) Ovarian Cancer Study Group.

GOALS OF WORK: Neurotoxicity is a common side effect of platinum/taxane-based therapy of ovarian cancer. We performed a double-blind randomized placebo-controlled trial to evaluate the influence of the cytoprotectant amifostine on the neurotoxicity of first-line therapy of ovarian cancer with paclitaxel/carboplatin with or without epirubicin. PATIENTS AND METHODS: Of 72 patients randomized, 71 were treated with paclitaxel 175 mg/m2 and carboplatin AUC5 with or without epirubicin 60 mg/m2 (q21 x 6) and randomized for i.v. premedication with amifostine 740 mg/m2 or placebo. Assessment included a questionnaire, NCI-CTC, tendon reflex activity (TRA), two-point discrimination (2-PD), measurement of vibration perception threshold (VPT) and vibration disappearance threshold (VDT), and quality of life. RESULTS: The majority of neurotoxicity criteria showed a significant impairment during therapy in both treatment arms. A significant protective effect of amifostine was observed for 2-PD, TRA, VPT and VDT. Amifostine failed to improve the 'global health status quality of life' score significantly. Toxicities according to NCI-CTC showed improved sensory neuropathy (P = 0.0046) but a worsening in terms of nausea (P = 0.0005) and vomiting (P = 0.0083). No significant differences were observed for single sensory and motor symptoms, except for a better skilfulness in the amifostine group (P = 0.0404). CONCLUSION: Amifostine improved sensory neuropathy according to NCI-CTC and with regard to objective neurological assessment, but there were almost no differences in self-estimated specific sensory or motor symptoms. Disadvantages with regard to non-neurological toxicities and inconsistent results for quality of life demand further evaluation of neuroprotection with amifostine as well as alternative approaches to prevent platinum-taxane induced neurotoxicity.

Adult↗
PubMed2005

[Leiomyomatosis peritonealis disseminata and borderline lesion].

Leiomyomatosis peritonealis disseminata (LPD) is a rare disease, which is most often found in women in reproductive age - seldom pre- and postmenaupausal. LPD has been described in women taking oral contraceptives or during pregnancy. LPD is mostly asymptomatic and discovered during operations like section caesarea, etc. Because of the macroscopic aspect (multiple small nodules <2 cm) a metastasing tumour is suspected during operation. These nodules consist of smooth muscle fibres and show benign histologic features. An increased level of cases with similar endometriosis (10%), myoms of uterus or functional ovarian tumours have been reported. Few cases of malignant transformation have also been described. In the pathogenesis of LPD a metaplastic change of submesothelial multipotential mesenchymal cells as an abnormal response on hormonal stimulation is debated. A regression of LPD after delivery or after stopping oral contraceptives is possible. Another therapeutic option is the application of GnRH-agonists. We present a case of a 35-year old female patient with sudden abdominal pain and suspicious findings in abominal ultrasound and CT-abdomen. The intraoperative aspect shows diffuse intraabdominal nodules consisting of smooth muscle fibres and a cystic left ovary. LPD, endometriosis and a borderline lesion of the left ovary were diagnosed by intraoperative histological examination. A bilateral salpingo-oophorectomy and omentectomy were performed.

Adult↗
PubMed2005

A phase II study of paclitaxel, carboplatin, and gemcitabine in previously untreated patients with epithelial ovarian cancer FIGO stage IC-IV (AGO-OVAR protocol OVAR-8).

PURPOSE: A multicenter, nonrandomized, phase II study was initiated to evaluate the tolerability, toxicity, and activity of paclitaxel, carboplatin, and gemcitabine combination in previously untreated ovarian cancer. PATIENTS AND METHODS: Chemonaive patients who had radical debulking surgery for primary epithelial ovarian cancer International Federation of Gynecology and Obstetrics (FIGO) IC-IV received sequentially paclitaxel 175 mg/m(2), carboplatin AUC 5, and gemcitabine 800 mg/m(2) on day 1 and gemcitabine 800 mg/m(2) on day 8, every 3 weeks. RESULTS: From October 2001 to July 2002, 55 patients were treated and evaluated. Main toxicities were hematological with NCI-CTC grade 3/4 anemia 12.7%, leukopenia 70.9%, neutropenia 76.3%, and thrombocytopenia 45.5. However, febrile neutropenia occurred only in 1.8%. Grade 3/4 nonhematological toxicities were rare and occurred in less than 10% of patients. Toxicity-induced treatment delays occurred in 3.1% of cycles and resulted in early treatment cessation in four patients. Dose intensity reached 90.8% for carboplatin and paclitaxel, and 73.3% for gemcitabine. Objective response was observed in 10 of 14 patients with measurable disease. CONCLUSIONS: The triplet combination of paclitaxel-carboplatin-gemcitabine is feasible and active, with manageable hematological toxicity and no unexpected nonhematological toxicity. This regimen has proceeded to phase III evaluation.

Adult↗
PubMed2005

[The Quality Assurance Program of the AGO Organkommission OVAR (QS-OVAR): Pattern of Care and Reality in Germany 2001].

PURPOSE: To evaluate pattern and quality of care for ovarian cancer in Germany and analyze adherence to treatment guidelines as well as prognostic factors for survival. METHODS: Nationwide survey including patients with histological proven invasive epithelial ovarian cancer diagnosed in the third quarter 2001 including descriptive analysis of pattern of surgical care and systemic treatment in early (FIGO I-IIA) and advanced (FIGO IIB-IV) ovarian cancer and both univariate and multivariate analysis of prognostic factors. RESULTS: 476, representing more than one third of all patients diagnosed in Q III 2001 in Germany were included. Standard care according to German guidelines was provided to only 35.5 % of patients with early ovarian cancer. Optimal debulking was reported for 61.4 % patients with FIGO stages IIB-IV. Recommended platinum-paclitaxel chemotherapy was given to 3 out of 4 patients in advanced disease. Multivariate analysis showed advanced stage, poor performance status, co-morbidity, ascites, postoperative tumor residuals, and less than standard care to be associated with inferior survival. CONCLUSIONS: Adherence to treatment guidelines showed remarkable variety among German hospitals indicating options and need for improvement.

Delivery of Health Care↗
PubMed2005

[Impact of center characteristics on outcome in ovarian cancer in Germany].

PURPOSE: To evaluate the relationship between hospital characteristics and quality of care and outcome in ovarian cancer in Germany. METHODS: This 2nd national survey in patients with histologically proven epithelial ovarian cancer diagnosed in the 3 (rd) quarter 2001 analyzed pattern of care in early (FIGO I-II A) and advanced (FIGO II B-IV) disease. We performed univariate and multivariate analysis of the role of hospital characteristics, like hospital-volume, participation in cooperative clinical studies, and hospital category (university vs central clinic vs. two lower categories in Germany) as prognostic factor. RESULTS: 165 hospitals documented 476 patients (= about one third of all patients diagnosed in Germany within one quarter). Patients treated in study-centres received more frequently standard care and showed superior survival (multivariate analysis including biologic prognostic factors: HR 1.71; 95 % CI 1.2-2.5; p = 0.007). 2-year-survival was 72 % and 64 % in study-centres and hospitals not participating in studies, respectively. Neither hospital category nor hospital-volume showed any significant impact on survival. Only analysis of surrogate parameters like pattern of care in early ovarian cancer revealed advantages related to hospital category. Furthermore, analysis of some surgical details revealed advantages for high-volume centres and hospital category. CONCLUSION: Participation in clincal studies was the only transparent hospital characteristic with significant impact on prognosis of ovarian cancer. Study participation as criterion for quality of care should be included in counselling ovarian cancer patients and should help guiding selection of hospitals for primary therapy. All German hospitals with information about participation in cooperative clinical studies as well as in this quality assurance program are listed on the web.

Clinical Trials as Topic↗