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Showing papers by "Jonathan A. Ledermann published in 1997"


Journal ArticleDOI
TL;DR: Oral altretamine is a useful agent in patients-who relapse after previously responsive ovarian cancer who entered clinical complete remission with CA125 levels less than 35 U/mL after initial or second-line chemotherapy, and relapsed more than 6 months later.
Abstract: PURPOSEA phase II study was performed of oral altretamine in 71 patients with ovarian carcinoma who entered clinical complete remission with CA125 levels less than 35 U/mL after initial or second-line chemotherapy, and relapsed more than 6 months later. Response was compared between standard and CA125-based criteria.PATIENTS AND METHODSAltretamine 260 mg/m2 was given in divided doses daily for 14 days per month. Response was evaluated according to European Organization for Research and Treatment of Cancer (EORTC) criteria in 45 of 66 eligible patients. Response was assessed according to precise CA125 criteria in 51 patients based on either a confirmed > or = 50% or > or = 75% decrease in CA125 levels.RESULTSA combination of domperidone, dexamethasona, and chlorpromazine at night controlled toxicity in most patients, which was mainly nausea (National Cancer Institute criteria grade 2 or 3 in 27), vomiting (grade 2 or 3 in 19, grade 4 in one), and tiredness (grade 2 or 3 in 15). Responses (complete plus par...

67 citations


Journal ArticleDOI
TL;DR: How CA125 in combination with other tests can be used in the differential diagnosis of pelvic masses and as part of the investigations for cancer screening is discussed.
Abstract: Epithelial ovarian cancer is the most common ovarian malignancy. CA125, the glycoprotein defined by the antibody OC 125, is the most important clinical marker for the diagnosis, treatment and follow-up of epithelial ovarian cancer. However, like most tumor markers, it is neither wholly specific nor sensitive for the disease. We discuss how CA125 in combination with other tests can be used in the differential diagnosis of pelvic masses and as part of the investigations for cancer screening. CA125 is an important indicator of response to treatment, guiding therapeutic decisions and identifying those patients whose response to chemotherapy and survival is short. CA125 has recently been shown to correlate well with response and can be used to define relapse. Thus, it can be used as a surrogate endpoint in the assessment of new therapeutic modalities as well as in reducing the need for tumor imaging. At the moment, the other tumor markers for non-germ-cell neoplasms of the ovary are clinically less important than CA125, but their role alone or in association with CA125 is the subject of intense study as the search for ideal tumor markers to identify early disease, prognosis, and relapse continues.

51 citations


Journal ArticleDOI
TL;DR: The response rate of this regimen compares favourably with reported trials of intra-arterial FUDR, and the schedule is currently being compared with a similar schedule of intravenous 5-FU and folinic acid in a randomized Medical Research Council trial (CR05).
Abstract: Forty patients with unresectable colorectal metastases confined to the liver were evaluated in a phase II study. 5-Fluorouracil (5-FU) was delivered via a surgically placed hepatic artery catheter. Patients received folinic acid (200 mg m-2) intravenously over 2 h followed by a loading dose of intra-arterial 5-FU (400 mg m-2) over 15 min, then 5-FU (1600 mg m-2) by intra-arterial infusion over the following 22 h. This was repeated on day 2 and the whole schedule was repeated every 2 weeks. Response was assessed after six treatments. The median follow-up was 17 months. Overall response rate was 46% with 8% complete response. Estimated median survival is 19 months. Site of progression was the liver alone in 55%, liver and lung in another 16% and 29% in other sites. Eight patients experienced grade 3 or 4 toxicity. The response rate of this regimen compares favourably with reported trials of intra-arterial FUDR, and our schedule is currently being compared with a similar schedule of intravenous 5-FU and folinic acid in a randomized Medical Research Council trial (CR05).

29 citations


Journal ArticleDOI
TL;DR: Paclitaxel given at 225 mg m(-2) to patients with stage IV epithelial ovarian cancer is active, well tolerated and does not require GCSF support.
Abstract: The aim of this study was to evaluate the efficacy of high-dose paclitaxel in patients with previously untreated stage IV epithelial ovarian cancer. Paclitaxel was administered intravenously over 3 h at a dose of 225 mg m(-2) on a 21-day cycle for six courses. Thirty-six patients were entered into this study; all 36 were assessed for toxicity and 33 patients were evaluable for response. One patient had a complete response and 12 patients had partial responses (overall response rate 39.4%, 95% CI 23-58%). The overall median duration of response was 9 months (range 3.5-23+ months). The response rate to carboplatin following failure of paclitaxel within 1 year of stopping therapy was 57% (four out of seven patients). The median survival of patients was 17.2 months. The main toxicity encountered was neutropenia which was WHO grade 3 in 11 patients (31%) and WHO grade 4 in seven patients (19%). Granulocyte colony-stimulating factor (GCSF) was not given to any patient during the study. Other toxicities were: grade 3/4 infection (11%) and nausea and vomiting (11%); grade 3 bone pain (22%), fatigue (14%), diarrhoea (3%), myalgia/arthralgia (3%) and dry eyes (3%). Transient peripheral neuropathy occurred in 16 patients (44%), and alopecia was encountered in most patients (grade 2/3, 78%). Paclitaxel given at 225 mg m(-2) to patients with stage IV epithelial ovarian cancer is active, well tolerated and does not require GCSF support.

10 citations