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Biomedical subjects

M Piccart

Publications and source records attributed to M Piccart.

At least 73 records · Page 4Linked to original sources
PubMed1998

Breast cancer.

Explore the source record for details and available documents.

Age Factors↗
PubMed1997

Phase II trials of docetaxel (Taxotere) in advanced ovarian cancer--an updated overview.

Docetaxel (Taxotere) has been studied at a dose of 100 mg/m2 i.v. as a one hour infusion every 3 weeks, in four phase II trials in patients with extensively pretreated ovarian cancer. A total of 340 patients were treated, including 256 patients in two separate EORTC (European Organization for Research and Treatment of Cancer) trials and 84 patients in two trials in the U.S.A. All patients had received prior cisplatin or carboplatin therapy and the treatment-free interval was less than 4 months in 155 patients. The overall response rate using conventional UICC criteria was 30% among 315 evaluable cases (95% confidence interval: 24-36%). Among 155 patients whose disease was most refractory (i.e. treatment-free interval was less than 4 months), the overall response rate was 28% (95% confidence interval: 19-36%). Response duration ranged from 4 to 17 months. Grade IV neutropenia was a common finding and fluid retention was observed. The incidence of febrile neutropenia ranged from 8 to 44% of patients with two deaths (i.e. 0.6% of the total treated) related to neutropenic sepsis. Docetaxel and paclitaxel (Taxol) have comparable activities in ovarian cancer. Ongoing studies with docetaxel include its use in patients as part of first-line therapy, as well as in patients refractory to paclitaxel. To prevent the development of fluid retention, these now involve the routine use of steroid prophylaxis. It is expected that docetaxel will prove to be an important addition to the drugs available for the treatment of ovarian cancer.

Adult↗
PubMed1997

Breast cancer therapies in development. A review of their pharmacology and clinical potential.

Although the management of breast cancer has improved over the past few decades, it remains an important challenge for the clinician. Cytotoxic chemotherapy and hormonotherapy, when given in the adjuvant setting, have a definitive though modest impact on the outcome of early-stage breast cancer. In metastatic disease, these therapies help to provide substantial palliation of symptoms but have a limited impact on survival. The discovery of vinorelbine and the taxanes, paclitaxel and docetaxel, certainly represented the most encouraging clinical development of the 1980s in breast cancer therapy. Several other new cytotoxic agents have been recognised for their potential in the treatment of this disorder. Many of them are only in a very early phase of their clinical development and it remains to be proven that they will have a major role in daily practice in the near future.

Antineoplastic Agents↗
PubMed1996

Tamoxifen aziridine labeling of the estrogen receptor-potential utility in detecting biologically aggressive breast tumors.

Expression of estrogen receptor (ER) is a helpful predictor of response to endocrine therapy and disease free survival in breast cancer patients. The presence of variant estrogen receptors has been demonstrated at the RNA/DNA level and might represent an escape of tumors from hormonal control mechanisms. However, the demonstration that the corresponding peptides do exist is a real challenge. Denaturing polyacrylamide gel electrophoresis (SDS-PAGE) of covalently bound [3H]tamoxifen aziridine ([3H]TAZ) to ER demonstrates a specific, multiband peptide pattern recognized by anti-ER monoclonal antibodies (anti-ER Mo Abs). The native 66 kDa ER form identified through its hormone binding domain by the H-222 Mo Ab was the most prominent one followed by 50, 35, and 28 kDa forms on fluorography. Such patterns from early human breast tumors were compared to the ones of more advanced disease, namely large primary breast cancers, metastatic lymph nodes, and soft tissue relapses: in these cases, molecular forms of 43 and 35 kDa were identified with a remarkable consistency. The 43 kDa peptide was more frequently identified by the H-226 Mo Ab (which maps a region near the DNA binding domain)-albeit with low labeling intensity as compared to H-222 Mo Ab. In addition, the 43 kDa peptide was inversely correlated to ER levels. This altered ER or related peptide could potentially be a marker of biologically aggressive breast tumors.

Antibodies, Monoclonal↗
PubMed1996

Characterisation of complete responders to combination chemotherapy for advanced breast cancer: a retrospective EORTC Breast Group study.

This retrospective study was undertaken to characterise the natural history of women achieving complete response (CR) following standard dose combination chemotherapy for metastatic breast cancer (MBC), and to analyse the significance of various patient, disease and treatment characteristics in determining survival and time to disease progression. 75 patients achieving a CR following standard dose combination chemotherapy or combined chemoendocrine therapy for MBC have been studied. At a median follow-up of 6 years, 28% of patients are still alive, with 18 of 21 patients showing no evidence of disease. 15 (20%) patients, with median follow-up of 61 months from start of chemotherapy, have never experienced relapse. Median overall survival is 32.5 months. Multivariate analysis for survival identified inclusion of anthracyclines and WHO performance status as significant predictors of good long-term outcome. Concomitant hormonotherapy almost reached statistical significance in our multivariate analysis. Neither dominant site of disease nor disease-free interval were significant determinants of complete remission. With conventional dose combination chemotherapy, approximately 20% of women with MBC who have achieved a clinical CR have been shown to be expected to remain alive and free of disease at 5 years. Inclusion of an anthracycline appears to be an important determinant of durability of CR and patient survival.

Adult↗
PubMed1996

Treatment of advanced breast cancer: current status.

Metastatic breast cancer is a major and increasing public health problem. The 5-year survival for this disease is only 15%, and while hormonal and chemotherapeutic options have had a significant impact on long-term survival for patients with localized disease, treatment for disseminated disease remains essentially palliative. New treatment options are urgently needed to improve the prospects for patients with metastatic breast cancer, particularly for those with disease characteristics indicating a particularly poor prognosis. Docetaxel (Taxotere) is a promising new drug and has shown encouraging activity in patients with disease resistant to anthracyclines and in patients with visceral metastases, both of which indicate a poor prognosis. Although docetaxel is, at present, only licensed for use in patients with anthracycline-resistant disease, this highly active drug should now be developed for first-line treatment, and eventually for adjuvant use.

Animals↗
PubMed1995

Intravenous pamidronate in patients with tumor-induced osteolysis: a biochemical dose-response study.

Bisphosphonates are used increasingly in normocalcemic patients for treating tumor-induced osteolysis (TIO) but little is known about the metabolic effects and the most appropriate therapeutic regimen. In 21 patients with breast cancer and TIO, we determined the biochemical effects of a single infusion of pamidronate given at 30 mg (n = 5), 60 mg (n = 5), 90 mg (n = 5), or 120 mg (n = 6). Patients received no other systemic antineoplastic therapy during the trial. We selected patients with baseline fasting urinary Ca/Creat (creatinine) > 0.105 mg/mg (median value of our normal range) and they were followed weekly for up to 14 weeks. The biochemical effects were maximal at day 7. For the whole group, mean (+/- SEM) Ca/Creat levels fell from 0.208 +/- 0.018 to 0.048 +/- 0.008 mg/mg on day 7 and remained significantly ( p < 0.01) lower than baseline up to day 56. Hydroxyproline excretion fell to a lesser degree, from 7.0 +/- 1.2 to 4.0 +/- 0.6 mg x 100/mg of Creat. The falls in Ca/Creat and hydroxyproline excretion were dose-related (ANCOVA, p < 0.05). Changes in serum parameters of calcium metabolism were, however, not significantly dose-related. Serum Ca levels fell from 9.3 +/- 0.1 to 8.7 +/- 0.1 mg/dl on day 7, but not patients developed symptomatic hypocalcemia, and the decrease within each dose group was significant only at 120 mg. Ca2+ levels followed a similar pattern. There was a slight increase in Mg levels and a pronounced fall in Pi levels, from 3.6 +/- 0.2 to 2.8 +/- 0.1 mg/dl. Intact PTH levels increased from 29 +/- 4 to 91 +/- 13 pg/ml and remained significantly (p < 0.05) elevated up to day 28.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1995

Docetaxel in advanced ovarian cancer: preliminary results from three phase II trials. EORTC Early Clinical Trials Group and Clinical Screening Group, and the MD Anderson Cancer Center.

Docetaxel has been evaluated in 293 patients with advanced ovarian cancer in three phase II trials. All patients had previously received cisplatin and/or carboplatin as first-line treatment. In all three studies, treatment comprised docetaxel 100 mg/m2 as a 1 h intravenous infusion every 3 weeks, without premedication for hypersensitivity reactions or emesis. To date, 200 patients are evaluable for response. Of these, 63 patients achieved complete or partial response, giving an overall response rate of 31.5% (95% confidence interval 24-39%) for all evaluable patients, or 21.5% for all patients entered in the studies. Of the 57 patients whose disease had progressed either during previous therapy or within 4 months of discontinuing previous therapy, 13 (23%) responded to docetaxel (EORTC data). Major adverse effects of docetaxel observed in approximately half the patients (particularly those who received more than four courses) included skin reactions and fluid retention. Grade III or IV neutropenia was common but short-lived. Severe acute hypersensitivity reactions occurred in approximately 5% of patients. Docetaxel now warrants evaluation as part of first-line therapy. Studies aimed at reducing the incidence of fluid retention and skin reactions with docetaxel are ongoing.

Adult↗
PubMed1995

Docetaxel: a new defence in the management of breast cancer.

The results of nine phase II trials of docetaxel in the first- and second-line treatment of patients with advanced breast cancer are summarized. All 316 patients included in this report received docetaxel at a dose of 100 mg/m2 administered over 1 h every 3 weeks on an outpatient basis. One hundred and fifty-four patients received docetaxel as first-line therapy for advanced disease, half of whom had received prior adjuvant chemotherapy (finished at least 1 year previously). An overall response rate of 59% (95% CI: 51-67) was achieved in these patients, with a median duration of response of 8.3 months and a median time to progression of 4.9 months. Similar results were seen in a subgroup of 68 patients with liver metastases. Among the 162 patients given docetaxel as second-line therapy, 134 had strictly defined anthracycline-resistant disease; 73 had liver metastases. The combined overall response rate for anthracycline-resistant patients in two US studies was 48% (95% CI: 37-59) while that in a multicenter French study was 29% (95% CI: 18-44). The median duration of response in each case was 6.3 and 5.5 months, respectively, with an overall median survival duration of 11 and 10 months, respectively. Among patients with liver metastases, second-line treatment with docetaxel achieved an overall response rate of 32%, a median duration of response of 7.8 months and a median survival duration of 9 months. These results for docetaxel as both first- and second-line therapy are comparable with those achieved with doxorubicin and are particularly promising in patients with liver metastases and anthracycline-resistant disease.

Antineoplastic Agents↗
PubMed1994

Phase II studies of Elsamitrucin in breast cancer, colorectal cancer, non-small cell lung cancer and ovarian cancer. EORTC Early Clinical Trials Group.

PURPOSE: To test the antitumor activity of Elsamitrucin in metastatic cancer of the breast, colon and rectum, non-small cell lung and ovary. PATIENTS AND METHODS: Eligibility required histologically proven cancer. Patients with colorectal or non-small cell lung cancer could not have received prior chemotherapy. Patients were entered if WHO PS was < or = 2 and organ functions were normal. Treatment consisted of Elsamitrucin 25 mg/m2/week given as a 5-10 min infusion for at least 3-6 weekly doses. RESULTS: One hundred and five patients entered the studies, 97 were eligible, 94 are evaluable for toxicity and 75 for response. Toxicity mainly consisted of mild nausea/vomiting, and less frequently reversible hepatotoxicity and malaise. No objective responses were seen. CONCLUSION: Elsamitrucin at this dose and schedule is not an active drug in metastatic breast cancer, colorectal cancer, non-small cell lung cancer or ovarian cancer.

Adolescent↗
PubMed1994

Docetaxel (Taxotere): an active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.

BACKGROUND: Docetaxel (Taxotere) is a new cytotoxic agent acting as a promoter of tubulin polymerisation with broad spectrum antitumor activity in preclinical testing. Phase I clinical trials have shown promising activity of docetaxel in patients with breast, ovarian and lung carcinomas. The objective of this open multicentre phase II study was to determine the efficacy and tolerability of this agent in patients with head and neck cancer. PATIENTS AND METHODS: Patients with proven advanced and/or recurrent squamous cell carcinoma of the head and neck without prior chemotherapy for advanced disease were eligible for this trial. Docetaxel was given at a dose of 100 mg/m2 as a 1 hour infusion every 3 weeks. Dose reductions were performed according to hematological and non-hematological toxicities. No pre-medication was given to prevent hypersensitivity reactions. RESULTS: Fourty-three patients entered this trial: 39 patients were evaluable for toxicity and 37 patients were evaluable for response. Sixty-five percent of the patients had locoregional disease, 28% had metastatic disease, and 7% had both. Twenty-five percent of the patients had previously received neo-adjuvant cisplatin-based chemotherapy. A total of 166 docetaxel courses were administered. The most frequent side-effects associated with docetaxel were alopecia (90% of the patients), asthenia (69% of the patients) and short lasting neutropenia (grade 3-4 neutropenia in 61% of the courses). Fifty-four percent of the patients experienced skin toxicity, 23% experienced hypersensitivity reaction, and 31% developed peripheral edema. Ten partial and 2 complete responses were observed, yielding a response rate of 32% (95% confidence interval 17%-47%). CONCLUSION: Docetaxel is an active drug in patients with advanced squamous cell carcinoma of the head and neck.

Adult↗
PubMed1994

A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.

BACKGROUND: Gemcitabine is a new pyrimidine antimetabolite with novel metabolic properties and mechanism of action. Phase I clinical trials have demonstrated acceptable toxicity and promising antitumor activity. The objectives of this open multicenter phase II trial were to determine the efficacy and toxicity of this agent in patients with advanced head and neck cancer. PATIENTS AND METHODS: Sixty-one patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with Gemcitabine as a weekly 30 minutes i.v. administration for 3 consecutive weeks followed by one week rest. The Gemcitabine starting dose was 800 mg/m2/week in 47 patients (a majority being pre-treated with chemotherapy) and was later increased to 1250 mg/m2 in 14 chemotherapy-naive patients. Dose adjustments were based on hematologic and non-hematologic toxicities. RESULTS: Seven partial responses were observed among 54 evaluable patients, yielding a response rate of 13% (95% confidence interval: 4%-22%). The incidence of hematologic toxicity was low, with grade 3-4 neutropenia in less than 10% of the courses. Fifty-three percent of the patients experienced an increased in liver enzymes, mainly grade 1 or 2. Fatigue was reported by 39% of the patients, frequently associated with flu-like symptoms. CONCLUSION: Gemcitabine is a drug with documented anti-tumor activity in patients with advanced squamous cell carcinoma of the head and neck.

Adult↗