PubMed Health⌕ Search

Biomedical subjects

P Cappelaere

Publications and source records attributed to P Cappelaere.

At least 19 recordsLinked to original sources
PubMed1995

Randomized phase III trial of edatrexate versus methotrexate in patients with metastatic and/or recurrent squamous cell carcinoma of the head and neck: a European Organization for Research and Treatment of Cancer Head and Neck Cancer Cooperative Group study.

PURPOSE: To compared the response rates and the toxicity of the new antifolate edatrexate (EDX) with that of methotrexate (MTX) in a randomized trial in patients with metastatic or recurrent squamous cell cancer of the head and neck (SCC) and to compare the durations of response and survival. PATIENTS AND METHODS: Two hundred seventy-three patients with SCC were randomized to receive either EDX or MTX as a weekly intravenous (IV) bolus injection. Doses of EDX were initially 80 mg/m2/wk, but because of the toxicity, this was later reduced to 70 mg/m2/wk. MTX was administered at a dose of 40 mg/m2/wk throughout. In both arms, two dose increments of 10% were scheduled in case of no toxicity. RESULTS: Of 264 eligible patients, 131 were treated with EDX and 133 with MTX. There were five treatment-related deaths: four on EDX and one on MTX. Overall, toxicity was similar in both arms; however, stomatitis, skin toxicity, and hair loss were more pronounced on the EDX arm. The overall response rate was 21% (six complete responses [CRs] and 21 partial responses [PRs]) for EDX and 16% (nine CRs and 12 PRs) for MTX (P = .392). Responses were mainly seen in patients with locoregional disease. Tumors that originated from the hypopharynx responded poorly in comparison to tumors from other sites. The median duration of response was 6.1 months for EDX and 6.4 months for MTX (log-rank P = .262). There was no difference in overall or progression-free survival. The median survival duration was 6 months on both treatment groups. CONCLUSIONS: Both EDX and MTX are moderately active against SCC. In this large phase III study, response rates, time to treatment failure, and overall survival appeared to be similar for both antifolates. However, EDX had more side effects than MTX and therefore cannot be recommended for routine palliative treatment of patients with SCC.

Agranulocytosis↗
PubMed1994

Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck. A phase III study of the EORTC Head and Neck Cancer Cooperative Group.

BACKGROUND: The EORTC Head and Neck Cancer Cooperative Group conducted a randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in chemotherapy naive patients with recurrent or metastatic squamous cell carcinoma of the head and neck. The primary objectives of this study were to investigate whether the CF regimen was in anyway superior to the CABO regimen and to detect any superiority of these two combinations over cisplatin alone. PATIENTS AND METHODS: Three hundred eighty-two patients were randomized to one of three treatments: (1) methotrexate (40 mg/m2) days 1 and 15, bleomycin (10 mg) and vincristine (2 mg) days 1, 8 and 15, cisplatin (50 mg/m2) day 4, repeated every 21 days, (2) cisplatin (100 mg/m2) and 5-FU (1 g/m2 x 4), repeated every 21 days, and (3) cisplatin (50 mg/m2) days 1 and 8, repeated every 28 days. After 3 cycles, all responding and stable disease patients in the three arms of the study continued with cisplatin alone. RESULTS: The overall response rates to CABO (34%) and CF (31%) were superior to C (15%) (p < 0.001, p = 0.003, respectively). In addition, complete response rate to CABO (9.5%) was superior to that of C (2.5%) (p = 0.02), and also superior to that of CF (1.7%) (p = 0.01). Response was associated with performance status and prior treatment, but by multivariate analysis treatment type was the important determinant of response (p = 0.0006). Although CABO and CF were superior to C with respect to time to progression within the first 6 to 8 months after randomization, there was no overall difference in progression-free survival or survival between the three arms of the study. Both hematologic and non-hematologic toxicity were worse in the combination chemotherapy arms. CONCLUSION: We conclude that the CF regimen has no advantage over the CABO regimen, which in fact showed a higher complete response rate. Both combinations showed improved response rates but also more toxicity and no improvement in overall survival in comparison with cisplatin alone.

Adult↗
PubMed1994

[Resistance and resistances].

Drug resistance is a frequent clinical event, induced by more than one mechanism. It is intrinsic and/or acquired by tumoral cell population. But the failure of chemotherapy is also associated to intratumoral drug incorporation and altered drug and/or cell metabolism. Prevention of drug resistance needs integration of pharmacokinetic, biochemical and pathological characteristics of tumoral cell population.

Antineoplastic Agents↗
PubMed1992

Drug resistance in oncology: from concepts to applications.

The complex problem of drug resistance is discussed with respect to host toxicity, to tumor characteristics (kinetic resistance, heterogeneity of cell subpopulations, hypoxia, mutation and gene amplification), and to the medication itself (pharmacokinetic and pharmacodynamic resistance: cell membrane, intracellular metabolism, intracellular target). After detailing each type of resistance, the possibilities of fighting against drug resistance are explored (dealing with host toxicity, tumor characteristics and drugs--intensifying therapy, multiple drug therapy, biochemical modulation, particular modalities of drug administration). Finally, perspectives of research and development of new drugs are summarized.

Animals↗
PubMed1992

A phase II trial of 10-ethyl-10-deaza-aminopterin, a novel antifolate, in patients with advanced and/or recurrent squamous cell carcinoma of the head and neck. The EORTC Head and Neck Cancer Cooperative Group.

Forty-seven patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with 10-ethyl-10-deaza-aminopterin (10-EdAM), a new analogue of methotrexate. The drug was given as a weekly i.v. bolus injection, starting at 80 mg/m2 with two dose increments of 10% if no toxicity was observed after two weeks. Only patients with tumors of the larynx, oral cavity, oropharynx and hypopharynx were included in the trial. Eighty-two percent of the patients had had prior surgery and/or radiotherapy. Forty-four patients were evaluable for response and toxicity. Five CR (12%) and five PR were obtained, yielding a response rate of 24% (CR+PR). The toxicity was similar to that usually seen with methotrexate; stomatitis and skin toxicity were rather pronounced. The data suggest that 10-EdAM has activity similar to that of methotrexate in patients with head and neck cancer.

Adult↗
PubMed1991

Tetracosactrin vs. methylprednisolone in the prevention of emesis in patients receiving FEC regimen for breast cancer.

0.5 mg tetracosactrin is considered to be equivalent to 40 mg methylprednisolone with regard to the induced cortisol secretion. 97 female breast cancer patients who received their first two FEC courses (epirubicin 50-75 mg/m2, 5-fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2) entered this randomised crossover study (76 had previously received an adjuvant treatment); tetracosactrin was administered intramuscularly and methylprednisolone intravenously immediately before chemotherapy administration. The tolerability was evaluated using a diary card during 5 days and patients were asked for their preference at the end of the two cycles. There was no difference either for vomiting (dry heaves were included) or nausea between the two treatments (the analysis was performed on day 1, the worse day of days 2 and 3 and the worse day of days 4 and 5). At day 1, 49% of the patients experienced no or mild nausea after tetracosactrin and 62% after methylprednisolone (not significant) (first period analysis); a complete control of vomiting (including dry heaves) was observed in 49% of the patients after tetracosactrin and 53% after methylprednisolone (not significant). No difference was observed between patients with or without previous chemotherapy. However, slightly more patients preferred tetracosactrin (P = 0.048).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

[Continuous Holter cardiac monitoring and chemotherapy by combination with platinum and fluoro-uracil].

Thirty-three male patients (pts) were given cisplatin and fluoro-uracil (1 g/m2/d) in IV continuous infusion over 96 h, for the primary or palliative treatment of locally advanced head and neck cancer. The mean age was 52 +/- 7 years (range: 37-65). Patients underwent continuous ECG monitoring and were monitored for 22.4 +/- 1.5 h before FU infusion, 91.9 +/- 7.3 h during FU infusion and 18.5 +/- 2 h after 5FU infusion. Patients were given one cycle of chemotherapy (32 pts), two (25 pts) or three consecutive cycles (20 pts). Seventeen pts (53%) had supraventricular arrythmia, 15 pts (47%) had ventricular arrythmia and 10 pts (31%) had ST segment deviation. The ECG abnormalities were more frequent during the first cycle of chemotherapy. No previous clinical or ECG parameter was associated to ECG changes. Platin-induced hypomagnesemia and hypokaliemia probably increase incidence of cardiac abnormalities, during and after FU infusion.

Adult↗
PubMed1990

[Palliative chemotherapy of epidermoid carcinoma of the upper respiratory and digestive tracts with a combination of carboplatin and 5-fluorouracil].

One hundred and thirteen patients with advanced squamous cell cancer of the head and neck were entered into a multicenter trial. Median age was 54 yr (range: 33-74 yr). Median Karnofsky index was 70 (60-100). Thirty-five patients had had prior induction chemotherapy. The first schedule was carboplatin 300 mg/m2, dl and fluoro-uracil 1000 mg/m2/d administered in continuous IV infusion for 96 h every 4 weeks (group 1). The second schedule was carboplatin 350 mg/m2, dl and fluoro-uracil administered at the same dose every 3 weeks (group II). Median number of cycles was 3 (range: 1-16). Seven patients were not eligible. The response rate was 26% (95% confidence limits: 18-34). Nine patients had a complete response. The median duration of response was 6 months (2-16+). The response rates in the 2 groups were not statistically different (21 and 31%) but disease progression was more frequent in group I (61%) than in group II patients (25%). Six early deaths occurred, without sign of drug toxicity. Grade 2 hematological toxicity between or before any cycle was more frequent in group II patients, in particular for leucopenia (13 vs 42%, P less than 0.05). One death was related to granulopenia. Grade 2 or 3 gastric toxicity was observed in 43 patients. No other major toxicity was observed. In our study, combination therapy with carboplatin and fluoro-uracil was found to be moderately active but myelotoxic.

Adult↗
PubMed1990

[Phase II trial as 2nd line chemotherapy with 5 fluorouracil and cisplatin (5FU-CDDP) for advanced breast cancer].

Thirty patients with advanced breast cancer, previously treated with anthracycline and 5 fluorouracil in bolus administration, were evaluated with a chemotherapy regimen generally used in head and neck cancer. Treatment schedule consisted of: cisplatin 100 mg/m2 on d 1 and 5 fluorouracil 1000 mg/m2 continuous infusion on d 2-3-4-5 every 21 d. With all measurable lesions and 27 evaluable patients, the response rate was 29% (95% confidence interval: 12-47%), with 5 complete responses (3 soft tissue - 2 lung) and 3 partial responses (1 lung - 2 liver). The median duration of response is 4.5 months (range 2-11 months). The 30 patients (93 courses) are evaluable for toxicity. Hematologic toxicity was mild: anemia 68% grade 0, neutropenia 68% grade 0 and thrombocytopenia 83% grade 0. Nausea and vomiting were severe 83% grade 3 + 4 at d 1. Others side effects were mild including 5/91 mucositis grade 2 + 3, peripheral neuropathy 1/31 grade 2 and 2/91 reversible rise in serum creatinine greater than 1.5 mg/dl.

Adult↗
PubMed1989

[Response of bone metastases to medical treatment: definition of evaluation criteria and classification trials].

Bone metastases are very frequent. Some are sensitive to the action of anticancer drugs. However, there is as yet an unsolved methodological problem in the evaluation of response to these drugs. The uniquely radiological UICC criteria are quite insufficient, in as much as they appear with a long delay and sometimes give erroneous results. In this work we give a brief review of biological and clinical knowledge about bone metastases, and we attempt to give an array of the possible evaluation criteria and their respective value. We propose as a working hypothesis a classification of responses taking into account the criteria: the urinary hydroxyproline to urinary creatinine ratio, the serum dosage of bone isoenzyme of alkaline phosphatase and propeptide of type III procollagen (P III NP), and as an essential element, an analysis of all available imaging techniques. A visual study of bone scintillation scans must precede that of radiographs and, when possible, it must be associated to computerized scintillation scanning. When metastasis are located to the pelvis, the vertebral column, or the sternum, a CT scan or better, a nuclear magnetic resonance study (IRM), is indispensable in order to have a direct measure of the tumor extension to soft tissues. Furthermore, in the case of isolated metastases, one of these imaging techniques allows a diagnostic biopsy. Finally an analysis of response at the bone level will always be associated with a measure of their duration and an evaluation of metastases to other sites.

Acid Phosphatase↗
PubMed1989

[Non-Hodgkin's malignant lymphoma with primary gastro-intestinal localisation. Therapeutic aspects].

A retrospective analysis of 38 patients with primary gastrointestinal non Hodgkin's lymphoma (PGINHL) referred to "Center Oscar Lambret, Lille, France", from January 1964 to December 1986 has been carried out. Kiel classification and the working formulation for clinical usage were used for histologic diagnosis and Ann Arbor classification modified by Musshoff for clinical staging. The patients, 29 males and 9 females, ranged in age from 7 to 71 years with a mean of 45.5 years for men and 45.1 years for women. Seventeen patients were classified as presenting with low-grade malignancy lymphomas and 21 as high-grade malignancy lymphomas. Nineteen patients presented with early clinical forms and 19 with advanced ones. Laparotomy was performed on all patients but one. Treatment modalities included: surgical resection, chemotherapy and radiotherapy in various combinations. There were 21 patients with recurrence, 6 of them responding to retreatment. The complete population survival curve reached a plateau at 48% after a 41-month follow-up. Five-year survival was 16% for early clinical forms and 80% for advanced ones (P less than 0.001) and 24% for high-grade malignancy lymphomas versus 75% for low-grade malignancy lymphomas (P less than 0.01). Moreover, the 5-year survival rate was 82% for patients with complete surgical resection of primary lesions versus 16% for those with incomplete resections (P less than 0.001). Laparotomy seems to play a major role in diagnostic accuracy, although the role of surgery in therapeutic management remains controversial. However our findings show that surgical resection is important to achieve local control of PGINHL. According to our results the only prognostic determinant that keeps its prognostic value is the extent of surgical resection (complete or incomplete) (P less than 0.05).

Adolescent↗
PubMed1988

[Tumor markers].

Explore the source record for details and available documents.

Acid Phosphatase↗
PubMed1988

Tamoxifen plus bromocriptine versus tamoxifen plus placebo in advanced breast cancer: results of a double blind multicentre clinical trial.

We carried out a double blind multicentre clinical trial in which 171 patients with advanced breast cancer were randomized to receive tamoxifen (30 mg/day) + bromocriptine (5 mg/day) or tamoxifen + placebo. No difference was found in the overall response rates in the two groups (37.5% for placebo; 38% for bromocriptine) or in subgroups (breast tumours, lymph nodes, lung, bone, skin metastases). Tolerability was good in both groups. Within the limits of the statistical power of the test (80%), our results do not show any benefit when bromocriptine was added to tamoxifen.

Antineoplastic Combined Chemotherapy Protocols↗