Biomedical subjects

P Biron

Publications and source records attributed to P Biron.

At least 37 records · Page 2Linked to original sources

PubMed2000

Research controversies in management of oral mucositis.

The management of mucositis is the subject of many controversies, and the optimal treatment is still not known. Several evaluation scoring systems have been described, but no one of these is appropriate to all clinical situations: a simple scale such as that devised by the WHO can be used routinely, and more sophisticated ones can be implemented by trained experimenters working in research. We have considered the impact of each of the treatments currently available on each stage of mucositis. In attempts at prevention, self-care, in the sense of oral hygiene, must remain atraumatic. It is probably advisable to differentiate patients with good previous oral care, in whom tooth brushing is beneficial, from others, in whom the risk of hemorrhage and infection excludes any brushing. Before the dosage of chemotherapy is reduced, the curative or palliative intent of the strategy must be carefully evaluated. In the vascular phase protection of the proliferating cells is attempted by means of vasoconstriction (cryotherapy), cytoprotection (prostaglandin E2 and other antioxidants) or epithelial cell-inhibiting factors such as TGF-B3. Treatments applied in the epithelial phase are directed at increasing the cell proliferation to accelerate epithelial restoration by sucralfate and several growth factors: hematopoietic GF, which has demonstrated a direct effect on the mucosa (GM-CSF), or epithelial growth factors such as keratinocyte GF. In the ulcerative and bacteriological phase attempts are made to attenuate sepsis by means of antiseptics (chlorhexidine), amphotericin B and antiviral agents or antibiotic lozenges. In the healing phase application of the low-energy helium-neon laser has demonstrably been followed by a later time of onset, less pronounced peak severity and shorter duration of oral mucositis. After cancer treatment, oral hygiene, inhibition of oral flora, and pain relief are the main goals. Physiopathogen-specific treatment is the next step, with the emphasis on the inhibition of epithelial cell proliferation during drug exposure and facilitation of epithelial maturation and healing.

Antineoplastic Agents↗

PubMed2000

Transplantation with selected autologous peripheral blood CD34+Thy1+ hematopoietic stem cells (HSCs) in multiple myeloma: impact of HSC dose on engraftment, safety, and immune reconstitution.

OBJECTIVE: The aims of our study performed in myeloma were to evaluate the performance and the safety of Systemix's high-speed clinical cell sorter, to assess the safety and efficacy of deescalating cell dose cohorts of CD34+Thyl+ hematopoietic stem cells (HSCs) as autologous grafts by determining engraftment, and to assess the residual tumor cell contamination using polymerase chain reaction (PCR) amplification assays of patient-specific complementarity determining region III (CDR III) analysis for residual myeloma cells. MATERIALS AND METHODS: The clinical trial was performed in 31 multiple myeloma patients, using purified human CD34+Thyl+ HSCs mobilized from peripheral blood with cyclosphosphamide and granulocyte-macrophage colony-stimulating factor to support a single transplant after high-dose melphalan 140 mg/m2 alone (cohort 1) and with total body irradiation (TBI) (cohorts 2-5) after an HSC transplant cell dose de-escalation/escalation design. RESULTS: Twenty-three patients were transplanted. Engraftment data in the melphalan + TBI cohorts confirmed that HSC doses above the threshold dose of 0.8 x 10(6) CD34+Thy1+ HSCs/ kg provided prompt engraftment (absolute neutrophil count >0.5 x 10(9)/L day 10; platelet count >50 x 10(9)/L day 13). A higher rate of infections was observed in the early and late follow-up phases than usually reported after CD34+ selected or unselected autologous transplantation, which did not correlate with the CD34+Thy1+ HSC dose infused. Successful PCR for CDR III could only be performed in five patients on initial apheresis product and final CD34+Thy1+ HSC product and showed a median tumor log reduction >3.12. CONCLUSIONS: CD34+Thy1+ HSCs are markedly depleted or free of detectable tumor cells in multiple myeloma and are capable of producing fast and durable hematopoietic reconstitution at cell doses >0.8 x 10(6) CD34+Thy1+ HSCs/kg. The delayed immune reconstitution observed is not different from that described in unselected autologous bone marrow and peripheral blood mononucleated cells transplants in multiple myeloma and may be corrected by addition of T cells either to the graft or to the patient in the posttransplant phase.

Adult↗

PubMed2000

Randomized comparison of ACVBP and m-BACOD in the treatment of patients with low-risk aggressive lymphoma: the LNH87-1 study. Groupe d'Etudes des Lymphomes de l'Adulte.

PURPOSE: To compare a short intensified regimen followed by sequential consolidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, cyclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressive lymphoma. PATIENTS AND METHODS: A total of 752 patients with intermediate- or high-grade lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, >/= two extranodal sites of disease, tumor burden >/= 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt's or lymphoblastic subtypes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. RESULTS: The complete remission rate was identical (86%) in the two groups. With a median follow-up duration of 7 years, the 5-year failure-free survival (FFS) rate was 65% in the ACVBP group and 61% in the m-BACOD group (P =.16). The 5-year overall survival rate was 75% in the ACVBP group and 73% in the m-BACOD group (P =.47). ACVBP was responsible for more severe and life-threatening infections (P <.01), but m-BACOD caused more pulmonary toxicity (P <.001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP was associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. CONCLUSION: In this population of patients with low-risk aggressive lymphoma, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regimen in patients with advanced disease is suggested by this analysis but remains to be assessed in prospective studies specifically designed for this purpose.

Adolescent↗

PubMed2000

A prospective study of the LMB regimen for diffuse large cell non Hodgkin's lymphoma in adults.

Although the CHOP regimen remains a standard first line chemotherapy for diffuse large cell lymphoma (DLCL) in adults, a majority of these patients will still experience disease progression after the completion of this treatment. The LMB protocol is an intensive chemotherapy regimen which yields high survival rates in Burkitt's lymphoma (BL) and diffuse large cell lymphoma (DLCL) in children, as well as in primary cerebral DLCL (PCL) of adults. Here, we report the long term results of this regimen in a prospective series of 22 adult patients with DLCL excluding PCL. Fifteen male and 7 female patients with a median age of 30 years (range: 20-55) were treated prospectively between 1988 and 1993. 16 (72%) patients had an age adjusted International Pronostic Index (IPI) > or = 1. The median duration of the treatment was 15 weeks (range 13-19). Nineteen of the 22 patients (87%) experienced an objective response (14 complete, and 5 partial responses) at the end of the protocol. The predominant toxicity was myelosuppression: 89% of the COPADEM courses were followed by grade IV neutropenia and 5% with grade IV infection. One patient died (4%) of treatment related toxicity. With a median follow-up of 94 months and a minimum follow-up of 65 months, 8-year overall and progression-free survival are 73% and 67% respectively. The 8 year overall survival were 100%, 78% and 42% in patients with an IPI 0, 1, and 2-3 respectively. This short intensive regimen yields promising long term survival rates in this monocentric prospective study and may deserve to be tested in a larger multicentric prospective study comparing it to the CHOP regimen.

Adult↗

PubMed2000

Primary cerebral lymphomas: unsolved issues regarding first-line treatment, follow-up, late neurological toxicity and treatment of relapses. The FNCLCC. French Fédération Nationale des Centres de Lutte contre le Cancer.

BACKGROUND: Primary cerebral non-Hodgkin's lymphomas (NHL) in immunocompetent patients (PCL) are located exclusively in the central nervous system, the eye, or meninges. Clinical management of these patients remains controversial. PATIENTS AND METHODS: Clinical characteristics of the patients and parameters influencing their outcome as of December 1998 were investigated and registered in a database of 226 patients treated in the French Federation of Cancer Centers between 1980 and 1995. RESULTS: Most PCL are diffuse large-cell NHL with a B phenotype. The incidence of PCL has been steadily increasing over the past 20 years in some but not all countries. The overall survival of primary cerebral lymphoma (PCL) patients in the published series, a median of 12-16 months and a five-year survival of 5%-20%, is poor. Several series have now reported long-term survivals of more than 10 years and PCL may therefore be a curable tumor in some patients. The optimal treatment of PCL is not known. Complete resection of the tumor does not improve outcome and multidisciplinary approaches combining chemotherapy and radiotherapy are now commonly used, although the superiority of combination over radiotherapy- or chemotherapy-alone has never been demonstrated in a phase III trial. The optimal chemotherapy regimen, the dose and even the usefulness of brain radiotherapy after chemotherapy are therefore still matters of debate. Recently, several authors have reported a relatively high incidence of late neurological sequelae after PCL treatment. CONCLUSIONS: The optimal treatment of PCL patients remains to be defined. Large cooperative international phase III trials are now required to define and improve the optimal treatment of PCL and reduce its sequelae.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed2000

[Standards, Options and Recommendations (SOR) for the surveillance and the prevention of cross infections in oncology. Fédération Nationale des Centres de Lutte Contre le Cancer].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of the Standards, Options and Recommendations project for the prevention and the surveillance of cross infection in oncology. METHODS: Data were identified by searching Medline and the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 106 independent reviewers, and to the medical committees of the 20 French Cancer Centres. RESULTS: 1) Criteria of infection status and nosocomiality defined by the Centers for Infectious Diseases (CDC) and Prevention and the Superior Council of Public Hygiene (CSHPF) are not adapted and have to be redefined in oncology. 2) The epidemiology of nosocomial infections in oncology is not well known but their incidence seems to be higher. Numerous risk factors of cross infections coexist in cancer patients, among which the duration and depth of neutropenia. 3) Surveillance and prevention of cross infection are compulsory and were taken into account in the accreditation of hospitals. Obligation is expressed in terms of means and results. 4) The objectives of the cross infection surveillance are to detect major problems and critic situations, to guide probabilistic antibiotic therapy and to assess the effectiveness of the infections control. The surveillance means consist in prevalence and incidence survey, punctually and continuously conducted. 5) The three specific behaviors to be adopted to prevent cross infections are to control: all the patients, infected patients carrying multiresistant bacteria, immunodepressed patients. 6) Standards of care have to be applied to a/l patients with cancer. 7) It is necessary to add particular septic cares for the patients infected with micro-organisms indicated on reference lists or carrying multiresistant bacteria. 8) The only objective of the protective isolation of immunodepressed cancer patients is to reduce the cross infection. There is no standard behavior for the indications and the modalities of protective isolation. The prevention behaviors to be taken are defined by expert agreements.

Algorithms↗

PubMed1999

High-dose chemotherapy with hematopoietic stem-cell support in germ-cell tumor patient treatment: the French experience.

Germ-cell tumors (GCTs) are very chemosensitive and highly curable cancers. For the small proportion of patients who fail conventional chemotherapy (CT), high-dose CT (HDCT) was introduced in France and elsewhere in 1982-1984. We report here on the French experience with HDCT in GCTs. At the Centre Léon Bérard, 75 patients were treated with HDCT between 1982 and 1996. Patients received HDCT in 2 different settings: 46 in consolidation of first-line treatment or in incomplete response, 29 in salvage of relapse or refractory disease. The most common regimens of HDCT were the combination of etoposide, double-dose cisplatin and either ifosfamide (VIC regimen, n = 46) or cyclophosphamide (PEC regimen, n = 9) and the combination of carboplatin, etoposide and cyclophosphamide (Carbo-PEC regimen, n = 17). Seven patients died of toxicity. The median follow-up was 42 months. Forty-five of 75 patients are alive and free of disease at long term, 2 of whom had refractory disease. The median time to recovery of a granulocyte count > or = 0.5 x 10(9)/l and a platelet count > or = 25 x 10(9)/l was 14 and 11 days, respectively. The French development was based on double-dose cisplatin until the results of the French randomized trial, which showed no advantage of HDCT in the first-line treatment of poor-risk group patients. Then carboplatin was associated with etoposide and cyclophosphamide in a phase I trial. A European randomized trial, which studies the role of HDCT in the first-line salvage treatment of non-refractory disease, is ongoing. So far, HDCT is not a standard treatment of GCT.

Adolescent↗

PubMed1999

Chemotherapy for patients with locally advanced or metastatic Merkel cell carcinoma.

BACKGROUND: Merkel cell carcinoma (MCC) is a highly malignant skin neoplasm. Regional lymph node and distant metastasis occur in 20-52% of patients. The role of chemotherapy in the treatment of patients with this rare tumor is unclear. METHODS: An exhaustive analysis of the literature (1980-1995) describing chemotherapy for patients with locally advanced or metastatic MCC was performed. All available published medical records (n = 101 patients) were entered in a database. In addition, data on six additional patients given chemotherapy during this time frame in Lyon, France, were included in the database. RESULTS: For the 107 patients, the overall objective response rate to first-line chemotherapy was 61% (61 of 101 evaluable patients). The response rate was 57 % (41 of 72) for patients with metastasis and 69% (20 of 29) for patients with locally advanced tumors. No clinical parameter was found to be correlated to response to chemotherapy. A high rate of toxic death during first-line treatment (n = 7.7%) was reported for these patients. The median overall survival from the date of chemotherapy initiation was 9 months for patients with metastasis and 24 months for patients with locally advanced tumors. The projected overall survival at 3 years was 17% for patients with metastasis and 35% for patients with locally advanced tumors. Progression after first-line chemotherapy was associated with significantly worse survival for patients with metastasis. Rates of response to second-line (n = 33) and third-line (n = 10) chemotherapy were 45% and 20%, respectively. CONCLUSIONS: MCC is chemosensitive but rarely chemocurable in patients with metastasis or locally advanced tumors. A high incidence of toxic death due to chemotherapy is reported in the literature.

Aged↗

PubMed1999

Comparison of high-dose therapy and autologous stem-cell transplantation with conventional therapy for Hodgkin's disease induction failure: a case-control study. Société Francaise de Greffe de Moelle.

PURPOSE: To determine the prognostic factors and outcome of first-line induction failure Hodgkin's disease patients who were treated with a salvage regimen of high-dose chemotherapy and autologous stem-cell transplantation, and to compare them with matched, conventionally treated patients. PATIENTS AND METHODS: We retrospectively analyzed data relating to 86 Hodgkin's disease patients who underwent autologous stem-cell transplantation after failure of the first chemotherapy regimen, either because they did not enter a complete remission and experienced progression of disease less than 3 months after the end of their first-line treatment or because they showed evidence of disease progression during first-line therapy. Graft patients were matched with 258 conventionally treated patients (three controls per case) for age, sex, clinical stage, B symptoms, and time at risk; patient data were obtained from international databases. RESULTS: Among the 86 graft patients, the median age at diagnosis was 29 years (range, 14 to 57 years). Thirty-nine percent of patients had stage II disease, 23% had stage III disease, and 38% had stage IV disease. Seventy percent of the patients received chemotherapy and 30% received combined modality therapy; 60% of the patients received a seven- or eight-drug regimen. After this first-line treatment, 91% had disease progression and 9% had a brief partial response. Eighty patients received a second-line treatment; pretransplantation status was as follows: 24% of patients had a complete remission, 38% had a partial remission (PR), 14% had stable disease, and disease progression occurred in 24%. With a median follow-up of 22 months (range, 4 to 105 months) from diagnosis, the 5-year event-free survival and overall survival rates from transplantation were 25% and 35% (95% confidence intervals, 15 to 36 and 23 to 49), respectively. In multivariate analysis, the pretransplantation disease status after salvage therapy was the only significant prognostic factor for survival (PR: relative risk = 2.8, P = .017; progressive disease: relative risk (RR) = 5.26, P < .001). From diagnosis, the 6-year overall survival rates of the graft patients and 258 matched conventionally treated patients were 38% and 29%, respectively (P = .058). CONCLUSION: Autologous stem-cell transplantation represents the best therapeutic option currently available for patients with primary induction failure and is associated with acceptable toxicity. Response to second-line treatment before high-dose chemotherapy is the only prognostic factor that can be correlated with survival.

Adolescent↗

PubMed1999

Risk model for severe anemia requiring red blood cell transfusion after cytotoxic conventional chemotherapy regimens. The Elypse 1 Study Group.

PURPOSE: Cancer patients frequently experience anemia as a consequence of myelosuppressive therapy or bone marrow invasion. PATIENTS AND METHODS: A risk model for chemotherapy-induced severe anemia requiring RBC transfusions (SARRT) within 31 days after the administration of chemotherapy was delineated in the cohort of cancer patients treated with chemotherapy in the Department of Medicine of Centre Léon Bérard in 1996 (CLB-1996). The risk model was tested on a series of 797 patients treated in 1997 (CLB-1997) and on 295 patients included in a multicenter prospective series (ELYPSE 1). RESULTS: One hundred seven of the 1,051 patients of the CLB-1996 cohort (10%) experienced SARRT. In univariate analysis, only female sex, performance status greater than 1, hemoglobin level less than 12 g/dL before chemotherapy on day 1 (d1), and d1 lymphocyte count < or = 700/microL significantly correlated with the risk of SARRT. Using logistic regression, d1 hemoglobin level less than 12 g/dL (odds ratio [OR] = 14.0; 95% confidence interval [CI], 7 to 30), performance status greater than 1 (OR = 2.2; 95% CI, 1.4 to 3.5), and d1 lymphocyte count < or = 700/microL (OR = 1.7; 95% CI, 1. 1 to 2.6) were identified as independent risk factors for SARRT. These three factors were given arbitrary risk coefficients of 3, 1, and 1 respectively, and a risk score for each individual patient was obtained by adding the coefficients. The calculated probability of RBC transfusions was 30% for patients with a score > or = 4, and 11%, 4%, and 1% in patients with a score of 2 or 3, 1, and 0 respectively. This model was then tested and validated in the CLB-1997 and ELYPSE 1 series. CONCLUSION: This risk index could be useful to identify patients at high risk for chemotherapy-induced SARRT who might be appropriate candidates for prophylactic erythropoietin treatment.

Adolescent↗

PubMed1999

[High dose chemotherapy with autologous stem cell support in the treatment of germ cell tumors: experience of the centre Léon-Bérard between 1982 and 1996].

More than 80% patients with metastatic germ cell tumors are cured by chemotherapy and surgery. Since 1980, intensive chemotherapy with autologous bone marrow was developed for the patients who where not cured by conventional chemotherapy. We present the experience of the Centre Léon-Bérard, between 1982 and 1996, seventy-five metastatic germ cell tumors patients were treated with high dose chemotherapy and autologous stem cell support. Forty-six patients received cisplatin, etoposide, ifosfamide (VIC regimen), 17 carboplatin, etoposide, cyclophosphamide (CarboPEC regimen), 9 cisplatin, etoposide, cyclophosphamide (PEC) and 10 had another regimen. The chemotherapy was administred in different situations: 31 patients with poor prognosis in first line, 15 in salvage of sensitive relapse, 15 in salvage of incomplete response, and 14 with a cisplatin refractory disease. The complete response rate was 31% among the 54 evaluable patients. Seven patients died as a consequence of the treatment. The two-year overall actuarial survival and the event free survival were respectively 67% and 57% (median 42 months). Only 2 patients who had a refractory disease are continuously disease-free at 42 and 87 months after regimen. The renal toxicity was more severe with regimen VIC than with CarboPEC 30% versus 60%, whereas the hematologic toxicity are similar with both. This study shows the feasability of high dose chemotherapy. Two refractory patients are alive, and the results seem to be interesting for the patients in salvage treatment. But this treatment is not a standard for germinal cell tumors and randomized trials are ongoing.

Adolescent↗

PubMed1999

[Epidemiology of non-Hodgkin's lymphoma: recent data].

Non-Hodgkin's lymphoma consists of a group of disorders which is increasing for the last decades. In the USA, since the early 1970s, the incidence rate has increased by almost 60% and ranges from 3 to 4% per year, which is faster than for the majority of cancers. Important advances in our knowledge of histopathology together with new diagnostic tools, as well as the improvement of the registered data and ageing of the population, only partially explain this increase. Two viruses have been identified as possible etiologic agents for non-Hodgkin's lymphoma: the Epstein-Barr virus and HTLV-I. More recently, HHV8 and the hepatitis C virus have been incriminated in the occurrence of non-Hodgkin's lymphomas. Congenital and acquired immunodeficiencies (due to immunosuppressive therapy and viral disease such as Aids) might also represent predisposing factors. However, the epidemic HIV infection is the most strongly correlated with the increasing incidence of non-Hodgkin's lymphoma in the United States. Finally, epidemiologic studies indicate that environmental factors may play an important role in the etiology of non-Hodgkin's lymphoma, specially toxic chemicals used in farming.

Adult↗

PubMed1998

The International Prognostic Index correlates to survival in patients with aggressive lymphoma in relapse: analysis of the PARMA trial. Parma Group.

The objectives of the present study were to investigate the prognostic value of the International Prognostic Index (IPI) at relapse in the 215 patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) included in the PARMA trial. The IPI at relapse was available in 204 (95%) of these patients. Response rates to 2 courses of DHAP were 77%, 54%, 55%, and 42% in patients with an IPI of 0, 1, 2 and 3, respectively (P <.02), whereas complete response (CR) rates were 33%, 29%, 20%, and 0% in the same groups of patients (P <.03). With a median follow-up period of 79 months, overall survival (OS) at 5 years was 46%, 25%, 25%, and 11% in these four groups (P <.001). One hundred nine patients responding to 2 courses of DHAP were randomized to receive either BEAC (carmustine, etoposide, cytarabine, cyclophosphamide and mesna) followed by autologous bone marrow transplantation (ABMT) or 4 additional courses of DHAP: IPI at relapse was found highly correlated to OS in patients treated in the DHAP arm (5-year OS: 48%, 21%, 33%, and 0% for IPI 0, 1, 2, and 3, respectively; P =.006), but not in the BEAC arm (5-year OS: 51%, 47%, 50%, and 50% for IPI 0, 1, 2, and 3, respectively; P =.90). OS was significantly superior in the BEAC arm as compared with the DHAP arm in patients with an IPI >0 (P <.05), but not in patients with an IPI of 0. In conclusion, these results show that IPI correlates to response and overall survival in patients with aggressive NHL in relapse and enables us to identify patients with a significantly different outcome among those treated with conventional chemotherapy alone.

Adolescent↗

PubMed1998

A risk model for thrombocytopenia requiring platelet transfusion after cytotoxic chemotherapy.

Severe thrombocytopenia is a rare but life-threatening side effect of cytotoxic chemotherapy for which risk factors are not well known. Our objective was to delineate a risk model for chemotherapy-induced thrombocytopenia requiring platelet transfusions in cancer patients. Univariate and multivariate analysis of risk factors for chemotherapy-induced thrombocytopenia requiring platelet transfusions were performed on the cohort of the 1,051 patients (CLB 1996) treated with chemotherapy in the Department of Medicine of the Centre Léon Bérard (CLB) in 1996. In univariate analysis, performance status (PS) greater than 1, platelet count less than 150, 000/microL at day 1 (d1) before the initiation of chemotherapy, d1 lymphocyte count < or = 700/microL, d1 polymorphonuclear leukocyte count less than 1,500/microL, and the type of chemotherapy (high risk v others) were significantly associated (P < .01) with an increased risk of severe thrombocytopenia requiring platelet transfusions. Using logistic regression, d1 platelet count less than 150,000/microL (odds ratio [OR], 4.3; 95% confidence interval [CI], 1.9 to 9.6), d1 lymphocyte counts < or = 700/microL (OR, 3.37; 95% CI, 1.77 to 6.4), the type of chemotherapy (OR, 3.38; 95% CI, 1.77 to 6.4), and PS greater than 1 (OR, 2.23; 95% CI, 1.22 to 4.1) were identified as independent risk factors for platelet transfusions. The observed incidences of platelet transfusions were 45%, 13%, 7%, and 1.5% for patients with > or = 3, 2, 1, or 0 risk factors, respectively. This model was then tested in 3 groups of patients treated with chemotherapy used as validation samples: (1) the series of 340 patients treated in the CLB in the first 6 months of 1997, (2) the prospective multicentric cohort of 321 patients of the ELYPSE 1 study, and (3) the series of 149 patients with non-Hodgkin's lymphoma treated in the CLB within prospective phase III trials (1987 to 1995). In these 3 groups, the observed incidences of platelet transfusions in the above-defined risk groups did not differ significantly (P > .1) from those calculated in the model. This risk index could be useful to identify patients at high risk for chemotherapy-induced thrombocytopenia requiring platelet transfusions.

Adult↗

PubMed1998

Vinorelbine and cisplatin (CIVIC regimen) for the treatment of metastatic breast carcinoma after failure of anthracycline- and/or paclitaxel-containing regimens.

BACKGROUND: A pilot study of a new chemotherapy, the CIVIC regimen, was performed in 58 patients with metastatic breast carcinoma previously treated with chemotherapy with or without hormonal therapy (n = 41). Cisplatin, 20 mg/m2/day, was given (Days 1-5) every 21 days during a 1-hour intravenous (i.v.) infusion, and vinorelbine (VNB) was delivered at a dose of 6 mg i.v. bolus followed by VNB, 6 mg/m2/day, in continuous i.v. infusion (Days 1-5) every 21 days. METHODS: Fifty-eight patients were included in this trial between June 1992 and March 1994 (median age, 46.5 years; range, 28-69 years). The number of previous chemotherapy in the adjuvant or metastatic phase were: 1 in 9 patients, 2 in 33 patients, and > or = 3 in 16 patients. Forty-four and 12 patients, respectively, were previously treated in metastatic phase with regimens containing anthracyclines and paclitaxel. Overall, 210 cycles were given (median, 3 cycles; range, 1-6 cycles). RESULTS: Among the 58 patients assessable for tumor response to the CIVIC regimen, 24 patients (41%) (95% confidence interval, 28-54) achieved an objective response (complete response or partial response) with 2 complete response (3%) and 22 partial response (38%). The median time to response was 11 weeks (range, 4-16 weeks). The median survival time from the initiation of the CIVIC regimen was 9.2 months (range, 0-45 months). The response rate was 43% (19 of 44 patients) in patients refractory to anthracyclines and 58% (7 of 12 patients) in patients with disease progression after treatment with anthracyclines and paclitaxel. Myelosuppression was the most frequent side effect. World Health Organization Grade 3 neutropenia occurred in 8 of 58 patients (14%) and in 41 of 210 cycles (20%), Grade 4 neutropenia occurred in 37 of 58 patients (64%) and in 63 of 210 cycles (30%), and Grade 3 and 4 thrombopenia occurred in 7 of 58 patients (12%) and in 9 of 210 cycles (4%). Grade 2 peripheral neuropathy was observed in 6 of 58 patients (10%) and in 12 of 210 cycles (6%), and Grade 3 peripheral neuropathy was observed in 3 of 58 patients (5%) and in 4 of 210 cycles (2%). The risk of Grade 2-3 neuropathy was significantly higher after the fourth chemotherapy cycle (14 of 23 patients vs. 3 of 35 patients: P = 0.00002). CONCLUSIONS: The CIVIC regimen is effective and has acceptable tolerance in patients with metastatic breast carcinoma refractory to previous anthracycline- and/or paclitaxel-containing chemotherapy. Four cycles were found to provide the best toxicity-efficacy ratio.

Adult↗

PubMed1998

Energy expenditure during allogeneic and autologous bone marrow transplantation.

Resting energy expenditure (REE) was measured by indirect calorimetry during allogeneic and autologous bone marrow transplantation in order to evaluate the evolution in allogeneic and autologous recipient patients. REE values obtained with indirect calorimetry and compared with values using the Harris-Benedict formula were different. Evolution of REE during aplasia were significantly different in autologous and allogeneic recipients with an increase 11.5 ' 10.8 cent for autologous and a decrease of - 7.3 ' 8.9 cent in allogeneic bone marrow transplantation (BMT) patients. There were no differences in nutritional status and REE before BMT, at discharge and 1 month after discharge between the two groups but all patients had inflicted damage on their nutritional status at discharge from hospital after BMT. However, these patients differed because of the decrease in oral nutritional intake and an increase in the length of aplasia and hospital stay in allogeneic patients. Currently, there is no proof that recommendations for nutritional interventions or results of nutritional investigations in allogeneic BMT can be extrapolated in autologous patients. Harris-Benedict formula does not estimate the energy expenditure of patients submitted to massive chemotherapy and BMT with enough precision because of the great differences in individuals.

Adult↗

PubMed1998

High-dose chemotherapy with hematopoietic stem cell transplantation in patients with mantle cell or diffuse centrocytic non-Hodgkin's lymphomas: a single center experience on 18 patients.

Between 1985 and 1996, 18 patients with diffuse centrocytic lymphoma (DCL), including nine patients with an established histological and phenotypic diagnosis of mantle cell lymphoma (MCL), received 19 courses of high-dose chemotherapy (HDCT) followed by hematopoietic stem cell transplantation. Five patients received HDCT as consolidation treatment after first-line standard chemotherapy, and 14 after a relapse or progression, including one patient in early relapse after the first transplant. Six patients (33%) were in complete response (CR) prior to HDCT and 12 (67%) were in partial response: 10 (83%) of these 12 patients achieved CR at day 60 following HDCT. With a median follow-up of 30 months after HDCT, the 2-year overall and progression-free survivals of the whole series are 91 and 75%, respectively. The 2-year progression-free survivals are 74 and 75%, respectively, in the MCL and DCL subgroups.

Adult↗

PubMed1998

Cefepime versus imipenem-cilastatin as empirical monotherapy in 400 febrile patients with short duration neutropenia. CEMIC (Study Group of Infectious Diseases in Cancer).

This open, comparative, randomized, multicentre equivalence study compared cefepime 2 g bd and imipenem-cilastatin 1 g tds (50 mg/kg/day) as empirical monotherapy for febrile episodes in a homogeneous cohort of cancer patients with short duration neutropenia following chemotherapy for solid tumour, lymphoma or myeloma. The study was conducted in 17 French anti-cancer centres in 1995 and 1996. Response to monotherapy was assessed 7 days after treatment and was based on resolution of fever and signs and symptoms, eradication of pathogens, absence of new infection, relapse, and death of infectious origin, without addition of other antibiotics. Patients were treated for a minimum of 4 days. Of the 400 episodes randomized, 344 (86%) were evaluable for efficacy. Patient characteristics were comparable between treatment groups. Success of monotherapy was observed in 79% of episodes with cefepime and 72% with imipenem-cilastatin (equivalence, P <0.0001). The response rate for microbiologically documented infections was 66% with cefepime and 61% with imipenem-cilastatin (bacteraemic episodes: 63% for cefepime; 44% for imipenem-cilastatin). A second antibiotic (usually a glycopeptide) was added in 20% and 21% of the cases, respectively. Overall, the response to therapy, with or without an additional antibiotic, was 95% (cefepime) and 90% (imipenem-cilastatin). Survival was similar in both groups (95% and 98%, respectively). Cefepime treatment was better tolerated, with 9% of the patients experiencing related intercurrent events compared with 19% in the imipenem-cilastatin group (P = 0.003). Nausea/vomiting was significantly more frequent in the imipenem-cilastatin group (15%) than in the cefepime group (5%; P = 0.001). Cefepime monotherapy was as effective as, and better tolerated than, imipenem-cilastatin in the empirical treatment of fever during short duration neutropenia.

Antineoplastic Agents↗