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Cohort I (cohort + i)
Selected AbstractsAdoptive immunotherapy with allogeneic Epstein,Barr virus (EBV)-specific cytotoxic T-lymphocytes for recurrent, EBV-positive Hodgkin diseaseCANCER, Issue 9 2004Kenneth G. Lucas M.D. Abstract BACKGROUND It has been shown that adoptive immunotherapy with Epstein,Barr virus (EBV)-specific cytotoxic T-lymphocytes (CTL) is effective for the treatment of EBV-induced lymphoproliferative disease in stem cell transplantation recipients and organ transplantation recipients. The role of EBV CTL in other tumors for which this virus has been implicated in pathogenesis, such as EBV-positive Hodgkin disease (HD), has not been demonstrated clearly. METHODS To investigate the antitumor effects and toxicity of allogeneic EBV CTL in EBV-positive HD, the authors initiated a pilot trial in which EBV CTL were cultured from allogeneic, partially human leukocyte antigen-matched donors and were infused into patients who had therapy-refractory disease. The first cohort of 3 patients (Cohort I) received 3 separate infusions of EBV CTL (5.0 × 106 EBV CTL/kg per dose), and the second cohort (Cohort II) received 30 mg/m2 per day of fludarabine for 3 days followed by a single CTL infusion (1.5 × 107 EBV CTL/kg). RESULTS All three patients in Cohort I had decreases in measurable disease after EBV CTL infusions, and one of those patients was without evidence of disease 22 months after infusion. Two of 3 patients in Cohort II had decreases in measurable disease, although it was not determined whether those decreases were related to fludarabine or to CTL, and 1 patient in Cohort II had 7 months without disease progression. Unlike the patients in Cohort I, fludarabine recipients did not have increases in antidonor CTL responses. Donor cells could not be detected in any of the CTL recipients. CONCLUSIONS Adoptive immunotherapy with allogeneic EBV CTL was safe for patients with recurrent, refractory, EBV-positive HD; and clinical responses may be observed without the establishment of detectable donor lymphoid chimerism. Cancer 2004. © 2004 American Cancer Society. [source] Mature results of a phase III randomized trial of bacillus Calmette,Guerin (BCG) versus observation and BCG plus dacarbazine versus BCG in the adjuvant therapy of American Joint Committee on Cancer Stage I,III melanoma (E1673),,CANCER, Issue 8 2004A trial of the Eastern Cooperative Oncology Group Abstract BACKGROUND The local and systemic effects of bacillus Calmette,Guerin (BCG) have been known for decades. To investigate the adjuvant effect of BCG on resected American Joint Committee on Cancer (AJCC) Stage I,III melanoma, the Eastern Cooperative Oncology Group conducted a large trial to study the use of BCG alone or a combination of BCG and dacarbazine between 1974 and 1978. METHODS A total of 734 patients were randomized to 4 clinical groups consolidated into 2 cohorts. Cohort I compared BCG with observation and Cohort II compared BCG with a combination of BCG and dacarbazine. The primary end points were survival time and time to disease progression. RESULTS Within Cohort I, no statistically significant difference in disease-free survival (DFS) (P = 0.84) or overall survival (OS) (5-year survival 67% vs. 62%; P = 0.40) was observed between BCG treatment and observation. Within Cohort II, the addition of dacarbazine to BCG did not improve DFS (P = 0.74) or OS (P = 0.81) compared with BCG alone. Toxicity was mild to moderate in both cohorts. Although toxicity with this agent is mild, the use of BCG is associated with the development of punctate abscesses in greater than two-thirds of patients treated. CONCLUSIONS In what to our knowledge is the largest ever trial to test the role of BCG as adjuvant therapy for melanoma, no benefit for BCG was observed for patients with AJCC Stage I,III disease. The mature results of the current trial projected to 30 years confirmed the negative results of previous smaller studies utilizing this agent. Cancer 2004. © 2004 American Cancer Society. [source] Smoking and Risk of Premature Death among Middle-aged Japanese: Ten-year Follow-up of the Japan Public Health Center-based Prospective Study on Cancer and Cardiovascular Diseases (JPHC Study) Cohort ICANCER SCIENCE, Issue 1 2002Megumi Hara To update the evidence on the association between smoking and mortality, we analyzed data from a population-based prospective study in Japan. In total, 19 950 men and 21 534 women aged 40,59 who reported their smoking history and had no serious disease at baseline survey were followed. During 1990,1999, 1014 men and 500 women died. Smokers were associated with an unhealthy life-style. Relative risks (RRs) for selected cause of death due to smoking were slightly attenuated by adjusting for possible confounding factors. Age- and area-adjusted RRs of male current smokers compared with never smokers were 1.66 (95% confidence intervals (CI): 1.40, 1.95) for all causes, 1.69 (1.31, 2.18) for all cancers, 1.67 (1.20, 2.34) for all circulatory system disease, and 1.63 (1.24, 2.15) for other causes, while those of females were 2.03 (1.52, 2.73), 2.06 (1.35, 3.15), 2.99 (1.75, 5.11), 1.31 (0.69, 2.51), respectively. After adjusting for multivariate variables, the corresponding RRs of male smokers were 1.55 (1.29, 1.86), 1.61 (1.20, 2.15), 1.41 (0.97, 2.03), and 1.61 (1.17, 2.19), against 1.89 (1.36, 2.62), 1.83 (1.14, 2.95), 2.72 (1.45, 5.07), and 1.39 (0.71, 2.73) for females. Twenty-two percent of death from all causes, 25% of all cancer, and 17% of all circulatory system disease deaths, could be attributed to cigarette smoking in males, and 5%, 4%, and 11% in females, respectively. Cumulative dose as indicated by pack-years was clearly associated with cancer death. These findings provided information as to the quantitative risk for premature death due to smoking among middle-aged Japanese men and women, and showed that the elevated risk was not explained by the unhealthy lifestyle of smokers. [source] Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: effects of prophylactic and therapeutic anticoagulationBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2004Maurizio Zangari Summary A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86%) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4·5; P < 0·0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11%). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4%. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention. [source] Child health services in transition: I. Theories, methods and launchingACTA PAEDIATRICA, Issue 3 2005C. SUNDELIN Abstract Aim: To describe an evidence-based model for preventive child health care and present some findings from baseline measurements. Methods: The model includes: parent education; methods for interaction and language training; follow-up of low birthweight children; identification and treatment of postnatal depression, interaction difficulties, motor problems, parenthood stress, and psychosocial problems. After baseline measurements at 18 mo (cohort I), the intervention was tested on children from 0 to 18 mo at 18 child health centres in Uppsala County (cohort II). Eighteen centres in other counties served as controls. Two centres from a privileged area were included in the baseline measurements as a "contrasting" sample. Data are derived from health records and questionnaires to nurses and mothers. Results: Baseline experiment (n= 457) and control mothers (n= 510) were largely comparable in a number of respects. Experiment parents were of higher educational and occupational status, and were more frequently of non-Nordic ethnicity. Mothers in the privileged area (n= 72) differed from other mothers in several respects. Experiment nurses devoted considerably fewer hours per week to child health services and to child patients than did control nurses. Conclusions : Despite certain differences, experiment and control samples appeared comparable enough to permit, in a second step, conclusions about the effectiveness of the intervention. [source] Deep vein thrombosis in patients with multiple myeloma treated with thalidomide and chemotherapy: effects of prophylactic and therapeutic anticoagulationBRITISH JOURNAL OF HAEMATOLOGY, Issue 5 2004Maurizio Zangari Summary A group of 256 newly diagnosed myeloma patients were enrolled in a phase III study that included 4 monthly cycles of induction chemotherapy and tandem transplant. All patients were randomized to either receive or not receive thalidomide. A total of 221 patients (86%) received no prophylactic anticoagulation (cohort I); 35 patients received low dose coumadin (cohort II). The incidence of deep vein thrombosis (DVT) was significantly higher in the thalidomide arm hazard ratio: 4·5; P < 0·0001). As low dose coumadin (1 mg/d) failed to decrease thrombotic complications in 35 patients (cohort II), low molecular weight heparin (LMWH, enoxaparin 40 mg s.c. q.d.) was instituted as DVT prophylaxis in the thalidomide-treated patients (n = 68) of the subsequent cohort (n = 130, cohort III). This intervention eliminated the difference in DVT incidence between the two arms (thalidomide and no thalidomide). Within cohorts I and II, 36 patients, in whom thalidomide was discontinued after experiencing a thrombotic episode during chemotherapy, subsequently resumed the drug on full anticoagulation; with a median follow-up of 22 months, DVT recurred in four patients (11%). After completing induction and tandem transplantation, 55 patients were re-exposed to thalidomide and chemotherapy during consolidation treatment. Thrombotic complications were observed in 4%. Our experience, although not based on a randomized study, suggests that the excess frequency of thrombosis in patients treated with chemotherapy and thalidomide can be safely reduced by the prophylactic use of LMWH. The rate of DVT recurrence observed in our study upon thalidomide resumption was sufficiently low to allow its continuation in patients who may benefit from this therapeutic intervention. [source] | ||||||||||