A high incidence of severe B-cell immunodeficiency and chronic reactivated Epstein-Barr virus (EBV) infection in patients with chronic fatigue syndrome (CFS) is reported herein. Of the 58 patients evaluated, 100% had evidence of prior EBV exposure and 72% had evidence for reactivated EBV infection. Notably, 94% of CFS patients had B-cell immunodeficiency with a marked depletion of their CD19+IgM+ mature B-lymphocyte population. A remarkable 81% of CFS patients experienced subjective improvement of their symptoms after treatment with folinic acid (CAS 58-05-9, leucovorin). The findings provide unprecedented evidence that CFS frequently is a folinic acid responsive clinical entity accompanied by B-cell immunodeficiency and inappropriate antibody responses to EBV.
BackgroundWe treated 62 patients with advanced Stage IV colorectal cancer in an outpatient setting with multiple cycles of Xeloda-based empirical chemotherapy regimens (“Xeloda regimens”), including Xeloda monotherapy, Xeloda + irinotecan, Xeloda + oxaliplatin, and Xeloda + mitomycin. Of these 62 patients, 15 were not previously treated with a 5-fluorouracil (5-FU)-containing regimen, while 47 had failed one (N = 21) or more (N = 26) treatments, including at least one 5-FU containing regimen.MethodsFusion technology with combined anatomic and functional imaging using CT/MRI scans fused with whole body PET scans along with serial cancer marker level measurements was employed to monitor response to therapy and tailor the treatments to each patient according to their treatment response. Patients who showed evidence of progression on a given Xeloda regimen were switched to a different Xeloda regimen.ResultsFailure to respond to a particular Xeloda regimen did not preclude objective responses to a different Xeloda regimen. For the 15 5-FU-naive patients, the median survival was 16 months. Of the 47 patients who were previously treated with at least one 5-FU regimen, 37 (79%) died at a Kaplan-Meier calculated median of 10 months (95% CI 9-15 months; log normal mean ± SD = 11.4 ± 2 months). The remaining 10 patients (21%) are alive, surviving progression-free at 7 months, 12 months (N = 3), 15 months, 16 months, 17 months, 26 months, 27 months, and 30 months, respectively, with a median progression-free survival time of > 15 months. No patient was hospitalized because of treatment-related complications. Our results demonstrate that a significant portion of previously treated Stage IV colorectal cancer patients with liver, lung, and/or brain metastases can achieve long-term progression-free survival with an excellent quality of life on empirical Xeloda-based outpatient treatments. By comparison, the overall average of the median survival times for 449 Stage IV colorectal cancer patients treated on a clinical trial arm from 8 major published clinical studies was 10.9 months.ConclusionsFusion technology provides medical oncologists with a powerful diagnostic tool for timely termination or modification of ineffective treatments. Patients with advanced colorectal cancer should be offered empirical patient-tailored chemotherapy as an alternative to the clinical trial and hospice options.
Background: In 1996, the average number of uninsured children in Bibb County was higher than for the state as a whole. Several key industries had left the area, unemployment had risen, and community-wide effects included declining school performance and child illness. The Bibb County Child Caring Initiative (BCCCI), created by a coalition of interested parties in 1996, coordinated two preexisting federal health plans (Medicaid, All-Kids) and offered insurance to other uninsured children through a state plan. By 2000, the goal of providing health coverage to all children in Bibb County seemed within reach. The present study was conducted as an evaluation of this program. Objectives: To evaluate the BCCCI program using parent satisfaction and community information on saturation levels as the defining measures. Methods: Qualitative research methods were used in this study. In 2003, face-to-face interviews were conducted with 248 parents and with 23 key informants (employers, policy-makers, teachers, physicians, and a school nurse). Additionally, two focus groups of parents were conducted for in-depth information on child health insurance in Bibb County. Results: The total number of uninsured children in Bibb County decreased over the study period and parents were grateful for the opportunity to enroll their children in a health plan. Some discrepancies were reported, such as parents not receiving forms, not knowing about the BCCCI program, lengthy waiting periods, ineligibility, providers who billed patients, and in a few cases, discriminatory practices. Conclusions: The BCCCI apparently improved access to health care for children in Bibb County. Currently, these gains are being threatened by the fiscal crisis affecting states' ability to fund insurance plans, unemployment, and rising premiums that affect parents' ability to provide health insurance for their children.
We examined the activity of vinorelbine-based salvage biochemotherapy regimens NNDR-I (Vinorelbine [Navelbine] 25 mg/m2 d1, d8, Mitoxantrone [Novantrone] 10 mg/m2 d1, Dexamethasone [Decadron] 20 mg BID d1 through 7, Rituximab [Rituxan] 375 mg/m2 d1,8,15,29) and NNDR-II (Vinorelbine 25 mg/m2 d1, Mitoxantrone 10 mg/m2 d1, Dexamethasone 20 mg BID d1 through7, Rituximab 375 mg/m2 d1,8,15,22, Fludarabine 25 mg/m2 d1, d2, d3) in 26 patients with lymphohematopoietic malignancies, including 3 adult chronic myeloid leukemia (CML) patients in blast crisis, 2 adult chronic lymphocytic leukemia (CLL) patients with rapidly progressive leukemia, 10 acute lymphoblastic leukemia (ALL)(2 adults, 8 children) patients in therapy refractory relapse, and 11 adult non-Hodgkin’s lymhoma (NHL) patients (9 in relapse with progressive lymphoma). All patients completed their salvage therapy as an outpatient without infectious disease complications or hospitalizations. Of the 26 patients, 20 had objective responses, including 14 complete remissions (CR). The median survival was 1.3 (95% CI:0.5–3.9) y and the probability of survival was 53± 10% at 1 year and 37 ± 10% at 3 years (Figure 1). All 3 CML patients achieved a CR; two subsequently underwent allogeneic stem cell transplantation and remain alive free of leukemia at 4.5 y and 5.0 y, respectively, post blast crisis. One died with progressive disease at 0.7y. Both CLL patients achieved a CR and remain alive in CCR at 0.6y and 4.5y, respectively. Of the 10 ALL patients, 5 achieved a CR; of these 5, 2 died of pulmonary Aspergillosis at 0.3 y, 1 died of CMV pneumonitis at 0.7 y, 1 relapsed and died of gram negative sepsis at 1.2 y during reinduction, and 1 remains alive at 4.5 y in continued CR on maintenance chemotherapy. The median survival was 4 months. Of the 11 NHL patients, 4 achieved a CR and 5 achieved a PR. The median survival was 1.5y and 4 remain alive disease-free at 2.5y, 2.5y, 3.5y and 4.0y, respectively. Drug sensitivity profiling of primary tumor cells was performed in 14 patients: the vinorelbine sensitivity of the patients’ leukemia/lymphoma cells predicted their clinical response to the NNDR regimens. Of the 9 responders tested, 8 were vinorelbine sensitive at the primary tumor cell level. Of the 5 non-responders tested, only one was vinorelbine sensitive at the primary tumor cell level. Taken together, these findings demonstrate that patients with high risk/poor prognosis leukemias and lymphomas can achieve meaningful objective responses in an outpatient setting using vinorelbine-based salvage regimens. Future application if the drug sensitivity profiling of primary tumor cells might help tailor the NNDR regimens to those who are most likely to respond. Figure 1. Treatment Outcome of Leukemia/Lymphoma Patients receiving NNDR I/II Therapy Figure 1. Treatment Outcome of Leukemia/Lymphoma Patients receiving NNDR I/II Therapy
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