Baseline blood count levels increase odds of cytopenia among CML patients in Kenya: a case control study

Background: Imatinib is the gold standard for the treatment of all phases of Philadelphia positive Chronic Myeloid Leukemia (CML). During treatment, patients may develop cytopenia. We aimed to study the baseline characteristics and factors associated with cytopenia at a Nairobi Hospital. Methods: This was a retrospective case-control study of patients aged ≥18 years on follow-up at the Glivec Inter‑ national Patient Access Program (GIPAP) clinic from 2007 to 2015. The cases consisted of CML patients on imatinib who developed cytopenia. The controls were CML patients on imatinib who did not develop cytopenia. Baseline socio – demographic, clinical, hematologic, and molecular data were retrieved from patients’ fles. Chi square or fshers’ exact tests were used to analyze for diferences between cytopenia and no cytopenia. Binary logistic regressions were employed to identify relationships. Univariate and multivariate analyses were done to identify independent predictors of cytopenia. Odds ratios (OR) were presented including the 95% confdence intervals and respective p values. Results: A total of 201 patients were studied consisting of ninety-four (94) patients with cytopenia and 107 with no cytopenia. Among the entire population, males were 52, and 42% were aged 36–50 years. Sex, age, marital status, occupation and education level were similar between the cytopenia and no cytopenia groups. Among the 201 patients, 70% had symptoms for \u3e12months before diagnosis, 78.6% had B symptoms at baseline, 80% had a moderate splenomegaly at baseline. Among patients with cytopenia, 40 and 37.4% developed cytopenia within 3months and 3–6months respectively after imatinib initiation. Baseline neutrophilia, neutropenia, anaemia, thrombocytosis, thrombocytopenia was found in 68, 11, 11, 23.5 and 11% respectively. Baseline hemoglobin, neutrophil and platelet level were signifcantly difer‑ ent between the cytopenia and the no cytopenia group. On univariable analysis, baseline anemia with hb\u3c7.9g/ dL (p =0.002), neutropenia (p =0.001), neutrophilia \u3e100,000/mm3 (p =0.002) and thrombocytopenia (p =0.001) increased the odds of developing cytopenia. On multivariable analysis, baseline anaemia (p value \u3c0.002), neutrope‑ nia (p value \u3c0.001), thrombocytopenia (p value, \u3c0.001) and thrombocytosis (p value, 0.033) increased the odds of developing cytopenia. Conclusion: Odds of cytopenia were higher in presence of baseline cytopenia and thrombocytosis. Clinicians should have a high index of suspicion for these patients

Cytopenia among CML Patients on Imatinib in Kenya: Types, Grades, and Time Course

Background: Imatinib mesylate is the gold standard for the treatment of all phases of Philadelphia-positive chronic myeloid leukemia. Patients on imatinib treatment may develop cytopenia due to drug toxicity. This study aimed to determine the types, grades, and time course of cytopenia in CML patients on imatinib at a Nairobi hospital. Methods: This was a cross-sectional descriptive study of adult patients aged ≥18 years followed up at the Glivec International Patient Access Program (GIPAP) clinic from 2007 to 2015. Patients who developed cytopenia within 12 months of initiating imatinib were eligible. Clinical and hematologic data were retrieved from the patients’ charts and entered into a study proforma. Measures of central tendency such as mean, median, mode, standard deviation, and variance were used for analysis. Results: Sixty three percent (63.6%) of the 94 patients developed a monocytopenia, with anemia seen in 34%, neutropenia in 27.6%, and thrombocytopenia in 8% of the 94 patients. Anemia plus neutropenia was the most common bicytopenia at 12.7%. Pancytopenia was seen in only 5 of the 94 patients. Most of the cytopenia was grades 2 and 3. Anemia was present at baseline while neutropenia and thrombocytopenia developed within 12 months of imatinib initiation. Anemia resolved during the first 12 months of therapy while neutropenia and thrombocytopenia resolved within 24–36 months of treatment. Conclusion: Monocytopenia, especially anemia, was the most common type of cytopenia. The cytopenia was predominantly grade 2, developed in majority of the patients within 6 months after imatinib initiation, and had resolved by 24–36 months after imatinib initiation

Developing Clinical Strength-of-Evidence Approach to Define HIV-Associated Malignancies for Cancer Registration in Kenya

Background Sub-Saharan Africa cancer registries are beset by an increasing cancer burden further exacerbated by the AIDS epidemic where there are limited capabilities for cancer-AIDS match co-registration. We undertook a pilot study based on a “strength-of-evidence” approach using clinical data that is abstracted at the time of cancer registration for purposes of linking cancer diagnosis to AIDS diagnosis. Methods/Findings The standard Nairobi Cancer Registry form was modified for registrars to abstract the following clinical data from medical records regarding HIV infection/AIDS in a hierarchal approach at time of cancer registration from highest-to-lowest strength-of-evidence: 1) documentation of positive HIV serology; 2) antiretroviral drug prescription; 3) CD4+ lymphocyte count; and 4) WHO HIV clinical stage or immune suppression syndrome (ISS), which is Kenyan terminology for AIDS. Between August 1 and October 31, 2011 a total of 1,200 cancer cases were registered. Of these, 171 cases (14.3%) met clinical strength-of-evidence criteria for association with HIV infection/AIDS; 69% (118 cases were tumor types with known HIV association – Kaposi’s sarcoma, cervical cancer, non-Hodgkin’s and Hodgkin’s lymphoma, and conjunctiva carcinoma) and 31% (53) were consistent with non-AIDS defining cancers. Verifiable positive HIV serology was identified in 47 (27%) cases for an absolute seroprevalence rate of 4% among the cancer registered cases with an upper boundary of 14% among those meeting at least one of strength-of-evidence criteria. Conclusions/Significance This pilot demonstration of a hierarchal, clinical strength-of-evidence approach for cancer-AIDS registration in Kenya establishes feasibility, is readily adaptable, pragmatic, and does not require additional resources for critically under staffed cancer registries. Cancer is an emerging public health challenge, and African nations need to develop well designed population-based studies in order to better define the impact and spectrum of malignant disease in the backdrop of HIV infection

Comparison of demographics and percentage with known HIV-associated cancer cases between those with HIV(+) serology and those who met clinical criteria only.

<p>[<u>Notes</u>: *Statistically significant difference (p = 0.005) between positive serology group (n = 47) and clinical criteria only group (n = 124) with respect to the patient characteristic (Chi-square test)].</p

Level of strength-of-evidence of HIV infection/AIDS in 171 cancer cases that were registered.

<p>Of the subsequent confirmed HIV(+) serology 12 were identified at the Comprehensive Care Clinic and 10 at the Department of Radiation Oncology at Kenyatta National Hospital. [<u>Notes</u>: *Statistically significant difference (p = 0.022) between positive serology group (n = 47) and clinical criteria only group (n = 124) with respect to the level strength-of-evidence (Chi-square test)].</p

Nairobi Cancer Registry (NCR) – reporting entities comprising this cancer population-based registry utilized for this study number of cases that met strength-of-evidence criteria for cancer-AIDS (HIV infection) match.

<p>Nairobi Cancer Registry (NCR) – reporting entities comprising this cancer population-based registry utilized for this study number of cases that met strength-of-evidence criteria for cancer-AIDS (HIV infection) match.</p

Tumor types of 171 cancer cases with hierarchal association of HIV infection/AIDS.

<p>Of these total cases, 118 (69%) had demonstrable HIV association (i.e., KS, cervix, NHL, conjunctiva and Hodgkin’s disease) and the remaining 53 would be considered non-AIDS-defining cancer. [<u>Notes</u>: <b><i>Bold italics</i></b> – known HIV-associated malignancy; NOS – not otherwise specified].</p