Cross-sectional assessments of participants' characteristics and loss to follow-up in the first Opioid Substitution Therapy Pilot Program in Kabul, Afghanistan.

BACKGROUND: Kabul has over 12,000 people who inject drugs (PWID), most of them heroin users, and opioid substitution therapy has recently been introduced as an effective method to reduce opioid use. We aimed to evaluate a pilot Opioid Substitution Therapy Pilot Program (OSTPP) in Kabul, Afghanistan, particularly to (1) describe characteristics of the participants enrolled in the program and (2) identify factors associated with client retention in the OSTPP. FINDINGS: Two cross-sectional surveys evaluated participants attending the OSTPP at baseline (n = 83) and 18 months after (n = 57). Questionnaires assessed socio-demographic, drug use behavior, and general and mental health factors. After 18 months, 57 participants remained in the OSTPP. Participants lost to follow-up were younger (p < 0.01) and married (p < 0.01) and had no family contact (p < 0.01). Participants at 18 months reported no criminal activity in the last month and only two (3.5 %) reported heroin use in the last month, constituting significant decreases from baseline. CONCLUSIONS: While preliminary results are promising, further evaluation is needed to determine the feasibility of implementing OSTPP in this setting and effectiveness in reducing injection risk behaviors in Afghanistan.

A prospective randomized pilot study to evaluate predictors of response in serial core biopsies to single agent neoadjuvant doxorubicin or paclitaxel for patients with locally advanced breast cancer.

INTRODUCTION: Response to neoadjuvant chemotherapy for locally advanced breast cancer can be correlated with long-term outcomes. Surrogate end-point biomarkers may be used to assess response to the treatment. Most reported studies assessed the effects of combination chemotherapy. We assessed the feasibility of obtaining serial core breast biopsies, and correlated rates of apoptosis, proliferation, and expression of related proteins at baseline, during, and after neoadjuvant single agent chemotherapy for locally advanced breast cancer with response. EXPERIMENTAL DESIGN: Women with a histologically confirmed unresected T(3) or T(4) infiltrating carcinoma of the breast were eligible. The first 20 patients received three cycles of doxorubicin 90 mg/m(2) followed by three cycles of paclitaxel 250 mg/m(2), or the reverse. Nine women received four cycles of each (doxorubicin 60 mg/m(2) and paclitaxel 175 mg/m(2)). Cycles were administered 14 days apart with filgastrim. End points included: (a). clinical and pathological response; (b). serial apoptotic [terminal deoxynucleotidyl transferase (Tdt)-mediated nick end labeling] and proliferation (immunohistochemistry, IHC) rates; and (c). expression (IHC) of estrogen receptor, HER2, bcl2, and p53. RESULTS: From April 1997 to June 2001, 29 women were randomized. Twelve patients (42%) had a clinical complete response (cCR), and 16 (55%) had a clinical partial response. Five women (17%) had a pathological complete response, 7 (24%) had microscopic residual disease, and 17 (58%) had macroscopic residual disease. Higher baseline apoptosis and proliferation were associated with an improved pathological response (P = 0.006 and 0.003, respectively). Among 14 evaluable patients, apoptosis increased in women who had a cCR to the first agent but not in women without a cCR. Estrogen receptor-positive patients had a worse pathological response (P = 0.004). CONCLUSIONS: The selected regimen is efficacious. It is feasible to obtain serial core biopsies that are informative for studies of apoptosis and IHC. This clinical design can serve as a model for combining standard chemotherapy and novel agents.