Flecainide for the treatment of chronic neuropathic pain: a Phase II trial.

BACKGROUND: Management of neuropathic pain is challenging. Medications that interfere with sodium channel transport, such as lidocaine, mexilitene and flecainide, are promising as analgesics. OBJECTIVE: In a general population of patients with a working diagnosis of neuropathic pain, whether if flecainide produces enough of an improvement in pain to warrant further clinical study is determined. DESIGN: Phase I/II prospective exploratory clinical trial. Eligible patients were observed for week 1, then 50 mg flecainide was administered twice daily for week 2 and then administered 100 mg twice daily for week 3. SETTING/ SUBJECTS: Multi-institutional members of the Eastern Co-operative Oncology Group. Patients had neuropathic pain diagnosed by their oncologists as defined by the International Association for the Study of Pain and a diagnosis of cancer or AIDS. MEASUREMENTS: The Wisconsin Brief Pain Inventory was used. The primary endpoint was a decrease of 3 points (0-10 numerical scale) or a decrease of 50% in the worst pain rating at either day 15 or day 22 relative to the average of days 1 and 8 ratings. RESULTS: Nineteen patients were registered for the study. Four patients were ineligible. Of the remaining 15, one was unevaluable due to incomplete pain rating. Four out of 14 patients had an average drop of 5 points or 53% in their worst pain ratings on a 0-10 numerical scale of pain. No patients withdrew from study because of toxicity. There were no life-threatening or lethal toxicities. All patients were alive at the time of the analysis. CONCLUSIONS: Flecainide produced a 30% response rate. Response in this study was defined to be highly relevant and clinically significant reduction in pain. The drug merits study in a randomized placebo-controlled trial.

Adjusting for patient selection suggests the addition of docetaxel to 5-fluorouracil-cisplatin induction therapy may offer survival benefit in squamous cell cancer of the head and neck.

When induction chemotherapy is used in locally advanced squamous cell cancer of the head and neck (SCCHN), patients often receive cisplatin-5-fluorouracil (PF) followed by radical loco-regional therapy. Phase II studies of docetaxel-cisplatin-5-fluorouracil (TPF) induction therapy, with or without leucovorin (L), have achieved high survival rates versus those reported in phase III PF trials. However, the distribution of prognostic factors may vary between phase II and phase III study populations, making the extrapolation of phase II TPF/L results to phase III PF populations difficult. This study used a patient selection standardization method and Cox model to adjust for potential selection bias. Thus, the survival benefit from adding docetaxel into PF induction regimens in SCCHN could be more accurately assessed. The TPF/L dataset comprised 195 patients from six phase II trials. The PF dataset of 585 patients was derived from five large randomized trials included in the Meta-Analysis of Chemotherapy in Head and Neck Cancer (MACH-NC) database. TPF/L and PF datasets differed significantly concerning the distribution of several prognostic factors. Adjusting for these differences, the relative risk of death in the PF versus TPF/L datasets was 1.85 (95% confidence interval 1.37-2.49), corresponding to a 20% 2-year survival benefit (p < 0.0001). Sensitivity analyses confirmed that this improved 2-year survival rate of TPF/L over PF was robust, irrespective of the distribution of studied prognostic factors between treatment datasets. We conclude that this improved survival might be due either to docetaxel's pharmacologic effect or to uncontrolled prognostic factors.

The talking touchscreen: a new approach to outcomes assessment in low literacy.

PURPOSE: Cancer patients who are deficient in literacy skills are particularly vulnerable to experiencing different outcomes due to disparities in care or barriers to care. Outcomes measurement in low literacy patients may provide new insight into problems previously undetected due to the challenges of completing paper-and-pencil forms. DESCRIPTION OF STUDY: A multimedia program was developed to provide a quality of life assessment platform that would be acceptable to patients with varying literacy skills and computer experience. One item at a time is presented on the computer touchscreen, accompanied by a recorded reading of the question. Various colors, fonts and graphic images are used to enhance visibility, and a small picture icon appears near each text element allowing patients to replay the sound as many times as they wish. Evaluation questions are presented to assess patient burden and preferences. RESULTS: An ethnically diverse group of 126 cancer patients with a range of literacy skills and computer experience reported that the 'talking touchscreen' (TT) was easy to use, and commented on the usefulness of the multimedia approach. CLINICAL IMPLICATIONS: The TT is a practical, user-friendly data acquisition method that provides greater opportunities to measure self-reported outcomes in patients with a range of literacy skills.

Quality of life assessment for low literacy Latinos: a new multimedia program for self-administration.

Cancer patients who have limited literacy skills or English language proficiency are particularly vulnerable to receiving sub-optimal care. Outcome measurement in these patients may provide new insight into previously undetected problems. This report describes the development and testing of a Spanish language, multimedia program for quality of life (QOL) assessment. Pilot testing was conducted with 30 Latino cancer patients with a range of education levels and computer experience. Patients found the program easy to use and understand. The "Talking Touchscreen" is a practical, user-friendly method that provides greater opportunities to assess QOL in Spanish-speaking patients with a range of literacy skills.