Clinical Experience of Edaravone in Amyotrophic Lateral Sclerosis

Objective: To describe clinical experience with edaravone in ALS over a period of 12 months Methods:The current study retrospectively investigated characteristics in a group of patients (n=31) with ALS who underwent edaravone treatment. Information including age, gender, race, and site of onset of symptoms were collected for all patients. Adverse events with edaravone therapy was documented where available. Results:The average age of the patients observed was 62.09 years, with 18 males and 13 females. 18 patients had limb onset, 12 bulbar onset, and 1 diaphragmatic onset. 7 of the 31 patients discontinued treatment at the end of one year. The average age of patients who discontinued edaravone was 65.71 years, of whom which 3 had limb onset, 3 bulbar onset, and 1 diaphragmatic onset. No perceived benefit, port complications, systemic bacteremia, and development of atrial fibrillation were documented as reasons for discontinuation of therapy.Conclusion: Edaravone is well tolerated in ALS patients at the end of one year. Lack of perceived benefit and port related complications are common reasons for discontinuation of treatment

Intraperitoneal chemotherapy (IPC) in older women with epithelial ovarian cancer (EOC)

5541 Background: Over half of patients (pts) diagnosed with EOC are ≥ 65 yrs of age. GOG 172 showed a significant survival advantage with post-operative IPC in all women with newly diagnosed stage III EOC, regardless of age. Toxicity can be significant and there is limited data for pts ≥ 65 yrs. Methods: A descriptive intention-to-treat analysis of pts ≥ 65yrs treated with IPC for EOC at our center from 1994–2008. Medical records were reviewed retrospectively to detail toxicity (CTCAEv3.0), compliance and outcome. Results: 118 pts with a median age of 70 yrs (range 65–83), KPS 90% (range 70–90), and co-morbidities 2 (range 0–6) were treated with IPC: 27 pts (23%) as primary postoperative IPC (IV paclitaxel 135mg/m2 D1, IP cisplatin 75mg/m2 D2 & IP paclitaxel 60mg/m2 D8) and 91 pts (77%) as consolidation (IP cisplatin regimen, alone or combined with IV paclitaxel or with IP gemcitabine). Median no. of cycles was 3 (range 0–7) with 55% pts completed total no. planned. 18% were switched to IV treatment. 14% had treatment delays. 32% required dose reductions, 22% at cycle 1. Toxicities included: 32% had IP port complications, 42% functional decline, 43% new ≥ Gr1 neuropathy (4% Gr3), 12% Gr2 hearing impairment, 60% ≥ Gr1 nausea/vomiting (4% Gr3), 57% ≥ Gr1 diarrhea/constipation (0% Gr3), 37% ≥ Gr1 abdominal pain (2% Gr3). For evaluable pts, 78% had ≥ Gr1 electrolyte disturbance (5% Gr3–4), 71% ≥ Gr1 nephrotoxicity (5% Gr2; 1% Gr3), 20% ≥ Gr2 neutropenia (6%Gr3; 3% Gr4). Ca125 normalized in 90% (pts with elevated baseline Ca125). Kaplan-Meier estimated median PFI was 1.2yrs (95% CI: 1–1.6yrs). Conclusions: Rate of completed full IPC cycles and toxicity is similar to published data. IPC can be safely administered in pts ≥ 65yrs with adequate support and dose modifications. Older patients must be adequately represented in future prospective trials. No significant financial relationships to disclose.