Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer. MATERIALS AND METHODS: One hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1~5 every 4 weeks. RESULTS: At the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths. CONCLUSION: Heptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.

Initial Therapy with High-Dose Dexamethasone for Patients with Idiopathic Thrombocytopenic Purpura

BACKGROUND: Corticosteroids have been widely used for treatingidiopathic thrombocytopenic purpura (ITP) as a first-line treatment. Several different pulsed high-dose dexamethasone therapies for adult ITP have been reported on. We assessed the effectiveness of a single course of high dose dexamethasone as first-line treatment for adult patients with ITP. METHODS: The subjects of the study were previously untreated adult patients with newly diagnosed ITP and who had a platelet count of less than 20,000/microliter or a platelet count less than 50,000/microliter. High-dose dexamethasone at a dose of 40mg/day for four consecutive days was given orally. A response was defined as an increase in the platelet count of at least 30,000/microliter and a platelet count of more than 50,000/microliter by day 10 after the initial treatment. A sustained response was defined as a platelet count of more than 50,000/microliter that was maintained for six months after the initial treatment. RESULTS: Twenty two patients were eligible. The median platelet count before treatment was 19,000/microliter. Seventeen patients (77%) among the 22 patients achieved an initial response by day 10: the mean platelet count 10 days after the initial treatment was 144,000/microliter (range: 51,000 to 428,000/microliter). Among the patients with a response, 4 (23.5%) had a sustained response, and the other 13 (76.5%) relapsed within six months. All the patients well tolerated the high-dose dexamethasone treatment. CONCLUSION: A single course of high-dose dexamethasone is effective as an initial treatment for adults ITP patients, although the response duration is short. To maintain the response, repeated high-dose dexamethasone treatment may be needed or other alternative therapies can be considered.

The effect of ketamine as adjuvant to opioid for intractable cancer pain / 대한내과학회지

BACKGROUND: There has been growing evidence of the importance of the N-methyl-D- aspartate (NMDA) receptor in intractable pain. There is good evidence from experimental animal models and clinical trials that ketamine as a NMDA receptor antagonist relieves neuropathic pain. We evaluated whether ketamine in low doses as an adjuvant to opioid treatment improves analgesia with tolerable adverse effects. METHODS: 58 patients with intractable cancer pain received ketamine for 3 days. Each pain type was classified as a somatic, visceral, or neuropathic pain. We assessed pain at 6 hourly intervals with vital signs using a numeric rating scale. Data on opioid doses, ketamine dose, and adverse effects were recorded daily on an assessment chart. To be designated as a responder, a patient had to show a 50% or greater reduction in the mean pain scale. RESULTS: The overall response rate was 34.5%. The results according to the type of pain mechanism showed that 47% (15/32) patients with neuropathic and 25% (5/20) patients with somatic pain responded. In 24 cases (41.4%), the requirement for an opioid dose was reduced after infusion of ketamine. The most common adverse effects were nausea and vomiting. Eleven patients complained of drowsiness or transient hallucination. However, most adverse effects were mild to moderate and were easily relieved by treatment. CONCLUSIONS: This study demonstrates that the infusion of ketamine in low doses may have an effect on intractable cancer pain and in reducing opioid requirements, especially neuropathic pain with acceptable toxicities. Therefore, ketamine may be useful as an adjuvant to opioid treatment in cancer patients who are receiving palliative care.

A Case of Bullous Systemic Lupus Erythematosus:Clustered Tense Bullae Localized on the Face

A 21-year-old woman, who had a one-year history of pancytopenia with histiocytic necrotizing lymphadenitis and hepatosplenomegaly, presented with a 5 day history of tense bullae, which were localized on the face. These clusters of tense bullae occurred on clinically normal skin, she did not have other skin lesions. A diagnosis of bullous systemic lupus erythematosus (BSLE) was established based on clinical, laboratory, histological, and immunological findings. The bullae showed good responses to dapsone (100mg, daily) and resolved within 10 days with-out scaring. Bullous lesions of SLE may be the first cutaneous manifestation in some patients with SLE and should be considered in the differential diagnosis of the other subepidermal bullous disorders.