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  • Article: Randomized controlled trial of standardized education and telemonitoring for pain in outpatients with advanced solid tumors.
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    ABSTRACT: PURPOSE: Previous studies have not defined the role of telemonitoring with educational tools in outpatients with advanced cancers. We tested the effectiveness of standardized education and telemonitoring for improving pain, distress, anxiety, depression, quality of life (QoL), and performance in outpatients with advanced cancers. METHODS: A total of 108 patients were randomly assigned to receive pain education alone (control arm) or pain education plus telemonitoring (experimental arm). Nursing specialists provided video-assisted educational material in both arms and daily telemonitoring for the first week in the experimental arm. Assessment was performed at baseline and 1 week and included evaluations of pain (Brief Pain Inventory, BPI), distress (Distress Thermometer, DT), anxiety, and depression (Hospital Anxiety and Depression Scale, HADS), QoL (QLQ-C30), and a Karnofsky score. RESULTS: Overall (n = 108), pain intensity was significantly improved at 1 week, including worst pain (7.3 to 5.7, P < 0.01) and average pain (4.6 to 3.8, P < 0.01). Additionally, anxiety (HADS score ≥ 11, 75 % to 56 %, P < 0.01), depression (HADS score ≥ 11, 73 % to 51 %, P < 0.01), QoL (fatigue and insomnia), and the Karnofsky score (32 to 66, P < 0.01) were also significantly improved at 1 week. However, the level of distress did not improve. The telemonitoring plus standardized education group showed more significant improvement in portion of pain >4 on VAS scale (35 % vs. 19 %, P = 0.02). CONCLUSIONS: Standardized pain education using nursing specialists is an efficient way to improve not only pain itself but also anxiety, depression, performance, and QoL. The addition of telemonitoring helps to improve pain management in the outpatient setting.
    Supportive Care in Cancer 01/2013; · 2.09 Impact Factor
  • Article: Irinotecan and oxaliplatin combination as the first-line treatment for patients with advanced non-small cell lung cancer
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    ABSTRACT: BackgroundWe conducted a prospective phase II trial of IrOx in patients with advanced non-small cell lung cancer to evaluate the efficacy and toxicity. Patients and methodsPatients with histologically or cytologically proven non-small cell lung cancer (NSCLC), aged ≥18 years, Eastern Cooperative Oncology Group performance status 0–1, at stage IIIB (pleural effusion)/IV or with recurrent disease not suitable for primary surgical treatment, with no palliative chemotherapy or radiotherapy to the chest or immunotherapy or biologic therapy, the presence of measurable disease by RECIST, and who had given signed written informed consent, were eligible. Treatment consisted of irinotecan 65 mg/m2 on days 1 and 8 and oxaliplatin 130 mg/m2 on day 1, repeated every 3 weeks. ResultsA total of 18 patients were enrolled in June and August 2007, the median age was 59 years (47–73). In total, 71 cycles were administered with a median of 4 cycles per patient (range, 1–6 cycles) and 18 patients were evaluable for treatment response. An independent review of tumor responses gave an overall response rate of 27.7% (CR: 0, PR: 5/18; 95% CI, 7–48.4%) by intent-to-treat analysis. The median overall survival of all patients was 14 months and the median time-to-progression was 4.2 months (95% CI, 1.959–6.441). The most common grade 3/4 toxicities were diarrhea (7% of all cycles) and neutropenia (5.6% of all cycles). Grade 3 peripheral neuropathy occurred in one patient and one patient died due to sepsis. ConclusionThis study suggests that IrOx combination therapy has moderate activity with a tolerable toxicity profile. However, it was not warranted to evaluate further this regimen as first-line treatment for patients with advanced or metastatic NSCLC using the current dosages and schedule.
    Cancer Chemotherapy and Pharmacology 04/2012; 64(5):917-924. · 2.83 Impact Factor
  • Article: A phase I/II trial of docetaxel and oxaliplatin in patients with advanced gastric cancer
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    ABSTRACT: PurposeWe designed this phase I/II study of docetaxel–oxaliplatin combination chemotherapy to determine the dose-limiting toxicity (DLT), maximum tolerated dose and efficacy as a first-line treatment in patients with advanced gastric cancer. MethodsPatients with histologically proven, chemo-naive gastric adenocarcinoma were eligible. For the phase I part, three dose levels of oxaliplatin and docetaxel every 3weeks were tested in a cohort of three patients for each level (respectively, 100 and 60mg/m2, 100 and 75mg/m2, 130 and 75mg/m2). Patients were treated up to a maximum of nine cycles of oxaliplatin and docetaxel unless there was documented disease progression, an unacceptable adverse event, or withdrawal of consent. ResultsNo DLT was observed at any of the three levels tested in the phase I portion. Therefore, oxaliplatin 130mg/m2 and docetaxel 75mg/m2 were recommended for the phase II study. All 47 patients were evaluable for toxicity and treatment response. The overall response rate was 55.3% (95% CI, 40.6–70.1%) and median duration of response was 4.2months (range 0.9–9.5months). After a median follow-up duration of 13.3months, median overall survival was 12.7months (95% CI: 10.4–14.9). The median time to progression was 5.0months (95% CI, 3.4–6.5months). The main toxicities (grade 3 or 4) were febrile neutropenia (14.9%), neutropenia (23.4%), diarrhea (10.6%) and neurotoxicity (8.5%). ConclusionThe combination of docetaxel and oxaliplatin was feasible with favorable toxicity profile and showed a promising anti-tumor activity in unresectable, metastatic gastric cancer patients.
    Cancer Chemotherapy and Pharmacology 04/2012; 64(2):347-353. · 2.83 Impact Factor
  • Article: Clinical significance of a serum CA15-3 surge and the usefulness of CA15-3 kinetics in monitoring chemotherapy response in patients with metastatic breast cancer
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    ABSTRACT: One hundred and twenty-two patients in whom the CA 15-3 level showed either a decline (92 patients) or an acute surge followed by a decline (30 patients) after chemotherapy were included. The clinical characteristics between the two groups and the CA 15-3 kinetics using receiver operating characteristic curves were analyzed. Patients with a surge had a significantly higher risk of disease progression than patients without a surge (P=0.004; odds ratio 2.62; 95% CI 1.45–4.72). The clinicopathologic characteristics were significantly different between the two groups with respect to the distribution of ER, PR, and HER2 status, relapse-free survival, and the severity and extent of the involved organs. For patients with a surge, a CA 15-3 slope threshold >−0.0038 was chosen with a sensitivity of 80.0% and a specificity of 80.4%. The area under the curve was 0.847 (95% CI 0.771–0.906; P=0.0001). A significant correlation between PFS and CA 15-3 slope was shown with Cox-regression modeling (P=0.036; hazard ratio [HR], 2.1; 95% CI 1.01–4.14).These kinetics may serve as a good predictive marker of treatment response and response duration.
    Breast Cancer Research and Treatment 04/2012; 118(1):89-97. · 4.43 Impact Factor
  • Article: Irinotecan monotherapy as second-line treatment in advanced pancreatic cancer
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    ABSTRACT: PurposeThe phase II study was conducted to evaluate the efficacy and safety of irinotecan as salvage single-agent chemotherapy in patients with advanced pancreatic cancer. MethodsPatients with measurable metastatic pancreatic cancer, progressive after previous gemcitabine-based chemotherapy were treated with irinotecan 150mg/m2 every 2weeks. Treatment was repeated until disease progression or unacceptable toxicity. ResultsBetween March 2004 to February 2007, 33 patients were registered and treated with irinotecan monotherapy. The patients’ median age was 59years (range 36–70) and two had an ECOG performance status of 2. A total of 167 chemotherapy cycles were delivered (median, 4; range 2–12). In an intent-to-treat analysis, three (9%) confirmed partial response and 13 patients with stable disease were observed for a disease control rate of 48%. The median progression-free and overall survivals were 2.0months (95% CI, 0.7–3.3) and 6.6months (95% CI, 5.8–7.4), respectively. Toxic effects were mainly gastrointestinal (nausea in 64% of patients, diarrhea in 36%), Toxicity profiles were generally predictable and manageable, and there was no treatment-related death. ConclusionsSecond-line chemotherapy with single-agent irinotecan is marginally effective and well tolerated regimen for gemcitabine-pretreated patients with advanced pancreatic cancer.
    Cancer Chemotherapy and Pharmacology 04/2012; 63(6):1141-1145. · 2.83 Impact Factor

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