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Miyagi, Japan

This prospective randomized Phase II study was designed to evaluate the preventive effect of an oral nutrition supplement composed of beta-hydroxy-beta-methylbutyrate, arginine and glutamine (beta-hydroxy-beta-methylbutyrate/arginine/glutamine) on radiation dermatitis in head and neck cancer patients. Forty patients with histologically proven head and neck cancer, treated with concurrent chemoradiotherapy involving cisplatin were recruited. They were randomly assigned to the beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplement treatment group (Group A) or the control group that received no supplement (Group B). The primary endpoint of this study was the percentage of patients developing ≥Grade 3 dermatitis. The secondary endpoints were the percentage of patients developing ≥Grade 2 dermatitis, and the duration of each grade of dermatitis relative to the observation period. The incidence of ≥Grade 3 dermatitis did not differ between the two groups. However, as secondary endpoints of this study, the incidence of ≥Grade 2 dermatitis was lower in Group A than B (62.6 vs. 94.4%; P < 0.05), and the duration of ≥Grade 1 dermatitis was shorter in Group A than B (44.8 vs. 56.7%; P < 0.01), as was the duration of ≥Grade 2 dermatitis (16.5 vs. 26.5%; P < 0.05). Our study indicated that beta-hydroxy-beta-methylbutyrate/arginine/glutamine supplementation was potentially effective in the prevention of radiation dermatitis in head and neck cancer patients.

Watanabe S.,Niigata University | Minegishi Y.,Infections Disease and Oncology | Yoshizawa H.,Niigata University | Maemondo M.,Miyagi Cancer Center | And 8 more authors.
Journal of Thoracic Oncology | Year: 2014

INTRODUCTION:: In non-small-cell lung cancer, an exon 19 deletion and an L858R point mutation in the epidermal growth factor receptor (EGFR) are predictors of a response to EGFR-tyrosine kinase inhibitors. However, it is uncertain whether other uncommon EGFR mutations are associated with sensitivity to EGFR-tyrosine kinase inhibitors. METHODS:: A post-hoc analysis to assess prognostic factors was performed with the use of patients with EGFR mutations (exon 19 deletion, L858R, G719X, and L861Q) who were treated with gefitinib in the NEJ002 study, which compared gefitinib with carboplatin-paclitaxel as the first-line therapy. RESULTS:: In the NEJ002 study, 225 patients with EGFR mutations received gefitinib at any treatment line. The Cox proportional hazards model indicated that performance status, response to chemotherapy, response to gefitinib, and mutation types were significant prognostic factors. Overall survival (OS) was significantly shorter among patients with uncommon EGFR mutations (G719X or L861Q) compared with OS of those with common EGFR mutations (12 versus 28.4 months; p = 0.002). In the gefitinib group (n = 114), patients with uncommon EGFR mutations had a significantly shorter OS (11.9 versus 29.3 months; p < 0.001). By contrast, OS was similar between patients with uncommon mutations and those with common mutations in the carboplatin-paclitaxel group (n = 111; 22.8 versus 28 months; p = 0.358). CONCLUSIONS:: The post-hoc analyses clearly demonstrated shorter survival for gefitinib-treated patients with uncommon EGFR mutations compared with the survival of those with common mutations and suggest that the first-line chemotherapy may be relatively effective for non-small-cell lung cancer with uncommon EGFR mutations. © 2013 by the International Association for the Study of Lung Cancer.

Maemondo M.,Miyagi Cancer Center
Japanese Journal of Cancer and Chemotherapy | Year: 2012

Lung cancer patients thus far have been given a non-treated period called "treatment holiday", followed by 4-6 courses of platinum-doublet. Now, maintenance therapy has attracted much attention after the approval of pemetrexed and bevacizumab. Treatments with both drugs are effective, with mild toxicity. However, it was not established how to apply maintenance therapy to patients. Maintenance therapy with pemetrexed requires the selection of patients by the efficacy of induction therapy (PR or SD), performance status, and the tendency of disease progression. In contrast, bevacizumab monotherapy should be applied to all patients having PR or SD, because the therapy is less toxic and no predictive factor has been identified. On the other hand, the efficacy of EGFR-TKI therapy for patients with EGFR activating mutation has been established. EGFR-TKIs are key drugs for patients with EGFR-mutation, and are recommended as standard first-line therapy. I consider that chemotherapies are the second important drugs for prolonging patient survival. It has not been confirmed which is superior, the first-line therapy with EGFR-TKIs or the second line. But when EGFR-TKIs are administered in first-line, we should change TKIs to chemotherapy immediately after determination of PD on the basis of RECIST. When EGFR-TKIs are administered after chemotherapy in the second line or more line, continuation of EGFR-TKIs after PD can be accepted as long as there is no obvious exacerbation.

Matsuura K.,Miyagi Cancer Center
Japanese Journal of Head and Neck Cancer | Year: 2015

According to the treatment guidelines, the first therapy for advanced tongue cancer is surgery. Postoperative dysfunction is inevitable with surgery, but it is important to minimize the disorder. There are three points for maintaining postoperative speech and swallowing function. The first is sufficient resection and the second is oral reconstruction with a flap of sufficient volume. The third is laryngeal elevation. These approaches enable laryngeal preservation in a subtotal or total resection case. For cases at high risk of recurrence, postoperative chemoradiotherapy using CDDP is the standard treatment. In particular, 3-weekly CDDP+RT treatment is the standard postoperative therapy. In chemoradiotherapy, it is important to prevent dropout, and so a therapeutic treatment that is as effective as the current standard treatment but with less toxicity needs to be developed. Therefore, the JCOG1008 study is being conducted, and the results are eagerly awaited. © 2015, Japan Society for Head and Neck Cancer. All rights reserved.

Seto T.,National Hospital Organization Kyushu Cancer Center | Kiura K.,Okayama University | Nishio M.,Cancer Institute Hospital | Nakagawa K.,Kinki University | And 12 more authors.
The Lancet Oncology | Year: 2013

Background: Currently, crizotinib is the only drug that has been approved for treatment of ALK-rearranged non-small-cell lung cancer (NSCLC). We aimed to study the activity and safety of CH5424802, a potent, selective, and orally available ALK inhibitor. Methods: In this multicentre, single-arm, open-label, phase 1-2 study of CH5424802, we recruited ALK inhibitor-naive patients with ALK-rearranged advanced NSCLC from 13 hospitals in Japan. In the phase 1 portion of the study, patients received CH5424802 orally twice daily by dose escalation. The primary endpoints of the phase 1 were dose limiting toxicity (DLT), maximum tolerated dose (MTD), and pharmacokinetic parameters. In the phase 2 portion of the study, patients received CH5424802 at the recommended dose identified in the phase 1 portion of the study orally twice a day. The primary endpoint of the phase 2 was the proportion of patients who had an objective response. Treatment was continued in 21-day cycles until disease progression, intolerable adverse events, or withdrawal of consent. The analysis was done by intent to treat. This study is registered with the Japan Pharmaceutical Information Center, number JapicCTI-101264. Findings: Patients were enrolled between Sept 10, 2010, and April 18, 2012. The data cutoff date was July 31, 2012. In the phase 1 portion, 24 patients were treated at doses of 20-300 mg twice daily. No DLTs or adverse events of grade 4 were noted up to the highest dose; thus 300 mg twice daily was the recommended phase 2 dose. In the phase 2 portion of the study, 46 patients were treated with the recommended dose, of whom 43 achieved an objective response (93·5%, 95% CI 82·1-98·6) including two complete responses (4·3%, 0·5-14·8) and 41 partial responses (89·1%, 76·4-96·4). Treatment-related adverse events of grade 3 were recorded in 12 (26%) of 46 patients, including two patients each experiencing decreased neutrophil count and increased blood creatine phosphokinase. Serious adverse events occurred in five patients (11%). No grade 4 adverse events or deaths were reported. The study is still ongoing, since 40 of the 46 patients in the phase 2 portion remain on treatment. Interpretation: CH5424802 is well tolerated and highly active in patients with advanced ALK-rearranged NSCLC. © 2013 Elsevier Ltd.

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