Miyagi, Japan
Miyagi, Japan

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Maemondo M.,Miyagi Cancer Center | Inoue A.,Tohoku University | Sugawara S.,Sendai Kousei Hospital | Harada T.,Hokkaido Social Insurance Hospital | And 11 more authors.
Oncologist | Year: 2014

Background. Standard first-line chemotherapy for elderly non-small cell lung cancer (NSCLC) patients has been monotherapywith vinorelbine or gemcitabine. Docetaxel has also been considered as an alternative option for the elderly population in Japan. We have previously demonstrated the high efficacy of carboplatin plus weekly paclitaxel for elderly NSCLC patients. Consequently, we conducted a randomized phase II study to select the proper regimen for a future phase III trial. Methods. Eligible patients were aged 70 years or older with newly diagnosed advanced NSCLC. Patients were randomly assigned either to a combination of carboplatin (area under the curve: 6 mg/mL per minute) with weekly paclitaxel (70 mg/m2) (CPregimen) or to single-agentdocetaxel (60mg/m2). The primary endpoint of this study was objective response rate. Secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results. Among 83 eligible patients (41 to CP, 42 to docetaxel), the objective response rates were 54% (95% confidence interval: 39%-69%) and 24% (95% confidence interval: 11%-37%) and median progression-free survival was 6.6 months and 3.5 months in the CP arm and the docetaxel arm, respectively. Severe neutropenia, febrile neutropenia, and nausea were significantly frequent in the docetaxel arm, whereas toxicities in the CParm were generally moderate.One treatment-related death was observed in the docetaxel arm. Conclusion. The CP regimen achieved higher activity with less toxicity than single-agent docetaxel. Considering the results of this phase II trial and the IFCT-0501 trial, we have selected the CP regimen for a future phase III trial in elderly patients with advanced NSCLC. © AlphaMed Press 2014.


Sakakibara T.,Tohoku University | Inoue A.,Tohoku University | Sugawara S.,Sendai Kousei Hospital | Maemondo M.,Miyagi Cancer Center | And 7 more authors.
Annals of Oncology | Year: 2010

Background: The optimal platinum doublet regimen in elderly patients with non-small-cell lung cancer (NSCLC) is still uncertain. We conducted a randomized phase II study to compare the efficacy and safety of weekly paclitaxel combined with carboplatin with those of the standard schedule. Patients and methods: Elderly patients (age ≥70 years) with advanced NSCLC were randomly assigned to either the weekly arm {70 mg/m2 paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1} or the standard arm [200 mg/m2 paclitaxel and carboplatin (AUC = 6) on day 1]. The primary end point was the overall response rate (ORR). Results: Eighty-two patients were enrolled. The ORR and median progression-free survival were 55% and 6.0 months for the weekly arm and 53% and 5.6 months for the standard arm. Grade 3/4 neutropenia and peripheral neuropathy were observed in 41% and 0% of the patients in the weekly arm and in 88% and 25% in the standard arm, respectively. Conclusions: This is the first randomized study that compares the platinum doublet designed specifically for the elderly. Regarding the safety, the weekly regimen was less toxic than the standard regimen and seems to be preferable for elderly patients with advanced NSCLC. © The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org.


Ito A.,Tohoku University | Shintaku I.,Tohoku University | Satoh M.,Sen en General Hospital | Ioritani N.,Sendai Shakai Hoken Hospital | And 19 more authors.
Journal of Clinical Oncology | Year: 2013

Purpose: We evaluated the efficacy of a single early intravesical instillation of pirarubicin (THP) in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma (UUT-UC). Patients and Methods: From December 2005 to November 2008, 77 patients clinically diagnosed with UUT-UC from 11 institutions participating in the Tohoku Urological Evidence-Based Medicine Study Group were preoperatively enrolled in this study. Patients were randomly assigned to receive or not receive a single instillation of THP (30 mg in 30 mL of saline) into the bladder within 48 hours after nephroureterectomy. Cystoscopy and urinary cytology were repeated every 3 months for 2 years or until the occurrence of first bladder recurrence. Results: Seventy-two patients were evaluable for efficacy analysis, 21 of whom had a subsequent bladder recurrence. Significantly fewer patients who received THP had a recurrence compared with the control group (16.9% at 1 year and 16.9% at 2 years in the THP group v 31.8% at 1 year and 42.2% at 2 years in the control group; log-rank P = .025). No remarkable adverse events were observed in the THP-treated group. Based on multivariate analysis, THP instillation (hazard rate [HR], 0.26; 95% CI, 0.07 to 0.91; P = .035) and open surgery (HR, 0.28; 95% CI, 0.09 to 0.84; P = .024) were independently predictive of a reduced incidence of bladder recurrence. Conclusion: In this prospective randomized phase II study, a single intravesical instillation of THP seemed to reduce bladder recurrence after nephroureterectomy. A phase III, large-scale, multicenter study is needed to confirm these observations. © 2013 by American Society of Clinical Oncology.


Ito A.,Tohoku University | Shintaku I.,Tohoku University | Satoh M.,Sen en Rifu Hospital | Ioritani N.,Sendai Shakai Hoken Hospital | And 11 more authors.
Japanese Journal of Clinical Oncology | Year: 2013

Objective: The Pirarubicin Monotherapy Study Group trial was a randomized Phase II study that evaluated the efficacy of intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper urinary tract urothelial carcinoma. This study conducted further analysis of the Pirarubicin Monotherapy Study Group cohort, focusing on intravesical seeding of cancer cells. Methods: Using the data from the Pirarubicin Monotherapy Study Group trial, bladder recurrence-free survival rates and factors associated with bladder recurrence in the control group were analyzed. Results: Of 36 patients in the control group, 14 with positive urine cytology had more frequent recurrence when compared with the 22 patients with negative cytology (P=0.004). Based on the multivariate analysis in the control group, voided urine cytology was an independent predictive factor of bladder recurrence (hazard ratio, 5.54; 95% confidence interval 1.12-27.5; P=0.036). Of 72 patients in the Pirarubicin Monotherapy Study Group trial, 31 had positive urine cytology. Among the 31 patients, 17 patients who received pirarubicin instillation had fewer recurrences when compared with 14 patients who received control treatment (P=0.0001). On multivariate analysis, pirarubicin instillation was an independent predictor of better recurrence-free survival rates in the patients with positive urine cytology (hazard ratio, 0.02; 95% confidence interval, 0.00-0.53; P=0.018). Of 21 patients with bladder recurrence, 17 had recurrent tumor around cystotomy or in the bladder neck compromised by the urethral catheter, supporting the notion that tumor cells seeded in the injured urothelium. Conclusions: Intravesical instillation of pirarubicin immediately after nephroureterectomy significantly reduced the bladder recurrence rate in patients with positive voided urine cytology. The results suggest that intravesical seeding of upper urinary tract urothelial carcinoma occurs during nephroureterectomy. © The Author 2013. Published by Oxford University Press. All rights reserved.


Nakata B.,Osaka City University | Tsuji A.,Kochi Health Science Center | Mitachi Y.,Tohoku Koseinenkin Hospital | Taenaka N.,Sumitomo Hospital | And 11 more authors.
Oncology | Year: 2010

Aims: The efficacy and the toxicity of oral fluorouracil derivative S-1 plus low-dose cisplatin in unresectable or recurrent gastric cancer were evaluated by a phase II study. Methods: S-1 was administered orally for 28 days following 14 days' rest at 80-120 mg/body/day, depending on body surface area. During administration of S-1, cisplatin was given twice a week at the recommended dose (10 mg/m2), which was determined by a phase I study. Data from 34 patients in phase II and 8 patients treated with the recommended dose of cisplatin in phase I were analyzed. The primary endpoint was objective response. Results: The response rate was 47.1%. The median survival time was 11.0 months and the median progression-free survival was 6.9 months. The grade 3/4 toxicities observed in 10% or more of the treated patients were neutropenia (16.7%), anemia (16.7%) and anorexia (11.9%). The serum concentration of cisplatin was 794 ± 341 ng/ml at day 25 of the first course. Conclusions: S-1 plus low-dose cisplatin may be a clinically useful regimen for unresectable or recurrent gastric cancer because of its infrequent adverse events in spite of considerable efficacy and its convenience of no hydration and no hospitalization. Copyright © 2011 S. Karger AG, Basel.


Akiyama S.,Tohoku University | Seya Y.,Tohoku University | Murayama M.,Tohoku University | Ogasawara K.,Tohoku University | And 8 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2013

The Great East Japan Earthquake was the first disaster we experienced after the administration of oncology care had mostly shifted from hospitals to outpatient departments in Japan. Disaster medical assistance teams (DMATs) were deployed immediately after the disaster, and actively assisted during the acute phase of the catastrophe. After experiencing the earthquake, we realized the necessity of medical support teams, even for chronic disease. Here we report a multicenter trial of regional medical cooperation for cancer chemotherapy. First, soon after the earthquake, representatives from the regional hospitals discussed the proper roles for each institution. As agreed to in the discussion, cancer patients were redistributed from a disaster base hospital to a local general hospital, and oncologists supported the other regional hospitals on a regular basis. This broad regional network functioned well and patients resumed their treatment as soon as the situation allowed. Second, we performed a survey of the patients and found that the most important problem was patients' lack of understanding of their own illnesses. Third, we conducted an opinion survey of medical professionals on regional medical cooperation. Based on the trial, we found it important in disasters to establish regional cooperation and solid communication systems, and to promote patient education.


Kambe M.,Senseki Hospital | Kikuchi H.,South Miyagi Medical Center | Gamo M.,Osaki Citizen Hospital | Yoshioka T.,Yamagata University | And 2 more authors.
International Journal of Clinical Oncology | Year: 2012

Background This study was intended to ascertain the feasibility of a combination therapy with irinotecan by 24-h intravenous infusion (24-h CPT-11) and 5-fluorouracil (5-FU) for patients with metastatic colorectal cancer, to estimate the dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD), to determine the recommended dose (RD) for the Phase II study, and to evaluate the efficacy of the combination therapy. Methods The dosage regimen was as follows: CPT-11 was given by 24-h CPT-11 on day 1, followed by 24-h intravenous infusion of 5-FU on day 2. This regimen was repeated every 2 weeks. The dose of CPT-11 was escalated in five steps from 50 to 75, 100, 125, or 150 mg/m (levels 1-5), whereas the dose of 5-FU was fixed at 800 mg/m . Results Twenty-six patients were recruited for this study, and 25 of the 26 patients were eligible for the assessment. The DLTs of 24-h CPT-11/5-FU therapy included grade 3 diarrhea in 1 patient treated at level 1, and grade 3 neutropenia in 1 patient and grade 4 neutropenia in 1 patient at level 4. In level 5, in 3 cases the next administration could not be done for 22 days or more as a consequence of anorexia. Thus, the level 5 was made a MTD and the level 4 was made a RD. The main side effects of grade 3 or higher, although nausea/vomiting occurred, were mild and tolerable in severity overall. The overall response rate was 24.0% (6PR/25). Conclusion This study suggests that 24-h CPT-11/5-FU therapy is feasible and effective for treatment of metastatic colorectal cancer. © 2011 CARS.


Orikasa S.,Senseki Hospital | Kanbe K.,Senseki Hospital | Shirai S.,Senseki Hospital | Shintaku I.,Senseki Hospital | Kurosu S.,Senseki Hospital
International Journal of Urology | Year: 2012

We evaluated the feasibility and the benefits of total prostatectomy with suprapubic cystostomy drainage instead of a urethral Foley catheter. Of 65 consecutive total retropubic prostatectomies, 42 were carried out with the suprapubic cystostomy, and 23 with the urethral Foley catheter. Patients were asked postoperatively to complete a 5-cm visual analog scale on pain intensity related to the catheter and to urination after catheter removal. No problem related to cystostomy per se was observed. In the cystostomy group, over 85% and 69% of men perceived no urinary symptoms during catherization and no painful urination after catheter removal, respectively; whereas in the Foley group, 91% and 65% perceived those symptoms (P < 0.001 and P < 0.01, respectively). These findings suggest that urethral catheter-free prostatectomy is a good alternative to that with a urethral Foley catheter, and it gives patients an improved quality of early postoperative life. © 2012 The Japanese Urological Association.

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