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Nozaki I.,Shikoku Cancer Center Hospital | Kato K.,National Cancer Center Hospital | Igaki H.,National Cancer Center Hospital | Ito Y.,National Cancer Center Hospital | And 7 more authors.
Surgical Endoscopy and Other Interventional Techniques | Year: 2015

Background: Thoracoscopic esophagectomy is rapidly and increasingly being used worldwide because it is a less invasive alternative to open esophagectomy. However, few prospective multicenter studies have evaluated its safety profile. This study aimed to evaluate the safety profile of thoracoscopic esophagectomy using perioperative data from the Japan Clinical Oncology Group Study (JCOG0502). Methods: JCOG0502 is a four-arm prospective study comparing esophagectomy with chemoradiotherapy for esophageal cancer, with randomized and patient preference arms. Patients with clinical stage T1bN0M0 esophageal cancer were enrolled until patient accrual was completed. Open or thoracoscopic esophagectomy was selected at the surgeon’s discretion. Perioperative complications were defined as adverse events of ≥grade 2 as per Common Terminology Criteria for Adverse Events ver. 3.0. Results: A total of 379 patients were enrolled between December 2006 and February 2013. Of the 210 patients who underwent surgery, 109 patients underwent open esophagectomy, and 101 patients underwent thoracoscopic esophagectomy. Although thoracoscopic esophagectomy decreased the incidence of postoperative atelectasis (open: 22.0 %, thoracoscopy: 10.9 %; P = 0.041), reoperation was more frequent in the thoracoscopy group (open: 1.8 %, thoracoscopy: 9.9 %; P = 0.016). The incidence of overall complications did not differ between the two groups (open: 44.0 %, thoracoscopy: 44.6 %; P = 1.00). There was one in-hospital death in each group (open: 0.9 %, thoracoscopy: 1.0 %; P = 1.00). Conclusions: Thoracoscopic esophagectomy is a safe procedure with morbidity and mortality comparable with those of open esophagectomy. However, it is associated with a higher frequency of reoperation. © 2015, The Author(s).

Katakami N.,Institute of Biomedical Research and Innovation | Inaba Y.,Aichi Cancer Center Hospital | Sugata S.,Shikoku Cancer Center Hospital | Tsurusaki M.,National Cancer Center | And 7 more authors.
Investigative Radiology | Year: 2011

Objectives: To determine the efficacy and safety of 2 doses of gadobutrol 1.0 M (0.1 and 0.2 mmol/kg body weight [BW]), compared with gadoteridol 0.5 M (0.2 mmol/kg BW), in contrast-enhanced magnetic resonance imaging (CE-MRI) of brain metastases in patients with known or suspected brain metastases from systemic malignancies. The study also compared the usefulness of gadobutrol in treatment planning for stereotactic radiosurgery (SRS). Materials and Methods: This was a Phase II/III, multicenter, single-blind, randomized, controlled, crossover, intraindividual comparison study. Each patient underwent one MRI study examination with gadobutrol and the other with gadoteridol, each at a dose of 0.1 mmol/kg BW, administered twice, for a total dose of 0.2 mmol/kg BW. Image acquisition was carried out after the first and second doses of gadobutrol, but only after the second dose of gadoteridol. Contrast agents were assigned in a randomized order and their administration separated by an interval of 1 to 14 days. Images were evaluated through blinded readings by 3 independent experienced radiologists. Treatment planning for SRS was assessed in a blinded manner, as a consensus between a diagnostic neuroradiologist and a radiation oncologist, in addition to the clinical investigator's assessment. The safety and tolerability of gadobutrol and gadoteridol were evaluated in all patients who received the study drugs. The primary efficacy variable was the number of lesions detected in CE-MRI images; the secondary efficacy variables were the degree of contrast enhancement and border delineation of lesions, and experts' confidence in treatment planning for SRS. Results: A total of 175 patients were enrolled and randomized, with 164 (93.7%) included in the safety analysis set, and 151 (86.2%) evaluable in the efficacy analysis. The mean number of detected lesions per patient using the average of the 3 blinded readers was 6.28, 6.92, and 6.87 for gadobutrol 0.1 and 0.2 mmol/kg BW, and gadoteridol 0.2 mmol/kg BW, respectively. Noninferiority of gadobutrol (both doses) to gadoteridol 0.2 mmol/kg BW was demonstrated. The degree of contrast enhancement and the border delineation of each lesion were categorized as "good" or "excellent" for most lesions for both agents. Almost all enhanced images were rated as "confident" in treatment planning for SRS. Sixty-five (43%) and 62 (41%) patients in the gadobutrol 0.1 and 0.2 mmol/kg BW groups, respectively, were selected as eligible for SRS treatment. The percentage of images assessed as "gadobutrol was better than gadoteridol" was higher than that assessed as "gadoteridol was better than gadobutrol" for both doses of gadobutrol. Eight adverse events were reported as being related to the study drug in 7 patients (4.3%) in each group. Conclusion: In this study, a single dose of gadobutrol was shown to be noninferior to a double dose of gadoteridol at detecting brain metastases, and could be effectively used for treatment planning in patients eligible for SRS. A dose of gadobutrol 0.1 mmol/kg BW is recommended as the clinical dose for the detection of brain metastases. Copyright © 2011 Lippincott Williams & Wilkins.

Yakushijin Y.,Ehime University | Morita J.,Shikoku Cancer Center Hospital | Yano T.,Sumitomo Besshi Hospital | Matsuhisa T.,Shikoku Cancer Center Hospital | And 9 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2014

The "Cancer Chemotherapy and its Management" subcommittee at the Ehime Cancer Care Network Priority Hospitals (Ehime Cancer Kyoten Hospitals) with a focus on medical expenses associated with chemotherapy, surveyed awareness among 98 clinicians regarding certifications of eligibility for Limited Health Insurance Payments during cancer treatment. This committee also lists social and clinical problems encountered at the Ehime Cancer Care Network Priority Hospitals. In our survey, 78% of clinicians were consulted about medical expenses associated with chemotherapy and were actively involved in resolving medical expense problems and resulting correspondences. However, only 38% of clinicians could explain the details of the Japanese guideline on the catastrophic cap and the certifications of eligibility for Limited Health Insurance Payments. This knowledge deficit was more pronounced in younger residents. From our analyses of the awareness about medical expenses among clinicians, we recommend the establishment of the following systems for the management of cancer patients. First, establish a reporting system and early consultation on the catastrophic cap and the certifications of eligibility before initiating cancer treatment. Second, education regarding medical expenses should be mandatory for clinicians, especially for young residents. Third, patients with cancer suffering in the interval of the medical expense and the social system should be relieved with new systems.

Kanzaki H.,Shikoku Cancer Center Hospital | Kataoka M.,Shikoku Cancer Center Hospital | Nishikawa A.,Shikoku Cancer Center Hospital | Uwatsu K.,Shikoku Cancer Center Hospital | And 3 more authors.
Japanese Journal of Clinical Oncology | Year: 2015

Objective: To determine the helpful factors to distinguish prostate-specific antigen failure from prostate- specific antigen bounce with large magnitude. Methods: From October 2004 to December 2009, 242 patients with prostate cancer treated with 125I brachytherapy were analyzed, 88 patients were excluded because the follow-up durations were shorter than 5 years. Their median follow-up was 80.4 months (60.0-123.9). Prostate-specific antigen failurewas determined using the Phoenix definition. Prostate-specific antigen bouncewas defined as an increase =0.2 ng/ml above the nadir, followed by a spontaneous return to the nadir. Prostatespecific antigen bounce +2 was defined as a prostate-specific antigen rise by 2.0 ng/ml or more above the nadir. Results: The 5-year biochemical relapse-free survival rate was 90.2%. Prostate-specific antigen failure and prostate-specific antigen bounce +2 were seen in 23 patients (14.9%) and 12 patients (7.8%), respectively. On univariate analysis, age at implant (P = 0.028), T stage (P = 0.020), time to prostatespecific antigen failure or prostate-specific antigen bounce (time to onset) (P = 0.0008), prostatespecific antigen velocity (P = 0.0003) and prostate-specific antigen doubling time (P = 0.0004) were significant for the distinction between prostate-specific antigen failure and prostate-specific antigen bounce +2. On multivariate analysis, no factor was the statistically significant factor. On receiver operating characteristic curve analysis, time to onset with a cutoff value of 29.8 months, prostate-specific antigen velocity of 0.18 ng/ml/month and prostate-specific antigen doubling time of 6.3 months had the highest accuracy of 82.9, 82.9 and 82.9% for prostate-specific antigen failure, respectively. Conclusions: Time to onset, prostate-specific antigen velocity and prostate-specific antigen doubling time would be helpful for distinction between prostate-specific antigen failure and prostatespecific antigen bounce +2. © The Author 2015.

Kanzaki H.,Shikoku Cancer Center Hospital | Kanzaki H.,Ehime University | Kataoka M.,Shikoku Cancer Center Hospital | Nishikawa A.,Shikoku Cancer Center Hospital | And 5 more authors.
International Journal of Clinical Oncology | Year: 2016

Background: We retrospectively investigated the impact on survival of early tumor reduction during definitive radiotherapy for inoperable stage III non-small cell lung cancer (NSCLC) patients, according to their histological subtypes. Methods: Between November 2006 and December 2012, 152 consecutive patients with inoperable stage III NSCLC who underwent definitive radiotherapy were reviewed retrospectively. Forty-one patients were excluded for not satisfying the inclusion criteria. Forty-five (40.5 %) and 48 (43.2 %) patients were diagnosed with squamous cell carcinoma (SQC) and adenocarcinoma (ADC), respectively. The tumor reduction rate (TRR) was defined as follows: TRR = 1−[gross tumor volume (GTV) on computed tomography at shrinking irradiation field planning]/(GTV on computed tomography at the initial treatment planning). The Cox proportional hazard model was used to identify significant prognostic factors for overall survival (OS) and progression-free survival (PFS). Results: We evaluated 111 patients, with a median follow-up time of 52.2 months in surviving patients. The median TRR was 45.9 %. In all patients, there were significant associations between TRR and PFS (P = 0.036) on multivariate analysis, although TRR had no correlation with OS (P = 0.141). With respect to histological subtype, multivariate analyses revealed that a higher TRR showed significant associations with better OS and PFS in the SQC group (P = 0.013 and 0.040, respectively). In contrast, a higher TRR was associated with poorer OS in the ADC group (P = 0.030); there was no association between TRR and PFS. Conclusion: We found that a higher TRR is a promising prognostic factor for better survival and disease control in SQC patients. © 2016 Japan Society of Clinical Oncology

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