Faculty Profiles - HOTTA Katsuyuki

Papers - HOTTA Katsuyuki

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Recent improvement in the survival of patients with advanced nonsmall cell lung cancer enrolled in phase III trials of first-line, systemic chemotherapy Reviewed

Katsuyuki Hotta, Yoshiro Fujiwara, Keitaro Matsuo, Takeshi Suzuki, Katsuyuki Kiura, Masahiro Tabata, Nagio Takigawa, Hiroshi Ueoka, Mitsune Tanimoto

CANCER 109 ( 5 ) 939 - 948 2007.3

Language：English Publishing type：Research paper (scientific journal) Publisher：JOHN WILEY & SONS INC

BACKGROUND. Few studies have assessed formally whether treatment outcomes have improved substantially over the years for patients with advanced nonsmall cell lung cancer (NSCLC) enrolled in Phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials.
METHODS. The literature was searched to identify trials that addressed the role of chemotherapy regimens in the first-line setting for the treatment of advanced NSCLC. Trends were tested by using multiple regression analysis.
RESULTS. In total, 121 Phase III trials were identified that involved 42,768 patients with 263 chemotherapy arms and 11 best supportive care (BSC) arms, all of which were initiated between 1982 and 2002. Although the number of randomized patients and the proportion of patients with metastatic disease had increased over the years, the number of patients with a poor performance status who were accrued into the trials had decreased. Cisplatin-based chemotherapy was been investigated most frequently during the period. The multiple regression analysis revealed a significant improvement in median survival and in the median time to disease progression over the years, with annual prolongations of 0.1203 months (3.609 days) and 0.0617 months (1.851 days), respectively (P < .0001 and P < .0130, respectively). In addition, the use of cisplatin and carboplatin was associated significantly with survival prolongation. The median survival for patients who received BSC also increased progressively over the years (P = .0487).
CONCLUSIONS. The survival of patients with NSCLC in Phase III trials improved slowly but steadily over time, although the main factors responsible for this improvement remain unknown. Nonetheless, the current results also suggested that novel targets and new agents will be required in the future fight against advanced NSCLC.

DOI： 10.1002/cncr.22478

Other Link： http://orcid.org/0000-0003-1761-6314

Gefitinib induces premature senescence in non-small cell lung cancer cells with or without EGFR gene mutation. International journal

Katsuyuki Hotta, Masahiro Tabata, Katsuyuki Kiura, Toshiyuki Kozuki, Akiko Hisamoto, Hideki Katayama, Nagio Takigawa, Nobukazu Fujimoto, Keiichi Fujiwara, Hiroshi Ueoka, Mitsune Tanimoto

Oncology reports 17 ( 2 ) 313 - 7 2007.2

Language：English Publishing type：Research paper (scientific journal)

Despite its tremendous antitumor effect in a subset of patients with non-small cell lung cancer (NSCLC), the exact mechanism of gefitinib-induced cell death has not been fully determined. In this study, forms of cell death in various NSCLC cell lines after gefitinib exposure was analyzed to elucidate the cell death mechanism of gefitinib. Though higher concentration of gefitinib (10 microM) induced extensive apoptosis in two cell lines (EGFR-mutated PC-9 cells and EGFR wild- type EBC-2/R cells), clinically relevant concentrations of gefitinib (1 microM) induced prominent premature senescence instead of apoptosis in these cells. This induction of senescence was preceded by immediate increase of p16INK4A, p21WAF1/Cip1 and p27Kip1 levels and subsequent G1 cell cycle arrest. These phenomena were not observed in gefitinib-resistant (RERF-LC-MS) cells. Additionally, ex vivo exposure to gefitinib induced senescence in short-term cultured tumor cells that were obtained from malignant pleural effusion of a patient with NSCLC, whose tumor was later revealed to be clinically sensitive to gefitinib. Our results indicate that senescence might be a major anti-tumor mechanism of gefitinib in these NSCLC cells regardless of the EGFR gene mutation status.

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非喫煙歴による術後再発非小細胞肺癌患者の長期生存予測(Never-smoking history predicts long-term survival in patients with non-small cell lung cancer with postoperative recurrence)

藤原義朗, 木浦勝行, 田端雅弘, 瀧川奈義夫, 谷本安, 堀田勝幸, 松尾恵太郎, 豊岡伸一, 佐野由文, 青江基, 伊達洋至, 谷本光音

日本癌治療学会誌 41 ( 2 ) 671 - 671 2006.9

A phase I and pharmacological study of amrubicin and topotecan in patients of small-cell lung cancer with relapsed or extensive-disease small-cell lung cancer. International journal

Takuo Shibayama, Katsuyuki Hotta, Nagio Takigawa, Atsuhiko Tada, Hiroshi Ueoka, Shingo Harita, Katsuyuki Kiura, Masahiro Tabata, Yoshihiko Segawa, Naoyuki Nogami, Shoichi Kuyama, Tetsu Shinkai, Mitsune Tanimoto

Lung cancer (Amsterdam, Netherlands) 53 ( 2 ) 189 - 95 2006.8

Language：English Publishing type：Research paper (scientific journal)

Cisplatin-based chemotherapy is considered to be a standard treatment in patients with relapsed or extensive-disease (ED) small-cell lung cancer (SCLC), the survival benefit remains modest. Relapsed or ED-SCLC patients were enrolled. Topotecan and amrubicin were administered on Days 1-5 and on Days 3-5, respectively. Nine patients received a total of 24 cycles. Since all three patients experienced dose-limiting toxicity (grade 4 neutropenia lasting for more than 4 days, grade 3 febrile neutropenia, and grade 4 thrombocytopenia) at the third dose level (topotecan: 0.75 mg/m2, amrubicin 40 mg/m2), the maximum tolerated dose was determined to be this dose level. Objective response was observed in six patients (67%). The maximum concentration (Cmax) and area under the plasma concentration-time curve (AUC) of amrubicin increased in a dose-dependent manner. Amrubicin did not influence the pharmacokinetics of topotecan. The Cmax and AUC of amrubicin were correlated with the duration of grade 4 neutropenia. The mean Cmax of topotecan on day 2 in responders (22.9+/-3.6) was significantly higher than that in non-responders (10.9+/-0.4). This phase I study showed the safety and activity of two-drug combination of amrubicin and topotecan in patients with relapsed or ED-SCLC.

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A phase I study of 3-day topotecan and cisplatin in elderly patients with small-cell lung cancer. International journal

Keiichi Fujiwara, Hiroshi Ueoka, Katsuyuki Kiura, Masahiro Tabata, Nagio Takigawa, Katsuyuki Hotta, Shigeki Umemura, Keisuke Sugimoto, Takuo Shibayama, Haruhito Kamei, Shingo Harita, Niro Okimoto, Mitsune Tanimoto

Cancer chemotherapy and pharmacology 57 ( 6 ) 755 - 60 2006.6

Language：English Publishing type：Research paper (scientific journal)

PURPOSE: The aim of this phase I study was to determine the maximum-tolerated dose (MTD) in elderly patients with small-cell lung cancer (SCLC). PATIENTS AND METHODS: Patients aged over 75 years with previously untreated SCLC were enrolled in this study. Both topotecan and cisplatin were administered on days 1-3 and repeated every 3 weeks. The starting dose of topotecan was 0.5 mg/m2/day, while cisplatin was fixed at the dose of 20 mg/m2/day. Patients with limited disease (LD) SCLC received thoracic irradiation after the completion of chemotherapy. RESULTS: Twenty-one elderly patients were enrolled in this study and received a total of 59 cycles. The major hematological toxicity was neutropenia and non-hematological toxicities including diarrhea were generally mild and reversible. The MTD of topotecan was determined as 1.2 mg/m2/day. The recommended phase II study dose of topotecan was determined as 1.0 mg/m2/day with cisplatin 20 mg/m2/day daily for 3 days. An objective response was observed in 6 of 10 patients (60%) with LD-SCLC and 6 of 11 (55%) with extensive disease (ED) SCLC. The median survival time in patients with LD-SCLC and those with ED-SCLC were 16.0 and 11.0 months, respectively. CONCLUSION: The combination chemotherapy of 3-day topotecan and cisplatin appears to be tolerable and effective in elderly patients with SCLC.

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定位脳照射後に長期不変である肺癌脳転移の検討

大橋圭明, 木浦勝行, 田端雅弘, 瀧川奈義夫, 堀田勝幸, 上月稔幸, 梅村茂樹, 内田亜希, 荻野敦子, 藤原義郎, 谷本光音

日本呼吸器学会雑誌 44 ( 増刊 ) 264 - 264 2006.6

Clustered incidence of acute promyelocytic leukemia during gefitinib treatment for non-small-cell lung cancer: experience at a single institution. International journal

Keitaro Matsuo, Katsuyuki Kiura, Masahiro Tabata, Akiko Uchida, Katsuyuki Hotta, Daigo Niiya, Shiro Kubonishi, Atsuko Ogino, Yoshiro Fujiwara, Hiromi Nakajima, Katsuji Shinagawa, Fumihiko Ishimaru, Hiroshi Ueoka, Mitsune Tanimoto

American journal of hematology 81 ( 5 ) 349 - 54 2006.5

Language：English Publishing type：Research paper (scientific journal)

Although gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, has been shown a significant activity for recurrent non-small-cell lung cancer (NSCLC), its long-term adverse effect with its continuous usage has hitherto not been clearly elucidated. Subjects were 108 consecutive NSCLC cases who were treated with gefitinib between November 2001 and December 2004 at our single institution. A crude incidence rate ratio was calculated by ratio of crude incidence rate in our subject to population-based incident rate of all leukemia (ICD: C91-95) in the same region. The 95% confidence intervals (CIs) were calculated based upon a Poisson distribution. Three cases of acute promyelocytic leukemia (APL) occurred during gefitinib treatment, and these patients' past treatment histories are presented herein. No other malignancy was identified. All of the cases were diagnosed at the stage of mild-to-moderate cytopenia, especially thrombocytopenia, without disseminated intravascular coagulation. All presented a normal karyotype with positive PML-RARalpha in RT-PCR, indicating submicroscopic translocation. They responded well to APL treatments, including all-trans-retinoic acid. The crude incident rate ratio was 639.9 (95% confidence interval: 131.6-1,878.9, P < 0.0001) when the APL incidence in this cohort was compared to all leukemia cases in the general population in the same district in Japan. Thus we had three cases of secondary APL patients within the gefitinib-treated NSCLC cohort. Although we cannot exclude an effect of past exposure of other cytotoxic agents and radiotherapy as a cause of APL, APL inducibility of gefitinib should be clarified in the further study.

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The combination effect of amrubicin with cisplatin or irinotecan for small-cell lung cancer cells. International journal

Nagio Takigawa, Masako Takeyama, Takuo Shibayama, Atsuhiko Tada, Noriko Kawata, Chiharu Okada, Keisuke Aoe, Toshiyuki Kozuki, Katsuyuki Hotta, Masahiro Tabata, Katsuyuki Kiura, Hiroshi Ueoka, Mitsune Tanimoto, Kiyoshi Takahashi

Oncology reports 15 ( 4 ) 837 - 42 2006.4

Language：English Publishing type：Research paper (scientific journal)

The single agent of amrubicin is active in untreated small-cell lung cancer (SCLC). Cytotoxicity of amrubicinol, the active form of amrubicin, was evaluated in a parent SCLC cell line (SBC-3); an active metabolite of irinotecan, 7-ethyl-10-hydroxy-camptothecin (SN-38)-resistant subline (SBC-3/SN-38); and cisplatin-resistant subline (SBC-3/CDDP) using AlamarBlue assay. Interaction of the combined drugs was evaluated by median-effect plot analysis, and the fraction of apoptotic cells was determined using flow cytometry. SBC-3/SN-38 was 34-fold more resistant to SN-38 and SBC-3/CDDP was 7.2-fold more resistant to cisplatin than parental SBC-3. However, these resistant sublines retained sensitivity to amrubicinol (1.8- and 1.7-fold, respectively). Simultaneous exposure of SBC-3/SN-38 cells to amrubicinol and cisplatin showed a synergistic effect. Simultaneous exposure of SBC-3/CDDP cells to amrubicinol and SN-38 displayed synergistic or additive effects. The two-drug combination produced an increase of apoptotic cells compared to each single agent alone in both resistant cells. These findings suggest that amrubicin alone and in combination with cisplatin or irinotecan is effective against SCLC refractory to irinotecan and/or cisplatin.

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Relationship between epidermal growth factor receptor gene mutations and the severity of adverse events by gefitinib in patients with advanced non-small cell lung cancer. International journal

Yoshiro Fujiwara, Katsuyuki Kiura, Shinichi Toyooka, Nagio Takigawa, Masaki Tokumo, Katsuyuki Hotta, Motoi Aoe, Masahiro Tabata, Keitaro Matsuo, Hiroshi Date, Mitsune Tanimoto

Lung cancer (Amsterdam, Netherlands) 52 ( 1 ) 99 - 103 2006.4

Language：English Publishing type：Research paper (scientific journal)

PURPOSE: Recent reports have demonstrated that mutation of epidermal growth factor receptor (EGFR) gene is predictive factor for tumor responsiveness to gefitinib suggesting the importance of EGFR status for the treatment of the patients with non-small cell lung cancer (NSCLC). However, the relationship between EGFR mutation and adverse events of gefitinib is still unknown. The aim of this study was to evaluate its correlation. PATIENTS AND METHODS: Twenty-six tumor samples from Japanese NSCLC patients who received gefitinib in Okayama University Hospital between November 2000 and October 2004 were examined exons 18-21 of EGFR using direct sequence method. We retrospectively reviewed the clinical records and compared EGFR mutation status with adverse events during gefitinib treatment. RESULTS: Of all 26 patients, EGFR mutation (exon 19 in-frame deletion, 6; exon 21 L858R, 5), were detected in 11 patients (42.3%). The principal adverse event was skin rash (89%), diarrhea (39%), and liver injury (39%). Grade 3 or more adverse events were not common. EGFR mutation status was correlated with neither its frequency nor severity of adverse events during gefitinib treatment including skin rash, diarrhea, liver injury, and interstitial lung disease. As expected, objective response rate of those with EGFR mutations was significantly higher than those without EGFR mutations (78% versus 21%, P<0.001). CONCLUSION: Our study did not demonstrate the presence of close relationships between EGFR mutation status and adverse events during gefitinib treatment.

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血清Arginine vasopressin(AVP)値と進展型小細胞肺癌の予後に関する検討

梅村茂樹, 上岡博, 堀田勝幸, 畝川芳彦, 瀧川奈義夫, 田端雅弘, 木浦勝行, 上月稔幸, 久本晃子, 徳田佳之, 大橋圭明, 別所昭宏, 新海哲, 谷本光音

肺癌 45 ( 5 ) 501 - 501 2005.11

Induction chemotherapy, surgical resection, and high-dose chemotherapy for mediastinal nonseminomatous germ-cell tumor Reviewed

Hiroshi Date, Katsuyuki Kiura, Hiroshi Ueoka, Masahiro Tabata, Katsuyuki Hotta, Hideki Katayama, Itaru Kataoka, Mitsune Tanimoto

Journal of Thoracic and Cardiovascular Surgery 130 ( 4 ) 1205 - 1206 2005.10

Systemic tumor embolism mimicking gefitinib ('IRESSA')-induced interstitial lung disease in a patient with lung cancer.

Shigeki Umemura, Daizo Kishino, Masahiro Tabata, Katsuyuki Kiura, Katsuyuki Hotta, Kenji Nishii, Yasushi Tanimoto, Arihiko Kanehiro, Kenji Notohara, Hiroshi Ueoka, Mitsune Tanimoto

Internal medicine (Tokyo, Japan) 44 ( 9 ) 979 - 82 2005.9

Language：English Publishing type：Research paper (scientific journal)

We describe a 55-year-old man with advanced adenocarcinoma of the lung who received gefitinib ('IRESSA'). After gefitinib administration for 7 months, computed tomography scan of the chest demonstrated diffuse ground glass opacity and he was suspected to have developed gefitinib-induced interstitial lung disease (ILD). However, transbronchial lung biopsy (TBLB) revealed tumor cells in the middle-size lung vessels. Afterwards, multiple infarctions of the brain, spleen and left kidney were detected. Then, he was considered to have developed systemic tumor emboli, a rare complication. The clinical presentation of this patient was difficult to discriminate from that of ILD, and TBLB was useful in the differential diagnosis.

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転移を有する,あるいは再発した小細胞肺癌患者に対するトポテカン(T)とアムルビシン(A)の併用療法の第I相試験

大橋圭明, 堀田勝幸, 瀧川奈義夫, 田端雅弘, 木浦勝行, 谷本光音, 柴山卓夫, 畝川芳彦, 張田信悟, 上岡博, 平木俊吉

肺癌 45 ( 4 ) 396 - 397 2005.8

進行非小細胞肺癌に対するイリノテカン(CPT-11)+アムルビシン(AMR)併用療法の臨床第I相試験

藤原義朗, 堀田勝幸, 木浦勝行, 田端雅弘, 梅村茂樹, 荻野敦子, 内田亜希子, 畝川芳彦, 新海哲, 張田信吾, 沖本二郎, 上岡博, 谷本光音

日本呼吸器学会雑誌 43 ( 増刊 ) 159 - 159 2005.4

Identification of epigenetic aberrant promoter methylation in serum DNA is useful for early detection of lung cancer. International journal

Keiichi Fujiwara, Nobukazu Fujimoto, Masahiro Tabata, Kenji Nishii, Keitaro Matsuo, Katsuyuki Hotta, Toshiyuki Kozuki, Motoi Aoe, Katsuyuki Kiura, Hiroshi Ueoka, Mitsune Tanimoto

Clinical cancer research : an official journal of the American Association for Cancer Research 11 ( 3 ) 1219 - 25 2005.2

Language：English Publishing type：Research paper (scientific journal)

PURPOSE: The purpose of this study is to evaluate the usefulness of serum DNA methylation of five tumor suppressor genes for early detection of lung cancer. EXPERIMENTAL DESIGN: Methylation status in serum DNA from 200 patients undergoing bronchofiberscopic examination for abnormal findings on chest radiograph detected by lung cancer screening or surveillance was examined using methylation-specific PCR. RESULTS: Ninety-one patients were given a pathologic diagnosis of lung cancer, 9 other malignant diseases, and 100 nonmalignant pulmonary diseases. In patients with lung cancer, methylation was detected in 18.7% for MGMT, 15.4% for p16(INK4a), 12.1% for RASSF1A, 11.0% for DAPK, and 6.6% for RAR-beta, which was higher compared with that in patients with nonmalignant diseases. Age and smoking status seemed to associate with methylation status. Sensitivity, specificity, and predictive value of methylation in at least one gene for diagnosis of lung cancer were 49.5%, 85.0%, and 75.0%, respectively. Adjusted odds ratio (95% confidence interval) for having lung cancer was 5.28 (2.39-11.7) for patients with methylation in one gene and 5.89 (1.53-22.7) for those with methylation in two or more genes. It is of note that methylation was identified in 50.9% of stage I lung cancer patients, whereas serum protein tumor markers were positive in 11.3% of them. CONCLUSIONS: These results suggest that identification of promoter methylation of tumor suppressor genes in serum DNA could be useful for early detection of lung cancer.

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Safety and efficacy of gefitinib treatment in elderly patients with non-small-cell lung cancer: Okayama Lung Cancer Study Group experience. International journal

Katsuyuki Hotta, Hiroshi Ueoka, Katsuyuki Kiura, Masahiro Tabata, Atsuko Ogino, Shigeki Umemura, Shingo Harita, Kenichi Gemba, Toshiro Yonei, Akihiro Bessho, Tadashi Maeda, Mitsune Tanimoto

Acta oncologica (Stockholm, Sweden) 44 ( 7 ) 717 - 22 2005

Language：English Publishing type：Research paper (scientific journal)

We evaluated the safety and efficacy of gefitinib treatment in elderly patients with non-small-cell lung cancer (NSCLC). We retrospectively compared toxicity, response and survival outcomes for gefitinib in patients aged 75 years or older (elderly group) with the same outcomes in patients aged younger than 75 years. In total, 350 patients were eligible for this analysis, of whom 92 were in the elderly group and 258 in the non-elderly group. In the elderly group, adverse events were generally mild to moderate and grade 3-4 adverse events were observed in 8 (9%) patients. The objective response rate (17 vs. 21% for elderly vs. non-elderly, respectively) and median survival time (7.6 vs. 9.3 months) were also similar in the two groups. Multivariate analysis revealed elderly patients with lower Brinkman index tended to be more sensitive to gefitinib (odds ratio: 4.57, 95% confidence interval: 0.91-22.72, p = 0.0642). In this study, treatment with gefitinib appeared to be as safe and effective in elderly patients (aged 75 or older) with NSCLC as in non-elderly patients.

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Gefitinib ('Iressa', ZD1839) may restore chemosensitivity in NSCLC patients? International journal

Keiichi Fujiwara, Katsuyuki Kiura, Kenichi Gemba, Yoshiko Ogata, Katsuyuki Hotta, Daizo Kishino, Masahiro Tabata, Hiroshi Ueoka, Mitsune Tanimoto

Anticancer research 25 ( 1B ) 547 - 9 2005

Language：English Publishing type：Research paper (scientific journal)

Gefitinib ('Iressa, ZD1839) has promising antitumor activity in non-small cell lung cancer (NSCLC). However, patients with advanced NSCLC have few treatment options available if they are refractory to gefitinib. We describe four cases of patients with advanced NSCLC who previously responded to gefitinib and obtained significant tumor regression through retreatment with other cytotoxic agents. Gefitinib might restore chemosensitivity to previously chemorefractory patients.

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Interstitial lung disease in Japanese patients with non-small cell lung cancer receiving gefitinib: an analysis of risk factors and treatment outcomes in Okayama Lung Cancer Study Group. International journal

Katsuyuki Hotta, Katsuyuki Kiura, Masahiro Tabata, Shingo Harita, Kenichi Gemba, Toshiro Yonei, Akihiro Bessho, Tadashi Maeda, Tomonori Moritaka, Takuo Shibayama, Keisuke Matsuo, Katsuya Kato, Arihiko Kanehiro, Yasushi Tanimoto, Keitaro Matsuo, Hiroshi Ueoka, Mitsune Tanimoto

Cancer journal (Sudbury, Mass.) 11 ( 5 ) 417 - 24 2005

Language：English Publishing type：Research paper (scientific journal)

UNLABELLED: Risk factors for the development of interstitial lung disease in patients with non-small cell lung cancer receiving gefitinib and the prognostic factors after interstitial lung disease development have not been established. The aim of this study was to retrospectively identify and evaluate these possible factors. PATIENTS AND METHODS: We reviewed the clinical records and radiographs of 365 consecutive patients with non-small cell lung cancer who received gefitinib in West Japan between 2000 and 2003. RESULTS: In total, 330 patients were eligible for interstitial lung disease evaluation, and 15 patients (4.5%) were finally confirmed to have developed interstitial lung disease by blinded expert review. Multivariate analysis revealed that preexisting pulmonary fibrosis, poor performance status, and prior thoracic irradiation were independent risk factors for interstitial lung disease, with odds ratios of 21.0 (95% confidence interval, 5.12-86.3, P < 0.0001), 9.70 (2.27-41.4, P = 0.001), and 4.33 (1.27-14.8, P = 0.019), respectively. Among the 15 patients who developed interstitial lung disease, eight have died of the condition. Short interval from the initiation of gefitinib treatment to the onset of interstitial lung disease, acute interstitial pneumonia pattern, and the presence of pre-existing pulmonary fibrosis were associated with poor prognosis. DISCUSSION: Our results suggest the importance of patient selection for gefitinib treatment based on interstitial lung disease risk factors in the Japanese population identified.

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非小細胞肺癌患者のgefitinib治療におけるInterstitial Lung Disease(ILD)発症の危険因子の解析

米井敏郎, 佐藤利雄, 堀田勝幸, 加藤勝也, 田端雅弘, 木浦勝行, 張田信吾, 上岡博, 平木俊吉, 谷本光音

肺癌 44 ( 5 ) 351 - 351 2004.10

Gefitinib有効症例の増悪(PD)時における抗癌剤再投与

藤原慶一, 木浦勝行, 玄馬顕一, 堀田勝幸, 細川忍, 見元淳子, 宮武和代, 田端雅弘, 上岡博, 谷本光音

肺癌 44 ( 5 ) 636 - 636 2004.10

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