Study of the QOL monitoring of the cancer patient

• Project/Area Number: 16K09562
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Respiratory organ internal medicine
• Research Institution: Nippon Medical School
• Principal Investigator: Kubota Kaoru 日本医科大学, 医学部, 教授 (70501857)
• Co-Investigator(Kenkyū-buntansha): 小林 国彦 埼玉医科大学, 医学部, 教授 (30205455) ; 松田 彩子 帝京大学, 医学部, 助教 (30618997) ; 井上 賢一 埼玉県立がんセンター(臨床腫瘍研究所), 臨床腫瘍研究所, 科長(兼)部長 (70443059)
• Project Period (FY): 2016-04-01 – 2019-03-31
• Project Status: Completed (Fiscal Year 2018)
• Budget Amount: ¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000); Fiscal Year 2018: ¥1,300,000 (Direct Cost: ¥1,000,000、Indirect Cost: ¥300,000); Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000); Fiscal Year 2016: ¥1,820,000 (Direct Cost: ¥1,400,000、Indirect Cost: ¥420,000)
• Keywords: QOL / 乳がん / 肺がん / 化学療法 / 生活の質（ＱＯＬ）

Outline of Final Research Achievements

Data collection of patients with breast cancer has been completed both in Japan and Holland. Furthermore, Japanese and Dutch data set was completed based on data cleaning. Data analyses are currently ongoing. First, we compared cultural differences between the two countries and published the results in foreign medical journal (Breat Cancer Res Treat. 166: 459-471, 2017). To demonstrate the evidence of self-monitored QOL and publish the results, the analyses are conducted both in Japan and Holland.

Academic Significance and Societal Importance of the Research Achievements

患者自身が報告するアウトカムの面からQOL自己モニタリングによる患者管理、健康状態、満足度についての有効性を検証することは、今後のがん診療の医療現場において大いに役立ち、医療者と患者間のコミュニケーション向上にも貢献し、患者のQOL向上に繋がると考える。さらに、QOL自己モニタリングの効果のエビデンスが示されることで、がん診療の医療現場でのQOL自己モニタリングの活用が推奨されることが期待できる。

Research Products

• [Journal Article] Eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: a phase II, multicenter, collaborative, open-label, single-arm clinical trial (2019)
  • Author(s): K Inoue
  • Journal Title: Investigational New Drugs Volume: 10 Issue: 3 Pages: 1-10
  • DOI: 10.1007/s10637-019-00755-x
  • Peer Reviewed / Open Access
• [Journal Article] Induction therapy with paclitaxel and bevacizumab followed by switch maintenance therapy with eribulin in Japanese patients with HER2-negative, metastatic breast cancer: a multicenter, collaborative, open-label, phase II clinical study for the SBCCSG 35 investigators (2018)
  • Author(s): K Inoue
  • Journal Title: BMC Cancer Volume: 18 Issue: 1 Pages: 1-11
  • DOI: 10.1186/s12885-018-4556-6
  • Peer Reviewed / Open Access
• [Journal Article] Pulmonary Tumor Embolism Due to Squamous Cell Carcinoma of the Uterine Cervix (2018)
  • Author(s): Okazaki S, Abe T, Takayanagi N, Yasuda M, Sakai F, Kobayashi K, Kato S.
  • Journal Title: A Case Report. In Vivo Volume: 32(2) Pages: 337-343
• [Journal Article] Updated survival outcomes of NEJ005/TCOG0902: a randomised phase II study of concurrent versus sequential alternating gefitinib and chemotherapy in previously untreated non-small cell lung cancer with sensitive EGFR mutations. (2018)
  • Author(s): Oizumi S, Sugawara S, Minato K, Harada T, Inoue A, Fujita Y, Maemondo M, Watanabe S, Ito K, Gemma A, Demura Y, Fukumoto S, Isobe H, Kinoshita I, Morita S, Kobayashi K, Hagiwara K, Aiba K, Nukiwa T.
  • Journal Title: ESMO Open Volume: 3(2) Issue: 2 Pages: e000313-e000313
  • DOI: 10.1136/esmoopen-2017-000313
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Prognostic Factors and Efficacy of First-Line Chemotherapy in Patients with Advanced Thymic Carcinoma (2018)
  • Author(s): Ko R, Shukuya T, Okuma Y, Tateishi K, Imai H, Iwasawa S, Miyauchi E, Fujiwara A, Sugiyama T, Azuma K, Muraki K, Yamasaki M, Tanaka H, Takashima Y, Soda S, Ishimoto O, Koyama N, Morita S, Kobayashi K, Nukiwa T, Takahashi K; North East Japan Study Group.
  • Journal Title: Oncologist Volume: unknown Issue: 10 Pages: 1210-1217
  • DOI: 10.1634/theoncologist.2017-0586
  • Peer Reviewed
• [Journal Article] Cross-cultural comparison of breast cancer patients’ Quality of Life in the Netherlands and Japan (2017)
  • Author(s): Fischer M. J.、Inoue K.、Matsuda A.、Kroep J. R.、Nagai S.、Tozuka K.、Momiyama M.、Weijl N. I.、Langemeijer-Bosman D.、Ramai S. R. S.、Nortier J. W. R.、Putter H.、Yamaoka K.、Kubota K.、Kobayashi K.、Kaptein A. A.
  • Journal Title: Breast Cancer Research and Treatment Volume: 166 Issue: 2 Pages: 459-471
  • DOI: 10.1007/s10549-017-4417-z
  • Int'l Joint Research
• [Journal Article] Neratinib Plus Paclitaxel vs Trastuzumab Plus Paclitaxel in Previously UntreatedMetastatic ERBB2-Positive Breast Cancer The NEfERT-T Randomized Clinical Trial (2017)
  • Author(s): Ahmad Awada, Ramon Colomer, Kenichi Inoue, Igor Bondarenko, Rajendra A. Badwe, Georgia Demetriou, Soo-Chin Lee, Ajay O. Mehta, Sung-Bae Kim, Thomas Bachelot, Chanchal Goswami, Suryanarayan Deo, Ron Bose, AlvinWong, Feng Xu, Bin Yao, Richard Bryce, Lisa A. Carey.
  • Journal Title: JAMA Oncol Volume: 2(12) Issue: 12 Pages: 1557-1564
  • DOI: 10.1001/jamaoncol.2016.0237
• [Journal Article] Comparison of an AC-Taxane Versus AC-Free Regimen and Paclitaxel Versus Docetaxel in Patients With Lymph Node-Positive Breast Cancer: Final Results of the National Surgical Adjuvant Study of Breast Cancer 02 Trial, a Randomized Comparative Phase 3 Study (2017)
  • Author(s): Toru Watanabe, Masaru Kuranami, Kenichi Inoue, Norikazu Masuda, Kenjiro Aogi, Shinji Ohno, Hiroji Iwata, Hirofumi Mukai, Yukari Uemura, Yasuo Ohashi.
  • Journal Title: Cancer Volume: 123 Issue: 5 Pages: 759-768
  • DOI: 10.1002/cncr.30421
• [Journal Article] The effects of illness beliefs and chemotherapy impact on quality of life in Japanese and Dutch patients with breast or lung cancer (2017)
  • Author(s): Willem A. van der Kloot, Yuka Uchida, Kenichi Inoue, Kunihiko Kobayashi, Kazue Yamaoka, Hans W. R. Nortier, Ad A. Kaptein
  • Journal Title: Chin Clin Oncol Volume: 5(1) Pages: 3-3
• [Journal Article] The international phase 4 validation study of the EORTC QLQ-SWB32: A stand-alone measure of spiritual well-being for people receiving palliative care for cancer (2017)
  • Author(s): Vivat B, Young TE, Winstanley J, Arraras JI, Black K, Boyle F, Bredart A, Costantini A, Guo J, Irarrazaval ME, Kobayashi K, Kruizinga R, Navarro M, Omidvari S, Rohde GE, Serpentini S, Spry N, Van Laarhoven HWM, Yang GM; EORTC Quality of Life Group.
  • Journal Title: Eur J Cancer Care (Engl) Volume: 26(6) Issue: 6 Pages: e12697-e12697
  • DOI: 10.1111/ecc.12697
• [Journal Article] A highly specific and sensitive massive parallel sequencer-based test for somatic mutations in non-small cell lung cancer. (2017)
  • Author(s): Inoue Y, Shiihara J, Miyazawa H, Ohta H, Higo M, Nagai Y, Kobayashi K, Saijo Y, Tsuchida M, Nakayama M, Hagiwara K.
  • Journal Title: PLoS One Volume: 12(4) Issue: 4 Pages: 1-14
  • DOI: 10.1371/journal.pone.0176525
  • Peer Reviewed / Open Access
• [Presentation] Eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: a multicenter, collaborative, open-label, phase II clinical trial for the SBCCSG-36 investigators (2018)
  • Author(s): K Inoue
  • Organizer: 2018 San Antonio Breast Cancer Symposium
  • Int'l Joint Research
• [Presentation] Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who had well-defined taxane resistance (2017)
  • Author(s): Kenichi Inoue, Tsuyoshi Saito, Katsuhiko Okubo, Kei Kimizuka, Hirofumi Yamada, Takashi Sakurai, Kazuo Ishizuna, Satoshi Hata, Toshihiro Kai, Masafumi Kurosumi
  • Organizer: ASCO2016
  • Int'l Joint Research
• [Presentation] 転移性乳癌患者を対象としたnab-paclitaxel 毎週投与法とドセタキセルとの比較第II 相試験 (2017)
  • Author(s): 井上賢一，増田慎三，高尾信太郎，柏葉匡寛，徳田裕，山本尚人，岩田広治，青儀健二郎，佐伯俊昭，田村研治
  • Organizer: 第24回日本乳癌学会学術総会
• [Presentation] 転移性乳癌患者を対象としたnab-paclitaxel 毎週投与法とドセタキセルとの比較第II 相試験 (2017)
  • Author(s): 井上賢一，二宮淳，齊藤毅，君塚圭，黒住昌史
  • Organizer: 第54回日本癌治療学会学術集会
• [Book] Health-Related Quality of Life in Molecular Targeted Therapy (2017)
  • Author(s): Kaoru Kubota
  • Publisher: Springer