Importance of Quality-of-Life evaluation in cancer chemotherapy for elderly

• Project/Area Number: 18K07443
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 52010:General internal medicine-related
• Research Institution: Nagoya University
• Principal Investigator: Masahiko Ando 名古屋大学, 医学部附属病院, 病院教授 (10322736)
• Project Period (FY): 2018-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000); Fiscal Year 2020: ¥390,000 (Direct Cost: ¥300,000、Indirect Cost: ¥90,000); Fiscal Year 2019: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000); Fiscal Year 2018: ¥1,690,000 (Direct Cost: ¥1,300,000、Indirect Cost: ¥390,000)
• Keywords: 高齢者 / がん / QOL / 高齢がん患者 / 化学療法 / QOL情報

Outline of Final Research Achievements

In the chemotherapy for elderly cancer patients, in which risk-benefit balance is generally small, quality of life (QOL) is an important outcome of treatment effectiveness. Based on the data from 3 large scale multi-institutional trials, we examined whether QOL was a predictor of important treatment outcomes after adjustment for performance status, age, gender, clinical stage, histology, and cognitive function, and clarified that preteratment QOL, measured using FACT-L scale, was an independent prognostic factor for overall survival. In addition, we investigated the “clinically meaningful” QOL change in the assessment of neurotoxicity, which is one of the important adverse events caused by cancer chemotherapy, and demonstrated that a 4-point deterioration in the FACT/GOG- Ntx score corresponded to the 1-grade worsening of physician-assessed CTCAE.

Academic Significance and Societal Importance of the Research Achievements

本研究で、生活の質（QOL）が年齢や高齢者機能評価とは独立した予後因子であることが明らかになったことから、高齢がん患者に対する化学療法実施の際に治療開始前のQOL評価を行い、治療アウトカム予測に役立てることが推奨される。また、がん化学療法における神経毒性の指標であるFACT/GOG-Ntxスコアにおいて、4点の変化が医療者評価によるCTCAEの1グレード変化に相当することが明らかとなったことで、抗がん剤による神経毒性の臨床的意義について評価・解釈することが容易となった。

Research Products

• [Journal Article] Carboplatin and irinotecan (CI) vs. carboplatin and etoposide (CE) for the treatment of extended-stage small-cell lung cancer in an elderly population: A phase II/III randomized control trial (2023)
  • Author(s): Shimokawa Tsuneo、Okamoto Hiroaki、Machida Ryunosuke、Misumi Yuki、Hosomi Yukio、Yoneshima Yasuto、Tanaka Hiroshi、Okishio Kyoichi、Simizu Junichi、Goto Koichi、Akamatsu Hiroaki、Kubota Kaoru、Nakagawa Kazuhiko、Horinouchi Hidehito、Ando Masahiko、Kataoka Tomoko、Ohe Yuichiro
  • Journal Title: Lung Cancer Volume: 181 Pages: 107195-107195
  • DOI: 10.1016/j.lungcan.2023.107195
  • Peer Reviewed / Open Access
• [Journal Article] A Multicenter, Randomized Phase III Study Comparing Platinum Combination Chemotherapy Plus Pembrolizumab With Platinum Combination Chemotherapy Plus Nivolumab and Ipilimumab for Treatment-Naive Advanced Non-Small Cell Lung Cancer Without Driver Gene Alterations: JCOG2007 (NIPPON Study) (2022)
  • Author(s): Shiraishi Yoshimasa、Hakozaki Taiki、Nomura Shogo、Kataoka Tomoko、Tanaka Kentaro、Miura Satoru、Sekino Yuta、Ando Masahiko、Horinouchi Hidehito、Ohe Yuichiro、Okamoto Isamu
  • Journal Title: Clinical Lung Cancer Volume: 23 Issue: 4 Pages: e285-e288
  • DOI: 10.1016/j.cllc.2021.10.012
  • Peer Reviewed
• [Journal Article] Nintedanib plus chemotherapy for nonsmall cell lung cancer with idiopathic pulmonary fibrosis: a randomised phase 3 trial (2022)
  • Author(s): Otsubo Kohei、Kishimoto Junji、Ando Masahiko、et al.
  • Journal Title: European Respiratory Journal Volume: 60 Issue: 6 Pages: 2200380-2200380
  • DOI: 10.1183/13993003.00380-2022
  • Peer Reviewed
• [Journal Article] Adjuvant S‐1 vs gemcitabine for node‐positive perihilar cholangiocarcinoma: A propensity score‐adjusted analysis (2021)
  • Author(s): Takahashi Daigoro、Mizuno Takashi、Yokoyama Yukihiro、Igami Tsuyoshi、Yamaguchi Junpei、Onoe Shunsuke、Watanabe Nobuyuki、Maeda Osamu、Ando Masahiko、Ebata Tomoki
  • Journal Title: Journal of Hepato-Biliary-Pancreatic Sciences Volume: 28 Issue: 9 Pages: 716-726
  • DOI: 10.1002/jhbp.1005
  • Peer Reviewed
• [Journal Article] Phase 3 Trial Comparing Nanoparticle Albumin-Bound Paclitaxel With Docetaxel for Previously Treated Advanced NSCLC (2021)
  • Author(s): Yoneshima Yasuto、Morita Satoshi、Ando Masahiko、et al.
  • Journal Title: Journal of Thoracic Oncology Volume: 16 Issue: 9 Pages: 1523-1532
  • DOI: 10.1016/j.jtho.2021.03.027
  • Peer Reviewed
• [Journal Article] Effects of Aerobic, Resistance, or Combined Exercise Training Among Older Adults with Subjective Memory Complaints: A Randomized Controlled Trial (2021)
  • Author(s): Makino T, Umegaki H, Ando M, Cheng XW, Ishida K, Akima H, Oshida Y, Yoshida Y, Uemura K, Shimada H, Kuzuya M
  • Journal Title: J Alzheimers Dis Volume: 82 Issue: 2 Pages: 701-717
  • DOI: 10.3233/jad-210047
  • NAID: 120007183212
  • Peer Reviewed / Open Access
• [Journal Article] QOL assessment after palliative surgery for malignant bowel obstruction caused by peritoneal dissemination of gastric cancer: a prospective multicenter observational study (2021)
  • Author(s): Ito Y, Fujitani K, Sakamaki K, Ando M, Kawabata R, Tanizawa Y, Yoshikawa T, Yamada T, Hirao M, Yamada M, Hihara J, Fukushima R, Choda Y, Kodera Y, Teshima S, Shinohara H, Kondo M
  • Journal Title: Gastric Cancer Volume: 24 Issue: 5 Pages: 1131-1139
  • DOI: 10.1007/s10120-021-01179-4
  • NAID: 40022652453
  • Peer Reviewed
• [Journal Article] Time-dependent discrepancies between physician-assessed and patient-reported oxaliplatin-induced peripheral neuropathy in patients with metastatic colorectal cancer who received mFOLFOX6 plus bevacizumab: a post hoc analysis (WJOG4407GSS2) (2020)
  • Author(s): Miura Yuji、Ando Masahiko、Yamazaki Kentaro、Hironaka Shuichi、Boku Narikazu、Muro Kei、Hyodo Ichinosuke
  • Journal Title: Supportive Care in Cancer Volume: - Issue: 7 Pages: 3715-3723
  • DOI: 10.1007/s00520-020-05891-2
  • Peer Reviewed
• [Journal Article] Weekly paclitaxel plus ramucirumab versus weekly nab-paclitaxel plus ramucirumab for unresectable advanced or recurrent gastric cancer with peritoneal dissemination refractory to first-line therapy?the P-SELECT trial (WJOG10617G)?a randomised phase II trial by the West Japan Oncology Group (2020)
  • Author(s): Hirata Kenro、Hamamoto Yasuo、Ando Masahiko、Imamura Chiyo K.、Yoshimura Kenichi、Yamazaki Kentaro、Hironaka Shuichi、Muro Kei
  • Journal Title: BMC Cancer Volume: 20 Issue: 1 Pages: 548-548
  • DOI: 10.1186/s12885-020-07047-1
  • Peer Reviewed
• [Journal Article] Prospective Observational Study of Treatment Resistance-related Gene Screening Using Plasma Circulating Tumor DNA in Third-generation EGFR-TKI Osimertinib Therapy (Elucidator) (2020)
  • Author(s): Tamiya Akihiro、Isa Shun-ichi、Taniguchi Yoshihiko、Nakagawa Hideyuki、Atagi Shinji、Ando Masahiko、Koh Yasuhiro
  • Journal Title: Clinical Lung Cancer Volume: 20 Issue: 3 Pages: 30163-30167
  • DOI: 10.1016/j.cllc.2020.05.023
  • Peer Reviewed
• [Journal Article] A randomized phase 3 study of maintenance therapy with S‐1 plus best supportive care versus best supportive care after induction therapy with carboplatin plus S‐1 for advanced or relapsed squamous cell carcinoma of the lung (WJOG7512L) (2020)
  • Author(s): Tanaka Kaoru、Morita Satoshi、Ando Masahiko、Yokoyama Takuma、Nakamura Atsushi、Yoshioka Hiroshige、Ishiguro Takashi、Miura Satoru、Toyozawa Ryo、Oguri Tetsuya、Daga Haruko、Ko Ryo、Bessho Akihiro、Tachihara Motoko、Iwamoto Yasuo、Hirano Katsuya、Nakanishi Yoichi、Nakagawa Kazuhiko、Yamamoto Nobuyuki、Okamoto Isamu
  • Journal Title: Cancer Volume: 126 Issue: 16 Pages: 3648-3656
  • DOI: 10.1002/cncr.32987
  • Peer Reviewed
• [Journal Article] A phase III randomized controlled trial comparing surgery plus adjuvant chemotherapy with preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy for locally recurrent rectal cancer: Japan Clinical Oncology Group study JCOG1801 (RC-SURVIVE study) (2020)
  • Author(s): Kadota Tomohiro、Tsukada Yuichiro、Ito Masaaki、Katayama Hiroshi、Mizusawa Junki、Nakamura Naoki、Ito Yoshinori、Bando Hideaki、Ando Masahiko、Onaya Hiroaki、Fukuda Haruhiko、Kanemitsu Yukihide
  • Journal Title: Japanese Journal of Clinical Oncology Volume: 50 Issue: 8 Pages: 953-957
  • DOI: 10.1093/jjco/hyaa058
  • Peer Reviewed
• [Journal Article] Comparison of Carboplatin Plus Pemetrexed Followed by Maintenance Pemetrexed With Docetaxel Monotherapy in Elderly Patients With Advanced Nonsquamous Non?Small Cell Lung Cancer (2020)
  • Author(s): Okamoto Isamu、Nokihara Hiroshi、Nomura Shogo、Niho Seiji、Sugawara Shunichi、Horinouchi Hidehito、Azuma Koichi、Yoneshima Yasuto、Murakami Haruyasu、Hosomi Yukio、Atagi Shinji、Ozaki Tomohiro、Horiike Atsushi、Fujita Yuka、Okamoto Hiroaki、Ando Masahiko、Yamamoto Nobuyuki、Ohe Yuichiro、Nakagawa Kazuhiko
  • Journal Title: JAMA Oncology Volume: 6 Issue: 5 Pages: e196828-e196828
  • DOI: 10.1001/jamaoncol.2019.6828
  • Peer Reviewed
• [Journal Article] Impact of somatic mutations on prognosis in resected non‐small‐cell lung cancer: The Japan Molecular Epidemiology for lung cancer study (2020)
  • Author(s): Tamiya Akihiro、Koh Yasuhiro、Isa Shun‐ichi、Kubo Akihito、Ando Masahiko、Saka Hideo、Yoshimoto Naoki、Takeo Sadanori、Adachi Hirofumi、Tagawa Tsutomu、Kawashima Osamu、Yamashita Motohiro、Kataoka Kazuhiko、Takenoyama Mitsuhiro、Takeuchi Yukiyasu、Watanabe Katsuya、Matsumura Akihide、Kawaguchi Tomoya
  • Journal Title: Cancer Medicine Volume: 9 Issue: 7 Pages: 2343-2351
  • DOI: 10.1002/cam4.2897
  • Peer Reviewed / Open Access
• [Journal Article] Phase I study of vorinostat with gefitinib in BIM deletion polymorphism/epidermal growth factor receptor mutation double-positive lung cancer. (2020)
  • Author(s): Shinji Takeuchi, Tetsunari Hase, et al.
  • Journal Title: Cancer science Volume: 111 Issue: 2 Pages: 561-570
  • DOI: 10.1111/cas.14260
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Major hepatectomy with or without pancreatoduodenectomy for advanced gallbladder cancer (2019)
  • Author(s): Mizuno T.、Ebata T.、Yokoyama Y.、Igami T.、Yamaguchi J.、Onoe S.、Watanabe N.、Ando M.、Nagino M.
  • Journal Title: BJS Volume: 106 Issue: 5 Pages: 626-635
  • DOI: 10.1002/bjs.11088
  • Peer Reviewed
• [Journal Article] Discrepancy between volume and functional recovery in early phase liver regeneration following extended hepatectomy with extrahepatic bile duct resection (2019)
  • Author(s): Maeda Takashi、Yokoyama Yukihiro、Ebata Tomoki、Igami Tsuyoshi、Mizuno Takashi、Yamaguchi Junpei、Onoe Shunsuke、Ando Masahiko、Nagino Masato
  • Journal Title: Hepatology Research Volume: 49 Issue: 10 Pages: 1227-1235
  • DOI: 10.1111/hepr.13378
  • Peer Reviewed
• [Journal Article] Use of an Ultrathin vs?Thin Bronchoscope for Peripheral Pulmonary Lesions (2019)
  • Author(s): Oki Masahide、Saka Hideo、Asano Fumihiro、Kitagawa Chiyoe、Kogure Yoshihito、Tsuzuku Akifumi、Ando Masahiko
  • Journal Title: Chest Volume: 156 Issue: 5 Pages: 954-964
  • DOI: 10.1016/j.chest.2019.06.038
  • Peer Reviewed
• [Journal Article] Effects of Oral Morphine on Dyspnea in Patients with Cancer: Response Rate, Predictive Factors, and Clinically Meaningful Change (CJLSG1101) (2019)
  • Author(s): Takahashi Kosuke、Kondo Masashi、Ando Masahiko、Shiraki Akira、Nakashima Harunori、Wakayama Hisashi、Kataoka Kensuke、Yamamoto Masashi、Sugino Yasuteru、Nishikawa Mitsunori、Imaizumi Kazuyoshi、Kojima Eiji、Sumida Atsushi、Takeyama Yoshihiro、Saito Hiroshi、Hasegawa Yoshinori
  • Journal Title: The Oncologist Volume: 24 Issue: 7 Pages: 721-727
  • DOI: 10.1634/theoncologist.2018-0468
  • Peer Reviewed
• [Journal Article] Clinical value of additional resection of a margin‐positive distal bile duct in perihilar cholangiocarcinoma (2019)
  • Author(s): Otsuka S.、Ebata T.、Yokoyama Y.、Mizuno T.、Tsukahara T.、Shimoyama Y.、Ando M.、Nagino M.
  • Journal Title: BJS Volume: 106 Issue: 6 Pages: 774-782
  • DOI: 10.1002/bjs.11125
  • Peer Reviewed
• [Journal Article] Pleural dissemination of cholangiocarcinoma caused by percutaneous transhepatic biliary drainage during the management of resectable cholangiocarcinoma (2019)
  • Author(s): Yamashita Hiromasa、Ebata Tomoki、Yokoyama Yukihiro、Igami Tsuyoshi、Mizuno Takashi、Yamaguchi Junpei、Onoe Shunsuke、Watanabe Nobuyuki、Ando Masahiko、Nagino Masato
  • Journal Title: Surgery Volume: 165 Issue: 5 Pages: 912-917
  • DOI: 10.1016/j.surg.2018.10.015
  • Peer Reviewed
• [Journal Article] Multicentre observational study of quality of life after surgical palliation of malignant gastric outlet obstruction for gastric cancer (2018)
  • Author(s): Kazumasa Fujitani, Masahiko Ando, Kentaro Sakamaki, Masanori Terashima, Ryohei Kawabata, Yuichi Ito, Takaki Yoshikawa, Masato Kondo, Yasuhiro Kodera, and Kazuhiro Yoshida
  • Journal Title: BJS Open Volume: 1 Pages: 165-174
  • Peer Reviewed / Open Access
• [Journal Article] A Randomized Phase III Study Comparing Carboplatin With Nab-Paclitaxel Versus Docetaxel for Elderly Patients With Squamous-Cell Lung Cancer: Study Protocol (2018)
  • Author(s): Kogure Yoshihito、Saka Hideo、Takiguchi Yuichi、Atagi Shinji、Kurata Takayasu、Ebi Noriyuki、Inoue Akira、Kubota Kaoru、Takenoyama Mitsuhiro、Seto Takashi、Kada Akiko、Yamanaka Takeharu、Ando Masahiko、Yamamoto Nobuyuki、Gemma Akihiko、Ichinose Yukito
  • Journal Title: Clinical Lung Cancer Volume: 19 Issue: 5 Pages: e711-e715
  • DOI: 10.1016/j.cllc.2018.05.005
  • Peer Reviewed
• [Journal Article] Placebo-Controlled, Double-Blinded Phase III Study Comparing Dexamethasone on Day 1 With Dexamethasone on Days 1 to 3 With Combined Neurokinin-1 Receptor Antagonist and Palonosetron in High-Emetogenic Chemotherapy (2018)
  • Author(s): Yuka Ito, Takashi Tsuda, Hiroko Minatogawa, Sayaka Kano, Kentaro Sakamaki, Masahiko Ando, Koichiro Tsugawa, Yasuyuki Kojima, Naoki Furuya, Kunihiro Matsuzaki, Mamoru Fukuda, Sadatoshi Sugae, Ichiro Ohta, Hitoshi Arioka, Yutaka Tokuda, Kazutaka Narui, Ayako Tsuboya, Takashi Suda, Satoshi Morita, et al.
  • Journal Title: J Clin Oncol Volume: 36 Issue: 10 Pages: 1000-1006
  • DOI: 10.1200/jco.2017.74.4375
  • Peer Reviewed
• [Journal Article] Randomized clinical trial of adjuvant gemcitabine chemotherapy versus observation in resected bile duct cancer (2018)
  • Author(s): Tomoki Ebata, Satoshi Hirano, Masaru Konishi, Katsuhiko Uesaka, Yoshiaki Tsuchiya, Masayuki Ohtsuka, Yuji Kaneoka, Masakazu Yamamoto, Yoshiyasu Ambo, Yasuhiro Shimizu, Fumiaki Ozawa, Akira Fukutomi, Masahiko Ando, Yuji Nimura, and Masato Nagino
  • Journal Title: Br J Surg Volume: 105 Issue: 3 Pages: 192-202
  • DOI: 10.1002/bjs.10776
  • Peer Reviewed
• [Journal Article] Efficacy of prophylactic treatment for oxycodone-induced nausea and vomiting among patients with cancer pain (POINT): A randomized, placebo-controlled, double-blind trial (2018)
  • Author(s): Hiroaki Tsukuura, Masayuki Miyazaki, Tatsuya Morita, Mihoko Sugishita, Hiroshi Kato, Yuka Murasaki,Bishal Gyawali, Yoko Kubo, Masahiko Ando, Masashi Kondo, Kiyofumi Yamada, Yoshinori Hasegawa, and Yuichi Ando
  • Journal Title: Oncologst Volume: 23 Issue: 3 Pages: 367-374
  • DOI: 10.1634/theoncologist.2017-0225
  • Peer Reviewed
• [Journal Article] Treatment Rationale and Design for J-SONIC: A Randomized Study of Carboplatin Plus Nab-paclitaxel With or Without Nintedanib for Advanced Non-Small-cell Lung Cancer With Idiopathic Pulmonary Fibrosis (2018)
  • Author(s): Kohei Otsubo, Junji Kishimoto, Hirotsugu Kenmotsu, Yuji Minegishi, Eiki Ichihara, Akira Shiraki, Terufumi Kato, Shinji Atagi, Hidehito Horinouchi, Masahiko Ando, Yasuhiro Kondo, Masahiko Kusumoto, Kazuya Ichikado, Nobuyuki Yamamoto, Yoichi Nakanishi, and Isamu Okamoto
  • Journal Title: Clin Lung Cancer Volume: 72 Issue: 1 Pages: 399-408
  • DOI: 10.1016/j.cllc.2017.06.003
  • Peer Reviewed