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Department of Gastrointestinal Medical Oncology
Narikazu Boku, Tetsuya Hamaguchi, Ken Kato, Satoru Iwasa, Yoshitaka Honma, Atsuo Takashima, Hirokazu Shoji, Shoko Nakamura, Takahiro Miyamoto
Introduction
The Department of Gastrointestinal Medical Oncology focuses on the development of new drugs and the establishment of standard therapy including multi-modality treatment with surgery and/or radiotherapy for advanced Esophageal/Gastric/Colorectal/Head&Neck cancers, gastrointestinal stromal tumor, and other gastrointestinal (GI) malignancies.
Over recent years, molecular-target agents have been developed for GI cancer. Anti- angiogenetic agents such as bevacizumab which directs against vascular endothelial growth factor (VEGF) have been used for colorectal cancer, and anti-VEGF receptor-2 antibody, ramcirumab (RAM), was approved for gastric cancer in 2015, and for colorectal cancer in 2016. Anti-epidermal growth factor receptor (EGFR) antibodies, such as cetuximab or panitumumab, have been used for colorectal cancer. Moreover, trastuzumab has been used for HER2-positive gastric cancer, and the multi-kinase inhibitor, regorafenib, and a new cytotoxic agent TPI/FTD were also approved for colorectal cancer. In addition, the efficacy of the immune-checkpoint inhibitor has also been evaluated for GI malignancies.
We have been devoted to develop other novel agents for the treatment of metastatic GI cancers including molecular target agents and immune checkpoint inhibitors. However, many unusual adverse effects and high medical cost have led to extensive discussion on more accurate target population using biomarkers. Although the response rate of monotherapy has not been high (about 5% to 20%) when used broadly in non-selected patients, there are a few new candidate biomarkers that may be useful for identifying patients for whom these drugs will be beneficial. For example, RAS mutation in tumor tissue is one of the negative predictive markers for the response to anti-EGFR antibody. Accordingly, the identification of molecular markers that can be used to predict tumor shrinkage and/or prolong prognosis will be critical for further progress in treatment of GI malignancies.
Routine activities
The staff of the Department of GI Medical Oncology consists of seven medical oncologists, two chief residents, and three or four residents. We have a daily case conference together at 5 pm after finishing routine clinical work, and also hold a weekly research conference for sharing and discussing the progress of clinical trials and in-house researches. Multidisciplinary meetings with each surgical department (Colorectal, Gastric, and Esophageal), and the Departments of Head and Neck Oncology, and Radiation Oncology are held weekly to decide optimal treatment strategies for each individual case and to discuss treatment consensus for the specific disease. Palliative care considering the physical and psychological aspects of each case is another important issue discussed in these meetings. The palliative care team and psycho-oncologists advise us on how to minimize patients'discomfort and anxiety throughout end-of-life care. In 2016, we treated 1,944 hospitalized patients (704 of whom were newly diagnosed). Of these patients, 178 were enrolled into protocol studies.
Research activities
An endoscopic biopsy and blood sample before and after chemotherapy provide an excellent opportunity to explore biomarkers predicting tumor response, overall survival, and time to progression or recurrence. We measured the gene expressions of possible predictive biomarkers by using paraffin-embedded GI cancer specimens obtained from surgical resection or endoscopic biopsy using several kinds of techniques such as genome sequencing, microarray, and real time PCR. We are also conducting translational researches using fresh samples, circulating DNA, and microRNA obtained from patients. These studies are being performed in collaboration not only with the National Cancer Center Research Institute but also with other institutions.
Clinical trials
We conducted several clinical trials in collaboration with the surgical departments and the Department of Radiation Oncology in our hospital (the National Cancer Center Hospital : NCCH) and other institutes, including the Japan Clinical Oncology Group (JCOG) trials, the West Japan Oncology Group (WJOG) trials, company initiated trials, and other collaborative investigator initiated trials. The details of clinical trials are summarized in the Table 1.
1.Esophageal Cancer
In neoadjuvant/adjuvant settings, a phase III trial, JCOG1109, comparing among preoperative 5-FU plus CDDP (CF), DCF (Docetaxel plus CF), and CF plus radiotherapy (CF-RT, 41.4Gy) regimen for stage IB/II/III esophageal cancer is ongoing. A placebo controlled phase III trial to evaluate the additive effect of nivolumab as adjuvant treatment after curative surgery following neoadjuvant chemoradiotherapy started in early 2017.
For a non-surgical treatment, definitive CRT, a result of phase II study, JCOG0909 on the efficacy of CF-RT (50.4 Gy) regimen followed by salvage surgery or endoscopic resection in stage IB/II/III esophageal cancer will be reported soon.
In first-line treatment, a phase III trial, JCOG1314, comparing biweekly DCF with standard CF regimen is underway.
In second-line treatment, two randomized controlled trials to investigate the efficacy of immune-checkpoint inhibitor are ongoing; (i) Taxan versus nivolumab (OPERA), and (ii) paclitaxel versus pembrolizumab (KEYNOTE-181).
In salvage-line treatment, a feasibility study to investigate the efficacy of pembrolizumab is ongoing.
2.Gastric cancer
For the peri-operative setting, investigator initiated phase II trial of TAS-118 (S-1 plus LV) + oxaliplatin before surgery followed by TAS-118 + oxaliplatin (APOLLO-11) is underway. For the adjuvant setting, a placebo controlled phase III trial to evaluate the additive effect of nivolumab, anti-PD-1 antibody, combined with S-1 or XELOX, started in cooperation with the Department of Gastric Surgery.
In first-line treatment, JCOG1013 comparing S-1/CDDP (CS) to S-1/CDDP/Docetaxel (DCS), and SOLAR trial comparing TAS-118 plus oxaliplatin with CS had finished the planned patient accrual. A phase II/III study, comparing FLTAX with 5FU/l-LV for patients with severe peritoneal dissemination is ongoing. A feasibility study of nivolumab with S-1 plus oxaliplatin (SOX) or XELOX had finished patient accrual. A phase III trial comparing nivolumab plus ipilimumab (anti-CTLA4 antibody) with fluoropyrimidine plus oxaliplatin started in early 2017. For elderly population, a randomized phase II trial, WJOG1315G, comparing S-1 monotherapy with SOX is ongoing.
In second-line treatment, molecular-targeted drugs for advanced gastric cancer have been investigated. ENRICH trial which evaluate the additive effect of nimotuzumab, anti-EGFR antibodies, combined with irinotecan for patients with high EGFR expression is ongoing. The result of GOLD trial to evaluate the additive effect of olaparib (PARP inhibitor) combined with paclitaxel, was reported as negative in the ESMO 2016 annual meeting. A phase III trial which evaluates the additive effect of BBI608 combined with paclitaxel, had finished the planned patient accrual. A new investigator initiated phase II trial to evaluate the efficacy and feasibility of nivolumab plus RAM started in early 2017.
For HER2 positive gastric cancer, a phase III trial which evaluates the additive effect of pertuzumab combined with capecitabine and cisplatin plus trastuzumab in first-line treatment (JACOB) finished patient accrual. A multi-center feasibility study of S-1/oxaliplatin plus trastuzumab in first-line treatment is ongoing. In second-line treatment, a phase II/III trial comparing TDM-1, ado-trastuzumab emtansine, with paclitaxel (GATSBY) was reported to be negative in the ASCO-GI 2016 meeting. A randomized phase II trial, WJOG 8315G, to evaluate the additive effect of trastuzumab with paclitaxel beyond progression in second-line setting had finished the planned patient accrual.
In salvage-line treatment, a randomized trial showed a survival benefit of nivolumab compared with best supportive care (BSC), reported in the ASCO-GI 2017 meeting. A phase III trial comparing avelumab, anti-PD-ligand 1 (PD-L1) antibody with physician's choice treatment including BSC had finished patient accrual.
3.Colorectal and Anal Canal Cancer
In first-line treatment, phase III PARADIGM trial, comparing FOLFOX/panitumumab with FOLFOX/BV in RAS-wild type population, is ongoing. We are also investigating whether SIRB (S-1/irinotecan plus BV) is non-inferior to XELOX (capecitabine/oxaliplatin) plus BV in a multicenter phase III trial (TRICOLORE), and finished patient accrual on schedule. A randomized trial to investigate the superiority of fluoropyrimidine/oxaliplatin/BV to fluoropyrimidine/BV targeted at frail or elderly patient is also ongoing (JCOG1018). A new phase III trial comparing pembrolizumab, anti-programed cell death 1 (PD-1) antibody, with standard chemotherapy for untreated MSI-high colorectal cancer started in 2016.
In second-line treatment, AXEPT trial investigating the non-inferiority of XELIRI (capecitabine/irinotecan) to FOLFIRI (5-FU/l-LV/irinotecan) for patients after first-line treatment with FOLFOX or XELOX plus BV failure had finished patient accrual. A new phase III trial to evaluate the additive effect BBI608 (an inhibitor targeted at cancer stem cell) combined with FOLFIRI started in early 2017.
In salvage-line treatment, investigator initiated phase II trial to evaluate the efficacy and feasibility of lenvatinib for patients who failed standard chemotherapy except regorafenib is ongoing.
As an adjuvant treatment, JCOG0603 comparing adjuvant mFOLFOX6 with observation after complete resection of liver metastasis from colorectal cancer is ongoing. A randomized controlled trial, JCOG1310, comparing postoperative with perioperative mFOLFOX6 chemotherapy for lateral lymph node positive lower rectal cancer is also under registration.
The phase II part of JCOG0903, a phase I/II trial of definitive chemoradiotherapy with S-1/MMC for locally advanced anal canal squamous cell carcinoma finished patient accrual on schedule.
4.Others
For metastatic neuroendocrine carcinoma (NEC) in GI-tract or hepato-billiary-Pancreatic field, a phase III trial comparing irinotecan plus CDDP with etoposide plus CDDP at first-line treatment (JCOG1213) is progressing faster than expected.
A new phase III trial (JCOG1502C) for curatively resected small bowel adenocarcinoma, comparing adjuvant XELOX with surgery alone is getting ready to start under Advanced Medical Care B program in global cooperation with International Rare Cancer Initiatives (IRCI) .
Table 1. Clinical trials conducted in 2016
For metastatic head and neck squamous cell carcinoma, a phase III trial comparing standard chemotherapy (CF plus cetuximab) with nivolumab plus ipilimumab in first-line setting, and a phase III trial comparing MEDI-4736 (anti-PD-L1 antibody) plus Tremelimumab (anti-CTLA-4 antibody), MEDI-4736, and standard chemotherapy (Docetaxel or Cetuximab or S-1) in second-line setting are ongoing, collaborating with doctors in the Department of Head and Neck Oncology.
Several other clinical trials have also been conducted and eligible patients have been enrolled as in Table 1.
List of papers published in 2016
Journal
1.Nishina T, Boku N, Gotoh M, Shimada Y, Hamamoto Y, Yasui H, Yamaguchi K, Kawai H, Nakayama N, Amagai K, Mizusawa J, Nakamura K, Shirao K, Ohtsu A. Randomized phase II study of second-line chemotherapy with the best available 5-fluorouracil regimen versus weekly administration of paclitaxel in far advanced gastric cancer with severe peritoneal metastases refractory to 5-fluorouracil-containing regimens (JCOG0407). Gastric Cancer, 19:902-910, 2016
2.Shimomura A, Fujiwara Y, Kondo S, Kodaira M, Iwasa S, Kitano S, Tanabe Y, Tamura K, Yamamoto N. Tremelimumab-associated tumor regression following after initial progression: two case reports. Immunotherapy, 8:9-15, 2016
3.Shoji H, Morizane C, Sakamoto Y, Kondo S, Ueno H, Takahashi H, Ohno I, Shimizu S, Mitsunaga S, Ikeda M, Okusaka T. Phase I clinical trial of oral administration of S-1 in combination with intravenous gemcitabine and cisplatin in patients with advanced biliary tract cancer. Jpn J Clin Oncol, 46:132-137, 2016
4.Takahashi N, Furuta K, Taniguchi H, Sasaki Y, Shoji H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Hamaguchi T, Shimada Y, Yamada Y. Serum level of hepatocyte growth factor is a novel marker of predicting the outcome and resistance to the treatment with trastuzumab in HER2-positive patients with metastatic gastric cancer. Oncotarget, 7:4925-4938, 2016
5.Hamamoto Y, Akutsu Y, Nagashima F, Hironaka S, Ito Y, Kato K, Hara H, Tsubosa Y, Nakagawa S, Daiko H, Ozawa S, Kitagawa Y. Multicenter questionnaire survey on patterns of care for elderly patients with esophageal squamous cell carcinoma by the Japan Esophageal Oncology Group. Jpn J Clin Oncol, 46:111-115, 2016
6.Kubo A, Hashimoto H, Takahashi N, Yamada Y. Biomarkers of skin toxicity induced by anti-epidermal growth factor receptor antibody treatment in colorectal cancer. World J Gastroenterol, 22:887-894, 2016
7.Hironaka S, Sugimoto N, Yamaguchi K, Moriwaki T, Komatsu Y, Nishina T, Tsuji A, Nakajima TE, Gotoh M, Machida N, Bando H, Esaki T, Emi Y, Sekikawa T, Matsumoto S, Takeuchi M, Boku N, Baba H, Hyodo I. S-1 plus leucovorin versus S-1 plus leucovorin and oxaliplatin versus S-1 plus cisplatin in patients with advanced gastric cancer: a randomised, multicentre, open-label, phase 2 trial. Lancet Oncol, 17:99-108, 2016
8.Takeuchi H, Saeki T, Aiba K, Tamura K, Aogi K, Eguchi K, Okita K, Kagami Y, Tanaka R, Nakagawa K, Fujii H, Boku N, Wada M, Akechi T, Udagawa Y, Okawa Y, Onozawa Y, Sasaki H, Shima Y, Shimoyama N, Takeda M, Nishidate T, Yamamoto A, Ikeda T, Hirata K. Japanese Society of Clinical Oncology clinical practice guidelines 2010 for antiemesis in oncology: executive summary. Int J Clin Oncol, 21:1-12, 2016
9.Kataoka K, Takeuchi H, Mizusawa J, Ando M, Tsubosa Y, Koyanagi K, Daiko H, Matsuda S, Nakamura K, Kato K, Kitagawa Y. A randomized Phase III trial of thoracoscopic versus open esophagectomy for thoracic esophageal cancer: Japan Clinical Oncology Group Study JCOG1409. Jpn J Clin Oncol, 46:174-177, 2016
10.Sudo K, Wang X, Xiao L, Wadhwa R, Shiozaki H, Elimova E, Rice DC, Lee JH, Weston B, Bhutani MS, Hiremath A, Charalampakis N, Komaki R, Blum MA, Swisher SG, Maru DM, Skinner HD, Garris JL, Rogers JE, Hofstetter WL, Ajani JA. A Nomogram to Predict Distant Metastases After Multimodality Therapy for Patients With Localized Esophageal Cancer. J Natl Compr Canc Netw, 14:173-179, 2016
11.Akutsu Y, Kato K, Igaki H, Ito Y, Nozaki I, Daiko H, Yano M, Udagawa H, Nakagawa S, Takagi M, Mizusawa J, Kitagawa Y. The Prevalence of Overall and Initial Lymph Node Metastases in Clinical T1N0 Thoracic Esophageal Cancer: From the Results of JCOG0502, a Prospective Multicenter Study. Ann Surg, 264:1009-1015, 2016
12.Hamamoto Y, Mizusawa J, Katayama H, Nakamura K, Kato K, Tsubosa Y, Ishikura S, Igaki H, Shinoda M, Fukuda H, Kitagawa Y, Ando N. Inter-institutional survival heterogeneity in chemoradiation therapy for esophageal cancer: exploratory analysis of the JCOG0303 study. Jpn J Clin Oncol, 46:389-392, 2016
13.Ueno M, Okusaka T, Omuro Y, Isayama H, Fukutomi A, Ikeda M, Mizuno N, Fukuzawa K, Furukawa M, Iguchi H, Sugimori K, Furuse J, Shimada K, Ioka T, Nakamori S, Baba H, Komatsu Y, Takeuchi M, Hyodo I, Boku N. A randomized phase II study of S-1 plus oral leucovorin versus S-1 monotherapy in patients with gemcitabine-refractory advanced pancreatic cancer. Ann Oncol, 27:502-508, 2016
14.Tsushima T, Mizusawa J, Sudo K, Honma Y, Kato K, Igaki H, Tsubosa Y, Shinoda M, Nakamura K, Fukuda H, Kitagawa Y. Risk Factors for Esophageal Fistula Associated With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Cancer: A Supplementary Analysis of JCOG0303. Medicine (Baltimore), 95:e3699, 2016
15.Yamazaki K, Nagase M, Tamagawa H, Ueda S, Tamura T, Murata K, Eguchi Nakajima T, Baba E, Tsuda M, Moriwaki T, Esaki T, Tsuji Y, Muro K, Taira K, Denda T, Funai S, Shinozaki K, Yamashita H, Sugimoto N, Okuno T, Nishina T, Umeki M, Kurimoto T, Takayama T, Tsuji A, Yoshida M, Hosokawa A, Shibata Y, Suyama K, Okabe M, Suzuki K, Seki N, Kawakami K, Sato M, Fujikawa K, Hirashima T, Shimura T, Taku K, Otsuji T, Tamura F, Shinozaki E, Nakashima K, Hara H, Tsushima T, Ando M, Morita S, Boku N, Hyodo I. Randomized phase III study of bevacizumab plus FOLFIRI and bevacizumab plus mFOLFOX6 as first-line treatment for patients with metastatic colorectal cancer (WJOG4407G). Ann Oncol, 27:1539-1546, 2016
16.Uesaka K, Boku N, Fukutomi A, Okamura Y, Konishi M, Matsumoto I, Kaneoka Y, Shimizu Y, Nakamori S, Sakamoto H, Morinaga S, Kainuma O, Imai K, Sata N, Hishinuma S, Ojima H, Yamaguchi R, Hirano S, Sudo T, Ohashi Y. Adjuvant chemotherapy of S-1 versus gemcitabine for resected pancreatic cancer: a phase 3, open-label, randomised, non-inferiority trial (JASPAC 01). Lancet, 388:248-257, 2016
17.Kudo M, Yamamoto Y, Koga Y, Hamaguchi T, Akimoto T, Yasunaga M, Matsumura Y. Effect of combined treatment with micelle-incorporated cisplatin (NC-6004) and S-1 on human gastric cancer xenografts. Mol Clin Oncol, 5:817-822, 2016
18.Shida D, Hamaguchi T, Ochiai H, Tsukamoto S, Takashima A, Boku N, Kanemitsu Y. Prognostic Impact of Palliative Primary Tumor Resection for Unresectable Stage 4 Colorectal Cancer: Using a Propensity Score Analysis. Ann Surg Oncol, 23:3602-3608, 2016
19.Booka E, Imamura CK, Takeuchi H, Hamamoto Y, Gomi D, Mizukami T, Ichiyama T, Tateishi K, Takahashi T, Kawakubo H, Soejima K, Boku N, Tanigawara Y, Kitagawa Y. Development of an S-1 dosage formula based on renal function by a prospective pharmacokinetic study. Gastric Cancer, 19:876-886, 2016
20.Tabuse H, Kashiwagi H, Hamauchi S, Tsushima T, Todaka A, Yokota T, Machida N, Yamazaki K, Fukutomi A, Onozawa Y, Mori K, Boku N, Ichinose M, Yasui H. Excessive watering eyes in gastric cancer patients receiving S-1 chemotherapy. Gastric Cancer, 19:894-901, 2016
21.Sasaki Y, Kato K. Chemoradiotherapy for esophageal squamous cell cancer. Jpn J Clin Oncol, 46:805-810, 2016
22.Sasaki Y, Akasu T, Saito N, Kojima H, Matsuda K, Nakamori S, Komori K, Amagai K, Yamaguchi T, Ohue M, Nagashima K, Yamada Y. Prognostic and predictive value of extended RAS mutation and mismatch repair status in stage III colorectal cancer. Cancer Sci, 107:1006-1012, 2016
23.Ohba A, Kato K, Ito Y, Katada C, Ishiyama H, Yamamoto S, Ura T, Kodaira T, Kudo S, Tamaki Y. Chemoradiotherapy with docetaxel in elderly patients with stage II/III esophageal cancer: a phase 2 trial. Adv Radiat Oncol, 1:230-236, 2016
24.Kato H, Kitagawa Y, Kuwano H, Toh Y, Kusano M, Oyama T, Muto M, Takeuchi H, Doki Y, Naomoto Y, Nemoto K, Matsubara H, Miyazaki T, Yanagisawa A, Uno T, Kato K, Yoshida M, Kawakubo H, Booka E, Nakajima M, Kaneko K, Shiotani A, The Committee for the"Guidelines for diagnosis, treatment of carcinoma of the esophagus"in the Japan Esophageal Society. Neo-adjuvant therapy or definitive chemoradiotherapy can improve laryngeal preservation rates in patients with cervical esophageal cancer: A Japanese nationwide survey. Esophagus, 13:276-282, 2016
25.Mukai H, Kato K, Esaki T, Ohsumi S, Hozomi Y, Matsubara N, Hamaguchi T, Matsumura Y, Goda R, Hirai T, Nambu Y. Phase I study of NK105, a nanomicellar paclitaxel formulation, administered on a weekly schedule in patients with solid tumors. Invest New Drugs, 34:750-759, 2016
26.Zenda S, Kojima T, Kato K, Izumi S, Ozawa T, Kiyota N, Katada C, Tsushima T, Ito Y, Akimoto T, Hasegawa Y, Kanamaru M, Daiko H. Multicenter Phase 2 Study of Cisplatin and 5-Fluorouracil With Concurrent Radiation Therapy as an Organ Preservation Approach in Patients With Squamous Cell Carcinoma of the Cervical Esophagus. Int J Radiat Oncol Biol Phys, 96:976-984, 2016
27.Shitara K, Yonesaka K, Denda T, Yamazaki K, Moriwaki T, Tsuda M, Takano T, Okuda H, Nishina T, Sakai K, Nishio K, Tokunaga S, Yamanaka T, Boku N, Hyodo I, Muro K. Randomized study of FOLFIRI plus either panitumumab or bevacizumab for wild-type KRAS colorectal cancer-WJOG 6210G. Cancer Sci, 107:1843-1850, 2016
28.Yokota T, Kato K, Hamamoto Y, Tsubosa Y, Ogawa H, Ito Y, Hara H, Ura T, Kojima T, Chin K, Hironaka S, Kii T, Kojima Y, Akutsu Y, Matsushita H, Kawakami K, Mori K, Nagai Y, Asami C, Kitagawa Y. Phase II study of chemoselection with docetaxel plus cisplatin and 5-fluorouracil induction chemotherapy and subsequent conversion surgery for locally advanced unresectable oesophageal cancer. Br J Cancer, 115:1328-1334, 2016
29.Kurokawa Y, Boku N, Yamaguchi T, Ohtsu A, Mizusawa J, Nakamura K, Fukuda H. Inter-institutional heterogeneity in outcomes of chemotherapy for metastatic gastric cancer: correlative study in the JCOG9912 phase III trial. ESMO Open, 1:e000031, 2016
30.Toh Y, Kitagawa Y, Kuwano H, Kusano M, Oyama T, Muto M, Kato H, Takeuchi H, Doki Y, Naomoto Y, Nemoto K, Matsubara H, Miyazaki T, Yanagisawa A, Uno T, Kato K, Yoshida M, Kawakubo H, Booka E. A nation-wide survey of follow-up strategies for esophageal cancer patients after a curative esophagectomy or a complete response by definitive chemoradiotherapy in Japan. Esophagus, 13:173-181, 2016
31.Kotaka M, Xu R, Muro K, Park YS, Morita S, Iwasa S, Uetake H, Nishina T, Nozawa H, Matsumoto H, Yamazaki K, Han S-W, Wang W, Ahn JB, Deng Y, Cho S-H, Ba Y, Lee K-W, Zhang T, Satoh T, Buyse ME, Ryoo B-Y, Shen L, Sakamoto J, Kim TW. Study protocol of the Asian XELIRI ProjecT (AXEPT): a multinational, randomized, non-inferiority, phase III trial of second-line chemotherapy for metastatic colorectal cancer, comparing the efficacy and safety of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab. Chin J Cancer, 35:102, 2016
32.Tsuda T, Kyomori C, Mizukami T, Taniyama T, Izawa N, Horie Y, Hirakawa M, Ogura T, Nakajima TE, Tsugawa K, Boku N. Infusion site adverse events in breast cancer patients receiving highly emetic chemotherapy with prophylactic anti-emetic treatment with aprepitant and fosaprepitant: A retrospective comparison. Mol Clin Oncol, 4:603-606, 2016
33.Araki T, Takashima A, Hamaguchi T, Honma Y, Iwasa S, Okita N, Kato K, Yamada Y, Hashimoto H, Taniguchi H, Kushima R, Nakao K, Boku N, Shimada Y. Amrubicin in patients with platinum-refractory metastatic neuroendocrine carcinoma and mixed adenoneuroendocrine carcinoma of the gastrointestinal tract. Anticancer Drugs, 27:794-799, 2016
34.Fujiwara Y, Tamura K, Kondo S, Tanabe Y, Iwasa S, Shimomura A, Kitano S, Ogasawara K, Turner PK, Mori J, Asou H, Chan EM, Yamamoto N. Phase 1 study of abemaciclib, an inhibitor of CDK 4 and 6, as a single agent for Japanese patients with advanced cancer. Cancer Chemother Pharmacol, 78:281-288, 2016
35.Iwasa S, Yamada Y, Heike Y, Shoji H, Honma Y, Komatsu N, Matsueda S, Yamada A, Morita M, Yamaguchi R, Tanaka N, Kawahara A, Kage M, Shichijo S, Sasada T, Itoh K. Phase I study of a new cancer vaccine of ten mixed peptides for advanced cancer patients. Cancer Sci, 107:590-600, 2016
36.Sasaki Y, Hamaguchi T, Yamada Y, Takahashi N, Shoji H, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Nagai Y, Taniguchi H, Boku N, Ushijima T, Shimada Y. Value of KRAS, BRAF, and PIK3CA Mutations and Survival Benefit from Systemic Chemotherapy in Colorectal Peritoneal Carcinomatosis. Asian Pac J Cancer Prev, 17:539-543, 2016
37.Nomura M, Iwasa S, Tsushima T, Kato K, Yasui H, Boku N, Muto M, Muro K. Active salvage chemotherapy versus best supportive care for patients with recurrent or metastatic squamous cell carcinoma of the esophagus refractory or intolerable to fluorouracil, platinum, and taxane. Cancer Chemother Pharmacol, 78:1209-1216, 2016
38.Satake H, Tahara M, Mochizuki S, Kato K, Hara H, Yokota T, Kiyota N, Kii T, Chin K, Zenda S, Kojima T, Bando H, Yamazaki T, Iwasa S, Honma Y, Hamauchi S, Tsushima T, Ohtsu A. A prospective, multicenter phase I/II study of induction chemotherapy with docetaxel, cisplatin and fluorouracil (DCF) followed by chemoradiotherapy in patients with unresectable locally advanced esophageal carcinoma. Cancer Chemother Pharmacol, 78:91-99, 2016
39.Tada K, Kitano S, Shoji H, Nishimura T, Shimada Y, Nagashima K, Aoki K, Hiraoka N, Honma Y, Iwasa S, Okita N, Takashima A, Kato K, Yamada Y, Katayama N, Boku N, Heike Y, Hamaguchi T. Pretreatment Immune Status Correlates with Progression-Free Survival in Chemotherapy-Treated Metastatic Colorectal Cancer Patients. Cancer Immunol Res, 4:592-599, 2016
40.Takahashi N, Iwasa S, Fukahori M, Sudo K, Sasaki Y, Shoji H, Honma Y, Okita NT, Takashima A, Hamaguchi T, Boku N, Shimada Y, Honda K, Yamada T, Yamada Y. A phase I study of the combination of panitumumab and bevacizumab in KRAS wild-type colorectal cancer patients previously treated with fluoropyrimidine, oxaliplatin, irinotecan and bevacizumab. Cancer Chemother Pharmacol, 78:567-575, 2016
41.Takahashi N, Iwasa S, Sasaki Y, Shoji H, Honma Y, Takashima A, Okita NT, Kato K, Hamaguchi T, Yamada Y. Serum levels of soluble programmed cell death ligand 1 as a prognostic factor on the first-line treatment of metastatic or recurrent gastric cancer. J Cancer Res Clin Oncol, 142:1727-1738, 2016
42.Takahashi N, Iwasa S, Taniguchi H, Sasaki Y, Shoji H, Honma Y, Takashima A, Okita N, Kato K, Hamaguchi T, Shimada Y, Yamada Y. Prognostic role of ERBB2, MET and VEGFA expression in metastatic colorectal cancer patients treated with anti-EGFR antibodies. Br J Cancer, 114:1003-1011, 2016
43.Tanabe Y, Ichikawa H, Kohno T, Yoshida H, Kubo T, Kato M, Iwasa S, Ochiai A, Yamamoto N, Fujiwara Y, Tamura K. Comprehensive screening of target molecules by next-generation sequencing in patients with malignant solid tumors: guiding entry into phase I clinical trials. Mol Cancer, 15:73, 2016
44.Yamaguchi T, Iwasa S, Nagashima K, Ikezawa N, Hamaguchi T, Shoji H, Honma Y, Takashima A, Okita N, Kato K, Yamada Y, Shimada Y. Comparison of Panitumumab Plus Irinotecan and Cetuximab Plus Irinotecan for KRAS Wild-type Metastatic Colorectal Cancer. Anticancer Res, 36:3531-3536, 2016
45.Miura N, Kamita M, Kakuya T, Fujiwara Y, Tsuta K, Shiraishi H, Takeshita F, Ochiya T, Shoji H, Huang W, Ohe Y, Yamada T, Honda K. Efficacy of adjuvant chemotherapy for non-small cell lung cancer assessed by metastatic potential associated with ACTN4. Oncotarget, 7:33165-33178, 2016
46.Honma Y, Yamada Y, Terazawa T, Takashima A, Iwasa S, Kato K, Hamaguchi T, Shimada Y, Ohashi M, Morita S, Fukagawa T, Machida N, Katai H. Feasibility of neoadjuvant S-1 and oxaliplatin followed by surgery for resectable advanced gastric adenocarcinoma. Surg Today, 46:1076-1082, 2016