PMID- 27084252 OWN - NLM STAT- MEDLINE DCOM- 20170313 LR - 20181113 IS - 1865-3774 (Electronic) IS - 0925-5710 (Linking) VI - 103 IP - 6 DP - 2016 Jun TI - Efficacy of upfront high-dose chemotherapy plus rituximab followed by autologous peripheral blood stem cell transplantation for untreated high-intermediate-, and high-risk diffuse large B-cell lymphoma: a multicenter prospective phase II study (JSCT-NHL04). PG - 676-85 LID - 10.1007/s12185-016-1976-4 [doi] AB - To evaluate the efficacy and feasibility of upfront high-dose chemotherapy (HDCT) and rituximab (R) followed by autologous peripheral blood stem cell transplantation (auto-PBSCT) in patients with newly diagnosed high-intermediate(HI)-, and high(H)-risk diffuse large B-cell lymphoma (DLBCL), we conducted a multicenter prospective phase II trial. In 15-60-year-old patients with H- or HI-risk DLBCL, after three courses of (R-)CHOP14, high-dose etoposide was given prior to peripheral blood stem cell harvesting. After an additional three courses of (R-)CHOP14, auto-PBSCT was performed following HDCT. The primary endpoint of the study is progression-free survival (PFS) at 2 years after registration in eligible patients. The expected PFS and the threshold PFS were estimated to be 70 and 50 %, respectively. Among 40 eligible patients registered, 30 patients completed treatment. With a median observation period in surviving eligible patients of 63 months, the 2- and 4-year PFS after registration were 79.9 and 72.0 %, respectively. The 2- and 4-year overall survival (OS) were 92.5 and 84.6 %, respectively. In 30 patients who completed treatment, the 4-year PFS and OS after auto-PBSCT were 79.2 and 85.9 %, respectively. In conclusion, the results of our study suggest that upfront HDCT and auto-PBSCT combined with rituximab is highly effective as an initial treatment for HI-, and H-risk DLBCL. FAU - Murayama, Tohru AU - Murayama T AD - Department of Hematology, Hyogo Cancer Center, 13-70, Kita-oji, Akashi, Hyogo, 673-8558, Japan. tmurayam@hp.pref.hyogo.jp. FAU - Fukuda, Takahiro AU - Fukuda T AD - Department of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan. FAU - Okumura, Hirokazu AU - Okumura H AD - Hematology Department, Toyama Prefectural Central Hospital, Toyama, Japan. FAU - Sunami, Kazutaka AU - Sunami K AD - Division of Hematology, Department of Internal Medicine National Hospital Organization, Okayama Medical Center, Okayama, Japan. FAU - Sawazaki, Aiko AU - Sawazaki A AD - Department of Hematology, Ishikawa Prefectural Central Hospital, Kanazawa, Japan. FAU - Maeda, Yoshinobu AU - Maeda Y AD - Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan. FAU - Tsurumi, Hisashi AU - Tsurumi H AD - First Department of Internal Medicine, Gifu University Graduate School of Medicine, Gifu, Japan. FAU - Uike, Naokuni AU - Uike N AD - Department of Hematology, National Kyushu Cancer Center, Fukuoka, Japan. FAU - Hidaka, Tomonori AU - Hidaka T AD - Division of Gastroenterology and Hematology, University of Miyazaki Hospital, Miyazaki, Japan. FAU - Takatsuka, Yoshifusa AU - Takatsuka Y AD - Department of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan. FAU - Eto, Tetsuya AU - Eto T AD - Department of Hematology, Hamanomachi Hospital, Fukuoka, Japan. FAU - Tsuda, Hiroyuki AU - Tsuda H AD - Division of Hematology and Oncology, Kumamoto City Hospital, Kumamoto, Japan. FAU - Fujisaki, Tomoaki AU - Fujisaki T AD - Department of Internal Medicine, Matsuyama Red Cross Hospital, Matsuyama, Japan. FAU - Miyamoto, Toshihiro AU - Miyamoto T AD - Department of Hematology and Oncology, Kyusyu University Hospital, Fukuoka, Japan. FAU - Tsuneyoshi, Naoko AU - Tsuneyoshi N AD - Division of Hematology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. FAU - Iyama, Satoshi AU - Iyama S AD - Fourth Department of Internal Medicine, Sapporo Medical University Hospital, Sapporo, Japan. FAU - Nagafuji, Koji AU - Nagafuji K AD - Division of Hematology and Oncology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. FAU - Harada, Mine AU - Harada M AD - Department of Internal Medicine, Karatsu Matsuura Ishikai Hospital, Karatsu, Japan. AD - Japan Study Group for Cell Therapy and Transplantation (JSCT), Tochigi, Japan. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20160321 PL - Japan TA - Int J Hematol JT - International journal of hematology JID - 9111627 RN - 4F4X42SYQ6 (Rituximab) RN - 5J49Q6B70F (Vincristine) RN - 6PLQ3CP4P3 (Etoposide) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - VB0R961HZT (Prednisone) RN - CHOP protocol SB - IM MH - Adolescent MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Cyclophosphamide/therapeutic use MH - Doxorubicin/therapeutic use MH - Etoposide/therapeutic use MH - Humans MH - Lymphoma, Large B-Cell, Diffuse/drug therapy/*mortality/*therapy MH - Middle Aged MH - *Peripheral Blood Stem Cell Transplantation MH - Prednisone/therapeutic use MH - Rituximab/*administration & dosage MH - Transplantation, Autologous MH - Treatment Outcome MH - Vincristine/therapeutic use OTO - NOTNLM OT - Autologous peripheral blood stem cell transplantation OT - CHOP14 OT - Diffuse large B-cell lymphoma OT - High-dose chemotherapy OT - Rituximab EDAT- 2016/04/17 06:00 MHDA- 2017/03/14 06:00 CRDT- 2016/04/17 06:00 PHST- 2015/08/05 00:00 [received] PHST- 2016/03/03 00:00 [accepted] PHST- 2016/03/01 00:00 [revised] PHST- 2016/04/17 06:00 [entrez] PHST- 2016/04/17 06:00 [pubmed] PHST- 2017/03/14 06:00 [medline] AID - 10.1007/s12185-016-1976-4 [pii] AID - 10.1007/s12185-016-1976-4 [doi] PST - ppublish SO - Int J Hematol. 2016 Jun;103(6):676-85. doi: 10.1007/s12185-016-1976-4. Epub 2016 Mar 21.