PMID- 27677906 OWN - NLM STAT- MEDLINE DCOM- 20180112 LR - 20180112 IS - 1099-1069 (Electronic) IS - 0278-0232 (Linking) VI - 35 IP - 4 DP - 2017 Dec TI - Y(90) -Ibritumomab tiuxetan (Y(90) -IT) and high-dose melphalan as conditioning regimen before autologous stem cell transplantation for elderly patients with lymphoma in relapse or resistant to chemotherapy: a feasibility trial (SAKK 37/05). PG - 576-583 LID - 10.1002/hon.2348 [doi] AB - Standard conditioning regimens for autologous stem cell transplantation (ASCT) are often not tolerated by elderly patients, on one hand. Single high-dose melphalan, on the other hand, has been shown to be safe and active as a pretransplant preparative regimen in elderly patients. Y(90) -Ibritumomab tiuxetan (Y(90) -IT) is well tolerated and feasible in the transplantation setting. We therefore investigated the combination of high-dose melphalan and Y(90) -IT as a conditioning regimen for patients >/=65 years of age. Patients with relapsed or resistant CD20-positive lymphoma in remission after salvage chemotherapy could be enrolled. High-dose therapy consisted of standard dose Y(90) -IT (0.4-mCi/kg body weight) followed by melphalan at escalating doses (100, 140, 170 and 200 mg/m(2) ) and ASCT. The primary objective was to identify the maximum tolerated dose; secondary end points were complete response (CR) rate 100 days after transplantation and toxicity. Twenty patients (median age 72 years) were included. No DLT occurred at any dose level. Thirteen patients completed the treatment, 11 were evaluable for response. Seven patients did not complete treatment because of mobilization failure (n = 3), progressive disease (n = 2), worsening of cardiac function (n = 1), and grade 3 dyspnea (n = 1). Seven patients achieved a CR/complete remission/unconfirmed (CRu) and 2 had stable disease. Five out of 7 responding patients were still alive more than 3 years after transplantation. The 2 patients with SD had a long-term survival of 3 and 5 years, respectively. Nonhematological grade 3 or higher treatment related adverse events (AEs) were infection (n = 6), including 2 cases of febrile neutropenia, diarrhea (n = 3), mucositis, anorexia, viral hepatitis, hypokalemia, dehydration, and multiorgan failure (n = 1 for each). The combination of Y(90) -IT and high-dose melphalan is feasible before ASCT for elderly patients, with promising activity and manageable toxicity. CI - Copyright (c) 2016 John Wiley & Sons, Ltd. FAU - Voegeli, Michele AU - Voegeli M AD - Medizinische Universitatsklinik, Liestal, Switzerland. FAU - Rondeau, Stephanie AU - Rondeau S AD - SAKK Coordinating Center, Bern, Switzerland. FAU - Berardi Vilei, Simona AU - Berardi Vilei S AD - SAKK Coordinating Center, Bern, Switzerland. FAU - Lerch, Erika AU - Lerch E AD - Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland. FAU - Wannesson, Luciano AU - Wannesson L AD - Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland. FAU - Pabst, Thomas AU - Pabst T AD - Inselspital Bern, Bern, Switzerland. FAU - Rentschler, Jochen AU - Rentschler J AD - Universitatsspital Basel, Basel, Switzerland. AD - Ortenau Klinikum Offenburg, Offenburg, Germany. FAU - Bargetzi, Mario AU - Bargetzi M AD - Kantonsspital Aarau, Aarau, Switzerland. FAU - Jost, Lorenz AU - Jost L AD - Kantonsspital Bruderholz, Bruderholz, Switzerland. FAU - Ketterer, Nicolas AU - Ketterer N AD - CHUV, Lausanne, Switzerland. AD - Hirslanden Lausanne SA, Lausanne, Switzerland. FAU - Bischof Delaloye, Angelika AU - Bischof Delaloye A AD - CHUV, Lausanne, Switzerland. FAU - Ghielmini, Michele AU - Ghielmini M AD - Oncology Institute of Southern Switzerland (IOSI), Bellinzona, Switzerland. LA - eng PT - Clinical Trial, Phase I PT - Journal Article PT - Multicenter Study DEP - 20160928 PL - England TA - Hematol Oncol JT - Hematological oncology JID - 8307268 RN - 0 (Antibodies, Monoclonal) RN - 0 (Yttrium Radioisotopes) RN - 4Q52C550XK (ibritumomab tiuxetan) RN - Q41OR9510P (Melphalan) SB - IM MH - Age Factors MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal/administration & dosage MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Drug Resistance, Neoplasm MH - Female MH - *Hematopoietic Stem Cell Transplantation/adverse effects MH - Humans MH - Lymphoma/mortality/*pathology/*therapy MH - Male MH - Melphalan/administration & dosage MH - Neoplasm Grading MH - Recurrence MH - Retreatment MH - Time Factors MH - *Transplantation Conditioning/adverse effects/methods MH - Transplantation, Autologous MH - Treatment Outcome MH - Yttrium Radioisotopes OTO - NOTNLM OT - Y90-Ibritumomab tiuxetan OT - autologous stem cell transplantation OT - high-dose melphalan OT - recurrent lymphoma EDAT- 2016/09/30 06:00 MHDA- 2018/01/13 06:00 CRDT- 2016/09/29 06:00 PHST- 2016/05/29 00:00 [received] PHST- 2016/07/24 00:00 [revised] PHST- 2016/08/01 00:00 [accepted] PHST- 2016/09/30 06:00 [pubmed] PHST- 2018/01/13 06:00 [medline] PHST- 2016/09/29 06:00 [entrez] AID - 10.1002/hon.2348 [doi] PST - ppublish SO - Hematol Oncol. 2017 Dec;35(4):576-583. doi: 10.1002/hon.2348. Epub 2016 Sep 28.