PMID- 31101627
OWN - NLM
STAT- MEDLINE
DCOM- 20200114
LR  - 20210202
IS  - 1528-0020 (Electronic)
IS  - 0006-4971 (Linking)
VI  - 134
IP  - 4
DP  - 2019 Jul 25
TI  - Short regimen of rituximab plus lenalidomide in follicular lymphoma patients in 
      need of first-line therapy.
PG  - 353-362
LID - 10.1182/blood-2018-10-879643 [doi]
AB  - The SAKK 35/10 phase 2 trial, developed by the Swiss Group for Clinical Cancer 
      Research and the Nordic Lymphoma Group, compared the activity of rituximab vs 
      rituximab plus lenalidomide in untreated follicular lymphoma patients in need of 
      systemic therapy. Patients were randomized to rituximab (375 mg/m(2) IV on day 1 
      of weeks 1-4 and repeated during weeks 12-15 in responding patients) or rituximab 
      (same schedule) in combination with lenalidomide (15 mg orally daily for 18 
      weeks). Primary end point was complete response (CR)/unconfirmed CR (CRu) rate at 
      6 months. In total, 77 patients were allocated to rituximab monotherapy and 77 to 
      the combination (47% poor-risk Follicular Lymphoma International Prognostic Index 
      score in each arm). A significantly higher CR/CRu rate at 6 months was documented 
      in the combination arm by the investigators (36%; 95% confidence interval [CI], 
      26%-48% vs 25%; 95% CI, 16%-36%) and confirmed by an independent response review 
      of computed tomography scans only (61%; 95% CI, 49%-72% vs 36%; 95% CI, 26%-48%). 
      After a median follow-up of 4 years, significantly higher 30-month CR/CRu rates 
      and longer progression-free survival (PFS) and time to next treatment (TTNT) were 
      observed for the combination. Overall survival (OS) rates were similar in both 
      arms (>/=90%). Toxicity grade >/=3 was more common in the combination arm (56% vs 22% 
      of patients), mainly represented by neutropenia (23% vs 7%). Addition of 
      lenalidomide to rituximab significantly improved CR/CRu rates, PFS, and TTNT, 
      with expected higher, but manageable toxicity. The excellent OS in both arms 
      suggests that chemotherapy-free strategies should be further explored. This trial 
      was registered at www.clinicaltrials.gov as #NCT01307605.
CI  - (c) 2019 by The American Society of Hematology.
FAU - Zucca, Emanuele
AU  - Zucca E
AUID- ORCID: 0000-0002-5522-6109
AD  - Division of Medical Oncology, Oncology Institute of Southern Switzerland, 
      Bellinzona, Switzerland.
AD  - Institute of Oncology Research, Bellinzona, Switzerland.
AD  - Department of Medical Oncology, Inselspital/Bern University Hospital, Bern, 
      Switzerland.
FAU - Rondeau, Stephanie
AU  - Rondeau S
AD  - SAKK Coordinating Center, Bern, Switzerland.
FAU - Vanazzi, Anna
AU  - Vanazzi A
AD  - Clinical Hemato-Oncology, European Institute of Oncology IRCCS, Milan, Italy.
FAU - Ostenstad, Bjorn
AU  - Ostenstad B
AD  - Department of Oncology, Oslo University Hospital, Oslo, Norway.
FAU - Mey, Ulrich J M
AU  - Mey UJM
AD  - Medical Oncology and Hematology, Kantonsspital Graubunden, Chur, Switzerland.
FAU - Rauch, Daniel
AU  - Rauch D
AD  - Division of Oncology, Spital Thun Simmenthal, Thun, Switzerland.
FAU - Wahlin, Bjorn E
AU  - Wahlin BE
AD  - Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, 
      Stockholm, Sweden.
FAU - Hitz, Felicitas
AU  - Hitz F
AUID- ORCID: 0000-0001-5653-5117
AD  - Oncology/Hematology, Kantonsspital St Gallen, St Gallen, Switzerland.
FAU - Hernberg, Micaela
AU  - Hernberg M
AD  - Department of Oncology, Comprehensive Cancer Center, Helsinki University 
      Hospital, Helsinki, Finland.
FAU - Johansson, Ann-Sofie
AU  - Johansson AS
AD  - Department of Oncology, Norrlands Universitetssjukhus, Umea, Sweden.
FAU - de Nully Brown, Peter
AU  - de Nully Brown P
AUID- ORCID: 0000-0002-6522-4086
AD  - Department of Hematology, Rigshospitalet, Copenhagen, Denmark.
FAU - Hagberg, Hans
AU  - Hagberg H
AD  - Oncology, Uppsala University Hospital, Uppsala, Sweden.
FAU - Ferreri, Andres J M
AU  - Ferreri AJM
AUID- ORCID: 0000-0001-9606-6124
AD  - Unit of Lymphoid Malignancies, IRCCS San Raffaele Scientific Institute, Milan, 
      Italy.
FAU - Lohri, Andreas
AU  - Lohri A
AD  - Department of Oncology/Hematology, Medical University Clinic, Liestal, 
      Switzerland.
FAU - Novak, Urban
AU  - Novak U
AUID- ORCID: 0000-0001-7642-2101
AD  - Department of Medical Oncology, Inselspital/Bern University Hospital, Bern, 
      Switzerland.
FAU - Zander, Thilo
AU  - Zander T
AUID- ORCID: 0000-0003-3691-7497
AD  - Department of Oncology, Luzerner Kantonsspital, Luzern, Switzerland.
FAU - Bersvendsen, Hanne
AU  - Bersvendsen H
AD  - Department of Oncology, University Hospital of North Norway, Tromso, Norway.
FAU - Bargetzi, Mario
AU  - Bargetzi M
AD  - Division of Hematology/Oncology, Kantonsspital Aarau, Aarau, Switzerland.
FAU - Mingrone, Walter
AU  - Mingrone W
AUID- ORCID: 0000-0001-7510-9041
AD  - Department of Medical Oncology, Kantonsspital Olten, Olten, Switzerland; and.
FAU - Krasniqi, Fatime
AU  - Krasniqi F
AUID- ORCID: 0000-0003-3742-4248
AD  - Department of Oncology and.
FAU - Dirnhofer, Stefan
AU  - Dirnhofer S
AD  - Institute of Pathology, University Hospital Basel, Basel, Switzerland.
FAU - Hayoz, Stefanie
AU  - Hayoz S
AUID- ORCID: 0000-0002-2265-6559
AD  - SAKK Coordinating Center, Bern, Switzerland.
FAU - Hawle, Hanne
AU  - Hawle H
AD  - SAKK Coordinating Center, Bern, Switzerland.
FAU - Vilei, Simona Berardi
AU  - Vilei SB
AUID- ORCID: 0000-0002-6226-9123
AD  - SAKK Coordinating Center, Bern, Switzerland.
FAU - Ghielmini, Michele
AU  - Ghielmini M
AD  - Division of Medical Oncology, Oncology Institute of Southern Switzerland, 
      Bellinzona, Switzerland.
FAU - Kimby, Eva
AU  - Kimby E
AD  - Unit of Hematology, Department of Medicine at Huddinge, Karolinska Institutet, 
      Stockholm, Sweden.
CN  - Swiss Group for Clinical Cancer Research and the Nordic Lymphoma Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01307605
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20190517
PL  - United States
TA  - Blood
JT  - Blood
JID - 7603509
RN  - 4F4X42SYQ6 (Rituximab)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Biopsy
MH  - Combined Modality Therapy
MH  - Female
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide/administration & dosage
MH  - Lymphoma, Follicular/diagnosis/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Neoplasms, Second Primary/etiology
MH  - Rituximab/administration & dosage
MH  - Symptom Assessment
MH  - Time Factors
MH  - Tomography, X-Ray Computed
MH  - Treatment Outcome
EDAT- 2019/05/19 06:00
MHDA- 2020/01/15 06:00
CRDT- 2019/05/19 06:00
PHST- 2018/10/11 00:00 [received]
PHST- 2019/04/03 00:00 [accepted]
PHST- 2019/05/19 06:00 [pubmed]
PHST- 2020/01/15 06:00 [medline]
PHST- 2019/05/19 06:00 [entrez]
AID - S0006-4971(20)42383-3 [pii]
AID - 10.1182/blood-2018-10-879643 [doi]
PST - ppublish
SO  - Blood. 2019 Jul 25;134(4):353-362. doi: 10.1182/blood-2018-10-879643. Epub 2019 
      May 17.