PMID- 30995666
OWN - NLM
STAT- MEDLINE
DCOM- 20190911
LR  - 20190911
IS  - 2296-5262 (Electronic)
IS  - 2296-5270 (Linking)
VI  - 42
IP  - 5
DP  - 2019
TI  - Clinical Experience of Immunotherapy Treatment: Efficacy and Toxicity Analysis of 
      the Compassionate Use Program of Nivolumab in Patients with Advanced Squamous 
      Cell Non-Small Cell Lung Cancer.
PG  - 243-255
LID - 10.1159/000499321 [doi]
AB  - BACKGROUND: Anti-PD1 monoclonal antibody nivolumab is an approved therapy option 
      for the treatment of advanced squamous cell non-small cell lung cancer (SQ-NSCLC) 
      patients. Data outside clinical trials about therapy efficacy and safety in later 
      therapy line treatments have rarely been described until now. METHODS: We 
      performed a retrospective data analysis of patients who were enrolled into the 
      nivolu-mab Compassionate Use Program (CUP) in Germany. Sufficient clinical data 
      of 40 patients were available for efficacy and safety analysis. RESULTS: Overall, 
      47.5% of all treated patients were not affected by any adverse events (AEs); 
      17.5% of patients suffered from severe AEs. The 1-year survival rate was 61.3%. 
      Estimated median progression-free survival (PFS) was 5.3 months. Patients who 
      received nivolumab as third or later therapy line treatment (77.5%) achieved 
      similar median PFS and 12-month overall survival rate of 52%. CONCLUSION: Our 
      findings of immunotherapy treatment outside clinical trials support the results 
      of studies in the past and confirm the efficacy and favorable toxicity profile of 
      nivolumab treatment in advanced SQ-NSCLC patients. In addition, we can present 
      some rarely described information about nivolumab treatment of heavily pretreated 
      patients, which provides some evidence that immunotherapy could also be useful in 
      later therapy lines.
CI  - (c) 2019 S. Karger AG, Basel.
FAU - Krefting, Frederik
AU  - Krefting F
AD  - Department of Medical Oncology, West German Cancer Center, University Hospital 
      Essen, Essen, Germany, Frederik.krefting@online.de.
FAU - Basara, Nadezda
AU  - Basara N
AD  - Department of Hematology and Oncology, Malteser Clinic St. Franziskus-Hospital, 
      Flensburg, Germany.
FAU - Schutte, Wolfgang
AU  - Schutte W
AD  - Department of Internal Medicine II, Martha-Maria Hospital Halle-Dolau, Halle, 
      Germany.
FAU - Spath-Schwalbe, Ernst
AU  - Spath-Schwalbe E
AD  - Department of Hematology and Oncology, Vivantes Clinic Spandau, Berlin, Germany.
FAU - Alt, Jurgen
AU  - Alt J
AD  - Department of Internal Medicine III, Universitatsmedizin Mainz, Mainz, Germany.
FAU - Thiel, Sebastian
AU  - Thiel S
AD  - Department of Pneumology, Helios Clinic Emil von Behring, Berlin, Germany.
FAU - Kimmich, Martin
AU  - Kimmich M
AD  - Department of Pneumology, Clinic Schillerhoehe, Gerlingen, Germany.
FAU - Fischer, Jurgen R
AU  - Fischer JR
AD  - Department of Internal Medicine II, Lungenklinik Lowenstein GmbH, Lowenstein, 
      Germany.
FAU - Kurz, Sylke
AU  - Kurz S
AD  - Department of Pneumology, Protestant Lung Hospital, Berlin, Germany.
FAU - Griesinger, Frank
AU  - Griesinger F
AD  - Department of Hematology and Oncology, Pius Hospital Oldenburg, Oldenburg, 
      Germany.
FAU - Christoph, Daniel C
AU  - Christoph DC
AD  - Department of Medical Oncology, West German Cancer Center, University Hospital 
      Essen, Essen, Germany.
LA  - eng
PT  - Journal Article
DEP - 20190417
PL  - Switzerland
TA  - Oncol Res Treat
JT  - Oncology research and treatment
JID - 101627692
RN  - 0 (Antineoplastic Agents, Immunological)
RN  - 31YO63LBSN (Nivolumab)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents, Immunological/adverse effects/therapeutic use
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/therapy
MH  - Clinical Trials as Topic
MH  - *Compassionate Use Trials
MH  - Female
MH  - Humans
MH  - *Immunotherapy
MH  - Lung Neoplasms/*drug therapy/therapy
MH  - Male
MH  - Middle Aged
MH  - Nivolumab/adverse effects/*therapeutic use
MH  - Progression-Free Survival
OTO - NOTNLM
OT  - Efficacy
OT  - Immunotherapy
OT  - Nivolumab
OT  - Non-small cell lung cancer
OT  - Safety
OT  - Squamous cell carcinoma
EDAT- 2019/04/18 06:00
MHDA- 2019/09/12 06:00
CRDT- 2019/04/18 06:00
PHST- 2018/11/23 00:00 [received]
PHST- 2019/02/27 00:00 [accepted]
PHST- 2019/04/18 06:00 [pubmed]
PHST- 2019/09/12 06:00 [medline]
PHST- 2019/04/18 06:00 [entrez]
AID - 000499321 [pii]
AID - 10.1159/000499321 [doi]
PST - ppublish
SO  - Oncol Res Treat. 2019;42(5):243-255. doi: 10.1159/000499321. Epub 2019 Apr 17.