PMID- 23370364
OWN - NLM
STAT- MEDLINE
DCOM- 20130912
LR  - 20220317
IS  - 1556-1380 (Electronic)
IS  - 1556-0864 (Linking)
VI  - 8
IP  - 4
DP  - 2013 Apr
TI  - A phase I study of pomalidomide (CC-4047) in combination with cisplatin and 
      etoposide in patients with extensive-stage small-cell lung cancer.
PG  - 423-8
LID - 10.1097/JTO.0b013e318282707b [doi]
AB  - INTRODUCTION: This phase I/IIA study evaluated the maximum-tolerated dose (MTD), 
      safety, and clinical benefit of pomalidomide, an immunomodulatory drug (IMiD), 
      combined with cisplatin+etoposide chemotherapy, in treatment-naive patients with 
      extensive-stage (ES) small-cell lung cancer (SCLC). METHODS: In this multicenter, 
      open-label, dose-escalation study, patients received 21-day cycles of oral 
      pomalidomide (1, 3, 5, and 4 mg/day) on days 1 to 14, plus cisplatin 25 mg/m and 
      etoposide 100 mg/m administered intravenously on days 1 to 3; the MTD was 
      determined during cycle 1 (standard 3+3 dose-escalation design), followed by a 
      five-cycle extension phase. RESULTS: Twenty-two patients with ES SCLC, with a 
      median age of 64.5 years received one or more doses of the study medication. 
      Dose-limiting toxicities included grade 4 cerebral ischemia and grade 5 sepsis 
      (1-mg cohort), grade 4 transient ischemic attack (5-mg cohort), and grade 5 
      neutropenic infection (5-mg cohort). The MTD for pomalidomide was 4 mg/day. In 
      the MTD phase, the most common pomalidomide-related adverse events (AEs) were 
      fatigue (72.7%), nausea (45.5%), and neutropenia (40.9%); 31.8% of patients 
      experienced pomalidomide-related serious AEs and 40.9% 
      cisplatin/etoposide-related serious AEs. Overall response rate was 31.8% (7 of 
      22); these were partial responses. Stable disease and progressive disease 
      occurred in four patients (18.2%) each. The median response duration was 12.4 
      weeks. Median overall survival was 49.6 weeks. CONCLUSIONS: Pomalidomide at the 
      MTD of 4 mg/day plus standard cisplatin+etoposide seems safe in treatment-naive 
      patients with ES SCLC. However, addition of pomalidomide does not seem to improve 
      the therapeutic index of chemotherapy alone.
FAU - Ellis, Peter M
AU  - Ellis PM
AD  - Juravinski Cancer Centre, 699 Concession St., Hamilton, Ontario L8V 5C2, Canada. 
      peter.ellis@jcc.hhsc.ca
FAU - Jungnelius, Ulf
AU  - Jungnelius U
FAU - Zhang, Jennie
AU  - Zhang J
FAU - Fandi, Abderrahim
AU  - Fandi A
FAU - Beck, Robert
AU  - Beck R
FAU - Shepherd, Frances A
AU  - Shepherd FA
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Thorac Oncol
JT  - Journal of thoracic oncology : official publication of the International 
      Association for the Study of Lung Cancer
JID - 101274235
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - 6PLQ3CP4P3 (Etoposide)
RN  - D2UX06XLB5 (pomalidomide)
RN  - Q20Q21Q62J (Cisplatin)
SB  - IM
EIN - J Thorac Oncol. 2019 Aug;14(8):1484. PMID: 31345334
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Cisplatin/administration & dosage
MH  - Etoposide/administration & dosage
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/pathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Small Cell Lung Carcinoma/*drug therapy/mortality/pathology
MH  - Survival Rate
MH  - Thalidomide/administration & dosage/analogs & derivatives
EDAT- 2013/02/02 06:00
MHDA- 2013/09/13 06:00
CRDT- 2013/02/02 06:00
PHST- 2013/02/02 06:00 [entrez]
PHST- 2013/02/02 06:00 [pubmed]
PHST- 2013/09/13 06:00 [medline]
AID - S1556-0864(15)32786-6 [pii]
AID - 10.1097/JTO.0b013e318282707b [doi]
PST - ppublish
SO  - J Thorac Oncol. 2013 Apr;8(4):423-8. doi: 10.1097/JTO.0b013e318282707b.