PMID- 31705269
OWN - NLM
STAT- MEDLINE
DCOM- 20200813
LR  - 20220224
IS  - 1432-0843 (Electronic)
IS  - 0344-5704 (Linking)
VI  - 85
IP  - 2
DP  - 2020 Feb
TI  - Characterization and outcomes of patients enrolled to multiple phase I cancer 
      trials.
PG  - 469-472
LID - 10.1007/s00280-019-03989-x [doi]
AB  - PURPOSE: Some patients who participate in early phase cancer trials enroll to 
      more than one trial. Whether these patients have different characteristics or 
      outcomes than patients who enroll to a single phase I trial is unknown. METHODS: 
      The study included all patients who participated in the solid tumor drug 
      development program of the Princess Margaret Cancer Centre, a specialized 
      academic cancer center, from July 2014 to January 2017. Patients sequentially 
      enrolled to multiple phase I trials were compared to those enrolled in a single 
      trial according to demographics, clinical characteristics, reported toxicities 
      and prognosis. RESULTS: The study cohort included 328 patients, including 61 
      (19%) enrolled to multiple phase I trials and 267 (81%) enrolled to a single 
      phase I trial. Demographics, comorbidities, performance status, cancer site and 
      time between initial diagnosis and initial enrollment to the phase I program were 
      comparable between both groups. Patients enrolled to multiple phase I trials 
      received more previous non-trial treatment lines (median 3 versus 2, p < 0.001) 
      and had a higher average response rate on phase I trials (18% versus 10%, 
      p = 0.03). Toxicity data, including number of any adverse events (AEs), grade 3/4 
      AEs, serious AEs and dose-limiting toxicities were comparable between both 
      groups. Time to disease progression and time to last documented follow-up were 
      also comparable between both groups. CONCLUSIONS: Patients enrolled to multiple 
      phase I trials and those enrolled to a single trial had similar toxicity and 
      prognostic profiles. These patients do not introduce bias into early-phase cancer 
      trials results.
FAU - Kuehne, Nathan
AU  - Kuehne N
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
FAU - Chen, Lina
AU  - Chen L
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
FAU - McDonald, Kate
AU  - McDonald K
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
FAU - Wang, Lisa
AU  - Wang L
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
FAU - Spreafico, Anna
AU  - Spreafico A
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Hansen, Aaron
AU  - Hansen A
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Razak, Albiruni Ryan Abdul
AU  - Razak ARA
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Bedard, Philippe Lucien
AU  - Bedard PL
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Siu, Lillian L
AU  - Siu LL
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada.
FAU - Shepshelovich, Daniel
AU  - Shepshelovich D
AUID- ORCID: 0000-0002-9145-618X
AD  - Division of Medical Oncology and Hematology, University Health Network, Princess 
      Margaret Cancer Centre, Toronto, ON, Canada. shepshelovich@yahoo.com.
AD  - Department of Medicine, University of Toronto, Toronto, ON, Canada. 
      shepshelovich@yahoo.com.
AD  - Sackler School of Medicine, Tel-Aviv University, Tel Aviv, Israel. 
      shepshelovich@yahoo.com.
AD  - Medicine A, Beilinson Hospital, Rabin Medical Center, 39 Jabotinsky Street, 
      49100, Petach Tikva, Israel. shepshelovich@yahoo.com.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
DEP - 20191108
PL  - Germany
TA  - Cancer Chemother Pharmacol
JT  - Cancer chemotherapy and pharmacology
JID - 7806519
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Adult
MH  - Antineoplastic Agents/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Neoplasms/*drug therapy/pathology
MH  - Prognosis
MH  - Young Adult
OTO - NOTNLM
OT  - Cancer
OT  - Multiple
OT  - Phase I
OT  - Prognosis
OT  - Toxicity
EDAT- 2019/11/11 06:00
MHDA- 2020/08/14 06:00
CRDT- 2019/11/10 06:00
PHST- 2019/09/23 00:00 [received]
PHST- 2019/11/01 00:00 [accepted]
PHST- 2019/11/11 06:00 [pubmed]
PHST- 2020/08/14 06:00 [medline]
PHST- 2019/11/10 06:00 [entrez]
AID - 10.1007/s00280-019-03989-x [pii]
AID - 10.1007/s00280-019-03989-x [doi]
PST - ppublish
SO  - Cancer Chemother Pharmacol. 2020 Feb;85(2):469-472. doi: 
      10.1007/s00280-019-03989-x. Epub 2019 Nov 8.