PMID- 28546463
OWN - NLM
STAT- MEDLINE
DCOM- 20180330
LR  - 20181113
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 22
IP  - 7
DP  - 2017 Jul
TI  - A Phase II Study of Everolimus Plus Oral Prednisone in Patients with Metastatic 
      Renal Cell Cancer.
PG  - 784-e74
LID - 10.1634/theoncologist.2017-0154 [doi]
AB  - LESSONS LEARNED: The combination of everolimus and low-dose prednisone 
      administered daily was hypothesized to prevent noninfectious pneumonitis (NIP) 
      and mucositis, two common adverse events related to everolimus. Although 
      mucositis was detected in only one case, all-grade NIP occurred in four of eight 
      cases (50%), and this was considered enough to stop accrual of the study.These 
      data suggest the need for careful monitoring of patients receiving everolimus who 
      are treated with corticosteroids. BACKGROUND: Everolimus is standard of care in 
      the treatment of patients affected by metastatic renal cell carcinoma (mRCC) that 
      has progressed after at least one previous line of treatment. Stomatitis and 
      noninfectious pneumonitis (NIP) are common adverse events (AEs) in patients 
      treated with everolimus. Prednisone could reduce the incidence of stomatitis, and 
      it is commonly used to treat NIP. We hypothesized that low doses of prednisone 
      could reduce the incidence and/or the severity of everolimus-induced NIP and 
      stomatitis. METHODS: We have conducted an open-label, single-arm, phase II trial 
      of prednisone 5 mg b.i.d. added to everolimus 10 mg/day in patients with mRCC. We 
      planned to evaluate the safety, tolerability, and activity of this combination in 
      mRCC patients. We aimed to reduce incidence of drug discontinuations due to 
      stomatitis or NIP from 25% to 10%. RESULTS: Three (38%) of the first eight 
      patients enrolled experienced grade >/=2 pneumonitis and stopped treatment. Grade 1 
      stomatitis occurred in only one patient (13%). Five of eight patients experienced 
      disease progression at the 2-month evaluation. Two patients (25%) were reported 
      free of disease progression at 1 year of treatment. CONCLUSION: The incidence of 
      NIP in these patients was considered too high for completing accrual of this 
      study. These results may be of interest for investigating the pathogenesis of NIP 
      and suggest that patients should be carefully followed if treated with chronic 
      corticosteroids while receiving everolimus.
CI  - (c) AlphaMedPress; the data published online to support this summary is the 
      property of the authors.
FAU - Lolli, Cristian
AU  - Lolli C
AD  - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Galla, Valentina
AU  - Galla V
AD  - Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo 
      Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Schepisi, Giuseppe
AU  - Schepisi G
AD  - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Barone, Domenico
AU  - Barone D
AD  - Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori 
      (IRST) IRCCS, Meldola, Italy.
FAU - Burgio, Salvatore Luca
AU  - Burgio SL
AD  - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Maugeri, Antonio
AU  - Maugeri A
AD  - Oncology Pharmacy Laboratory, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Vertogen, Bernadette
AU  - Vertogen B
AD  - Unit of Biostatistics and Clinical Trials, Istituto Scientifico Romagnolo per lo 
      Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Amadori, Dino
AU  - Amadori D
AD  - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FAU - De Giorgi, Ugo
AU  - De Giorgi U
AD  - Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy ugo.degiorgi@irst.emr.it.
LA  - eng
SI  - ClinicalTrials.gov/NCT02479490
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20170525
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Antineoplastic Agents)
RN  - 9HW64Q8G6G (Everolimus)
RN  - VB0R961HZT (Prednisone)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*adverse effects/therapeutic use
MH  - Carcinoma, Renal Cell/*drug therapy/pathology
MH  - Everolimus/*adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Kidney Neoplasms/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Mucositis/chemically induced/prevention & control
MH  - Pneumonia/*chemically induced/prevention & control
MH  - Prednisone/administration & dosage/*therapeutic use
MH  - Treatment Outcome
PMC - PMC5507652
EDAT- 2017/05/27 06:00
MHDA- 2018/03/31 06:00
PMCR- 2017/05/25
CRDT- 2017/05/27 06:00
PHST- 2017/03/03 00:00 [received]
PHST- 2017/04/04 00:00 [accepted]
PHST- 2017/05/27 06:00 [pubmed]
PHST- 2018/03/31 06:00 [medline]
PHST- 2017/05/27 06:00 [entrez]
PHST- 2017/05/25 00:00 [pmc-release]
AID - theoncologist.2017-0154 [pii]
AID - ONCO12159 [pii]
AID - 10.1634/theoncologist.2017-0154 [doi]
PST - ppublish
SO  - Oncologist. 2017 Jul;22(7):784-e74. doi: 10.1634/theoncologist.2017-0154. Epub 
      2017 May 25.