PMID- 23359179
OWN - NLM
STAT- MEDLINE
DCOM- 20140324
LR  - 20240109
IS  - 1699-3055 (Electronic)
IS  - 1699-048X (Linking)
VI  - 15
IP  - 9
DP  - 2013 Sep
TI  - Phase II trial of sequential subcutaneous interleukin-2 plus interferon alpha 
      followed by sorafenib in renal cell carcinoma (RCC).
PG  - 698-704
LID - 10.1007/s12094-012-0991-z [doi]
AB  - PURPOSE: Immunotherapy (IL-2 and INF-alpha) was the treatment of choice for advanced 
      renal cell carcinoma (RCC) until antiangiogenic therapy with tyrosin kinase 
      inhibitors was developed in the early 2000s. This clinical trial explored the 
      efficacy and toxicity of sequential treatment of IL-2 plus INF-alpha followed by 
      sorafenib. METHODS: Eligibility criteria included measurable, non-resectable, 
      histologically confirmed predominantly clear cell RCC, no prior systemic 
      treatment, and ECOG PS 0-2. The treatment regimen was a 6-week cycle of 
      subcutaneous IL-2 at 9 x 10(6) IU on days 1-6 of weeks 1, 2, 4 and 5 plus s.c. 
      INF-alpha at 6 x 10(6) IU on days 1, 3 and 5 of weeks 1-6. Responders received 6 
      additional weeks of this regimen. All patients received oral sorafenib (400 mg 
      bid) after immunotherapy until disease progression. The primary endpoint was 
      progression-free survival. RESULTS: Forty-one patients were enrolled, median age 
      57 years. ECOG was 0/1 in 17/20 patients, 35 patients had prior nephrectomy and 
      18 patients pure clear cell cancer. Median PFS was 7.4 months (95 % CI 6.5-13.1) 
      and OS was 16.6 months (95 % CI not reached). In 36 patients evaluable for 
      response, ORR was 44.4 % and control rate was 94.4 %. Most adverse events (AEs) 
      were Grade 1 or 2 toxicities (84.7 %). During immunotherapy the most common AEs 
      were pyrexia (82.9 %), asthenia (56.1 %) and anorexia (46.3 %), whereas during 
      sorafenib were diarrhoea (48.8 %) and hand-foot syndrome (46.3 %). CONCLUSIONS: A 
      sequential regimen of IL-2 and INF-alpha followed by sorafenib showed effectiveness 
      and manageable toxicity in patients with advanced RCC.
FAU - Maroto, J P
AU  - Maroto JP
AD  - Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08025, Barcelona, Spain. 
      jmaroto@santpau.cat
FAU - del Muro, X G
AU  - del Muro XG
FAU - Mellado, B
AU  - Mellado B
FAU - Perez-Gracia, J L
AU  - Perez-Gracia JL
FAU - Andres, R
AU  - Andres R
FAU - Cruz, J
AU  - Cruz J
FAU - Gallardo, E
AU  - Gallardo E
FAU - Domenech, M
AU  - Domenech M
FAU - Arranz, J A
AU  - Arranz JA
FAU - Meana, J A
AU  - Meana JA
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130129
PL  - Italy
TA  - Clin Transl Oncol
JT  - Clinical & translational oncology : official publication of the Federation of 
      Spanish Oncology Societies and of the National Cancer Institute of Mexico
JID - 101247119
RN  - 0 (Interferon-alpha)
RN  - 0 (Interleukin-2)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 9ZOQ3TZI87 (Sorafenib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Carcinoma, Renal Cell/*drug therapy/therapy
MH  - Combined Modality Therapy/methods
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Female
MH  - Humans
MH  - Immunotherapy/methods
MH  - Interferon-alpha/*administration & dosage
MH  - Interleukin-2/*administration & dosage
MH  - Kidney Neoplasms/*drug therapy/therapy
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Niacinamide/administration & dosage/*analogs & derivatives
MH  - Phenylurea Compounds/*administration & dosage
MH  - Probability
MH  - Protein Kinase Inhibitors/*administration & dosage
MH  - Sorafenib
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2013/01/30 06:00
MHDA- 2014/03/25 06:00
CRDT- 2013/01/30 06:00
PHST- 2012/07/24 00:00 [received]
PHST- 2012/12/14 00:00 [accepted]
PHST- 2013/01/30 06:00 [entrez]
PHST- 2013/01/30 06:00 [pubmed]
PHST- 2014/03/25 06:00 [medline]
AID - 10.1007/s12094-012-0991-z [doi]
PST - ppublish
SO  - Clin Transl Oncol. 2013 Sep;15(9):698-704. doi: 10.1007/s12094-012-0991-z. Epub 
      2013 Jan 29.