PMID- 37345082
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 15
IP  - 10
DP  - 2023 May 13
TI  - Efficacy and Safety of First-Line Cytokines versus Sunitinib and Second-Line 
      Axitinib for Patients with Metastatic Renal Cell Carcinoma (ESCAPE Study): A 
      Phase III, Randomized, Sequential Open-Label Study.
LID - 10.3390/cancers15102745 [doi]
LID - 2745
AB  - BACKGROUND: The sequence of first-line cytokine and second-line molecular 
      targeted therapies may be suitable for some patients with metastatic renal cell 
      carcinoma (mRCC) because of the expectation of complete remission and durable 
      response achieved with cytokine therapy. METHODS: This was a phase III randomized 
      controlled trial investigating the outcomes of low-dose interleukin-2 (IL-2) plus 
      interferon alfa (IFNalpha) versus sunitinib as the first line and axitinib as the 
      second line in patients with low- and intermediate-risk mRCC. RESULTS: 
      Thirty-five patients were randomly assigned. The total progression-free survival 
      (PFS) to the end of the second line was 29.0 months (95% CI, 11.7-46.3) in the 
      IL-2 + IFNalpha group and 16.3 months (95% CI, 6.3-26.4) in the sunitinib group. The 
      PFS hazard ratio for the IL-2 + IFNalpha group relative to the sunitinib group was 
      0.401 (95% CI, 0.121-1.328; p = 0.135). The hazard ratio for overall survival 
      (OS) was 1.675 (95% CI, 0.418-6.705; p = 0.466), which was better in the 
      sunitinib group than in the IL-2 + IFNalpha group but not statistically significant. 
      The types of adverse events (AEs) differed significantly, although there was no 
      significant difference in the incidence of AEs. CONCLUSIONS: There was a trend 
      toward better total PFS for IL-2 + IFNalpha, but it was not significant. There was 
      also no advantage of IL-2 + IFNalpha in terms of OS. The study was underpowered to 
      draw any definitive conclusions. The results showed no clear advantage of IL-2 + 
      IFNalpha over sunitinib in the first-line setting; however, it may be an option in 
      some relatively low-risk mRCC cases due to the difference in the AE profile. This 
      trial was registered with the University Hospital Medical Information Network 
      (UMIN), center identifier UMIN 000012522.
FAU - Kadono, Yoshifumi
AU  - Kadono Y
AUID- ORCID: 0000-0001-5780-4032
AD  - Department of Integrative Cancer Therapy and Urology, Kanazawa University 
      Graduate School of Medical Science, Kanazawa 920-8640, Japan.
FAU - Konaka, Hiroyuki
AU  - Konaka H
AD  - Department of Integrative Cancer Therapy and Urology, Kanazawa University 
      Graduate School of Medical Science, Kanazawa 920-8640, Japan.
AD  - Department of Urology, Japanese Red Cross Society Kanazawa Hospital, Kanazawa 
      921-8162, Japan.
FAU - Nohara, Takahiro
AU  - Nohara T
AD  - Department of Integrative Cancer Therapy and Urology, Kanazawa University 
      Graduate School of Medical Science, Kanazawa 920-8640, Japan.
FAU - Izumi, Kouji
AU  - Izumi K
AUID- ORCID: 0000-0002-8480-9100
AD  - Department of Integrative Cancer Therapy and Urology, Kanazawa University 
      Graduate School of Medical Science, Kanazawa 920-8640, Japan.
FAU - Anai, Satoshi
AU  - Anai S
AD  - Department of Urology, Nara Medical University, Kashihara 634-8522, Japan.
FAU - Fujimoto, Kiyohide
AU  - Fujimoto K
AUID- ORCID: 0000-0003-1507-2464
AD  - Department of Urology, Nara Medical University, Kashihara 634-8522, Japan.
FAU - Koguchi, Tomoyuki
AU  - Koguchi T
AD  - Department of Urology, Fukushima Medical University School of Medicine, Fukushima 
      960-1295, Japan.
FAU - Ishibashi, Kei
AU  - Ishibashi K
AD  - Department of Urology, Fukushima Medical University School of Medicine, Fukushima 
      960-1295, Japan.
AD  - Ishibashi Urology Clinic, Koriyama 963-8002, Japan.
FAU - Kawai, Noriyasu
AU  - Kawai N
AUID- ORCID: 0000-0002-2257-3892
AD  - Department of Nephro-urology, Nagoya City University Graduate School of Medical 
      Sciences, Nagoya 467-8601, Japan.
FAU - Nakane, Keita
AU  - Nakane K
AUID- ORCID: 0000-0002-2589-1722
AD  - Department of Urology, Gifu University Graduate School of Medicine, Gifu 
      501-1194, Japan.
FAU - Iba, Akinori
AU  - Iba A
AD  - Department of Urology, Wakayama Medical University, Wakayama 641-8509, Japan.
FAU - Masumori, Naoya
AU  - Masumori N
AD  - Department of Urology, Sapporo Medical University School of Medicine, Sapporo 
      060-8556, Japan.
FAU - Takahara, Shizuko
AU  - Takahara S
AUID- ORCID: 0009-0003-4752-248X
AD  - Innovative Clinical Research Center (iCREK), Kanazawa University Hospital, 
      Kanazawa 920-8641, Japan.
FAU - Mizokami, Atsushi
AU  - Mizokami A
AUID- ORCID: 0000-0002-5643-2182
AD  - Department of Integrative Cancer Therapy and Urology, Kanazawa University 
      Graduate School of Medical Science, Kanazawa 920-8640, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230513
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC10216557
OTO - NOTNLM
OT  - axitinib
OT  - cytokine
OT  - interferon alfa
OT  - interleukin-2
OT  - metastatic renal cell carcinoma
OT  - sunitinib
COIS- The authors declare no conflict of interest.
EDAT- 2023/06/22 06:42
MHDA- 2023/06/22 06:43
PMCR- 2023/05/13
CRDT- 2023/06/22 01:00
PHST- 2023/01/30 00:00 [received]
PHST- 2023/03/25 00:00 [revised]
PHST- 2023/05/12 00:00 [accepted]
PHST- 2023/06/22 06:43 [medline]
PHST- 2023/06/22 06:42 [pubmed]
PHST- 2023/06/22 01:00 [entrez]
PHST- 2023/05/13 00:00 [pmc-release]
AID - cancers15102745 [pii]
AID - cancers-15-02745 [pii]
AID - 10.3390/cancers15102745 [doi]
PST - epublish
SO  - Cancers (Basel). 2023 May 13;15(10):2745. doi: 10.3390/cancers15102745.