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@ARTICLE{Zhou:278582,
      author       = {X. Zhou and L. Zhou and Z. Yao and M. Huang and Y. Gong and
                      B. Zou and J. Zhu and Y. Liu and F. Peng and Y. Zhang and M.
                      Yu and Y. Li and F. Na and Y. Wu and K. Kang and W. Xiu and
                      X. Zhang and L. Zhou and Y. Xu and J. Wang and Y. Wang and
                      X. Yang and Y. Wu and R. Li and Y. Zhang and Z. Yang and Z.
                      Zhou and J. Bai and X. Yi and R. Tong and L. Yin and C. Chen
                      and G. Niedermann$^*$ and Y. Lu and J. Xue},
      title        = {{S}afety and {T}olerability of {L}ow-{D}ose {R}adiation and
                      {S}tereotactic {B}ody {R}adiotherapy + {S}intilimab for
                      {T}reatment-{N}aive {S}tage {IV} {PD}-{L}1+
                      {N}on-{S}mall-{C}ell {L}ung {C}ancer {P}atients.},
      journal      = {Clinical cancer research},
      volume       = {29},
      number       = {20},
      issn         = {1078-0432},
      address      = {Philadelphia, Pa. [u.a.]},
      publisher    = {AACR},
      reportid     = {DKFZ-2023-01663},
      pages        = {4098-4108},
      year         = {2023},
      note         = {2023 Oct 13;29(20):4098-4108},
      abstract     = {Low-dose radiation therapy (LDRT) may enhance the
                      synergistic anti-tumor effect of combined immunotherapy and
                      stereotactic body radiation therapy (SBRT). The safety and
                      efficacy of this novel triple-combination therapy were
                      evaluated for the first time as first-line treatment for
                      patients with metastatic non-small-cell lung cancer
                      (NSCLC).This prospective phase 1 study enrolled 29 patients
                      and included a dose-escalation and dose-expansion phase.
                      Patients received SBRT (30 Gy/3f) to small lesions and LDRT
                      (2 Gy/1f, 4 Gy/2f, or 10 Gy/5f) to a large lesion
                      concurrently, followed by sintilimab (a PD-1 inhibitor). The
                      primary endpoint was safety and tolerability; secondary
                      endpoints included objective response rate (ORR),
                      progression-free survival (PFS), and overall survival
                      (OS).No dose-limiting toxicities were observed during the
                      dose-escalation phase; 4 Gy/2f was the recommended LDRT
                      dose. Median follow-up was 15.6 months. Treatment-related
                      adverse events (TRAEs) occurred in $96.6\%$ (28/29) of
                      patients (grade ≥ 3, $20.7\%$ [6/29]); two patients
                      $(6.9\%)$ discontinued due to TRAEs. Seven patients
                      experienced pneumonitis (grade 2, n = 6; grade 3, n = 1).
                      Immune-related adverse events were noted in $58.6\%$ (17/29)
                      of patients. In patients with tumor assessment (n = 28), ORR
                      and confirmed ORR were $60.7\%$ and $57.1\%,$ respectively.
                      Median PFS was 8.6 months $(95\%$ confidence interval
                      3.7-16.5), and median OS was not reached. Exploratory
                      analyses suggested both expanded and newly emerging TCR
                      clonotypes were associated with better PFS.The findings
                      indicate that the novel SBRT + LDRT + sintilimab therapy is
                      safe and promising in patients with PD-L1-positive, driver
                      gene-negative primary metastatic NSCLC.},
      cin          = {FR01},
      ddc          = {610},
      cid          = {I:(DE-He78)FR01-20160331},
      pnm          = {899 - ohne Topic (POF4-899)},
      pid          = {G:(DE-HGF)POF4-899},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:37581611},
      doi          = {10.1158/1078-0432.CCR-23-0315},
      url          = {https://inrepo02.dkfz.de/record/278582},
}