JCO: Pegilo decakin and FOLFOX second-line therapy failed to improve the efficacy of giesythabin incurable metastatic pancreatic cancer

Pegilodecakin (PEG) combined calcium folate, fluorouracil and FOLFOX for second-line treatment of Gisitabin refractional pancreatic cancer (PDAC), failed to improve its OS, PFS or ORR, and no new safety signals were observed.
but the exploratory pharmacodynamic results of FOLFOX were consistent with the immunostatious signals of the IL-10R pathway, and there was no significant increase in IFN-γ, granulase B and IL-18 compared to PEG and FOLFOX solutions.
the study's Phase III. study was published online Feb. 8.
this global Phase III. randomized study is designed to detect OS and assess security.
the study, between March 1, 2017 and September 9, 2019, 567 patients were randomly assigned PEG and FOLFOX (n s 283) or FOLFOX (n s 284).
94.7 per cent of patients received gisithambin combined nab yew alcohol treatment.
well balanced for all baseline disease characteristics between the two groups.
analyzed the final OS using the September 9, 2019 deadline.
follow-up time was 15.0 months for the PEG and FOLFOX groups, while the medium follow-up time for the FOLFOX group was 14.5 months.
the median OS for PEG and FOLFOX (5.8 months) and FOLFOX (6.3 months), HR is 1.045 (95% CI, 0.863-1.265), with an estimated OS rate of 14.7% over a one-year period, according to Kaplan-Meier.
19.1% of the PEG, FOLFOX and FOLFOX groups.
analyzed the final OS using the September 9, 2019 deadline.
follow-up time was 15.0 months in the PEG and FOLFOX groups, while the medium follow-up time in the FOLFOX group was 14.5 months.
the median OS for PEG and FOLFOX (5.8 months) and FOLFOX (6.3 months), HR is 1.045 (95% CI, 0.863-1.265), with an estimated OS rate of 14.7% over a one-year period, according to Kaplan-Meier.
19.1% of the PEG and FOLFOX groups and FOLFOX groups.
two groups of PFS were 2.1 months old and there was no significant difference (HR s 0.918; 95% CI, 0.808-1.190).
two orRs (4.6% v 5.6%) also did not differ significantly.
cries were not observed in any of the treatment groups.
reaction duration and reaction time between the two groups are similar.
compared to FOLFOX, the most common treatment-related adverse events were thyroid reduction (55% v 20%), anemia (40% v 16%), fatigue (61% v 45%), and neutral granules Cell reduction (39 per cent v28 per cent), abdominal pain (37 per cent v 29 per cent), nausea (45 per cent v 41 per cent), neuropathy (37 per cent v 38 per cent) and loss of appetite (35 per cent v 31 per cent).
74.5% (394/529) of patients with level 3 or above of TEAE.
compared to FOLFOX, the more common adverse events of PEG and FOLFOX are plate reduction, anemia (, neutral granulocyte reduction, and fatigue).
combination of PEG and FOLFOX showed safety consistent with previous safety observed in PDAC patients in phase I.I. studies (IVY).
, however, combined therapy was more toxic overall than using FOLFOX alone.
analysis showed that the cytokine levels were comparable between FOLFOX and PEG and FOLFOX.
PEG and FOLFOX at C1D13, C2D13 and C4D13 have increased both the particle enzyme B, IFN gamma and IL-18 than the baseline, while FOLFOX has not observed this change.
treatment options for the second-tier Gissythabin incurable metastasis PDAC are still not progressing well.
addition of FOLFOX to PEG does not improve the efficacy of late Gissythabin refrapsion PDAC.
results are consistent with previous observations in PEG chemotherapy, toxicity is controllable and tolerable.
the exploratory pharmacodynamic results of FOLFOX were consistent with the immunostatious signals of the IL-10R pathway.
, although the safety and validity data for phase I studies using PEG and FOLFOX for IVY are encouraging, the results of SEQUOIA did not show improvements in OS, PFS, or ORR in this large randomized Phase III trial.
Reference:J. Randolph Hecht, Sara Lonardi, Johanna Bendell,et al. Randomized Phase III Study of FOLFOX Alone or With Pegilodecakin as Second-Line Therapy in Patients With Metastatic Pancreatic Cancer That Progressed After Gemcitabine (SEQUOIA). published on February 8, 2021. DOI:10.1200/JCO.20.02232 Journal of Clinical Oncology.MedSci Original Source: MedSci Original Copyright Notice: All Notes on this website Source: Met Medical Or "Source: MedSci Original" text, images and audio-visual materials, copyrights are owned by Metz Medicine, without authorization, no media, website or individual may reproduce, authorized to reproduce with the words "Source: Mets Medicine".
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