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Platinum-based new complementary chemotherapy followed by delayed primary surgery (DPS) is a well-established treatment strategy for newly diagnosed advanced endoplastic ovarian cancer.
Although the treatment has been validated in randomized Phase 3 trials, there have been no reports of the use of solid tumor efficacy evaluation criteria 1.1 (RECIST) and tumor antigen 125 (CA125) to evaluate the efficacy of new complementary chemotherapy.
report in this paper the response of RECIST and Gynaecological Malignant Oncology Association (GCIG) CA125 in patients treated with platinum-based new complementary chemotherapy in the ICON8 trial.
ICON8 trial is an international, multi-center randomized Phase 3 trial that recruits newly diagnosed FIGO phased IC-I with ECOG performance status of 0-2 points and life expectancy of 12 weeks Patients with high-level slurry, transparent cells, or any lowly differentiated, or histological stage 3/FIGO IIB-IV ovaries, fallopian tubes, or primary peritina epithelial cell carcinoma were randomly treated in three groups.
the patients were strated according to GCIG, disease stages, and tumor cell reduction, as well as the prognostics.
June 11, 2011 - November 28, 2014, ICON8 recruited 1,566 women, 799 (50%) of whom were to undergo DPS therapy after new complementary chemotherapy.
followed up for 29.5 months (IQR 15.6-54.3) in the population treated with new assisted chemotherapy and DPS.
348 (62%) of the 564 patients assessed for RECIST received full or partial remission.
610 (84%) of the 727 patients who could be assessed at the time of diagnosis under the GCIG CA125 standard received CA125 remission.
progression-free survival was 14.4 months in patients with full or partial remission of RECIST and 13.3 months in patients with RECIST's stable condition.
progression-free survival was 13.8 months for patients with GCIG CA125 remission and 9.7 months for patients without GCIG CA125 remission.
187 (56%) of the 335 patients with complete or partial remission of RECIST received complete tumor cell reduction (R0), while 73 (42%) of the 172 patients with a stable RECIST course received complete tumor cell reduction.
50% (290/576) and 30% (30/101) of patients who received and did not receive GCIG CA125 remission received complete tumor cell reduction, respectively.
the imaging remission rate assessed by RECIST was lower than that of clinically commonly cited imaging remission.
RECIST and GCIG CA125 remission of endocyst ovarian cancer with new complementary chemotherapy cannot be used as predictive markers for individual patients to distinguish or benefit from DPS, but can be combined with the clinical characteristics of patients for tumor reduction.
patients cannot be operated on until RECIST or GCIG CA125 has not been alleviated.
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