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RECIST 1.1 versus clinico-radiological response assessment for locally advanced cervical cancer: implications on interpreting survival outcomes of future trials
  1. Mayuri Charnalia1,
  2. Supriya Chopra1,
  3. Jaahid Mulani1,
  4. Palak Popat2,
  5. Sushmita Rath3,
  6. Maarten Thomeer4,
  7. Prachi Mittal5,
  8. Ankita Gupta1,
  9. Ingrid Boere6,
  10. Sudeep Gupta7 and
  11. Remi A Nout8
    1. 1Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India
    2. 2Department of Radiodiagnosis, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
    3. 3Department of Medical Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
    4. 4Department of Radiology and Nuclear Medicine, Erasmus MC Cancer Centre, Rotterdam, Zuid-Holland, Netherlands
    5. 5Department of Radiation Oncology, Tata Memorial Hospital, Tata Memorial Centre, Homi Bhabha National Institute, Mumbai, Maharashtra, India
    6. 6Department of Medical Oncology, Erasmus MC Cancer Centre, Rotterdam, Zuid-Holland, The Netherlands
    7. 7Department of Medical Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India
    8. 8Department of Radiotherapy, Erasmus MC Cancer Centre, Rotterdam, Zuid-Holland, Netherlands
    1. Correspondence to Dr Supriya Chopra, Department of Radiation Oncology, Advanced Centre for Treatment Research and Education in Cancer, Tata Memorial Centre, Homi Bhabha National Institute, Navi Mumbai, Maharashtra, India; schopra{at}actrec.gov.in; Dr Remi A Nout, Department of Radiation Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands; r.nout{at}erasmusmc.nl

    Abstract

    OBJECTIVE To investigate differences in standard clinico-radiological evaluation versus Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 for reporting survival outcomes in patients with locally advanced cervical cancer treated with chemoradiation and brachytherapy.

    METHODS Between November 2017 and March 2020, patients recruited in cervical cancer trials were identified. MRI at diagnosis and at least one follow-up imaging was mandatory. Disease-free survival and progression-free survival were determined using standard evaluation (clinical examination and symptom-directed imaging) and RECIST 1.1. Agreement between criteria was estimated using κ value. Sensitivity analysis was done to test the sensitivity, specificity, and accuracy of RECIST 1.1 in detecting response to treatment.

    RESULTS Sixty-nine eligible patients had at least one target lesion. Thirty-three patients (47.8%) had pathological lymph nodes. Of these 33 patients, RECIST 1.1 classified only 18% (6/33) as ‘target nodal lesions’ and the remaining nodes as ‘non-target’. There were 6 (8.7%) and 8 (11.6%) patients with disease events using RECIST 1.1 and standard evaluation, respectively. The disease-free survival at 12, 18, and 24 months using RECIST 1.1 was 94.2%, 91.2%, 91.2%, and with standard evaluation was 94.2%, 89.7%, and 88.2%, respectively (p=0.58). Whereas, progression-free survival at 12, 18, and 24 months using RECIST 1.1 and standard evaluation were same (94.2%, 91.2%, and 91.2%, respectively). The κ value was 0.84, showing strong agreement in assessing disease-free survival, although an absolute difference of 3% between endpoint assessment methodologies. RECIST 1.1 had a sensitivity of 75% (95% CI 34.91% to 96.81%), specificity of 100% (95% CI 94.13% to 100%), and accuracy of 97.1% (95% CI 89.92% to 99.65%).

    CONCLUSIONS The study showed 1.5% and 3% difference in disease-free survival at 18 and 24 months and no difference in progression-free survival between RECIST 1.1 and standard evaluation in a patient cohort with low event rate.

    • Cervical Cancer
    • Radiation Oncology

    Data availability statement

    Data are available upon reasonable request. Due to ongoing of index trial and confidentiality requirements, the data for this project are not available outside of the study team at Tata Memorial Hospital.

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    Data availability statement

    Data are available upon reasonable request. Due to ongoing of index trial and confidentiality requirements, the data for this project are not available outside of the study team at Tata Memorial Hospital.

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    Footnotes

    • X @DrPrachiMittal, @ACTREC_TMC

    • Presented at The manuscript was presented as a digital poster presentation at the European Society for Radiotherapy and Oncology 2022 conference.

    • Contributors MC: data curation, formal analysis, visualization, validation, writing - original draft, editing, guarantor. SC: conceptualization, methodology, data curation, formal analysis, visualization, validation, writing – original draft, review and editing, supervision, guarantor. JM: data curation, formal analysis, visualization, validation, writing - review and editing. PP, SR, MT, PM, AG, IB, SG: writing - review and editing. RAN: conceptualization, methodology, data curation, formal analysis, visualization, writing – original draft, review and editing, supervision, guarantor. SC and RAN contributed equally. All authors have approved the final version of the manuscript for submission.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.