RECIST 1.1 versus clinico-radiological response assessment for locally advanced cervical cancer : implications on interpreting survival outcomes of future trials
© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
International journal of gynecological cancer : official journal of the International Gynecological Cancer Society - (2024) vom: 22. Apr. |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Charnalia, Mayuri [VerfasserIn] |
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Date Revised 22.04.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1136/ijgc-2024-005336 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM371381711 |
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| 245 | 1 | 0 | |a RECIST 1.1 versus clinico-radiological response assessment for locally advanced cervical cancer |b implications on interpreting survival outcomes of future trials |
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| 500 | |a Citation Status Publisher | ||
| 520 | |a © IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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%) | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cervical Cancer | |
| 650 | 4 | |a Radiation Oncology | |
| 700 | 1 | |a Chopra, Supriya |e verfasserin |4 aut | |
| 700 | 1 | |a Mulani, Jaahid |e verfasserin |4 aut | |
| 700 | 1 | |a Popat, Palak |e verfasserin |4 aut | |
| 700 | 1 | |a Rath, Sushmita |e verfasserin |4 aut | |
| 700 | 1 | |a Thomeer, Maarten |e verfasserin |4 aut | |
| 700 | 1 | |a Mittal, Prachi |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Ankita |e verfasserin |4 aut | |
| 700 | 1 | |a Boere, Ingrid |e verfasserin |4 aut | |
| 700 | 1 | |a Gupta, Sudeep |e verfasserin |4 aut | |
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