FIGO Classification 2018: Validation Study in Patients With Locally Advanced Cervix Cancer Treated With Chemoradiation

Raut, Atul; Chopra, Supriya; Mittal, Prachi; Patil, Gayatri; Mahantshetty, Umesh; Gurram, Lavanya; Swamidas, Jamema; Ghosh, Jaya; Gulia, Seema; Popat, Palak; Deodhar, Kedar; Maheshwari, Amita; Gupta, Sudeep

doi:10.1016/j.ijrobp.2020.07.020

Cited by 17 publications

(17 citation statements)

References 17 publications

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“…CT scanning, which is a sufficiently accurate tool for assessing lymph node involvement and distant metastasis, is more commonly used in LMICs. Raut et al [12] reported the outcomes of lymph node-positive disease in regular clinic settings where most patients underwent CT scans for staging purposes [12]. If these modalities are not available, then a chest X-ray is often used instead to rule out distant metastasis to the lungs prior to treatment and endoscopy (cystoscopy and proctoscopy) is used to assess adjacent organ extension.…”

Section: Imaging Modalities For Stagingmentioning

confidence: 99%

Incidence, Treatment and Outcomes of Cervical Cancer in Low- and Middle-income Countries

et al. 2021

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Section: Imaging Modalities For Stagingmentioning

confidence: 99%

Incidence, Treatment and Outcomes of Cervical Cancer in Low- and Middle-income Countries

et al. 2021

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“…Tumor size is closely related to the prognosis of cervical cancer patients 26 - 28 . However, in our study, the mid-RT tumor regression rates were similar between the CR and PR group, and significant differences were seen only after the end of treatment.…”

Section: Discussionmentioning

confidence: 99%

Methylation of PAX1 gene promoter in the prediction of concurrent chemo-radiotherapy efficacy in cervical cancer

Li¹,

Zhou²,

Zeng³

et al. 2021

J. Cancer

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Objectives: Cervical cancer is the fourth leading cause of cancer death among women worldwide. In currently, aberrant methylation of PAX1 is found in variety of solid tumors, including cervical cancer. In addition, the role of PAX1 gene methylation in cervical cancer and precancerous lesions screening has been confirmed in previous study. Here, we evaluated the predictive value of PAX1 methylation in concurrent chemo-radiotherapy (CCRT) outcomes in cervical cancer. Methods: This study enrolled 82 cervical cancer patients from August 2018 to August 2020. We compared the clinical results between different PAX1 methylation status. Hyper-methylation patients were subjects to MRI and quantitative methylation-specific PCR (QMSP) for PAX1 before, in the middle, immediately after, 1 month and 3 months after CCRT. The changes in PAX1 methylation during CCRT were analyzed. Results: The lower PAX1 methylation status were related to a poor tumor response. Based on the MRI findings three months post-treatment, the hypermethylated patients were classified into the complete response (CR; n=50) and partial remission (PR; n=18) groups. The average PAX1 △Cp value of CR and PR groups before radiotherapy was 5.08±1.98 and 4.32±2.00 respectively, and after concurrent chemo-radiotherapy was significantly increased to 17.35±4.96 and 16.99±6.17, respectively (P<0.05). Furthermore, the PAX1 △Cp value between CR and PR groups were significantly different at mid-treatment and performed well in predicting short-term efficacy (AUC 0.84) in this period, and its sensitivity and specificity for predicting PR were 0.72 and 0.88, respectively. Conclusion: The PAX1 methylation level may predict the sensitivity and efficacy of CCRT in cervical cancer.

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“…The study’s primary endpoint is 3-year DFS which will be defined as time in months from date of randomization to date of any recurrence/relapse/death due to any cause. This is a superiority trial design that intends to demonstrate a 3-year improvement in DFS from 65%6 9 39 to 75%. Using a group sequential design, considering a HR of 0.66, 1:1 randomisation is planned.…”

Section: Methods and Analysismentioning

confidence: 99%

“…Chemoradiation results in 5-year overall survival (OS) of approximately 50%–55% in stage III LACC 5. The 3-year disease-free survival (DFS) ranges from 61% to 74% 6. Since chemoradiation trials, further improvement in local control and DFS is also reported by integrating image-based brachytherapy and radiation dose escalation.…”

Section: Introductionmentioning

confidence: 99%

Concurrent chemoradiation and brachytherapy alone or in combination with nelfinavir in locally advanced cervical cancer (NELCER): study protocol for a phase III trial

et al. 2022

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IntroductionIn locally advanced cervical cancer, nodal, local and distant relapse continue to be significant patterns of relapse. Therefore, strategies to improve the efficacy of chemoradiation are desirable such as biological pathway modifiers and immunomodulating agents. This trial will investigate the impact of nelfinavir, a protease inhibitor that targets the protein kinase B (AKT) pathway on disease-free survival (DFS).Methods and analysisRadiosensitising effect of nelfinavir in locally advanced carcinoma of cervix is a single-centre, open-label, parallel-group, 1:1 randomised phase-III study. Patients aged over 18 years with a diagnosis of carcinoma cervix stage III are eligible for the study. After consenting, patients will undergo randomisation to chemoradiation and brachytherapy arm or nelfinavir with chemoradiation and brachytherapy arm. The primary aim of the study is to compare the difference in 3-year DFS between the two arms. Secondary aims are locoregional control, overall survival, toxicity and quality of life between the two arms. Pharmacokinetics of nelfinavir and its impact on tumour AKT, programmed cell death ligand 1, cluster of differentiation 4, cluster of differentiation 8 and natural killer 1.1 expression will be investigated. The overall sample size of 348 with 1 planned interim analysis achieves 80% power at a 0.05 significance level to detect a HR of 0.66 when the proportion surviving in the control arm is 0.65. The planned study duration is 8 years.Ethics and disseminationThe trial is approved by the Institutional Ethics Committee-I of Tata Memorial Hospital, Mumbai (reference number: IEC/0317/1543/001) and will be monitored by the data safety monitoring committee. The study results will be disseminated via peer-reviewed scientific journals, and conference presentations. Study participants will be accrued after obtaining written informed consent from them. The confidentiality and privacy of study participants will be maintained.Trial registration numberThe trial is registered with Clinical Trials Registry-India (CTRI/2017/08/009265) and ClinicalTrials.gov (NCT03256916).

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FIGO Classification 2018: Validation Study in Patients With Locally Advanced Cervix Cancer Treated With Chemoradiation

Cited by 17 publications

References 17 publications

Incidence, Treatment and Outcomes of Cervical Cancer in Low- and Middle-income Countries

Incidence, Treatment and Outcomes of Cervical Cancer in Low- and Middle-income Countries

Methylation of PAX1 gene promoter in the prediction of concurrent chemo-radiotherapy efficacy in cervical cancer

Concurrent chemoradiation and brachytherapy alone or in combination with nelfinavir in locally advanced cervical cancer (NELCER): study protocol for a phase III trial

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