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BACKGROUND: Research waste is a considerable problem in clinical trials, with nonpublication being a significant contributor. We aimed to determine the prevalence of discontinuation and nonpublication of randomized controlled trials (RCTs) on cervical cancer or precancer. METHODS: We searched ClinicalTrials.gov for registered RCTs investigating cervical cancer or precancer that started between January 2000 and December 2020. The primary and secondary outcomes were trial nonpublication and premature discontinuation, respectively. Publication status was determined by systematic searches of peer-reviewed journals using the PubMed and Scopus databases. RESULTS: A total of 113 RCTs met the inclusion criteria. Among the 85 trials completed before December 2020, 44 (51.8%) were prematurely discontinued and 40 (47.1%) were unpublished. A single-center design (61.4% vs. 34.1%, P = .012) and lack of external funding (59.1% vs. 36.6%, P = .038) were significantly associated with trial discontinuation. Large-scale (target sample size >400; 46.7% vs. 17.5%, P = .004) and externally funded trials (66.7% vs. 35.0%, P = .004) were more likely to be published. Multivariate logistic analysis revealed that a large sample size [odd ratio (OR): 4.125, 95% confidence interval (CI): 1.511-11.259, P = .006] and presence of external funding (OR: 3.714, 95% CI: 1.513-9.117, P = .004) were independent positive factors for trial publication. CONCLUSION: A significant proportion of RCTs related to cervical cancer or precancer were discontinued early or remain unpublished, resulting in a waste of research resources.
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PURPOSE: Systemic inflammation and body composition are associated with survival outcomes of cancer patients. This study aimed to examine the combined prognostic value of systemic inflammatory markers and body composition parameters in patients with locally advanced cervical cancer (LACC). METHODS: Patients who underwent concurrent chemoradiotherapy (CCRT) for LACC at a tertiary referral teaching hospital between January 2010 and January 2018 were enrolled. A predictive model was established based on systemic immune-inflammation index (SII) and computer tomography-derived visceral fat-to-muscle ratio (vFMR). Overall survival (OS) and progression-free survival (PFS) were assessed using the Kaplan-Meier method and Cox regression models. The model performance was assessed using discrimination, calibration, and clinical usefulness. RESULTS: In total, 212 patients were enrolled. The SII and vFMR were closely related, and both independently predicted survival (P < 0.05). A predictive model was established based on the above biomarkers and included three subgroups: high-risk [both high SII (>828) and high vFMR (>1.1)], middle-risk (either high SII or high vFMR), and low-risk (neither high SII nor high vFMR). The 3-year OS (PFS) rates for low-, middle-, and high-risk patients were 90.5% (86.0%), 73.9% (58.4%), and 46.8% (36.1%), respectively (P < 0.05). This model demonstrated satisfactory predictive accuracy (area under the curve values for predicting 3-year OS and PFS were 0.704 and 0.718, respectively), good fit (Hosmer-Lemeshow tests: P > 0.05), and clinical usefulness. CONCLUSION: Systemic inflammatory markers combined with body composition parameters could independently predict the prognosis of patients with LACC, highlighting the utilization of commonly collected indicators in decision-making processes. CLINICAL SIGNIFICANCE: The SII and vFMR, as well as their composite indices, were promising prognostic factors in patients with LACC who received definitive CCRT. Future studies are needed to explore novel therapies to improve the outcomes in high-risk patients.
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Objective: To explore the clinical efficacy of sodium cantharidate vitamin B6 combined with concurrent chemoradiotherapy in the treatment of local advanced cervical cancer and its influence on tumor markers. Methods: A total of 120 patients with locally advanced cervical cancer were enrolled at our hospital from January 2021 to December 2022, and these cases were randomly divided into two groups using a random number table method. The control group was treated with concurrent chemoradiotherapy, while the study group was treated with sodium cantharidate vitamin B6 on the basis of the control group. The clinical efficacy, changes in self-immune function (CD3+, CD4+, CD4+/CD8+ cells ratio), tumor marker levels [Squamous Cell Carcinoma Antigen (SCCA), Carbohydrate Antigen 125 (CA125), Carcinoembryonic Antigen (CEA)], quality of life (Nottingham Health Profile questionnaire), and incidence of adverse events were compared between the two groups. Results: After treatment, there was no significant difference in the overall efficacy and disease control rates between the two groups (P > .05). Before treatment, there was no difference in auto-immune function between the two groups (P > .05). However, after treatment, the study group showed a significant improvement in auto-immune function, and when compared to the control group, the levels of CD3+, CD4+ cells, and the ratio of CD4+/CD8+ cells were higher in the study group (P < .05). Before treatment, there was no difference in tumor markers between the two groups (P > .05). While after treatment, tumor markers in both groups decreased significantly, and in comparison to the control group, the levels of SCCA, CA125, and CEA in the study group were lower (P < .05). Before treatment, there was no significant difference in the quality of life between the two groups (P > .05). However, after treatment, the quality of life in both groups improved, and the study group had a higher quality of life score than the control group (P < .05). There was no significant difference in thrombocytopenia between the two groups (P > .05). The total incidence of leukopenia, neutropenia, and radio-chemotherapy-related gastroenteritis in the study group was lower than that in the control group (P < .05). Conclusions: Sodium cantharidate vitamin B6 combined with concurrent chemoradiotherapy in the treatment of local advanced cervical cancer can not only effectively enhance the autoimmune function, downregulate the level of tumor markers, and improve the quality of patient life, but also cause relatively few adverse reactions.
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OBJECTIVE: Surgical quality plays a vital role in the treatment of malignant tumors. We investigated the classification of intraoperative adverse events (iAE) (ClassIntra) in relation to the surgical quality control of laparoscopic radical hysterectomies. METHODS: A prospective cohort of 195 patients who had undergone laparoscopic radical hysterectomies for early stage cervical cancer between July 2019 and July 2021 was enrolled. Participants were classified into either an iAE or non-iAE groups in accordance with their intraoperative status. Surgical outcomes, patient satisfaction, and quality of life were compared between the two groups. RESULTS: Overall, 48 (24.6%) patients experienced 71 iAE. The iAE group was associated with significantly longer operative times (mean: 270 vs. 245 min, P < 0.001), greater blood loss (mean: 215 vs. 120 mL, P < 0.001), and longer postoperative hospital stays (median: 16 vs. 11 days). Larger tumors and poor technical performance significantly increased the risk of iAE (P < 0.05). Multivariate analysis revealed that iAE were the only independent risk factors for postoperative complications (hazard ratio, 15.100; 95% confidence interval: 4.735-48.158, P < 0.001). Moreover, patients who experienced iAE had significantly lower satisfaction scores and poorer quality of life (P < 0.05). CONCLUSIONS: ClassIntra may serve as an effective adjunctive tool for surgical quality control in laparoscopic radical hysterectomies.