Thermocoagulation versus cryotherapy for the treatment of cervical precancers.

AIM: To compare thermocoagulation and cryotherapy for treatment of high-grade cervical intraepithelial neoplasia (CIN). METHODS: From May 2017 to May 2018, women with CIN2/3 were randomized to thermocoagulation or cryotherapy at Peking University Shenzhen Hospital. Follow-up at 4 and 8 months included cytology and human papillomavirus (HPV) testing. Women who were HPV-positive or had atypical squamous cells of undetermined significance or higher-grade disease underwent colposcopy/biopsy. RESULTS: Among 149 women enrolled, 74 were randomized to thermocoagulation, and 75 to cryotherapy (excluded four were immediately referred for thermocoagulation due to large lesions). At follow-up, there was no difference between the thermocoagulation and cryotherapy groups in HPV-negative (4/8 months: 72.5%/86.2% vs 68.6%/80.6%) and pathology-negative (97.1%/98.5% vs 94.3%/92.3%) rates (all P > 0.05). The cytology-negative rate was similar for thermocoagulation and cryotherapy at 4 months (79.7% vs 78.9%, P > 0.05), but higher for thermocoagulation at 8 months (100% vs 88.7%, P < 0.05). No lesions were observed among the four referral women at follow-up. As compared with cryotherapy, thermocoagulation was associated with shorter duration of treatment and less vaginal discharge, but higher pain during application and longer bleeding after treatment. CONCLUSION: Thermocoagulation was as effective and safe as cryotherapy and might be easily applied to treat high-grade cervical lesions.

The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer.

OBJECTIVE: Evaluate the significance of BMRT HPV assay viral load and its performance for secondary screening. METHODS: BMRT-HPV reports type-specific viral loads/10,000 cells. We tested 1,495 physician collected, stored specimens from Chinese Multiple-center Screening Trial (CHIMUST), that were positive by Cobas, SeqHPV, and/or Cytology (≥LSIL); and 2,990 age matched, negatives in a nested case control study. We explored the relationship between BMRT HR-HPV viral load and cervical lesions, determined alternative CIN2+ cut-points by ROC curve, and evaluated BMRT HR-HPV for primary / secondary cervical cancer screening. RESULTS: The viral loads of HPV16/18, 12 other subtypes HR-HPV and 14 HR-HPV were statistically different in all grades of cervical lesions (P<0.05, among which HPV16, 33 and 58 showed the strongest relationship (P<0.01). The viral load of HR-HPV also increased with the grade of cervical lesions (P<0.05). The sensitivity for CIN2+ and CIN3+ of BMRT was comparable to Cobas (92.6% vs 94.3%, 100% vs 100%, P>0.05), specificity was higher than Cobas (84.8% vs 83.3%, 83.5% vs 82.0%, P<0.001). When using HPV16/18 viral load(log cut-point ≥3.2929), plus the viral-load of 12 other subtypes (log cut-point ≥3.9625) as secondary triage, compared with Cobas HPV16/18+ plus cytology ≥ASC-US as triage, the sensitivities for CIN2+ and CIN3+ were similar (P>0.05). However, the BMRT HR-HPV viral load combined with subtypes did not require cytology. CONCLUSION: BMRT is as sensitive as Cobas4800 for primary cervical cancer screening. BMRT HR-HPV viral load combined with subtypes can be used as a secondary strategy for cervical cancer screening, especially for areas with insufficient cytological resources.

The effectiveness of HPV viral load, reflected by Cobas 4800 HPV-Ct values for the triage of HPV-positive women in primary cervical cancer screening: Direct endocervical samples.

OBJECTIVE: To explore the relationship between the viral load reflected by the Ct value of Cobas 4800 HPV test and cervical lesions, and the effectiveness of the viral load for secondary triage of HPV-positive women. METHODS: The Chinese Multi-Center Screening Trial (CHIMUST) evaluated both self-collected samples and physician-collected samples from women, aged 30 to 59, who were screened for cervical cancer in 6 regions across China. Using physician collected samples, the relationship between the HPV-Ct values of different subtypes and the cervical lesions was analyzed. Then the combined use of the HPV-Ct values with the HPV subtypes was evaluated as a secondary screening algorithm for the women who were HPV positive. RESULTS: The Ct values of HPV16 and 12 other HPV subtypes(12-type pool), tested with Cobas decreased with the progression of cervical lesion (HPV16: r = -0.429, P<0.001; 12 other HR-HPV subtypes: r = -0.099, P<0.01). The HPV18-Ct value was not correlated with cervical lesion(P>0.05). Compared with HPV16/18 and cytology (HPV16/18 positive and 12-type pool plus cytology ≥ ASC-US), the sequential secondary screening using HPV16/18 and the viral load of 12-type pool (cut-point HPV-Ct≤31) had equal sensitivities for CIN2+ and CIN3+ (83.1%vs.80.3%,100%vs.92.6%,P>0.05), with slightly lower specificities (96.2%vs.94.4%,96.5%vs.93.9%,P<0.001) and higher colposcopy referral rate (4.90%vs.6.59%, P<0.05), but required no cytology. CONCLUSION: Type-specific HPV viral load is closely related to cervical lesions severity. It is feasible and efficient to use HPV16/18 and the viral load of 12 other HPV subtypes (with cut-point HPV-Ct≤31) as the secondary screening for HPV positive women. This algorithm may be useful in low resource regions.