Cervical intraepithelial neoplasia III: long-term follow-up after cold-knife conization with involved margins

Reich, Olaf; Lahousen, M.; Pickel, H.; Tamussino, Karl; Winter, Raimund

doi:10.1016/s0029-7844(01)01683-0

Cited by 87 publications

(80 citation statements)

References 14 publications

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“…Removing CIN does not necessarily eliminate persistence of the HPV infection as shown by the frequency of recurrence of CIN after LEEP [39]. Administration of immunotherapies such as HspE7 may be an attractive alternative to ablative surgical intervention for a subset of women with high-grade CIN yet identified.…”

Section: Discussionmentioning

confidence: 99%

Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III

Einstein

Kadish

Burk

et al. 2007

Gynecologic Oncology

129

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Objectives-SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7. This trial was designed to evaluate the efficacy and toxicities of HspE7 in women with CIN III.Methods-HIV (−) women with biopsy-proven CIN III were eligible. Two cohorts were accrued; one cohort to establish efficacy and a second cohort with a longer follow-up period to improve the precision of the trial to estimate response rates. Each patient underwent 3 monthly subcutaneous vaccinations with 500 µg of HspE7 followed by monthly colposcopic follow-up for 1 month in cohort 1 and an extended observation period (2 months) in cohort 2. All patients then underwent a LEEP or cone biopsy of the cervix. A complete pathologic response (pCR) was defined as no evidence of CIN or CIN I (only HPV changes). A partial response (PR) was defined as colposcopic lesion regression of >50% in size. Cervicovaginal lavage samples were obtained at each visit for HPV typing using MY09/ MY11 HPV PCR.Results-Seventy-two patients were registered and screened, of whom 64 were eligible. Fifty-eight patients completed the trial and were evaluable (31 in cohort 1, 27 in cohort 2). There were no significant epidemiologic or HPV type differences between the 2 cohorts so responses were combined for analysis. Of the 58 evaluable patients, 13 (22.5%) had a pCR; 32 (55%) had a PR and 11 (19%) had stable disease. Two (3.5%) patients in cohort 2 had microinvasive disease and were defined as progressive disease. Thirty-three of 58 (57%) of the patients were infected with HPV 16 prior to vaccination or in subsequent visits. There was no significant difference in regression in women infected with HPV 16 compared to those without HPV 16 infection (88% vs. 70%; p=0.12). Women who had a previous LEEP or ablation for CIN were 2.7 times more likely to have a complete response compared to patients without previous treatment, although the difference was not statistically significant (95% CI for rate ratio: 0. 95-6.19, p=0.10). At a cellular level, there was a significant association between local inflammation and response; lower grade of lesional inflammation correlated with a response to HspE7 (p=0.04 using Wilcoxon rank sum test). Conclusions-HspE7 appeared to demonstrate activity in women with CIN III and met a priori assumptions for efficacy; however, it is unclear whether this response was due to natural regression rather than treatment effect. HspE7, which targets the HPV 16 E7 oncoprotein, had efficacy in patients infected with HPV types other than 16, suggesting cross-reactivity. A larger randomized, controlled trial is needed to better define efficacy and to identify subsets of women most likely to benefit from immunotherapy.

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Section: Discussionmentioning

confidence: 99%

Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III

Einstein

Kadish

Burk

et al. 2007

Gynecologic Oncology

129

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“…Approximately 30%-50% of patients with positive margins were found to have no residual tumor on subsequent hysterectomy. In addition, several studies report on the feasibility of conservative management for patients with CIN 3 who had positive resection margins after conization but did not develop persistent or recurrent disease [8,17,18]. This suggests that conservative management of patients with stage IA1 cervical cancer might be feasible even if the resection margin evidenced a high-grade lesion without invasive disease.…”

Section: Discussionmentioning

confidence: 99%

“…As such, further treatment for residual neoplasia can be seen to depend on the margin status of the conization specimen [6,8]. Recent reports have suggested that patients with stage IA1 squamous cell carcinoma can be managed conservatively after conization and vaporization, even when the conization specimen had positive margins but no invasive disease [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Conservative management of stage IA1 squamous cell carcinoma of the cervix with positive resection margins after conization

Kim

Chang

et al. 2010

Intl J Gynecology & Obste

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Objective: To evaluate the efficacy of cold knife conization with electrocauterization and the feasibility of conservative management in patients with stage IA1 carcinoma of the cervix according to margin status after conization. Methods: Medical and histopathological records of 108 patients with stage IA1 cervical carcinoma were reviewed retrospectively. Patients underwent cold knife conization with electrocauterization or conization followed by hysterectomy. Disease recurrence was defined as a histologic diagnosis of cervical intraepithelial neoplasia (CIN) 2 or higher grade lesion. Results: Forty patients underwent conization followed by hysterectomy; of 27 women with positive margins, 14 (35%) had a residual lesion. Sixty-eight patients underwent conization without further surgical intervention. Forty patients had a negative resection margin without recurrence, while 28 had a positive resection margin: positive exocervical (n = 11), positive endocervical (n = 17). Among these, there were 7 cases of recurrence: positive exocervical (n = 1); positive endocervical (n = 6). Conclusion: Cold knife conization with electrocauterization appears to be a safe treatment option for patients with stage IA1 cervical carcinoma if careful follow-up is guaranteed for patients with CIN 3 exocervical resection margins. However, patients with CIN 3 endocervical resection margins should be managed surgically with repeat conization or hysterectomy. Crown

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“…In spite of the relatively high rate of clearance (95% (Reich et al, 2002)), patients after conisation due to CIN2 -3 are at a higher risk of developing residual or recurrent disease than controls. Their regular follow-up protocol after conisation includes continued cytological and colposcopic examination as well as reconisation in cases of suspected residual/recurrent lesions (Milojkovic, 2002).…”

Section: Discussionmentioning

confidence: 99%

Clinical and economic benefit of HPV-load testing in follow-up and management of women postcone biopsy for CIN2–3

et al. 2003

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This study aimed to evaluate the clinical and economic implications of integrating human papilloma virus (HPV) load testing into the follow-up and management protocol of women postconisation for high-grade cervical intraepithelial neoplasia (CIN2 -3). We evaluated 130 suitable women: 63 were screened biannually by Pap smears ('conventional approach') and 67 also had HPV-load testing ('HPV approach'). More stringent criteria for undergoing colposcopy or reconisation were observed by the former group compared to the latter. Both approaches were analysed for cost effectiveness. There were 33 out of 67 (49.2%) colposcopic referrals and 24 out of 67 (35.8%) reconisation/hysterectomies with the 'conventional approach' compared to 9 out of 63 (14.2%) and 7 out of 63 (11.1%) with the 'HPV approach'. Cervical intraepithelial neoplasia 2 -3 residual disease was detected in 7 out of 67 (10.5%) and 7 out of 63 (11.1%) women. The 'conventional approach' had more negative colposcopic biopsies and more negative reconisation/hysterectomy histologies than the 'HPV approach'. The respective cost per detection of one case of residual disease was US$3573 and US$3485. The 'HPV approach' required fewer colposcopic and reconisation procedures to detect one case of residual CIN2 -3. Its higher positive predictive value than that of cytology provided a significant decrease in false positive rates and a reduction of US$88 per detected case.

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Cervical intraepithelial neoplasia III: long-term follow-up after cold-knife conization with involved margins

Abstract: Expectant management is reasonable for patients with CIN III and positive margins after cold-knife conization. However, these patients require careful follow-up, particularly during the first year.

Cited by 87 publications

References 14 publications

Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III

Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III

Conservative management of stage IA1 squamous cell carcinoma of the cervix with positive resection margins after conization

Clinical and economic benefit of HPV-load testing in follow-up and management of women postcone biopsy for CIN2–3

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