Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II.

PURPOSE: The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS: GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS: From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL (P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION: Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

Providing a quality service: direct referral from the cytology laboratory to the colposcopy clinic.

OBJECTIVES: To compare the time taken for the referral process and the accuracy of referrals before and after a process review and the introduction of a system of direct referral from the cytology laboratory to the colposcopy clinic. SETTING: The colposcopy service in a large teaching hospital in Teesside. METHODS: Data on time points within the referral process and smear histories were collected. Data on time points were obtained retrospectively from the case-notes from before the new system of referral ('pre' group) and from an electronic database after the changes ('post' group). Smear histories were retrieved from the cytology database. RESULTS: The overall time that patients waited from the time the smear was taken until the time they were seen in the colposcopy clinic was significantly reduced. The median time between smear and colposcopy decreased from 92.5 days (range 35-254 days) in the 'pre' group to 33 days (range 13-43 days) in the 'post' group (P=0.0001). The median time taken from the smear report being issued until the report arrived in the colposcopy clinic was 14 days (range 4-123 days) in the 'pre' group, compared with two days (range 0-17 days) in the 'post' group (P=0.0001). There was a significant reduction in the number of inaccurate referrals in the 'post' group compared with the 'pre' group (P=0.02). CONCLUSIONS: Direct referral significantly reduces the time patients wait for colposcopy appointments and improves the accuracy of referrals.

Does the interval from primary surgery to chemotherapy influence progression-free survival in ovarian cancer?

OBJECTIVES: The objective of this study was to determine whether the length of the interval from primary surgery to commencement of chemotherapy has any direct effect on progression-free survival in ovarian cancer. METHODS: The progression-free survival of 472 patients enrolled in four trials who had all received platinum-containing chemotherapy (either in combination with a taxane or cyclophospamide) was subjected to univariate analysis. Dividing subjects into those above and below the median interval from surgery to chemotherapy formed two groups for analysis. The analysis was stratified by study and arm/cohort within study to remove any possible influence of the different studies and study doses. Multivariate analysis was then performed including stage, bulk of residual disease, and performance status as well as interval to starting chemotherapy. RESULTS: The median interval from surgery to chemotherapy was 22 days (range 7-100). Univariate analysis of the above median and below median groups showed worse progression-free survival for those with earlier treatment (hazard ratio 0.84, P = 0.14, 95% CI 0.67-1.06); however, those treated earlier tended to have bulkier residual disease (>2 cm; P = 0.006). When multivariate analysis was performed incorporating residual disease status, FIGO stage, and performance status, the hazard rate ratio for interval to surgery was 0.99 (P = 0.91, 95% CI 0.79-1.24). CONCLUSIONS: This study suggests that the interval from surgery to commencement of chemotherapy is not an independent prognostic factor for progression-free survival.