Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.

BACKGROUND: In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial. METHODS: The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211. FINDINGS: Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). INTERPRETATION: Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer. FUNDING: MD Anderson Cancer Center and Medtronic.

A Non-Gas-Based Cryotherapy System for the Treatment of Cervical Intraepithelial Neoplasia: A Mixed-Methods Approach for Initial Development and Testing.

BACKGROUND: Gas-based cryotherapy is the most widely used treatment strategy for cervical intraepithelial neoplasia (CIN) in low-resource settings, but reliance on gas presents challenges in low- and middle-income countries (LMICs). Our team adapted the original CryoPen Cryosurgical System, a cryotherapy device that does not require compressed gas and is powered by electricity, for use in LMICs. METHODS: A mixed-methods approach was used involving both qualitative and quantitative methods. First, we used a user-centered design approach to identify priority features of the adapted device. U.S.-based and global potential users of the adapted CryoPen participated in discussion groups and a card sorting activity to rank 7 features of the adapted CryoPen: cost, durability, efficacy and safety, maintenance, no need for electricity, patient throughput, and portability. Mean and median rankings, overall rankings, and summary rankings by discussion group were generated. In addition, results of several quantitative tests were analyzed including bench testing to determine tip temperature and heat extraction capabilities; a pathology review of CIN grade 3 cases (N=107) to determine target depth of necrosis needed to achieve high efficacy; and a pilot study (N=5) investigating depth of necrosis achieved with the adapted device to assess efficacy. RESULTS: Discussion groups revealed 4 priority themes for device development in addition to the need to ensure high efficacy and safety and low cost: improved portability, durability, ease of use, and potential for cure. Adaptions to the original CryoPen system included a single-core, single-tip model; rugged carrying case; custom circuit to allow car battery charging; and sterilization by high-level disinfection. In bench testing, there were no significant differences in tip temperature or heat extraction capability between the adapted CryoPen and the standard cryotherapy device. In 80% of the cases in the pilot study, the adapted CryoPen achieved the target depth of necrosis 3.5 mm established in the pathology review. CONCLUSION: The LMIC-adapted CryoPen overcomes barriers to standard gas-based cryotherapy by eliminating dependency on gas, increasing portability, and ensuring consistent freeze temperatures. Further testing and evaluation of the adapted CryoPen will be pursued to assess scalability and potential impact of this device in decreasing the cervical cancer burden in LMICs.

[Parametrial involvement in cervical cancer IB1 patients treated with radical hysterectomy in Peru]. / Compromiso parametrial en pacientes con cáncer de cérvix IB-1 tratadas con histerectomía radical en Perú

OBJECTIVES: To assess the frequency and factors associated with parametrial involvement (PI) in patients with cervical cancer IB1 who underwent radical hysterectomy (RH) at the National Institute of Neoplastic Diseases in Peru. MATERIALS AND METHODS: Cross-sectional study of 214 patients with cervical cancer IB1 undergoing RH with pelvic lymphadenectomy between 2007 and 2012. The population was compared with and without clinicopathological variables associated with PI such as age, tumor size, depth of infi histological grade and pelvic lymph node involvement. RESULTS: Ten patients (4.6%) had PI. Multivariate analysis showed that the depth of invasion (OR 8.37, 95% CI 1.24- 56.41, p=0.029) and pelvic node involvement (OR 18.03; 95% CI 3.30-98.44, p=0.001) were all independent predictors of PI. The presence of tumor size = 2 cm, invasion = 10 mm, absence of lymphovascular permeation and absence of nodal involvement identifi 97 patients at low risk of PI, none of whom had PI pathology. CONCLUSIONS: We confi the low frequency of PI in the cervical cancer IB1 subgroup and its association with the depth of invasion and lymph node involvement suggested in previous studies. This information will allow the identifi of a subgroup of patients at low risk of PI for less radical surgery in our institution.

Compromiso parametrial en pacientes con cáncer de cérvix IB-1 tratadas con histerectomía radical en Perú / Parametrial involvement in cervical cancer IB1 patients treated with radical hysterectomy in Peru

Objetivos. Evaluar la frecuencia y factores asociados al compromiso parametrial (CP) en pacientes con cáncer de cérvix IB-1 sometidas a histerectomía radical (HR) en el Instituto Nacional de Enfermedades Neoplásicas del Perú. Materiales y métodos. Estudio transversal analítico en 214 pacientes con cáncer de cérvix IB-1 sometidas a HR con linfadenectomía pélvica entre el 2007 y 2012. Se comparó la población con y sin CP según variables clinicopatológicas como edad, tamaño tumoral, profundidad de infiltración, grado histológico y afectación ganglionar pélvica. Resultados. Diez pacientes (4,6%) presentaron CP. El análisis multivariable mostró que la profundidad de la invasión (OR 8,37, IC 95%: 1,24-56,41, p=0,029) y el compromiso de ganglios pélvicos (OR 18,03, IC 95%: 3,30-98,44, p=0,001) resultaron ser predictores independientes del CP. La presencia de tamaño tumoral ≤ 2 cm, invasión ≤ 10 mm, ausencia de permeación linfovascular y ausencia de compromiso ganglionar permitió identificar 97 pacientes de bajo riesgo de CP, de los cuales ninguno tuvo CP en patología. Conclusiones. Confirmamos la baja frecuencia del CP en el subgrupo de cáncer de cervix IB-1 y su asociación con la profundidad de la invasión y con el compromiso ganglionar linfático sugeridos en estudios previos. Esta información permitirá identificar un subgrupo de pacientes con bajo riesgo de CP candidatas a una cirugía menos radical en nuestra institución...

Objectives. To assess the frequency and factors associated with parametrial involvement (PI) in patients with cervical cancer IB1 who underwent radical hysterectomy (RH) at the National Institute of Neoplastic Diseases in Peru. Materials and methods. Cross-sectional study of 214 patients with cervical cancer IB1 undergoing RH with pelvic lymphadenectomy between 2007 and 2012. The population was compared with and without clinicopathological variables associated with PI such as age, tumor size, depth of infiltration, histological grade and pelvic lymph node involvement. Results. Ten patients (4.6%) had PI. Multivariate analysis showed that the depth of invasion (OR 8.37, 95% CI 1.24- 56.41, p=0.029) and pelvic node involvement (OR 18.03; 95% CI 3.30-98.44, p=0.001) were all independent predictors of PI. The presence of tumor size ≤ 2 cm, invasion ≤ 10 mm, absence of lymphovascular permeation and absence of nodal involvement identified 97 patients at low risk of PI, none of whom had PI pathology. Conclusions. We confirmed the low frequency of PI in the cervical cancer IB1 subgroup and its association with the depth of invasion and lymph node involvement suggested in previous studies. This information will allow the identification of a subgroup of patients at low risk of PI for less radical surgery in our institution...

Linfoma difuso de células grandes b primario de vulva: presentación de un caso / Diffuse large b cell primary vulva: case report

Los linfomas no Hodking (LNH) constituyen un grupo heterogéneo de canceres que tienen diferentes modelos de comportamiento y diversas respuestas al tratamiento . Se originan en ganglios linfáticos o en sitios extranodales y suelen diseminarse a diversos órganos. Los LNH de linaje B cutáneos primarios (LNHB) representan únicamente el 20-25% de todos los linfomas primarios cutáneos. En este trabajo reportamos el caso de una mujer con diagnóstico final de LDCGB. Este tumor es extremadamente raro e implica un particular abordaje diagnóstico y terapéutico.La localización vulvar del Linfoma no Hodgkin de células ôBõ primario cutáneo (LNHB) es extremadamente rara, , con menos de 100 casos reportados en la literatura. Los LNHB cutáneos, como los de otra localización, son característicamente CD20 positivos , aunque se ha reportado un caso CD 30+ . Conclusiones: Los LNH extranodales genitales constituyen el 1.5 % de los linfomas ,teniendo una gran variedad de presentaciones clínicas. Los LNHB cutáneos primarios del tracto genital femenino son entidades clínicas y patológicas poco frecuentes, con un comportamiento indolente y un pronóstico favorable incluso con terapia local, siendo importante el diagnostico temprano de esta entidad clínica.

NonûHodgkinÆs lymphoma form a heterogenous group of cancers that have different models from behavior and diverse answers from the treatment. They are originated in lymphatic ganglia or extranodal sites and usually they are scattered to diverse organs. The primary LNH of lineage B cutaneous (LNHB) represent the 20-25% of all the solely linfomas primary cutaneous. We reported the case of a woman with final diagnosis of LDCGB. This tumor is extremely rare and implies a particular boarding therapeutic and diagnosis. The location to vulvar of the Linfoma Hodgkin of cutaneous cells ôprimary Bõ (LNHB) is not extremely rare, with less than 100 cases reported in Literature. The cutaneous LNHB, like those of another location, are characteristically positive CD20, although it has been reported a case CD 30+. Conclusions: The genital extranodal LNH constitute 1,5% of linfomas, having a great variety of clinical presentations. Primary the cutaneous LNHB of the feminine genital tract are little frequent clinical and pathological organizations, with an indolent behavior and a favorable prognosis even with local therapy, being important the early diagnosis of this disease.