Adjuvant platinum-based chemotherapy for early stage cervical cancer.

BACKGROUND: This is the second updated version of the original Cochrane review published in the Cochrane Library 2009, Issue 3. Most women with early cervical cancer (stages I to IIA) are cured with surgery or radiotherapy, or both. We performed this review originally because it was unclear whether cisplatin-based chemotherapy after surgery, radiotherapy or both, in women with early stage disease with risk factors for recurrence, was associated with additional survival benefits or risks. OBJECTIVES: To evaluate the effectiveness and safety of adjuvant platinum-based chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer. SEARCH METHODS: For the original 2009 review, we searched the Cochrane Gynaecological Cancer Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library 2009, Issue 1), MEDLINE, Embase, LILACS, BIOLOGICAL ABSTRACTS and CancerLit, the National Research Register and Clinical Trials register, with no language restriction. We handsearched abstracts of scientific meetings and other relevant publications. We extended the database searches to November 2011 for the first update and to September 2016 for the second update. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing adjuvant cisplatin-based chemotherapy (after radical surgery, radiotherapy or both) with no adjuvant chemotherapy, in women with early stage cervical cancer (stage IA2-IIA) with at least one risk factor for recurrence. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently. Meta-analysis was performed using a random-effects model, with death and disease progression as outcomes. MAIN RESULTS: For this second updated version we identified only one small trial reporting grade 4 toxicity results, without disease-free or overall survival data with a median follow-up of 16 months.From the first updated version, we identified three trials that were ongoing, and remain so in 2016.Four trials including 401 women with evaluable results with early cervical cancer were included in the meta-analyses. The median follow-up period in these trials ranged from 29 to 42 months. All women had undergone surgery first. Three trials compared chemotherapy combined with radiotherapy versus radiotherapy alone; and one trial compared chemotherapy followed by radiotherapy versus radiotherapy alone. It was not possible to perform subgroup analyses by stage or tumour size.Compared with adjuvant radiotherapy, chemotherapy combined with radiotherapy significantly reduced the risk of death (two trials, 297 women; hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (two trials, 297 women; HR = 0.47, 95% CI 0.30 to 0.74), with no heterogeneity between trials (I² = 0% for both meta-analyses). Acute grade 4 toxicity occurred significantly more frequently in the chemotherapy plus radiotherapy group than in the radiotherapy group (three trials, 321 women; risk ratio (RR) 6.26, 95% CI 2.50 to 15.67). We considered the evidence for all three outcomes to be of a moderate quality, using the GRADE approach due to small numbers and limited follow-up in the included studies. In addition, it was not possible to separate data for bulky early stage disease.In the one small trial that compared adjuvant chemotherapy followed by radiotherapy with adjuvant radiotherapy alone there was no difference in disease recurrence between the groups (one trial, 71 women; HR = 1.34; 95% CI 0.24 to 7.66) and overall survival was not reported. We considered this evidence to be of a low quality.No trials compared adjuvant platinum-based chemotherapy with no adjuvant chemotherapy after surgery for early cervical cancer with risk factors for recurrence. AUTHORS' CONCLUSIONS: The addition of platinum-based chemotherapy to adjuvant radiotherapy (chemoradiation) may improve survival in women with early stage cervical cancer (IA2-IIA) and risk factors for recurrence. Adjuvant chemoradiation is associated with an increased risk of severe acute toxicity, although it is not clear whether this toxicity is significant in the long term due to a lack of long-term data. This evidence is limited by the small numbers and low to moderate methodological quality of the included studies. We await the results of three ongoing trials, which are likely to have an important impact on our confidence in this evidence.

Laparoscopy versus laparotomy for FIGO stage I ovarian cancer.

BACKGROUND: This is an updated version of the original review that was first published in the Cochrane Database of Systematic Reviews 2008, Issue 4. Laparoscopy has become an increasingly common approach to surgical staging of apparent early-stage ovarian tumours. This review was undertaken to assess the available evidence on the benefits and risks of laparoscopy compared with laparotomy for the management of International Federation of Gynaecology and Obstetrics (FIGO) stage I ovarian cancer. OBJECTIVES: To evaluate the benefits and harms of laparoscopy in the surgical treatment of FIGO stage I ovarian cancer (stages Ia, Ib and Ic) when compared with laparotomy. SEARCH METHODS: For the original review, we searched the Cochrane Gynaecological Cancer Group Trials (CGCRG) Register, Cochrane Central Register of Controlled Trials (CENTRAL 2007, Issue 2), MEDLINE, Embase, LILACS, Biological Abstracts and CancerLit from 1 January 1990 to 30 November 2007. We also handsearched relevant journals, reference lists of identified studies and conference abstracts. For the first updated review, the search was extended to the CGCRG Specialised Register, CENTRAL, MEDLINE, Embase and LILACS to 6 December 2011. For this update we searched CENTRAL, MEDLINE, and Embase from November 2011 to September 2016. SELECTION CRITERIA: Randomised controlled trials (RCTs), quasi-RCTs and prospective cohort studies comparing laparoscopic staging with open surgery (laparotomy) in women with stage I ovarian cancer according to FIGO. DATA COLLECTION AND ANALYSIS: There were no studies to include, therefore we tabulated data from non-randomised studies (NRS) for discussion as well as important data from other meta-analyses. MAIN RESULTS: We performed no meta-analyses. AUTHORS' CONCLUSIONS: This review has found no good-quality evidence to help quantify the risks and benefits of laparoscopy for the management of early-stage ovarian cancer as routine clinical practice.

Behavioral interventions to promote condom use among women living with HIV.

BACKGROUND: High rates of HIV infection among women of reproductive age have dramatic consequences for personal and public health. Prophylaxis during sexual intercourse in the form of condoms has been the most effective way to prevent both STI and HIV transmission among people living with HIV. OBJECTIVES: To investigate the effectiveness of behavioral interventions in promoting condom use among women living with HIV. SEARCH STRATEGY: We conducted a comprehensive literature search in several scientific databases, clinical trials databases, conference proceedings, and conference websites to identify studies produced between 1980 and May 2010 that met our selection criteria. SELECTION CRITERIA: Studies were included in the analysis if they conducted a randomized controlled trial that examined the effects of behavioral interventions on condom use among HIV-positive women; considered at least one HIV-related behavioral outcome (e.g., reported protected anal, vaginal, or oral sex) or biological outcome (e.g., acquisition of STIs); and one follow-up assessment three months or more after the intervention. Studies were assessed irregardless of langauge or publication status. DATA COLLECTION AND ANALYSIS: We used random effects models to summarize odds ratios (ORs) that compared intervention and control groups with respect to a dichotomous outcome (consistent versus inconsistent condom use). We used funnel plots to examine publication bias and a χ(2) statistic to test for heterogeneity. The methodological and evidence quality was evaluated through risk of bias criteria and the GRADE system, respectively. MAIN RESULTS: Five primary studies that collectively researched a total of 725 women living with HIV were analysed. When compared to standard care or minimal HIV support intervention, meta-analysis showed that behavioral interventions had no effect on increasing condom use among HIV-positive women. This finding was consistent at various follow-up meetings (3, 6, and 12-months) as well as over the entire 12-month follow-up period (OR= 0.82; 95% CI 0.65-1.04; p=0.11). Only one study presented adequate data to analyze the relationship between behavioral interventions and STI incidence. Studies included in this analysis demonstrated low risk of bias based on the risk of bias criteria. However, sample size was considered inadequate across all studies. AUTHORS' CONCLUSIONS: Meta-analysis shows that behavioral interventions have little effect on increasing condom use among HIV-positive women. However, these findings should be used with caution since results were based on a few small trials that were targeted specifically towards HIV-positive women. To decrease sexual transmission of HIV among this population, we recommend interventions that combine condom promotion, family planning provision and counselling, and efforts to reduce viral loads among HIV-positive women and their partners (e.g., HAART treatment provision). New research is needed to address the needs of HIV-positive women, including an assessment of the impact of interventions that combine safer sexual behavior and harm reduction approaches.

Adjuvant platinum-based chemotherapy for early stage cervical cancer.

BACKGROUND: Patients with early stage cervical cancer (stages IA2, IB1 or IIA) with risk factors such as lymph node metastasis, lympho vascular space invasion, depth invasion of more than 10mm, microscopic parametrial invasion, non-squamous histology and positive surgical margins have a high risk of recurrence when compared to patients with early stage cervical cancer with no risk factors for recurrence. OBJECTIVES: To evaluate the effectiveness and safety of platinum-based adjuvant chemotherapy after radical hysterectomy, radiotherapy, or both in the treatment of early stage cervical cancer (stages IA2, IB1 or IIA). SEARCH STRATEGY: We searched the Cochrane Gynaecological Cancer Group Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library Issue 1, 2009), MEDLINE, EMBASE, LILACS, BIOLOGICAL ABSTRACTS and Cancerlit, the National Research Register and Clinical Trials register, with no language restriction. Abstracts of scientific meetings and the citation lists of included studies and other relevant publications were checked through hand searching and experts in the field were contacted to identify further reports of trials. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing adjuvant radiotherapy with adjuvant radiotherapy and cisplatin-chemotherapy after radical surgery for early stage cervix cancer were included. DATA COLLECTION AND ANALYSIS: Two review authors extracted data independently to assess whether the studies met the specified inclusion criteria. Any discrepancies were solved by a third and a forth review author. Meta-analysis was performed using a random effects model, with death and disease progression as outcomes. MAIN RESULTS: Three trials were included. Two trials enrolling 325 participants, of whom 297 (91%) were assessed and compared radiotherapy and chemotherapy with radiotherapy alone found that adjuvant chemotherapy significantly reduced the risk of death (hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.36 to 0.87) and disease progression (HR = 0.47, 95%CI: 0.30 to 0.74), with no heterogeneity between trials (I(2) = 0% for both meta-analyses). One trial assessing 71 participants compared chemotherapy followed by radiotherapy with radiotherapy alone and found no significant difference between the two groups (HR = 1.34; 95%CI: 0.24 to 7.66). The median follow up of patients varied from 29 to 42 months. AUTHORS' CONCLUSIONS: The addition of platinum-based chemotherapy to radiotherapy may offer clinical benefit in the adjuvant treatment of early stage cervical cancer with risk factors for recurrence. However, the evidence is limited because the selected studies were quantitatively and qualitatively limited, with small number of patients and limited period of follow-up.