A Non-Surgical and Cost-Effective Treatment Approach Employing Topical Imiquimod, 5-Fluorouracil, and Tretinoin for Primary Non-Melanoma Skin Cancers.

BACKGROUND: Minimally invasive alternative approaches to treat non-melanoma skin cancers remain limited and unproven. OBJECTIVE: We aim to assess the efficacy of varying combinations of anti-tumor agents—imiquimod 5% cream, 5-fluorouracil 2% solution, and tretinoin 0.1% cream—with brief cryotherapy in treating non-melanoma skin cancers. METHODS: This retrospective study included 690 cases of non-melanoma skin cancers in 480 patients who received a diagnosis of a basal cell carcinoma or squamous cell carcinoma during a ten-year period. During treatment period, patients applied 30 applications of one of three combinations (imiquimod/tretinoin, 5-fluorouracil/tretinoin, or imiquimod/5-fluorouracil/tretinoin) and had cryotherapy every 2 weeks. Each patient had a clinical examination at least three years post-treatment or documented treatment failure. Clearance was defined by a lack of persistence or recurrence for 3 years following the completion of treatment. The likelihood of lesion clearance was evaluated using multivariable logistic regression analysis. RESULTS: A total of 186 cases (97; basal cell carcinoma and 89; squamous cell carcinoma) in 133 patients [37% women and 63% men; median (interquartile range) age, 77 (69, 83) years] met the inclusion criteria. Multivariable logistic regression analysis adjusting for clinical and lesion variables demonstrated that, relative to the imiquimod/5-fluorouracil/tretinoin treatment approach, imiquimod/ tretinoin (odds ratio, 0.05; 95% confidence interval, 0.00-0.99) and 5-fluorouracil/tretinoin (0.02; 0.00–0.45) were associated with lower likelihoods of lesion clearance. Likewise, morpheaform basal cell carcinoma had a lower probability of clearance (0.05; 0.00–0.72). CONCLUSIONS: The combination of imiquimod/5-fluorouracil/tretinoin with cryotherapy had high clearance rates and was the most effective treatment regimen. J Drugs Dermatol. 2021;20(3):260-267. doi:10.36849/JDD.5427.

Systems-level barriers to treatment in a cervical cancer prevention program in Kenya: Several observational studies.

OBJECTIVE: To identify health systems-level barriers to treatment for women who screened positive for high-risk human papillomavirus (hrHPV) in a cervical cancer prevention program in Kenya. METHODS: In a trial of implementation strategies for hrHPV-based cervical cancer screening in western Kenya in 2018-2019, women underwent hrHPV testing offered through community health campaigns, and women who tested positive were referred to government health facilities for cryotherapy. The current analysis draws on treatment data from this trial, as well as two observational studies that were conducted: 1) periodic assessments of the treatment sites to ascertain availability of resources for treatment and 2) surveys with treatment providers to elicit their views on barriers to care. Bivariate analyses were performed for the site assessment data, and the provider survey data were analyzed descriptively. RESULTS: Seventeen site assessments were performed across three treatment sites. All three sites reported instances of supply stockouts, two sites reported treatment delays due to lack of supplies, and two sites reported treatment delays due to provider factors. Of the 16 providers surveyed, ten (67%) perceived lack of knowledge of HPV and cervical cancer as the main barrier in women's decision to get treated, and seven (47%) perceived financial barriers for transportation and childcare as the main barrier to accessing treatment. Eight (50%) endorsed that providing treatment free of cost was the greatest facilitator of treatment. CONCLUSION: Patient education and financial support to reach treatment are potential areas for intervention to increase rates of hrHPV+ women presenting for treatment. It is also essential to eliminate barriers that prevent treatment of women who present, including ensuring adequate supplies and staff for treatment.

Experimental study for evaluation of a low-cost spray cryotherapy system.

OBJECTIVE: To evaluate the feasibility and applicability of a low-cost cryotherapy system. METHODS: Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. RESULTS: Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). CONCLUSION: The low-cost spray cryotherapy system proved feasible and safe.

Anatomic, Visual, and Financial Outcomes for Traditional and Nontraditional Primary Pneumatic Retinopexy for Retinal Detachment.

PURPOSE: To determine factors predictive of anatomic, visual, and financial outcomes after traditional and nontraditional primary pneumatic retinopexy (PR) for rhegmatogenous retinal detachment (RD). DESIGN: Retrospective interventional case series and cost comparison. METHODS: Participants: Total of 178 eyes (156 patients) with PR-repaired primary RD by a single surgeon at a clinical practice from January 2001 to December 2013 and followed for ≥1 year. The cohort had 2 subgroups: traditional (TPR) and nontraditional (NTPR) PR. MAIN OUTCOME MEASURES: Characteristics associated with best-corrected visual acuity (BCVA) and anatomic outcomes. Cost analysis and potential cost savings comparing PR to scleral buckle and vitrectomy. RESULTS: One hundred thirty-one of 178 eyes (73.5%) were successfully treated at 1 year (postoperative year 1): 72.8% (75/103) in TPR and 74.6% (56/75) in NTPR. Macula-off detachment (-0.44 logMAR, P < .001) and clock hours of RD (-0.84 logMAR, P < .001) correlated with improved BCVA; pseudophakia (0.26 logMAR, P = .002) and inferior retinal tears (0.62 logMAR, P = .009) correlated with worsening BCVA. Pseudophakia (-0.15, P = .03), inferior quadrant RD (-0.27, P < .001), and proliferative vitreoretinopathy (-0.68, P < .001) correlated with anatomic failure. Total average cost for TPR and NTPR was $1248.37 ± $882.11 and $1471.91 ± $942.84, respectively (P = .10). PR had a potential cost savings of 62% and 60.8% when compared to scleral buckle and vitrectomy, respectively. CONCLUSIONS: PR results in successful anatomic and visual outcomes in both TPR and NTPR repair of primary RD. Preoperative pseudophakia is associated with worse visual outcomes and less anatomic success. The cost of primary PR and subsequent procedures to achieve final anatomic success was not significantly different between TPR and NTPR, and supports the possible cost-effectiveness of expanded indications for PR.

Experimental study for evaluation of a low-cost spray cryotherapy system / Estudo experimental para avaliação de um sistema de baixo custo para crioterapia em spray

ABSTRACT Objective To evaluate the feasibility and applicability of a low-cost cryotherapy system. Methods Experimental study with 25kg Landrace pigs submitted to a longitudinal cervico-thoraco-abdominal incision for exposure of the trachea, thorax and abdomen. The tissues were frozen by continuous spray application at different periods of time (5, 10 and 15 seconds). Spray cryotherapy was performed using a fluorinated gas (tetrafluorethane) delivered at - 47°C temperature (DermaFreeze®, Emdutos; ANVISA registration 80409950001; price R$ 394,00). via an adapted, disposable 1.8mm cholangiography catheter (Olympus; price R$ 280,00). The specimens were resected for histopathological analysis. Results Thirty samples were obtained from ten different organs and divided according to spray cryotherapy application time. System activation for 5, 10 or 15 seconds led to consumption of 14g, 27g and 40g of gas respectively (average gas consumption, 2.7g/s using a 1.8mm catheter). The system comprising a spray tube and catheter proved user-friendly and effective, with constant gas dispersion and adequate tissue freezing. In spite of effective freezing, microscopy failed to reveal tissue changes. This may have reflected methodological constraints precluding evaluation at tissue damage peak time (48 hours). Conclusion The low-cost spray cryotherapy system proved feasible and safe.

RESUMO Objetivo Avaliar a exequibilidade e a aplicação de um sistema de baixo custo de crioterapia. Métodos Estudo experimental realizado com um suíno da raça Landrace, 25kg, submetido à cervicotoracolaparotomia longitudinal, com exposição de traqueia, tórax e abdome. Procedemos ao congelamento das estruturas em tempos diferentes (5, 10 e 15 segundos) com jato contínuo. A crioterapia foi realizada com gás fluoretado (tetrafluoretano), na forma de spray em tubo, que atinge a temperatura de -47°C (DermaFreeze®, Emdutos; registro ANVISA 80409950001; preço R$ 394,00). A este tubo, adaptamos um cateter descartável de colangiografia de 1,8mm (Olympus; preço R$ 280,00). As peças foram ressecadas para análise histopatológica. Resultados Foram obtidas 30 amostras em 10 órgãos diferentes, divididos em três intervalos de tempo distintos. Quando o sistema foi acionado por 5 segundos, gastaram-se 14g de gás; por 10 segundos, 27g; e por 15 segundos, 40g; o gasto médio foi de 2,7g/s pelo cateter de 1,8mm. O sistema confeccionado com tubo de gás e cateter proporcionou resultado efetivo, com dispersão adequada e constante do gás, congelamento adequado e de fácil execução. Apesar da técnica evidenciar congelamento efetivo, na microscopia não houve alteração tecidual. Isso ocorreu porque o pico de lesão tecidual por congelamento ocorre após 48 horas, o que não foi possível avaliar por este método proposto. Conclusão O sistema de crioterapia em spray de baixo custo foi exequível e seguro.

Costs and cost-effectiveness of LEEP versus cryotherapy for treating cervical dysplasia among HIV-positive women in Johannesburg, South Africa.

BACKGROUND: Cervical cancer incidence is significant in countries, such as South Africa, with high burdens of both HIV and human papillomavirus (HPV). Cervical cancer is largely preventable if dysplasia is diagnosed and treated early, but there is debate regarding the best approaches for screening and treatment, especially for low-resource settings. Currently South Africa provides Pap smears followed by colposcopic biopsy and LEEP if needed in its public health facilities. We estimated the costs and cost-effectiveness of two approaches for treating cervical intraepithelial neoplasia grade 2 or higher (CIN2+) among HIV-infected women, most of whom were taking antiretroviral treatment, at a public HIV treatment facility in Johannesburg, South Africa. METHODS: Method effectiveness was derived from an intention-to-treat analysis of data gathered in a clinical trial completed previously at the study facility. In the trial, women who were diagnosed with CIN2+ and eligible for cryotherapy were randomized to cryotherapy or LEEP. If women were CIN2+ at six months as determined via Pap smear and colposcopic biopsy, all women-regardless of their original treatment assignment-received LEEP. "Cure" was then defined as the absence of disease at 12 months based on Pap smear and colposcopic biopsy. Health service costs were estimated using micro-costing between June 2013 and April 2014. Capital costs were annualized using a discount rate of 3%. Two different service volume scenarios were considered, and results from an as-treated analysis were considered in sensitivity analysis. RESULTS: In total, 166 women with CIN2+ were enrolled (86 had LEEP; 80 had cryotherapy). At 12 months, cumulative loss to follow-up was 12.8% (11/86) for the LEEP group and 13.8% (11/80) for cryotherapy. Based on the unadjusted intention-to-treat analysis conducted for this economic evaluation, there was no significant difference in efficacy. At 12 months, 83.8% (95% CI 73.8-91.1) of women with CIN2+ at baseline and randomized to cryotherapy were free of CIN2+ disease. In contrast, 76.7% (95% CI 66.4-85.2) of women assigned to LEEP were free from disease. On average, women initially treated with cryotherapy were less costly per patient randomized at US$ 118.00 (113.91-122.10), and per case "cured" at US$ 140.90 (136.01-145.79). Women in the LEEP group cost US$ 162.56 (157.90-167.22) per patient randomized and US$ 205.59 (199.70-211.49) per case cured. In the as-treated analysis, which was based on trial data, LEEP was more efficacious than cryotherapy; however, the difference was not significant. Cryotherapy remained more cost-effective than LEEP in all sensitivity and scenario analyses. CONCLUSIONS: For this cost-effectiveness analysis, using an intention-to-treat approach and taking into consideration uncertainty in the clinical and cost outcomes, a strategy involving cryotherapy plus LEEP if needed at six months was dominant to LEEP plus LEEP again at six months if needed for retreatment. However, compared to other studies comparing LEEP and cryotherapy, the efficacy results were low in both treatment groups-possibly due to the HIV-positivity of the participants. Further research is needed, but at present choosing the "right" treatment option may be less important than ensuring access to treatment and providing careful monitoring of treatment outcomes.

A systematic review of cost-effective treatment of postoperative rotator cuff repairs.

OBJECTIVE: The Bundled Payments for Care Improvement initiative combines payment of multiple services for episodes of care into 1 bundle. Rotator cuff repair is a likely candidate for future inclusion. The objective of this study was to determine cost-effective, high-quality postoperative rehabilitation dosing and cryotherapy for patients undergoing rotator cuff repair based on systematic review of the literature. METHODS: Systematic review of level I and level II articles was performed in PubMed, Cochrane Databases, and PEDro. Conference references and bibliographies were also reviewed. For postoperative therapy, keywords included rotator cuff, rotator cuff repair, exercise therapy, exercise, unsupervised, self-care, postoperative period, physical therapy, and physiotherapy; for cryotherapy, keywords included rotator cuff repair, shoulder, cryotherapy, and ice. RESULTS: Five studies compared postoperative outcomes in participants assigned to supervised therapy vs. unsupervised therapy. Three found no difference between groups. One found improved outcomes in supervised therapy. Limitations included that therapies were not consistently defined and significant methodologic issues were present, decreasing the applicability and validity of the results. Five articles examined cryotherapy outcomes in the postoperative shoulder. Two studies showed improved patient outcomes with cryotherapy vs. no cryotherapy; 2 studies showed no decrease in joint space temperatures at 90 minutes but decrease in temperature at 4 to 23 hours postoperatively. One study indicated that an ice bag and Ace bandage might be as effective as continuous, compressive cryotherapy units using patient-reported outcomes. CONCLUSION: Further studies are needed to determine effective dosing of physical therapy after rotator cuff repair. Cryotherapy is favorable and cost-effective using simple methods for delivery.

Icing oral mucositis: Oral cryotherapy in multiple myeloma patients undergoing autologous hematopoietic stem cell transplant.

Background Up to 70% of patients receiving hematopoietic stem cell transplant develop oral mucositis as a side effect of high-dose melphalan conditioning chemotherapy. Oral cryotherapy has been documented to be potentially effective in reducing oral mucositis. The aim of this study was to examine the effectiveness of the cryotherapy protocol implemented within the hematopoietic stem cell transplant program. Methods A retrospective chart review was conducted of adult multiple myeloma patients who received high-dose melphalan conditioning therapy for autologous hematopoietic stem cell transplant. Primary endpoints were incidence and severity of oral mucositis. Secondary endpoints included duration of oral mucositis, duration of hospital stay, parenteral narcotics use and total parenteral nutrition use. Results One hundred and forty patients were included in the study, 70 patients in both no cryotherapy and cryotherapy groups. Both oral mucositis incidence and severity were found to be significantly lower in the cryotherapy group. Fifty (71.4%) experienced mucositis post cryotherapy compared to 67 (95.7%) in the no cryotherapy group (p < 0.001). The median oral mucositis severity, assessed using the WHO oral toxicity scale from grade 0-4, experienced in the no group was 2.5 vs. 2 in the cryotherapy group (p = 0.03). Oral mucositis duration and use of parenteral narcotics were also significantly reduced. Duration of hospital stay and use of parenteral nutrition were similar between the two groups. Conclusion The cryotherapy protocol resulted in a significantly lower incidence and severity of oral mucositis. These results provide evidence for the continued use of oral cryotherapy, an inexpensive and generally well-tolerated practice.

A cost-utility analysis of ingenol mebutate gel for the treatment of actinic keratosis: a Scottish perspective.

BACKGROUND: Actinic keratosis (AK) is a UV-induced, pre-malignant skin condition that is common in adults over 60 years of age with fair skin in Scotland. The most commonly prescribed first-line treatment for AK in Scotland is currently diclofenac gel (3 %). Ingenol mebutate gel is a recently developed topical therapy available in two strengths for the treatment of AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days). OBJECTIVE: To compare the cost-effectiveness of two strengths of ingenol mebutate gel developed to treat AK lesions on the face and scalp (150 mcg/g once daily for 3 consecutive days) or trunk and extremities (500 mcg/g once daily for 2 consecutive days) with other first-line AK therapies including diclofenac gel, 5-FU, 5-FU/salicylic acid, and cryotherapy for the first-line treatment of AK in adult patients, from the perspective of the National Health Service (NHS) in Scotland. METHODS: A cost-utility analysis was conducted using a decision-tree approach to calculate the costs and benefits of different treatment strategies for AK on the face and scalp or trunk and limbs over a 12-month time horizon. Data on the relative efficacy of treatments were obtained from a systematic literature review and meta-analysis. Utility scores and resource-use data were obtained from published sources. RESULTS: Over 12 months, ingenol mebutate 150 mcg/g gel and 500 mcg/g gel were cost-effective compared with the most commonly used topical therapy in Scotland, diclofenac (3 %) gel, at a willingness-to-pay threshold of £20,000 per QALY, with a minimal additional cost of £43 and £105, respectively per QALY gained. CONCLUSIONS: Ingenol mebutate gel is a cost-effective therapy for the first-line treatment of AK from a Scottish NHS perspective.

Decision analytic cost-effectiveness model to compare prostate cryotherapy to androgen deprivation therapy for treatment of radiation recurrent prostate cancer.

OBJECTIVE: To determine the cost-effectiveness of salvage cryotherapy (SC) in men with radiation recurrent prostate cancer (RRPC). DESIGN: Cost-utility analysis using decision analytic modelling by a Markov model. SETTING AND METHODS: Compared SC and androgen deprivation therapy (ADT) in a cohort of patients with RRPC (biopsy proven local recurrence, no evidence of metastatic disease). A literature review captured published data to inform the decision model, and resource use data were from the Scottish Prostate Cryotherapy Service. The model was run in monthly cycles for RRPC men, mean age of 70 years. The model was run over the patient lifetime, to assess changes in patient health states and the associated quality of life, survival and cost impacts. Results are reported in terms of the discounted incremental costs and discounted incremental quality-adjusted life years (QALYs) gained between the 2 alternative interventions. Probabilistic sensitivity analysis used a 10,000 iteration Monte Carlo simulation. RESULTS: SC has a high upfront treatment cost, but delays the ongoing monthly cost of ADT. SC is the dominant strategy over the patient lifetime; it is more effective with an incremental 0.56 QALY gain (95% CI 0.28 to 0.87), and less costly with a reduced lifetime cost of £29,719 (€37,619) (95% CI -51,985 to -9243). For a ceiling ratio of £30,000, SC has a 100% probability to be cost-effective. The cost neutral point was at 3.5 years, when the upfront cost of SC (plus any subsequent cumulative cost of side effects and ADT) equates the cumulative cost in the ADT arm. Limitations of our model may arise from its insensitivity to parameter or structural uncertainty. CONCLUSIONS: The platform for SC versus ADT cost-effective analysis can be employed to evaluate other treatment modalities or strategies in RRPC. SC is the dominant strategy, costing less over a patient's lifetime with improvements in QALYs. TRIAL REGISTRATION NUMBER: This economic analysis was undertaken as part of the CROP RCT study ISRCTN: 72677390; it was a pre-trial economic model developed and analysed during the pre-results stage of the RCT.

Consensus for Nonmelanoma Skin Cancer Treatment, Part II: Squamous Cell Carcinoma, Including a Cost Analysis of Treatment Methods.

BACKGROUND: Cutaneous squamous cell carcinoma (cSCC) is the second most common cancer in the United States. Cutaneous squamous cell carcinoma has an estimated incidence of more than 700,000 new cases per year and a 5% risk of metastasis. OBJECTIVE: To provide clinicians with guidelines for the management of cSCC based on evidence from a comprehensive literature review and consensus among the authors. MATERIALS AND METHODS: The authors conducted an extensive review of the medical literature on treatment methods for cSCC, taking into consideration cure rates, recurrence and metastatic rates, aesthetic and functional outcomes, and cost effectiveness of the procedures. RESULTS: Surgical treatments provide the best outcomes for cSCC. Mohs micrographic surgery is a cost-effective procedure that affords the highest cure rate, maximal tissue preservation, and superior cosmetic outcomes. Nonsurgical methods may be used as a primary treatment for low-risk squamous cell carcinomas, but the cure rates are lower. CONCLUSION: The cure rate remains the most important consideration in choosing the treatment method, but additional factors, such as the patient's general medical condition, psychosocial circumstances, the location of the tumor and cost effectiveness of the therapy should be considered. Mohs micrographic surgery remains the preferred treatment for high-risk tumors and tumors located in cosmetically sensitive areas.

Effectiveness of erbium:YAG laser and cryosurgery in seborrheic keratoses: Randomized, prospective intraindividual comparison study.

BACKGROUND AND OBJECTIVE: Seborrheic keratoses (SK) are benign cutaneous lesions frequently seen in old age. The aim of the study is to compare the efficiency of Er:YAG lasers with cryotherapy in the treatment of SK. PATIENTS AND METHODS: The study was carried out on 42 patients with SK sized 0.5-3 cm, located on the back, chest, face and neck. Lesions with a similar size and location on the same patient were matched. In the same session, half of the lesions were treated with cryotherapy, while the other half were treated with Er:YAG lasers. All of the patients were clinically evaluated in two recalls with a one-month interval between appointments. The efficiency of the treatments was clinically evaluated. RESULTS: Following the first treatment, complete healing was detected in all of the lesions (100%) treated with Er:YAG lasers, while the healing rate was 68% in the cryotherapy group (p < 0.01). In the Er:YAG laser-treated group, hyperpigmentation was significantly lower and more erythema developed than in the cryotherapy group. CONCLUSION: Er:YAG lasers offer a one-step procedure which is a very simple and economic treatment and provides an alternative treatment method with better cosmetic results compared to cryotherapy.

Cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% in the treatment of actinic keratosis in Spain.

OBJECTIVE: The aim of this study is to conduct a cost-effectiveness analysis of 5-fluorouracil 0.5%/salicylic acid 10% (5-FU/SA) in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain. METHODS: An analytical decision-making model was constructed to compare whether 5-FU/SA was a cost-effective option compared with cryotherapy from the perspective of the Spanish National Health System with a time horizon of 6 months. Costs were expressed in 2014 euros. RESULTS: The cost of patients with hyperkeratotic actinic keratosis treated with 5-FU/SA or cryotherapy was €266 and €285, respectively. 5-FU/SA was associated with higher rates of treatment success and, consequently, more quality-adjusted life years, than cryotherapy. Therefore, 5-FU/SA was the dominant treatment, as it was associated with a lower treatment cost and greater effectiveness than cryotherapy. CONCLUSIONS: Economically, 5-FU/SA was a dominant option compared with cryotherapy in the treatment of isolated hyperkeratotic actinic keratosis lesions in Spain.

Estimating the costs of cervical cancer screening in high-burden Sub-Saharan African countries.

OBJECTIVE: To estimate the capital investment and recurrent costs of national cervical cancer screening and precancer treatment programs in 23 high-incidence countries in Sub-Saharan Africa in order to provide estimates of the investment required to tackle the burden of cervical cancer in this region. These 23 countries account for 64% of the annual cervical cancer deaths in this region. METHODS: Secondary data were used to estimate the financial costs of equipment purchases and economic costs of screening and treating eligible women over a 10-year period. Screening would be by visual inspection with acetic acid and treatment by cryotherapy or loop electrosurgical excision procedure. RESULTS: Approximately US $59 million would be required to purchase treatment equipment if cryotherapy were placed at every screening facility. Approximately 20 million women would be screened over 10 years. Cost per woman screened in a screen-and-treat program was either US $3.33 or US $7.31, and cost per woman treated was either US $38 or US $71 depending on the location of cryotherapy equipment. CONCLUSION: It would take less than US $10 per woman screened to significantly decrease the cervical cancer deaths that will occur in Sub-Saharan Africa over the next 10 years.

Population-based comparative effectiveness of salvage radical prostatectomy vs cryotherapy.

OBJECTIVE: To characterize population-based practice patterns, disease-specific and overall mortality, and cost associated with salvage cryotherapy (SCT) vs salvage radical prostatectomy (SRP). METHODS: We retrospectively identified 440 men who failed primary radiation therapy and subsequently underwent SCT (n = 341, 77.5%) or SRP (n = 99, 22.5%) between 1992 and 2009 from Surveillance, Epidemiology, and End Results-Medicare linked data. Propensity score analyses were used to compare overall and prostate cancer-specific mortality and associated Medicare expenditures for SRP vs SCT. RESULTS: Men undergoing SCT were more likely to be white (P <.001), less likely to be high school graduates (P = .008), and experienced shorter median time from diagnosis to salvage therapy (44.1 vs 60.1, P <.001) and from primary radiotherapy to salvage therapy (38.7 vs 55.8 months, P <.001). In adjusted analyses, overall mortality was higher (21.6 vs 6.1 deaths/100 person years, P <.001) for SRP vs SCT. There was a trend for higher prostate cancer-specific death rates with SRP vs SCT (6.5 vs 1.4 deaths/100 person years, P = .061). Medicare expenditures for SRP vs SCT were more than 2-fold higher ($19,543 vs $8,088, P <.001). CONCLUSION: SRP vs SCT is associated with higher overall mortality and greater health care expenditures. However, longer follow-up is needed to assess long-term functional outcomes and cancer control.

Efficacy, safety, acceptability and affordability of cryotherapy: a review of current literature.

As a result of widespread screening and treatment programs, the incidence of cervical cancer has decreased by as much as 75% in the developed world. Commonly used treatment modalities for precancerous lesions include cone biopsy, the Loop Electrosurgical Excision Procedure (LEEP), laser ablation and cryotherapy. In recent years LEEP has replaced cryotherapy as a commonly provided outpatient procedure in many places; however increased awareness of the burden of cervical cancer in the developing world and increased awareness of long term consequences of LEEP ­ such as cervical insufficiency ­ have renewed interest in cryotherapy. We reviewed current literature addressing the technique, efficacy, safety and acceptability of cryotherapy, as well as special topics such as cost effectiveness, HIV, and low resource settings. Among studies we reviewed, cure rates ranged from 56.8-96.6% among prospective controlled trials and from 70-95.5% among observational studies. Cryotherapy has very low complication rates and serious complications requiring medical intervention or affecting future reproductive outcomes are extremely rare. Side effects including vaginal discharge and cramping are temporary, generally self-limited, and well tolerated after anticipatory patient counseling. When surveyed, women find cryotherapy highly acceptable. Compared to other treatment modalities, cryotherapy is very affordable and feasible to integrate into cervical cancer screening and treatment programs.

Comparative effectiveness of cryotherapy vs brachytherapy for localised prostate cancer.

UNLABELLED: Despite the increased popularity of emerging therapies for localised prostate cancer, such as cryotherapy and brachytherapy, outcomes data remains sparse beyond single-centre comparative studies. The present study identified that although less costly, cryotherapy was associated with more urinary and ED complications and a greater need for salvage ADT. Conversely, cryotherapy was associated with fewer bowel complications. Patients and providers alike should consider these population-based outcomes when discussing therapeutic options for localised prostate cancer. OBJECTIVE: To compare prostate cryotherapy vs brachytherapy outcomes and costs, as despite the greater popularity of these emerging therapies for localised prostate cancer, outcomes data remains sparse beyond single-centre comparative studies. PATIENTS AND METHODS: Observational study of 10 928 men who underwent primary cryotherapy (943 patients) or brachytherapy (9985) with ≥2 years of follow-up using USA Surveillance, Epidemiology, and End Results (SEER-) Medicare linked data. Weighted propensity score methods were used. RESULTS: Use of cryotherapy increased four-fold whereas brachytherapy utilization remained the same from 2001 to 2005 (P < 0.001). Men who underwent cryotherapy vs brachytherapy were older (P < 0.001), more likely to be Black (P < 0.001), less likely to live in areas of higher education (P < 0.001), less likely to live in areas with greater income (P < 0.001), and were more likely to live in urban vs rural areas (P = 0.007). In propensity score-weighted analyses, cryotherapy was associated with more urinary (41.4% vs 22.2%, P < 0.001) and erectile dysfunction (ED) complications (34.7% vs 21.0%, P < 0.001) while brachytherapy was associated with more bowel complications (19.0% vs 12.1%, P < 0.001). Cryotherapy was associated with greater use of salvage androgen deprivation therapy (ADT; 1.4 vs 0.5 per 100 person-years, P < 0.001), suggesting worse cancer control. Finally costs were significantly greater for brachytherapy vs cryotherapy ($16 887 vs $12 629 USA dollars, P < 0.001). CONCLUSIONS: Although less costly, cryotherapy was associated with more urinary and ED complications and greater need for salvage ADT. Conversely, cryotherapy was associated with fewer bowel complications. Patients and providers alike should consider these population-based outcomes when discussing therapeutic options for localised prostate cancer.