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The New England Journal of Medicine Jun 2022The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical... (Comparative Study)
Comparative Study Randomized Controlled Trial
BACKGROUND
The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking.
METHODS
We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer.
RESULTS
Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test).
CONCLUSIONS
Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.).
Topics: Adult; Anus Neoplasms; Biopsy; Female; HIV Infections; Homosexuality, Male; Humans; Male; Papillomavirus Infections; Precancerous Conditions; Prospective Studies; Squamous Intraepithelial Lesions; Watchful Waiting
PubMed: 35704479
DOI: 10.1056/NEJMoa2201048 -
Annals of Oncology : Official Journal... Sep 2021
Topics: Anus Neoplasms; Follow-Up Studies; Humans; Societies, Medical
PubMed: 34175386
DOI: 10.1016/j.annonc.2021.06.015 -
CMAJ : Canadian Medical Association... Jul 2019
Review
Topics: Administration, Topical; Calcium Channel Blockers; Conservative Treatment; Fissure in Ano; Humans
PubMed: 31266788
DOI: 10.1503/cmaj.190074 -
Ugeskrift For Laeger Feb 2023Anal cancer risk is increased in certain risk groups including people living with HIV (PLWH), especially in men who have sex with men, but also in organ transplant... (Review)
Review
Anal cancer risk is increased in certain risk groups including people living with HIV (PLWH), especially in men who have sex with men, but also in organ transplant recipients and women with a history of cervical or vulva dysplasia or cancer. High-resolution anoscopy (HRA) is a tool to diagnose anal high-grade squamous intraepithelial lesions (HSIL), and HRA-guided treatment of anal HSIL has been shown to reduce the risk of anal cancer in PLWH. The purpose of this review is to increase the awareness of HRA but also of tertiary prevention by digital anal rectal examination.
Topics: Male; Humans; Female; Homosexuality, Male; Sexual and Gender Minorities; Risk Factors; Endoscopy; Anus Neoplasms; Anal Canal; HIV Infections; Papillomavirus Infections
PubMed: 36896618
DOI: No ID Found -
Journal of Clinical Oncology : Official... Aug 2020To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naïve advanced anal cancer to establish the optimal regimen. (Randomized Controlled Trial)
Randomized Controlled Trial
International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct.
PURPOSE
To compare cisplatin plus fluorouracil (FU) versus carboplatin plus paclitaxel in chemotherapy-naïve advanced anal cancer to establish the optimal regimen.
PATIENTS AND METHODS
Patients who had not received systemic therapy for advanced anal cancer were randomly assigned 1:1 to intravenous cisplatin 60 mg/m (day 1) plus FU 1,000 mg/m (days 1-4) every 21 days or carboplatin (area under the curve, 5; day 1) plus paclitaxel 80 mg/m (days 1, 8, and 15) every 28 days for 24 weeks, until disease progression, intolerable toxicity, or withdrawal of consent. Primary end point was objective response rate (ORR). Primary and secondary end points were assessed in a hierarchic model to compare the regimens and pick the winner.
RESULTS
We conducted an international multicenter randomized phase II study in 60 centers between December 2013 and November 2017. Median follow-up was 28.6 months. A total of 91 patients were randomly assigned: 46 to cisplatin plus FU and 45 to carboplatin plus paclitaxel. ORR was 57% (95% CI, 39.4% to 73.7%) for cisplatin plus FU versus 59% (95% CI, 42.1% to 74.4%) for carboplatin plus paclitaxel. More serious adverse events were noted in the cisplatin plus FU arm (62%) compared with the carboplatin plus paclitaxel arm (36%; = .016). Median progression-free survival was 5.7 months (95% CI, 3.3 to 9.0 months) for cisplatin plus FU compared with 8.1 months (95% CI, 6.6 to 8.8 months) for carboplatin plus paclitaxel. Median overall survival was 12.3 months for cisplatin plus FU (95% CI, 9.2 to 17.7 months) compared with 20 months (95% CI, 12.7 months to not reached) for carboplatin plus paclitaxel (hazard ratio, 2.00; 95% CI, 1.15 to 3.47; = .014).
CONCLUSION
This is the first international randomized trial to our knowledge conducted in chemotherapy-naïve advanced anal cancer. Although there was no difference in ORR, the association with clinically relevant reduced toxicity and a trend toward longer survival suggest that carboplatin plus paclitaxel should be considered as a new standard of care.
Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Anus Neoplasms; Carboplatin; Cisplatin; Female; Fluorouracil; Follow-Up Studies; Humans; International Agencies; Male; Middle Aged; Paclitaxel; Prognosis; Survival Rate
PubMed: 32530769
DOI: 10.1200/JCO.19.03266 -
British Journal of Cancer Mar 2020Improving outcomes for uncommon tumours such as anal cancer can be challenging. Evolution of care tends to be incremental rather than transformative and identifying the...
Improving outcomes for uncommon tumours such as anal cancer can be challenging. Evolution of care tends to be incremental rather than transformative and identifying the specific factors facilitating improvement can be difficult. Outcome from specialist units may be better than that demonstrated in trials, posing challenges for development of future trials.
Topics: Anus Neoplasms; Chemoradiotherapy; Cohort Studies; Humans
PubMed: 31932753
DOI: 10.1038/s41416-019-0690-4 -
Ugeskrift For Laeger May 2024
Topics: Humans; Condylomata Acuminata; Male; Female; Anus Neoplasms
PubMed: 38847314
DOI: 10.61409/V72029 -
Ugeskrift For Laeger Dec 2020Anal abscesses are well-known conditions worldwide. The golden standard of acute treatment is incision and drainage. Knowledge of the anatomy of the anal area and the... (Review)
Review
Anal abscesses are well-known conditions worldwide. The golden standard of acute treatment is incision and drainage. Knowledge of the anatomy of the anal area and the abscess involvement of perianal spaces is crucial in order to perform safe and correct surgical treatment as summarised in this review. Pre- and perioperative imaging with magnetic resonance imaging, endoanal ultrasonography or CT facilitates correct incision and drainage, while antibiotics as conservative approach have no place in the treatment of abscesses. One third of the patients have an underlying fistula, and if suspected referral to a fistula centre is warranted.
Topics: Abscess; Anal Canal; Anus Diseases; Drainage; Humans; Rectal Fistula
PubMed: 33317691
DOI: No ID Found -
Diseases of the Colon and Rectum Aug 2021
Topics: Chronic Disease; Fissure in Ano; Humans; Lateral Internal Sphincterotomy
PubMed: 34214059
DOI: 10.1097/DCR.0000000000002125 -
International Journal of Cancer Feb 2023Squamous cell carcinoma of the anus (SCCA) is caused by HPV, and is elevated in persons living with HIV (PLWHIV). We aimed to estimate sex- and HIV-stratified SCCA...
Squamous cell carcinoma of the anus (SCCA) is caused by HPV, and is elevated in persons living with HIV (PLWHIV). We aimed to estimate sex- and HIV-stratified SCCA burden at a country, regional and global level. Using anal cancer incidence estimates from 185 countries available through GLOBOCAN 2020, and region/country-specific proportions of SCCA vs non-SCCA from the Cancer Incidence in Five Continents (CI5) Volume XI database, we estimated country- and sex-specific SCCA incidence. Proportions of SCCA diagnosed in PLWHIV, and attributable to HIV, were calculated using estimates of HIV prevalence (UNAIDS 2019) and relative risk applied to SCCA incidence. Of 30 416 SCCA estimated globally in 2020, two-thirds occurred in women (19 792) and one-third among men (10 624). Fifty-three percent of male SCCA and 65% of female SCCA occurred in countries with a very high Human Development Index (HDI). Twenty-one percent of the global male SCCA burden occurred in PLWHIV (n = 2203), largely concentrated in North America, Europe and Africa. While, only 3% of global female SCCA burden (n = 561) occurred in PLWHIV, mainly in Africa. The global age-standardized incidence rate of HIV-negative SCCA was higher in women (0.55 cases per 100 000) than men (0.28), whereas HIV-positive SCCA was higher in men (0.07) than women (0.02). HIV prevalence reached >40% in 22 countries for male SCCA and in 10 countries for female SCCA, mostly in Africa. Understanding global SCCA burden by HIV status can inform SCCA prevention programs (through HPV vaccination, screening and HIV control) and help raise awareness to combat the disease.
Topics: Female; Humans; Male; Anus Neoplasms; Carcinoma, Squamous Cell; HIV Infections; Incidence; Papillomavirus Infections; Global Health; Sex Distribution
PubMed: 36054026
DOI: 10.1002/ijc.34269