Objectives: To assess the methodological quality of intention to treat analysis as reported in randomised controlled trials in four large medical journals. Design: Survey of all reports of randomised controlled trials published in 1997 in the BMJ, Lancet, JAMA , and New England Journal of Medicine . Main outcome measures: Methods of dealing with deviations from random allocation and missing data. Results: 119 (48%) of the reports mentioned intention to treat analysis. Of these, 12 excluded any patients who did not start the allocated intervention and three did not analyse all randomised subjects as allocated. Five reports explicitly stated that there were no deviations from random allocation. The remaining 99 reports seemed to analyse according to random allocation, but only 34 of these explicitly stated this. 89 (75%) trials had some missing data on the primary outcome variable. The methods used to deal with this were generally inadequate, potentially leading to a biased treatment effect. 29 (24%) trials had more than 10% of responses missing for the primary outcome, the methodsof handling the missing responses were similar in this subset. Conclusions: The intention to treat approach is often inadequately described and inadequately applied. Authors should explicitly describe the handling of deviations from randomised allocation and missing responses and discuss the potential effect of any missing response. Readers should critically assess the validity of reported intention to treat analyses. Key messages Intention to treat gives a pragmatic estimate of the benefit of a change in treatment policy rather than of potential benefit in patients who receive treatment exactly as planned Full application of intention to treat is possible only when complete outcome data are available for all randomised subjects About half of all published reports of randomised controlled trials stated that intention to treat was used, but handling of deviations from randomised allocation varied widely Many trials had some missing data on the primary outcome variable, and methods used to deal with this were generally inadequate, potentially leading to bias Intention to treat analyses are often inadequately described and inadequately applied

https://www.bmj.com/content/bmj/319/7211/670.full.pdf

What is meant by intention to treat analysis? Survey of published randomised controlled trials

PURPOSE: To determine whether the addition of cisplatin-based chemotherapy (CT) to pelvic radiation therapy (RT) will improve the survival of early-stage, high-risk patients with cervical carcinoma. PATIENTS AND METHODS: Patients with clinical stage IA2, IB, and IIA carcinoma of the cervix, initially treated with radical hysterectomy and pelvic lymphadenectomy, and who had positive pelvic lymph nodes and/or positive margins and/or microscopic involvement of the parametrium were eligible for this study. Patients were randomized to receive RT or RT + CT. Patients in each group received 49.3 GY RT in 29 fractions to a standard pelvic field. Chemotherapy consisted of bolus cisplatin 70 mg/m2 and a 96-hour infusion of fluorouracil 1,000 mg/m2/d every 3 weeks for four cycles, with the first and second cycles given concurrent to RT. RESULTS: Between 1991 and 1996, 268 patients were entered onto the study. Two hundred forty-three patients were assessable (127 RT + CT patients and 116 RT patients). Progression-fre...

Concurrent Chemotherapy and Pelvic Radiation Therapy Compared With Pelvic Radiation Therapy Alone as Adjuvant Therapy After Radical Surgery in High-Risk Early-Stage Cancer of the Cervix

Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Cervical cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

Cervical cancer is the fourth most common malignancy diagnosed in women worldwide. Nearly all cases of cervical cancer result from infection with the human papillomavirus, and the prevention of cervical cancer includes screening and vaccination. Primary treatment options for patients with cervical cancer may include surgery or a concurrent chemoradiotherapy regimen consisting of cisplatin-based chemotherapy with external beam radiotherapy and brachytherapy. Cervical cancer causes more than one quarter of a million deaths per year as a result of grossly deficient treatments in many developing countries. This warrants a concerted global effort to counter the shocking loss of life and suffering that largely goes unreported. This article provides a review of the biology, prevention, and treatment of cervical cancer, and discusses the global cervical cancer crisis and efforts to improve the prevention and treatment of the disease in underdeveloped countries. Cancer 2017;123:2404-12. © 2017 American Cancer Society.

Cervical cancer: A global health crisis

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(97)02250-2.pdf

Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer

https://www.gynecologiconcology-online.net/article/S0090-8258(00)96010-4/pdf

Class II versus class III radical hysterectomy in stage IB-IIA cervical cancer: a prospective randomized study.

Conservative surgery for Stage I ovarian carcinoma in women of childbearing age

https://www.gynecologiconcology-online.net/article/S0090-8258(08)00674-4/pdf

Neoadjuvant chemotherapy and conservative surgery for stage IB1 cervical cancer.

Concurrent Preoperative Chemotherapy with 5-Fluorouracil and Mitomycin C and Radiotherapy (FUMIR) Followed by Limited Surgery in Locally Advanced and Recurrent Vulvar Carcinoma

Andrea Maneo

Papers

Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer

Class II versus class III radical hysterectomy in stage IB-IIA cervical cancer: a prospective randomized study.

Conservative surgery for Stage I ovarian carcinoma in women of childbearing age

Neoadjuvant chemotherapy and conservative surgery for stage IB1 cervical cancer.

Concurrent Preoperative Chemotherapy with 5-Fluorouracil and Mitomycin C and Radiotherapy (FUMIR) Followed by Limited Surgery in Locally Advanced and Recurrent Vulvar Carcinoma