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. 2010 Dec 8;2010(12):CD007926. doi: 10.1002/14651858.CD007926.pub2

Rendina 1984.

Methods Balanced prognostic study
Participants 93 patients with stage III or IV stage endometrial cancer
45 patients received tamoxifen (TMX) and 48 patients medroxyprogesterone acetate (MPA)
Single‐centre trial from Italy
Interventions TMX 20 mg bd
MPA 1g/week IM
Outcomes 1‐year survival
Side effects
Notes It is not stated if the included patients received any treatment prior to enrolment (chemotherapy, radiotherapy or hormonal therapy)
45 patients received TMX and 48 patients MPA
In the TMX group 23 of the responders later relapsed and received combination therapy of TMX and MPA
In the MPA group 24 of the responders later relapsed and received combination therapy of TMX and MPA
The follow up was 1 year
Side effects were reported by treatment arm, but their categorisation was different and therefore not directly comparable:
"The side‐effects with MPA were similar to those previously reported in the literature (Ganzina and Robustelli della Cuna, 1982) and included weight gain due to fluid retention (70%), facies lunaris (16%), tremors (14%), gluteal abscess (10%) and vaginal bleeding (10%). These and other reversible side‐effects such as sweating, muscular cramps, thrombophlebitis and raised blood pressure were never severe enough to require withdrawal of therapy and the clinical tolerance to MPA treatment was generally good when compared to other agents used in oncology. Treatment was not interrupted in any of the patients on TMX because of side‐effects. Those reported were slight nausea (31%) and/or gastralgia (20%), anorexia (38%), urticarial skin reactions (22%), minimal transitory thrombocytopenia (16%) and transitory tumour flare in the first week of therapy in 91% of patients."
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk "Treatment was allocated without a code, but always ensuring that the two groups were well balanced for age, menopausal status, disease‐free interval and both stage and site of tumour.' Table 1 depicts patient characteristics by treatment arm".
Allocation concealment? High risk Not applicable
Blinding? 
 All outcomes Unclear risk Not reported
Incomplete outcome data addressed? 
 All outcomes Low risk % analysed: 93/93 (100%)
Free of selective reporting? Unclear risk Insufficient information to permit judgement
Free of other bias? Unclear risk Insufficient information to assess whether an additional risk of bias exists
Accurate classifications of outcomes? Low risk "The IUCC classification of response was used as shown below:
 Complete remission (CR), Complete disappearance of all evidence of neoplastic disease.
 Partial remission (PR), A 50% or more reduction in the diameters of all lesions and/or a 50% reduction in ascites or pleural effusion.
 No change (NC), No change in the size of lesions.
 Progressive disease (PD), A 50% or more increase in the diameters of all lesions and/or effusions or the appearance of new lesions.
 Tumour response was assessed by clinical examination and radiography (Hayward et al., 1977)."