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Hormones

Women with rectal cancer treated with preoperative radiotherapy (RT) and surgery.

Women with rectal cancer treated with surgery alone (no RT).

Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.

Preoperative radiotherapy

Anna Martling

Preoperative radiotherapy (RT) and pelvic surgery is recommended to many patients with rectal cancer. For women there are theoretical reasons to believe that the treatment may affect hormone levels, sexual function and wellbeing. To address these questions a longitudinal observational study was initiated where androgen levels and sexual function were assessed before treatment (baseline) and during a follow-up period of two years.

Women with rectal cancer stage I to III planned for abdominal surgery was included in the study. Women treated with preoperative RT were assigned to the exposed group and women treated with surgery alone were assigned to the unexposed group.

142 participants were enrolled at five outpatient rectal cancer centres in Sweden between 2008 and 2013. Patient data, fasting venous blood samples and questionnaires regarding sexual function and well-being were collected at a baseline visit before start of oncologic treatment, 1 year after surgery and 2 years after surgery (only questionnaires). Women treated with preoperative RT for rectal cancer had an additional venous blood sample taken the day before surgery.

Changes in serum levels of testosterone and sexual function during follow-up was assessed and compared between exposed and unexposed participants.

Sexual Function and Wellbeing in Females With Rectal Cancer

Sexual Function and Wellbeing in Females Diagnosed With Rectal Cancer

Fasting venous blood samples were collected at baseline visit (prior to oncological treatment) and 1 year follow-up. Participants treated with preoperative radiotherapy (RT) had an additional blood sample taken the day before surgery. Serum testosterone levels (T) were measured with liquid chromatography-mass spectrometry using the LC-MS/MS Quattro Premier Xevo TQ MS (Waters Corporation, Milford, MA, USA). The total coefficients of variation (CVtot) were 7% at 2.8 nmol/L and 6% at 15 nmol/L.

Sexual function was assessed using the Female Sexual Function Index (FSFI). The FSFI questionnaire is a 19-item multiple-choice, self-assessment tool validated for use in the general population as well as for patients with cancer. It covers six domains of sexual function in women; desire (2 items), arousal (4 items), lubrication (4 items), orgasm (3 items), satisfaction (3 items) and pain (3 items). Items scores between 0 or 1 to 5, with lower scores indicating worse function. A total FSFI score can be calculated when all items are completed. Minimal total score is 4 points and maximal score is 95 points, with lower scores indicating worse function. A total FSFI score of less than 26.55 points was used to define overall sexual dysfunction.

Swedish Cancer Society

Karolinska Institutet

Professor, Senior Consultant Surgeon

Preoperative RT

No Preoperative RT

Preoperative Radiotherapy

No Preoperative Radiotherapy

Total

Age, Continuous

Sex: Female, Male

Missing

ASA score is a classification system for physical status ranging from scores I to VI with higher scores indicating worse physical status. Definitions of scores: I = Normal healthy person, II = A patient with mild systemic disease, III = A patient with severe systemic disease.

ASA score

0-4 cm

5-10 cm

11-15 cm

Tumour distance from anal verge

Short course (5Gy x5)

Long course (2 Gy x25 or 1.8 x28)

No RT

Type of preoperative RT

Anterior resection

Abdominal excision

No abdominal surgery

Type of Surgery

Hysterectomy

Unilateral/bilateral oophorectomy

Partial vaginal resection

No resection

Includes resections before study inclusion and as part of rectal cancer surgery.

Resection of gynaecological organs

Pathological tumour stage is determined by examining tissue removed during surgery. Staging is based on the American Joint Committee on Cancer (AJCC) TNM system, with T being the extent of the tumour, N spread to nearby lymph nodes and M spread to distant sites. This is summarised into a score ranging from 0 to IV, with 0 being very early cancer and higher numbers indicating more advanced cancer.

Pathological tumour stage

Neoadjuvant chemotherapy

Adjuvant chemotherapy

Professor Anna Martling

The change in serum testosterone levels between baseline and 1 year was assessed using longitudinal regression analysis (GEE).

Baseline

After RT/before surgery

1 year after surgery

17 of the included 142 participants were excluded due to history of oophorectomy, resulting in 125 participants analysed. Participants in the group "No preoperative radiotherapy" had no blood samples taken at the time point "After RT/before surgery".

Change in Serum Testosterone Levels Between Baseline and 1 Year After Surgery.

The association between mean change in total FSFI score and preoperative RT was assessed using longitudinal regression analysis (GEE), using "no preoperative radiotherapy" as the reference group.

2 years after surgery

Of the 142 participants included in the study, 3 were excluded due to not answering FSFI questionnaires at any timepoint. Total FSFI scores were only calculated for available questionnaires without missing items.

Change in Sexual Function (Total FSFI Scores) Between Baseline and 2 Years Follow-up.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet
Sexual Function and Wellbeing in Females With Rectal Cancer	NCT01216189	Rectal Cancer	Preoperative ra...	18 Years -	Karolinska Institutet

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