Patient-reported outcomes after neoadjuvant chemoradiotherapy for rectal cancer: a multicenter prospective observational study.
OBJECTIVE
To prospectively describe patient-reported outcomes (PROs) after preoperative chemoradiotherapy (pCRT) for rectal cancer.


BACKGROUND
Little evidence is available on PROs after pCRT for rectal cancer.


METHODS
Patients with rectal cancer, candidates to receive pCRT, were enrolled in a multicenter prospective observational trial. Health-related quality of life was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and its colorectal cancer module (QLQ-CR38), and fecal incontinence and bowel function were evaluated using the fecal incontinence score questionnaire and a set of ad hoc questions. Questionnaires were filled out before CRT (t₀), 2 to 3 weeks after completion of CRT (t₁), and at 6 (t₂) and 12 months (t₃) after surgery. Primary analysis of selected scales included: global quality of life, physical functioning, social functioning, fatigue, body image, future prospective, and gender-related sexual problems.


RESULTS
Of 149 eligible patients, questionnaires were completed in 100%, 95%, 88% and 77% of cases at t0, t₁, t₂, and t₃, respectively. At t₃, 78% of patients reported stool fractionation and 72% sensation of incomplete defecation. Only 14% of patients had optimal continence. Physical/social functioning, fatigue, and body image showed a decrease just after pCRT and returned to baseline levels at 1 year after treatment. Global quality of life was stable over time. Male sexual problems were greatly impaired throughout the study period (P < 0.001) with major clinically meaningful changes between baseline and 1 year after treatment.


CONCLUSIONS
These findings add to the body of evidence available regarding pCRT and help clinicians to make more informed treatment decisions.
Dipartimento di Scienze Oncologiche e Chirurgiche, Sezione di Clinica Chirurgica II, Università di Padova, Italy. puc@unipd.it
Salvatore
S
Pucciarelli
Paola
P
Del Bianco
Fabio
F
Efficace
Samantha
S
Serpentini
Carlo
C
Capirci
Antonino
A
De Paoli
Antonio
A
Amato
Dajana
D
Cuicchi
Donato
D
Nitti
D000230:Adenocarcinoma / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D019583:Dose Fractionation, Radiation; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D018714:Radiotherapy, Adjuvant; D012004:Rectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D005472:Fluorouracil