Adjuvant therapy sparing in rectal cancer achieving complete response after chemoradiation.
OBJECTIVE
To evaluate the long-term results of conventional chemoradiotherapy and laparoscopic mesorectal excision in rectal adenocarcinoma patients without adjuvant therapy.


METHODS
Patients with biopsy-proven adenocarcinoma of the rectum staged cT3-T4 by endoscopic ultrasound or magnetic resonance imaging received neoadjuvant continuous infusion of 5-fluorouracil for five weeks and concomitant radiotherapy. Laparoscopic surgery was planned after 5-8 wk. Patients diagnosed with ypT0N0 stage cancer were not treated with adjuvant therapy according to the protocol. Patients with ypT1-2N0 or ypT3-4 or N+ were offered 5-fluorouracil-based adjuvant treatment on an individual basis. An external cohort was used as a reference for the findings.


RESULTS
One hundred and seventy six patients were treated with induction chemoradiotherapy and 170 underwent total mesorectal excision. Cancer staging of ypT0N0 was achieved in 26/170 (15.3%) patients. After a median follow-up of 58.3 mo, patients with ypT0N0 had five-year disease-free and overall survival rates of 96% (95%CI: 77-99) and 100%, respectively. We provide evidence about the natural history of patients with localized rectal cancer achieving a complete response after preoperative chemoradiation. The inherent good prognosis of these patients will have implications for clinical trial design and care of patients.


CONCLUSIONS
Withholding adjuvant chemotherapy after complete response following standard neoadjuvant chemoradiotherapy and laparoscopic mesorectal excision might be safe within an experienced multidisciplinary team.
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Xabier
X
García-Albéniz
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Rosa
R
Gallego
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Ralf Dieter
RD
Hofheinz
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Gloria
G
Fernández-Esparrach
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Juan Ramón
JR
Ayuso-Colella
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Josep Antoni
JA
Bombí
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Carles
C
Conill
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Miriam
M
Cuatrecasas
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Salvadora
S
Delgado
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Angels
A
Ginés
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Rosa
R
Miquel
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Mario
M
Pagés
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Estela
E
Pineda
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Verónica
V
Pereira
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Aarón
A
Sosa
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Oscar
O
Reig
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Iván
I
Victoria
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Luis
L
Feliz
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Antonio
A
María de Lacy
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Antoni
A
Castells
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Iris
I
Burkholder
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Andreas
A
Hochhaus
Xabier García-Albéniz, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02115, United States.
Joan
J
Maurel
D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage*; D001706:Biopsy; D059248:Chemoradiotherapy; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D019160:Endosonography; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D006801:Humans; D010535:Laparoscopy; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic; D012004:Rectal Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D013030:Spain; D013997:Time Factors; D016896:Treatment Outcome; D019564:Unnecessary Procedures
D000964:Antimetabolites, Antineoplastic; D005472:Fluorouracil
Exercise; Follow-up; Gastrointestinal diseases; Irritable bowel syndrome; Physical activity