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2.2.2.3 La Legislación de las Comunidades Autónomas.

Matched  Patients  In  A  Teaching  Hospital’s  Clinico-­‐Pathological  Database    

 

INTRODUCTION    

One   of   the   continuing   dilemmas   for   gastrointestinal   oncologists   is   the   question   of   optimal  adjuvant  treatment  for  patients  with  locally  advanced  rectal  cancer.  This  may  have   arisen   from   improvements   in   surgery,   radiotherapy   and   chemotherapy   while   information   relating   to   their   combined   use   has   lagged   behind.   In   surgery,   there   has   been   widespread   adoption   of   precise   anatomical   mobilisation   of   the   rectum   by   sharp   dissection   (Total   Mesorectal  Excision  (TME)  surgery)  together  with  the  impact  of  surgical  sub  specialization.   The  ensuing  low  rates  of  local  recurrence  and  improved  survival  from  individual  surgical  units   have  prompted  some  colorectal  surgeons  to  question  the  routine  use  of  adjuvant  therapies.  

1-­‐3   In   radiotherapy,   improvements   in   planning   and   scheduling   have   occurred,   including   the  

introduction   of   short   and   long   course   neoadjuvant   protocols   in   an   attempt   to   reduce   the   frequency  of  small  bowel  toxicity,  diarrhoea  and  incontinence  that  complicated  earlier  post-­‐ operative  adjuvant  radiotherapy  regimens.  4,  5  Chemotherapy  for  colorectal  cancer  has  seen   the  development  of  new  infusional  schedules  of  5-­‐fluorouracil  and  the  introduction  of  new   drugs   including   oxaliplatin,   irinotecan,   capecitabine   and   the   molecular   targeted   therapies,   bevacizumab,   cetuximab   and   panitumumab.   However,   their   optimal   use   in   rectal   cancer   patients,   especially   in   the   adjuvant   and   neoadjuvant   settings   in   combination   with   radiotherapy   remains   uncertain.   Furthermore,   identification   of   optimal   adjuvant   chemotherapy  protocols  for  rectal  cancer  has  been  complicated  by  the  fact  that  rectal  cancer   patients  have  been  excluded  from  most  large  international  adjuvant  studies.      

Despite   these   uncertainties,   it   has   been   clearly   established   in   large   prospective   randomized   studies   that   adjuvant   chemoradiation   reduces   local   recurrence   and   produces   small  increments  in  survival  for  those  patients  with  locally  advanced  disease  (T3  tumours  and   locally  involved  lymph  nodes).  6,  7  Short  course  neoadjuvant  radiotherapy  in  selected  patients  

has  been  shown  to  be  as  effective  as  longer  courses  of  radiotherapy.  8,  9  However,  there  are  

groups  of  rectal  cancer  patients  for  whom  radiation  might  not  be  necessary  (due  to  the  site   of  the  tumour  10,  small  primary  tumour  size  or  small  numbers  of  involved  lymph  nodes  not  

recognized  pre-­‐operatively),  or  actually  contraindicated  (because  of  prior  therapy  for  other   diseases   or   local   surgical   issues).     Such   patients   might   still   benefit   from   effective   systemic   adjuvant   therapy   and   there   are   some   data   to   support   the   use   of   adjuvant   chemotherapy   alone.  11-­‐13   For   example,   in   the   Japanese   National   Surgical   Adjuvant   Study   of   Colorectal  

Cancer,  patients  who  had  undergone  standardized  mesorectal  excision  with  selective  lateral   pelvic   lymphadenectomy   for   stage   III   rectal   cancer   were   randomly   assigned   to   receive   postoperative   adjuvant   oral   uracil-­‐tegafur   for   one   year   or   no   further   treatment.   14   Radiotherapy  was  not  used  either  pre-­‐  or  postoperatively.  The  3-­‐year  overall  survival  rate  in   the  treated  group  was  91%  compared  to  81%  in  the  untreated  group  (p  =    0.0048).  

Another  issue  that  has  been  difficult  to  control  for  in  adjuvant  studies  in  rectal  cancer   has  been  the  quality  of  the  surgery.  It  has  been  recognized  that  there  are  major  differences   in  recurrence  rates  and  outcomes  between  individual  surgeons  and  different  surgical  units   based   on   experience   and   training   of   the   operator.   Attempts   have   been   made   to   reduce   variability  in  surgical  quality  through  the  use  of  surgical  trainers  and  mentors  15,  16  prior  to  

and  during  randomised  trials,  and  by  undertaking  audit  of  pathology  specimens  during  such   studies  and  providing  feedback  to  the  surgeons.  17,  18  However,  such  capacity  has  not  been  

We  evaluated  the  efficacy  of  chemotherapy  alone  in  a  cohort  of  patients  who  had  a   resection  for  stage  C  (III)  rectal  cancer  at  Concord  Hospital  and  for  whom  information  had   been  recorded  in  a  prospective  hospital  registry  of  colorectal  cancer.  Concord  Hospital  has  a   large  colorectal  unit  with  a  clinicopathological  database  that  has  accumulated  the  outcomes   of   all   resected   patients   with   over   95%   accuracy   since   1971.   In   addition,   since   1981   all   resections  have  been  performed  by  a  small  group  of  surgeons  using  a  standardized  operative   technique.  3     Surgical   quality   was   also   assessed   by   the   involvement   of   a   small   number   of  

specialist  colorectal  pathologists  during  that  same  period.  The  unit  was  slow  to  adopt  routine   use  of  adjuvant  radiotherapy  and  used  adjuvant  chemotherapy  only  for  high  risk  stage  C  (III)   rectal  cancer  patients  as  positive  results  accrued  for  stage  C  (III)  colon  cancer  patients.  19,  20  

The   aim   of   the   present   study   was   to   compare   patients   who   had   received   adjuvant   chemotherapy   with   patients   earlier   in   the   series   before   chemotherapy   was   introduced   in   order  to  evaluate  the  benefits  of  postoperative  adjuvant  chemotherapy  in  this  patient  group.  

 

PATIENTS  AND  METHODS    

The  Concord  Hospital  prospective  registry  of  consecutive  patients  having  a  resection   for  colorectal  cancer  21,  22  has  the  approval  of  the  South  Western  Sydney  Health  Area  Ethics   Committee.   Treatment   of   patients   was   discussed   in   regular   multidisciplinary   meetings   comprising  surgeons,  pathologists,  oncologists,  nurses  and  allied  health  providers.  Additional   information  on  patients  receiving  adjuvant  chemotherapy  in  the  period  from  May  1992  to   December  2007  was  compiled  retrospectively  from  patient  records  by  an  oncologist  (PK)  and   a  surgeon  (PC).  

  All   resections   since   1981   were   performed   by   colorectal   surgeons   along   anatomical   planes   following   a   standardized   technique   as   described   previously.3   Co-­‐morbidity   and