The second British Stomach Cancer Group trial of adjuvant radiotherapy or chemotherapy in resectable gastric cancer: five-year follow-up Adjuvant chemoradiotherapy in patients with stage III or IV radically resected gastric cancer: a pilot study. Neoadjuvant chemotherapy versus surgery alone for locally advanced gastric cancer: a retrospective comparative study. Patients with curative resection of cT3-4 rectal cancer after preoperative radiotherapy or radiochemotherapy: does anybody benefit from adjuvant fluorouracil-based chemotherapy? A trial of the European Organisation for Research and Treatment of Cancer Radiation Oncology Group. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. A controlled, prospective, randomised trial of adjuvant chemotherapy or radiotherapy in resectable gastric cancer: interim report. British Stomach Cancer Group. Impact of adjuvant therapy on locally advanced adenocarcinoma of the stomach. Adjuvant treatments following curative resection for gastric cancer Further evidence of effective adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer Comparing Efficacy of Preoperative neo-Adjuvant Chemotherapy and Surgery versus Surgery Alone in Patients with Resectable Gastroesophageal Cancer Neoadjuvant Chemoradiotherapy and Surgery Versus Surgery Alone in Resectable Pancreatic Cancer: A Single-Center Prospective, Randomized, Controlled Trial Which Failed to Achieve Accrual Targets Updated analysis of SWOG-directed intergroup study 0116: a phase III trial of adjuvant radiochemotherapy versus observation after curative gastric cancer resection. Concentrated preoperative radiotherapy for resectable gastric cancer: 20-years follow-up of a randomized trial. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer Prognostic factors in resectable gastric cancer: Results of EORTC study no. 40813 on FAM adjuvant chemotherapy Neoadjuvant therapy of high-risk gastric cancer: a phase II trial of preoperative FAMTX and postoperative intraperitoneal fluorouracil-cisplatin plus intravenous fluorouracil. Neoadjuvant radiochemotherapy and surgery for advanced rectal cancer
The overall survival in patients with gastric cancer is low , even among those undergoing resection . It has been hoped that the development of adjuvant therapy might improve survival in patients following surgery when tumour burden was minimal and both chemotherapy and radiotherapy have been proposed as suitable for use in gastric cancer . Their value has been evaluated by the British Stomach Cancer Group Second adjuvant therapy trial . 436 patients entered a prospect i ve , r and omised , controlled trial of adjuvant radiotherapy or cytotoxic chemotherapy with mitomycin , doxorubicin , and fluorouracil  after gastrectomy for adenocarcinoma . After at least 5 years , there have been 372 deaths of which 7 were due to surgical complications and 327 from recurrent cancer . Following stratified r and omisation , 145 patients were allocated to  surgery alone  , 153 to receive adjuvant radiotherapy , and 138 to adjuvant combination chemotherapy . The overall 2-year and 5-year survival were 33 % ( 95 % confidence interval 31 - 35 % ) and 17 % ( 13 - 21 % ) . No survival advantage has been shown for those patients receiving either adjuvant therapy compared to those undergoing surgery alone . The 5-year survival for surgery alone was 20 % , for surgery plus radiotherapy 12 % , and for surgery plus chemotherapy 19 % . Surgery , therefore , remains the st and ard treatment for this condition and the use of adjuvant treatments should be restricted to controlled trials BACKGROUND Adjuvant chemoradiotherapy does not represent the st and ard of care in patients with resected high-risk gastric cancer ; however , results from phase 2 and r and omized trials suggest improvement in overall survival . We assessed the feasibility and toxic effects of chemoradiotherapy as adjuvant treatment in locally advanced gastric cancer . DESIGN Pilot study . SETTING University hospital . PATIENTS Twenty-nine patients with T4N+ or any TN23 gastric cancer previously treated with potentially curative surgery were enrolled . All of the patients received combined adjuvant chemotherapy with FOLFOX-4 ( ie , a combination of folinic acid [ leucovorin ] , fluorouracil , and oxaliplatin [ Eloxatin ] ) for 8 cycles and concomitant radiotherapy ( 45 Gy in 25 daily fractions over 5 weeks ) . Radiotherapy was begun after the first 2 cycles of FOLFOX-4 , which was reduced by 25 % during the period of concomitant radiotherapy . MAIN OUTCOME MEASURES Treatment toxic effects according to the National Cancer Institute-Common Toxicity Criteria classification , overall and disease-free survival rates , and identification of prognostic indicators . RESULTS All of the patients completed treatment . Severe hematologic and gastrointestinal toxic effects occurred in 10 % and 33 % , respectively . No acute hepatic or renal toxic effects were observed ; 1 patient experienced severe neurotoxicity . Disease-free and overall survival rates at 1 , 2 , and 3 years were 79 % , 35 % , and 35 % and 85 % , 62.6 % , and 50.1 % , respectively , and were shown to be substantially better than those observed in untreated patients . Long-term outcome was related to TNM stage , basal serum tumor marker level , and , particularly , lymph node ratio . CONCLUSION A multimodal approach with FOLFOX-4 and radiotherapy is feasible and effective for the treatment of patients with resected high-risk gastric cancer BACKGROUND / AIMS Preoperative chemotherapy is considered an effective treatment option for patients with gastric cancer . We retrospectively evaluated neoadjuvant chemotherapy with oxaliplatin , leucovorin and 5-flurouracil ( OLF ) in patients with locally advanced gastric cancer to determine its feasibility , as well as impact on the curative resection rate and patients ' survival . METHODOLOGY A total of 87 patients with locally advanced gastric cancer that underwent preoperative chemotherapy combined with surgery or surgery alone were r and omly matched according to the clinical TNM stage . The clinical responses to chemotherapy were assessed . The curative rate , postoperative complications and patients ' survival between both groups were compared . RESULTS The two groups were well matched . Complete or partial response was observed in 51.7 % ( 15/29 ) of patients in the OLF group , and three ( 10.3 % ) of them had complete pathologic response . The curative resection rates were 89.7 % in the OLF group and 77.6 % in the surgery alone group . The postoperative complications were equal for both groups . The mean survival is 20.6 months in the OLF group vs. 19.9 months in the surgery alone group ( p=0.02 ) . CONCLUSIONS Neoadjuvant chemotherapy using OLF combination is active in gastric cancer and the toxicity level is acceptable . This treatment improves the curative resection rate and patients ' survival in locally advanced gastric cancer PURPOSE European Organisation for Research and Treatment of Cancer ( EORTC ) trial 22921 compared adjuvant fluorouracil-based chemotherapy ( CT ) to no adjuvant treatment in a 2 x 2 factorial trial with r and omization for preoperative (chemo)radiotherapy in patients with resectable T3 - 4 rectal cancer . The results showed no significant impact of adjuvant CT on progression-free or overall survival , although a difference seemed to emerge at approximately , respectively , 2 and 5 years after the start of preoperative treatment . We further explored the data with the aim of refining our underst and ing of the long-term results . PATIENTS AND METHODS Data of 785 of the 1,011 r and omly assigned patients who whose disease was M0 at curative surgery were used . Using meta-analytic methods , we investigated the homogeneity of the effect of adjuvant CT on the time to relapse or death after surgery ( disease-free survival [ DFS ] ) and survival in patient subgroups . RESULTS Although there was no statistically significant impact of adjuvant CT on DFS for the whole group ( P > .5 ) , the treatment effect differed significantly between the ypT0 - 2 and the ypT3 - 4 patients ( heterogeneity P = .009 ) : only the ypT0 - 2 patients seemed to benefit from adjuvant CT ( P = .011 ) . The same pattern was observed for overall survival . CONCLUSION Exploratory analyses suggest that only good-prognosis patients ( ypT0 - 2 ) benefit from adjuvant CT . This could explain why , in the whole group , the progression-free and overall survival diverged only after the poor-prognosis patients ( ypT3 - 4 ) had experienced treatment failure . Patients in whom no downstaging was achieved did not benefit . This also suggests that the same prognostic factors may drive both tumor sensitivity for the primary treatment and long-term clinical benefit from further adjuvant CT The efficacy of combined radiation and fluorouracil as adjuvant therapy for pancreatic cancer is suggested by a prospect i ve r and omized study conducted by the Gastrointestinal Tumor Study Group ( GITSG ) . Twenty-two patients r and omized to no adjuvant treatment and 21 to combined therapy were analyzed . Neither life-threatening toxic reaction nor death due to toxic effect was encountered . The study was terminated prematurely because of an unacceptably low rate of accrual combined with the observation of increasingly large survival differences between the study arms . Median survival for the treatment group ( 20 months ) was significantly longer than that observed for the control group ( 11 months ) . Four patients , three in the treated and one in the control group , have survived five years or longer following surgery . The extent of the tumor and initial performance status were significantly and independently related to survival A prospect i ve , r and omised controlled trial of surgery , surgery with adjuvant radiotherapy and surgery with adjuvant chemotherapy ( 5-fluorouracil , adriamycin and mitomycin C ) in operable gastric cancer is described . Four hundred and thirty-six patients were r and omly allocated to one of three treatment groups . With 12 months ' minimum follow-up , 334 patients have died , 292 from recurrent cancer . The median survival for all patients was 15 months . Neither form of adjuvant therapy provides any survival advantage . Surgery remains the principal treatment for operable gastric cancer . Care should be taken to st and ardise surgical treatment and any adjuvant treatments must be compared within the confines of controlled , r and omised trials From 1975 to 1988 , 120 consecutive patients with locally advanced ( T3/T4 or N1/N2 ) adenocarcinoma of the stomach underwent attempted curative resection . Seventy patients were treated with surgery alone while 50 patients also received adjuvant therapy consisting of either chemotherapy ( 5-FU/FAM ) alone , radiation therapy alone , or chemotherapy+radiation therapy . Adjuvant therapy was tolerated relatively well with only one patient experiencing a grade 3 ( RTOG/EORTC ) toxicity , and none experiencing grade 4/5 toxicity . In patients with T3/T4 tumors , the median survival was 10 months for surgery alone as compared to 18 months for the adjuvant treatment group , and a 5-year survival of 10 % versus 24 % in the adjuvant therapy group ( p = .01 ) . In patients with lymph node positive disease , the median survival was 10 months in patients treated with surgery as compared to 15 months for those treated with adjuvant therapy , and a 5-year survival of 8 % for surgery alone versus 16 % for the adjuvant therapy group ( p = .04 ) . Patients having both T3/T4 tumor and positive lymph nodes had a median survival of 9 months with surgery versus 13 months for the adjuvant therapy group , and a 5-year survival of 4 % versus 22 % ( p = .03 ) for the adjuvant group . Seventy-four patients were evaluable for pattern of relapse . Thirty developed locoregional recurrence ; 17 of 38 ( 45 % ) in the surgery alone group and 13 of 36 ( 36 % ) in the adjuvant therapy group . The improvement in local control in the adjuvant group was totally accounted for by the group receiving both chemotherapy and radiation therapy , in which the recurrence rate was 19 % . Statistically significant improvement in the 2-year local control rate was limited to patients with negative surgical margins who received radiation , 93 % , versus those who did not , 55 % ( p = 0.03 ) . The modest improvement in survival seen in patients receiving adjuvant therapy appears to be related to improved local control . No improvement in the rate of distant failure was seen . Chemotherapeutic regimens used seem to be critical in enhancing the effects of radiation in improving local control and survival . Results may be further improved by the extended use of intraoperative radiation The results of a prospect i ve r and omized trial of adjuvant treatment after curative resection for gastric cancer are reported . The study consisted of three arms : ( 1 ) surgery only ; ( 2 ) chemotherapy ( 5‐fluoro‐uracil ( FU ) and 1‐(2‐chloroethyl)‐3‐(4‐methylcyclohexil)‐1‐nitrosourea ( Me‐CCNU ) ) after surgery ; ( 3 ) chemo‐immunotherapy ( FU , Me‐CCNU and levamisole ) after surgery .  Between March 1977 and June 1981 , 235 patients were included in the study by 18 co‐operating institutions . Thirteen per cent of patients in arm 2 and thirteen per cent in arm 3 suffered major toxicity , necessitating interruption of treatment . Two of these patients died of marrow aplasia . Statistical analysis of survival showed that prognosis was influenced by the well‐known prognostic variables , invasion of the wall , nodal status and site of tumour . The different treatments in the three arms , however , did not show any impact on prognosis , even when adjustments were made for the most relevant prognostic variables . Given the lack of effect on survival and the presence of clinical ly important toxicity , FU and Me‐CCNU ± levamisole can not be recommended as adjuvant therapy for resected gastric cancer The Gastrointestinal Tumor Study Group ( GITSG ) previously demonstrated a significant survival advantage for patients who receive adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer.1  Median survival in the group r and omized to control was 10.9 months , compared with 21.0 months for those r and omized to treatment . GITSG registered 30 additional patients , who received the adjuvant therapy to demonstrate that the results of the r and omized trial could be replicated . Characteristics of registered patients were similar to those of patients in the r and omized phase , with the exception of an improved performance status . The registered patients had median survival time of 18 months . Ten patients were alive at 18.9 to 42.4 months ( median , 25.0 ) . Two‐year actuarial survival was 46 % ( 95 % confidence interval [ CI ] , 0.28 , 0.65 ) compared with 43 % ( 95 % CI , 0.25 , 0.63 ) for 21 patients r and omized to treatment and 18 % ( 95 % CI , 0.08 , 0.36 ) for 22 patients r and omized to control . Based on the original study and the confirmatory findings , the combined use of radiation therapy and fluorouracil as adjuvant therapy after curative resection is effective and is preferred to no adjuvant therapy Background Recent research es have led to find strategies to prevent relapse and to improve survival for gastric cancer patients , including preoperative neo-adjuvant approaches . However , the efficacy of some neo-adjuvant regimens including 5-fluorouracil , cisplatin , and docetaxel have been less investigated . The present study evaluated the outcome and mid-term survival of patients with gastric cancer who undergoing this regimen . Methods In a r and omized double-blinded controlled trial performed at the Firoozgar hospital in Tehran in 2011 - 12 , 61 patients were r and omly assigned to treatment ( 32 to neo-adjuvant chemotherapy with docetaxel , cisplatin and 5-fluorouracil ( 5-FU ) before surgery and 27 to surgery alone ) . The present study tried to assess the efficacy of neoadjuvant chemotherapy regarding improvement of mid-term survival , complications , and R0 resection status . Results The two groups were matched in terms of gender , mean age , cancer location , and TNM staging . However , R0 resection in the former group was 85.7 % ; while this indicator in the isolated surgery group was significantly lower ( 61.5 % ) . Regarding WHO performance , no significant difference was observed across the two groups . Patients in  neo-adjuvant chemotherapy group were followed for mean follow-up time 10.32 months and those who categorized in isolated surgery group were followed for mean follow-up time 10.88 months . Mid-term mortality rate in the two groups was 14.3 % and 15.4 % , respectively ( p = 0.866 ) . In this regard , 3- , 6- , and 9-month survival rate in neo-adjuvant chemotherapy group was 96.4 % , 89.3 % , and 85.7 % , respectively . These survival rates in the surgery group were 92.3 % , 88.5 % , and 84.6 % , respectively . Multivariable logistic regression analysis showed that among all study variables , only R0 resection status could predict mid-term mortality .  Conclusion Neo-adjuvant chemotherapy and surgery compare to surgery alone more improve R0 resection status , but mid-term survival rate is similar in the two regiments . R0 resection status can effectively predict appropriate mid-term survival in undertreated patients Objective The objective of the study is to evaluate the usefulness of neoadjuvant chemoradiotherapy in resectable pancreatic cancer . Methods A single-center RCT of patients affected by resectable pancreatic adenocarcinoma which included arm A ( surgery alone ) and arm B ( neoadjuvant chemoradiation and surgery ) . The primary endpoint was R0 resection ; the secondary endpoints were toxicity ; number of patients who completed the neoadjuvant therapy ; radiological and pathological response after chemoradiation ; and pTNM stage , postoperative morbidity , mortality , and overall and disease-free survival .  A sample size of 32 patients was required for each group . Results The study was terminated early , and 38 patients were r and omized : 20 in arm A and 18 in arm B. There was no significant difference regarding R0 resection rate in the two groups ( intention-to-treat , OR = 1.91 , P = 0.489 ) . Neoadjuvant chemoradiotherapy was completed in 14 out of 18 cases ( 77.8 % ) and the radiological and pathological response was efficacious in 72.3 and 90.9 % of cases , respectively . Conclusions Neoadjuvant chemoradiation was feasible , safe , and efficacious , although non-significant results were obtained as a result of the underpowered data due to the difficulty in recruiting patients . Additional multicenter RCTs are needed in the future PURPOSE Surgical resection of gastric cancer has produced suboptimal survival despite multiple r and omized trials that used postoperative chemotherapy or more aggressive surgical procedures . We performed a r and omized phase III trial of postoperative radiochemotherapy in those at moderate risk of locoregional failure ( LRF ) following surgery . We originally reported results with 4-year median follow-up . This up date , with a more than 10-year median follow-up , presents data on failure patterns and second malignancies and explores selected subset analyses . PATIENTS AND METHODS In all , 559 patients with primaries ≥ T3 and /or node-positive gastric cancer were r and omly assigned to observation versus radiochemotherapy after R0 resection . Fluorouracil and leucovorin were administered before , during , and after radiotherapy . Radiotherapy was given to all LRF sites to a dose of 45 Gy . RESULTS Overall survival ( OS ) and relapse-free survival ( RFS ) data demonstrate continued strong benefit from postoperative radiochemotherapy . The hazard ratio ( HR ) for OS is 1.32 ( 95 % CI , 1.10 to 1.60 ; P = .0046 ) . The HR for RFS is 1.51 ( 95 % CI , 1.25 to 1.83 ; P < .001 ) . Adjuvant radiochemotherapy produced substantial reduction in both overall relapse and locoregional relapse . Second malignancies were observed in 21 patients with radiotherapy versus eight with observation ( P = .21 ) . Subset analyses show robust treatment benefit in most subsets , with the exception of patients with diffuse histology who exhibited minimal nonsignificant treatment effect . CONCLUSION Intergroup 0116 ( INT-0116 ) demonstrates strong persistent benefit from adjuvant radiochemotherapy . Toxicities , including second malignancies , appear acceptable , given the magnitude of RFS and OS improvement . LRF reduction may account for the majority of overall relapse reduction . Adjuvant radiochemotherapy remains a rational st and ard therapy for curatively resected gastric cancer with primaries T3 or greater and /or positive nodes BACKGROUND AND OBJECTIVES The role of radiation therapy in resectable gastric cancer is question able . To study the value of concentrated preoperative radiotherapy , a r and omized clinical trial had been carried out . METHODS From 1974 to 1978 , 152 patients were r and omized and underwent exploratory laparotomy ; in 50 patients curative surgery was not possible , while 102 patients satisfied protocol requirements and entered in the trial . Patients in the experimental group were treated with preoperative radiotherapy ( 20 Gy/5 days ) and subtotal or total gastrectomy . Patients in the control group underwent surgery alone . RESULTS Study showed acceptable tolerance of radiotherapy regime with no increase of postoperative mortality and morbidity . There was no significant difference in survival between the two treatment groups ( chi 2 = 0.349 , df = 1 , P = 0.555 ) . Subset analysis also failed to demonstrate significant survival advantages of the combined treatment ; however , some positive trends were seen in patients with locally advanced gastric cancer . CONCLUSIONS Concentrated preoperative radiotherapy in the dose of 20 Gy is safe and feasible , but seems to be insufficient to improve survival in gastric cancer patients . However , the results are promising in selected subgroups of patients , which encourages future trials with adjuvant radiation therapy Background Although radical surgery remains the cornerstone of cure in resectable gastric cancer , survival remains poor . Current evidence -based (neo)adjuvant strategies have shown to improve outcome , including perioperative chemotherapy , postoperative chemoradiotherapy and postoperative chemotherapy . However , these regimens suffer from poor patient compliance , particularly in the postoperative phase of treatment . The CRITICS-II trial aims to optimize preoperative treatment by comparing three treatment regimens : ( 1 ) chemotherapy , ( 2 ) chemotherapy followed by chemoradiotherapy and ( 3 ) chemoradiotherapy . Methods In this multicentre phase II non-comparative study , patients with clinical stage IB-IIIC ( TNM 8th edition ) resectable gastric adenocarcinoma are r and omised between : ( 1 ) 4 cycles of docetaxel+oxaliplatin+capecitabine ( DOC ) , ( 2 ) 2 cycles of DOC followed by chemoradiotherapy ( 45Gy in combination with weekly paclitaxel and carboplatin ) or ( 3 ) chemoradiotherapy . Primary endpoint is event-free survival , 1 year after r and omisation ( events are local and /or regional recurrence or progression , distant recurrence , or death from any cause ) . Secondary endpoints include : toxicity , surgical outcomes , percentage radical ( R0 ) resections , pathological tumour response , disease recurrence , overall survival , and health related quality of life . Exploratory endpoints include translational studies on predictive and prognostic biomarkers . Discussion The aim of this study is to select the most promising among three preoperative treatment arms in patients with resectable gastric adenocarcinoma . This treatment regimen will subsequently be compared with the st and ard therapy in a phase III trial . Trial registration clinical trials.gov NCT02931890 ; registered 13 October 2016 . Date of first enrolment : 21 December 2017 Abstract Background : The high incidence of locoregional recurrences and distant metastases after curative surgery for gastric cancer calls for improved locoregional control and systemic adjuvant treatment . Methods : In a r and omized clinical trial on adjuvant FAM2 chemotherapy , quality of surgery was evaluated by comparing surgical and pathology data . Univariate and multivariate analysis was made to evaluate the effect of prognostic factors on survival and time of recurrence in relation to patients , tumor , and therapy . Results : Of 314 patients r and omized from 28 European institutions , 159 comprised the control and 155 the FAM2 group .  After a median follow-up of 80 months , no statistically significant difference was found between survivals . However , for recurrence time , treated patients had a significant advantage over controls ( p=0.02 ) . At univariate analysis , statistically significant differences in survival and time to progression emerged for T , N , disease stage , and “ adequacy ” of surgery . The multivariate analysis retained preoperative Hb level , T , N , and “ adequacy ” of surgery for time of survival ; and T , N , “ adequacy ” of surgery and adjuvant chemotherapy  for recurrence time . Conclusions : Disease stage is the most important prognostic factor . “ Adequate ” surgery has an important effect . Adjuvant FAM2 delayed time of recurrence , but did not influence overall survival PURPOSE AND METHODS We identified patients with gastric cancer at high risk for recurrence before therapy using endoscopic ultrasonography ( EUS ) .  Neoadjuvant therapy using the fluorouracil , doxorubicin , and metrotrexate ( FAMTX ) regimen was given for three courses before planned laparotomy with the intention to perform curative resection . Postoperatively , intraperitoneal ( IP ) cisplatin and fluorouracil ( FU ) and intravenous ( i.v . ) FU were administered to patients undergoing resection . RESULTS Fifty-six assessable patients were treated . Preoperative FAMTX therapy was tolerable , with the major toxicity being neutropenic fever . One treatment-related death was seen . Eighty-nine percent of patients underwent surgical exploration and 61 % had potentially curative resections . There were two postoperative deaths . Comparison of pathologic tumor ( pT ) stage with EUS-predicted tumor stage showed apparent downstaging in 51 % of patients . Postoperative IP chemotherapy was delivered to 75 % of eligible patients . Toxicity was acceptable . There was no increase in operative morbidity or mortality compared with concurrent non study patients undergoing a similar operative procedure and not receiving preoperative therapy . With a median follow-up time of 29 months , the median survival duration was 15.3 months . For patients who underwent potentially curative resections , the median survival duration was 31 months . Peritoneal failure was seen in 16 % of patients . CONCLUSION Chemotherapy with the FAMTX regimen is tolerable in patients with locally advanced gastric cancer , without an increase in operative morbidity or mortality . IP therapy can be successfully delivered to most resected patients . The intraabdominal failure pattern appears to be decreased compared with expected . This approach is an appropriate investigational arm to pursue in future studies Purpose : Preoperative radiochemotherapy is widely used in the treatment of locally advanced rectal cancer . The predictive value of response to neoadjuvant treatment remains uncertain . We retrospectively evaluated the impact of downstaging and tumor regression as prognostic factors and its influence on the ability to perform sphincter-sparing surgery . Patients and Methods : A total of 72 consecutive patients with advanced rectal cancer were included in this retrospective analysis . All patients were treated with preoperative 5-fluorouracil-based chemotherapy and pelvic radiation with a total dose of 50.4 Gy followed by surgery 6 weeks later . Results : A sphincter-preserving procedure could be performed on 42 patients , and in all 72 patients complete resection ( R0 ) was achieved . A pathological complete response ( ypT0 , ypN0 ) was achieved in 8 ( 11 % ) patients . None of the patients showing a complete pathological response relapsed or died during the follow-up period . At a median follow-up of 28 months , 65 patients were alive , none of these patients had local recurrence and 15 patients had metastatic disease . Patients showing a complete pathological response had a significantly better 2-year disease-free survival compared to patients with ≥10 % residual tumor cells ( p = 0.024 ) . Patients < 65 years showed a significantly better response rate , compared with those > 65 years of age ( p = 0.036 ) . Acute toxicity was moderate . Conclusion : Preoperative radiochemotherapy is an effective and safe treatment for patients with locally advanced rectal cancer . Pathological parameters after preoperative radiochemotherapy , including tumor regression grading , could be correlated with disease-free survival . The impact of tumor regression grading needs to be further vali date d in prospect i ve clinical trials . Hintergrund : Die präoperative Radiochemotherapie ( RChT ) gefolgt von einer Operation stellt heute die St and ardbeh and lung für Patienten mit lokal fortgeschrittenem Rektumkarzinom dar . Der Vorhersagewert des Ansprechens auf eine neoadjuvante RChT ist nicht definiert . Wir untersuchten retrospektiv die Bedeutung des Tumoransprechens ( Downstaging ) und der Tumorregression als prognostische Faktoren und ihren Einfluss , eine sphinktererhaltende Operation zu ermöglichen . Material und Method e : Die vorliegende Analyse umfasst 72 konsekutive Patienten mit fortgeschrittenen Rektumkarzinomen , die i m Zeitraum Januar 1999 bis Dezember 2006 eine neoadjuvante RChT erhielten . Die Beh and lung best and aus einer perkutanen Radiotherapie mit 50,4 Gy und einer simultanen 24-h-Dauerinfusion von 5-Fluorouracil ( Woche 1 und 5 ) gefolgt von einer radikalen Tumorresektion . Neben dem Ansprechen des Tumors i m Sinne eines Downstagings wurden mögliche prognostische Faktoren analysiert . Ergebnisse : Nach einer medianen Nachbeobachtungszeit von 28 Monaten kam es bei keinem Patienten zu einem Lokalrezidiv und bei allen 72 Patienten gelang eine komplette Resektion ( R0 ) . Das Ansprechen auf die neoadjuvante RChT i m Sinne einer histopathologischen Tumorregression konnte als relevanter Prognosefaktor für das krankheitsfreie Überleben herausgearbeitet werden ( Abbildung 1 ) . 8 Patienten ( 11 % ) erreichten eine histopathologische komplette Remission ( ypT0 , ypN0 ) . Darüber hinaus zeigten Patienten unter 65 Jahre ein signifikant besseres Ansprechen auf die präoperative RChT i m Sinne eines Downstagings als Patienten über 65 Jahre ( p = 0,036 ) . Die Akuttoxizität der neoadjuvanten Therapie ist moderat . Schlussfolgerung : Die neoadjuvante RChT mit anschließender radikaler Resektion ist eine effektive und sichere Beh and lung lokal fortgeschrittener Rektumkarzinome . Die Tumorregression konnte mit dem krankheitsfreien Überleben korreliert werden . Inwieweit die Tumorregression als valider Prognoseparameter angesehen werden kann , muss in prospektiven klinischen Studien überprüft werden
Furthermore , this therapy could increase the dem and on radiation re sources .
There is no evidence on which to make a recommendation for patients with node-negative tumours that have not penetrated the muscularis propria .
For patients unable to undergo radiation , adjuvant chemotherapy alone may be of benefit , particularly for those with lymph-node metastases .
There is insufficient evidence from r and omized trials to recommend neoadjuvant chemotherapy , or neoadjuvant or adjuvant radiotherapy or immunotherapy , either alone or in combination , outside a clinical trial .
OBJECTIVE To make recommendations on the use of neoadjuvant or adjuvant therapy in addition to surgery in patients with resectable gastric cancer ( T1 - 4 , N1 - 2 , M0 ) .
OPTIONS Neoadjuvant or adjuvant treatments compared with " curative " surgery alone .
OUTCOMES Overall survival , disease-free survival , and adverse effects .
The radiation fields used can possibly damage the left kidney , result ing in hypertension and other renal problems .