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Objective: In a recent randomized study, we demonstrated that XELOX (oxaliplatin + oral capecitabine) was well tolerated and not inferior in terms of efficacy to the infusional FOLFOX-6 regimen in first-line treatment of metastatic colorectal cancer (mCRC). The objective of this additional analysis was to compare the cost of XELOX and FOLFOX-6. Methods: This cost-minimisation study took into account costs related to drug acquisition, hospital care for chemotherapy administration and for serious adverse event management. Hospital care costs were based on French 'diagnosis-related group' tariffs. Drug acquisition costs were drawn from French official sources. Analysis was performed from the French health insurance perspective. Results: Baseline characteristics of the 282 patients included (143 XELOX, 139 FOLFOX-6) were well balanced. Patients reported less and shorter hospitalisations (day and overnight hospital care) with XELOX: 6.4 ± 2.2 hospitalisations versus 9.7 ± 3.1 (p < 0.001); 11.4 ± 10.6 days versus 17.7 ± 11.8 (p < 0.001). Mean disease management cost per patient was significantly lower with XELOX (EUR 12,918 ± 5,075 vs. EUR 17,229 ± 8,665, p < 0.001). Conclusion: In the perspective of our analysis, taking into account hospitalisation and drug acquisition costs, the treatment of mCRC patients with XELOX in comparison to FOLFOX-6 significantly decreased the costs, as well as the mean overall hospitalisation length of stay. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Focuses on the diagnosis of the disease adenocarcinoma of the colon among the people of France. Use of colonoscopy and biopsy for the diagnosis of cancer; Description of surgical requirements for the disease.

Background: Longer times between diagnosis and treatments of cancer patients have been estimated as effects of the COVID-19 pandemic. However, relatively few studies attempted to estimate actual delay to treatment at the patient level., Objective: To assess changes in delays to first treatment and surgery among newly diagnosed patients with localized breast cancer (BC) during the COVID-19 pandemic., Methods: We used data from the PAPESCO-19 multicenter cohort study, which included patients from 4 French comprehensive cancer centers. We measured the delay to first treatment as the number of days between diagnosis and the first treatment regardless of whether this was neoadjuvant chemotherapy or surgery. COVID-19 pandemic exposure was estimated with a composite index that considered both the severity of the pandemic and the level of lockdown restrictions. We ran generalized linear models with a log link function and a gamma distribution to model the association between delay and the pandemic., Results: Of the 187 patients included in the analysis, the median delay to first treatment was 42 (IQR:32-54) days for patients diagnosed before and after the start of the 1st lockdown (N = 99 and 88, respectively). After adjusting for age and centers of inclusion, a higher composite pandemic index (> = 50 V.S. <50) had only a small, non-significant effect on times to treatment. Longer delays were associated with factors other than the COVID-19 pandemic., Conclusion: We found evidence of no direct impact of the pandemic on the actual delay to treatment among patients with localized BC., Competing Interests: The authors declare no conflict of interest with this research., (Copyright: © 2024 Zhou et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Cancer patients may experience a decrease in cognitive functioning before, during and after cancer treatment. So far, the Quality of Life Group of the European Organisation for Research and Treatment of Cancer (EORTC QLG) developed an item bank to assess self-reported memory and attention within a single, cognitive functioning scale (CF) using computerized adaptive testing (EORTC CAT Core CF item bank). However, the distinction between different cognitive functions might be important to assess the patients' functional status appropriately and to determine treatment impact. To allow for such assessment, the aim of this study was to develop and psychometrically evaluate separate item banks for memory and attention based on the EORTC CAT Core CF item bank., Methods: In a multistep process including an expert-based content analysis, we assigned 44 items from the EORTC CAT Core CF item bank to the memory or attention domain. Then, we conducted psychometric analyses based on a sample used within the development of the EORTC CAT Core CF item bank. The sample consisted of 1030 cancer patients from Denmark, France, Poland, and the United Kingdom. We evaluated measurement properties of the newly developed item banks using confirmatory factor analysis (CFA) and item response theory model calibration., Results: Item assignment resulted in 31 memory and 13 attention items. Conducted CFAs suggested good fit to a 1-factor model for each domain and no violations of monotonicity or indications of differential item functioning. Evaluation of CATs for both memory and attention confirmed well-functioning item banks with increased power/reduced sample size requirements (for CATs ≥ 4 items and up to 40% reduction in sample size requirements in comparison to non-CAT format)., Conclusion: Two well-functioning and psychometrically robust item banks for memory and attention were formed from the existing EORTC CAT Core CF item bank. These findings could support further research on self-reported cognitive functioning in cancer patients in clinical trials as well as for real-word-evidence. A more precise assessment of attention and memory deficits in cancer patients will strengthen the evidence on the effects of cancer treatment for different cancer entities, and therefore contribute to shared and informed clinical decision-making., (© 2023. The Author(s).)

Background: The impact of the first coronavirus disease 2019 (COVID-19) wave on cancer patient management was measured within the nationwide network of the Unicancer comprehensive cancer centers in France., Patients and Methods: The number of patients diagnosed and treated within 17 of the 18 Unicancer centers was collected in 2020 and compared with that during the same periods between 2016 and 2019. Unicancer centers treat close to 20% of cancer patients in France yearly. The reduction in the number of patients attending the Unicancer centers was analyzed per regions and cancer types. The impact of delayed care on cancer-related deaths was calculated based on different hypotheses., Results: A 6.8% decrease in patients managed within Unicancer in the first 7 months of 2020 versus 2019 was observed. This reduction reached 21% during April and May, and was not compensated in June and July, nor later until November 2020. This reduction was observed only for newly diagnosed patients, while the clinical activity for previously diagnosed patients increased by 4% similar to previous years. The reduction was more pronounced in women, in breast and prostate cancers, and for patients without metastasis. Using an estimated hazard ratio of 1.06 per month of delay in diagnosis and treatment of new patients, we calculated that the delays observed in the 5-month period from March to July 2020 may result in an excess mortality due to cancer of 1000-6000 patients in coming years., Conclusions: In this study, the delays in cancer patient management were observed only for newly diagnosed patients, more frequently in women, for breast cancer, prostate cancer, and nonmetastatic cancers. These delays may result is an excess risk of cancer-related deaths in the coming years., Competing Interests: Disclosure JYB reports research support and honoraria from Troche, BMS, MSD, PharmaMar, Bayer, Deciphera, GSK, Novartis, and AstraZeneca. JPD reports institutional fees for advisory or speaker roles for Genentech, Roche, BMS, MSD, and Novartis, and institutional grants for research projects with Genentech, Roche, BMS, MSD, Debiopharm, and Astra Zeneca. JCS reports shares from AstraZeneca, Daiichi Sankyo, Gritstone, and is also a full-time employee of AstraZeneca from September 2017 to December 2019. All other authors have declared no conflicts of interest., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: Cancer management is a public health issue in France. Its incidence is stabilizing even decreasing, but the prevalence increases. Public policies give at the general practitioner (GP) a central role in oncological care: it must be present at all stages of the disease, from screening to post-cancer., Methods: One-year prospective monocentric study in a cancer institute. Distribution of a questionnaire to unplanned hospitalized patients and collection of socio-demographic and medical data in their files., Results: Fifty-four percent of the study patients did not consult their GP for the health problem that motivated hospitalization. Sixty-nine percent of patients surveyed believe that GP is not the primary care physician for the management of complications and adverse effects of oncology treatments. A large majority of patients have metastatic cancer while only 40 % followed by the support care team., Discussion: GP's are not yet integrated into the active management of cancer for study patients. The symptoms that GP's say they can easily manage are the most frequent reasons for hospitalization., (Copyright © 2019. Published by Elsevier Masson SAS.)

Background: This document is a summary of the French intergroup guidelines regarding the management of pancreatic adenocarcinoma (PA), updated in July 2018., Design: This collaborative work was produced under the auspices of all French medical and surgical societies involved in the management of PA. It is based on the previous guidelines, recent literature review and expert opinions. Recommendations were graded in three categories, according to the level of evidence., Results: Over the last seven years, significant changes in PA management have been implemented in clinical practice. Imaging/staging: diffusion magnetic resonance imaging is useful before surgery to rule out small liver metastases., Surgery: centralization of pancreatic surgery in expert centers is associated with a decreased postoperative mortality. Adjuvant chemotherapy: modified FOLFIRINOX in fit patients, or gemcitabine, or 5-FU, or gemcitabine plus capecitabine, to be discussed on a case-by-case basis. Locally advanced PA: no survival benefit of chemoradiotherapy. Metastatic PA: FOLFIRINOX and gemcitabine plus nab-paclitaxel combination are first-line standards in fit patients; second-line with 5FU/nal-IRI or 5FU/oxaliplatin combination after first-line gemcitabine., Conclusion: Guidelines for management of PA are continuously evolving and need to be regularly updated. This constant progress is made possible through clinical and translational research. However, as each individual case is particular, they cannot substitute to multidisciplinary tumor board discussion., (Copyright © 2018 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Purpose: To characterize response shift effects in patients with breast cancer (BC)., Methods: The QLQ-C30, BR23, and EurQOL-EQ-5D were assessed at baseline and at the end of the first hospitalization. We used the then-test approach to characterize changes in internal standards by calculating the mean difference between the then-test (retrospective measure) and pre-test baseline QoL assessments. The Ideal Scale Approach was also used to assess changes in standards by comparing health and QoL expectancies between baseline and the end of the first hospitalization. Successive Comparison Approach was used to assess changes in values through the longitudinal assessment of the relative importance of EuroQOL dimensions., Results: The results of this study showed that recalibration RS effects occurred early after the first hospitalization for 6/15 dimensions of QLQ-C30 (emotional, cognitive, fatigue, insomnia, appetite loss, diarrhea) and 2/8 of BR-23 (future perspective, systemic therapy side effects). Moreover, health and QoL expectancies changed between the baseline and the end of the first hospitalization, and changes in values were seen for the self-care and usual activities dimensions of the EuroQOL-EQ-5D., Conclusions: The occurrence of RS early after the first hospitalization suggests that it needs to be taken into account to interpret QoL changes in BC.

Circumferential resection margin (CRM) appears as a new powerful prognostic factor of survival after surgery for rectal cancer. We aimed to evaluate predictive factors of positive CRM following preoperative radiochemotherapy in a French trial. Patients with rectal cancer were randomised in long course preoperative radiotherapy 45 Gy plus capecitabine versus 50 Gy plus capecitabine and oxaliplatin. Mesorectal excision was performed 6 weeks after treatment. Impact of clinical, pathological and surgical variables on positive CRM (≤1 mm) were analysed by multivariate analysis. Of 565 randomised patients, CRM was recorded in 390 cases and was positive in 8% (30/390). Patients with 50 Gy plus capecitabine and oxaliplatin had a 6% rate of positive CRM while those treated by 45 Gy plus capecitabine had a 10% rate (p=0.128). Three independent predictive factors of positive CRM were identified: abdominoperineal resection (APR) (odds ratio OR=3.24; p=0.004), vascular tumour invasion (OR=2.78; p=0.026) and poor histological response (modified Dworak 0-2) (OR=9.01; p=0.003). Significant predictive factors of positive CRM are related to type of surgery, especially APR, and poor histological prognostic factors. Intensification of neoadjuvant radiochemotherapy does not seem to have a major role in this study., (Copyright © 2012 Elsevier Ltd. All rights reserved.)

Background: The aim of this study was to compare the responsiveness of the European Organization for Research and Treatment (EORTC) quality of life questionnaires (QLQ-C30, QLQ-CR38) and the Functional Assessment of Cancer Therapy-colorectal version 4 questionnaire (FACT-C)., Method: This prospective study included 127 patients with colorectal cancer: 71 undergoing chemotherapy and 56 radiation therapy. Responsiveness statistics included the Standardized Response Mean (SRM) and the Effect Size (ES). The patient's overall assessment of his/her change in state of health status was the reference criterion to evaluate the responsiveness of the QoL questionnaires., Results: 34 patients perceived their health as stable and 17 as improved between the first and the fourth courses of chemotherapy. 21 patients perceived their health as stable and 22 as improved between before and the last week of radiotherapy.The responsiveness of the 3 questionnaires differed according to treatments. The EORTC QLQ-C30 questionnaire was more responsive in patients receiving chemotherapy, particulary functional scales (SRM > 0.55). The QLQ-CR38 and the FACT-C questionnaires provided little clinically relevant information during chemotherapy or radiotherapy., Conclusion: The EORTC QLQ-C30 questionnaire appears to be more responsive in patients receiving chemotherapy.

Background: The aim of this study was to test the psychometric properties of the French version of the European Organization for Research and Treatment (EORTC) quality-of-life colorectal questionnaire (QLQ-CR38) and the functional assessment of cancer therapy-colorectal version 4 (FACT-C)., Method: This prospective study included 209 patients with colorectal cancer: 71 undergoing chemotherapy, 56 radiation, 15 surgery, and 67 survivors. Patients first completed in random order the FACT-C and the EORTC QLQ-CR38 and were asked if they had any preference for either questionnaire. The timing of administration of instruments differed according to patients' treatment to better assess psychometric properties., Results: The FACT-C showed good acceptability, good reproducibility and excellent internal consistency. The QLQ-CR38 had lower internal consistency. Patients did not express a preference for one survey over another., Conclusion: This study confirms the value of the FACT-C and suggests some limits of the QLQ-CR38 for patients with colorectal cancer.

Patient satisfaction is now recognised as an important quality of care outcome which is particularly relevant in oncology. Adapted from the EORTC In-Patsat32, the Out-Patsat35 is a 35-item satisfaction with care questionnaire measuring cancer outpatients' perception of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric properties of this scale. Patients undergoing ambulatory chemotherapy (CT) or radiotherapy (RT) in 7 cancer centres in France were invited to complete at home the Out-Patsat35 as well as EORTC QLQ-C30 for psychometric testing. Of 416 eligible patients recruited, 96% returned the questionnaire. Most patients (71% in CT; 69% in RT) completed this scale within 15 minutes and the mean rate of item omission was only 4.4%. Confirmatory analyses revealed good convergent validity and excellent internal consistency, although some subscales within the Out-Patsat35 were relatively highly correlated. Items and subscales of the Out-Patsat35 and of the QLQ-C30 were not significantly correlated, underlying that the two questionnaires are assessing quite distinct concepts. The subscales of the Out-Patsat35 were not related to age, gender and education, suggesting a cultural evolution in French cancer patients towards a greater homogeneity in their opinion toward care. This study supports the acceptability to patients, and the psychometric properties of the EORTC Out-Patsat35 questionnaire.

Background: For pertinent investigation of patient satisfaction it is important to know what type of data collection procedure yields optimal results. In this study, we compared a self- versus interview administration of the European Organisation for Research and Treatment of Cancer (EORTC) patient satisfaction questionnaire (QLQ-SAT32), noting response and item omission rates. We also assessed the correlation and agreement between responses according to these modalities of questionnaire administration., Methods: 123 patients recruited in two anti-cancer Centers in France were asked to complete the QLQ-SAT32 at home within 2 weeks of hospital discharge and were randomly allocated to participate in a telephone interview-administration of the QLQ-SAT32, either before or after self-completing the QLQ-SAT32., Results: 104 patients completed both modalities of questionnaire administration. Agreement proved excellent for the doctors' and nurses' subscales and satisfactory for the services' subscale and the general satisfaction single item. However, a significant difference in response rate showed up between Centers (different interviewers) and the interview modality revealed an item omission rate higher than for the self-administration modality., Conclusion: Self- and interview-administration of the QLQ-SAT32 provided similar responses however different response rate between interviewers and higher item omission rate in interviews suggests a biasing effect of that modality of data collection.

The aim of this study was to assess the validity of the French version of the Functional Assessment of Cancer Therapy - General (FACT-G), and to compare its psychometric properties with those of two other cancer-specific quality of life questionnaires, European Organisation for Research and Treatment of Cancer Quality of Life - Core 30 (EORTC QLQ-C30) and Functional Living Index - Cancer (FLIC). Two hundred and twenty three patients with breast or colorectal cancer completed the FACT-G questionnaire in French followed by (in random order) the QLQ-C30 and FLIC. An additional 87 patients with head and neck (H&N) cancer completed the FACT-H&N followed by the QLQ-C30 and H&N-Besançon. The French version of FACT-G was internally consistent, and its reproducibility was excellent. FACT-G Physical Well-Being and global scores correlated with all QLQ-C30 subscales. There was evidence of discriminant validity. Compared with the other tools, FACT-G included a statistically significantly higher proportion of items patients considered to be confusing or upsetting. Patients with breast or colorectal cancer expressed a preference for QLQ-C30. Use of the specific H&N additional items increased the responsiveness to change of FACT-G. The French version of FACT-G is valid and has psychometric properties similar to those of FLIC and QLQ-C30.

Context: "The Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French regional cancer centers, and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients., Objectives: To elaborate clinical practice guidelines for patients with stomach adenocarcinoma. These recommendations cover the diagnosis, treatment and follow-up of these tumors., Methods: The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. The Standards, Options and Recommendations are thus based on the best available evidence and expert agreement., Results: Adjuvant radiation therapy alone is not a standard treatment for patients with stomach adenocarcinoma. Adjuvant concomitant chemoradiotherapy is not a standard treatment for patients with stage II or III stomach adenocarcinoma R0, with Dl or D2 lymphadenectomy who have undergone surgery. Following surgical resection, adjuvant concomitant chemoradiotherapy should be proposed to patients without denutrition with a lymphadenectomy < Dl (fewer than 15 lymph nodes examined) and those with T3 and/or N+ tumours following the protocol used in the MacDonald trials (SWOG-9008) (Level of evidence B1). Adjuvant concomitant chemoradiotherapy can be administered to patients without denutrition with DI or D2 lymphadenectomy and with involvement of regional lymph nodes (N2 or N3).

Doubts are expressed on the validity of patient satisfaction questionnaires. High satisfaction levels are consistently reported. Within the European Organisation for Research and Treatment of Cancer (EORTC) quality of life group, we developed a cancer inpatient satisfaction questionnaire (QLQ-SAT32), adopting several precautions to overcome the ceiling effect commonly reported in satisfaction ratings. Since patients are often more critical when expressing themselves in an interview, in order to study the validity of the QLQ-SAT32, we assessed the agreement between self- and interview-administered QLQ-SAT32 responses. One hundred and twenty three patients were asked to complete the QLQ-SAT32 at home within 2 weeks of hospital discharge and were randomly allocated to participate in a telephone interview-administration of the QLQ-SAT32, either before or after self-completing the QLQ-SAT32. One hundred and four of them completed both modalities of questionnaire administration. Correlation and agreement between self- and interview-administered QLQ-SAT32 ratings were examined, for each subscale and the general satisfaction item of the QLQ-SAT32, using Spearman correlation, intra-class correlation coefficients (ICC) or weighted kappa coefficients. Agreement showed excellent for the doctors' and nurses' subscales and satisfactory for the services' subscale and the general satisfaction single item. The telephone interview-administration modality did not prove an adequate procedure to assess the validity of a patient satisfaction questionnaire.

Purpose: To collect data on the health-related quality of life (QOL) of long-term survivors and to determine to what extent QOL might be an appropriate end point in the comparison of treatment options in oropharyngeal carcinoma., Methods and Materials: All patients treated between 1992 and 1998, in two French comprehensive cancer centers, by brachytherapy (BT) +/- external beam radiotherapy (EBRT) or surgery plus RT, or exclusive EBRT for T1-T3 (International Union Against Cancer staging system) oropharynx squamous cell carcinoma, were included. QOL was measured once in disease-free patients at least 2 years after treatment initiation. The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire and the specific H&N35 module were self-administered by all participating patients. Sociodemographic data were collected using a questionnaire specifically designed for the study. The association between the QOL scores of the various treatment-, disease-, and patient-related variables was performed through bivariate analysis and then by multivariate analysis. The mean QOL scores of the EORTC QLQ-C30 questionnaire were compared with the mean scores in the general population., Results: Of the 159 eligible patients, 113 agreed to participate (97 men and 16 women, median age 61 years, range 41-83). The initial treatment was EBRT plus BT in 49 patients, surgery plus RT in 27, and EBRT alone in 37. The median follow-up time was 62 months (range 24-110). Compared with the general population, the three scores indicating the most impaired QOL were emotional and social functioning and fatigue. The clinical significance of global QOL impairment was borderline. The physical functioning, role functioning, and pain scores did not significantly differ from those of the general population. In multivariate analysis, the initial treatment had no significant influence on any dimension of QOL, except global QOL and emotional functioning. Surprisingly, surgery plus RT, as the initial treatment, favorably influenced the emotional functioning score and EBRT plus BT negatively influenced the global QOL score. None of these treatment modalities influenced any symptom scales. Patient selection was, at least partially, responsible for these paradoxical results., Conclusion: The results of this study bring original and useful data about the QOL of long-term survivors of oropharynx carcinoma. In these patients, the QOL was significantly impaired, particularly in its psychosocial dimensions. The level of symptoms and functioning (except global QOL and emotional) was similar whatever the initial treatment. These results suggest the importance of coping processes. In a trial comparing treatment options from a long-term perspective, survival remains the most relevant end point, and a QOL evaluation should be a secondary end point. More prospective studies on QOL in head-and-neck cancer patients are needed to determine new strategies for rehabilitation management.

Context: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the French National Federation of Comprehensive Cancer Centers (FNCLCC), the 20 French Cancer Centers and specialists from French Public University or General Hospitals, and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome of cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery., Objectives: To define, according to the definitions of the Standards, Options and Recommendations project, the characteristics of the main tumor markers in colorectal cancer and their potential role in the management of patients with this malignancy., Methods: Data were identified by searching Medline and the personal reference lists of members of the expert groups. Once the guidelines were defined, the document was submitted for review to 117 independent reviewers, and to the medical committees of the 20 French Cancer Centers., Results: The main recommendations for the tumor markers in colorectal cancer are: 1) The carcinoembryonic antigen (CEA) is the reference serum marker (standard). 2) All the analyses for a given patient must be performed in the same laboratory, using the same technique (standard, expert agreement). 3) CEA or CA 19-9 should not be used for screening or diagnosis (standard, level of evidence B2). 4) High initial serum concentration of CEA is of bad predictive value (standard, level of evidence C). CEA is an independent prognostic factor of survival in colorectal cancers with lymph node metastases (standard, level of evidence B2). 5) CEA is the most sensitive biological parameter for the screening of hepatic metastases (standard, level of evidence B2). 6) CEA serum concentration before palliative chemotherapy is an independent prognostic factor of survival (standard, level of evidence B2). The combination of CEA assay with imagery techniques and clinical examination can help monitor the response to palliative chemotherapy (standard), in particular in non measurable disease (standard, expert agreement). 7) In 65% of the cases, CEA is the first indicator of relapse (standard, level of evidence B2). CEA is the choice marker for monitoring patients with colorectal cancer (standard, level of evidence B2). 8) A sustained biological follow-up including CEA assay can be used to predict the operability of recurring tumors (standard, level of evidence B2). Nevertheless, no survival advantage has been shown (standard).

Objectives: The aim of this study was to analyze the efficacy and tolerance of preoperative radiochemotherapy in esophageal squamous cell carcinoma. Patterns of recurrence and prognostic factors were also studied., Patients and Methods: This multicentric phase II trial included patients deemed operable. Preoperative treatment associated 5-FU 800 mg/m2/d by continuous infusion, cisplatin 20 mg/m2/d and radiotherapy 3 Gy/d D 1-5 and D 22-26. Resection was planned 50 to 60 days after the beginning of therapy., Results: Seventeen centers accrued 96 patients, mean age 55.4 years. According to UICC 1978 classification: stage I 13%, stage II 53% and stage III 30%. Mean follow-up was 73 months. Pre-operative treatment was delivered at full dose in half of the patients. Ten percent of the patients did not receive the second cycle. Toxicity reached grade 3 in 23% and grade 4 in 7% of the patients. Two preoperative deaths occurred. Curative resection was performed in 82% of the patients. Operative mortality was 9%. tumors were sterilized on the operative specimen in 20% of the patients and microscopic remnants were observed in 13%. Preoperative clinical work-up overestimated histologic response in 10% of the cases underestimated it in 29%. After 2 years, a recurrence was observed in 56% of the patients: loco-regional in 30%, metastases in 19% and both in 7%. Median survival was 17 months and survival rates were 58% at 1 year and 25% at 5 years. Four prognostic factors influenced survival in multivariate analysis (Cox model): hematological toxicity grade 3 or 4, no complete response, circumferential extension > 2/3 and nodes visible on CT-scan. Factors positively influencing complete response were in multivariate analysis: a fungating tumor, weight loss < 8% and a full dose preoperative treatment., Conclusion: In this study, preoperative treatment associating 5-FU-cisplatin and radiotherapy allowed a high resectability rate, with one third of patients achieving complete or nearly complete histologic response. A randomized study is warranted to know whether this combined treatment is better than surgery alone.