Comparison between MRI and choline-PET trans-perineal target biopsies and saturation biopsies for detection and topography of intra-prostatic recurrence after primary radiation therapy for prostate cancer.

INTRODUCTION: Biochemical recurrence of prostate cancer after radiation therapy occurs in 5 to 50% of cases depending on the radiation technique used. The diagnosis of recurrence of prostate adenocarcinoma must be made accurately. The aim of this study was to compare transperineal saturation and target biopsies to index lesion (IL) as defined on MRI and 18FCholine PET-CT (PETc) for detection of intra-prostatic recurrence after primary radiation therapy for prostate cancer. MATERIALS AND METHODS: Thirty-eight patients with an history of prostate radiation for prostate cancer and biochemical recurrence were retrospectively included between March 2013 and June 2017. All patients had PETc and multiparametric MRI (MRI) defining IL. All patients had transperineal saturation biopsies and target biopsies the IL. RESULTS: Among 38 patients with biochemical recurrence, 33 (87%) had biopsy proven recurrence in the prostate. The sensitivity and specificity of MRI were 32% (SD:19%) and 91% respectively (SD:7%). The sensitivity and specificity of PETc were 33% (SD:22%) and 78% respectively (SD:12%). Saturation trans-perineal and target biopsies allowed detection of disease recurrence in 79% and 84% of patients, respectively. CONCLUSION: In case of positive imaging, both trans-perineal prostate saturation and target biopsies offer good performance to confirm intraprostatic recurrence. However, MRI and PETc low sensitivity to detect all sites of local recurrence of prostate cancer after radiation still justify the completion of systematic saturation biopsies. LEVEL OF EVIDENCE: 3.

[Longitudinal follow-up of the IPSS within the 5 years following treatment of a localized prostate cancer: overall analysis and by type of treatment]. / Suivi longitudinal de l'IPSS dans les cinq ans suivant un traitement d'un cancer de prostate localisé: analyse globale et par type de traitement.

OBJECTIVES: The International Prostate Score Symptom (IPSS) and the question of quality of life (QOL-Q) associated were used in this study for monitoring patients treated for localized prostate cancer (P-Ca). PATIENTS AND METHODS: Three groups treated with radical prostatectomy (RP), external beam radiotherapy (RT) or brachytherapy (BRACHY) completed the self-administered questionnaire IPSS and Q-QOL before treatment (bef-TT), after 3 months and once a year for 5 years. RESULTS: The study included 40 PR, 40 RT and 40 BRACHY. There was no difference between the three groups in bef-TT for the IPSS and Q-QOL or in the patients' characteristics, and P-Ca except for age and a higher PSA in the RT group (70.6 years old and 10.0 ng/mL vs. 66.5/66.2 and 7.1/6.2 for RP and CURIE respectively). The impact, no matter what treatment they received, was significant after the third month and then went back to the pre-AN1 at TT. The analysis by group treatment showed no significant difference between groups at 3months and during the first 4 years of follow-up. In the fifth year the RT group had a greater IPSS than BRACHY and PR groups (P<0.04). CONCLUSION: This study showed no degradation of the IPSS or Q-QOL remote treatment of localized prostate cancer. Urinary incontinence has been partially exploring. His study would have allowed a better urinary quality of life analysis in these patients.

Impact of learning curve and technical changes on dosimetry in low-dose brachytherapy for prostate cancer.

PURPOSE: To assess the impact of experience and technical changes on peri- and postimplantation (1 month later) dosimetry for permanent prostate brachytherapy (PPB). PATIENTS AND METHODS: From July 2003 to May 2010, 150 prostate cancer patients underwent low-dose, loose-seed I(125) PPB as monotherapy with intraoperative planning. Patients were divided into three groups-P1 (n = 64), P2 (n = 45), P3 (n = 41)-according to the technical changes that occurred during the study period: use of an automatic stepper at the beginning of P2 and a high-frequency ultrasound probe in P3. Peri- and postimplantation dosimetric parameters (on day 30) were reported: D90 (dose received by 90% of prostate volume), V100 and V150 (prostate volume receiving, respectively, 100% and 150% of the prescribed dose), D2 cc and D0.1 cc (doses received by 2 cc and 0.1 cc of the rectum), R100 (rectum volume that received 100% of the prescribed dose), and D10 and D30 (doses received by 10% and 30% of the urethra, only during peri-implantation). RESULTS: We observed a decrease in the number of needles and seeds used over time. The mean peri-implantation D90 was 187.52 Gy without a significant difference between the three periods (p = 0.48). The postimplantation D90, V100, and V150 parameters were, respectively, 168.3 Gy, 91.9%, and 55% with no significant difference between the three periods. The peri-implantation and postimplantation D0.1 cc and R100 significantly decreased over time; on day 30: D0.1 cc P1 = 223.1 Gy vs. D0.1 cc P3 = 190.4 Gy (p = 8.10(-5)) and R100 P1 = 1.06 cc vs. R100 P3 = 0.53 cc (p = 0.0008). CONCLUSION: We observed a learning curve for the implantation parameters, which led to a significant decrease in the rectal doses without having any impact on the prostate dosimetric parameters.

[Seminal vesicle biopsies: Interest in the prostate cancer staging before radiation therapy or brachytherapy]. / Biopsies des vésicules séminales : intérêt dans le bilan d'extension du cancer de la prostate avant radiothérapie ou curiethérapie.

OBJECTIVE: Seminal vesicle biopsies (SVB) in the staging of prostate cancer are controversial. Our main objective was to assess their contribution before radiation therapy or brachytherapy. Our secondary objective was to compare pathologic findings of the SVB to the magnetic resonance imaging's (MRI) results. PATIENTS AND METHODS: From 2000 to 2008, 135 men (median age: 70 years) with prostate cancer (cT1a to cT3) underwent SVB right and left. The median PSA was 12 ng/ml. The median Gleason score was 7. Forty-one patients had an endorectal MRI. The median follow-up was 47 months. RESULTS: Seminal vesicle involvement was found in 10% of patients. In 9.2% of cases, the biopsy was not contributive. The risk of invasion was significantly associated with the stage T3, the Gleason score up to 7 and the percentage of prostate positive biopsies. A MRI was performed in 41 cases: the correlation between MRI and SVB for the invasion of seminal vesicle was significant but moderate (kappa=0.38). The complications rate of SVB was 10%. CONCLUSION: SVB were a simple and profitable method. They have provided supplementary information that could improve the staging and that could lead to the make use of an appropriate treatment. This information was comparable to the information provided by MRI. Further studies should establish their role in relation to MRI and in particular confirm the best specificity of the SVB.

Patterns of practice of androgen deprivation therapy combined to radiotherapy in favorable and unfavorable intermediate risk prostate cancer. Results of The PROACT Survey from the French GETUG Radiation Oncology group.

PURPOSE: The intermediate-risk (IR) prostate cancer (PCa) group is heterogeneous in terms of prognosis. For unfavorable or favorable IR PCa treated by radiotherapy, the optimal strategy remains to be defined. In routine practice, the physician's decision to propose hormonal therapy (HT) is controversial. The PROACT survey aimed to evaluate pattern and preferences of daily practice in France in this IR population. MATERIALS AND METHODS: A web questionnaire was distributed to French radiotherapy members of 91 centers of the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG). The questionnaire included four sections concerning: (i) the specialists who prescribe treatments and multidisciplinary decisions (MTD) validation; (ii) the definition of IR subsets of patients; (iii) radiotherapy parameters; (iv) the pattern of practice regarding cardiovascular (CV) and (iv) metabolic evaluation. A descriptive presentation of the results was used. RESULTS: Among the 82 responses (90% of the centers), HT schedules and irradiation techniques were validated by specific board meetings in 54% and 45% of the centers, respectively. Three-fourths (76%) of the centers identified a subset of IR patients for a dedicated strategy. The majority of centers consider PSA>15 (77%) and/or Gleason 7 (4+3) (87%) for an unfavorable IR definition. Overall, 41% of the centers performed systematically a CV evaluation before HT prescription while 61% consider only CV history/status in defining the type of HT. LHRH agonists are more frequently prescribed in both favorable (70%) and unfavorable (98%) IR patients. Finally, weight (80%), metabolic profile (70%) and CV status (77%) of patients are considered for follow-up under HT. CONCLUSION: To the best of our knowledge, this is the first survey on HT practice in IR PCa. The PROACT survey indicates that three-quarters of the respondents identify subsets of IR-patients in tailoring therapy. The CV status of the patient is considered in guiding the HT decision, its duration and type of drug.

[Clinical and dosimetric analysis of 469 prostate cancer patients treated in France in 2005 by permanent implant brachytherapy using the Iodin 125 seeds IsoSeed Bebig: report to the French Economic committee of health products (CEPS)]. / Analyse clinique et dosimétrique de 469 patients traités en France en 2005 par implantation prostatique de grains d'iode 125 IsoSeed Bebig: rapport pour le Comité économique des produits de santé (CEPS).

A French decree of February 3rd 2005, allowed the Iodin 125 seeds from several companies to be reimbursed after a permanent implantation brachytherapy for a prostate cancer. Within this frame, the French "Comité économique des produits de santé" (CEPS; Economic committee for health products) made mandatory the annual writing and publication of a follow-up study with three main aims; make sure that the seeds were used for prostate cancer patients with criterias corresponding to the national recommendations, analyze the quality of the dosimetric data, and report all side effects, complications and possible accidents. We therefore report here a clinical and dosimetric analysis of 469 patient cases treated in France in nine centers in 2005 with the Iodin 125 IsoSeed Bebig. This analysis shows that: 1) The national recommendations for selecting patients for exclusive prostate brachytherapy have been taken into account in 97% of the cases; 2) The dosimetric quality criterias totally fulfilled the recommendations in a large majority of cases; the intra-operative D90 was found to be superior to 145 Gy in 98% of the patients, and the intra-operative V100 was superior to 95% in 96% of the cases; 3) The early toxicity (mainly urinary) was found to be at the lower range of what is reported in the literature, with in particular a retention rate of 2.4%.

[Prostate cancer brachytherapy]. / Curiethérapie des cancers de la prostate.

Prostate brachytherapy techniques are described, concerning both Iodine 125 high dose rate brachytherapy. The following parts are presented: brachytherapy indications, technical description, immediate postoperative management and post-treatment evaluation, and 4 to 6 weeks as well as long-term follow-up.

[Propositions for the selection and the delineation of peritumoral microscopic disease volumes in oral cavity and oropharyngeal cancers (lymph nodes excluded)]. / Proposition de sélection et délimitation des volumes cibles microscopiques péritumoraux dans les cancers de la cavité buccale et de l'oropharynx (aires ganglionnaires exclues).

This article reviews the concept of selectivity in peritumoral microscopic disease to be included in the Clinical Target Volume (CTV) for elective treatment for oral cavity and oropharyngeal squamous cell carcinoma, using the local tumoral spread. The objective of the present article is to present a procedure for the delineation of the target volumes, required for an appropriate application of 3-DCRT and IMRT for head and neck cancers. These propositions are for the delineation of microscopic peritumoral target volumes when external beam irradiation is required. CTVs are illustrated on CT sections.

Conservative management of rectal adenocarcinoma by radiotherapy.

PURPOSE: The aim of this study was to analyze the experience of Centre GF Leclerc for conservative and curative treatment by radiotherapy of low rectal cancer. PATIENTS AND METHODS: A total of 151 patients received radiotherapy alone for rectal adenocarcinoma with curative intent. They were clinically staged according to size (T1 < 3 cm, and T2 > 3 cm) and depth of infiltration (A=superficial, and B=impaired mobility and T3 fixed). Over the past 6 years, rectal ultrasound (US) has been used systematically, compared with computed tomographic scan and magnetic resonance imaging when needed. Intracavitary contact X ray was given to 129 patients (69%), and brachytherapy in 45 of 151. External radiotherapy was used in 34 cases (22.5%). RESULTS: Complete response was obtained in 93%. Local failures were observed in 50 cases (28%); two occurred in pelvic nodes after intracavitary X rays. Size (tumors > 3 cm) and alteration of mobility significantly influenced the rate of local failure (p=0.009 and 0.007). The addition of external radiotherapy in patients with poor prognostic factors improved the local control rate. A total of 39 patients with recurrence were amenable to salvage surgery. After salvage treatment, the local control rate was 82% with unlimited follow-up. The 5-year actuarial survival rate was 57%, with a specific survival of 66%. There was no difference in local control or survival according to differentiation of the tumors and distance between anal margin and the inferior level of the lesion. Severe late effect (grade 3) was 3.8%. The sphincter preservation was obtained in 104 of 124 cases (84%). The sphincter function was judged to normal in 102 of 104 patients (98%). CONCLUSION: Intracavitary contact X ray is the treatment of choice for clinical Stage T1A rectal tumors. External radiotherapy significantly improved the results of treatment of tumors > 3 cm. Clinical staging and transrectal ultrasound allows a safe selection of indications. Radiotherapy alone may be proposed for selected cases as an alternative to mutilating surgery for small rectal adenocarcinoma.

Postoperative brachytherapy alone for T1-2 N0 squamous cell carcinomas of the oral tongue and floor of mouth with close or positive margins.

PURPOSE: To evaluate the efficacy of postoperative brachytherapy alone (brachy) for Stage T1-2 squamous cell carcinomas (SCC) of the floor of mouth (FM) and the oral tongue (OT) with close or positive margins. METHODS AND MATERIALS: Between 1979 and 1993, 36 patients with T1-2 N0 (24 T1, 12 T2) OT (19), and FOM (17) SCC with close or positive margins following surgery underwent postoperative brachy. Mean patient age was 56 years (range 37-81) and sex ratio was 3.5:1 male:female. Mean surgery to brachy interval was 36 days (range 16-68). The technique used was interstitial Iridium-192 ((192)Ir) brachytherapy with plastic tubes and manual afterloading. Mean total dose was 60 Gy (range 50-67.4) at a mean dose rate of 0.64 Gy/h (range 0.32-0.94). Mean patient follow-up was 80 months. RESULTS: The 5-year actuarial overall and cause-specific survivals of the entire group were 75% and 85%, respectively. The local control was 88.5% at 2 years, with a plateau apparent after 23 months. Of the 4 local relapses, 2 were salvaged with surgery and external beam radiotherapy (EBR). No tumor or treatment factors, including tumor size, margin status, disease site, or radiation dose, were correlated with local control. The 2 head and neck second primaries underwent curative treatment on nonirradiated tissue. One patient developed a grade 3 sequelae (bone and soft tissue necrosis). Grade 2-3 chronic sequelae were seen in 7 of 17 and 3 of 19 FOM and OT tumors, respectively (p = 0.09). CONCLUSION: Postoperative brachy is a promising approach in T1-2 N0 OT and FOM SCC with close or positive margins. This approach is associated with high rate of locoregional control and low risk of chronic sequelae, obviates major surgery, avoids potential sequelae of EBR (xerostomia, dysgueusia, fibrosis), and avoids treatment of second head and neck primary on nonirradiated tissues.

Curved angiocatheter metal guide for the implantation in velo-tonsillar carcinomas.

Brachytherapy in velo-tonsillar region is not applied in all the institutions because of difficulties to learn it. For the implantation of wires in the soft palate, the Reverdin needle is replaced by a curved guide of angiocatheter 14 Gauge. This technique is easy and reduces the risk of tear mucosa.

[Target-volume and critical-organ delineation for conformal radiotherapy of prostate cancer: experience of French dose-escalation trials]. / Délimitation des volumes-cibles et des organes critiques pour la radiothérapie conformationnelle du cancer de la prostate: expérience des essais français d'escalade de dose.

The delineation of target volume and organs at risk depends on the organs definition, and on the modalities for the CT-scan acquisition. Inter-observer variability in the delineation may be large, especially when patient's anatomy is unusual. During the two french multicentric studies of conformal radiotherapy for localized prostate cancer, it was made an effort to harmonize the delineation of the target volumes and organs at risk. Two cases were proposed for delineation during two workshops. In the first case, the mean prostate volume was 46.5 mL (extreme: 31.7-61.3), the mean prostate and seminal vesicles volume was 74.7 mL (extreme: 59.6-80.3), the rectal and bladder walls varied respectively in proportion from 1 to 1.45 and from 1 to 1.16; in the second case, the mean prostate volume was 53.1 mL (extreme: 40.8-73.1), the volume of prostate plus seminal vesicles was 65.1 mL (extreme: 53.2-89), the rectal wall varied proportionally from 1 to 1, 24 and the vesical wall varied from 1 to 1.67. For participating centers to the french studies of dose escalation, a quality control of contours was performed to decrease the inter-observer variability. The ways to reduce the discrepancies of volumes delineation, between different observers, are discussed. A better quality of the CT images, use of urethral opacification, and consensual definition of clinical target volumes and organs at risk may contribute to that improvement.

[Prostate cancer: what treatment techniques for which tumors? Ethical and methodological issues]. / Cancers de prostate : quelles techniques de radiothérapie pour quelles tumeurs ? Enjeux éthiques et méthodologiques.

The identification of the optimal radiation technique in prostate cancer is based on the results of dosimetric and clinical studies, although there are almost no randomized studies comparing different radiation techniques. The feasibility of the techniques depends also on the technical and human resources of the radiation department, on the cost of the treatment from the points of view of the society, the patient and the radiation oncologist, and finally on the choice of the patient. The slow evolution of prostate cancer leads to consider the biochemical failure as the main judgment criteria in the majority of the studies. A proper urinary radio-induced toxicity evaluation implies a long follow-up. Intensity-modulated radiotherapy (IMRT) combined with image-guided radiotherapy (IGRT) is recommended in case of high dose (≥76Gy) to the prostate, pelvic lymph nodes irradiation and hypofractionation schedules. For low-risk tumors, the aim of the treatment is to preserve quality of life, while limiting costs. Stereotactic body radiotherapy shows promising results, although the follow-up is still limited and phase III trials are ongoing. Focal radiation techniques are in the step of feasibility. For intermediate and high-risk tumors, the objective of the treatment is to increase the locoregional control, while limiting the toxicity. IMRT combined with IGRT leads to either a well-validated dose escalation strategy for intermediate risk tumors, or to a strategy of moderate hypofractionated schedules, which cannot be yet considered as a standard treatment. These combined radiation techniques allow finally large lymph node target volume irradiation and dose escalation potentially in the dominant intraprostatic lesion. The feasibility of simultaneous integrated boost approaches is demonstrated.

[Postoperative radiotherapy of prostate cancer]. / Radiothérapie postopératoire des cancers de la prostate.

Between 10 and 40% of patients who have undergone a radical prostatectomy may have a biologic recurrence. Local or distant failure represents the possible patterns of relapse. Patients at high-risk for local relapse have extraprostatic disease, positive surgical margins or seminal vesicles infiltration or high Gleason score at pathology. Three phase-III randomized clinical trials have shown that, for these patients, adjuvant irradiation reduces the risk of tumoral progression without higher toxicity. Salvage radiotherapy for late relapse allows a disease control in 60-70% of the cases. Several research in order to improve the therapeutic ratio of the radiotherapy after prostatectomy are evaluate in the French Groupe d'Étude des Tumeurs Urogénitales (Gétug) and of the French association of urology (Afu). The Gétug-Afu 17 trial will provide answers to the question of the optimal moment for postoperative radiotherapy for pT3-4 R1 pN0 Nx patients, with the objective of comparing an immediate treatment to a differed early treatment initiated at biological recurrence. The Gétug-Afu 22 questions the place of a short hormonetherapy combined with image-guided, intensity-modulated radiotherapy (IMRT) in adjuvant situation for a detectable prostate specific antigen (PSA). The implementation of a multicenter quality control within the Gétug-Afu in order to harmonize a modern postoperative radiotherapy will allow the development of a dose escalation IMRT after surgery.

[High dose rate prostate brachytherapy]. / Curiethérapie prostatique de haut débit de dose.

This article aims at presenting the interest of high dose rate brachytherapy in the radiation treatment of prostatic adenocarcinoma. We will discuss successively the biological and dosimetric specificity of brachytherapy for this particular cancer. Afterwards, we will review the main phase II and III studies, the therapeutic indications in the daily practice from the evidence based medicine as well as the techniques of external beam radiation therapy for the same indications. Finally, the principal avenues of development will be discussed.

[Hypofractionated radiotherapy in prostate cancer]. / Hypofractionnement à visée curative dans le cancer de la prostate.

Radiotherapy plays a central role in the management of localized prostate cancer, but the total duration of treatment of nearly 2 months poses not only problems of fatigue related to repetitive transports, especially for older patients, but also increases the overall cost of treatment including linear accelerators occupancy and patient transportation. To address this problem, various teams have developed hypofractionated radiotherapy protocols seeking to maintain the same efficacy and toxicity while reducing the total duration of treatment. These hypofractionated protocols require recent techniques such as image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT). Single centre series have validated the feasibility of "light" hypofractionation schemes at doses per fraction less than 6 Gy Similarly, different teams have shown the possibility of stereotactic irradiation for delivering "severe" hypofractionation schemes at doses greater than 6 Gy per fraction. Whatever the dose per fraction, the current clinical data support the conclusion that hypofractionated radiotherapy does not increase mid-term toxicity and could even improve biochemical control. Studies with the objective of demonstrating non-inferiority are expected to definitively validate the role of hypofractionated irradiation in the treatment of prostate cancer.

Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide.

AIMS: The treatment of intermediate- to high-risk prostate cancer with radical radiotherapy is usually in combination with neoadjuvant androgen deprivation therapy. The aim of the present trial was to investigate whether degarelix achieves comparable efficacy with that of goserelin plus bicalutamide as neoadjuvant therapy before radiotherapy. MATERIALS AND METHODS: The study was a randomised, parallel-arm, active-controlled, open-label trial in 244 men with a UICC prostate cancer TNM category T2b-T4, N0, M0, Gleason score ≥7, or prostate-specific antigen ≥10 ng/ml and a total prostate volume >30 ml, who were scheduled to undergo radical radiotherapy and in whom neoadjuvant androgen deprivation therapy was indicated. Eligible patients received treatment with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks, the latter patients also receiving bicalutamide (50 mg) for 17 days initially. The primary efficacy measure was the mean percentage reduction in total prostate volume from baseline at week 12 measured by transrectal ultrasound. The severity and relief of lower urinary tract symptoms were assessed by the International Prostate Symptom Score questionnaire. Quality of life was assessed by the eighth question of the International Prostate Symptom Score. About 50% of the patients had moderate to severe lower urinary tract symptoms at baseline. RESULTS: The total prostate volume decreased significantly from baseline to week 12 in both treatment groups, reaching -36.0 ± 14.5% in degarelix-treated patients and -35.3 ± 16.7% in goserelin-treated patients (adjusted difference: -0.3%; 95% confidence interval: -4.74; 4.14%). At the end of the therapy, more degarelix- than goserelin-treated patients reported International Prostate Symptom Score decreases of ≥3 points (37% versus 27%, P = 0.21). In addition, in patients with a baseline International Prostate Symptom Score of ≥13, the magnitude of the decrease was larger in degarelix- (n = 53) versus goserelin-treated patients (n = 17) (6.04 versus 3.41, P = 0.06). CONCLUSIONS: The efficacy of degarelix in terms of prostate shrinkage is non-inferior to that of goserelin plus bicalutamide. The added benefits of degarelix in terms of more pronounced lower urinary tract symptom relief in symptomatic patients could be the reflection of differences in the direct effects on extra-pituitary receptors in the lower urinary tract [Clinicaltrials.gov ID: NCT00833248].

[Multisite validation study of questionnaire assessing out-patient satisfaction with care questionnaire in ambulatory chemotherapy or radiotherapy treatment]. / Validation multicentrique d'un questionnaire de satisfaction des soins lors d'un traitement de chimiothérapie ou radiothérapie ambulatoire.

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.