A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group.

Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents. Methods: The Aide et Recherche en Cancérologie Digestive (ARCAD) Group, an international scientific committee involving oncologists from all over the world, addressed these issues and developed and uniformly accepted a simplified informed consent documentation for future clinical research. Results: A simplified form of informed consent with the leading part of 1200-1800 words containing all of the key information necessary to meet ethical and regulatory requirements and 'relevant supportive information appendix' of 2000-3000 words is provided. Conclusions: This position paper, on the basis of the ARCAD Group experts discussions, proposes our informed consent model and the rationale for its content.

Quality-of-life and performance status results from the phase III RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma.

BACKGROUND: The phase III RAINBOW trial demonstrated that the addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma. Here, we present results from quality-of-life (QoL) and performance status (PS) analyses. PATIENTS AND METHODS: Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg i.v.) or placebo on days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m(2)) on days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and 6-week intervals. PS was assessed at baseline and day 1 of every cycle. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. RESULTS: Of the 665 patients randomized, 650 (98%) provided baseline QLQ-C30 and EQ-5D data, and 560 (84%) also provided data from ≥1 postbaseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR < 1, indicating similar or longer TtD in QoL for ramucirumab + paclitaxel. Treatment with ramucirumab + paclitaxel was also associated with a delay in TtD in PS to ≥2 (HR = 0.798, P = 0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥ 3 (HR = 0.656, P = 0.0508), deterioration by ≥1 PS level (HR = 0.802, P = 0.0444), and deterioration by ≥2 PS levels (HR = 0.608, P = 0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsened at discontinuation. CONCLUSION: In patients with previously treated advanced gastric/GEJ adenocarcinoma, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration. CLINICALTRIALSGOV: NCT01170663.

Conversion to resection of liver metastases from colorectal cancer with hepatic artery infusion of combined chemotherapy and systemic cetuximab in multicenter trial OPTILIV.

BACKGROUND: Systemic chemotherapy typically converts previously unresectable liver metastases (LM) from colorectal cancer to curative intent resection in ∼15% of patients. This European multicenter phase II trial tested whether hepatic artery infusion (HAI) with triplet chemotherapy and systemic cetuximab could increase this rate to 30% in previously treated patients. PATIENTS AND METHODS: Participants had unresectable LM from wt KRAS colorectal cancer. Main non-inclusion criteria were advanced extra hepatic disease, prior HAI and grade 3 neuropathy. Irinotecan (180 mg/m(2)), oxaliplatin (85 mg/m(2)) and 5-fluorouracil (2800 mg/m(2)) were delivered via an implanted HAI access port and combined with i.v. cetuximab (500 mg/m(2)) every 14 days. Multidisciplinary decisions to resect LM were taken after every three courses. The rate of macroscopic complete resections (R0 + R1) of LM, progression-free survival (PFS) and overall survival (OS) were computed according to intent to treat. RESULTS: The patient population consisted of 42 men and 22 women, aged 33-76 years, with a median of 10 LM involving a median of six segments. Up to 3 extrahepatic lesions of <1 cm were found in 41% of the patients. A median of six courses was delivered. The primary end point was met, with R0-R1 hepatectomy for 19 of the 64 previously treated patients, 29.7% (95% confidence interval 18.5-40.9). Grade 3-4 neutropenia (42.6%), abdominal pain (26.2%), fatigue (18%) and diarrhea (16.4%) were frequent. Objective response rate was 40.6% (28.6-52.3). Median PFS and OS reached 9.3 (7.8-10.9) and 25.5 months (18.8-32.1) respectively. Those with R0-R1 hepatectomy had a median OS of 35.2 months (32.6-37.8), with 37.4% (23.6-51.2) alive at 4 years. CONCLUSION: The coordination of liver-specific intensive chemotherapy and surgery had a high curative intent potential that deserves upfront randomized testing. PROTOCOL NUMBERS: EUDRACT 2007-004632-24, NCT00852228.

Walking with eyes closed is easier than walking with eyes open without visual cues: The Romberg task versus the goggle task.

BACKGROUND: The Romberg test, with the subject standing and with eyes closed, gives diagnostic arguments for a proprioceptive disorder. Closing the eyes is also used in balance rehabilitation as a main way to stimulate neural plasticity with proprioceptive, vestibular and even cerebellar disorders. Nevertheless, standing and walking with eyes closed or with eyes open in the dark are certainly 2 different tasks. We aimed to compare walking with eyes open, closed and wearing black or white goggles in healthy subjects. METHODS: A total of 50 healthy participants were randomly divided into 2 protocols and asked to walk on a 5-m pressure-sensitive mat, under 3 conditions: (1) eyes open (EO), eyes closed (EC) and eyes open with black goggles (BG) and (2) EO, EO with BG and with white goggles (WG). Gait was described by velocity (m·s(-1)), double support (% gait cycle), gait variability index (GVI/100) and exit from the mat (%). Analysis involved repeated measures Anova, Holm-Sidak's multiple comparisons test for parametric parameters (GVI) and Dunn's multiple comparisons test for non-parametric parameters. RESULTS: As compared with walking with EC, walking with BG produced lower median velocity, by 6% (EO 1.26; BG 1.01 vs EC 1.07 m·s(-1), P=0.0328), and lower mean GVI, by 8% (EO 91.8; BG 66.8 vs EC 72.24, P=0.009). Parameters did not differ between walking under the BG and WG conditions. CONCLUSION: The goggle task increases the difficulty in walking with visual deprivation compared to the Romberg task, so the goggle task can be proposed to gradually increase the difficulty in walking with visual deprivation (from eyes closed to eyes open in black goggles).

Postoperative irinotecan in resected stage II-III rectal cancer: final analysis of the French R98 Intergroup trial†.

BACKGROUD: The R98 trial explores the addition of irinotecan to a 5-fluorouracil (5-FU) plus leucovorin (5-FU/LV) adjuvant regimen in optimally resected stages II-III rectal cancers. We report the updated long-term results. Disease-free survival (DFS) was the primary end point. PATIENST AND METHODS: Between March 1999 and December 2005, 357 patients were randomized: 178 in 5-FU/LV and 179 in LV5-FU2 + irinotecan arm. The trial was stratified by control arm: Mayo Clinic regimen or LV5-FU2 regimen. RESULTS: Three hundred and fifty-seven randomized patients were evaluable for efficacy. With a follow-up of 156 months, the DFS was in favour of experimental arm but did not reach statistical significance [hazard ratio (HR) = 0.80, P = 0.154]. The same was observed for overall survival (OS) (HR = 0.87, P = 0.433). The 5-year DFS was 58% in the control arm and 63% in the experimental arm. The 5-year OS was 74% in the control arm and 75% in the experimental arm. Patients allocated to the experimental arm had more grade 3-4 neutropenia when compared with the LV5-FU2 arm (33% versus 6%, P = 0.03), but not when compared with the Mayo Clinic arm (33% versus 36%, P = 0.84). Grade 3-4 diarrhoea tended to be higher in the experimental arm, but analyses stratified by control arm or by radiotherapy failed to show significant differences across strata (test for interaction P = 0.44). CONCLUSION: Even though a benefit of irinotecan in subgroups of patients cannot be excluded, due to early termination and lack of power, the study does not support the addition of irinotecan to 5-FU/LV in routine in patients with resected stage II-III rectal cancer.

Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study.

BACKGROUND: Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. PATIENTS AND METHODS: Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1 : 1 : 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). RESULTS: Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. CONCLUSION: These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC. CLINICALTRIALS.GOV: Identifier Trial registration number: NCT00382720.

Taking into account successive treatment lines in the analysis of a colorectal cancer randomised trial.

The FFCD 2000-05 randomised trial included 410 patients with advanced colorectal cancer and compared a sequential arm S treated with 5-fluorouracil and leucovorin (LV5FU2) followed by FOLFOX (LV5FU2+oxaliplatin) and then FOLFIRI (LV5FU2+irinotecan) and a combination arm C that begins directly with FOLFOX followed by FOLFIRI. The first aim of this study was to analyse the prognostic effects on overall survival of disease progression, and of toxicities under first-line therapy. We also studied the benefit of introducing irinotecan in each arm. Finally, we compared the effect of treatment on repeated progression and toxicities. For this purpose, we used Cox regression models with time-dependent variables and shared gamma frailty regression models. We found that early on during follow-up, the prognostic effect on survival of progression under first-line therapy was greater in C (hazard ratio [HR]=18.0 [7.9-41.2]) than in S (HR=7.7 [3.9-17.4]). This difference was significant, but it decreased over time. The prognostic effect of severe toxicities was greater in S (HR=2.0 [1.4-2.9]) than in C (HR=1.3 [0.9-1.9]). Introducing irinotecan was significantly more beneficial in S (HR=0.2 [0.1-0.4]) than in C (HR=0.3 [0.2-1.5]). The risk of repeated progression was not significantly different between the two groups (HR=0.9 [0.8-1.1]) whereas the risk of toxicities was greater in C (HR=1.7 [1.4-2.1]). Overall, this study suggests that starting with less toxic first-line treatment is a valid option since it does not exert a deleterious effect on the risk of overall progression or death.

The balance control effects on sitting posture induced by lumbosacral orthosis wear vary depending on the level of stability.

This study aimed to assess the differential impacts of lumbosacral orthosis (LO) wear in different sitting conditions through posturographic measurements. Twelve healthy subjects sat on a force platform with three variable stability levels (stable and on seesaws with a long and short radius, inferring slightly and highly unstable sitting, respectively) and three orthosis conditions (no LO, neutral LO, lordotic LO). Using fractional Brownian motion modelling of the centre of pressure (CoP) displacements, it appears that a stable sitting position did not highlight any particular differences between the LO models. With the lordotic LO, a slightly unstable sitting position decreased the mean time by 72% (p < 0.002) before postural corrective mechanisms took over. In contrast, in highly unstable sitting conditions, the lordotic LO induced larger CoP displacements (increasing variance by 162%, p < 0.038). Thus, depending on the amount of perturbation and the device design, wearing an LO may have a neutral, positive or negative impact on postural control in the sitting position.

Biomechanical analysis of postural strategies over the first two months following anterior cruciate ligament reconstruction.

To assess the postural strategies developed over the first 2 months following surgery by ACL patients during rehabilitation and highlight the sensory-motor impairment recovery, 21 patients were measured at three timeframes. Three two-legged standing conditions were assessed: with the eyes open, with the eyes closed either wearing or not wearing a knee orthosis. The results indicate that the weight-bearing asymmetry, initially observed (i.e., 56-44% of body-weight), disappeared progressively during rehabilitation (51-49%). The comparison of the plantar center-of-pressure displacements under both sound and operated legs demonstrated noticeable differences that also tended to decrease but without reaching a matched behavior during the last measures. These effects were seen in both eyes open and eyes closed conditions with the greatest effects in the latter condition. Wearing a knee orthosis inferred no particular changes in the postural control behaviors. These data could be used as benchmarks for highlighting the effects on undisturbed postural control of various surgery techniques and/or rehabilitation protocols.

Contribution of CXCR4 and SMAD4 in predicting disease progression pattern and benefit from adjuvant chemotherapy in resected pancreatic adenocarcinoma.

BACKGROUND: Prognosis of patients with pancreatic adenocarcinoma is poor. Many prognostic biomarkers have been tested, but most studies included heterogeneous patients. We aimed to investigate the prognostic and/or predictive values of four relevant biomarkers in a multicentric cohort of patients. PATIENTS AND METHODS: A total of 471 patients who had resected pancreatic adenocarcinoma were included. Using tissue microarray, we assessed the relationship of biomarker expressions with the overall survival: Smad4, type II TGF-ß receptor, CXCR4, and LKB1. RESULTS: High CXCR4 expression was found to be the only independent negative prognostic biomarker [hazard ratio (HR) = 1.74; P < 0.0001]. In addition, it was significantly associated with a distant relapse pattern (HR = 2.19; P < 0.0001) and was the strongest prognostic factor compared with clinicopathological factors. In patients who did not received adjuvant treatment, there was a trend toward decrease in the overall survival for negative Smad4 expression. Loss of Smad4 expression was not correlated with recurrence pattern but was shown to be predictive for adjuvant chemotherapy (CT) benefit (HR = 0.59; P = 0.002). CONCLUSIONS: CXCR4 is a strong independent prognostic biomarker associated with distant metastatic recurrence and appears as an attractive target to be evaluated in pancreatic adenocarcinoma. Negative SMAD4 expression should be considered as a potential predictor of adjuvant CT benefit.

Modern insights into hepatic arterial infusion for liver metastases from colorectal cancer.

Hepatic arterial infusion (HAI) selectively achieves high drug exposure of liver metastases from colorectal cancer. Such pharmacologic advantage has doubled the response rate of liver metastases on fluoropyrimidines (FP) delivered as HAI rather than intravenously, in a meta-analysis of randomised clinical trials (RCT). However, the improvement in antitumour efficacy did not consistently translate into any significant survival advantage across all randomised studies. However, the results of this meta-analysis should be cautiously interpreted due to the heterogeneity of the studies, inadequate study designs, obsolete therapy and high rate of early treatment discontinuation due to HAI technical failures or hepato-biliary toxicity. Most studies actually were performed before year 2000 and did not integrate the considerable progresses accomplished in the management of CRC, such as multidrug regimens instead of single agent FP and secondary resection of metastases, a major contributing factor for prolonged survival. Furthermore, the systemic exposure of patients given HAI was low without concomitant IV therapy, facilitating extra-hepatic relapses. The role of HAI in liver metastases from CRC should, therefore, be revisited, using modern multidisciplinary therapeutic approaches and appropriate study designs. Recommendations for the design of future RCTs exploring HAI are provided.

The diagnosis and management of gastric cancer: expert discussion and recommendations from the 12th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2010.

Well-recognized experts in the field of gastric cancer discussed during the 12th European Society Medical Oncology (ESMO)/World Congress Gastrointestinal Cancer (WCGIC) in Barcelona many important and controversial topics on the diagnosis and management of patients with gastric cancer. This article summarizes the recommendations and expert opinion on gastric cancer. It discusses and reflects on the regional differences in the incidence and care of gastric cancer, the definition of gastro-esophageal junction and its implication for treatment strategies and presents the latest recommendations in the staging and treatment of primary and metastatic gastric cancer. Recognition is given to the need for larger and well-designed clinical trials to answer many open questions.

Estimation of centre of gravity movements in sitting posture: application to trunk backward tilt.

The aim of this study was to highlight, in sitting posture, the value of distinguishing between the movements of the vertical projection of the centre of gravity (CG(v)) and its difference from the centre of pressure (CP-CG(v)). A protocol for healthy, young, trained adults, consisting in tilting their trunk backward or keeping it vertical was used. A frequency analysis shows that statistically significant effects were only seen on CP-CG(v) movements: the RMS increased by 37% (p = 0.004), while the MPF decreased by 5% (p = 0.016), suggesting an increased muscular activity in these tilting postures. In contrast, no statistically significant effects on CP and CG(v) were reported. These data highlight the advantage, in sitting posture, of splitting overall CP displacements into basic components (i.e. CG(v) and CP-CG(v)), each of them having a biomechanical significance.

[Locally advanced unresectable pancreatic cancer: Induction chemoradiotherapy followed by maintenance gemcitabine versus gemcitabine alone: Definitive results of the 2000-2001 FFCD/SFRO phase III trial]. / Cancer du pancréas localement évolué non resécable : chimioradiothérapie d'induction suivie de chimiothérapie par gemcitabine contre chimiothérapie exclusive par gemcitabine : résultats définitifs de l'étude de phase III 2000-2001de la FFCD et de la SFRO.

PURPOSE: To compare chemoradiation with systemic chemotherapy to chemotherapy alone in locally advanced pancreatic cancer. PATIENTS AND METHODS: One hundred and nineteen patients with locally advanced pancreatic cancer, with World Health Organization performance status of zero to two were randomly assigned to either the induction chemoradiation group (60 Gy, 2 Gy/fraction; concomitant 5-fluoro-uracil infusion, 300 mg/m(2) per day, days 1-5 for 6 weeks; cisplatin, 20 mg/m(2) per day, days 1-5 during weeks 1 and 5) or the induction gemcitabine group (GEM: 1000 mg/m(2) weekly for 7 weeks). Maintenance gemcitabine (1000 mg/m(2) weekly, 3/4 weeks) was given in both arms until disease progression or toxicity. RESULTS: Overall survival was shorter in the chemoradiation than in the gemcitabine arm (median survival 8.6 [99% confidence interval 7.1-11.4] and 13 months [8,9,9-18], p=0.03). One-year survival was, respectively, 32 and 53%. These results were confirmed in a per-protocol analysis for patients who received 75% or more of the planned dose of radiotherapy. More overall grades 3-4 toxic effects were recorded in the chemoradiation arm, both during induction (36 versus 22%) and maintenance (32 versus 18%). CONCLUSION: This intensive induction schedule of chemoradiation was more toxic and less effective than gemcitabine alone.

Short-term effects on postural control can be evidenced using a seesaw.

Postural control strategies are frequently assessed through posturography on a firm surface. Their motor efficiency is related to the coordination between center-of-gravity (CG) and center-of-pressure (CP) movements, which results from long-term training. However, when standing on a seesaw favoring pitching body motions, a new coordination, requiring short-term training, needs to be learned again. On this type of device, somesthetic cues from the ankle joints become invalid and motor command is amplified because of the curvature of the contact ridges. To highlight the mechanisms involved in short-term improvements of postural control, 11 healthy young adults were trained for 20 min by standing on a seesaw with their eyes closed. Two series of posturographic measurements, before and after the training, were recorded whilst the subjects stood on the seesaw with eyes closed. The results indicate a reduction in the horizontal CG displacements along the anteroposterior axis and CP-CG displacements along both anteroposterior and mediolateral axes. Fractional Brownian motion (fBm) analysis further explains these lessened CG movements by highlighting a reduced distance covered before the corrective mechanisms take over. The other fBm parameters, the contribution of stochastic activity during the shortest and longest time intervals or the time interval of the transition points (which expresses the mean delay before the corrective mechanisms take over), remained unchanged. These results could likely be explained by reduced tonic muscular activity of the lower limbs and/or recalibration of the sensory systems in order to improve the detection of the CG movements.

In healthy subjects, the sitting position can be used to validate the postural effects induced by wearing a lumbar lordosis brace.

AIM OF THE STUDY: To assess the validity of the sitting position when testing lumbar braces for the maintenance of lordosis. PATIENTS AND METHODS: Twelve young adult subjects participated in the experiment, in which they were seated on force platform. The four experimental conditions (with or without a brace and with or without enforced lordosis) were chosen in order to distinguish between the roles played by lordosis and the brace, respectively. The trajectories of the centre of pressure (CP) were analyzed and compared, in order to assess postural orientation and stabilisation processes. RESULTS: Although no effect was seen in terms of orientation, our data showed that use of a lumbar brace led to a notable reduction in CP displacement along the mediolateral and anteroposterior axes. Lordosis barely affected postural performance and only an increase in the mean CP velocity was observed. Lastly, an analysis of variance failed to reveal an interaction between the "lordosis" and "brace" factors. CONCLUSION: A lumbar brace (in the absence or presence of lordosis) helps subjects to improve their sitting performance. In contrast to previous studies based on the standing posture, the fact that significant differences were found as a function of brace wear emphasises the discriminant power of the sitting position. This task should therefore be applied more widely in the development of more appropriate, validated equipment for lower back pain sufferers.

Molecular markers and biological targeted therapies in metastatic colorectal cancer: expert opinion and recommendations derived from the 11th ESMO/World Congress on Gastrointestinal Cancer, Barcelona, 2009.

The article summarizes the expert discussion and recommendations on the use of molecular markers and of biological targeted therapies in metastatic colorectal cancer (mCRC), as well as a proposed treatment decision strategy for mCRC treatment. The meeting was conducted during the 11th ESMO/World Gastrointestinal Cancer Congress (WGICC) in Barcelona in June 2009. The manuscript describes the outcome of an expert discussion leading to an expert recommendation. The increasing knowledge on clinical and molecular markers and the availability of biological targeted therapies have major implications in the optimal management in mCRC.

Low back pain sufferers: is standing postural balance facilitated by a lordotic lumbar brace?

INTRODUCTION: The use of a lumbar lordosis orthotic device in the treatment of discogenic low back pain could be a valuable option and rehabilitation tool. The lumbar lordosis brace has been designed to meet these requirements and acts as a reminder to the patient to maintain a physiological lumbar lordosis curvature since it comprises a vertical panel on the chest and a curved rigid shell at the back. This lumbar lordosis brace exerts the necessary degree of compression in the lumbar region and achieves correction of the sagittal plane spine balance to improve postural control of the lumbar spine. Quantitative analysis of the centre of pressure (CoP) deviations, which are necessary to maintain the standing posture helps evaluate the impact of such device on postural balance. PATIENTS AND METHODS: Eleven patients suffering from lumbar pain with discopathy (seven females and four males) had to stand on a force platform with their eyes closed under two basic conditions (fitted or not with a lumbar lordosis brace). RESULTS: On the antero-posterior axis, the lordosis brace achieved a 6mm CP deviation from its mean position and a 51% reduction in the mean displacement prior to the initiation of the postural control mechanisms. DISCUSSION: The forces applied by the lumbar lordosis brace (through compression and/or change in the spinal sagittal balance) seem to improve the quality of the patient's balance strategy. Posturography appears as a valuable tool for in situ investigation of the postural benefits achieved when using a thoracolumbosacral orthosis in patients suffering from lumbar pain. LEVEL OF EVIDENCE LEVEL IV: .