Treatment of infertility in 31 men with spinal cord injury.

INTRODUCTION: The majority of men with a spinal cord injury (SCI) are infertile due to ejaculatory dysfunction and poor semen quality. The goal of this retrospective study is to present the outcomes of assisted reproductive technology (ART) in a group of couples with SCI male partners. MATERIALS AND METHODS: A review was conducted of the records of 31 couples with SCI male partners who were treated at the Institut de réadaptation Gingras-Lindsay-de-Montréal, at PROCREA Cliniques or at a hospital center. A semen sample was obtained either by manual stimulation, penile vibratory stimulation, electroejaculation or testicular sperm extraction. ART technique was selected according to the sperm parameters. RESULTS: The mean age of the men was 29 years (23-48) and of their female partners, 29 years (25-41). The average sperm count was 110.4 M/mL ± 16.2 M/mL and the average sperm motility rate was 12.3% ± 16.5%. Among the 10 couples treated with intravaginal insemination, 9 pregnancies occurred among 7 couples. No pregnancies resulted from intrauterine insemination (2 cases). Among the 18 couples treated with in vitro fertilization, 12 pregnancies were reported among 10 couples. The pregnancy rate/cycle was 43%. Following these ART techniques, the pregnancy rate reached 55%. Three pregnancies occurred from the use of donor sperm in 7 couples. Overall, 20 men with a SCI (64% of the group) became fathers to at least one child. CONCLUSIONS: Fertility treatments are effective for couples with SCI male partners and secondary infertility.

Phase II study of preoperative radiation plus concurrent daily tegafur-uracil (UFT) with leucovorin for locally advanced rectal cancer.

BACKGROUND: Considerable variation in intravenous 5-fluorouracil (5-FU) metabolism can occur due to the wide range of dihydropyrimidine dehydrogenase (DPD) enzyme activity, which can affect both tolerability and efficacy. The oral fluoropyrimidine tegafur-uracil (UFT) is an effective, well-tolerated and convenient alternative to intravenous 5-FU. We undertook this study in patients with locally advanced rectal cancer to evaluate the efficacy and tolerability of UFT with leucovorin (LV) and preoperative radiotherapy and to evaluate the utility and limitations of multicenter staging using pre- and post-chemoradiotherapy ultrasound. We also performed a validated pretherapy assessment of DPD activity and assessed its potential influence on the tolerability of UFT treatment. METHODS: This phase II study assessed preoperative UFT with LV and radiotherapy in 85 patients with locally advanced T3 rectal cancer. Patients with potentially resectable tumors received UFT (300 mg/m/2/day), LV (75 mg/day), and pelvic radiotherapy (1.8 Gy/day, 45 Gy total) 5 days/week for 5 weeks then surgery 4-6 weeks later. The primary endpoints included tumor downstaging and the pathologic complete response (pCR) rate. RESULTS: Most adverse events were mild to moderate in nature. Preoperative grade 3/4 adverse events included diarrhea (n = 18, 21%) and nausea/vomiting (n = 5, 6%). Two patients heterozygous for dihydropyrimidine dehydrogenase gene (DPYD) experienced early grade 4 neutropenia (variant IVS14+1G > A) and diarrhea (variant 2846A > T). Pretreatment ultrasound TNM staging was compared with postchemoradiotherapy pathology TN staging and a significant shift towards earlier TNM stages was observed (p < 0.001). The overall downstaging rate was 42% for primary tumors and 44% for lymph nodes. The pCR rate was 8%. The sensitivity and specificity of ultrasound for staging was poor. Anal sphincter function was preserved in 55 patients (65%). Overall and recurrence-free survival at 3 years was 86.1% and 66.7%, respectively. Adjuvant chemotherapy was administered to 36 node-positive patients (mean duration 118 days). CONCLUSION: Preoperative chemoradiotherapy using UFT with LV plus radiotherapy was well tolerated and effective and represents a convenient alternative to 5-FU-based chemoradiotherapy for the treatment of resectable rectal cancer. Pretreatment detection of DPD deficiency should be performed to avoid severe adverse events.

Effectiveness of ultrasound-guided corticosteroid injection for the treatment of gluteus medius tendinopathy.

OBJECTIVE: The objective of our study was to evaluate the effectiveness of ultrasound-guided corticosteroid injection for the treatment of gluteus medius tendinopathy. SUBJECTS AND METHODS: We prospectively evaluated 54 consecutive patients (48 women, six men; mean age, 54.7 years; mean body mass index, 26 kg/m2) with a clinical diagnosis of gluteus medius tendinopathy. Pain assessment using a 10-cm visual analog scale (VAS) was obtained as part of the initial clinical evaluation of all patients. A hip ultrasound study was performed followed by a gluteus medius peritendinous ultrasound-guided injection of 30 mg of triamcinolone combined with 3 mL of bupivacaine 0.5% using an anterior oblique coronal plane. One month after treatment, participants were reassessed clinically, and they were asked to quantify their pain using the VAS pain score and their satisfaction with the outcome of the injection using a 4-point rating scale (very satisfied, somewhat satisfied, somewhat dissatisfied, or very dissatisfied). Statistical analysis included a paired Student's t test (comparison of pain levels before and after treatment, p=0.05) and a multivariate analysis of covariance. RESULTS: There was a 55% average reduction of pain level before versus after treatment (mean VAS pain score, 6.4 vs 2.9 cm, respectively; p<0.001). One month after treatment, 72% of the patients showed a clinically significant improvement in pain level, which was defined as a reduction in the VAS pain score of >or=30%. Seventy percent of patients were satisfied with the results of the intervention. No correlation was shown between treatment outcome and any of the clinical variables or ultrasound findings. CONCLUSION: Our study shows that a peritendinous ultrasound-guided corticosteroid injection may be an effective treatment of gluteus medius tendinopathy.

Experience of Health Leadership in Partnering With University-Based Researchers in Canada - A Call to "Re-imagine" Research.

BACKGROUND: Emerging evidence that meaningful relationships with knowledge users are a key predictor of research use has led to promotion of partnership approaches to health research. However, little is known about health system experiences of collaborations with university-based researchers, particularly with research partnerships in the area of health system design and health service organization. The purpose of the study was to explore the experience and perspectives of senior health managers in health service organizations, with health organization-university research partnerships. METHODS: In-depth, semi-structured interviews (n = 25) were conducted with senior health personnel across Canada to explore their perspectives on health system research; experiences with health organization-university research partnerships; challenges to partnership research; and suggested actions for improving engagement with knowledge users and promoting research utilization. Participants, recruited from organizations with regional responsibilities, were responsible for system-wide planning and support functions. RESULTS: Research is often experienced as unhelpful or irrelevant to decision-making by many within the system. Research, quality improvement (QI) and evaluation are often viewed as separate activities and coordinated by different responsibility areas. Perspectives of senior managers on barriers to partnership differed from those identified in the literature: organizational stress and restructuring, and limitations in readiness of researchers to work in the fast-paced healthcare environment, were identified as major barriers. Although the need for strong executive leadership was emphasized, "multi-system action" is needed for effective partnerships. CONCLUSION: Common approaches to research and knowledge translation are often not appropriate for addressing issues of health service design and health services organization. Nor is the research community providing expertise to many important activities that the healthcare system is taking to improve health services. A radical rethinking of how we prepare health service researchers; position research within the health system; and fund research activities and infrastructure is needed if the potential benefits of research are to be achieved. Lack of response to health system needs may contribute to research and 'evidence-informed' practice being further marginalized from healthcare operations. Interventions to address barriers must respond to the perspectives and experience of health leadership.

Risk factors and prevention for spinal cord injury from diving in swimming pools and natural sites in Quebec, Canada: a 44-year study.

BACKGROUND: Diving is the most frequent cause of spinal cord injury (SCI) from recreation and sport in Canada. This study was done to identify risk factors for SCI from diving in the province of Quebec. METHODS: An interview survey was done for a target population of 203 subjects with a SCI from diving treated in the two specialized rehabilitation centers in Quebec during 1961-2004. Telephone interviews of consenting individuals were used to collect pertinent personal, equipment, and environmental factors for each incident. RESULTS: Response was 44% (89/203); 92% were male and 85% <35 years old. Only 37% were aware prior to injury of the risk of SCI from diving, and only 33% had received water safety training. Swimming pools were the site of 51% (n=45) and natural bodies of water for 49% (n=44). 87% (n=39) of pools were single-unit home pools and 57% (n=26) above-ground. Depth indicators were absent for 100% of above-ground and 74% of in-ground pools. For SCI in in-ground pools, 63% resulted from striking the up-slope between deep and shallow ends. For dives at natural sites, a dock or wharf was the most frequent location, 36% (n=16). In 52% of pools and 79% of natural sites, depth was <1.4m (4.6ft). Signs prohibiting diving were absent in 96% of above-ground and 89% of in-ground pools. Alcohol was reported in 47% of SCIs. INTERPRETATION: The target for prevention of diving SCI is male youths and young adults. Above-ground pools are too shallow and small for diving. Deep ends of many in-ground pools are excessively shallow and short since many SCIs resulted from striking the up-slope. Prevention of SCI from diving needs to focus on education of potential victims, pool vendors and manufacturers, and regulations for safety norms in private pools. Water safety should highlight diving as a high-risk activity, and emphasize that most home pools and natural sites are unsafe. Safer evidence-based pool designs and more effective warnings need to be implemented.

A phase III randomized trial comparing adjuvant concomitant chemoradiotherapy versus standard adjuvant chemotherapy followed by radiotherapy in operable node-positive breast cancer: final results.

PURPOSE: To compare concomitant and sequential adjuvant chemoradiotherapy regimens in node-positive, operable breast cancer patients. METHODS AND MATERIALS: This was a randomized, French, multicenter, phase III trial enrolling 638 eligible women with prior breast surgery and positive axillary dissection. Patients in Arm A received 500 mg/m2 5-fluorouracil, 12 mg/m2 mitoxantrone, and 500 mg/m2 cyclophosphamide, with concomitant radiotherapy (50 Gy +/- 10-20-Gy boost). Patients in Arm B received 500 mg/m2 5-fluorouracil, 60 mg/m2 epirubicin, and 500 mg/m2 cyclophosphamide, with subsequent radiotherapy. Chemotherapy was administered on Day 1 every 21 days for 4 cycles. RESULTS: Median treatment durations were 64 and 126 days (Arms A and B, respectively), with no significant difference in overall or disease-free survival. Five-year locoregional relapse-free survival favored patients with conservative surgery (two thirds of the population), with less local and/or regional recurrence in Arm A than in Arm B (3% vs. 9%; p = 0.01). Multivariate analysis in this subgroup showed a 2.8-fold increased risk of locoregional recurrence with sequential chemoradiotherapy, independent of other prognostic factors (p = 0.027). Febrile neutropenia and Grade 3-4 leukopenia were significantly more frequent in Arm A. Subclinical left ventricular ejection fraction events at 1 year were more frequent with concomitant radiotherapy (p = 0.02). CONCLUSIONS: Concomitant radiotherapy with adjuvant fluorouracil, mitoxantrone, and cyclophosphamide has significantly better locoregional control in node-positive breast cancer after conservative surgery and 50% shorter treatment, albeit with slightly more acute toxicity. With mitoxantrone no longer available for adjuvant breast cancer treatment, alternative concomitant chemoradiotherapy studies are needed.

Sequential addition of an anthracycline-based regimen to docetaxel as neoadjuvant chemotherapy in patients with operable breast cancer.

BACKGROUND: The objective of this phase II study was to attempt to maximize response and survival in patients with bulky, operable breast cancer by combining sequential neoadjuvant docetaxel to a semi-intensive anthracycline-based regimen. PATIENTS AND METHODS: Eligible patients (N = 53) were included to receive 4 cycles of docetaxel, followed by a maximum of 4 cycles of TNCF (THP [theprubican]-doxorubicin/vinorelbine/cyclophosphamide/5-fluorouracil) every 21 days before definitive surgery and radiation therapy. RESULTS: After a median number of 4 cycles of docetaxel and 2 cycles of TNCF, the overall clinical response rate was 81.1%, including a 13.2% complete remission rate and only 2 incidences of progressive disease. Breast conservation was achieved in 87% of patients. According to Chevallier classification, a pathologic complete response in breast and axilla was confirmed in 6 patients (11.3%) and in 9 patients (17%) using the Sataloff's classification. The important myelosuppression observed in this trial was expected but limited by the prophylactic use of growth factors. After a median follow-up of 40.4 months, only 5 recurrences were documented, with a median time to first recurrence of 12.8 months. CONCLUSION: Despite disappointing results of this trial for pathologic complete response rate, possibly because of the order of drug administration, clinical response, breast conservation, and survival were optimized.

Midodrine in patients with spinal cord injury and anejaculation: A double-blind randomized placebo-controlled pilot study.

OBJECTIVE: The objective of this study is to evaluate the efficacy of midodrine in the treatment of anejaculation in men with spinal cord injury (SCI). STUDY DESIGN: Prospective, double-blind, randomized, placebo-controlled pilot study. METHOD: Men with anejaculation associated with SCI (level of injury above T10) of more than 1 year in duration were approached. Those with no ejaculatory response to one penile vibratory stimulation (PVS) trial were assigned in a double-blind manner to one of the two following interventions once a week for a maximum of 3 weeks or until ejaculation occurred: oral administration of flexible midodrine (7.5-22.5 mg max) followed by PVS (group M), or oral administration of flexible sham-midodrine (placebo) followed by PVS (group P). Sociodemographic data, medical characteristics, and plasma desglymidodrine concentration were collected for all participants. OUTCOME MEASURE: Ejaculation success rate in each group. RESULTS: Among the 78 men approached, 23 participants (level of SCI: C4-T9) were randomized. Three participants abandoned the study and 20 completed the study; 10 were assigned to group M, 10 to group P. Ejaculation was reached for one participant of group M and for two participants of group P. Autonomic dysreflexia associated to PVS occurred in three patients. CONCLUSION: In this small sample study, treatment of anejaculation after SCI with midodrine and PVS did not result in a better rate of antegrade ejaculation in 10 men than in 10 men treated with a placebo and PVS.

Colonic transit time after spinal cord injury: any clinical significance?

BACKGROUND: Both bowel dysfunction and increases in colonic transit time (CTT) are frequently observed in individuals with spinal cord injury; however, it is unknown whether there is an association between chronic intestinal problems and changes in CTTs. The current study investigates a possible relationship between the main intestinal symptoms of SCI patients and CTT values. METHODS: The following clinical variables and symptoms were investigated and collected in 30 individuals with SCI: total time for bowel care, abdominal pain, abdominal gas, success of rectal emptying, fecal incontinence, and decrease in quality of life. Total and segmental CTTs (right colon, left colon, and rectosigmoid colon) were assessed using radiopaque markers. The effects of the sociodemographic variables and the clinical symptoms on the different CTTs (total and segmental) were analyzed. RESULTS: The assessed clinical conditions were observed in the following percentages of subjects: abdominal gas symptoms (70%), fecal incontinence (56%), abdominal pain (63%), total time for bowel care > 1 hour (11%), difficult rectal emptying (66%), and decrease in quality of life (36%). We also observed an increase in total CTT in 47% of subjects; increases in segmental CTT were found in the right colon in 23%, in the left colon (60%), and in the rectosigmoid segment (23%). Statistical analyses failed to show a significant difference in mean CTT values between the group of symptomatic patients (1 or more symptoms) and the group of asymptomatic patients. No significant difference could be detected in the incidence of each intestinal symptom between the group of participants with normal CTT values and those with abnormal CTT values. For each of the clinical data assessed separately, a significantly longer CTT (left colon) was associated with the lack of abdominal pain (P < .03) and the presence of fecal incontinence (P < .01); successful rectal emptying was associated with significantly shorter total (P < .02) and segmental CTTs for the left colon (P < .01) and rectosigmoid colon (P < .05). CONCLUSIONS: Besides an association between shorter CTT and successful rectal emptying, there was little relationship between CTTs and intestinal symptoms in this study of patients with SCI.

Health-related quality of life after spinal cord injury.

PURPOSE: The purpose of this study was to assess health-related quality of life (HRQOL) in spinal-cord-injured adults living in Quebec (Canada). METHOD: Subjects with spinal cord injury (SCI) all of whom were members of the Quebec Paraplegic Association who gave their consent to participate completed the 36-item Short Form Health Survey (SF-36); sociodemographic and medical data were also solicited. RESULTS: Five hundred and eighty-seven participants were studied. The findings show a significant decrease in the score of the eight health concepts as measured by the SF-36 as well as that of the physical component summary measure (p<0.05). Analysing the various medical and sociodemographic variables with the eight scales of the SF-36 indicate that younger age, employment and the lack of hospitalization in the previous year were associated with a better quality of life. Mid- and long-term medical complications related to a spinal cord lesion and the impact of ageing are discussed briefly. CONCLUSION: HRQOL is decreased in the studied population with an SCI.

Adenocarcinoma of the right breast in a man with intellectual disability.

A 64-year-old man with moderate intellectual disability developed a large right breast carcinoma with lymph node metastases. Cancer treatment is often difficult in persons with intellectual disability. However, the patient could be treated according to the current protocols with surgery, chemotherapy, and radiotherapy. He is alive and in good health two years after discovery of his tumor. Although breast cancer is estimated as frequent in women with intellectual disability as it is in nondisabled women, our patient is the second man with intellectual disability reported with a breast carcinoma.

Estimated prevalence of obstructive sleep apnea-hypopnea syndrome after cervical cord injury.

OBJECTIVES: To estimate the prevalence of obstructive sleep apnea-hypopnea syndrome (OSAHS) in patients with cervical cord injury and to identify predictive factors. DESIGN: Cross-sectional study. SETTING: Rehabilitation center. PARTICIPANTS: Forty-one adults with cervical cord injury of more than 6 months in duration. INTERVENTIONS: Medical history, physical exam, and full in home overnight polysomnography were undertaken. Data were collected on characteristics of spinal cord injury, current medication, sleeping habits, daytime sleepiness, body mass index (BMI), and neck circumference. MAIN OUTCOME MEASURE: Presence or absence of OSAHS as defined by the American Academy of Sleep Medicine criteria (1999). RESULTS: Twenty-two (53%) patients (95% confidence interval [CI], 38.4%-68.9%) had OSAHS. Daytime sleepiness (odds ratio [OR], 41.1; 95% CI, 2.3-739.7; P=.02), BMI of 30 kg/m2 or higher (OR=17.2; 95% CI, 1.4-206.4; P=.03), and 3 or more awakenings during sleep (OR=34; 95% CI, 1.6-744.8; P=.03) were the best predictive factors of OSAHS obtained by a forward stepwise multiple logistic regression. CONCLUSIONS: The estimated prevalence of OSAHS is high after cervical cord injury. OSAHS should be suspected, especially in patients with daytime sleepiness, obesity, and frequent awakenings during sleep.

Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203.

PURPOSE: In 1992, preoperative radiotherapy was considered in France as the standard treatment for T3-4 rectal cancers. The present randomized trial compares preoperative radiotherapy with chemoradiotherapy. PATIENTS AND METHODS: Patients were eligible if they presented a resectable T3-4, Nx, M0 rectal adenocarcinoma accessible to digital rectal examination. Preoperative radiotherapy with 45 Gy in 25 fractions during 5 weeks was delivered. Concurrent chemotherapy with fluorouracil 350 mg/m2/d during 5 days, together with leucovorin, was administered during the first and fifth week in the experimental arm. Surgery was planned 3 to 10 weeks after the end of radiotherapy. All patients should receive adjuvant chemotherapy with the same fluorouracil/leucovorin regimen. The primary end point of the trial was overall survival. RESULTS: A total of 733 patients were eligible. Grade 3 or 4 acute toxicity was more frequent with chemoradiotherapy (14.6% v 2.7%; P < .05). There was no difference in sphincter preservation. Complete sterilization of the operative specimen was more frequent with chemoradiotherapy (11.4% v 3.6%; P < .05). The 5-year incidence of local recurrence was lower with chemoradiotherapy (8.1% v 16.5%; P < .05). Overall 5-year survival in the two groups did not differ. CONCLUSION: Preoperative chemoradiotherapy despite a moderate increase in acute toxicity and no impact on overall survival significantly improves local control and is recommended for T3-4, N0-2, M0 adenocarcinoma of the middle and distal rectum.

Pathological and clinical response of a primary chemotherapy regimen combining vinorelbine, epirubicin, and paclitaxel as neoadjuvant treatment in patients with operable breast cancer.

This phase II study investigated the efficacy and tolerability of a primary chemotherapy regimen combining vinorelbine, epirubicin, and paclitaxel (VEP protocol) in women with stage II/III operable breast cancer. Patients (n = 50) were treated with six cycles of VEP according to the following schedule: vinorelbine (Navelbine); Pierre Fabre, Boulogne, France; http://www.pierre-fabre.com) 20 mg/m2, epirubicin (Farmorubicin; Pharmacia, New York, NY; http://www.pnu.com) 35 mg/m2 given on days 1 and 8, paclitaxel (Taxol; Bristol-Myers Squibb, New York, NY; http://www.bmsoncology.com) 175 mg/m2 given on day 9, and G-CSF 5 mg/kg/day given on days 10-20 of a 21-day cycle, followed by surgery and radiotherapy. After six cycles of VEP, the pathological response rate (pCR) in breast was confirmed in six patients (12%; 95% confidence interval [CI]: 3-21)) using Chevallier's classification and in nine patients (18%; 95% CI: 7.4-28.6) using Sataloff's classification. The clinical response rate was 42% (95% CI: 28.3-55.7), including 26% complete responses. Breast conservation was achieved in 68% of patients. After a median follow-up of 48 months (range, 34-62 months), 16 relapses were observed. The overall and disease-free survivals at 5 years were 54.1% (95% CI: 40.3-67.9) and 38% (95% CI: 24.1-51.9), respectively. The principal toxicities of VEP were grade 3/4 neutropenia observed in 30% of patients and grade 3 anemia observed in 12% of patients. There was no case of severe cardiac toxicity, thrombocytopenia, or any other serious adverse events. In conclusion, whereas this regimen was relatively well tolerated, it appears inferior to other regimens and its use is not recommended.

High prognostic significance of residual disease after neoadjuvant chemotherapy: a retrospective study in 710 patients with operable breast cancer.

Prognostic factors are used to help clinical decision-making in selecting the appropriate treatment for individual patients. The purpose of this retrospective study was to identify one or more factors associated with overall survival (OS) and disease-free survival (DFS), in 710 patients with operable breast cancer, subjected to neoadjuvant chemotherapy followed by surgery, radiotherapy and adjuvant treatments. At a median follow-up of 7.6 years, univariate analysis showed that pathological complete response (pCR) was significantly related to survival (p < 0.003), as well as accepted prognostic factors, as SBR and MSBR grades, hormonal receptors or node involvement at surgery, who remained significant in our study (p < 0.001). The revised Nottingham prognostic index (NPI) and related indices (BGI, MNPI and MBGI) were also significantly associated to survival (p < 0.003). In multivariate analysis, node involvement and MSBR grade remained prognostic factors for OS and DFS (p < 0.0003 and p < 0.02, respectively). The MNPI and pCR were significantly related with OS (p = 0.04) and pts with hormonal receptor-positive tumours had a better DFS than others (p = 0.004). Among all clinical and pathological parameters, axillary dissection after neoadjuvant chemotherapy is still important to determine node involvement, a major prognostic factor. Moreover, MSBR grade seemed to be more accurate and predictive of long-term outcome than the standard SBR grade. It is concluded that, outside any other 'biological' factor, residual disease in breast and nodes must be strongly considered after an induction chemotherapy so as to choose adjuvant treatment for the individual patient.

Treatment of calcifying tendinitis of the shoulder by acetic acid iontophoresis: a double-blind randomized controlled trial.

OBJECTIVE: To assess the effects of acetic acid iontophoresis on the treatment of calcifying tendinitis of the shoulder. DESIGN: Double-blind randomized controlled trial. SETTING: Ambulatory academic hospital in Quebec, Canada. PARTICIPANTS: Thirty-six subjects with a calcifying tendinitis of the shoulder. INTERVENTIONS: Subjects were randomized into 1 of 2 groups: physiotherapy during 6 weeks (10 sessions) plus acetic acid iontophoresis for the treatment group (n=18) and sham acetic acid iontophoresis for the control group (n=18). MAIN OUTCOME MEASURES: The Shoulder Pain and Disability Index (SPADI), shoulder range of motion (ROM); and radiologic evaluation of shoulder calcifications. RESULTS: Nine patients dropped out, leaving 27 assessable subjects for analysis. Interim analysis showed that, in both groups, treatment led to improvement, as measured by the SPADI score (P=.004), ROM of the shoulder for abduction (P<.001), internal rotation (P=.001), external rotation (P<.001), and the mean number of calcifications per subject (P=.010). Although no formal significant intervention effects (P=.13) were found for the primary endpoint (SPADI), exploratory analyses suggest a greater improvement in the treatment group (P=.001) than in the control group (P=.33). CONCLUSIONS: Despite a trend toward greater improvement in the SPADI score in the treatment group, the use of acetic acid iontophoresis and physiotherapy for the treatment of calcifying tendinitis of the shoulder did not result in better clinical and radiologic effects than those observed in subjects treated by physiotherapyalone.

Efficacy of a primary chemotherapy regimen combining vinorelbine, epirubicin, and methotrexate (VEM) as neoadjuvant treatment in 89 patients with operable breast cancer.

PURPOSE: In order to improve the breast conservation rate for noninflammatory operable breast cancer stage II and IIIa, neoadjuvant chemotherapy containing vinorelbine, 25 mg/m(2), epirubicin, 35 mg/m(2), and methotrexate, 20 mg/m(2), VEM, was administered days 1 and 8 every 28 days for six cycles. METHODS: From October, 1991 to April, 1996, 89 patients (median age 52 years, range 31-72; 68 stage II and 19 stage IIIa) received 519 cycles (median six) of VEM chemotherapy. RESULTS: Hematotoxicity was mild (World Health Organization grade 3-4 neutropenia in 28% of cycles for 22 patients, and anemia or thrombocytopenia >grade 2) when it occurred, and there were no toxic deaths. The clinical objective response was 90% (28% complete response and 62% partial response). All patients underwent surgery: 77 (87%) had conservative and 12 (13%) had modified radical mastectomy, and 12 (14%) reached pathological complete response. At December, 2000, with a median follow-up of 86 months (39-100), 13 patients had relapsed, and five had died of metastatic disease. Median disease-free survival was 100 months (8.4 years) and median survival had not yet been reached.