Press-fit vs. cemented humeral stem fixation for reverse shoulder arthroplasty: functional outcomes at a mean follow-up of 9.5 years.

BACKGROUND: Reverse shoulder arthroplasty (RSA) is a reliable, long-term treatment option for degenerative shoulder pathology. However, the functional outcomes degrade around the fifth year postoperation, particularly for internal and external rotation. Long-term radiographic changes have been reported around the humeral stem, depending on the fixation method. OBJECTIVES: The primary objective was to compare the clinical outcomes of RSAs by fixation method-cemented vs. press-fit-after a minimum follow-up of 5 years. We hypothesized that proximal humeral osteolysis impacts the functional outcomes. DESIGN AND METHODS: Our study compared 2 matched cohorts: 56 RSAs with cemented stems and 56 RSAs with press-fit stems. We evaluated all the patients using the Constant-Murley score (CMS) and range of motion (ROM), which we measured preoperatively and at the final follow-up visit. We evaluated radiographs from the final follow-up visit to look for proximal humeral osteolysis with tuberosity resorption, signs of stress shielding, periprosthetic radiolucent lines, and scapular notching. RESULTS: At a mean follow-up of 9.5 years (5-21), regardless of the fixation method, the RSA procedure helped to improve the CMS and active joint ROM postoperatively, except for internal and external rotation with elbow at side in the press-fit group. Shoulder ROM was significantly better in the group with cemented stems for anterior elevation (P < .001), abduction (P = .006), and external (P = .02) and internal rotation with elbow at side (P = .02). The CMS did not differ between groups. The presence of tuberosity resorption or scapular notching had no effect on the CMS and active ROM in either group. Osteopenia, which was more prevalent in the press-fit group, had no impact on the functional outcome. CONCLUSION: There was no significant difference between groups in the CMS, although the active shoulder ROM was significantly worse in the press-fit group. This difference could be attributed to more frequent tuberosity resorption in this group.

Induction chemotherapy followed by cisplatin or cetuximab concomitant to radiotherapy for laryngeal/hypopharyngeal cancer: Long-term results of the TREMPLIN randomised GORTEC trial.

BACKGROUND: In Europe, induction chemotherapy (ICT) followed by radiotherapy is preferred to conventional chemoradiotherapy to avoid total laryngectomy in patients with laryngeal/hypopharyngeal cancer. In comparison with conventional radiotherapy, bioradiotherapy with cetuximab significantly improves locoregional control rates (LCRs) and overall survival (OS) without any increase in unmanageable toxicity. METHODS: Patients included had untreated non-metastatic stage III-IV laryngeal/hypopharyngeal invasive squamous cell carcinoma. Good responders after three cycles of docetaxel-cisplatin-5-fluorouracil (TPF)-ICT (docetaxel and cisplatin, 75 mg/m2 each on day 1, and 5-fluorouracil, 750 mg/m2/day on days 1-5) every 3 weeks were randomised to receive radiotherapy (70 Gy) with concurrent cisplatin (100 mg/m2/day on days 1, 22 and 43 of radiotherapy) or cetuximab (400 mg/m2 of loading dose, 250 mg/m2/week during radiotherapy). The primary end-point was larynx preservation. The secondary end-points were laryngo-oesophageal dysfunction-free survival (LEDFS), LCR and OS. RESULTS: A total of 153 patients were enrolled. Among 126 TPF-ICT responders, 116 were randomised to receive either cisplatin (n = 60) or cetuximab (n = 56). The median follow-up was 77.5 months. Five-year OS rates were 66.6% (95% confidence interval [CI]: 0.54-0.79) versus 66.9% (95% CI: 0.54-0.79) (p = 0.9), respectively. Five-year LCRs were 79.8% (95% CI: 69.5-90.0) versus 67.8% (95% CI: 55.1-80.5%) (p = 0.18). Five-year LEDFS was 62.2% (95% CI: 49.7-74.8%) versus 56.2% (95% CI: 43.0-69.4) (p = 0.38). Late grade III/IV salivary gland and laryngeal toxicity occurred in 10.3% versus 9.8% and 6.8% versus 11.8% of patients receiving cisplatin-radiotherapy versus cetuximab, respectively. CONCLUSIONS: No significant difference in LEDFS was observed between the two arms. TPF-ICT followed by conventional chemoradiotherapy or cetuximab was feasible, and long-term toxicity was not statistically different between the two arms. LEDFS appears as a relevant end-point.

Stereotactic prostate focal reirradiation therapy for local recurrence: preliminary results of Hartmann Oncology Radiotherapy Group.

OBJECTIVE: Our objective was to report our experience and to evaluate the feasibility and toxicity of focal salvage stereotactic body radiation therapy (SBRT) in patients with post-radiation local recurrence of prostate cancer. METHODS: We retrospectively reviewed medical records of patients treated with Cyberknife ® between October 2014 and April 2017 at our institution for a focal reirradiation delivered to the prostate/prostatic bed for local recurrence after radical or adjuvant radiotherapy. All patients underwent prostate biopsies at recurrence at the time of fiducial markers placement, had choline PET/CT and pelvic MRI. The treatment consisted in 36 Gy in six fractions delivered every other day. Post reirradiation toxicities were assessed according to the CTCAE v4 (Common Terminology Criteria for Adverse Events). RESULTS: 42 patients were treated with followed with a median follow-up of 21 months (range 3 - 31). 34 patients had biopsy proven recurrence. The initial treatment was radical prostatectomy and radiation therapy for 9 patients and radiation therapy alone for 33 patients. 23 patients from the group of prostate reirradiation had placement of rectal spacers. No Grade 4 or 5 toxicity were observed. 27 acute urinary events were recorded: 18 patients experienced Grade 1, 9 patients experienced Grade 2 toxicity and 1 patient experienced Grade 3 urinary toxicity, namely cystitis and/or dysuria. No Grade 2 or more digestive toxicity was observed. Rectal doses were significantly lower with rectal spacers. CONCLUSION: Salvage focal Cyberknife ® seems feasible and show promising results. ADVANCES IN KNOWLEDGE: SBRT for local prostate cancer recurrence after initial radiotherapy is well tolerated with short follow-up.

Impact of setting up a bone and joint infection referral center on arthroscopic treatment of septic arthritis of the knee and shoulder: Retrospective study.

INTRODUCTION: Referral Centers for Bone and Joint Infection (BJI) were set up to optimize BJI management thanks to multidisciplinary teamwork. The main aim of the present study was to assess the impact of setting up the Western France Bone and Joint Infection Referral Center on arthroscopic treatment of septic arthritis of the shoulder and knee. The secondary aim was to identify other risk factors for failure of this treatment. The null hypothesis was that there was no difference between the "success group" and the "failure group". MATERIAL AND METHODS: This single-center retrospective study included 52 patients treated for septic arthritis between January 1, 2000 and December 31, 2013 by arthroscopic joint lavage associated to at least 4 weeks' antibiotic therapy. Exclusion criteria comprised: retrospective diagnosis of rheumatoid arthritis after negative bacteriological analysis, early cessation of antibiotic treatment, and follow-up less than 4 weeks. Failure was defined as non-healing after first-line treatment. The primary endpoint was date of treatment compared to the launch date of the Center in the first quarter of 2010. The influence of pre- and intraoperative criteria related to patient, treatment and microorganism was assessed. RESULTS: At follow-up, 17 patients (32.9%) showed failure of first-line treatment and 5 (9.6%) were non-healed at end of treatment, whatever the re-intervention. The failure rate significantly decreased after setting up the Center, from 42.9% to 11.8% (p=0.03). In the failure group, 70.6% of patients showed immunosuppression, versus 37.2% in the success group (p=0.01). Neither time to surgery (p=1), type of microorganism, or performance of antiseptic lavage (p=0.25) or synovectomy (p=0.62) influenced outcome. CONCLUSION: Multidisciplinary management of septic arthritis improved treatment success. LEVEL OF EVIDENCE: III, Retrospective comparative study.

Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial.

PURPOSE: Both concurrent chemoradiotherapy (CT-RT) and cetuximab radiotherapy (cetux-RT) have been established as the standard of care for the treatment of locally advanced squamous cell carcinoma of the head and neck. It was not known whether the addition of induction chemotherapy before cetux-RT could improve outcomes compared with standard of care CT-RT. PATIENTS AND METHODS: The current trial was restricted to patients with nonmetastatic N2b, N2c, or N3 squamous cell carcinoma of the head and neck and fit for taxotere, cisplatin, fluorouracil (TPF). Patients were randomly assigned to receive three cycles of TPF followed by cetux-RT versus concurrent carboplatin fluorouracil and RT as recommended in National Comprehensive Cancer Network guidelines. The trial was powered to detect a hazard ratio (HR) of 0.66 in favor of TPF plus cetux-RT for progression-free survival at 2 years. The inclusion of 180 patients per arm was needed to achieve 80% power at a two-sided significance level of .05. RESULTS: Between 2009 and 2013, 370 patients were included. All patients and tumors characteristics were well balanced between arms. There were more cases of grade 3 and 4 neutropenia in the induction arm, and the induction TPF was associated with 6.6% treatment-related deaths. With a median follow-up of 2.8 years, 2-year progression-free survival was not different between both arms (CT-RT, 0.38 v TPF + cetux-RT, 0.36; HR, 0.93 [95% CI, 0.73 to 1.20]; P = .58). HR was 0.98 (95% CI, 0.74 to 1.3; P = .90) for locoregional control and 1.12 (95% CI, 0.86 to 1.46; P = .39) for overall survival. These effects were observed regardless of p16 status. The rate of distant metastases was lower in the TPF arm (HR, 0.54 [95% CI, 0.30 to 0.99]; P = .05). CONCLUSION: Induction TPF followed by cetux-RT did not improve outcomes compared with CT-RT in a population of patients with advanced cervical lymphadenopathy.

Are Carpal Tunnel Syndrome and Regional Degenerative Osteoarthritis Linked? Results of a Case-Control Study.

BACKGROUND: Causality has not been formally demonstrated between carpal tunnel syndrome and osteoarthritis of the wrist or at the base of the thumb. The purpose of this study was to assess the relationship between carpal tunnel syndrome and concomitant degenerative osteoarthritis of the wrist or basal thumb joint. We hypothesised that wrist osteoarthritis by reducing the free volume of the carpal tunnel would be associated with carpal tunnel syndrome, while basal thumb osteoarthritis would show no direct correlation with carpal tunnel syndrome. METHODS: A case-control study including 95 cases and 99 control subjects, has been carried out. Sixty-eight per group were matched for age and sex. Posterior-anterior and lateral plain wrist radiographs for the two matched groups were analysed. RESULTS: Except for scaphotrapeziotrapezoid location, degenerative osteoarthritis of the wrist was significantly linked with carpal tunnel syndrome, whereas there was no significant difference between case and control groups for prevalence of basal osteoarthritis of the thumb. CONCLUSIONS: These results suggest that basal osteoarthritis of the thumb is not a causal factor in carpal tunnel syndrome. In contrast, degenerative osteoarthritis of the wrist was strongly associated with carpal tunnel syndrome, suggesting a causal relation.

Long-Term Outcomes of Reverse Total Shoulder Arthroplasty: A Follow-up of a Previous Study.

BACKGROUND: Despite the increasing numbers of reverse total shoulder arthroplasty (RTSA) procedures, the long-term results have been rarely reported. We previously reported early outcomes of a cohort of patients treated with a Grammont-style RTSA. The purpose of this study was to evaluate the outcomes after a minimum of 10 years, and to document prosthetic survival and complications. METHODS: Clinical outcome assessment was based on the absolute and relative Constant scores and the active range of motion. Radiographic evaluations of scapular notching, tuberosity osteolysis, and periprosthetic radiolucent lines were done as well. Complications and revisions were compiled, and a Kaplan-Meier survival analysis was performed. RESULTS: The original report included the outcomes for 186 patients (191 RTSAs) who had been followed for a mean of 40 months. In the present study, in which the mean duration of follow-up was 150 months, follow-up clinical evaluations were available for 84 patients (87 prostheses) and radiographic assessments were available for 64 patients (67 prostheses). Seventy-seven patients (79 prostheses) had died before the 10-year follow-up, and 17 patients (17 prostheses) had been lost to follow-up. The mean absolute and relative Constant scores (and standard deviations) were 55 ± 16 points and 86 ± 26 points, respectively, with both having decreased significantly compared with the scores at the medium-term follow-up evaluation (at a minimum of 2 years) (p < 0.001 and p = 0.025, respectively). Forty-nine shoulders (73%) exhibited scapular notching. Forty-seven complications (29%) were recorded, with 10 cases (10%) occurring after 2 years. Sixteen (12%) of the original patients underwent revision surgery. The 10-year overall prosthetic survival rate using revision as the end point was 93%. CONCLUSIONS: Despite a high arthroplasty survival rate and good long-term clinical results, RTSA outcomes showed deterioration when compared with medium-term results. The cause of this decrease is probably related to patient aging coupled with bone erosion and/or deltoid impairment over time. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Long-term Results of a Multicenter Randomized Phase III Trial of Induction Chemotherapy With Cisplatin, 5-fluorouracil, ± Docetaxel for Larynx Preservation.

BACKGROUND: The purpose of GORTEC 2000-01 was to compare the long-term efficacy and safety of induction chemotherapy with cisplatin (P) and 5-fluorouracil (F) with or without docetaxel (T) for larynx preservation. METHODS: Operable patients with untreated stage III or IV larynx or hypopharynx invasive squamous cell carcinoma who required total laryngectomy were randomly assigned to three cycles of induction chemotherapy with either TPF or PF, followed by radiation therapy for responders. The primary endpoint was three-year larynx preservation rate. Secondary endpoints included larynx dysfunction-free survival (LDFFS), overall survival (OS), disease-free survival (DFS), loco-regional control rate (LCR), cause of death, and later toxicity rates. Survival and other data were analyzed by Kaplan-Meier methods. All statistical tests were two-sided. RESULTS: Two hundred thirteen patients were treated with median follow-up of 105 months. The five- and 10-year larynx preservation rates were 74.0% (95% CI = 0.64 to 0.82) vs 58.1% (95% CI = 0.47 to 0.68) and 70.3% (95% CI = 0.58 to 0.8) vs 46.5% (95% CI = 0.31 to 0.63, P = .01) in the TPF vs PF arm, respectively. The five- and 10-year LDFFS rates were 67.2% (95% CI = 0.57 to 0.76) vs 46.5% (95% CI = 0.36 to 0.57) and 63.7% (95% CI = 0.52 to 0.74) vs 37.2% (95% CI = 0.24 to 0.52, P = .001), respectively. OS, DFS, and LCR were not statistically improved in the TPF vs the PF arm. Statistically fewer grade 3-4 late toxicities of the larynx occurred with the TPF regimen compared with the PF arm (9.3% vs 17.1%, G-test, P = .038). CONCLUSION: Long-term follow-up confirms that induction chemotherapy with TPF increased larynx preservation and larynx dysfunction-free survival. In this larynx preservation approach using induction chemotherapy, TPF should be recommended, followed by radiation therapy.

Evaluation of the role of glenosphere design and humeral component retroversion in avoiding scapular notching during reverse shoulder arthroplasty.

BACKGROUND: Scapular notching is a common observation during radiological follow-up of reverse shoulder arthroplasty. The purpose of this study was to evaluate the effect of glenosphere design and humeral component retroversion on movement amplitude in the scapular plane and inferior scapular impingement. MATERIALS AND METHODS: The Aequalis Reversed Shoulder Prosthesis (Tornier) was implanted into 40 cadaver shoulders. On the glenoid side, 8 different combinations were tested: 36-mm glenosphere: centered (standard), eccentric, with an inferior tilt, or with the center of rotation (COR) lateralized by 5 or 7 mm; and 42-mm centered glenosphere: used alone or with the COR lateralized by 7 or 10 mm. The humeral component was positioned in 0°, 10°, 20°, 30°, and 40° of retroversion. Maximum adduction and abduction were measured when inferior impingement and superior impingement, respectively, were detected. RESULTS: The average increase in abduction amplitude was 10° and inferior impingement occurred 18° later with a 42-mm glenosphere, especially when it was lateralized by 10 mm, relative to a 36-mm centered glenosphere (P < .05). These 2 combinations provided a 28° increase in the movement amplitude in the scapular plane. Positioning of the humeral component in 10° or 20° of retroversion or in anatomical retroversion was most effective at avoiding inferior impingement but had less effect on abduction range of motion (except with the 42-mm glenosphere). CONCLUSION: Our study confirmed published results with various glenosphere designs but was unique in describing the effect of humeral retroversion on scapular impingement. Inferior scapular notching can be most effectively prevented by using large-diameter glenospheres with lateralized COR and by making sure to replicate the patient's native humeral retroversion.

Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study.

PURPOSE: To compare the efficacy and safety of induction chemotherapy (ICT) followed by chemoradiotherapy (CRT) or bioradiotherapy (BRT) for larynx preservation (LP). PATIENTS AND METHODS: Previously untreated patients with stage III to IV larynx/hypopharynx squamous cell carcinoma received three cycles of ICT-docetaxel and cisplatin 75 mg/m(2) each on day 1 and fluorouracil 750 mg/m(2) per day on days 1 through 5. Poor responders (< 50% response) underwent salvage surgery. Responders (≥ 50% response) were randomly assigned to conventional radiotherapy (RT; 70 Gy) with concurrent cisplatin 100 mg/m(2) per day on days 1, 22, and 43 of RT (arm A) or concurrent cetuximab 400 mg/m(2) loading dose and 250 mg/m(2) per week during RT (arm B). Primary end point was LP at 3 months. Secondary end points were larynx function preservation (LFP) and overall survival (OS) at 18 months. RESULTS: Of the 153 enrolled patients, 116 were randomly assigned after ICT (60, arm A; 56, arm B). Overall toxicity of both CRT and BRT was substantial following ICT. However, treatment compliance was higher in the BRT arm. In an intent-to-treat analysis, there was no significant difference in LP at 3 months between arms A and B (95% and 93%, respectively), LFP (87% and 82%, respectively), and OS at 18 months (92% and 89%, respectively). There were fewer local treatment failures in arm A than in arm B; salvage surgery was feasible in arm B only. CONCLUSION: There is no evidence that one treatment was superior to the other or could improve the outcome reported with ICT followed by RT alone (French Groupe Oncologie Radiothérapie Tête et Cou [GORTEC] 2000-01 trial [Induction CT by Cisplatin, 5FU With or Without Docetaxel in Patients With T3 and T4 Larynx and Hypopharynx Carcinoma]). The protocol that can best compare with RT alone after ICT is still to be determined.

Depression is associated with some patient-perceived cosmetic changes, but not with radiotherapy-induced late toxicity, in long-term breast cancer survivors.

OBJECTIVE: Although depression is prevalent in long-term breast cancer survivors (LTBCS; ≥ 5 years since diagnosis), it is underdiagnosed and undertreated. A better understanding of factors associated with depression could improve depression screening, treatment, and prevention in this population. Our study aimed to assess the link between patient and doctor ratings of breast cosmetic outcomes, late radiotherapy toxicity, and depression in LTBCS. METHODS: In all, 214 patients recruited from the ARCOSEIN study were assessed for late radiotherapy toxicity (by using the LENT-SOMA scale) and patient and doctor ratings of breast cosmetic outcomes (mean = 6.7 years since the end of treatment). We reassessed 120 of these patients for depression (HAD) during a second wave of long-term assessment (mean = 8.1 years since the end of treatment). We used univariate analyses and polytomous logistic regression analyses to predict the HAD depression, which was defined as follows: normal, 0-7 points; and significant depression, ≥ 8 points (8-10 points, possible depression; ≥ 11 points, probable depression). RESULTS: The mean HAD depression score was 4.5 ± 3.6. 19. 2% of our population had significant depression, 6.7% with probable depression, and 12.5% with possible depression. Significant depression was not associated with late radiotherapy toxicity or initial cancer-related variables. Patients with probable depression reported worse cosmetic outcomes than nondepressed patients in terms of perceived breast largeness (p = 0.04), breast deformation (p = 0.02), and changes in skin pigmentation (p = 0.03). CONCLUSIONS: In LTBCS, depression seems to be more strongly associated with changes in some patients' perceived breast cosmetic outcome than late treatment toxicity or initial cancer-related variables.

[Impact of late treatment-related radiotherapy toxicity, depression, and anxiety on quality of life in long-term breast cancer survivors]. / Impact des complications tardives de la radiothérapie, de la dépression et de l'anxiété sur la qualité de vie à long terme dans le cancer du sein.

INTRODUCTION: This study aimed to assess the impact of late treatment toxicity (especially radiotherapy toxicity), chemoradiotherapy treatment type (concurrent or sequential), depression and anxiety on overall, physical and emotional quality of life (QoL) in long-term breast cancer survivors. Method. We assessed 117 patients (mean follow-up since the end of treatment = 8.1 years) for late radiotherapy toxicity (LENT-SOMA scale), patient and doctor ratings of breast cosmetic outcomes, QoL (EORTC QLQ-C30), depression and anxiety (Hospital and Anxiety Depression scale). RESULTS: In univariate analyses, factors associated with significantly decreased QoL were: use of sequential treatment and decreased overall QoL (P = 0.002) and emotional QoL (P = 0.02) ; few radiotherapy late toxicity symptoms (pain and decreased physical QoL, P = 0.01 ; fibrosis and decreased emotional QoL, P = 0.04) ; probable depression or probable anxiety and decreased overall, physical and emotional QoL (P ≤ 0.005). In multivariate analyses, probable depression and probable anxiety were the most stronger predictors for decreased QoL in the overall, physical and emotional domains (P ≤ 0.02). CONCLUSION: Improving screening for and treatment of depression and anxiety might improve QoL in long-term breast cancer survivors.

Subcutaneous compared with intravenous administration of amifostine in patients with head and neck cancer receiving radiotherapy: final results of the GORTEC2000-02 phase III randomized trial.

PURPOSE: To compare compliance with and efficacy of intravenous (IV) and subcutaneous (SC) amifostine for the treatment of patients undergoing radiotherapy for head and neck cancer. PATIENTS AND METHODS: Patients with newly diagnosed squamous cell carcinoma of the head and neck, who were eligible for radiotherapy and who were not receiving concurrent chemotherapy, were randomly assigned to receive either IV amifostine (200 mg/m(2) daily for 3 minutes, 15 to 30 minutes before irradiation) or SC amifostine (500 mg; two sites; 20 to 60 minutes before irradiation). The primary end point was late xerostomia at 1 year as indicated by unstimulated and stimulated salivary flow rates, a patient benefit questionnaire score, and Radiation Therapy Oncology Group (RTOG) late toxicity grade. RESULTS: Results for IV (n = 143) versus SC (n = 148) administration were as follows. There was no significant difference in compliance (69% for IV v 71% for SC) in patients receiving a full dose of amifostine. Reasons for dose reduction were acute toxicity (25% for IV v 27% for SC; P = .51) and logistics (18% for IV v 9% for SC administration; P = .09). Acute toxicity differed significantly in terms of grade 1 to 2 hypotension (19% for IV v 8% for SC; P = .01), grade 1 to 2 skin rash (9% for IV v 21% for SC; P = .01), and local pain (0% for IV v 8% for SC; P = .003). The incidence of grade 2 or greater xerostomia was significantly higher for patients who received amifostine via SC administration (37% for IV v 62% for SC; P = .005) in the 127 patients (n = 67, IV; n = 60, SC) evaluable at 1 year but not at 2 or 3 years (36% for IV v 51% for SC administration; P = .19; 32% for IV v 41% for SC; P = .63). A generalized linear mixed-model analysis of all data revealed no significant difference in patient self-assessment of salivary function (P = .25), unstimulated or stimulated salivary flow rates (P = .054 and .82, respectively), or grade 2 or greater xerostomia (P = .23). CONCLUSION: SC amifostine administration was not significantly superior to IV amifostine administration in terms of patient compliance or efficacy.

Concomitant chemoradiotherapy using carboplatin, tegafur-uracil and leucovorin for stage III and IV head-and-neck cancer: results of GORTEC Phase II study.

PURPOSE: Concomitant chemoradiotherapy is the standard treatment of locally advanced, nonresectable, head-and-neck squamous cell carcinoma. However, the optimal chemotherapy regimen is still controversial. The objective of this Phase II study was to evaluate the feasibility and efficacy of a concomitant treatment using tegafur-uracil, leucovorin, carboplatin, and radiotherapy. METHODS AND MATERIALS: A total of 77 patients with head-and-neck squamous cell carcinoma Stage III and IVA were enrolled between October 2003 and July 2005. Of the 77 patients, 72 were eligible. They were treated with tegafur-uracil (300 mg/m(2)/d) and leucovorin (75 mg/d) from Days 1 to 19 and from Days 29 to 47 and carboplatin (70 mg/m(2) intravenously for 4 consecutive days), in three cycles every 21 days. Conventional radiotherapy was delivered to a total dose of 70 Gy in 35 fractions. RESULTS: With a mean follow-up of 22.8 months, the 3-year locoregional control, overall survival and disease-free survival actuarial rate was 33.1%, 41.9%, and 27.2%, respectively. The compliance of the treatment was correct. The main acute toxicity was mucositis, with 62% Grade 3-4. Three patients (4.2%) died of acute toxicity. The incidence and severity of late toxicity was acceptable, with 32% Grade 3 and no Grade 4 toxicity. CONCLUSION: The protocol of concomitant chemoradiotherapy using tegafur-uracil, leucovorin, and carboplatin for locally advanced unresectable head-and-neck squamous cell carcinoma is feasible. The compliance was correct. The incidence and severity of the acute and late toxicities were acceptable, but not improved. The efficacy of this regimen seems equivalent to the main protocols of concurrent chemoradiotherapy. It represents a possible alternative for patients without an intravenous catheter.

Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation.

BACKGROUND: Chemotherapy with cisplatin (P) and 5-fluorouracil (F) followed by radiotherapy in patients who respond to chemotherapy is an alternative to total laryngectomy for patients with locally advanced larynx and hypopharynx cancer. Data suggest that docetaxel (T) may add to the efficacy of PF. The objective of this trial was to determine whether adding T to PF could increase the larynx preservation rate. METHODS: Patients who had larynx and hypopharynx cancer that required total laryngectomy were randomly assigned to receive three cycles of TPF or PF. Patients who responded to chemotherapy received radiotherapy with or without additional chemotherapy. Patients who did not respond to chemotherapy underwent total laryngectomy followed by radiotherapy with or without additional chemotherapy. The primary endpoint was 3-year larynx preservation rate. Secondary endpoints included acute toxicities and overall response. All statistical tests were two-sided. RESULTS: Baseline patient and tumor characteristics were well balanced between the TPF (n = 110) and PF (n = 103) groups. With a median follow-up of 36 months, the 3-year actuarial larynx preservation rate was 70.3% with TPF vs 57.5% with PF (difference = 12.8%; P = .03). Patients in the TPF group had more grade 2 alopecia, grade 4 neutropenia, and febrile neutropenia, whereas patients in the PF group had more grade 3 and 4 stomatitis, thrombocytopenia, and grade 4 creatinine elevation. The overall response was 80.0% in the TPF group vs 59.2% in the PF group (difference = 20.8%; P = .002). CONCLUSIONS: In patients with advanced larynx and hypopharynx carcinomas, TPF induction chemotherapy was superior to the PF regimen in terms of overall response rate. These results suggest that larynx preservation could be achieved for a higher proportion of patients.

Scapular notching in reverse shoulder arthroplasty.

The causes and consequences of scapular notching after reverse shoulder arthroplasty (RSA) were investigated in 326 consecutive patients (337 shoulders) undergoing RSA between 1991 and 2003. Patients underwent 269 (80%) primary RSAs and 68 revisions of unconstrained shoulder prosthesis. At last follow-up (average, 47 months; range, 24-120 months) 62% had scapular notching. Notching frequency and extension were correlated to the length of follow-up (P = .0005). Notching was more frequent in cuff tear arthropathy (P = .0004), grade 3 or 4 fatty infiltration of the infraspinatus (P = .01), and narrowed acromiohumeral distance (P < .0001). Glenoids preoperatively oriented superiorly were more at risk for notching (P = .006). More notching occurred when the RSA was implanted using an anterosuperior approach vs a deltopectoral approach (P < .0001). Notching was correlated with humeral radiolucencies in proximal zones (P < .0001) and with glenoid radiolucent lines (P < .0001). Positioning of the baseplate definitely influences scapular notching. High positioning of the baseplate and superior tilting must be avoided.

Does concurrent radiochemotherapy affect cosmetic results in the adjuvant setting after breast-conserving surgery? Results of the ARCOSEIN multicenter, Phase III study: patients' and doctors' views.

PURPOSE: To evaluate the cosmetic results of sequential vs. concurrent adjuvant chemotherapy with radiotherapy after breast-conserving surgery for breast cancer, and to compare ratings by patients and physicians. METHODS AND MATERIALS: From 1996 to 2000, 716 patients with Stage I-II breast cancers were included in a multicenter, Phase III trial (the ARCOSEIN study) comparing, after breast-conserving surgery with axillary dissection, sequential treatment with chemotherapy first followed by radiotherapy vs. chemotherapy administered concurrently with radiotherapy. Cosmetic results with regard to both the overall aspect of the breast and specific changes (color, scar) were evaluated in a total of 214 patients (107 in each arm) by means of questionnaires to both the patient and a physician whose rating was blinded to treatment allocation. RESULTS: Patients' overall satisfaction with cosmesis was not statistically different between the two arms, with approximately 92% with at least satisfactory results (p = 0.72), although differences between the treated and untreated breasts were greater after the concurrent regimen (29% vs. 14% with more than moderate differences; p = 0.0015). Physician assessment of overall cosmesis was less favorable, with lower rates of at least satisfactory results in the concurrent arm (60% vs. 85%; p = 0.001). Consequently, the concordance for overall satisfaction with cosmesis between patients and doctors was only fair (kappa = 0.62). CONCLUSION: After breast-conserving surgery, the concurrent use of chemotherapy with radiotherapy is significantly associated with greater differences between the breasts. These differences do not translate into patients' lessened satisfaction with cosmesis.

Phase III trial of concurrent or sequential adjuvant chemoradiotherapy after conservative surgery for early-stage breast cancer: final results of the ARCOSEIN trial.

PURPOSE: In 1996, we initiated the French multicenter phase III randomized trial to compare the effect on disease-free survival (DFS) of concurrent versus sequential chemotherapy (CT) and radiotherapy (RT) after breast-conserving surgery for stages I and II breast cancer. This report presents the clinical results with a median follow-up of 60 months. PATIENTS AND METHODS: Between February 1996 and April 2000, 716 patients were entered onto this trial. Adjuvant treatment began within 6 weeks after surgery. Sequential treatment of CT administered first followed by RT was compared with concurrent treatment of CT administered with RT. The CT regimen consisted of mitoxantrone (12 mg/m2), fluorouracil (500 mg/m2), and cyclophosphamide (500 mg/m2) on day 1, and it was repeated every 21 days for six courses. RT was delivered to the breast and, when indicated, to the regional lymphatics. RESULTS: There was no statistically significant difference in treatment in the 5-year DFS (80% in both groups; P = .83), locoregional recurrence-free survival (LRFS; 92% in sequential v 95% in concurrent; P = .76), metastasis-free survival (87% in sequential v 84% in concurrent; P = .55), or overall survival (90% in sequential v 91% in concurrent; P = .76). Nevertheless, in the node-positive subgroup, the 5-year LRFS was statistically better in the concurrent arm (97% in concurrent v 91% in sequential; P = .02), corresponding to a risk of locoregional recurrence decreased by 39% (hazard ratio, 0.61; 95% CI, 0.38 to 0.93). CONCLUSION: This treatment protocol remains an appealing clinical option for many women with operable breast cancer at a high risk of recurrence. Combination treatments with new drugs for breast cancer are warranted.

Concurrent administration of adjuvant chemotherapy and radiotherapy after breast-conserving surgery enhances late toxicities: long-term results of the ARCOSEIN multicenter randomized study.

PURPOSE: In 1996, a multicenter randomized study was initiated that compared sequential vs. concurrent adjuvant chemotherapy (CT) with radiation therapy (RT) after breast-conserving surgery (ARCOSEIN study). After a median follow-up of 6.7 years (range, 4.3-9 years), we decided to prospectively evaluate the late effects of these 2 strategies. METHODS AND MATERIALS: A total of 297 patients from the 5 larger participating institutions were asked to report for a follow-up examination. Seventy-two percent (214 patients) were eligible for evaluation of late toxicity. After breast-conserving surgery, patients were treated either with sequential treatment with CT first followed by RT (Arm A) or CT administered concurrently with RT (Arm B). In all patients, CT regimen consisted of mitoxantrone (12 mg/m2), 5-FU (500 mg/m2), and cyclophosphamide (500 mg/m2), 6 cycles (Day 1 to Day 21). Conventional RT was delivered to the whole breast by administration of a 2 Gy per fraction protocol to a total dose of 50 Gy (+/- boost to the primary tumor bed). The assessment of toxicity was blinded to treatment and was graded by the radiation oncologist, according to the LENT/SOMA scale. Skin pigmentation was also evaluated according to a personal 5-points scoring system (excellent, good, moderate, poor, very poor). RESULTS: Among the 214 evaluable patients, 107 were treated in each arm. The 2 populations were homogeneous for patient, tumor, and treatment characteristics. Subcutaneous fibrosis (SF), telangectasia (T), skin pigmentation (SP), and breast atrophy (BA) were significantly increased in Arm B. No statistical difference was observed between the 2 arms of the study concerning Grade 2 or higher pain, breast edema, or lymphedema. No deaths were caused by late toxicity. CONCLUSION: After breast-conserving surgery, the concurrent use of CT with RT is significantly associated with an increase incidence of Grade 2 or greater late side effects.

Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma.

PURPOSE: We report the 5-year survival and late toxicity results of a randomized clinical trial, which showed a 3-year improvement in overall survival and locoregional control of stage III or IV oropharynx carcinoma, using concomitant radiochemotherapy (arm B), compared with standard radiotherapy (arm A). PATIENTS AND METHODS: A total of 226 patients were entered onto a phase III multicenter randomized trial comparing radiotherapy alone (70 Gy in 35 fractions; arm A) with concomitant radiochemotherapy (70 Gy in 35 fractions with three cycles of a 4-day regimen comprising carboplatin and fluorouracil; arm B). Prognostic factors were evaluated by univariate and multivariate analysis. Five-year late toxicity was evaluated using National Cancer Institute Common Toxicity Criteria for neurological toxicity, hearing, taste, mandibula, and teeth damage, and Radiation Therapy Oncology Group toxicity criteria for skin, salivary gland, and mucosa. RESULTS: Five-year overall survival, specific disease-free survival, and locoregional control rates were 22% and 16% (log-rank P =.05), 27% and 15% (P =.01), and 48% and 25% (P =.002), in arm B and arm A, respectively. Stage IV, hemoglobin level lower than 125 g/L, and standard treatment were independent prognostic factors of short survival and locoregional failure by univariate and multivariate analysis. One or more grade 3 to 4 complications occurred in 56% of the patients in arm B, compared with 30% in arm A (P was not significant). CONCLUSION: Concomitant radiochemotherapy improved overall survival and locoregional control rates and does not statistically increase severe late morbidity. Anemia was the most important prognostic factor for survival in both arms.