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Secondary hyperparathyroidism (SHPT) affects a significant number of hemodialysis patients, and metabolic disturbances associated with it may contribute to their high mortality rate. As patients with lower serum calcium, phosphorus, and parathyroid hormone are reported to have improved survival, we tested whether prescription of the calcimimetic cinacalcet to hemodialysis patients with SHPT improved their survival. We prospectively collected data on hemodialysis patients from a large provider beginning in 2004, a time coincident with the commercial availability of cinacalcet hydrochloride. This information was merged with data in the United States Renal Data System to determine all-cause and cardiovascular mortality. Patients included in the study received intravenous (i.v.) vitamin D therapy (a surrogate for the diagnosis of SHPT). Of 19,186 patients, 5976 received cinacalcet and all were followed from November 2004 for up to 26 months. Unadjusted and adjusted time-dependent Cox proportional hazards modeling found that all-cause and cardiovascular mortality rates were significantly lower for those treated with cinacalcet than for those without calcimimetic. Hence, this observational study found a significant survival benefit associated with cinacalcet prescription in patients receiving i.v. vitamin D. Definitive proof, however, of a survival advantage awaits the performance of randomized clinical trials.

Background/Aims: Data describing real-world use and effectiveness of cinacalcet are limited. We aimed to characterize predictors of treatment and changes in secondary hyperparathyroidism (SHPT) biochemistry after cinacalcet initiation. Methods: We studied 25,250 in-center hemodialysis patients from a large dialysis provider, alive through November 2004, with no prior cinacalcet prescription. Patients were followed until initiation of cinacalcet, censoring, death, or July 31, 2007. Initiators were further followed for dose titration and discontinuation. Predictors of these events were evaluated using Cox proportional hazards modeling. Biochemical parameters and other SHPT medication use were compared between baseline, pre-initiation, and post-initiation time points. Results: Over an average of 1.25 years of follow-up, 30% of patients initiated cinacalcet therapy. Between baseline and initiation (mean of 386 days), parathyroid hormone (PTH) and phosphorus levels increased 78 and 7%, respectively, in these patients. After adjustment, cinacalcet initiation was associated with higher SHPT severity, younger age, African-American race, higher phosphorus levels, and more comorbidity. Within 1 month of initiation, median PTH was reduced by 15-30% and phosphorus by 3-5%. Reductions were sustained or increased over 12 months, depending on initiating PTH level and whether dose up-titration occurred. Discontinuation was common, although many patients reinitiated. Conclusions: A substantial proportion of patients experienced SHPT progression and initiated cinacalcet treatment. Reductions in biochemistry varied by disease severity and whether doses were titrated.

Background/Aims: African-Americans with end-stage renal disease receiving dialysis have more severe secondary hyperparathyroidism than Whites. We aimed to assess racial differences in clinical use of cinacalcet. Methods: This retrospective cohort study used data from DaVita, Inc., for 45,589 prevalent hemodialysis patients, August 2004, linked to Centers for Medicare & Medicaid Services data, with follow-up through July 2007. Patients with Medicare as primary payer, intravenous vitamin D use, or weighted mean parathyroid hormone (PTH) level >150 pg/ml at baseline (August 1-October 31, 2004) were included. Cox proportional hazard modeling was used to evaluate race and other demographic and clinical characteristics as predictors of cinacalcet initiation, titration, and discontinuation. Results: Of 16,897 included patients, 7,674 (45.4%) were African-American and 9,223 (54.6%) were white; 53.2% of cinacalcet users were African-American. Cinacalcet was prescribed for 47.7% of African-Americans and 34.5% of Whites, and for a greater percentage of African-Americans at higher doses at each PTH strata. After covariate adjustment, African-Americans were more likely than Whites to receive cinacalcet prescriptions (hazard ratio 1.17, p < 0.001). The direction and magnitude of this effect appeared to vary by age, baseline PTH, and calcium, and by elemental calcium use. African-Americans were less likely than Whites to have prescriptions discontinued and slightly more likely to undergo uptitration (hazard ratio 1.09, 95% confidence interval 0.995-1.188), but this relationship lacked statistical significance. Conclusion: Cinacalcet is prescribed more commonly and at higher initial doses for African-Americans than for Whites to manage secondary hyperparathyroidism.

Background To analyze the association of pathologic‐complete‐response (PCR) and survival after neoadjuvant concurrent chemo‐radiotherapy, we evaluated a large cohort of patients with potentially resectable stage IIIA–IIIC non‐small cell lung cancer (NSCLC) treated with a trimodality approach. Methods Consecutive patients underwent neoadjuvant induction chemotherapy, followed by concurrent chemo‐radiotherapy and surgery. Patients received established imaging, and diagnostics. Leave‐one‐out cross‐validation was employed to identify the most effective prognostic classifier. Results Altogether, 403 patients treated between 06/2000 and 01/2020 were included. Median follow‐up was 111 months (IQR: 71–127 months). PCR was achieved in 34% (137 patients) after neoadjuvant therapy and major‐pathologic response without PCR in 30% (MPR> 0%–≤ 10% defined as viable cells in > 0% and ≤ 10% of the sample). PCR was significantly dependent on histology (p = 0.0005) and radiotherapy fractionation schedule (p = 0.027). PCR rates were higher for squamous than for non‐squamous carcinoma with 46.2% (95% CI: 37.8%–54.7%) versus 27.3% (95% CI: 22.0%–33.2%). PCR was the most significant prognostic factor for long‐term survival with an associated hazard ratio of 0.272 (0.192–0.386), while MPR was associated with a hazard ratio of 0.671 (0.498–0.905) in comparison to lesser response. Overall survival at 5/10 years with PCR was 72.9% (95% CI: 64.4%–79.6%)/ 62.8% (53.0%–71.1%)/ event‐free survival at 5 years 69.5% (60.9%–76.7%). Identified through cross‐validation, key prognostic features included PCR, MPR, and treatment period following 18F‐FDG‐PET/CT‐guided staging. Conclusions Induction chemotherapy followed by chemo‐radiotherapy results in high PCR rates. In this investigation, PCR is followed by high event‐free and overall survival rates. These data warrant further investigation of chemo‐radiotherapy as a significant component of neoadjuvant treatment regimens in trials combined with immunotherapy. This strategy may increase the PCR rates, particularly for patients with more advanced, potentially resectable stage III NSCLC. Pathologic complete response predicts long‐term survival following neoadjuvant induction chemotherapy and chemo‐radiation in stage‐III Non‐small cell lung cancer. Through Induction‐chemotherapy and Chemoradiation to Surgery and Beyond: Pathologic Complete Response and Overall Survival in stage III NSCLC—A Long‐term observational study.

Bridgestone said yesterday it has increased output at the three factories in Japan that have been making replacement tires since last week, and it added production at a fourth factory. Bridgestone now expects to produce 650,000 replacement tires by the end of this year, or one-tenth of the tires needed for the U.S. recall. Last week, the company had projected its Japan plants would be able to churn out just 450,000 by the end of the year. Bridgestone hopes to complete the recall by early 2001. Last Wednesday, Bridgestone started sending tires to the U.S. from Japan by air cargo but had transported just 2,000 tires as of Sunday. Bridgestone's Japanese factories can't churn out more replacement tires immediately because of a shortage of molds for the American tire models. Before last week, Bridgestone hadn't made the American models in Japan. Michelin is increasing production of some tire models by 400% over the next three months to provide replacements for the recalled Firestone tires by moving other products out of three factories, in Oklahoma, Alabama and Nova Scotia. This will make room for additional capacity, said Nancy Banks, a spokeswoman at Michelin headquarters in Clermont-Ferrand, France. The company, which also sells under the BFGoodrich and Uniroyal brands, explains on its U.S. Web site how consumers can buy Michelin replacement tires and get reimbursed by Firestone.

Scrambling to support its vast U.S. recall of Firestone tires, Japan's Bridgestone Corp. said it will further boost production of replacement tires at plants in Japan and will charter Boeing 747 jumbo jets to shuttle the tires to the U.S. next month.

So Sen. Bill Frist (R-Tenn.) will pull the \"nuclear option\" on Judge Samuel Alito's Supreme Court nomination [\"Frist warns against filibuster,\" Newsday.com, Dec. 11]. Frist is getting ahead of himself. The last I remember, the Senate's responsibility is advice and consent on court nominees. Why bother to have the Judiciary Committee review and recommend to the full Senate? By recently mentioning the 30,000-plus Iraqi deaths, President George W. Bush has finally acknowledged some of the damage for which he is directly responsible [\"Bush puts Iraqi dead at about 30,000,\" Newsday.com, Dec. 13]. It also reminds me of comments that Secretary of State Condoleezza Rice made about the liberation of the Iraqi people being similar to that of the U.S. civil rights movement. I found that statement to be insulting to all those involved with the past movement. Perhaps, in line with her thinking, Rice might want us to equate Bush to Martin Luther King Jr., and perhaps equate herself to Rosa Parks. And if that were the case, there'd be one tremendous difference: The civil rights leaders were not responsible for innocent people being killed. Newsday welcomes letters of 250 words or fewer. Include name, address, day and night telephone numbers, and relevant political or other interests. Send e-mail to letters@newsday.com, fax to 631-843- 2986 or mail to Letters, Newsday, 235 Pinelawn Rd., Melville, NY 11747. Letters will be edited, become property of Newsday and may be republished in any format.

The lucky winners of the Arista Records Wordspinners contest (June 30, 1982 issue of Circus Magazine) will each win a Sony Walkman.