In a study of the effectiveness of high intravenous doses of metoclopramide as an antiemetic, 41 patients with advanced cancer who were being treated with cisplatin were entered into two double-blind trials. In the first trial patients were randomly assigned to receive either metoclopramide or placebo, and in the second trial they received either metoclopramide or prochlorperazine. Patients given metoclopramide had significantly fewer episodes of emesis than patients given placebo (medians, 1.0 vs. 10.5; P = 0.001) or prochlorperazine (medians, 1.5 vs. 12.0; P = 0.005). Metoclopramide was superior to placebo and to prochlorperazine in reducing the volume of emesis (P = 0.001 and P = 0.022, respectively) and was more effective than placebo in shortening the duration of nausea (P = 0.042) and vomiting (P = 0.028). Side effects from metoclopramide were minor, with mild sedation frequently observed; one patient had a brief extrapyramidal reaction. We conclude that metoclopramide in high intravenous doses has greater antiemetic activity than placebo or prochlorperazine in patients receiving cisplatin chemotherapy.
Improvements in mammography in the past 25 years have made it possible to detect before surgery many lesions with a high probability of being pre-invasive carcinoma. Because these cancers are virtually all cured by mastectomy, there has been considerable interest in alternative types of treatment. Retrospective studies of pre-invasive carcinoma treated by biopsy only revealed subsequent carcinoma in 30 to 40% of patients. Among women with lobular carcinoma in situ (LCIS), the frequency of subsequent carcinoma was nine times the expected rate, and mortality due to the disease was 11 times greater than expected. The risk of later invasive carcinoma appeared to involve both breasts equally when LCIS was present and to be largely limited to the breast that harbored intraductal carcinoma (IDC). When mastectomy was performed for pre-invasive carcinoma, unsuspected invasion was found in 4% of patients with LCIS and 6% with IDC.It remains to be determined whether multicentric preinvasive carcinoma will follow the same course in patients with palpable invasive carcinoma treated by partial mastectomy and some form of adjuvant therapy. At present, it is prudent to treat pre-invasive breast cancer by ipsilateral mastectomy with low axillary dissection and to perform a contralateral breast biopsy. However, prospective, controlled investigations are urgently needed to identify groups of patients with a high or low risk of developing invasive carcinoma and to determine whether non-surgical treatment can alter the course of pre-invasive disease. By pursuing these studies, it may ultimately be possible to measure the success of breast cancer detection by the number of patients cured without mastectomy. Accepted for publication November 7, 1979.nomas, there was an appreciable risk of metastases. Metastases were documented in axillary lymph nodes of 13.4% of patients who had invasive cancer and who had at least 5 lymph nodes examined. Axillary metastases were found in 20.2% of cases with primary tumors 0.5-0.9 cm in diameter reported by the SEER program of the National Cancer Institutez8 and in 23.1%of a series of patients with clinically occult or nonpalpable invasive carcinomas detected by mammography in a recent clinical series.z6 Few have questioned the clinical significance of the small invasive tumors, despite debate over therapy, and therefore, the detection of these lesions was generally considered to be a beneficial result of breast cancer screening, including mammography. The advantage gained by detecting pre-invasive or in situ carcinoma has been more controversial. 134329 Variation in the frequency of the lesions depends in part on the clinical setting and may influence the intensity of debate about treatment. Intraductal carcinoma and LCIS each constitute about 5% of all carcinomas diagnosed in our institution.lR However, among non-palpable lesions detected by mammography 78% were pre-invasive, and of these, nearly 90% were intraductal. In the setting of screening mammography, the recent BCDDP review revealed that ...
Recurrence and survival data at 10 years were examined for 147 women with single axillary lymph node metastases found in a modified radical or standard radical mastectomy. The cases were identified through a review of all patients with primary operable breast cancer treated at Memorial Hospital from 1964 to 1970. The patients were stratified into groups according to size of the primary tumor and of the metastatic deposit (micro less than or equal to 2 mm; macro greater than 2 mm) as well as level of the positive node. In the entire series, there was a significantly poorer prognosis among those patients with single macrometastases (30/77 patients; 39% recurrence rate) when compared with those having micrometastases (17/70 patients: 24% recurrence rate). A major prognostic difference emerged after stratification by tumor size. Within the first six years of the follow-up period, T1 patients with negative nodes and those with single micrometastases had similar survival curves, significantly better than those with macrometastases. However, at 12 years, the survival rats of those patients with either a micro- or macrometastases was nearly identical, and significantly worse than for those patients with negative lymph nodes. On the other hand, among women with primary tumors 2.1-5.0 cm (T2), patients with negative lymph nodes or single micrometastases had survival curves that did not differ significantly throughout the course of the follow-up period. Both had an outcome significantly better than observed for patients with macrometastases. These findings have important implications for our understanding of the clinical behaviour of breast cancer and for the stratification of patients entered into randomized treatment trials.
IMPORTANCE There are few population-based studies addressing trends in neonatal intensive care unit (NICU) admission and NICU patient-days, especially in the subpopulation that, by gestational age (GA) and birth weight (BW), might otherwise be able to stay in the room with their mothers. OBJECTIVE To describe population-based trends in NICU admissions, NICU patient-days, readmissions, and mortality in the birth population of a large integrated health care system. DESIGN, SETTING, AND PARTICIPANTS This cohort study was conducted using data extracted from electronic medical records at Kaiser Permanente Southern California (KPSC) health care system. Participants included all women who gave birth at KPSC hospitals and their newborns from January 1, 2010, through December 31, 2018. Data extraction was limited to data entry fields whose contents were either numbers or fixed categorical choices. Rates of NICU admission, NICU patient-days, readmission rates, and mortality rates were measured in the total population, in newborns with GA 35 weeks or greater and BW 2000 g or more (high GA and BW group), and in the remaining newborns (low GA and BW group). Admissions to the NICU and NICU patient-days were risk adjusted with a machine learning model based on demographic and clinical characteristics before NICU admission. Changes in the trends were assessed with 2-sided correlated seasonal Mann-Kendall test. Data analysis was performed in August 2019. EXPOSURES Admission to the NICU and NICU patient-days among the birth cohort. MAIN OUTCOMES AND MEASURES The primary outcomes were NICU admission and NICU patient-days in the total neonatal population and GA and BW subgroups. The secondary outcomes were readmission and mortality rates. RESULTS Over the study period there were 320 340 births (mean [SD] age of mothers, 30.1 [5.7] years; mean [SD] gestational age, 38.6 [1.97] weeks; mean [SD] birth weight, 3302 [573] g). The riskadjusted NICU admission rate decreased from a mean of 14.5% (95% CI, 14.2%-14.7%) to 10.9% (95% CI, 10.7%-11.7%) (P for trend = .002); 92% of the change was associated with changes in the care of newborns in the high GA and BW group. The number of risk-adjusted NICU patient-days per birth decreased from a mean of 1.50 patient-days (95% CI, 1.43-1.54 patient-days) to 1.40 patientdays (95% CI, 1.36-1.48 patient-days) (P for trend = .03); 70% of the change was associated with newborns in the high GA and BW group. The unadjusted 30-day readmission rates and mortality rates did not change. CONCLUSIONS AND RELEVANCE Admission rates to the NICU and numbers of NICU patient-days decreased over the study period without an increase in readmissions or mortality. The observed decrease was associated with the high GA and BW newborn population. How much of this decrease (continued) Key Points Question How are neonatal intensive care unit (NICU) admission rates and NICU patient-days changing over time for various birth weight, gestational age, and acuity subgroups? Findings In this cohort study of neonates in a large integr...
Background: This multicenter, randomized, phase III study compared the efficacy, including progression-free survival (PFS), and safety of gemcitabine -docetaxel (GD) combination versus cisplatin-vinorelbine (CV) in the treatment of advanced non-small-cell lung cancer (NSCLC). Results: A total of 311 patients were enrolled (155 GD and 156 CV). Neither PFS nor overall survival differed significantly between the two arms (median PFS 4.2 and 4 months; median survival 11.1 and 9.6 months; 1-year survival 46% and 42%, for GD and CV, respectively). For the GD arm compared with the CV arm, the hazard ratio for PFS was 1.04 [95% confidence interval (CI) 0.83 -1.32], and for overall survival, it was 0.90 (95% CI 0.70 -1.16). Objective response rates did not differ significantly (31% for GD, 35.9% for CV). Myelosupression, emesis and frequency of febrile neutropenia were less pronounced on the GD arm, whereas fluid retention and pulmonary events were more pronounced. The CV arm experienced a higher number of serious adverse events and a lower compliance with the protocol. There was no quality of life (QoL) difference between arms. Median time to definite impairment of health-related QoL was 153 and 168 days in GD and CV arms, respectively. Conclusions: There was no advantage in PFS with GD compared with CV; however, the CV regimen had higher rate of toxic events, mainly myelosuppression. The herein, non-platinum-containing regimen could be considered as a rational alternative to the cisplatin-based doublet.
IMPORTANCE Most neonates admitted to a neonatal intensive care unit (NICU) are born at gestational age (GA) of 34 weeks or more. The degree of uniformity of admission criteria for these infants is unclear, particularly at the low-acuity end of the range of conditions warranting admission.OBJECTIVES To describe variation in NICU admission rates for neonates born at GA of 34 weeks or more and examine whether such variation is associated with high illness acuity or designated facility level of care. DESIGN, SETTING, AND PARTICIPANTSCross-sectional study of 35 921 NICU inborn admissions of GA at 34 weeks or more during calendar year 2015, using a population database of inborn NICU admissions at 130 of the 149 hospitals in California with a NICU. The aggregate service population comprised 358 453 live births. The individual NICU was the unit of observation and analysis. The analysis was stratified by designated facility level of care and correlations with the percentage admissions with high illness acuity were explored. The hypothesis at the outset of the study was that inborn admission rates would correlate positively with the percentage of admissions with high illness acuity.EXPOSURES Live birth at GA of 34 weeks or more. MAIN OUTCOMES AND MEASURES Inborn NICU admission rate.RESULTS Of the total of 358 453 live births at GA of 34 weeks or more, 35 921 infants were admitted to a NICU and accounted for 79.2% of all inborn NICU admissions; 4260 (11.9%) of these admissions met high illness acuity criteria. Inborn admission rates varied 34-fold, from 1.1% to 37.7% of births (median, 9.7%; mean [SD], 10.6% [5.8%]). Percentage with high illness acuity varied 40-fold, from 2.4% to 95% (median, 11.3%; mean, 13.2% [9.9%]). Inborn admission rate correlated inversely with percentage of admissions with high illness acuity (Spearman ρ = −0.3034, P < .001). Among regional NICUs capable of caring for patients with the highest degree of illness and support needs, inborn admission rate did not significantly correlate with percentage of admissions with high illness acuity (Spearman ρ = −0.21, P = .41). CONCLUSIONS AND RELEVANCEPercentage of admissions with high illness acuity does not explain 34-fold variation in NICU inborn admission rates for neonates born at GA of 34 weeks or more. The findings are consistent with a supply-sensitive care component and invite future investigation to clarify the lower-acuity end of the range of conditions considered to warrant neonatal intensive care.
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