Concomitant chemoradiation versus neoadjuvant chemotherapy in locally advanced cervical carcinoma: results from two consecutive phase II studies.

BACKGROUND: Randomized studies comparing induction chemotherapy followed by surgical resection with radiation alone found that the neoadjuvant approach produces better results. So far, this latter modality has not been compared with standard concomitant chemoradiation. The objective of this report was to compare the results of two consecutive phase II studies: neoadjuvant chemotherapy followed by surgery or chemoradiation for the unresectable cases versus standard cisplatin-based chemoradiation. PATIENTS AND METHODS: From February 1999 to July 1999, 41 patients with cervical carcinoma, stages IB2-IIIB, were treated with neoadjuvant chemotherapy. Treatment consisted of three 21-day courses of cisplatin 100 mg/m(2) on day 1 and gemcitabine 1000 mg/m(2) on days 1 and 8, followed by either surgery or concomitant chemoradiation for the non-operable cases. From August 1999 to December 1999, an equal number of patients having comparable clinicopathological characteristics were treated with six weekly courses of cisplatin 40 mg/m(2) during standard pelvic radiation. RESULTS: A total of 82 patients were analyzed. Both groups were similar with regard to age, histology, International Federation of Gynecology and Obstetrics (FIGO) stage, tumor size, pretreatment hemoglobin levels, parametrial infiltration and performance status. In the neoadjuvant arm the overall response rate to induction chemotherapy was 95% (95% confidence interval 88% to 100%). Twenty-three patients had surgery and 14 underwent chemoradiation. In the definitive chemoradiation study, 38 patients completed treatment, the median number of cisplatin courses was six for a dose intensity of 33 mg/m(2)/week. Doses to points A and B were 85 Gy (range 68-95) and 55 Gy (range 51-65), respectively. Chemoradiation was delivered in 44.6 (range 28-113) days. Complete response rates after all treatment were similar: 97% and 87% in the neoadjuvant and chemoradiation groups, respectively. At a median follow-up of 28 (range 2-33) and 24 (range 3-30) months, respectively, there were no differences in overall survival. To date, 15 and 13 patients in the neoadjuvant and chemoradiation groups, respectively, have died of disease (P = 0.8567). CONCLUSIONS: The results of this non-randomized comparison suggest that induction chemotherapy followed by surgery or chemoradiation is at least as effective in terms of response and survival as standard cisplatin-based chemoradiation. A randomized study is needed to confirm these findings.     

Antimicrobial resistance and characterization of Helicobacter pylori strains isolated from Mexican adults with clinical outcome

Eradication of Helicobacter pylori infection in Mexico is of great importance due to the elevated seroprevalence, however, there is yet very little information about antibiotic resistance rates in H. pylori isolates in our country. We analyzed susceptibility to three antimicrobials used in therapy of 49 H. pylori strains isolated from patients with active chronic gastritis, active chronic gastritis with lymphoid follicles, intestinal metaplasia and gastric cancer. All isolated strains were susceptible to amoxicillin, 28 (58%) were resistant to metronidazole and 2 (4%) were resistant to both clarithromycin and metronidazole. Sequence analysis of the 23S rRNA of the two clarithromycin-resistant strains showed the A2142G mutation in one and A2143G and T2182C mutations in the other. Metronidazole resistance was associated with cagA negative strains with a frequency of 82% (9/11). No significant correlation was found between vacA s/m alleles and metronidazole resistance.     

Long-term results of paclitaxel in FIGO stage III ovarian carcinoma

The combination of platinum and paclitaxel is the standard treatment of advanced ovarian carcinoma; however, recent studies have questioned the actual role of the combination as compared to either of the two agents alone. We report an open-label, two-center, phase II study of upfront paclitaxel for patients with histological diagnosis of stage III ovarian carcinoma. Treatment consisted of paclitaxel at 175 mg/m2 administered in a 3-h infusion every 21 days. Response was evaluated after the third course by either laparoscopy or exploratory laparotomy. Patients with stable or progressive disease discontinued treatment, whereas responding patients continued treatment until a maximum of six courses. Response, toxicity, time to progression (TTP) and survival were evaluated. From November 1993 to December 1995, 30 patients were accrued. All patients underwent primary cytoreduction; 17 (57%) and 13 (43%) patients had residual tumors <2 and >2 cm, respectively. Of 27 patients evaluable, objective responses were seen in 18 (66.4%) (95% CI 49.5-83.2)--12 complete (45%) and six partial (22%). Four patients had stable disease (15%) and five (18%) patients progressed. A total of 149 courses were administered to 30 patients, median 4 (range 1-6). Grade 3/4 neutropenia was seen in 13% of courses, peripheral neuropathy, myalgia and arthralgia were frequent, but transitory and relieved with analgesics. At a median follow-up time of 44.5 months (0-99) the TTP and median survival were 16.6 and 43.1 months, respectively. We conclude that single-agent paclitaxel is an effective and well-tolerated first-line treatment for advanced ovarian carcinoma.     

Nursing care delivered at academic community-based nurse-managed center

The academic community-based nurse-managed center (CNC) in this study represents an innovative "nontraditional" model of primary healthcare that seeks to improve access for vulnerable uninsured urban populations. This article describes the nature of the services delivered by an academic CNC, the users of these services, and interventions provided by nurses in the CNC.     

Feasibility of early hospital discharge directly from coronary care unit after primary angioplasty for uncomplicated acute myocardial infarction

Current European and American guidelines recommend early discharge for patients with uncomplicated acute myocardial infarction (AMI). However, this concept has not been widely accepted, and experience with direct discharge from the coronary care unit is limited. We aimed to investigate safety and cost effectiveness of early discharge directly from coronary care unit following successful percutaneous coronary angioplasty (PTCA) in patients with uncomplicated AMI. We included consecutive thirty-one patients with uncomplicated AMI and successful PTCA admitted to coronary care unit of a university hospital. Uncomplicated course was defined as absence of reinfarction, ischemia, VF/VT, repeated PTCA, and heart failure within first 72 hours. Incidence of death, reinfarction, VF/VT, need for revascularisation, and hospitalisation due to heart failure at 1, 6, and 12 months was compared with 56 randomly selected AMI patients with successful PTCA but longer hospitalisation. Average hospital stay was 4 days in early and 6.7 days in control group (p<0.05). Control group had more extensive coronary disease (54% two or more vessels vs. 28% in early discharge, p<0,05). During follow up, none of the early discharged patients died, the only observed event was repeat PTCA due to angina pectoris. In the control group, mortality at 12 months was 3.5% (p<0.05). Cumulative 12 month event free survival was 96% in early discharge group and 87% in control group, but difference was not significant (p=0.15, Cox-Mantel test). Cost reduction of early discharge amounted to 1100 Euro per patient. In conclusions, our study confirmed that for a selected population of patients with AMI, successful PTCA, and uncomplicated clinical course during first 72 hours, discharge as early as three days following the admission is safe.     

The spectrum of clinical and pathological manifestations of AIDS in a consecutive series of autopsied patients in Mexico.

OBJECTIVE: Little is known about the clinical profile of AIDS in Latin American populations. This study characterizes the clinical and pathological manifestations of AIDS in a representative series of Mexican AIDS patients at autopsy. DESIGN: The clinical and pathological findings were abstracted retrospectively for a sequential series of autopsied AIDS patients. SETTING: Autopsies were conducted at the four major tertiary level hospitals that serve the majority of AIDS patients in Mexico City. PATIENTS: Subjects included 177 consecutive patients diagnosed with AIDS between March 1984 and January 1989 who subsequently died and were autopsied in the same period in the study hospitals. MAIN OUTCOME MEASURES: Demographic characteristics, including age, gender, residence, socioeconomic status, and risk group; clinical presentation and autopsy findings, including opportunistic infections and malignancies. RESULTS: Sixty per cent of the AIDS patients presented with wasting syndrome. The most common infections were cytomegalovirus (69%), tuberculosis (25%), and Pneumocystis carinii pneumonia (24%). Central nervous system infections were also common and included toxoplasmosis (19%) and cryptococcoses (10%). Kaposi's sarcoma was present in 30% of cases and non-Hodgkin's lymphoma in 9%. CONCLUSION: Clinical manifestation, and types and frequency of opportunistic infections in our Mexican AIDS patients were more similar to those seen in AIDS patients in Africa and Haiti than in the United States and Europe. These findings suggest that the AIDS epidemic in Mexico has an 'intermediate' pattern and may be a prototype for Latin American countries.     

Eradication rate of Helicobacter pylori in a Mexican population at high risk for gastric cancer and use of serology to assess cure

OBJECTIVES: Helicobacter pylori causes gastric adenocarcinoma. We assessed the success of H. pylori eradication therapy in a medically underserved population in Chiapas, Mexico, that is at high risk for gastric cancer risk. METHODS: Healthy volunteers with both antibodies to CagA and gastrin levels > or = 25 ng/ml were randomly assigned to receive either a combination of omeprazole, amoxicillin, and clarithromycin or matched placebo for 1 wk. Endoscopy with seven biopsies was performed at baseline, at 6 wk, and 1 yr after treatment. Treatment success was defined as loss of H. pylori by histological analysis. Cure was assessed using change in serology based on the standardized absorbance of a H. pylori ELISA. RESULTS: H. pylori eradication rates were high (intent-to-treat analysis: 76.3% [95% CI = 68.7-84.0%] after 6 wk and 76.1% [95% CI = 67.7-84.6%] after 1 yr; per protocol analysis: 77.8% [95% CI = 70.1-85.4%] after 6 wk and 75.2% [95% CI = 66.5-84.0%] after 1 yr). Nine subjects on active treatment and one subject on placebo who were without H. pylori at 6 wk were infected at 1 yr (recurrence rates 10.7% and 33.3%, respectively, p = 0.31). Median changes in standardized absorbance at 1 yr were 47% and 1% for successfully and unsuccessfully treated patients, respectively. A 10% decline in standardized absorbance after 1 yr had 84% sensitivity and 100% specificity for H. pylori eradication. CONCLUSIONS: Even with a short course of treatment against H. pylori, a high rate of eradication rate can be achieved in populations at high risk for stomach cancer. Serum antibodies are useful in assessing efficacy of therapy.