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A dose escalation study of docetaxel and oxaliplatin combination in patients with metastatic breast and non-small cell lung cancer.
Anticancer Research. 2003 Jan-Feb; 23(1B):785-791.Objectives: To determine the maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of docetaxel in combination with oxaliplatin (L-OHP) as first-line treatment of patients with advanced breast (ABC) and non-small cell lung cancer (NSCLC). Patients and methods: Fifty-two patients (26 with NSCLC and 26 with ABC), who had not received prior chemotherapy for metastatic disease, were enrolled. The patients' median age was 64 years, and 42 (71%) had a performance status (WHO) 0-1. Docetaxel was given as a 1-hour infusion after standard premedication on day 1 and L-OHP as a 2 to 6-hour infusion on day 2 every 3 weeks. Doses were escalated at increments of 10mg/m2. Results: The DLT1 was reached at the doses of docetaxel 75mg/m2 and L-OHP 80mg/m2. The addition of rhG-CSF permitted further dose escalation (DLT2: docetaxel 90mg/m2 and L-OHP 130mg/m2). The dose-limiting events were grade 4 neutropenia, febrile neutropenia, grades 3 or 4 diarrhea and grade 3 fatigue. Out of 239 delivered cycles, grades 3 or 4 neutropenia occurred in 22 (9%) cycles with 5 (2%) neutropenic febrile episodes. There was one septic death. Grades 3 or 4 fatigue was observed in seven (13%) patients and grades 3-4 diarrhea in five (10%). Out of 42 patients evaluable for response, seven (27%) patients with ABC and five (19%) patients with NSCLC experienced a partial response. Conclusion: The combination of docetaxel and oxaliplatin is a feasible and well-tolerated regimen. The recommended doses for future phase II studies are 75mg/m2 for docetaxel on day 1 and 70mg/m2 for L-OHP on day 2 without rhG-CSF support and 85mg/m2 and 130mg/m2, respectively, with rhG-CSF support. (author's)
MMWR. Morbidity and Mortality Weekly Report. 1986 Jan 24; 35(3):35-46.As of September 30, 1985, 1573 cases of acquired immunodeficiency syndrome (AIDS) had been reported by the 21 European countries that are participants in the World Health Organization (WHO) European Collaborating Center on AIDS. An average increase of 27 new cases/week has been noted. Of the total cases, there have been 792 deaths, for a case-fatality rate of 50%. The greatest increases in numbers of AIDS cases have occurred in the Federal Republic of Germany, France, the UK, and Italy. The highest rates exist in Switzerland (11.8), Denmark (11.2), and France (8.5). 65% of European AIDS patients have 1 or more opportunistic infection. 20% had Kaposi's sarcoma, alone, and 13% had opportunistic infections with Kaposi's sarcoma. 92% of cases have involved males, and 42% fall into the 30-39-year age group. Of the 1330 (85%) cases involving Europeans, 78% were homosexual or bisexual men, 70% were intravenous drug abusers, and 2% had both these risk factors. Africans have contributed 10% of European AIDS cases. A questionnaire on public health measures related to blood transfusion found that systematic screening of blood donors for lymphadenopathy-associated virus/human T-lymphotropic virus type III (LAV/HTLV-III) antibodies became effective in 16 of the 21 European countries between June-November 1985. Screening is compulsory in 13 countries. The test used is the enzyme-linked immunosorbent assay (ELISA). Portugal is the only country to have organized a national register of seropositive blood donors, although Norway is considering such a register. Methods to exclude donors at risk have been taken in all the countries except Czechoslovakia, Finland, and Portugal. Although male homosexuals account for 69% of reported AIDS cases in Europe, there has been an increase in cases among intavenous drug abusers from 2% of the total in July 1984 to 8% in September 1985. Over 40% of AIDS cases in Italy and Spain occurred in this group. Moreover, several studies carried out in 1985 showed a high frequency (20-50%) of serologic markers of LAV/HTLV-III infection in intravenous drug abusers.
MMWR. Morbidity and Mortality Weekly Report. 1985 Sep 27; 34(38):583-9.As of June 30, 1985, 1226 cases of acquired immunodeficiency syndrome (AIDS) had been reported by the 18 countries participating in the World Health Organization (WHO) European Collaborating Center on AIDS. 285 new cases were reported by the 17 countries that were corresponding with the Center on March 31, 1985, for an average increase of 22 new cases/week. The greatest increases in numbers of cases were observed in France, Federal Republic of Germany, and the United Kingdom. The highest rates of AIDS cases/millon population in 1985 occurred in Switzerland (9.7), Denmark (9.4), and France (7.0). A total of 626 deaths were reported for the 1226 AIDS cases, yielding a case-fatality rate of 5.1%. 795 (65%) of cases presented with at least 1 opportunistic infection. 245 (20%) had Kaposi's sarcoma alone and 171 (14%) had opportunistic infections with Kaposi's sarcoma. Males accounted for 91% of cases, and 42% occurred in the 30-39-year age group. 29 cases involving children under 15 years of age have been reported. 82% of total cases in Europe have involved Europeans, 3% have involved Caribbeans, and 12% have involved Africans. Of the European patients, 80% were homosexual or bisexual, 5% were intravenous drug abusers, and 1% were from both risk groups. AIDS patients belonging to the male homosexual risk group comprise 60-100% of the total number of AIDS cases in 11 of 15 European countries, but less than 50% of cases in Belgium, Greece, Italy, and Spain. Patients not belonging to any identified risk group contribute the 2nd largest number of cases. 9 countries have reported cases among intravenous drug abusers, 9 have reported AIDS in hemophilia patients, and 5 have reported cases among blood transusion recipients. 3 patterns have been noted: 1) in northern Europe (Denmark, Finland, Netherlands, Norway, and Sweden), most cases occur among male homosexuals; 2) in certain countries in southern Europe (Italy, Spain), most cases occur among those with no identifiable risk factor, but intravenous drug abusers seem to be more affected than in other countries; and 3) in Belgium, most cases occur among patients from central Africa.