Phase II study of the combination of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer.

BACKGROUND: To date, no phase II trial of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) has been published. The safety and efficacy of the combination of nedaplatin and weekly paclitaxel in patients with NSCLC was examined. PATIENTS AND METHODS: Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0 to 2, were 75 years or younger and had adequate organ function. Patients were treated with nedaplatin (80 mg/m(2) on day 1) and weekly paclitaxel (90 mg/m(2) on days 1, 8 and 15). RESULTS: From March 2005 through March 2008, 47 patients (31 men and 16 women; median age, 66 years; age range, 38 to 75 years) were enrolled. The overall response rate was 53.2% (95% confidence interval, 38.1% to 67.9%). The median survival time was 13 months (range, 1 to 36 months), the 1-year survival rate was 62% and the median time to disease progression was 5 months (range, 1 to 19 months). Grade 3 to 4 hematologic toxicities included neutropenia in 38.3% of patients, thrombocytopenia in 2.1% and anemia in 23.4% . Although frequent non-hematologic toxicities were nausea, hepatic dysfunction and peripheral neuropathy, all cases were of only mild to moderate severity. Although 1 patient had grade 3 pulmonary toxicity due to drug-induced pneumonia, this patient recovered after receiving steroid therapy. CONCLUSION: This combination chemotherapy is effective and well tolerated and is an acceptable therapeutic option for patients with untreated advanced NSCLC.

Phase II study of irinotecan and carboplatin in patients with the refractory or relapsed small cell lung cancer.

We examined the safety and efficacy of the combination of irinotecan plus carboplatin in patients with refractory or relapsed small cell lung cancer (SCLC). Patients with previously treated SCLC were eligible. Patients were treated every 3 weeks with carboplatin (with a target area under the concentration versus time curve of 5 mg min/ml using the Calvert formula on day 1) plus irinotecan (50 mg/m(2) on days 1 and 8). From May 2000 to January 2002, 24 patients were eligible. None of the 22 patients achieved a complete response, but 15 achieved a partial response with an overall response rate of 68.2% (95% confidence interval, 45.1-86.1%). In 13 patients with sensitive disease, the response rate was 92.3% (95% confidence interval, 64.0-99.8%). The median survival time (MST) was 194 days (range 27-605 days). The MST did not differ significantly between patients with sensitive disease (245 days) and those with refractory disease (194 days, P=0.88). One patient died of treatment-related sepsis. Grade 3-4 hematologic toxicities included leukopenia in 58% of patients, neutropenia in 63%, thrombocytopenia in 58%, and anemia in 67%. Grade 3 diarrhea developed in 21% of patients and grade 3-4 infection in 13%. No patients had grade 4 diarrhea or grade 3-4 nausea and vomiting. This regimen is effective and well tolerated in patients with relapsed or refractory SCLC. However, the search for even more active regimens should be continued.

[Tuberculosis control of construction workers living in Hanba].

Construction workers living in temporal quarters, HANBA, rarely have opportunity to receive the routine health screening program such as that for general inhabitants organized by the local government or that for permanent employees by the employer. Long delay in detecting TB and high drop-out rate from TB treatment among them have been reported. We carried out the following interventions to cope with the problems: In 1999 and 2000, we organized TB screening with X-ray and further examination in the same day when necessary among workers in 6 HANBA in Chiba City. A total of 382 workers were screened, and they also received structured interviews to assess their health-related behaviors and conditions. Four active pulmonary TB cases were detected, and the incidence of 1,047/1,000,000 was forty times higher than that of Chiba City. All four patients were treated and cured. According to the experiences through our intervention, we developed the following recommendations on TB control of construction workers living in HANBA: 1) A system carry out the health examination routinely in the HANBA should be provided, and its implementation be supervised by the public health center and the Labor Standards Inspection Office. 2) It is necessary to guarantee worker's minimum living conditions and medical treatment, and for this regular purpose, close cooperation should be established between clinical service providers and public health, social welfare, and work management authorities. 3) We should start "DOTS" (Directly Observed Treatment Short-Course) not only to the patients in the hospital but also to the outpatients and in the HANBA. To control TB among those workers, further effort is necessary to motivate them to receive basic regular health screening program that is provided in free of charge in Japan.

[Role of public hospitals regarding the support of patients at home].

Eight sickbeds for the support of patients at home were established in Chiba Municipal Hospital in response to a request from the Chiba City Medical Association in 1997. These sickbeds were run by physicians and nurses in the hospital and nurses from Chiba City Public Health Center to promote a tight relation among the medical care, the health care and the public welfare systems. The role of the public health nurses is to receive and manage the documents of the patients from regional medical practitioners and to communicate with the related organizations. These sickbeds were set up to offer medical care, educational teaching to the family, and the social environment to support the patients at home. The patients, who were consulted by regional medical practitioners, were pre-registered by them. The length of stay at the hospital was limited to 2 weeks. The number of patients who were registered and hospitalized increased every year: thus 374 patients receiving treatment from 44 medical practitioners have already been registered. The average age of the patients was 81.1 and almost all of the patients were sick in bed for the whole day at home. Sixty-three patients were hospitalized making use of those sickbeds this year. Further promotion of the relation among the organizations involved in medical care, health care, and welfare is very important to support the patients to be able to stay at home.