Phase II randomized trial of vinorelbine and gemcitabine versus carboplatin and paclitaxel in advanced non-small-cell lung cancer.

BACKGROUND: The purpose of this study was to compare quality of life and overall toxicity in patients with advanced non-small-cell lung cancer (NSCLC) treated with vinorelbine-gemcitabine (VG) or carboplatin-paclitaxel (Taxol) (CP). PATIENTS AND METHODS: A total of 165 previously untreated patients were randomized to the two regimens. Quality of life was assessed by the Lung Cancer Symptom Scale (LCSS). Overall toxicity and secondary efficacy end points were evaluated by standard WHO criteria. RESULTS: There was no significant difference in overall quality of life between the two treatments. Neutropenia, thrombocytopenia, peripheral neuropathy, and alopecia, were more common in the CP arm, whereas constipation was more frequent in the VG arm. Response rates were 14.6% in the VG arm and 16.9% in the CP arm. Median survival times were 7.8 and 8.6 months, and 1 year survival rates were 38.4% and 31.9%, respectively. CONCLUSIONS: Patients treated with VG experienced lower toxicity, but overall quality of life was similar in both arms. Efficacy seemed comparable between VG and CP. Our study shows that VG is a viable alternative to platinum-based chemotherapy in patients with advanced NSCLC.

A role for businesses in HIV prevention in Asia.

PIP: The estimated number of HIV cases in Asia now exceeds the "worst case" scenario envisioned by the World Bank in 1993. While prevention efforts have failed to contain the epidemic in other parts of the world, Asia's private sector has the resources to contain the epidemic if it acts quickly. In parts of Asia, work place-based medical and health services already exist, but, to date, efforts to gain the cooperation of business and industry in HIV prevention programs have led to disappointment. Businesses in Thailand, on the other hand, have begun a vigorous prevention campaign led by the Thailand Business Coalition on AIDS. The countries where the epidemic has not yet made a big impact (Japan, Korea, Hong Kong, Indonesia, Viet Nam, and the Philippines) are those where intervention could be most effective. Unfortunately, little corporate cooperation is occurring in these areas. Asian companies seem to fear contamination from the disease if they engage in prevention activities. Businesses in Asia have not faced the reality of the costs of AIDS which will rob companies of highly skilled workers who are expensive to replace, drive away foreign capital, and shrink the home market as people dedicate their resources to health care. While the impact of AIDS on businesses follows a tiered approach, all enterprises will eventually be affected adversely. The interrelated nature of Asia economies will also mean that even nations which are not experiencing the epidemic will feel its economic impact (for example, Japan will see its gross national product decrease because of trade losses caused by the epidemic in Thailand). Prevention efforts by businesses must be supported and encouraged by governments with financial and other incentives. Multinational corporations can have an effect on national companies as well as organize programs for their own employees. Because they depend upon longterm strategic thinking, Asian financial institutions are beginning to understand the role that businesses can play and the severity of the economic impact of AIDS. The private sector in Asia must act quickly, however, in order to be able to take advantage of the opportunity to contribute to the prevention of HIV infections.^ieng

Rapid in vitro assay for predicting response to fluorouracil in patients with metastatic breast cancer.

PURPOSE: To determine if a rapid 3H-uridine uptake assay using breast tumor cells from biopsy specimens could predict clinical response to fluorouracil (5FU) in patients with metastatic breast cancer. PATIENTS AND METHODS: A double-blind prospective study was conducted of 60 patients with measurable, metastatic breast cancer who had failed to respond to at least one prior chemotherapy regimen. Patients received 5FU 300 mg/m2/d by continuous infusion and were monitored for response. Tumor cells from biopsy specimens were grown in microwells and exposed for 3 days to 0.1, 1.0, 10.0, and 100.00 micrograms/mL of 5FU on strips coated with drug and extracellular matrix. Cells were pulsed with 3H-uridine overnight. Incorporated radioactivity was compared for wells with and without drug. Results were available 4 days from specimen submission. RESULTS: Of 45 eligible patients, 11 (24%) were not assessable in vitro. Nine patients were assessable in vitro, but not clinically. Of the remaining 25 patients, who were assessable both clinically and in vitro, there was one complete response (CR), five partial responses (PRs), five cases of stable disease, and 14 cases of progressive disease, for an objective response rate of 24%. Response in vitro was significantly correlated with clinical response (P = .002). Of six clinical responders, five also responded in vitro, for an assay sensitivity of 83%. Of 19 nonresponders, 17 were nonresponders in vitro, for a specificity of 89%. The positive predictive value of the test was 71% (five of seven), and the negative predictive value was 94% (17 of 18). CONCLUSION: Results of an in vitro assay were significantly correlated with clinical response in patients with metastatic breast cancer treated with continuous infusion 5FU.

Acute myelocytic leukemia in a patient treated with hexamethylmelamine.

This case report describes a 76-year-old white woman who was found to have ovarian cancer and underwent chemotherapy with hexamethylmelamine. After 34 months of therapy, she developed an acute myelocytic leukemia. Although commonly reported as a side effect of alkylating agents, this is believed to be the first reported case of an acute nonlymphocytic leukemia associated with hexamethylmelamine use.

Neuroblastoma in an adult.

Neuroblastoma in adults is probably a more frequent disease than is generally recognized, owing to difficulties in the microscopic diagnosis. It has no sex predominance and has occurred in patients aged 18 to 72 years. Based on the results in the patient we have described, cyclophosphamide and prednisone would seem an effective and well tolerated chemotherapeutic combination.

Possible enhancement of vincristine neuropathy by VP-16.

Eleven consecutive patients with small cell carcinoma of the lung treated intensively with a combination chemotherapy regimen cyclophosphamide, Adriamycin, VP-16, and vincristine experienced peripheral neuropathy. Four of the 11 patients had severe (Grade III) neuropathy, leaving them virtually bedridden; the remaining seven patients had mild to moderate neuropathy. Only 8 of the 14 patients treated less intensively with vincristine and VP-16 had Grade I and II neuropathy. Predisposing factors for severe neuropathy included advanced age and preexisting peripheral neuropathy. All patients' performance status declined and all lost much weight before developing neuropathy. From accumulated treatment experience of small cell carcinoma with vincristine alone or with vincristine, Adriamycin, cyclophosphamide combinations, the authors feel that the severe neuropathy observed was due to an interaction of vincristine and VP-16. This conclusion is supported by electron microscopic observation of electronopaque granular degeneration of the myelin lamellae of affected nerve fibers.