Results of a phase III, double-blind, placebo-controlled trial of megestrol acetate modulation of P-glycoprotein-mediated drug resistance in the first-line management of small-cell lung carcinoma.

The objective of this study was to determine if the addition of megestrol acetate (MA), a modulator of P-glycoprotein-mediated drug resistance, to first-line cytotoxic therapy in patients with limited and advanced stage small-cell lung cancer (SCLC) would improve median time to disease progression and median overall survival. Secondary outcomes evaluated were response rates and patient symptom profile. Between 1992 and 1995, 130 eligible patients were randomized in a double-blind fashion to receive standard first-line therapy consisting of alternating courses of cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin (and thoracic radiotherapy for limited stage patients), along with either placebo or MA 160 mg t.i.d. for 8 days commencing 3 days before initiation of each cycle of chemotherapy. Treatment was continued for a maximum of six cycles. A total of 130 eligible patients were randomized, 65 to each arm. Fifty-two per cent of patients had limited disease and 48% had advanced disease. The median time to disease progression in limited stage disease was 46 weeks in the placebo arm and 43 weeks in the MA arm (P = 0.71) and in advanced stage disease was 28 weeks in the placebo arm and 27 weeks in the MA arm (P = 0.92). The median overall survival in limited stage disease was 75 weeks in the placebo arm and 75 weeks in the MA arm (P = 0.56) and in advanced stage disease was 41 weeks in the placebo arm and 39 weeks in the MA arm (P = 0.96). There was no consistent statistical difference in response rates or patient symptom profiles between the two treatment arms. The addition of MA, in the dose and schedule used, to standard first-line cytotoxic therapy in SCLC did not result in a significant improvement in response rates, symptom profile, median time to disease progression or overall survival.

Crystalglobulinemia syndrome. A manifestation of multiple myeloma.

BACKGROUND: Crystalglobulinemia syndrome (CS) is a rare vasculopathy that may arise as a complication of multiple myeloma (MM). METHODS AND RESULTS: A patient with multiple myeloma in whom crystalglobulinemia syndrome was the initial manifestation with polyarthralgias, cutaneous ulceration, and lower limb ischemia requiring bilateral amputations is reported. CONCLUSION: The rare syndrome of crystalglobulinemia may be associated with multiple myeloma, so it is important that clinicians be aware of this syndrome and its clinical and morphologic features.

Idiopathic pulmonary hemosiderosis: two cases in a family.

Two patients, a mother and her son, had idiopathic pulmonary hemosiderosis. In the son, the onset was acute and he died of massive hemoptysis. The mother's disorder developed less acutely and the condition improved after temporary respiratory support and massive corticosteroid therapy. This is the first reported instance of idiopathic pulmonary hemosiderosis occurring in more than one member of the same family. The diagnosis of idiopathic pulmonary hemosiderosis depends on compatible clinical and pathologic data and on exclusion of secondary causes of intrapulmonary hemorrhage.

Lymphoma of the spinal extradural space.

Ninety-four patients with lymphoma involving the extradural space with spinal cord compression proven at the time of laminectomy were reviewed. There were about three times as many patients with non-Hodgkin's lymphoma than with Hodgkin's disease. The majority of those with Hodgkin's disease had a proven histologic diagnosis before the onset of the spinal cord compression syndrome, whereas only 15% of those with non-Hodgkin's lymphoma had previously been so diagnosed. Plain roentgenograms of the spine were suggestive of tumor involvement in less than one-third of the patients, whereas myelograms were invariably abnormal. As noted by others, the outlook for functional recovery and extended life expectancy is relatively good for patients with this type of cancer, in contrast to reports in the literature regarding prognosis for patients who have metastatic carcinoma with extradural spinal cord compression.