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Purpose: We conducted a multicenter phase II study of amrubicin, a novel 9-aminoanthracycline, to evaluate its efficacy and safety in patients with non-small-cell lung cancer (NSCLC). Patients and methods: Entry requirements included cytologically or histologically proven measurable NSCLC, stage III or IV, no prior therapy, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and adequate organ function. Amrubicin was given by daily intravenous injection at 45 mg/m2/day for three consecutive days, repeated at 3 week intervals. Each patient received at least three treatment cycles. Results: Sixty-two patients were enrolled in this study. Of the 62 registered patients, 60 were eligible and assessable for efficacy, and 59 for toxicity. Overall response rate was 18.3% (95% confidence interval [CI], 9.5 to 30.4%) and median survival time was 8.2 months (95% CI, 6.7 to 10.4 months). Major toxicity was myelosuppression, with incidences of grade 3 or 4 toxicity of 78.0% for neutropenia, 54.2% for leukopenia, 30.5% for anemia, and 28.8% for thrombocytopenia. Non-hematological toxicities with a greater than 50% incidence were anorexia (69.5%), nausea/vomiting (55.9%), and alopecia (75.9%), but were relatively mild, with grade 3 toxicities observed in only one patient each (1.7%). Conclusion: Amrubicin was an active, well-tolerated agent in the treatment of NSCLC.

55歳,女性. 2002年7月進行型小細胞肺癌の診断のもとに,全身化学療法を行い, partial response (PR)を得た.しかし平成15年1月多発性脳転移にて再燃再入院した.全脳照射,メソトレキセート(MTX)の髄空内投与を行ったところ,汎血球減少をきたした.その原因として,全脳照射, MTXの髄腔内投与, disseminated intravascular coagulation (DIC)の関与等も想定されたが,骨髄所見より血球貪食症候群が原因と診断した.二次性の血球貪食症候群としては,感染症・悪性腫瘍・自己免疫等が報告されているが,悪性腫瘍,なかでも肺癌に伴うものは少ないため報告する.

A unique bronchial tumor is reported. The tumor grew as an endobronchial polyp and obstructed the right main bronchus. Histologically the lesion consisted of two different types of neoplastic cells; epithelial small cell nests and atypical spindle-shaped cells. Immunohistochemical studies with a panel of antibodies showed that the small cell nests were immunoreactive for epithelial and neuroendocrine markers. The spindle-shaped cells showed positive staining for smooth muscle actin. Epithelial markers were also positive focally in the spindle cells. Electron microscopy confirmed that the spindle-shaped cells had both epithelial and mesenchymal features. Based on these results, the tumor was considered to be a unique combination of small cell and spindle cell carcinoma.