Docetaxel (Taxotere) is an active single agent in the treatment of non–small-cell lung cancer. Weekly administration of docetaxel(Drug information on docetaxel) minimizes myelosuppression and is generally well tolerated. To further evaluate the efficacy and toxicity of this novel schedule, we performed a phase II trial in patients with advanced non–small-cell lung cancer who were either elderly (age > 65 years) or poor candidates for combination chemotherapy due to coexistent illness or poor performance status.
Eligible patients were required to have stage IIIB or IV disease (not eligible for combined-modality therapy); no previous chemotherapy; Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2; no central nervous system metastases; and normal bone marrow, liver, and kidney function. Between February 1998 and January 1999, 39 patients were enrolled. All patients received docetaxel 36 mg/m² weekly for 6 consecutive weeks, followed by 2 weeks without treatment. Patients were reevaluated after 8 weeks of treatment; responding patients continued weekly docetaxel for a maximum of 32 weeks or until progression. The median age was 71 years (range: 55–82 years).
Performance status was ECOG 1, 21 patients (54%); ECOG 2, 16 patients (41%). Seven of 36 evaluable patients (19%) had an objective response to treatment (6 partial responses, 1 complete response). An additional 13 patients (36%) had stable disease or a minor response. The median response duration was 8 months, and median survival for the entire group was 5 months, with an actuarial 1-year survival rate of 27%. The response rate in patients with an ECOG performance status of 0 or 1 was 26%, vs 6% in patients with an ECOG performance status of 2; however, 1-year survival rates of these two groups were not significantly different (32% vs 24%).
Treatment was well tolerated, with no grade IV leukopenia and no severe thrombocytopenia or anemia requiring transfusions. Grade III/IV nonhematologic toxicity included asthenia (10%), nausea/vomiting (10%), skin toxicity (3%), neuropathy (3%), and hypersensitivity reactions (3%).
CONCLUSION: Weekly docetaxel is active and well tolerated in elderly patients with advanced non–small-cell lung cancer. The mild toxicity seen with this dose and schedule of docetaxel suggests that the development of combination regimens is feasible.
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