RESUMO
The results of a clinical trial involving 599 patients with inoperable squamous cell, large cell anaplastic, and adenocarcinoma of the lung are summarized. Patients were randomized to initial therapy with Cytoxan (CTX) (cyclophosphamide), or to one of two schedules of Adriamycin (doxorubicin) 50, or 75 mg/m2 IV every three weeks, or to a combined regimen of ADR and CTX. Upon disease progression, CTX patients were randomized to one of the two ADR schedules, while ADR patients were randomly assigned to CTX alone, or in combination with Cisdiamminedichloroplatinum (Cis-Platinum) 15 mg/m2 IV every three weeks. No statistically significant response or survival differences were observed between the two dose schedules of Adriamycin for any of the cell types studied. The two dose levels did, however, differ with respect to toxicity. There were some response and survival differences among the various cell types in the comparison of low-dose Adriamycin and Cytoxan: (1) patients with adenocarcinoma treated with low-dose Adriamycin tended to survive longer (P = 0.04) than those treated with Cytoxan; and (2) patients with large cell carcinoma receiving Cytoxan experienced a greater tumor response rate than those receiving low dose Adriamycin (P = 0.03). Because of the difficulties involved in distinguishing these two cell types on pathologic examination, the evidence of apparent treatment differences should not be regarded as definitive. During the period when Adriamycin plus Cytoxan was open to patient entry 61 evaluable patients received that regimen, 21 received low-dose Adriamycin and 22 received Cytoxan. Because relatively few patients received the latter two regimens, comparisons of these treatments with Adriamycin plus Cytoxan lack statistical power. However, there is no suggestion in the available data that Adriamycin plus Cytoxan increased survival either in the overall population or in the subset of patients with squamous histology. Initial performance status, metastatic disease symptoms, primary disease symptoms, and weight loss were significantly correlated to survival time, and are recommended as stratification factors in future studies.
