Randomized phase II study of cyclophosphamide, doxorubicin, and vincristine compared with single-agent carboplatin in patients with poor prognosis small cell lung carcinoma

BACKGROUND. Information on the effect of chemotherapy in a group of patient s with poor prognosis, poor performance status small cell lung carcinoma (S CLC) is scarce. A randomized study comparing single-agent carboplatin with combination chemotherapy in this largely unreported population of SCLC pati ents was undertaken. METHODS. One hundred nineteen patients were allocated to four cycles of eit her cyclophosphamide, doxorubicin, and vincristine (CAV) or single-agent ca rboplatin. Patients had either a Karnofsky performance score less than or e qual to 50 and/or a prognostic score indicative of a 1-year survival rate l ess than or equal to 15%. RESULTS. Grade 3-4 neutropenia and intravenous antibiotic use were signific antly more common with the CAV regimen (P < 0.005). Conversely, Grade 3-4 t hrombocytopenia was more common (P < 0.0009) and platelet transfusion was m ore frequent (P < 0.05) with carboplatin therapy. Nonhematologic toxicity w as similar in both treatment arms, except for alopecia with CAV therapy (P < 0.0007). Symptom relief occurred in 48% and 41% of patients in the CAV an d carboplatin treatment arms, respectively. Dyspnea was improved in 66% and 41% of patients and cough was improved in 21% and 7% of patients in the CA V and carboplatin treatment arms, respectively. CAV therapy produced a high er response rate than carboplatin (38% vs. 25%), but this was not statistic ally significant (P = 0.15). The median overall survival for patients in th e CAV and carboplatin treatment arms was 17 weeks and 15.9 weeks, respectiv ely, with 1-year survival rates of 12% and 6%. CONCLUSIONS. Single-agent carboplatin is a feasible treatment in patients w ith poor prognosis SCLC and produces response rates, relief of tumor-relate d symptoms, and survival similar to what is seen in patients who receive CA V chemotherapy. The lower risk of life-threatening sepsis and less need for hospitalization or intravenous antibiotic courses is advantageous in this susceptible patient population. Cancer 2001;92:601-8. (C) 2001 American Can cer Society.