Early death during chemotherapy in patients with small-cell lung cancer: derivation of a prognostic index for toxic death and progression

Based on an increased frequency of early death (death within the first trea tment cycle) in our two latest randomized trials of combination chemotherap y in small-cell lung cancer (SCLC), Mle wanted to identify patients at risk of early non-toxic death (ENTD) and early toxic death (ETD). Data were sto red in a database and logistic regression analyses were performed to identi fy predictive factors for early death. During the first cycle, 118 out of 9 37 patients (12.6%) died. In 38 patients (4%), the cause of death was sepsi s. Significant risk factors were age, performance status (PS), lactate dehy drogenase (LDH) and treatment with epipodophyllotoxins and platinum in the first cycle (EP). Risk factors for ENTD were age, PS and LDH. Extensive sta ge had a hazard ratio of 1.9 (P = 0.07). Risk factors for ETD were EP, PS a nd LDH, whereas age and stage were not. For EP, the hazard ratio was as hig h as 6.7 (P = 0.0001). We introduced a simple prognostic algorithm includin g performance status, LDH and age. Using a prognostic algorithm to exclude poor-risk patients from trials, we could minimize early death, improve long -term survival and increase the survival differences between different regi mens. We suggest that other groups evaluate our algorithm and exclude poor prognosis patients from trials of dose intensification.