Phase II study of doxorubicin and paclitaxel as second-line chemotherapy of small-cell lung cancer - A Hoosier Oncology Group Trial

Forty-six evaluable patients with recurrent small-cell lung cancer were ent ered on a phase II Hoosier Oncology Group (HOG) protocol evaluating bolus d oxorubicin 40 mg/m(2) followed by paclitaxel 175 mg/m(2) over 3 hours. Cour ses were repeated every 3 weeks for a maximum of 6 courses. Therapy was wel l-tolerated with grade III neurotoxicity in 5 patients (11%), grade III/IV emesis in 5 (11%), and grade III mucositis in 2 patients. One patient had g rade IV myalgias and one patient had grade III cardiotoxicity. The main tox icity was myelosuppression. Twenty-nine patients (63%) had grade IV and 8 ( 17%) grade III granulocytopenia. Nine patients (20%) were hospitalized for granulocytopenic fever. There was no treatment-related mortality. Nineteen of 46 patients (41%) had an objective response, including 3 complete remiss ions. Two of 14 patients with refractory disease (progression less than 3 m onths after initial therapy) responded, compared to 17 of 32 (52%) with sen sitive disease (progression beyond 3 months of initial chemotherapy regimen ).