Phase II Study of Vinorelbine in Heavily Previously Treated Small Cell Lung Cancer

Abstract

Twenty-four previously treated patients with refractory or relapsed small cell lung cancer (SCLC) were entered into a prospective, multicenter phase II study. All 24 patients had been pretreated with some form of cisplatin-based chemotherapy. The median time of chemotherapy was 4.2 months (range 1.4–9.4 months). Patients were treated with a dose of 25 mg/m² of vinorelbine weekly. Twenty-four patients were eligible for response and for toxicity. Partial response was observed in 3 out of 24 eligible patients (12.5%; 95% confidence interval, 2.7–32.4%). All 3 patients who responded had previous chemotherapy including vincristine. The most common toxicity was leukopenia (91.7%, 66.7% in WHO 3-4 grade) and anemia (70.8%, 20.8% in WHO 3 grade). Nonhematological toxicities were moderate and mild. These results support a two-stage sequential study design of previously untreated patients for further phase II study in SCLC.

Retrospective analysis of efficacy and safety of amrubicin in refractory and relapsed small-cell lung cancer

“…A randomized phase III trial comparing topotecan chemotherapy to best supportive care demonstrated signifi cant prolongation Several reports have been made on single-agent activity for newer chemotherapeutic agents, including irinotecan, [20][21][22] topotecan, 23 paclitaxel, 24,25 docetaxel, 26 gemcitabine, 27,28 and vinorelbine, 29,30 in the second-line setting. However, few single agents can elicit a good response in patients with early relapse or disease progression during treatment.…”

Current standards for clinical management of small cell lung cancer

“…However, multiple other chemotherapies have shown activity comparable to topotecan in the second-line setting, including irinotecan (50), paclitaxel (51,52), docetaxel (53), gemcitabine (54,55), vinorelbine (56,57), and temozolomide (58,59). Regardless of the cytotoxic regimen used, patients with "sensitive" disease (relapse >90 days after completion of first line therapy) overall have better outcomes than patients with "refractory" disease.…”

Treatment of extensive-stage small cell lung carcinoma: current status and future prospects

“…Several other cytotoxic agents, including taxanes, gemcitabine, vinorelbine, irinotecan and pemetrexed, have been investigated as second-line treatment, in either single-agent or combination treatment (table 3) [41,65,[76][77][78][79][80][81][82][83][84][85][86][87][88][89][90]. Some agents, such as paclitaxel and irinotecan, have shown some degree of activity in phase II trials.…”