Paclitaxel and G-CSF in Previously Untreated Patients With Extensive Stage Small-Cell Lung Cancer

Abstract

Paclitaxel is an antimicrotubule agent that interferes with cell division. It has demonstrated promising single-agent activity against non-small-cell lung cancer. The purpose of this study was to evaluate the therapeutic effectiveness of paclitaxel in previously untreated patients with extensive stage small-cell lung cancer (SCLC). The study was designed as a two-stage phase II trial. All patients who entered received paclitaxel by intravenous infusion at a dose of 250 mg/m2 during 24 hours. Granulocyte colony stimulating factor was also provided to ameliorate neutropenia. Cycles were repeated at 21-day intervals. Patients who achieved a complete response received a maximum of 10 cycles of treatment, whereas those who achieved a partial response/regression continued treatment until progression or undue toxicity developed. Patients who progressed or maintained stable disease for six cycles were crossed over to cisplatin and etoposide. Forty-three patients entered the study and all were evaluable for analysis. Responses were observed in 23 (53%) of the patients. There was no significant difference in the response rates in patients with measurable or evaluable disease (13/23 versus 10/20, p = 0.76). At the time of analysis, 39 patients had progressed with a median time to progression of 95 days, and 39 patients had died with a median survival of 278 days. The 1-year achieved survival rate was 24%. Significant neutropenia (absolute neutrophil count <1,000/microl) occurred in 24 (56%) of the patients, but only 2 patients experienced severe infection (grade > or = 3), and there were no septic deaths. The results indicate that paclitaxel is active against SCLC. Myelosuppression was the main side effect in this patient population. Response duration was short (median = 3.4 months), which suggests that paclitaxel is not sufficient as a single agent. Further studies of paclitaxel in combination with other agents against SCLC are currently in progress within the North Central Cancer Treatment Group and other cancer treatment groups. Key Words: Paclitaxel-G-CSF-Small-cell lung cancer-North Central Cancer Treatment Group.

Concurrent chemotherapy (carboplatin, paclitaxel, etoposide) and involved-field radiotherapy in limited stage small cell lung cancer: a Dutch multicenter phase II study

“…The study actually enrolled 38 patients in three years and it was decided to halt the trial because of the highly positive experience with this concurrent chemo-radiotherapy. This decision was also weighed by data from other studies (Kirschling et al, 1999;Thomas et al, 2001). Survival was analysed using a Kaplan Meier curve.…”

A phase II study of paclitaxel in heavily pretreated patients with small-cell lung cancer

“…In addition, it has shown considerable anti-tumour activity in chemotherapy naive patients with SCLC (Kirschling et al, 1994;Ettinger et al, 1995). Therefore, we initiated a phase II trial of paclitaxel (taxol) in patients with clinically resistant SCLC, which is the subject of this report.…”

Epirubicin/paclitaxel/etoposide in extensive-stage small-cell lung cancer: a phase I–II study

“…This drug showed encouraging single-agent activity as second-line treatment: in patients with ED pretreated with CDE as first-line combination, single-agent paclitaxel showed an overall response rate of 29%, which is at the upper level of activity for any single agent in this setting (Smit et al, 1998). An interesting activity was also observed in untreated patients; in the Eastern Cooperative Oncology Group (ECOG) phase II study a 34% remission rate and a 43-week median survival were observed (Ettinger et al, 1995); the North Central Cancer Treatment Group (NCCTG) also reported a 53% response rate in 43 untreated patients (Kirschling et al, 1999). These phase II studies, evaluating the activity of paclitaxel in ED -SCLC, provided the basis for inclusion of this drug in polichemotherapy regimens.…”