Abstract
BackgroundBasic research of gefitinib (Iressa, ZD1839) has demonstrated the combination effects of gefitinib and chemotherapy were sequence-dependent. To evaluate the efficacy of sequential administration of gefitinib following a minor response or partial response to two to three cycles of chemotherapy, a phase II clinical trial was done in Chinese patients with advanced non-small-cell lung cancer (NSCLC).MethodsThirty-three consecutive patients with advanced NSCLC that had been pretreated with at least one chemotherapeutic regimen and were responding to chemotherapy following 2 to 3 cycles of treatment, entered the trial from May 2004 to February 2006. Patients received gefitinib at an oral dose of 250 mg once daily for 4 weeks.ResultsThirty-three patients were evaluable for response and toxicity. The objective response rate was 24.2% (8 of 33)(95% CI, 11% to 42%). The symptom improvement rate was 54.5% (18 of 33) (95% CI, 41% to 69%). The median duration of response was 7 months (95%CI, 4.0 to 13.2 months). The median time to disease progression (TTP) was 6.5 months (95%CI, 0.7 to 16.6 months). The median overall survival time (OS) was 9.8 months (range, 2.1 to 18.0 months), and the actuarial 1-year survival was 36.4%. Toxicity was relatively mild and included only one patient (3.0%) with grade 4 diarrhea, 1 (3.0%) with grade 3 rash, 1 (3.0%) with grade 3 nausea, and 1 with grade 3 vomiting (3.0%).ConclusionPreliminary results suggest that sequential administration of gefitinib following a response to chemotherapy may be beneficial for Chinese patients with advanced NSCLC. Further randomized clinical trials are needed.
Highlights
Basic research of gefitinib (Iressa, ZD1839) has demonstrated the combination effects of gefitinib and chemotherapy were sequence-dependent
Two combination trials with gefitinib, INTACT 1 and 2, counting over 2,000 enrolled patients, failed to demonstrate any improvement in overall survival (OS), time to disease progression (TTP), and response rates (RR) with the gefitinib combination compared to standard chemotherapy [11,12]
Patients were older than 18 years of age, and had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 3, a life expectancy of 12 weeks or longer, a WBC count ≥ 3.0 × 109/L, platelet count ≥ 100 × 109/L, bilirubin less than 1.5-fold of the upper limit of normal (ULN), ALT or AST less than three-fold of the upper limit of institutional reference value, and a calculated creatinine clearance rate of more than 45 mL/min
Summary
Basic research of gefitinib (Iressa, ZD1839) has demonstrated the combination effects of gefitinib and chemotherapy were sequence-dependent. To evaluate the efficacy of sequential administration of gefitinib following a minor response or partial response to two to three cycles of chemotherapy, a phase II clinical trial was done in Chinese patients with advanced non-small-cell lung cancer (NSCLC). Second line treatment options, including docetaxel, pemetrexed, and erlotinib, have been approved in the United States for patients who failed to platinum-based chemotherapy, but they have limited efficacy and potentially considerable toxicity [5,6]. Two combination trials with gefitinib, INTACT 1 and 2, counting over 2,000 enrolled patients, failed to demonstrate any improvement in overall survival (OS), time to disease progression (TTP), and response rates (RR) with the gefitinib combination compared to standard chemotherapy [11,12]. Based on our clinical experience, response is usually apparent after the initial two to three cycles of chemotherapy
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