AI Article Synopsis

  • The phase I study evaluated the safety and effectiveness of gefitinib combined with vinorelbine or vinorelbine/cisplatin in patients with advanced non-small cell lung cancer (NSCLC) who hadn't received chemotherapy before.
  • Participants were divided into two groups, receiving either gefitinib with vinorelbine or with vinorelbine/cisplatin, with some variations in dosage.
  • Adverse effects were mostly consistent with what was expected from the individual treatments, but there was an alarming rate of severe hematologic side effects, leading to the conclusion that this combination therapy isn't a suitable option for treating advanced NSCLC.

Article Abstract

This phase I study assessed the safety, pharmacokinetics, and efficacy of gefitinib (IRESSA) combined with vinorelbine or vinorelbine/cisplatin in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC). Patients received gefitinib 250 mg/day and vinorelbine (group A; n = 6) or vinorelbine/cisplatin (group B; n = 8). An additional set of group B patients (n = 9) received gefitinib 500 mg/day with vinorelbine/cisplatin. Adverse events were consistent with individual treatments of gefitinib (mild reversible rash, diarrhea) and chemotherapy (asthenia, fever, nausea, vomiting, constipation), although there was a higher than expected incidence of Common Toxicity Criteria grade 3 or 4 hematologic adverse events, specifically febrile neutropenia and neutropenia. Pharmacokinetic data suggested that neither of the chemotherapy regimens affected steady-state exposure to gefitinib and also that steady-state gefitinib did not alter exposure to vinorelbine or cisplatin. Objective, durable antitumor activity was observed: five partial responses (one in group A; four in group B) and six patients with stable disease (all in group B). The safety data demonstrated that gefitinib with vinorelbine or vinorelbine/cisplatin resulted in severe myelosuppression leading to an unacceptable rate of febrile neutropenia. This study does not support the concurrent administration of gefitinib and vinorelbine, with or without cisplatin, as a valid treatment for advanced NSCLC.

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