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Irinotecan plus docetaxel in previously treated non-small cell lung cancer (NSCLC): An Alpe Adria Thoracic Oncology Multidisciplinary group phase II study (ATOM 007).

7363 Background: Two phase III trials have demonstrated an improvement in survival with docetaxel compared to other single-agents or best supportive care in previously treated NSCLC patients. Still, the combination of docetaxel with another active agent may be feasible and provide further improvement. In vitro studies have demonstrated the synergistic cytotoxicity of irinotecan followed by docetaxel; previous phase I/II studies have assessed the feasibility of this combination in several tumor types.


METHODS
In this multicenter phase II study, we evaluated the activity and toxicity of irinotecan (160 mg/sqm iv d1) plus docetaxel (65 mg/sqm iv d1) in relapsed or progressing NSCLC patients. Cycles were repeated every 3 weeks up to a maximum of 6 courses. Eligibility criteria: age ≥ 18 yrs; ECOG PS 0-2; measurable disease (RECIST); no prior treatment with irinotecan or docetaxel; adequate hematologic, hepatic and renal function; brain metastases allowed. The impact of treatment on quality of life and tumor-related symptoms was assessed by the EORTC questionnaires QLQ-C30 and LC-13.


RESULTS
Thirty-nine patients have been enrolled. Patient characteristics: median age, 61 yrs (46-73); male/female, 29/10; ECOG PS 0/1/2, 13/20/6 patients; adenocarcinoma 36%, squamous cell carcinoma 31%; previous platinum-based treatment, 95%; previous paclitaxel-containing treatment, 46%. One-hundred and sixteen cycles have been given (median 2, range 1-6). Thirty-seven patients are evaluable for toxicity. Grade 3-4 toxicities include 59% neutropenia, 10% anemia, 24% neutropenic fever, 32% diarrhea; 16% nausea/vomiting, 16% fatigue. There has been PR in 3 patients (8%); SD in 11 patients (30%); PD in 13 patients (35%). Median time to progression is 2.7 months; median survival (MST) is 8.4 months. Compliance with quality of life assessment is high (79%).


CONCLUSIONS
The combination of irinotecan and docetaxel has an acceptable toxicity profile in previously treated NSCLC patients. Although response rate is low, disease stabilization occurred in 30% of patients and an encouraging MST has been observed. No significant financial relationships to disclose.