Second-line weekly paclitaxel in patients with inoperable non-small cell lung cancer who fail combination chemotherapy with cisplatin.

UNLABELLED: This phase II study was designed to assess single-agent paclitaxel (Taxol), as second-line chemotherapy. ELIGIBILITY CRITERIA: pathological diagnosis of inoperable non-small cell lung cancer (NSCLC) relapsing or refractory to standard front-line platinum (P)-based chemotherapy, performance status < or = 3, normal lab tests, informed consent. Ineligibility criteria: history of second or third cancer (unless surgically cured), mental instability or impairment, pre-existing moderate/severe peripheral neuropathy, previous chemotherapy non-including cisplatin, and previous second-line chemotherapy. Paclitaxel was given by intravenous infusion at a dose of 100 mg/m2 every week, until completion of the treatment plan of 21 weeks, disease progression, persistent toxicity, or patient refusal. Thirty-eight patients (32 males) entered the study; median age was 63 years (range 44-74); cell types were: adenocarcinoma (20), squamous (14), large cell (4). Previous chemotherapies: P and vinorelbine (31 patients) and P, mitomycin C and vinblastine (7 subjects), followed by 21 objective responses. Two patients had one course of paclitaxel; six other patients had early treatment suspensions. The median number of weekly infusions was 12 (range 1-21); median dose-intensity was 75% of projected. Toxicity was generally mild, mainly neurological and never life threatening (only 2 grade 4 toxicity out of 468 pre-chemotherapy evaluations). Six patients obtained a partial response; 7 others showed some tumor regression, 3 had tumor stabilization, and 13 disease progression. From the start of paclitaxel, the estimated median time to progression was 20 weeks, the median survival 58 weeks. Second-line treatment with single-agent paclitaxel is well-tolerated, active, and associated to long survivals.