INTRODUCTION: Adjuvant cisplatin-based chemotherapy improves overall survival; however, chemotherapy compliance has been difficult. Carboplatin (C) is better tolerated than cisplatin, and carboplatin-based adjuvant therapy may have better chemotherapy compliance. METHODS: The primary end point of this multicenter phase II trial was the feasibility of delivering carboplatin and docetaxel (C/D). An "adequate exposure" was defined as receiving four cycles of C/D within 12 weeks of initiating adjuvant therapy. A sample size of 72 patients provided 88% power to detect a true adequate exposure of rate of at least 80%. Patients with resected non-small cell lung cancer, a good functional status, and preserved organ function were eligible. Adjuvant therapy was initiated between 2 and 8 weeks after surgery, and consisted of four cycles C (area under the curve = 6), and D 75 mg/m every 3 weeks. RESULTS: Seventy-two patients were treated, and the patient demographics were: median age 65 years (range 47-84), gender male/female 67%/33%, stage I (40%), II (36%) IIIA (22%) and IIIB (1%), and the two most common histologies were: adenocarcinoma (44%), and squamous cell carcinoma (42%). Fifty-seven patients (79%) received four cycles within 12 weeks, and 15 (21%) of patients did not complete four cycles for the following reasons: adverse events (n = 5), patient refusal (n = 5), disease progression during active therapy (n = 3), and intercurrent illness (n = 2). No treatment related deaths were observed and the primary toxicities were hematologic (grade 4 neutropenia 42% and febrile neutropenia 11% of patients). Twenty-six patients (36%) received growth colony stimulating factor (G-CSF) supportive therapy during their treatment, and G-CSF supportive therapy was used in 21.6% of all cycles. CONCLUSIONS: C/D has an acceptable toxicity profile with the use of G-CSF supportive therapy and the majority of patients completed four cycles of therapy within 12 weeks.
INTRODUCTION: Adjuvant cisplatin-based chemotherapy improves overall survival; however, chemotherapy compliance has been difficult. Carboplatin (C) is better tolerated than cisplatin, and carboplatin-based adjuvant therapy may have better chemotherapy compliance. METHODS: The primary end point of this multicenter phase II trial was the feasibility of delivering carboplatin and docetaxel (C/D). An "adequate exposure" was defined as receiving four cycles of C/D within 12 weeks of initiating adjuvant therapy. A sample size of 72 patients provided 88% power to detect a true adequate exposure of rate of at least 80%. Patients with resected non-small cell lung cancer, a good functional status, and preserved organ function were eligible. Adjuvant therapy was initiated between 2 and 8 weeks after surgery, and consisted of four cycles C (area under the curve = 6), and D 75 mg/m every 3 weeks. RESULTS: Seventy-two patients were treated, and the patient demographics were: median age 65 years (range 47-84), gender male/female 67%/33%, stage I (40%), II (36%) IIIA (22%) and IIIB (1%), and the two most common histologies were: adenocarcinoma (44%), and squamous cell carcinoma (42%). Fifty-seven patients (79%) received four cycles within 12 weeks, and 15 (21%) of patients did not complete four cycles for the following reasons: adverse events (n = 5), patient refusal (n = 5), disease progression during active therapy (n = 3), and intercurrent illness (n = 2). No treatment related deaths were observed and the primary toxicities were hematologic (grade 4 neutropenia 42% and febrile neutropenia 11% of patients). Twenty-six patients (36%) received growth colony stimulating factor (G-CSF) supportive therapy during their treatment, and G-CSF supportive therapy was used in 21.6% of all cycles. CONCLUSIONS: C/D has an acceptable toxicity profile with the use of G-CSF supportive therapy and the majority of patients completed four cycles of therapy within 12 weeks.