Randomized Phase II Trial of Carboplatin Combined with Weekly Paclitaxel (CWP) and Docetaxel Alone (D) in Elderly Patients with Advanced Non-Small-Cell Lung Cancer (NSCLC): NJLCG 0801

ABSTRACT Background Standard first-line chemotherapy for elderly NSCLC patients has been considered as a monotherapy with vinorelbine or gemcitabine globally. However, we have demonstrated the high efficacy of CwP for elderly patients in our previous trial (Ann Oncol 2010). Meanwhile, D has been considered as an alternative option for this population in Japan according to the result of WJTOG9904 (JCO 2006). Thus we compared the two regimens to select the proper candidate for future phase III trial. Methods Eligible patients were aged 70 years or older with newly diagnosed stage IIIB/IV NSCLC; ECOG performance status 0-1; adequate organ function; written informed consent. Patients were randomized to receive carboplatin (AUC 6) on day 1 and paclitaxel (70 mg/m2 on day 1, 8, and 15) every 4 weeks or D (60 mg/m2 on day 1) every 3 weeks. The primary end point was overall response rate (ORR), and secondary end points were progression-free survival (PFS), overall survival, and toxicity profile. Assuming that the ORR of 40% would be potential usefulness while the ORR of 20% would be the lower limit of interest, 40 patients in each arm were required if we expect 10% loss to follow-up. Results Between July 2006 and September 2010, 84 patients were enrolled and 41 patients in CwP arm and 42 patients in D arm were eligible (median age, 76 years; 75% male; 72% stage IV). Median treatment cycle was four in each arm (CP, range 1–6; D, range 1–8). ORRs were 51% (95% CI: 36–66%) and 26% (95% CI: 12–39%) in the CP and D arm, respectively. With a median follow-up of 18.4 months, median PFS were 6.5 and 3.9 months in the CP and D arm, respectively. Grade 3 or severer toxic effects were as follows: neutropenia (CP, 56% and D, 79%), anemia (CP, 15% and D, 7%), thrombocytopenia (CP, 10% and D, 0%), infection (CP, 20% and D, 25%). One treatment-related death occurred in D arm (neutropenia, pneumonia, and lethal arrhythmia in the same patient) and none in CP arm. Conclusions The platinum doublet CwP achieved higher activity with an acceptable toxicity profile for elderly patients with advanced NSCLC compared with monotherapy with D, which is consistent with the result of recent IFCT-0501 trial (Lancet 2011).