Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 19046
© 2008 American Society of Clinical Oncology

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Abstract

Randomized, phase II trial comparing carboplatin (C) and tri-weekly paclitaxel (tP) with C and weekly paclitaxel (wP) in elderly patients (pts) with advanced non-small cell lung cancer (NSCLC)

North Japan Lung Cancer Study Group; Miyagi Cancer Center, Natori, Japan; Tohoku University Hospital, Sendai, Japan; Sendai Kousei Hospital, Sendai, Japan; School of Medicine, Fukushima Medical University, Fukushima, Japan; Kanto Medical Center NTT-EC, Tokyo, Japan; Tohoku Kousei-nenkin Hospital, Sendai, Japan; Senseki Hospital, Yamoto, Japan; Osaki Citizen Hospital, Osaki, Japan

19046

Background: The appropriate platinum doublet regimen for elderly pts with advanced NSCLC is still matter of debate. Although previous randomized trial failed to show a survival benefit of C + wP against standard C + tP in advanced NSCLC, less toxic profile of C + wP may be favorable for elderly population. This elderly specific, randomized phase II study was conducted to evaluate the efficacy and safety of C + tP and C + wP for future large scale trials. Methods: Previously untreated elderly (70 years old) pts with advanced NSCLC were randomized to receive C (AUC 6, day1) + tP (200 mg/m², day1) or C (AUC 6, day1) + wP (70 mg/m², day1, 8, 15). The primary endpoint was overall response rate (ORR), and secondary endpoints were progression-free survival (PFS) and toxicity profile. Assuming that ORR of 40% in eligible pts would indicate potential usefulness while ORR of 20% would be the lower limit of interest, with alpha = 0.05 and beta = 0.20, the estimated accrual was 36 pts in each arm. Results: From November 2004 to June 2007, 82 pts were enrolled from 12 institutions. All the pts were evaluable for safety and 81 pts were evaluable for efficacy. Patient characteristics were: Male/Female 69/13; median age 75 (range 70–87); Performance status 0/1 42/40; Stage IIIB/IV/postoperative recurrence 26/47/9. The median numbers of treatment cycles were 3 (range 1–6) in both arms. ORRs and disease control rates were 53% (95%CI: 38–68) and 88% for tP arm, and 55% (95%CI: 40–70) and 91% for wP arm. Median PFS on tP arm was 4.3 months and on wP arm was 4.9 months. Grade 3 peripheral neuropathy was observed only in tP arm (25%). Grade 3/4 neutropenia and febrile neutropenia were more frequent in tP arm (88% and 10%) than wP arm (41% and 2%). One treatment related death due to interstitial lung disease was observed in wP arm. Conclusions: C and wP is similarly effective and less toxic than C and tP in this study. Further evaluation of this regimen for elderly population with advanced NSCLC is warranted

No significant financial relationships to disclose.