1301P - Final analysis of randomized phase II trial of carboplatin combined with weekly paclitaxel (CP) and docetaxel alone (D) in elderly patients (pts) wi...

Date 29 September 2012
Event ESMO Congress 2012
Session Poster presentation I
Topics Anti-Cancer Agents & Biologic Therapy
Non-Small-Cell Lung Cancer, Metastatic
Presenter Toshiyuki Harada
Authors T. Harada1, M. Maemondo2, S. Sugawara3, A. Inoue4, K. Usui5, M. Ando6, N. Morikawa7, Y. Mori8, A. Gemma9, T. Nukiwa10
  • 1Hokkaido Social Insurance Hospital, 062-8618 - Sapporo/JP
  • 2Department Of Respiratory Medicine, Miyagi Cancer Center, 981-1293 - Natori/JP
  • 3Department Of Respiratory Medicine, Sendai Kousei Hospital, Sendai/JP
  • 4Department Of Respiratory Medicine, Tohoku University, JP-980-8575 - Sendai/JP
  • 5Division Of Respirology, NTT Medical Center Tokyo, Tokyo/JP
  • 6Division Of Internal Medicine, Tsuboi Cancer Center Hospital, Kooriyama/JP
  • 7Department Of Medical Oncology, Tohoku Kosei Nenkin Hospital, Sendai/JP
  • 8Division Of Respiratory Medicine, Iwate Prefectural Central Hospital, Morioka/JP
  • 9Nippon Medical School, Tokyo/JP
  • 10President, South Miyagi Medical Center, Miyagi/JP

Abstract

Background

Standard first-line chemotherapy for elderly NSCLC pts has been considered as a monotherapy with vinorelbine or gemcitabine. D has been considered as an alternative option for this population in Japan (WJTOG9904, JCO 2006). Meanwhile, we have shown the high efficacy of CP for elderly pts (NJLCG0403, Ann Oncol 2010). Thus we compared the two regimens to select a proper candidate for future phase III trial.

Methods

Eligible pts were aged 70 years or older with newly diagnosed stage IIIB/IV NSCLC; ECOG performance status 0-1; adequate organ function; written informed consent. Pts were randomized to receive carboplatin (AUC 6) on day 1 and paclitaxel (70mg/m2 on day 1, 8, and 15) every 4 weeks or D (60mg/m2 on day 1) every 3 weeks. The primary endpoint was overall response rate (ORR), and secondary endpoints were progression-free survival (PFS), overall survival, and toxicity profile. Assuming that ORR of 40% would be potential usefulness while ORR of 20% would be the lower limit of interest, 40 pts in each arm were required if expect 10% loss to follow up.

Results

Between July 2006 and September 2010, 84 pts were enrolled and 41 pts in CP arm and 42 pts in D arm were eligible (median age, 76 years; 75% male; 72% stage IV). Median treatment cycle was 4 in each arm (CP, range 1-6; D, range 1-8). ORRs were 54% (95%CI: 39-69%) and 24% (95%CI: 11-37%) in the CP and D arm, respectively. With a median follow-up of 27.6 months, median PFS were 6.6 and 3.5 months in the CP and D arm, respectively (P = 0.0005) and median survival time were 14.3 and 13.8 months in the CP and D arm, respectively (P = 0.24). Grade 3 or severer toxicities 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 due to neutropenia, pneumonia, and lethal arrhythmia occurred in D arm.

Conclusions

The platinum doublet CP achieved higher activity with less toxicity profile for elderly pts with advanced NSCLC compared to monotherapy with D. The superiority of CP to the monotherapy in this trial is consistent with results of recent IFCT-0501 trial (Lancet 2011).

Disclosure

M. Maemondo: Makoto Maemondo receives honoraria from Sanofi.

S. Sugawara: Shunichi Sugawara receives honoraria from Sanofi.

A. Inoue: Akira Inoue receives honoraria from Sanofi.

All other authors have declared no conflicts of interest.